JP6574313B2 - Intragastric device for the treatment of obesity - Google Patents

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of US patent application Ser. No. 14 / 862,706 entitled “Intragastric Device for Treating Obesity” filed on September 23, 2015. Claimed priority based on US Provisional Patent Application No. 62 / 158,406 filed with the same title on the same day and US Provisional Patent Application No. 62 / 054,230 filed with the same title on September 23, 2014 To do.

  US patent application Ser. No. 14 / 862,706 is also a continuation-in-part of US patent application Ser. No. 14 / 214,609, entitled “Intragastric Device for Treating Obesity” filed on Mar. 14, 2014. US Provisional Patent Application No. 61 / 884,981 entitled “Gastrointestinal Device for Treating Obesity” filed September 30, 2013, and “Intragastric Device for Treating Obesity” filed March 14, 2013 Claims priority based on US Provisional Patent Application No. 61 / 782,564.

Further, US patent application No. 14 / 214,609 is a continuation-in-part of US patent application Ser. No. 14 / 096,505 filed Dec. 4, 2013, entitled “Intragastric Device for Treating Obesity”. , A continuation of US patent application Ser. No. 12 / 814,481, filed Jun. 13, 2010 and issued as US Pat. No. 8,628,554 on Jan. 14, 2014. .
All of the above applications are incorporated herein by reference in their entirety.

  The present description relates generally to medical devices useful in the treatment of obesity. In particular, the present specification provides a dynamic weight stomach that reduces stomach volume, delays emptying the stomach, and / or provides a detour in a portion of the small intestine, thereby reducing patient weight. Relates to internal and gastrointestinal devices.

  Obesity is a common disease in developed countries, including the United States, and is a growing public health problem. As of 2009, approximately 127 million, more than two-thirds of US adults, were overweight or obese. Over one-third of US adults are obese. According to the data, 300,000 Americans die each year from complications associated with obesity. Many children in the United States are also overweight or obese. Thus, the total number of overweight Americans is expected to increase in the future. It is estimated that obesity directly and indirectly costs more than $ 100 billion annually in the United States, reducing productivity. This trend is also evident in many other developed countries.

In the case of an adult, a body mass index (BMI) is used to determine whether the person is overweight or obese. A person's BMI is calculated by multiplying the weight in pounds by 703 and dividing the sum by the square of the height in inches. A person's BMI is expressed as kilograms per square meter. In adults, a BMI of 25-30 kg / m ² is considered overweight. Obesity is defined as BMI is 30-40 kg / ^{m 2.} When BMI exceeds 30 kg / m ² , it is said to be associated with serious comorbidities. Morbid obesity is defined as having a body weight that is 100 pounds higher than ideal or a BMI higher than 40 kg / m ² . About 5% of Americans meet at least one of the criteria for morbid obesity. Morbid obesity is associated with many illnesses and disorders. Such diseases and disorders include, for example, diabetes; hypertension; heart attack; stroke; dyslipidemia; sleep apnea; pickwick syndrome; asthma; lumbar and disc disease; And osteoarthritis of the legs; thrombophlebitis and pulmonary embolism; interstitial dermatitis; stress urinary incontinence; gastroesophageal reflux disease (GERD); gallstones; It is done. In women, in addition, infertility, uterine cancer, and breast cancer are associated with morbid obesity. In summary, diseases related to morbid obesity significantly reduce the probability of reaching life expectancy. These sequelae increase the annual mortality of affected individuals more than 10 times.

  Current treatments for obesity include diet, exercise, behavioral therapy, medication, surgery (laparotomy and laparoscopic surgery), and endoscopic devices. New drug treatments for obesity are currently being evaluated in clinical trials. However, highly effective drug treatment has not yet been developed. In addition, the short and long-term side effects of current medications are a concern for consumers, drug providers, and / or insurance companies. In general, diet or medication regimens are consistently disappointing and cannot provide significant and sustained weight loss for most morbidly obese people.

  Currently, most surgeries used to treat morbid obesity involve gastric restriction procedures. This includes forming a small (eg, 15-35 ml) gastric pouch above. This gastric sac drains (food) from a small drainage hole (e.g., 0.75-1.2 cm), triggering the body's fullness mechanism. About 15% of the operations used to treat morbid obesity in the United States involve a combination of gastric restriction treatment and malabsorption treatment. The usual malabsorption procedure divides the flow into the small intestine into the bile and pancreatic ducts and the food tube. Long-term side effects that can occur in connection with abdominal surgery include hernia formation and small bowel obstruction. Long-term problems unique to obesity treatment also include gastric outlet obstruction, terminal ulcers, protein malnutrition, and vitamin deficiencies.

  Other surgical measures for treating obesity include endoscopic procedures, many of which are still under development. Laparoscopic procedures are repeated using an endoscopic procedure in which a gastric pouch is provided to perform gastrojejunostomy and an endoscopic device. An intragastric balloon placed using an endoscopic instrument limits the volume of the stomach, resulting in a feeling of fullness with fewer meals. For example, U.S. Patent Application No. 10 / 221,562, issued as U.S. Patent No. 7,172,613 and granted to Districlass Medical SA, describes "inserting into the patient's stomach via the endoscopic route. Intragastric device "is described. According to the above specification, “the device comprises a balloon or envelope having a specific nominal volume. The balloon is airtightly connected to a connecting member, which supports the balloon against the inner wall of the stomach. The device also includes a flexible tube or catheter that connects the balloon to the filling device, and a capture member that is integral with the tube or catheter, which allows the physician to Can set or remove the balloon, fix the filling device in or under the patient's body, and make the balloon or envelope to its predetermined nominal volume. "

  Silicone intragastric balloons (IGB) weighed over 40% of the ideal body weight and were not obese and did not provide satisfactory treatment results despite being treated by a multidisciplinary team. Developed for temporary assistance to achieve weight loss for humans. This treatment is also desirable for morbidly obese patients with severe morbidity and high risk of mortality from surgery. IGB placement and removal is an endoscopic procedure, and the balloon is designed to float freely inside the stomach. IGB technology reduces stomach volume and provides an early feeling of fullness. However, the IGB showed no convincing evidence for large weight loss. The relative risk for mild complications (eg gastric ulcers and gastric erosions) was greatly increased. All inflatable IGB devices have the problem of aging of the balloon. This deterioration may cause the balloon to contract and lose its efficacy, and may cause complications such as small bowel obstruction as the balloon moves. IGB devices are recommended only for a short period (less than 6 months) due to loss of efficacy over time. Also, if the balloon suddenly expands, there is a risk of puncture in the esophagus or stomach, both of which are surgical emergencies. Deaths from patients who have received IGB treatment have been reported.

  Endoscopic procedures are used to deploy mesh structures within the stomach in an attempt to occupy the stomach volume and provide an artificial satiety. For example, US patent application Ser. No. 11 / 657,231, granted to Wilson-Cook Medical, Inc., “Generally, a string-like, digestion resistant, operable between a first configuration and a second configuration. Intragastric device comprising a mesh material ”. According to this specification, “the first configuration is small enough to allow the digestion resistant mesh material to be introduced into the stomach lumen of a mammal. The second configuration is the digestion resistance. It is large enough to prevent the mesh material from passing through the mammalian pylorus, thereby allowing the mesh member to act as an artificial gastrolith. "

  A balloon structure placed with an endoscopic device may be effective, but is not without its associated risks and complications. The mesh structure is effective in occupying the available stomach volume, but does not address emptying the stomach. Migration and small bowel obstruction from such devices remains a major problem. Therefore, there is a need for an intragastric device that combines the benefits obtained by reducing stomach volume, delaying emptying of the stomach, diverting food from the pylorus and parts of the small intestine, while remaining relatively safe. is there. The device must also include components to prevent the entire device from moving outside the stomach. This device should have limited side effects and should be relatively easy to deploy or remove in a non-invasive manner. The device must also have additional obesity treatment options by including the benefits gained by bypass treatments that cause malabsorption. Adding the benefits of this option would be an effective device for treating type II diabetes as well as obesity.

  Normal metal structures cannot withstand the harsh environment of the stomach, especially in high acidity. Intragastric devices that include acid-sensitive components such as metal wires are typically coated or coated with an acid resistant material (or silicone) to prevent degradation of these components by the contents of the acid stomach. In the conventional manufacturing process for making these coated intragastric devices, the metal wire of the device is first coated and then the metal wire is formed into the desired final shape of the device. Due to the more complex shape and structure of intragastric devices, these conventional processes cannot accurately produce the desired final product. Shape memory metals such as Nitinol are heat-set at temperatures above 400 ° C. If the metal is coated with an acid resistant material and finalized by heat setting, the coating will break during exposure to high temperatures. Therefore, there is a need for a manufacturing method in which the metal wire of the intragastric device is first formed into the desired final shape and then coated with a corrosion resistant material. In such a method, care is taken to prevent the spaces or openings between the metal wires of the wire mesh from being coated and covered or clogged. In addition, a final device having sufficient flexibility can be manufactured even if the first pre-deployment shape compressed by such a method is converted into the expanded shape after expansion.

  Particular surgical options for the treatment of obesity also include laparoscopic sleeve gastrectomy (LSG) and laparoscopic rouwai gastric bypass (RGB). Gastrectomy refers to the removal of part or all of the stomach by surgery. LSG is a restrictive therapy and is a surgical weight loss treatment. In LSG, the stomach is greatly removed along a large vagina by surgery to reduce it to about 25% of its original size. The open edges are then joined together (often using surgical staples) to form a banana-like sleeve or tube. This procedure permanently reduces the size of the stomach. This procedure is performed by laparoscopic surgery and is not reversible. After surgery, the stomach quickly drains the contents to the small intestine, but there is little or no vomiting (other restrictive feature).

  LSG involves a longitudinal excision of the stomach on the large heel side, starting from the pyloric sinus, through the opposite side of the Latarjet nerve (pyloric sinus branch nerve) to the hiss angle. The first stage of treatment is to divide the blood supply of the stomach vaginal. This is accomplished by splitting the gastrocolic and gastrosplenic mesenteres close to the stomach. The vaginal cavity is completely dissected to the left leg of the diaphragm and the fundus that stores ghrelin-secreting cells in the stomach is removed. The second stage of the procedure is a longitudinal gastrectomy, which makes the stomach smaller and “sleeves” or thin tubes. A “restricted” stomach sleeve based on the gavel is obtained, leaving part of the pylorus and pyloric cave.

  Sleeve gastrectomy (also referred to as gastric sleeve) is usually performed in extremely obese patients with a body mass index of 40 or greater, but the risk of performing gastric bypass or duodenal switch conversion surgery may be too high. A two-step procedure is performed. The first stage is a sleeve gastrectomy and the second stage is a gastric bypass or conversion to duodenal conversion. Usually, the patient's excess weight is greatly reduced after the first stage sleeve gastrectomy, but if the weight loss stops, the second stage is performed.

  For patients who are obese but not extreme, only sleeve-like gastrectomy is an appropriate operation with the least risk. Sleeve gastrectomy is a weight loss surgery option currently accepted as a single treatment for obese patients. Most surgeons prefer to use a bougie (tapered tubular instrument) of 32-60 French (optimal bougie size is 32Fr-36Fr) in surgery. The ideal remaining volume of the stomach after surgery is approximately 15 ml.

  One of the mechanisms involved in weight loss after LSG is a dramatic decrease in stomach volume. The concept of restriction has been widely used in bariatric surgery in vertical zonal gastroplasty (VBG) and laparoscopic controlled gastric banding (LAGB). The expansion of the small gastric sac in LAGB treatment or VBG is intended to cause the early satiety, intense satiety and reduced feeling of hunger experienced by patients after ingesting small amounts of food.

  Hormonal fluctuations induced by LSG are different from those after pure restriction treatment such as LAGB. The peptide hormone ghrelin is mainly produced in the fundus but is thought to be involved in the fasting regulation mechanism. Ghrelin greatly decreases with removal of the fundus.

  LSG is the preferred option because it is a clear procedure that can usually be completed laparoscopically even in extremely obese patients. The risk of internal hernia is eliminated because no mesenteric defect occurs without any digestive system anastomosis. Moreover, no foreign substance is used as in the case of gastric banding, and the entire digestive tract remains in a state where it can be examined with an endoscope. In addition, there is no association with dumping syndrome. Also, the risk of peptic ulcer is low and the absorption of nutrients, vitamins, minerals and drugs remains unchanged.

  Early reports of LSG showed the safety and efficacy of LSG, significant weight loss, and a significant reduction in major obesity-related comorbidities. The question of whether LSG can function as a single long-term obesity treatment has not yet been answered. For this reason, duodenal switch conversion is due to very high BMI (super obesity = body mass index> 50 or ultra super obesity = body mass index> 60) and / or related diseases whether or not related to obesity. LSG is suggested as the first step in a step-by-step approach for patients with associated bile and pancreatic duct bypass (BPD-DS) or RGB that may be too dangerous.

  Laparoscopic Rouwai gastric bypass (RGB) involves a roux leg (usually, rerouting the small stomach (20-30 ml) and part of the digestive tract to bypass the distal stomach and the proximal small intestine. 75-105 cm). After RGB, multifaceted endocrine responses may contribute to improved glycemic control, loss of appetite, and long-term weight changes. RGB also has a very positive impact on obesity-related comorbidities and quality of life. Other benefits include long-term effectiveness of sustained weight loss, reduced comorbidities, minimized risk of long-term nutritional sequelae, and effective mitigation of gastroesophageal reflux disease (GERD). Can be mentioned. RGB is not without risk. Common causes of death include pulmonary embolism and anastomotic leakage. Non-fatal perioperative complications include suture failure, venous thromboembolism, wound infection, small intestinal obstruction, and bleeding. Postoperative gastrointestinal complications can include nausea and vomiting, micronutrient deficiencies, and weight rebound.

  Failure after these obesity treatments is common and patients begin to rebound in weight, or gradual weight loss stops at sub-therapeutic levels. Therefore, there is a need for salvage treatment after one or more failed obesity treatments. What is needed is a device used after bariatric surgery that combines the benefits of gastric volume reduction, biliary pancreatic bypass and / or bowel bypass to increase the weight loss effect of the device. There is also a need for a device that further reduces the volume of calories that can be consumed, further reducing the volume of the stomach that is limited by surgery. The device also bypasses the proximal small intestine or intestinal roul leg to achieve intestinal malabsorption, biliary pancreatic bypass, or both. The device can further act to delay emptying the stomach, release gastric hormones associated with satiety, and stimulate gastric nerves associated with feelings of fullness. This device may be combined with other therapeutic agents such as electrical stimulation, magnetic stimulation, or pharmaceuticals.

  This device can be used as the main therapeutic treatment for weight loss or as a bridge to surgery for the final weight loss treatment. The device may also be used to treat other conditions, such as, but not limited to, metabolic syndrome, diabetes mellitus, dyslipidemia, and cardiovascular disease.

  The present specification discloses an intragastric device adapted to be deployed in a person's stomach. The apparatus includes a housing and a catheter including a lumen having an inner diameter of 2 cm or less extending through the housing; a compression having a first volume of 110 ml or less and a first length of 75 cm or less within the lumen of the catheter. A first unfolded shape and a first unfolded shape defined by a first plurality of curved surfaces in the stomach of the person and having a second volume of 125 ml or more that is porous and closed; A wire mesh structure; a compressed undeployed shape separated from the first wire mesh structure and having a third volume of 100 ml or less and a second length of 70 cm or less within the lumen of the catheter. And a second wire mesh structure having an expanded, expanded shape having a fourth volume of 110 ml or more defined by a plurality of curved surfaces, porous and closed in the human stomach; and Second Formed between a portion of the first wire mesh structure defining the opening surface region and a portion of the second wire mesh structure defining the third opening surface region, the first wire mesh structure and the second wire mesh structure It includes a connection part for flexibly connecting the wire mesh structure. The first wire mesh structure further includes an upper portion and a lower portion, and the upper portion has a first opening surface region in which material enters from the outside of the second volume to the inside of the second volume. And the lower part has a second opening surface region, the second wire mesh structure further has an upper part and a lower part, and the upper part has a fourth volume from the outside of the fourth volume. It has a third open surface area that is adapted to receive material inside, and the lower part has a fourth open surface area.

  The first wire mesh structure and the second wire mesh structure may be continuously arranged in the lumen of the catheter.

  Optionally, at least one of the first plurality of curved surfaces is defined by an arc, the arc being determined by a radius in the range of 0.2 cm to 20 cm and a central angle in the range of 5 ° to 175 °.

  Optionally, at least one of the second plurality of curved surfaces is defined by an arc, the arc being determined by a radius in the range of 0.1 cm to 15 cm and a central angle in the range of 1 ° to 179 °.

  If necessary, the connecting portion includes a plurality of free end portions of the first wire mesh structure that defines the second opening surface region and a second wire mesh structure that defines the third opening surface region. And a plurality of free end portions.

  The first wire mesh structure and the second wire mesh structure may have at least one of a spherical shape and an elliptical shape.

  If necessary, the connecting portion includes a plurality of seams. Optionally, the plurality of seams have a first end attached to a first point on the second open surface area and a second end on the second open surface area. Including a first flexible seam attached to the point.

  The length of the connecting portion from the first point of the second opening surface region to the second point of the third opening surface region may be in the range of 0.01 mm to 200 mm.

  Optionally, the plurality of seams have a first end attached to a third point of the second opening surface area and a second end being a fourth point of the third opening surface area. A second flexible seam attached to the point, wherein the first point is different from the third point and the second point is different from the fourth point; The length of the connecting portion from the third point of the second opening surface region to the fourth point of the third opening surface region may be in the range of 0.01 mm to 300 mm. The first flexible seam and the second flexible seam may be 180 ° apart. Optionally, the plurality of seams have a first end attached to a fifth point of the second opening surface region and a second end attached to a sixth point of the third opening surface region. A third flexible seam attached to the point, wherein the fifth point is different from the first point and the third point, and the sixth point is the second point and the fourth point It is different from point. The length of the connecting portion from the fifth point of the second opening surface region to the sixth point of the third opening surface region may be in the range of 0.01 mm to 300 mm. Optionally, the plurality of seams have a first end attached to a seventh point of the second opening surface area and a second end attached to the eighth opening of the third opening surface area. A fourth flexible seam attached to the point, wherein the seventh point is different from the first point, the third point, and the fifth point, and the eighth point is the second point Different from the fourth point and the sixth point. The length of the connecting portion from the seventh point of the second opening surface region to the eighth point of the third opening surface region is in the range of 0.01 mm to 300 mm.

  Optionally, the first wire mesh structure and the second wire mesh structure have a relative motion angle with respect to each other in all directions, the motion angle being a center of the first wire mesh structure, The center of the first opening surface area, the first longitudinal axis passing through the center of the second opening surface area and the center of the second wire mesh structure, the center of the third opening surface area, and Defined by an angular displacement between a second longitudinal axis through the center of the fourth open surface area. The angular displacement may be 90 ° or less.

  If necessary, the connection portion of the first wire mesh structure with the second wire mesh structure may be formed by compressing the first wire mesh structure without compressing the second wire mesh structure. It has such a length that it can be compressed to 99%.

  If necessary, the connection portion of the first wire mesh structure with the second wire mesh structure is compressed more than 90% of the first wire mesh structure. A length having an angular displacement of 10% or less with respect to the first wire mesh structure, the angular displacement being the center of the first wire mesh structure, the center of the first opening surface region, And a first longitudinal axis passing through the center of the second opening surface region and the center of the second wire mesh structure, the center of the third opening surface region, and the center of the fourth opening surface region. Defined by the relative angle between the second longitudinal axes through.

  If necessary, the first wire mesh structure and the second wire mesh structure are connected by a connecting portion within the lumen of the catheter.

  If necessary, the first wire mesh structure and the second wire mesh structure are not connected by a connecting portion within the lumen of the catheter.

If necessary, the connecting portion is formed by weaving a plurality of free end portions of the second opening surface region and a plurality of free end portions of the third opening surface region.
The second volume and the fourth volume may occupy 25% to 95% of the stomach.

  Optionally, the intragastric device further includes a sleeve having a proximal end, a distal end, and a lumen, the proximal end connected to the lower portion of the second wire mesh structure, and the distal end. The distal end is located in the patient's duodenum and the sleeve further includes a first opening in fluid communication with the fourth opening surface region and a second opening at the distal end, the sleeve comprising the intragastric device; To send food to the duodenum.

  If necessary, the first wire mesh structure has at least one of a spherical shape and an oval shape, and the first wire mesh structure has a volume of more than 5 ml and less than 5000 ml.

  If necessary, the second wire mesh structure has at least one of a spherical shape and an oval shape, and the second wire mesh structure has a volume of more than 20 ml and less than 4000 ml.

The present specification also discloses an intragastric device that is adapted to deploy in a person's stomach. The device is defined by a compressed pre-deployment shape having a first volume of 110 ml or less and a first length of 75 cm or less in the lumen of the catheter and a first plurality of curved surfaces in the human stomach. A first wire mesh structure having an expanded, deployed shape having a second volume of 125 ml or more that is porous and closed; a third volume of 100 ml or less and 70 cm or less within the lumen of the catheter; A compressed pre-deployment shape having a second length and an expanded post-expansion having a fourth volume of 110 ml or more which is defined by a second plurality of curved surfaces in the stomach of the person and is porous and closed And a plurality of flexible members that flexibly connect the first wire mesh structure and the second wire mesh structure. The first wire mesh structure further includes an upper portion and a lower portion, and the upper portion is a first open surface region in which material enters from the outside of the second volume to the inside of the second volume. Wherein the lower portion has a second open surface area, the first wire mesh structure further includes an upper portion and a lower portion, wherein the upper portion is from the outside of the fourth volume to the inside of the fourth volume. Having a third opening surface region adapted to contain material, the lower portion having a fourth opening surface region, and the plurality of flexible members having a first end at the second end. The first flexible member is attached to a first point of the opening surface region, and a second end is attached to the second point of the third opening surface region, and the plurality of flexible members are The first end is attached to the third point of the second opening surface area and the second end is the third opening. Comprising a second flexible member attached to the fourth point of the surface region, wherein the first point different from the point of the third, the second point different from the point of the fourth.

Optionally, the length of the first flexible member from the first point of the second opening surface region to the second point of the third opening surface region is 0.01 mm to 300 mm It is a range.

If necessary, the length of the second flexible member from the third point of the second opening surface region to the fourth point of the third opening surface region is in the range of 0.01 mm to 100 mm. It is.
The first flexible member and the second flexible member may be 180 ° apart.

Optionally, the plurality of flexible members have a first end attached to a fifth point of the second opening surface region and a second end attached to the fifth opening surface region. A third flexible member attached to the sixth point, the fifth point is different from the first point and the third point, and the sixth point is the second point and the third point Different from the fourth point. The length of the third flexible member from the fifth point of the second opening surface region to the sixth point of the third opening surface region ranges from 0.01 mm to 300 mm. Also good. Optionally, the plurality of flexible members have a first end attached to a seventh point of the second opening surface region and a second end attached to the third opening surface region. A fourth flexible member attached to the eighth point, wherein the seventh point is different from the first point, the third point, and the fifth point, and the eighth point is Different from the second point, the fourth point, and the sixth point. The length of the fourth flexible member from the seventh point of the second opening surface region to the eighth point of the third opening surface region ranges from 0.01 mm to 100 mm. Also good.

  If necessary, the first wire mesh structure and the second wire mesh structure have a relative movement angle with respect to each other in all directions, and the movement angle is a center of the first wire mesh structure, A center of the first opening surface region and a first longitudinal axis passing through a center of the second opening surface region; a center of the second wire mesh structure; a center of the third opening surface region; And an angular displacement with a second longitudinal axis passing through the center of the fourth open surface area. The angular displacement may be 90 ° or less.

If necessary, each of the plurality of flexible members can compress the first wire mesh structure to 95% of its equator diameter without compressing the second wire mesh structure. Have such a length.

If necessary, each of the plurality of flexible members includes a first wire mesh structure in which the second wire mesh structure is 10% or less when the first wire mesh structure is compressed more than 90%. The angular displacement passes through the center of the first wire mesh structure, the center of the first opening surface region, and the center of the second opening surface region. By a relative angle between the first longitudinal axis and the center of the second wire mesh structure, the center of the third opening surface region, and the second longitudinal axis passing through the center of the fourth opening surface region. It is prescribed.

  The present specification also discloses an intragastric device that is adapted to deploy in a person's stomach. The apparatus includes a housing and a catheter that extends through the housing and includes a lumen having an inner diameter of 2 cm or less; a first volume of 110 ml or less and a first length of 75 cm or less within the lumen of the catheter. A compressed pre-deployment shape having a first expanded curved shape defined by a plurality of curved surfaces in the stomach of the person and having a second volume of 125 ml or more that is porous and closed; A wire mesh structure; and a ring attached to the lower portion, wherein the first wire mesh structure further includes a first upper portion and a first lower portion. The first upper portion has a first opening through which material enters from the outside of the second volume to the inside of the second volume, and the lower portion is gradually narrowed and defined by a diameter. A plurality of first curved surfaces that fit within the second opening formed, and the ring is formed by rotating a semicircle in a three-dimensional space around an axis passing through the center of the second opening. The ring is defined by a diameter of 25 mm or more.

  The present specification also discloses a delivery device for delivering a gastrointestinal device into the patient's gastrointestinal tract. The gastrointestinal device comprises a porous structure that can change between a compressed pre-deployment configuration and an expanded post-deployment configuration, a migration-preventing ring proximate a distal end of the porous structure, and the An elongate sleeve connected to the distal end of the porous structure. The delivery device includes a flexible outer catheter having a proximal end, a distal end, and a lumen, a flexible inner catheter having a proximal end, a distal end, and a lumen that slidably receives a guide wire including. The inner catheter is slidably movable within the lumen of the outer catheter. The outer catheter is adapted to retract the outer side of the inner catheter in a proximal direction while holding the inner catheter in place so that the gastrointestinal device is exposed from the distal end of the delivery device.

  Optionally, the sleeve may be configured such that once the gastrointestinal device is delivered, the proximal end of the sleeve is located near the patient's pylorus and the distal end of the sleeve is in a portion of the patient's duodenum. It has the length which is located in.

  Optionally, the outer catheter is about 1.5 meters long and the total length of the delivery device is about 3 meters.

  If necessary, the anti-migration ring of the gastrointestinal device is inclined proximally and the distal portion of the porous structure has a distal end of the porous structure facing the porous structure. Folds so that it points towards the proximal end. If desired, the anti-migration ring is a structure that does not damage any curved / tissue located circumferentially around the distal end of the porous structure.

  Optionally, the outer catheter includes a distal end radiopaque marker for radiography during delivery.

  Optionally, the delivery device is attached to the proximal end of the inner catheter and has a proximal end, a distal end, and a first handle having a lumen slidably receiving a guide wire And a second handle having a proximal end, a distal end, and a lumen adapted to slidably receive the inner catheter, attached to the proximal end of the outer catheter. Prior to delivery of the intragastric device, the proximal portion of the inner catheter located between the first and second handles is exposed and not covered by the outer catheter. The delivery device has a proximal end, a distal end, and a length having non-constant stiffness, and includes a distal sphere and a proximal sphere, and an elongate flexibility extending from the distal end of the inner catheter A first stop mechanism removably attached to the exposed portion of the inner catheter; and a first stop mechanism removably attached to the exposed portion of the inner catheter and located proximal to the first stop mechanism. Includes a second stop mechanism. The first stop mechanism and the second stop mechanism are sequentially removed from the inner catheter as the outer catheter is retracted.

  The delivery device may further include a hydrophilic coating covering at least one of the guide member and the distal end of the outer catheter, and when the hydrophilic coating is activated, insertion and guidance of the delivery device Has become easier.

  The delivery device further includes an inlet in at least one of the first handle for injecting fluid into the lumen of the inner catheter and the second handle for injecting fluid into the lumen of the outer catheter. May be included.

  Optionally, the proximal sphere is adapted to prevent tissue damage and includes a radiopaque marker for radiography during delivery. The distal sphere has a spherical tip shape that does not damage tissue.

  If desired, the non-constant stiffness of the guide member is less than the stiffness of the distal end of the outer catheter at the proximal end and is comparable to the stiffness of the 0.035 inch guide wire at the distal end.

  Optionally, the first stop mechanism and the second stop mechanism include a plastic ring that is secured to the inner catheter using a wing nut.

  The present specification also discloses a method of delivering a gastrointestinal device into a patient's gastrointestinal tract using the delivery device. The gastrointestinal device comprises a porous structure that can change form between a compressed pre-deployment configuration and an expanded post-deployment configuration, an anti-migration ring proximate a distal end of the porous structure, and An elongate sleeve coupled to a distal end of the porous structure. The delivery device includes a flexible outer catheter having a proximal end, a distal end, and a lumen, a flexible inner catheter having a proximal end, a distal end, and a lumen that slidably receives a guide wire including. The flexible inner catheter is coaxially disposed within the lumen of the outer catheter and is slidably movable. The delivery device is attached to a proximal end of the inner catheter and has a proximal end, a distal end, and a first handle having a lumen slidably receiving a guide wire; the outer catheter A second handle attached to the proximal end of the catheter and having a proximal end, a distal end, and a lumen slidably received by the inner catheter; attached to the exposed portion of the inner catheter for removal And a second stop mechanism removably attached to the exposed portion of the inner catheter and located proximal to the first stop mechanism. The method includes sliding the delivery device outside the guide wire into the gastrointestinal tract of the patient; using fluoroscopy to determine the position of the distal end of the flexible outer catheter and delivering Ensuring accurate positioning of the device; holding the first handle to hold the inner catheter in place and retracting the outer catheter to the first stop mechanism; Retracting the entire delivery device until the distal end is just proximal to the patient's pylorus; removing the first stop mechanism from the inner catheter; holding the first handle to define the inner catheter Holding in position and retracting the outer catheter to the second stop mechanism; removing the second stop mechanism; holding the first handle and holding the inner catheter Comprises the step of taking out and said delivery device from the patient; keeping the Le in place, step retracting the outer catheter to said first handle.

  Optionally, when the outer catheter is retracted to the first stop mechanism, a portion of the sleeve is delivered to and positioned within a portion of the patient's gastrointestinal tract.

  Optionally, when the outer catheter is retracted to the second stop mechanism, a portion of the sleeve and a portion of the porous structure are delivered to a predetermined portion of the intestine of the patient's gastrointestinal tract. , Located in the predetermined part.

  Optionally, when the outer catheter is retracted to the first handle, all of the porous structure is delivered to and located at a predetermined portion of the intestine of the patient's gastrointestinal tract.

  If necessary, the anti-migration ring of the gastrointestinal device is inclined proximally and the distal portion of the porous structure has a distal end of the porous structure facing the porous structure. Folds so that it points towards the top edge. If desired, the anti-migration ring is a structure that does not damage any curved / tissue located circumferentially around the distal end of the porous structure.

  Prior to delivery of the gastrointestinal device, the proximal portion of the inner catheter located between the first and second handles may be exposed and not covered by the outer catheter. .

  Optionally, the delivery device may further include an elongate flexible guide member having a distal sphere and a proximal sphere and extending from the distal end of the inner catheter.

  At least one of the guide member and the distal end of the outer catheter may include a hydrophilic coating, and the method activates the hydrophilic coating prior to sliding the delivery device outside the guide wire. The process of carrying out may be further included.

  The present specification also discloses a delivery system for delivering a gastrointestinal device into a patient's gastrointestinal tract, including the gastrointestinal device and a delivery device. The gastrointestinal device comprises a porous structure that can change form between a compressed pre-deployment configuration and an expanded post-deployment configuration; a non-migration ring proximate a distal end of the porous structure; and An elongate sleeve connected to the distal end of the porous structure. The delivery device includes a flexible outer catheter having a proximal end, a distal end, and a lumen; a flexible inner catheter having a proximal end, a distal end, and a lumen that slidably receives a guide wire The inner catheter is coaxially disposed within the lumen of the outer catheter and is slidably movable therein. The delivery device is attached to a proximal end of the inner catheter and has a proximal end, a distal end, and a first handle having a lumen slidably receiving a guide wire; the outer catheter A second handle having a proximal end, a distal end, and a lumen slidably receiving the inner catheter, wherein the second handle is disposed between the first handle and the second handle. The proximal portion of the located inner catheter is not entirely covered by the outer catheter. The delivery device also includes a distal sphere and a proximal sphere, a long flexible member extending from the distal end of the inner catheter; and a first removably attached to the exposed portion of the inner catheter Including a stop mechanism. A second stop mechanism is removably attached to the exposed portion of the inner catheter and located proximal to the first stop mechanism. A distal end of the inner catheter is adapted to pass through an opening in the porous structure, and the sleeve is wound coaxially around the inner catheter. The outer catheter may be retracted to a position beyond the inner catheter in the proximal direction while holding the inner catheter in place. The first stop mechanism and the second stop mechanism are adapted to be sequentially removed from the inner catheter when the outer catheter is retracted and exposed to deliver the gastrointestinal device from the distal end of the delivery device. .

  The delivery system may include a hydrophilic coating covering at least one of the elongate flexible member and the distal end of the outer catheter, and when the hydrophilic coating is activated, Facilitates insertion and guidance.

6. The delivery system of claim 1, wherein at least one of the first handle for injecting fluid into the lumen of the inner catheter and the second handle for injecting fluid into the lumen of the outer catheter is provided. An inlet may further be included.
If desired, the delivery device has a non-constant stiffness along its length.

  If necessary, the anti-migration ring of the gastrointestinal device is inclined proximally, and the distal portion of the porous structure has an end facing the distal side of the porous structure of the porous structure. Folds so that it points towards the proximal end. Optionally, the anti-migration ring is a structure that does not damage any curved / tissue located circumferentially around the distal end of the porous structure.

  The present specification also discloses a delivery device that uses an endoscopic instrument to deliver an intragastric device into the gastrointestinal tract of a patient. The intragastric device includes a porous structure that can change between a compressed pre-deployment configuration and an expanded post-deployment configuration, and a long sleeve connected to a distal end of the porous structure. including. The delivery device is for limiting an elongate body having a proximal end and a distal end, and the gastrointestinal device in the pre-deployment configuration, coaxially disposed to cover the distal end of the elongate body Includes a limiting mechanism.

  In one aspect, the delivery device may further include a locking mechanism that locks the delivery device in place.

  In one aspect, the distal end includes a distal most portion and a proximal distal portion, the distal most portion being more flexible than the proximal distal portion.

  In one aspect, the delivery device further includes a thread pull at the proximal end, and the restriction mechanism includes a thread wrapped around the pre-deployed form of the gastrointestinal device.

  In one aspect, the restriction mechanism includes a zippered sheath that coaxially covers the pre-deployed form of the gastrointestinal device. In another aspect, the restriction mechanism includes a withdrawal sheath that coaxially covers the pre-deployed form of the gastrointestinal device. In another aspect, the restriction mechanism includes a tear sheath that coaxially covers the pre-deployed form of the gastrointestinal device.

  The delivery device restricts the gastric device in the undeployed configuration coaxially disposed outside the distal end of a proximal end, a distal end, and an elongate body of the delivery device to provide the stomach An elongate body having a drawing sheath that slides coaxially on the outside of the inner device may be included. Also, the method for delivering the intragastric device comprises the step of coaxially placing the contracted intragastric device in the pre-deployment configuration outside the distal end of the elongate body of the delivery device; Using to insert the delivery device into a patient and advance the distal end of the delivery device elongate to the patient's duodenum or jejunum, once the intragastric device is positioned, the intragastric device automatically Pulling the sheath coaxially with a tool so as to expand to a deployed configuration and pulling the sheath from the contracted intragastric device; and the distal end of the delivery device elongate body; The method may include the steps of removing the delivery device from the patient by sliding coaxially away from the expanded intragastric device.

  Optionally, the method further comprises applying a cooling member to the compressed intragastric device to delay expansion of the porous structure upon removal of the sheath to facilitate removal of the delivery device. May be included.

  The present specification also discloses a retrieval device for removing an intragastric device from a patient's gastrointestinal tract using an endoscopic instrument. The intragastric device includes a porous structure that can change between a compressed pre-deployment configuration and an expanded post-deployment configuration, and a long sleeve connected to a distal end of the porous structure. including. The porous structure includes at least one peripheral contraction mechanism located around the porous structure and a retrieval mechanism at a proximal end thereof. The retrieval device includes a proximal end and a distal end and an elongated body having a lumen therein; an elongated metal wire disposed in the lumen and having a proximal end and a distal end; the at least one A gripping mechanism formed from a free end of a peripheral contraction mechanism and a distal end of the metal wire that grips a retrieval mechanism of the porous structure; and an actuator attached to the proximal end of the metal wire.

Optionally, the retrieval device further includes a handle at the proximal end of the elongate body.
Optionally, the actuator is in the handle.

  In one aspect, the retrieval device is attached to a distal end of the elongate body and has a gripping member having two opposing jaws operatively connected to the actuator at a proximal end of the metal wire, and It further includes at least one clamp located between the jaws of the gripping member. The jaws are adapted to compress a clamp around a free end of the at least one peripheral contraction mechanism.

  The present specification also discloses a method of delivering an intragastric device into the patient's gastrointestinal tract using the delivery device. The intragastric device includes a porous structure that can change between a compressed pre-deployment configuration and an expanded post-deployment configuration, and a long sleeve connected to a distal end of the porous structure. including. The method comprises the steps of deploying the porous structure without the sleeve in a first procedure and expanding the porous structure to the post-deployment configuration; Deploying within an expanded porous structure; and connecting a proximal end of the sleeve to a distal end of the porous structure during the second procedure.

  Optionally, the method further includes applying a cooling member to the compressed intragastric device to delay expansion of the porous structure during deployment during the first procedure.

  If necessary, the first procedure is performed using a first catheter.

  If necessary, the second procedure is performed using a second catheter.

  The present specification also discloses a method for recovering a device from a patient's gastrointestinal tract using the recovery device. The device includes a porous structure that can change form between a compressed pre-deployment configuration and an expanded post-deployment configuration, and an elongate sleeve coupled to a distal end of the porous structure. The porous structure includes at least one peripheral contraction mechanism located around the porous structure and a retrieval mechanism at a proximal end thereof. The retrieval device includes a proximal end and a distal end and an elongated body having a lumen therein; an elongated metal wire disposed within the lumen and having a proximal end and a distal end; and the at least A gripping mechanism formed from a distal end of the metal wire that grips a free end of one peripheral contraction mechanism and a retrieval mechanism of the porous structure; and an actuator attached to the proximal end of the metal wire . The method includes the step of inserting the retrieval device into the patient using an endoscopic instrument to advance the distal end of the elongate body of the retrieval device to the proximal end of the device; Operating a gripping mechanism to engage a free end of the at least one peripheral contraction mechanism located about the porous structure; pulling an actuator of the recovery device to contract the at least one peripheral contraction mechanism Automatically locking and thereby compressing the porous structure into the pre-deployment shape; operating the gripping mechanism of the recovery device to engage the free end of the at least one peripheral contraction mechanism Operating the gripping mechanism to engage the recovery mechanism with the proximal end of the porous structure; pulling the actuator to place the proximal portion of the device within the lumen of the recovery device Fit in That; and from the patient comprising the step of removing the collecting device and the device.

  The intragastric device may include three peripheral contraction mechanisms positioned around the porous structure, and the method may sequentially operate the grasping mechanism of the recovery device to operate the three peripheral contraction mechanisms. Engaging each free end, and pulling the actuator of the retrieval device to contract and automatically lock each of the three surrounding contraction mechanisms, thereby completely compressing the porous structure and It may further include a step of making the shape before deployment.

  In one aspect, the method further comprises applying a cooling member to the compressed device to prevent the porous structure from re-expanding upon removal of the recovery device and the device.

  The retrieval device is attached to the distal end of the elongate body and has two opposing jaws operatively connected to the actuator at the proximal end of the metal wire; and It may further include at least one clamp located between the jaws. The method may further include the step of manipulating a gripping member of the recovery device to grip the free end of the at least one peripheral contraction mechanism proximate to the compressed porous structure with the at least one clamp. Good.

  The present specification also discloses a retrieval device for removing an intragastric device from a patient's gastrointestinal tract using an endoscopic instrument. The intragastric device includes a porous structure that can change shape between a compressed pre-deployment configuration and an expanded post-deployment configuration, and is connected to a distal end of the porous structure. Includes sleeve. The retrieval device is a flexible catheter having a proximal end, a distal end, and a lumen therein; located within the lumen of the catheter, having a proximal end and a distal end, and the distal A portion of the end having an elongated metal wire formed in a gripping mechanism; a handle located at the proximal end of the catheter; and a proximal end, a distal end and a first lumen therein; A long tube coaxially positioned outside the catheter. The gripping mechanism is configured to grip the porous structure, and the long tube is configured to receive the porous structure at a distal end thereof.

  The handle may include a first handle member and a second handle member. The long tube can be slid back and forth over the catheter by moving the first handle member and the second handle member in different directions. If necessary, the first handle member and the second handle member are assembled and held together using screws.

  The elongate tube may further include an adapter at its proximal end, the adapter being adapted to be attached to the second handle member.

  Optionally, the elongate tube can be an inflatable balloon located at the distal end of the elongate tube; a blowing port located at the proximal end of the elongate tube; the inflatable balloon and the blowing port A separate second lumen in fluid communication; and a compartment located at a distal end of the elongate tube and adapted to receive the balloon when the balloon is deflated. The balloon is inflatable through the insufflation port and the second lumen, and the balloon when deflated is used to assist in compressing the porous structure into a pre-deployment configuration.

  Optionally, the elongate tube further includes an infusion port at the proximal end for instilling cold fluid into the first lumen of the elongate tube. The porous structure is made of a temperature sensitive material and the cold fluid is used to assist in compressing the porous structure into a pre-deployment form.

  The catheter may further include a sheath that restricts the gripping mechanism. Optionally, the gripping mechanism includes a hook.

  The present specification also discloses a method of retrieving an intragastric device from a patient's gastrointestinal tract using the retrieval device. The intragastric device includes a porous structure that can change form between a compressed pre-deployment configuration and an expanded post-deployment configuration, and is connected to a distal end of the porous structure. Includes sleeve. The retrieval device is a flexible catheter having a proximal end, a distal end, and a lumen therein; located within the lumen of the catheter, having a proximal end and a distal end, and the distal A long metal wire having a portion of the end formed in the grasping mechanism; a handle located at the proximal end of the catheter; a long tube having a proximal end, a distal end, and a first lumen therein including. The tube is located coaxially outside the catheter. The method includes the step of inserting the catheter into an operating channel of an endoscope inserted into the patient, the distal end of the endoscope being positioned in the patient's stomach near the intragastric device. Manipulating the elongated metal wire to extend the grasping mechanism beyond the distal end of the catheter and grasping the porous structure with the grasping mechanism; removing the handle from the catheter Sliding the elongate tube outside the catheter; exchanging the handle; pulling the elongate metal wire to pull the porous structure into the elongate tube; and from the patient Removing the collection device together with the intragastric device.

  The elongate tube comprises an inflatable balloon located at the distal end of the elongate tube, a blowing port located at the proximal end of the elongate tube, and an individual in fluid communication between the inflatable balloon and the blowing port. A second lumen, and a compartment positioned at a distal end of the elongate tube and adapted to receive the balloon when the balloon is deflated. The method may further include the step of inflating the balloon through the inlet and the second lumen. The inflated balloon extends from the compartment and is used to assist in compressing the porous structure into a pre-deployed configuration.

  Optionally, the elongate tube further includes an infusion port at the proximal end for instilling cold fluid into the first lumen of the elongate tube. The porous structure is made of a material that is susceptible to temperature. The method further includes instilling a cold fluid into the first lumen to assist in compressing the porous structure to a pre-deployed configuration.

The present specification also includes a porous structure having a pre-deployment shape having a first volume and a post-deployment shape having a second volume that is greater than the first volume, including an upper portion, a lower portion, and an interior. An intragastric device including a body is disclosed. The porous structure comprises, in the deployed shape, at least one first opening proximate the top and at least one second opening proximate the bottom, whereby food is the at least one The porous structure is entered through a first opening, passes through the interior, and exits the porous structure through the at least one second opening. The porous structure further includes a wire mesh. The wire mesh has a substantially spherical shape after deployment, and is located at least at the first group of knots at the top, at the bottom of the second group of knots, and at a side location between the top and the bottom. Includes a third group of knots. Each knot includes a single unsupported free end or bend in the metal wire of the wire mesh. The porous structure includes a ring located at a bottom thereof, and the ring has a bend. The bend includes an extension of the metal wire that curves away from the longitudinal central axis of the porous structure and then curves upward toward the top of the porous structure. The intragastric device includes a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve having a sleeve interior. The food from the at least one second opening enters the sleeve through the third opening, passes through the sleeve, and exits the sleeve through the fourth opening. The proximal end of the sleeve is connected to a second group of knots in the porous structure.
Optionally, the proximal end of the sleeve is connected to the ring.

  Each group of knots may include 10 to 100 individual knots. Optionally, each group of knots includes 44 knots. Optionally, each group of knots includes 36 knots.

The porous structure has a predetermined length. The porous structure may include 2 to 60 groups of knots distributed in the latitudinal direction at different positions along the length. At least 10% of the total number of knots in the porous structure may be located at the top and the bottom. If necessary, 75% or less of the total number of knots is located in any one of the knot groups.
The wire mesh may be made of a shape memory metal.

  The metal wire has a predetermined thickness, and the bend of the ring has a bending radius. As the porous structure is compressed into the pre-deployment shape, the bend when the ring is folded in the distal direction may be defined by the bending strain rate. This bending strain rate is equal to twice the thickness divided by the radius multiplied by 100. If necessary, the bending strain rate is in the range of 0.1-20%. If necessary, the bending strain rate is 8% or less.

  If necessary, the thickness is in the range of 0.1 to 1 mm. If necessary, the bending radius is in the range of 0.013 to 20 cm.

  The thickness and the bending radius may be configured such that the radius is larger than twice the thickness and smaller than 2000 times the thickness.

  The present specification also includes a porous structure having a pre-deployment shape having a first volume and a post-deployment shape having a second volume that is greater than the first volume, including an upper portion, a lower portion, and an interior. An intragastric device is disclosed. The porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom, whereby food in the unfolded shape is the at least one The porous structure is entered through a first opening and exits the porous structure through the at least one second opening. The porous structure has a substantially spherical post-deployment shape, and is positioned at least at the top of the first group of knots, at the bottom of the second group of knots, and at side portions of the top and bottom A wire mesh comprising a third group of knots. Each knot includes a single unsupported free end or bend in the metal wire of the wire mesh. The porous structure includes a ring having a bend located at the bottom of the porous structure. The bend includes an extension of the metal wire that curves away from the longitudinal central axis of the porous structure and then curves upward toward the top of the porous structure. The metal wire has a predetermined thickness, and the bend of the ring has a predetermined bending radius. As the porous structure is compressed into the pre-deployment shape, the bend when the ring is folded in the distal direction is defined by the bending strain rate, which is twice the thickness. Is equal to 100 divided by the radius multiplied by 100. Furthermore, this bending strain rate is in the range of 0.1 to 20%. The intragastric device includes a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve having a sleeve interior. The sleeve so that food from the at least one second opening enters the sleeve through the third opening, passes through the inside of the sleeve, and exits the sleeve through the fourth opening. Is connected to the knot of the second group of the porous structure.

  If necessary, the bending strain rate is 8% or less. If necessary, the thickness is in the range of 0.1 to 1 mm. If necessary, the bending radius is in the range of 0.013 to 20 cm.

  The thickness and the bending radius may be configured such that the radius is larger than twice the thickness and smaller than 2000 times the thickness.

  The present description includes a porous structure including an upper portion, a lower portion, and an interior, and a pre-deployment shape having a first volume and a post-deployment shape having a second volume greater than the first volume. An intragastric device is disclosed. The porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom, whereby food in the unfolded shape is the at least one The porous structure is entered through a first opening and exits the porous structure through the at least one second opening. The porous structure has a substantially spherical post-deployment shape, and at least a first group of knots on the top, a second group of knots on the bottom, and side portions of the top and the bottom. It further includes a wire mesh with three groups of knots. Each knot includes a single unsupported free end or bend in the metal wire of the wire mesh. Each group of knots contains 44 or more individual knots. The porous structure includes a ring having a bend located at the bottom of the porous structure. The bend includes an extension of the metal wire that curves away from the longitudinal central axis of the porous structure and then curves upward toward the top of the porous structure. The metal wire has a predetermined thickness, and the bend of the ring has a predetermined bending radius. The bend when the ring is folded in the distal direction as the porous structure is compressed into the undeployed shape is defined by the bending strain rate. This bending strain rate is equal to twice the thickness divided by the radius multiplied by 100. Furthermore, this bending strain rate is in the range of 0.1 to 20%. The intragastric device includes a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve having a sleeve interior. The sleeve so that food from the at least one second opening enters the sleeve through the third opening, passes through the inside of the sleeve, and exits the sleeve through the fourth opening. Is connected to the knot of the second group of the porous structure.

  The present specification also includes a porous structure having a pre-deployment shape having a first volume and a post-deployment shape having a second volume that is greater than the first volume, including an upper portion, a lower portion, and an interior. An intragastric device is disclosed. The porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom, whereby food in the unfolded shape is the at least one The porous structure is entered through a first opening and exits the porous structure through the at least one second opening. The intragastric device has a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve interior and having a first length prior to deployment. A sleeve having a shape and a deployed shape having a second length longer than the first length. Food from the at least one second opening enters the sleeve through the third opening when the sleeve is in the unfolded shape, passes through the sleeve and passes through the fourth opening. The proximal end of the sleeve is connected to the bottom of the porous structure so as to exit the sleeve. The sleeve further includes at least one helical metal wire extending along the elongate body adapted to support the sleeve when in the deployed configuration. The helical metal wire has a strain rate defined by the thickness of the metal wire and the pitch of the metal wire, the pitch being in the same plane along the longitudinal axis of the sleeve. Defined by the distance between any two points along.

  The helical metal wire may be made of a shape memory metal. Optionally, the shape memory metal is nitinol.

  The helical metal wire when compressed as the sleeve is compressed and folded into the pre-deployment shape may have a strain rate of 0.1-20%. If necessary, the helical metal wire when compressed as the sleeve is compressed and folded into the pre-deployment shape has a strain rate of 8% or less. The pitch may be in the range of 5 to 150 mm. If necessary, the pitch is 60 mm.

  The sleeve may have a length in the range of 1 cm to 120 cm, and may be adapted to enter and exit the patient's pylorus without damaging the tissue.

  The sleeve may be substantially funnel-shaped and may have a diameter that decreases as the sleeve extends from the proximal end to the distal end.

  Optionally, the proximal portion of the sleeve is funnel shaped. The diameter of the proximal portion of the sleeve is greater than the diameter along any other portion of the sleeve body, and the proximal end diameter gradually decreases as the sleeve body extends distally.

  Optionally, the distal portion of the sleeve body may include two or more layers adapted to reinforce the distal portion and maintain the sleeve body in an elongated shape when in the deployed configuration. Including.

  Optionally, the sleeve includes a proximal portion and a distal portion, said proximal portion extending from a proximal end of said sleeve to a transition point on said sleeve body, said distal portion being said transition. Extends from a point to the distal end of the sleeve. Further, the proximal portion is funnel-shaped and has a diameter that decreases as the proximal portion extends from the proximal end of the sleeve to the transition point. This is also optional, but the distal portion is funnel-shaped and has a diameter that decreases as the distal portion extends from the transition point to the distal end of the sleeve. Alternatively, the distal portion is cylindrical and has a constant diameter when the distal portion extends from the transition point to the distal end of the sleeve. Optionally, the diameter of the distal portion increases as the distal portion extends from the transition point to the distal end of the sleeve.

  The sleeve can be made of one or a combination of polytetrafluoroethylene (PTFE), polyethylene (PE), low density polyethylene (LDPE), high density polyethylene (HDPE), and ultra high molecular weight polyethylene (UHMWPE). It may consist of at least one layer. Optionally, the sleeve can be any one of polytetrafluoroethylene (PTFE), polyethylene (PE), low density polyethylene (LDPE), high density polyethylene (HDPE), and ultra high molecular weight polyethylene (UHMWPE) or It includes at least two layers made of a combination of these and further includes at least one metal wire support located between the layers.

  Optionally, the intragastric device further includes a member attached to the distal end of the sleeve to prevent the distal end from damaging body tissue. The member includes a tubular body, a proximal end, a distal end, and an inner lumen, the ends of which are open, and the lumen of the member is in fluid communication with the sleeve interior. Further, the outer surface of the member includes a groove and an annular member located in the groove. The member is attached to the sleeve by placing a portion of the sleeve in the groove and below the annular element.

  Optionally, the member further includes a flange extending from the outer surface. The flange covers the free end of the distal end of the sleeve. Alternatively, the member further includes a heat shrinkable tube positioned to cover the annular member and the groove. If necessary, the distal end of the sleeve is folded under the annular member so that the free end of the distal end of the sleeve is located within the sleeve interior.

  Optionally, the intragastric device further includes at least one tail extending from the distal end of the sleeve. The tail is adapted to pull the sleeve distally to assist in proper orientation of the sleeve within the patient's gastrointestinal tract.

  The distal portion of the sleeve may include a plurality of sleeve tufts. The tuft is attached to a member at the distal end of the sleeve. Further, the member is adapted to pull the sleeve distally to assist in proper orientation of the sleeve within the patient's gastrointestinal tract. Optionally, the tuft and distal member are parabolic.

  The distal end of the sleeve may include a plurality of seams each having a proximal end and a distal end. The proximal end of the seam is attached to the distal end of the sleeve, and the distal end of the seam pulls the sleeve distally to orient the sleeve within the patient's gastrointestinal tract It is attached to a member designed to assist. Optionally, the tuft and distal member are parabolic.

  The distal end of the sleeve may include a plurality of seams each having a proximal end and a distal end. The proximal end of the seam is attached to the distal end of the sleeve, and each distal end of the seam pulls the sleeve distally so that the sleeve is properly oriented within the patient's gastrointestinal tract. It is attached to a separate member designed to assist.

  Optionally, the sleeve is folded and folded at least once along the longitudinal axis of the sleeve to provide additional structure to the sleeve.

  The sleeve may include at least one channel extending along the longitudinal axis of the sleeve. The at least one channel receives a support member to provide additional structure to the sleeve.

  At least a portion of the sleeve may have a corrugated structure consisting of alternating grooves and ridges to provide additional structure to the sleeve.

  At least a portion of the sleeve may include a flexible metal wire configured in a braided structure to provide additional structure to the sleeve.

  The sleeve may include at least one channel extending along the longitudinal axis of the sleeve. The at least one channel is adapted to receive fluid to provide additional structure to the sleeve.

  The present specification also includes a porous structure having a pre-deployment shape having a first volume and a post-deployment shape having a second volume that is greater than the first volume, including an upper portion, a lower portion, and an interior. An intragastric device is disclosed. The porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom, whereby food in the unfolded shape is the at least one The porous structure is entered through a first opening and exits the porous structure through the at least one second opening. The intragastric device has a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve interior and having a first length prior to deployment. A sleeve having a shape and a deployed shape having a second length greater than the first length. Food from the at least one second opening enters the sleeve through the third opening when the sleeve is in the unfolded shape, passes through the sleeve and passes through the fourth opening. The proximal end of the sleeve is connected to the bottom of the porous structure so as to exit the sleeve. The sleeve further includes three helical metal wires extending along the elongate body adapted to support the sleeve when in the deployed shape. Each of these helical metal lines has an individual strain rate defined by the thickness of the individual metal lines and the individual pitch of the individual metal lines. Furthermore, the individual pitch is defined by the distance between any two points along the individual metal line that are in the same plane along the longitudinal axis of the sleeve.

  Each of the helical metal wires may be made of a shape memory metal. Optionally, the shape memory metal is nitinol.

  Each of the helical metal wires may have an individual strain rate in the range of 0.1 to 20% when compressed as the sleeve is compressed and folded into the pre-deployment shape. Optionally, each of the helical metal wires has an individual strain rate of 8% or less when compressed as the sleeve is compressed and folded into the pre-deployed shape.

  The individual pitch of each of the helical metal wires may be in the range of 5 to 150 mm. If necessary, the individual pitch of each of the helical metal wires is 60 mm.

  Optionally, each of the metal lines is adjacent as defined as the distance between any two points along two adjacent metal lines that are in the same plane along the longitudinal axis of the sleeve. It has a metal wire pitch. The adjacent metal wire pitch is 20 mm.

  Optionally, the proximal portion of the sleeve is funnel-shaped and the diameter of the proximal end of the sleeve is greater than the diameter along any other portion of the sleeve body. The proximal end diameter gradually decreases as the sleeve body extends distally.

  Optionally, the distal portion of the sleeve body includes two or more layers adapted to reinforce the distal portion and maintain the sleeve body in an elongated shape in the deployed configuration. .

  The present specification also includes a porous structure having a pre-deployment shape having a first volume and a post-deployment shape having a second volume that is greater than the first volume, including an upper portion, a lower portion, and an interior. An intragastric device is disclosed. The porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom, whereby food in the unfolded shape is the at least one The porous structure is entered through a first opening and exits the porous structure through the at least one second opening. The intragastric device has a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve interior and having a first length prior to deployment. A sleeve having a shape and a deployed shape having a second length greater than the first length. Food from the at least one second opening enters the sleeve through the third opening when the sleeve is in the unfolded shape, passes through the sleeve and passes through the fourth opening. The proximal end of the sleeve is connected to the bottom of the porous structure so as to exit the sleeve. The sleeve further includes at least one helical metal wire extending along the elongate body that is adapted to support the sleeve when in the deployed configuration. The spiral metal wire has a distortion rate defined by the thickness of the metal wire and the pitch of the metal wire. The sleeve can be folded at least 5 times so that the strain rate does not exceed 20%. Further, the pitch is defined by the distance between any two points along the metal line that are in the same plane along the longitudinal axis of the sleeve.

  The present specification also includes a porous structure having a pre-deployment shape having a first volume and a post-deployment shape having a second volume that is greater than the first volume, including an upper portion, a lower portion, and an interior. An intragastric device is disclosed. The porous structure includes at least one first opening proximate to the top and at least one second opening proximate to the bottom, wherein food in the deployed shape is the at least one first opening. The porous structure is entered through an opening and exits the porous structure through the at least one second opening. The porous structure has a substantially spherical post-deployment shape, and is positioned at least at the first group of knots at the top, at the bottom of the second group of knots, and at the side portions of the top and bottom. A wire mesh comprising a third group of knots. Each knot includes a single unsupported free end or bend in the metal wire of the wire mesh. The porous structure includes a ring having a bend located at the bottom of the porous structure. The bend includes an extension of the metal wire that curves away from the longitudinal central axis of the porous structure and then curves upward toward the top of the porous structure. The intragastric device includes a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve having a sleeve interior. The food from the at least one second opening enters the sleeve through the third opening, passes through the sleeve, and exits the sleeve through the fourth opening. The proximal end of the sleeve is connected to the second group of knots of the porous structure. At least a portion of the total number of knots in the second group is connected to the proximal end of the sleeve by a seam.

  Each portion of the knots of the second group of knots may be sewn to the proximal end of the sleeve at the most distal position at each knot. Optionally, the portion of the total number of knots in the second group includes all of the knots in the second group of knots. Optionally, the portion of the total number of knots of the second group includes every other knot within the second group of knots.

  It may be made loose so that some relative movement between the wire mesh and the sleeve is possible.

  The seam connecting the sleeve to each of the knots in the portion of the total number of knots in the second group may have only one knot.

  The metal wire of the wire mesh may have at least two ends, and the ends are bundled together and crimped using a metal tube.

  The metal wire of the wire mesh may have at least two ends, and the end is bent back to form a metal wire end that does not damage the tissue, or the end is looped outward to form the ring. Form attachment points to the sleeve.

  The sleeve may be provided with a supporting metal wire. The metal wire may have at least two ends, and the end is bent back to form a metal wire end that does not damage the tissue, or a ring is formed outward at the end to form the wire mesh. The sleeve is pulled during the process of compressing the device using the end to form an attachment point that couples to the device.

  The present specification also includes a porous structure having a pre-deployment shape having a first volume and a post-deployment shape having a second volume that is greater than the first volume, including an upper portion, a lower portion, and an interior. An intragastric device is disclosed. The porous structure includes at least one first opening proximate to the top and at least one second opening proximate to the bottom, wherein food in the deployed shape is the at least one first opening. The porous structure is entered through an opening and exits the porous structure through the at least one second opening. The porous structure has a substantially spherical post-deployment shape, and is positioned at least at the top of the first group of knots, at the bottom of the second group of knots, and at side portions of the top and bottom A wire mesh comprising a third group of knots. Each knot includes a single unsupported free end or bend in the metal wire of the wire mesh. The porous structure includes a ring having a bend located at the bottom of the porous structure. The bend includes an extension of the metal wire that curves away from the longitudinal central axis of the porous structure and then curves upward toward the top of the porous structure. The intragastric device includes a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve having a sleeve interior. The food from the at least one second opening enters the sleeve through the third opening, passes through the sleeve, and exits the sleeve through the fourth opening. The proximal end of the sleeve is connected to the second group of knots of the porous structure. A portion of the metal line proximate to each knot and another portion of the metal line proximate to an adjacent knot are intersected to form an intersection, and the total number of intersections at the bottom of the porous structure At least a portion of them is connected to the proximal end of the sleeve by a seam.

  If necessary, at least a part of the total number of the intersections at the bottom of the porous structure includes all the intersections close to the bottom of the porous structure. Optionally, at least a portion of the total number of intersections at the bottom of the porous structure includes every other intersection close to the bottom of the porous structure.

  The seam may be made loose so that some relative movement is possible between the wire mesh and the sleeve.

  The seam connecting the sleeve to each of the partial intersections of the total number of intersections close to the bottom of the porous structure may have only one knot.

  The metal wire of the wire mesh may have at least two ends, and the ends are bundled together and crimped using a metal tube.

  The metal wire of the wire mesh may have at least two ends, and the end is bent back to form a metal wire end that does not damage the tissue, or the end is looped outward to form the ring. Form attachment points to the sleeve.

  The sleeve may be provided with a supporting metal wire. The metal wire may have at least two ends, and the end is bent back to form a metal wire end that does not damage the tissue, or a ring is formed outward at the end to form the wire mesh. The sleeve is pulled during the process of compressing the device using the end to form an attachment point that couples to the device.

  The present specification also discloses a method for compressing an intragastric device and mounting it on a delivery device prior to deployment. The intragastric device includes an upper portion, a lower portion, and an interior, and a porous structure having a pre-deployment shape having a first volume and a post-deployment shape having a second volume larger than the first volume including. The porous structure includes at least one first opening proximate the top and at least one second opening proximate the bottom, whereby food in the unfolded shape is the at least one first opening. The porous structure is entered through one opening and exits the porous structure through the at least one second opening. The porous structure has a substantially spherical post-deployment shape, and is positioned at least at the top of the first group of knots, at the bottom of the second group of knots, and at side portions of the top and bottom A wire mesh comprising a third group of knots. Each knot includes a single unsupported free end or bend in the metal wire of the wire mesh. The porous structure includes a ring having a bend located at the bottom of the porous structure. The bend includes an extension of the metal wire that curves away from the longitudinal central axis of the porous structure and then curves upward toward the top of the porous structure. The intragastric device includes a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve having a sleeve interior. The food from the at least one second opening enters the sleeve through the third opening, passes through the sleeve, and exits the sleeve through the fourth opening. The proximal end of the sleeve is connected to the second group of knots in the porous structure. At least a portion of the total number of knots in the second group is connected to the proximal end of the sleeve by a seam. The method includes compressing the wire mesh around a longitudinal central axis of the porous structure, and pulling the distal end of the sleeve so that the ring is substantially straight. A step of bending the bend in a downward direction.

  The seam may be made loose so that some relative movement is possible between the wire mesh and the sleeve.

  The sleeve may be provided with a supporting metal wire. The metal wire may have at least two ends, and the end is bent back to form a metal wire end that does not damage the tissue, or a ring is formed outward at the end to form the wire mesh. The sleeve is pulled in the process of compressing the device using the end to form an attachment point that couples to the device.

  The present specification also includes a porous structure having a pre-deployment shape having a first volume and a post-deployment shape having a second volume that is greater than the first volume, including an upper portion, a lower portion, and an interior. An intragastric device is disclosed. The porous structure includes at least one first opening proximate to the top and at least one second opening proximate to the bottom so that in the unfolded shape, food is the at least one The porous structure is entered via one first opening and exits the porous structure via the at least one second opening. The intragastric device has a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve interior and having a first length prior to deployment. A sleeve having a shape and a deployed shape having a second length greater than the first length. When the sleeve is in the unfolded shape, food from the at least one second opening enters the sleeve through the third opening, passes through the sleeve, and passes through the fourth opening. The proximal end of the sleeve is connected to the bottom of the porous structure so as to exit the sleeve. The sleeve is such that the sleeve is at least folded, wrapped around a portion of the deployment device, and can be pulled and retracted during deployment, and fully deployed without structural damage to the sleeve Has a coefficient of friction.

  This coefficient of friction may be in the range of 0.01 to 0.45. If necessary, the coefficient of friction is 0.10 or less.

The sleeve has an outer surface. The outer surface may be a matte surface. Particulate matter may be applied to the outer surface of the sleeve. Optionally, the particulate material is corn starch. Optionally, the particulate material is a biocompatible powder.
The sleeve may be folded at least twice.

The present specification also discloses a method of delivering an intragastric device into the gastrointestinal tract of a patient. The intragastric device includes an upper portion, a lower portion, and an interior, and a porous structure having a pre-deployment shape having a first volume and a post-deployment shape having a second volume larger than the first volume including. The porous structure includes at least one first opening proximate to the top and at least one second opening proximate to the bottom so that in the unfolded shape, food is the at least one The porous structure is entered via one first opening and exits the porous structure via the at least one second opening. The intragastric device has a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve interior and having a first length prior to deployment. A sleeve having a shape and a deployed shape having a second length greater than the first length. When the sleeve is in the unfolded shape, food from the at least one second opening enters the sleeve through the third opening, passes through the sleeve, and passes through the fourth opening. The proximal end of the sleeve is connected to the bottom of the porous structure so as to exit from the sleeve. The sleeve is such that the sleeve can be folded at least, wrapped around a portion of the deployment device, pulled or retracted during deployment, and fully deployed without structural damage to the sleeve. Has a coefficient of friction. The method includes mounting the porous structure on a delivery device, folding the sleeve, wrapping the folded sleeve around a portion of the delivery device, the porous structure, and the sleeve. Inserting the delivery device into the gastrointestinal tract of the patient, manipulating the delivery device to fully deploy the sleeve, and manipulating the delivery device to fully deploy the porous structure; And removing the delivery device from the patient.
The coefficient of friction may be in the range of 0.01 to 0.45.

The method may further include applying a particulate material to the outer surface of the sleeve before folding the sleeve. Optionally, the particulate material is corn starch. Optionally, the particulate material is a biocompatible powder.
The sleeve may be folded at least twice.

The present specification also discloses a method of delivering an intragastric device into the gastrointestinal tract of a patient. The intragastric device includes an upper portion, a lower portion, and an interior, and a porous structure having a pre-deployment shape having a first volume and a post-deployment shape having a second volume larger than the first volume including. The porous structure includes at least one first opening proximate to the top and at least one second opening proximate to the bottom so that in the unfolded shape, food is the at least one The porous structure is entered via one first opening and exits the porous structure via the at least one second opening. The intragastric device has a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve interior and having a first length prior to deployment. A sleeve having a shape and a deployed shape having a second length greater than the first length. When the sleeve is in the unfolded shape, food from the at least one second opening enters the sleeve through the third opening, passes through the sleeve, and passes through the fourth opening. The proximal end of the sleeve is connected to the bottom of the porous structure so as to exit the sleeve. The sleeve is such that the sleeve can be folded at least, wrapped around a portion of the deployment device, pulled or retracted during deployment, and fully deployed without structural damage to the sleeve. Has a coefficient of friction. The method includes mounting the porous structure on a delivery device, folding the sleeve, wrapping the folded sleeve around a portion of the delivery device, the porous structure, and the sleeve. Inserting the delivery device into the patient's gastrointestinal tract; manipulating the delivery device to partially release the sleeve so that the sleeve is fully released from the delivery device and partially expanded from the collapsed state; Unfolding, further manipulating the delivery device to fully deploy the porous structure, removing the delivery device from the patient, and contracting the bowel on the sleeve for vagina operation Fully expanding the sleeve.
The coefficient of friction may be in the range of 0.01 to 0.45.

The method may further include the step of applying particulate material to the outer surface of the sleeve before folding the sleeve. Optionally, the particulate material is corn starch. Optionally, the particulate material is a biocompatible powder.
The sleeve may be folded at least twice.

  The present specification also discloses a delivery device for delivering an intragastric device into the gastrointestinal tract of a patient. The intragastric device includes a porous structure that can change between a compressed pre-deployment configuration and an expanded post-deployment configuration, and an elongate sleeve coupled to a distal end of the porous structure including. The delivery device includes a flexible elongated body having a proximal end, a distal end, and a lumen inside the elongated body. The elongate body includes an opening at the distal end and a first handle attached to the proximal end. The delivery device includes a flexible plunger member positioned coaxially within the elongate lumen and movable longitudinally, the plunger including a proximal end, a distal end, and an interior thereof And a second handle attached to the proximal end. The delivery device includes a flexible elongate rod coaxially positioned within the plunger lumen and movable longitudinally, the rod comprising a proximal end and a distal end, the distal end And a second spherical member located at the distal end. The diameter of the first spherical member is larger than the diameter of the second spherical member. The rod further includes a third handle attached to the proximal end. The delivery device is removably coupled to a first end attached to the sleeve of the intragastric device and the rod in a position between the first spherical member and the second spherical member. A pulling mechanism including a second end formed. The intragastric device is disposed within the delivery device for delivery such that the porous structure is located within the elongate lumen distal to the plunger tip and proximal to the sleeve. Installed. The rod passes through at least two openings in the porous structure but does not follow the central longitudinal axis of the porous structure. The sleeve is located within the elongate body distal to the porous structure and proximal to the first spherical member, is folded and wrapped around a portion of the rod. Furthermore, the sleeve is attached to the first end of the pulling mechanism.

  The delivery device may further include a fastener located on a plunger between the tip and the second handle.

  If desired, the pulling mechanism is biodegradable and includes a seam or hook. Alternatively, the pulling mechanism is non-biodegradable and includes a seam with a ring at the end.

  If necessary, the sleeve is restrained by an annular, conical or umbrella-like restraining device.

As necessary, the tip of the plunger includes a net holding portion including a plurality of fins. The proximal portion of the porous structure is positioned over the fin so that the fin moves the porous structure proximally as the plunger moves proximally.
The sleeve may be folded twice to ten times before being wrapped around the rod.

  The delivery device includes an inflatable balloon at the distal end of the elongate body, an inlet provided at a proximal end of the elongate body, and the balloon and the inlet extending along the elongate body May further include a channel in fluid communication. The inlet and the inlet are used to inflate the balloon and the inflated balloon is used to secure the delivery device within the patient's gastrointestinal tract.

  Optionally, the delivery device further includes a water flow mechanism or a water injection mechanism that reduces the deployment force during delivery.

The long body may have a predetermined length, and the length may have rigidity that is not constant. Optionally, the length has at least three regions, the most distal region being more flexible than the central distal region, the central distal region being more proximal than the most proximal distal region. Is also flexible.
The elongate body may include a braided catheter.
The elongate body, the plunger, and the distal end of the rod may be adapted not to damage tissue.

  The present specification also discloses a delivery device for delivering an intragastric device into the gastrointestinal tract of a patient. The intragastric device includes a porous structure that can change between a compressed pre-deployment configuration and an expanded post-deployment configuration, and an elongate sleeve coupled to a distal end of the porous structure including. The delivery device includes a flexible elongate having a proximal end, a distal end, and an elongate lumen therein, the elongate having an opening in the distal end and the proximal Includes an actuation mechanism attached to the end. The actuation mechanism includes a flexible plunger member that is coaxially positioned in the lumen of the elongated body and is movable in the longitudinal direction. The plunger includes a proximal end, a distal end, and a plunger lumen therein, and includes a tip at the distal end. The proximal end is operatively attached to the actuation mechanism. The delivery device includes an actuator handle and an actuation trigger attached to the actuating mechanism, and when actuated, the actuating mechanism moves the plunger back and forth longitudinally relative to the elongated body. The delivery device includes a flexible elongate rod coaxially positioned within the plunger lumen and movable longitudinally, the rod comprising a proximal end and a distal end, the distal end And a second spherical member located at the distal end. The diameter of the first spherical member is larger than the diameter of the second spherical member. The rod further includes a rod handle attached to the proximal end. The delivery device is removably coupled to a first end attached to the sleeve of the intragastric device and the rod in a position between the first spherical member and the second spherical member. A pulling mechanism including a second end formed. The intragastric device is disposed within the delivery device for delivery such that the porous structure is located within the elongate lumen distal to the plunger tip and proximal to the sleeve. Installed. The rod passes through at least two openings in the porous structure, but these openings are not along the central longitudinal axis of the porous structure. The sleeve is located within the elongate body distal to the porous structure and proximal to the first spherical member, is folded and wrapped around a portion of the rod. Furthermore, the sleeve is attached to the first end of the pulling mechanism.

  The delivery device may further include a fastener located on the plunger between the tip and the actuation mechanism.

  If desired, this pulling mechanism is biodegradable and includes a seam or hook. Alternatively, the pulling mechanism is non-biodegradable and includes a seam with a ring at the end.

  If necessary, the sleeve is restrained by an annular, conical or umbrella-like restraining device.

As necessary, the tip of the plunger includes a net holding portion including a plurality of fins. The proximal portion of the porous structure is positioned over the fin such that when the plunger moves in the proximal direction, the fin moves the porous structure in the proximal direction.
The sleeve may be folded twice to ten times before being wrapped around the rod.

  The delivery device includes an inflatable balloon at the distal end of the elongate body, an inlet at the proximal end of the elongate body, and fluid communication between the balloon and the inlet extending along the elongate body. It may further include a channel to perform. The inlet and the inlet are used to inflate the balloon and the inflated balloon is used to secure the delivery device within the patient's gastrointestinal tract.

Optionally, the delivery device further includes a water flow mechanism or a water injection mechanism that reduces the deployment force during delivery.
The elongate body may include a braided catheter.

  The present specification also discloses a method of delivering an intragastric device into the gastrointestinal tract of a patient. The intragastric device includes a porous structure that can change between a compressed pre-deployment configuration and an expanded post-deployment configuration, and a long sleeve connected to a distal end of the porous structure. Including. The delivery device includes a flexible elongated body having a proximal end, a distal end, and an elongated body lumen therein. The elongate body includes an opening at the distal end and a first handle attached to the proximal end. The delivery device includes a flexible plunger member positioned coaxially within the lumen of the elongate body and movable longitudinally. The plunger includes a proximal end, a distal end, and a plunger lumen therein, and includes a tip at the distal end and a second handle attached to the proximal end. The delivery device includes a flexible elongate rod coaxially positioned within the plunger lumen and movable longitudinally, the rod comprising a proximal end and a distal end, the distal end And a second spherical member located at the distal end. The diameter of the first spherical member is larger than the diameter of the second spherical member. The rod includes a third handle attached to the proximal end, a first end attached to the sleeve of the intragastric device, and the first and second spherical members. And a pulling mechanism including a second end removably coupled to the rod in a position therebetween. The intragastric device is positioned within the delivery device such that the porous structure is located within the elongate lumen distal to the plunger tip and proximal to the sleeve. Mounted for delivery. The rod passes through at least two openings in the porous structure, but these openings are not along the central longitudinal axis of the porous structure. The sleeve is located within the elongate body distal to the porous structure and proximal to the first spherical member, is folded and wrapped around a portion of the rod. Further, the sleeve is attached to a first end of the pulling mechanism. The method includes sliding the delivery device along the outside of a guide wire into the gastrointestinal tract of the patient; using the first handle to place the distal end of the elongate body in the patient's duodenum Pushing the second handle to push the plunger member until the sleeve is pushed out of the elongate body; pushing the third handle to push the rod into the plunger lumen until the sleeve is fully deployed. Moving the delivery device back to reposition the distal end of the elongate body in the patient's stomach; holding the second handle firmly while pulling back the first handle; Holding the jar in place and releasing the wire mesh structure; and removing the delivery device from the patient.

  The delivery device may further include a fastener located on the plunger between the tip and the second handle. The fastener is adapted to stop the plunger from moving further distally once the sleeve is pushed out of the elongate body.

  The delivery device includes an inflatable balloon at the distal end of the elongate body, an inlet at the proximal end of the elongate body, and fluid communication between the balloon and the inlet extending along the elongate body. It may further include a channel to perform. The method may further include inflating the balloon using the inlet and the channel to secure the delivery device within the patient's gastrointestinal tract.

  The present specification also discloses a delivery device for delivering an intragastric device into the gastrointestinal tract of a patient. The intragastric device includes a porous structure that can change between a compressed pre-deployment configuration and an expanded post-deployment configuration, and an elongate sleeve coupled to a distal end of the porous structure including. The delivery device includes a flexible elongated body having a proximal end, a distal end, and an elongated body lumen therein. The elongate body includes an opening at the distal end and a first handle attached to the proximal end. The delivery device includes a flexible elongate rod positioned coaxially within the elongate lumen and movable longitudinally. The rod has a proximal end and a distal end, and includes a first spherical member located proximal to the distal end and a second spherical member located at the distal end. The diameter of the first spherical member is larger than the diameter of the second spherical member. The rod further includes a second handle attached to the proximal end. The delivery device includes a flexible plunger member that is coaxially positioned outside a proximal portion of the flexible elongate rod and movable longitudinally. The plunger includes a distal end tip having a proximal end and a distal end and attached to the second handle at the proximal end. The delivery device is removably coupled to a first end attached to the sleeve of the intragastric device and the rod in a position between the first spherical member and the second spherical member. A pulling mechanism including a second end formed. The intragastric device is disposed within the delivery device for delivery such that the porous structure is located within the elongate lumen distal to the plunger tip and proximal to the sleeve. Installed. The rod passes through at least two openings in the porous structure, but these openings are not along the central longitudinal axis of the porous structure. The sleeve is located within the elongate body distal to the porous structure and proximal to the first spherical member, is folded and wrapped around a portion of the rod. Furthermore, the sleeve is attached to the first end of the pulling mechanism.

The pulling mechanism may be biodegradable and may include seams or hooks. Alternatively, the pulling mechanism is non-biodegradable and includes a seam with a ring at the end.
The sleeve may be restrained by an annular, conical or umbrella-like restraining device.

  As necessary, the tip of the plunger includes a net holding portion including a plurality of fins. The proximal portion of the porous structure is positioned over the fin such that when the plunger moves in the proximal direction, the fin moves the porous structure in the proximal direction.

  If necessary, the sleeve is folded twice to ten times before being wrapped around the rod.

  Optionally, the delivery device includes an inflatable balloon at the distal end of the elongate body, an inlet at the proximal end of the elongate body, and the balloon extending along the elongate body and the It further includes a channel in fluid communication with the inlet. The inlet and the inlet are used to inflate the balloon and the inflated balloon is used to secure the delivery device within the patient's gastrointestinal tract.

  Optionally, the delivery device further includes a water flow mechanism or a water injection mechanism that reduces the deployment force during delivery.

  This long body may have a predetermined length. The length is not constant.

The elongated body may include at least three regions. The distal most region is more flexible than the central distal region, and the central distal region is more flexible than the most proximal distal region.
The elongate body may include a braided catheter.
The elongate body, the plunger, and the distal end of the rod may be adapted not to damage tissue.

  The present specification also discloses a method of delivering an intragastric device into the gastrointestinal tract of a patient. The intragastric device includes a porous structure that can change between a compressed pre-deployment configuration and an expanded post-deployment configuration, and an elongate sleeve coupled to a distal end of the porous structure including. The delivery device includes a flexible elongated body having a proximal end, a distal end, and an elongated body lumen therein. The elongate body includes an opening at the distal end and a first handle attached to the proximal end. The delivery device includes a flexible elongate rod positioned coaxially within the elongate lumen and movable longitudinally. The rod has a proximal end and a distal end, and includes a first spherical member located proximal to the distal end and a second spherical member located at the distal end. The diameter of the first spherical member is larger than the diameter of the second spherical member. The rod further includes a second handle attached to the proximal end. The delivery device includes a flexible plunger member that is coaxially positioned outside a proximal portion of the flexible elongate rod and movable longitudinally. The plunger includes a distal end tip having a proximal end and a distal end and attached to the second handle at the proximal end. The delivery device is removably coupled to a first end attached to the sleeve of the intragastric device and the rod in a position between the first spherical member and the second spherical member. A pulling mechanism including a second end formed. The intragastric device is positioned within the delivery device such that the porous structure is located within the elongate lumen distal to the plunger tip and proximal to the sleeve. Mounted for delivery. The rod passes through at least two openings in the porous structure, but these openings are not along the central longitudinal axis of the porous structure. The sleeve is located within the elongate body distal to the porous structure and proximal to the first spherical member, is folded and wrapped around a portion of the rod. Further, the sleeve is attached to a first end of the pulling mechanism. The method includes sliding the delivery device along the outside of a guide wire into the gastrointestinal tract of the patient; using the first handle to place the distal end of the elongate body in the patient's duodenum Pushing the second handle to push the plunger member and rod until the sleeve is fully deployed; pulling back the delivery device to reposition the distal end of the elongate body in the patient's stomach; Holding the second handle firmly to keep the plunger and rod in place and releasing the wire mesh structure; and removing the delivery device from the patient.

  Optionally, the delivery device further includes a fastener located on the plunger between the tip and the second handle. Once the sleeve is pushed out of the elongate body, the plunger and rod stop moving further distally.

  Optionally, the delivery device includes an inflatable balloon at the distal end of the elongate body, an inlet at the proximal end of the elongate body, and the balloon extending along the elongate body and the It further includes a channel in fluid communication with the inlet. The method further includes inflating the balloon using the inlet and the channel to secure the delivery device in the gastrointestinal tract of the patient.

  The present specification also discloses a delivery system for delivering an intragastric device. The delivery system has a proximal end and a distal end, and an outer catheter having a non-constant stiffness along its length; and is positioned coaxially within the outer catheter and does not harm the proximal end, tissue A flexible inner catheter having a distal end and a lumen for receiving a guide device is included. The intragastric device is located in a space between the inner catheter and the outer catheter, the inner catheter including a flexible extension having a length of at least 5 cm at a distal end thereof. This extension extends beyond the distal end of the outer catheter.

If necessary, the guide device is a guide wire. Alternatively, the guide device is an endoscope for delivering a delivery article on the tip.
The tip that does not damage the tissue may be spherical.
The inner catheter may have a non-constant stiffness along its length.

  Optionally, the flexible extension comprises a proximal end and a distal end and has a non-constant stiffness along its length. This stiffness differs between the guide wire stiffness at the distal end and the inner catheter stiffness at the proximal end.

  The present specification also includes a porous structure having a pre-deployment shape having a first volume and a post-deployment shape having a second volume that is greater than the first volume, including an upper portion, a lower portion, and an interior. An intragastric device is disclosed. The porous structure includes at least one first opening proximate to the top and at least one second opening proximate to the bottom so that in the unfolded shape, food is the at least one The porous structure is entered via one first opening and exits the porous structure via the at least one second opening. The porous structure further includes a wire net having a substantially spherical expanded shape, and a ring having a bend located at the bottom of the porous structure. The bend includes an extension of the metal wire that curves away from the longitudinal central axis of the porous structure and then curves upward toward the top of the porous structure. The intragastric device includes a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve having a sleeve interior. The food from the at least one second opening enters the sleeve through the third opening, passes through the sleeve, and exits the sleeve through the fourth opening. The proximal end of the sleeve is connected to the ring. The sleeve is designed to intermittently engage the pylorus without blocking the patient's pylorus so that food enters the small intestine from the stomach through the lumen of the sleeve.

  The present specification also discloses a system for delivering an intragastric device into the gastrointestinal tract of a patient. The intragastric device includes a porous network structure having a first lumen, a sleeve attached to the porous network structure and having a second lumen, and a coaxial catheter system including an outer catheter and an inner catheter. Including. The porous mesh structure and the sleeve are pushed into the space between the outer and inner catheters prior to delivery. The outer catheter covers a substantial portion of the intragastric device, and the inner catheter passes through the first lumen of most meshes, but exits from the main portion of the second lumen of the sleeve .

  When activated, the inner catheter is operated at its distal end so that the inner catheter pushes the sleeve out of the coaxial catheter system and then the inner catheter is removed from the sleeve to deliver the intragastric device into the gastrointestinal tract. To be attached to the sleeve.

  The present specification also discloses a system for promoting weight loss of a patient. The system includes an intragastric device, a delivery device, and a retrieval device. The intragastric device is adapted to be temporarily deployed in a patient's gastrointestinal tract, including an upper portion, a lower portion, and an interior, having a first volume with a pre-deployment shape and larger than the first volume A porous structure having a deployed shape having a second volume is included. The porous structure includes at least one first opening proximate to the top and at least one second opening proximate to the bottom so that in the unfolded shape, food is the at least one The porous structure is entered via one first opening and exits the porous structure via the at least one second opening. The porous structure further includes a ring having a bend located at the bottom of the porous structure. The bend includes an extension of the metal wire that curves away from the longitudinal central axis of the porous structure and then curves upward toward the top of the porous structure. The intragastric device includes a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve having a sleeve interior. The food from the at least one second opening enters the sleeve through the third opening, passes through the sleeve, and exits the sleeve through the fourth opening. The proximal end of the sleeve is connected to the bottom of the porous structure. Once the intragastric device is deployed in the patient's gastrointestinal tract, at least a portion of the intragastric device is part of the patient's gastrointestinal tract without being physically attached to any part of the patient's anatomy. Always in physical contact with the part.

  Physical contact may be caused by pulling the sleeve of the intragastric device in the small intestine due to the intestinal movement of the small intestine.

  A portion of the intragastric device may include a portion of the porous structure and the portion of the patient's gastrointestinal tract may include a portion of the stomach near the pylorus. If desired, a portion of the stomach may include the gastric drainage area, and the intragastric device does not occlude this area.

  A portion of the intragastric device may include a portion of the sleeve and the portion of the patient's gastrointestinal tract may include a portion of the pylorus.

  A portion of the intragastric device may include a portion of the sleeve, and the portion of the patient's gastrointestinal tract may include a portion of the duodenum.

  The intragastric device may allow food to pass therethrough, thereby allowing food to pass from the patient's stomach to the small intestine without blocking the food passage. Optionally, at least 10%, preferably 50%, of the food delivered from the patient's stomach into the small intestine passes through the intragastric device.

  The intragastric device may always bypass the patient's pylorus substantially completely. If desired, the intragastric device may always bypass the patient's pylorus and duodenum substantially completely.

  The present specification also discloses a system for promoting weight loss of a patient. The system includes an intragastric device, a delivery device, and a retrieval device. The intragastric device is adapted to be temporarily deployed in the patient's gastrointestinal tract. The intragastric device includes an upper portion, a lower portion, and an interior, and a porous structure having a pre-deployment shape having a first volume and a post-deployment shape having a second volume larger than the first volume including. The porous structure includes at least one first opening proximate to the top and at least one second opening proximate to the bottom so that in the unfolded shape, food is the at least one The porous structure is entered via one first opening and exits the porous structure via the at least one second opening. The porous structure further includes a ring having a bend located at the bottom of the porous structure. The bend includes an extension of the metal wire that curves away from the longitudinal central axis of the porous structure and then curves upward toward the top of the porous structure. The intragastric device includes a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve having a sleeve interior. The food from the at least one second opening enters the sleeve through the third opening, passes through the sleeve, and exits the sleeve through the fourth opening. The proximal end of the sleeve is connected to the bottom of the porous structure. Once the intragastric device is deployed in the patient's gastrointestinal tract, the porous structure is located in the patient's stomach and physically contacts a portion of the stomach. The sleeve is located within the patient's pylorus and duodenum so that the intragastric device always bypasses the patient's pylorus substantially completely so that any portion of the pylorus that food digested by the patient can be Even physical contact is not possible.

  The sleeve of the intragastric device may be pulled in the small intestine due to a small bowel movement, thereby causing physical contact with the stomach portion.

  The intragastric device may allow food to pass therethrough, thereby allowing food to pass from the patient's stomach to the small intestine without blocking the food passage. Optionally, at least 10%, preferably 50%, of the food delivered from the patient's stomach into the small intestine passes through the intragastric device.

  Optionally, the intragastric device is not physically attached to any part of the patient's anatomy.

  The present specification also discloses a system for promoting weight loss of a patient, including an intragastric device, a delivery device, and a retrieval device. The intragastric device is adapted to be temporarily deployed in the patient's gastrointestinal tract. The intragastric device includes an upper portion, a lower portion, and an interior, a porous structure having a pre-deployment shape having a first volume and a post-deployment shape having a second volume greater than the first volume including. The porous structure includes at least one first opening proximate to the top and at least one second opening proximate to the bottom so that in the unfolded shape, food is the at least one The porous structure is entered via one first opening and exits the porous structure via the at least one second opening. The porous structure further includes a ring having a bend located at the bottom of the porous structure. The bend includes an extension of the metal wire that curves away from the longitudinal central axis of the porous structure and then curves upward toward the top of the porous structure. The intragastric device includes a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve having a sleeve interior. The food from the at least one second opening enters the sleeve through the third opening, passes through the sleeve, and exits the sleeve through the fourth opening. The proximal end of the sleeve is connected to the bottom of the porous structure. Once the intragastric device is deployed in the patient's gastrointestinal tract, the porous structure is located in the patient's stomach and is in physical contact with a portion of the stomach. The sleeve is located within the patient's pylorus and duodenum so that the intragastric device always bypasses the patient's duodenum substantially completely. The food digested by the patient cannot physically touch any part of the duodenum.

  The system is in physical contact with the portion of the stomach by pulling the sleeve of the intragastric device within the small intestine for vagina operation of the small intestine.

  The intragastric device may allow food to pass therethrough, thereby allowing food to pass from the patient's stomach to the small intestine without blocking the food passage. Optionally, at least 10%, preferably 50%, of the food delivered from the patient's stomach into the small intestine passes through the intragastric device.

  Optionally, the intragastric device is not physically attached to any part of the patient's anatomy.

  These and other aspects of the invention are described more fully in the drawings and detailed description set forth below.

These and other features and advantages of the present invention will be better understood by reference to the following detailed description, taken in conjunction with the accompanying drawings.
FIG. 1 shows the upper gastrointestinal system.

FIG. 2A is a view of a wire mesh structure in a deployed configuration having a proximally inclined anti-movement disc or anti-movement ring attached to the distal end, according to one aspect of the specification.

FIG. 2B is a view of a deployed form of wire mesh structure having a proximally curved anti-migration ring formed at the distal end, according to one aspect of the specification.

FIG. 2C is another view of a wire mesh structure according to one embodiment of the present specification.

FIG. 3A is a diagram illustrating a plurality of free ends or knots located at the proximal and distal ends of a wire mesh structure according to one aspect of the present description.

FIG. 3B is a diagram illustrating a plurality of overlapping knots located at one end of a wire mesh structure in accordance with an aspect of the present description.

FIG. 3C is a diagram illustrating a first group of knots located at one end of the wire mesh structure and a second group of knots located proximal to the first group of knots according to one aspect of the present specification.

FIG. 3D is a diagram of a first group of knots and a second group of knots at one end of a wire mesh structure, according to one embodiment of the present specification, showing a ring formed on the metal wires of the first group of knots. .

FIG. 3E is a diagram of a first group of knots and a second group of knots at one end of a wire mesh structure, according to one embodiment of the present specification, showing a ring formed on a metal wire of the second group of knots. .

FIG. 3F is a diagram of a first group of knots and a second group of knots at one end of a wire mesh structure, according to one embodiment of the present specification, of both the first group of knots and the second group of knots. Rings alternately formed on the line are shown.

FIG. 3G illustrates a wire mesh structure having a first group of knots at the proximal end and a second group of knots at the distal end, according to one embodiment of the present specification.

FIG. 3H illustrates a third group of knots and a fourth group having a first group of knots and a second group of knots at the proximal and distal ends, respectively, distributed along the surface, according to one embodiment of the present specification. It is a figure which shows the wire-mesh structure which has a knot of a group.

FIG. 3I is a diagram illustrating various possible shapes of knots in accordance with aspects herein.

FIG. 4A is a detailed view of an anti-migration ring that does not damage the tissue of the wire mesh structure of the intragastric device, according to one embodiment of the present specification.

FIG. 4B is a detailed view of an anti-migration ring that does not damage tissue of the wire mesh structure of the intragastric device, according to another aspect of the present description.

FIG. 4C is a detailed view of an anti-migration ring that does not damage tissue of the wire mesh structure of the intragastric device, according to yet another aspect of the present description.

FIG. 5A is a view of a portion of a sleeve member of a deployed intragastric device, according to one embodiment of the present specification, showing a single metal wire support helically wound along the sleeve body. .

FIG. 5B is a view of a portion of the sleeve member of the deployed intragastric device, according to one aspect of the present specification, showing a plurality of metal wire supports spirally wound along the sleeve body.

FIG. 5C is an illustration of a sleeve member having a funnel shape of an intragastric device in a deployed configuration, according to one embodiment of the present specification, showing a metal wire support in a loop wound helically around the sleeve.

FIG. 5D is a view of the sleeve member of the intragastric device in a deployed configuration, according to one aspect of the specification, showing a funnel-shaped opening at the proximal end of the sleeve.

FIG. 5E is an illustration of a sleeve member having the funnel shape of an intragastric device in a deployed configuration, according to one aspect of the specification, showing a plurality of indicia provided on the outer surface of the sleeve body.

FIG. 5F is an illustration of a sleeve member having a funnel shape of an intragastric device in a deployed configuration, according to one aspect of the present specification, showing an indicator line extending along the length of the sleeve on the outer surface of the sleeve body.

FIG. 5G is an illustration of a sleeve member having a funnel shape of an intragastric device in a deployed configuration, according to one aspect of the present specification, with a plurality of indicators and indicators extending along the length of the sleeve on the outer surface of the sleeve body Show the line.

FIG. 6A is a cross-sectional view of a sleeve member having a funnel shape of an intragastric device in a deployed configuration, according to one aspect of the present specification, showing a plurality of sleeve layers.

FIG. 6B is a cross-sectional view of a sleeve member having a funnel shape of an intragastric device in a deployed configuration, according to another aspect of the present specification, showing a plurality of sleeve layers.

FIG. 6C is a cross-sectional view of a sleeve member having a funnel shape of an intragastric device in a deployed configuration, according to another aspect of the present specification, showing a plurality of sleeve layers.

FIG. 6D is a cross-sectional view of a sleeve member having a funnel shape of an intragastric device in a deployed configuration, according to another aspect of the present specification, showing a plurality of sleeve layers.

FIG. 6E is a cross-sectional view of a sleeve member having a funnel shape of an intragastric device in a deployed configuration, according to yet another aspect of the specification.

FIG. 6F is an illustration of a stent support for a sleeve member of an intragastric device, according to one embodiment herein.

6G is an illustration of a sleeve member of an intragastric device having the stent support of FIG. 6F.

FIG. 6H is a diagram illustrating a portion of a sleeve of a wire mesh device covered with a nanofiber membrane, according to one embodiment of the present specification.

FIG. 7 is an illustration of a funnel shaped sleeve for an intragastric device, according to one aspect of the present description.

FIG. 8 is an illustration of a funnel shaped sleeve for an intragastric device according to another aspect of the present description.

FIG. 9A is a view of a deployed form of wire mesh structure with a sleeve member attached, according to one aspect of the specification, showing the unsharp end of the wire mesh support toward the proximal end of the sleeve.

FIG. 9B is an illustration of a deployed form of a wire mesh structure having a sleeve member attached to a proximal portion, according to one aspect of the specification, illustrating a delivery catheter located within the wire mesh structure.

FIG. 10A is an illustration of a short braided sleeve member having a funnel shape in a deployed form, according to one aspect of the specification.

FIG. 10B is an illustration of a short braided sleeve member having a funnel shape in a deployed form, having a conical shaped distal end, in accordance with an aspect of the present specification.

FIG. 10C is an illustration of a short braided sleeve member having a conical shape in a deployed form, according to one aspect of the specification.

FIG. 10D is an illustration of a short braided sleeve member having the conical shape of FIG. 10C attached to a wire mesh structure in accordance with an aspect of the present description.

FIG. 10E is an illustration of a short braided sleeve member having a conical shape in a deployed configuration, according to another aspect of the specification.

FIG. 10F is an illustration of a short braided sleeve member having the conical shape of FIG. 10E attached to a wire mesh structure in accordance with an aspect of the present description.

FIG. 10G is an illustration of a short braided sleeve member having a post-deployed configuration of a conical shape with a distal tip that does not harm tissue, in accordance with an aspect of the present description.

FIG. 10H is an illustration of a short braided sleeve member having a conical shape in a deployed configuration with a distal tip that does not harm tissue, according to another aspect of the specification.

FIG. 11A is a cross-sectional view illustrating one embodiment of an intragastric device in a deployed form with a sleeve attached.

FIG. 11B is a cross-sectional view showing the intragastric device of FIG. 11A in a form before deployment.

FIG. 11C is a cross-sectional view showing another embodiment of the intragastric device in the deployed configuration with the sleeve attached.

FIG. 11D is a cross-sectional view showing the intragastric device of FIG. 11C in a form before deployment.

FIG. 12A is a diagram of a plurality of knots located at the distal end of a wire mesh structure coupled to the proximal end of a funnel-shaped sleeve, according to one aspect of the specification.

FIG. 12B is a diagram of a plurality of knots located at the distal end of a wire mesh structure coupled to the proximal end of a funnel-shaped sleeve, according to another aspect of the specification.

FIG. 12C is an illustration of a plurality of knots located at the distal end of a wire mesh structure coupled to the proximal end of a funnel-shaped sleeve, according to another aspect of the specification.

FIG. 12D is a diagram of a plurality of knots located at the distal end of a wire mesh structure coupled to the proximal end of a funnel-shaped sleeve, according to another aspect of the specification.

FIG. 12E is a diagram of a plurality of knots located at the distal end of a wire mesh structure coupled to the proximal end of a funnel-shaped sleeve, according to another aspect of the specification.

FIG. 12F is a diagram of a plurality of knots located at the distal end of a wire mesh structure coupled to the proximal end of a funnel-shaped sleeve, according to yet another aspect of the specification.

FIG. 13A is a diagram of a plurality of knots located at the distal end of a wire mesh structure coupled to the proximal end of a funnel-shaped sleeve, according to one aspect of the specification.

FIG. 13B is a view of the distal end of a metal wire structure and the proximal end of a funnel-shaped sleeve covered with a connected heat shrink tube, in accordance with an aspect of the present description.

FIG. 14 is an illustration of a deployed intragastric device having a funnel-shaped sleeve, according to one embodiment of the present specification.

FIG. 15 is an illustration of a deployed intragastric device having a cylindrical sleeve in accordance with an aspect of the present description.

FIG. 16A is a detailed view of a funnel-shaped sleeve attached to a detent ring of a wire mesh structure of an intragastric device, according to one embodiment of the present specification.

FIG. 16B is a detailed view of a funnel-shaped sleeve attached to the anti-migration ring of a wire mesh structure of an intragastric device and having a frayed sleeve proximal end according to another aspect of the present specification.

FIG. 16C is an illustration of an intragastric device including a wire mesh structure and an attached sleeve, according to one aspect of the present description.

FIG. 16D is a view of the intragastric device of FIG. 16C with the sleeve straightened to show the dimensions of the device relative to the surrounding anatomy.

FIG. 16E is an illustration of a wire mesh structure and sleeve of an intragastric device, according to one embodiment of the present specification, showing a recovery string attached to the wire mesh structure.

FIG. 16F is a diagram of a wire mesh structure and sleeve of an intragastric device, according to one embodiment of the present specification, showing a single retrieval cord attached to the wire mesh structure.

FIG. 17A is a cross-sectional view of the distal end of the sleeve, showing one embodiment of one member of the distal end designed to not damage body tissue.

FIG. 17B is a cross-sectional view of the distal end of the sleeve showing another embodiment of one member of the distal end designed to not damage body tissue.

FIG. 17C is a cross-sectional view of the distal end of the sleeve showing another embodiment of one member of the distal end designed to not damage body tissue.

FIG. 18 is a view of the distal end of a sleeve having a positioning tail, according to one aspect of the specification.

FIG. 19A is a view of the distal end of a sleeve including a plurality of tufts coupled to a ring, according to one aspect of the specification.

FIG. 19B is a view of the distal end of a sleeve including a plurality of tufts coupled to a ball, according to one aspect of the specification.

FIG. 19C is a cross-sectional view of a ball attached to the distal end of a sleeve, according to one aspect of the specification.

FIG. 19D is a view of the distal end of a sleeve having a plurality of seams extending from the sleeve and coupled to a ball, according to one aspect of the specification.

FIG. 19E is a view of the distal end of the sleeve, showing at least one seam extending from the distal end and a seam ring or bead attached to the seam, according to one aspect of the specification.

FIG. 20A is a view of the distal end of a sleeve, according to one aspect of the present specification, showing at least one fold provided in the sleeve wall.

FIG. 20B is a view of the distal end of the sleeve, showing at least one channel and support structure provided in the sleeve wall, according to one aspect of the specification.

FIG. 20C is an illustration of a portion of a sleeve, showing a corrugated sleeve wall, according to one aspect of the specification.

FIG. 20D is an illustration of a portion of a sleeve, showing a braided sleeve wall, according to one aspect of the specification.

FIG. 20E is an illustration of a portion of a sleeve, showing a braided sleeve wall and a frayed distal end of the sleeve, according to one aspect of the present description.

FIG. 20F is an illustration of an exemplary sleeve braid pattern in accordance with various aspects herein.

FIG. 21A is an illustration of an intragastric device having an elliptical wire mesh structure deployed in a patient's gastrointestinal tract, according to one embodiment of the present specification.

FIG. 21B is an illustration of an intragastric device having an elliptical wire mesh structure deployed in a patient's gastrointestinal tract according to another aspect of the present description.

FIG. 21C shows a plurality of pylorus open and closed states when the sleeve of the intragastric device passes through and does not pass through the patient's pylorus, according to some embodiments herein. FIG.

FIG. 22 illustrates an expanded wire mesh structure of a first intragastric device and a contracted wire mesh structure of a second gastric device coupled to the distal end of an infusion catheter according to one embodiment of the present specification. FIG.

FIG. 23 is an illustration of an intragastric device having a partially constrained wire mesh structure on a delivery catheter, according to one embodiment of the present specification.

FIG. 24A is a diagram of a first exemplary delivery device for an intragastric device, according to one embodiment herein.

24B is a flow diagram illustrating a process that includes delivering an intragastric device using the delivery device of FIG. 24A, according to one aspect of the specification.

FIG. 25A is a diagram of a second exemplary delivery device for an intragastric device, according to one aspect of the specification.

FIG. 25B is a flow diagram illustrating a process that includes delivering an intragastric device using the delivery device of FIG. 25A, according to one aspect of the specification.

FIG. 25C is a flow diagram illustrating a process that includes delivering an intragastric device using a delivery device that includes a withdrawal sheath, according to one embodiment of the present specification.

FIG. 26A is a diagram of a third exemplary delivery device for an intragastric device, according to one aspect of the specification.

FIG. 26B is a flow diagram illustrating a process that includes delivering an intragastric device using the delivery device of FIG. 26A according to one aspect of the specification.

FIG. 26C is a flow diagram illustrating a process that includes delivering an intragastric device using the delivery device of FIG. 26A according to another aspect herein.

FIG. 26D is a flow diagram illustrating a process that includes delivering the wire mesh structure and sleeve separately and assembling the intragastric device within the gastrointestinal tract of the patient.

FIG. 27A is a diagram of a fourth exemplary delivery device for an intragastric device, according to one embodiment herein.

FIG. 27B is another view of the delivery device of FIG. 27A showing the relative lengths of the various members of the delivery device.

FIG. 27C is a view of the distal end of the delivery device, according to one aspect of the present specification, showing a guiding olive tip for guidance.

FIG. 27D is a diagram of a portion of a delivery device, according to one aspect of the present specification, showing a net holder.

FIG. 27E is a flow diagram illustrating a process that includes delivering an intragastric device using the delivery device of FIG. 27A, according to one embodiment herein.

FIG. 28A is a diagram of a fifth exemplary delivery device for an intragastric device, according to one aspect of the specification.

FIG. 28B is a flow diagram illustrating a process that includes delivering an intragastric device using the delivery device of FIG. 28A, according to one aspect of the specification.

FIG. 29A is a diagram of a sixth exemplary delivery device for an intragastric device, according to one aspect of the specification.

FIG. 29B is a cross-sectional view illustrating a coaxial arrangement prior to deployment of a sleeve of an intragastric device within a delivery device, in accordance with an aspect of the present description.

FIG. 29C is a cross-sectional view illustrating a coaxial arrangement prior to deployment of a sleeve of an intragastric device within a delivery device, in accordance with other aspects herein.

FIG. 29D is a cross-sectional view illustrating a coaxial arrangement prior to deployment of a sleeve of an intragastric device within a delivery device, positioned outside the endoscope, according to one aspect of the specification.

FIG. 29E is a flow diagram illustrating a process that includes delivering an intragastric device using the delivery device of FIG. 29A, according to one embodiment herein.

FIG. 30A is a diagram of a seventh exemplary delivery device for an intragastric device, according to one aspect of the specification.

FIG. 30B is a diagram of an exemplary embodiment of an outer catheter for using the delivery device of FIG. 30A.

FIG. 30C is an illustration of another aspect of the outer catheter, showing the dimensions of the compressed sleeve and compressed wire mesh structure of the intragastric device relative to the dimensions of the outer catheter.

FIG. 30D is a detailed view of the distal end of the delivery device of FIG. 30A showing a guide member, a proximal sphere, and a distal sphere.

FIG. 30E is a proximal end view of the delivery device of FIG. 30A showing the outer catheter retracted to the first stop mechanism.

FIG. 30F is a view of one embodiment of a partially deployed intragastric device sleeve corresponding to the position of the outer catheter shown in FIG. 30E.

FIG. 30G is a view of the proximal end of the delivery device of FIG. 30A showing the outer catheter retracted to a second stop mechanism.

FIG. 30H is an illustration of one embodiment of a partially deployed intragastric device wire mesh structure corresponding to the position of the outer catheter shown in FIG. 30I.

FIG. 30I is a flow diagram illustrating steps that include delivering an intragastric device using the delivery device of FIG. 30A according to one aspect of the specification.

FIG. 31A is a diagram of a wire mesh structure of an intragastric device mounted on a delivery device according to one embodiment of the present specification.

FIG. 31B is a diagram of the wire mesh structure of FIG. 31A further mounted on a delivery device.

FIG. 31C is a diagram of the wire mesh structure of FIG. 31A mounted on the delivery device such that only the anti-migration ring remains unmounted.

FIG. 31D is a view of the wire mesh structure of FIG. 31A fully loaded into the delivery device.

FIG. 31E is a view of the sleeve of the intragastric device of FIG. 31A partially mounted on a delivery device.

FIG. 31F is a view of the intragastric device of FIG. 31A fully loaded into the delivery device.

FIG. 32A is an illustration of a retrieval device for removing an intragastric device according to one embodiment of the present specification.

FIG. 32B is a flow diagram illustrating a process that includes removing an intragastric device from a patient using the collection device of FIG. 31A according to one aspect of the specification.

FIG. 33A is a view of one embodiment of an exemplary post-deployment intragastric device having a dumbbell shape.

FIG. 33B is a view of one embodiment of an intragastric device having a two-stage wire mesh structure, in which the lower wire mesh is formed of a turn-up prevention member.

FIG. 34A is a diagram of an exemplary intragastric device having a two-stage wire mesh structure in a deployed configuration, according to one embodiment of the present specification.

FIG. 34B is a diagram of another exemplary intragastric device having a bi-level wire mesh structure in a deployed configuration, according to one aspect of the specification.

FIG. 34C is a diagram of another exemplary intragastric device having a two-stage wire mesh structure in a deployed configuration, according to one aspect of the specification.

FIG. 34D is a diagram of another exemplary intragastric device having a two-stage wire mesh structure in a deployed configuration, according to one aspect of the specification.

FIG. 34E is a diagram of another exemplary intragastric device having a two-stage wire mesh structure in a deployed configuration, according to one aspect of the specification.

FIG. 34F is a diagram of another exemplary intragastric device having a two-stage wire mesh structure in a deployed configuration, according to one aspect of the specification.

FIG. 34G is a diagram of another exemplary two-stage wire mesh intragastric device in a deployed configuration, according to one aspect of the specification.

FIG. 34H shows an intragastric device having two wire meshes coupled to a detent mechanism according to one aspect of the present description.

FIG. 35 is a diagram of an exemplary single gastric device attached to a single gastric device previously deployed in the stomach.

FIG. 36 is a diagram of an exemplary intragastric device fully deployed and connected in the stomach.

FIG. 37A is a side perspective view of an exemplary intragastric device having two connected wire mesh structures in a deployed configuration, according to one aspect of the specification.

FIG. 37B is a perspective view of the intragastric device of FIG. 37A.

FIG. 37C is a diagram of a plurality of seams flexibly connecting the first and second wire mesh structures of the intragastric device of FIG. 37A.

FIG. 37D is an illustration of a sleeve coupled to the intragastric device of FIG. 37A, according to one aspect of the specification.

FIG. 37E is a diagram of two exemplary stitch points that flexibly connect the first and second wire mesh structures of the intragastric device of FIG. 37A.

FIG. 37F is a diagram showing the relative movement angles of the first wire mesh structure and the second wire mesh structure of the intragastric device of FIG. 37A.

FIG. 38A illustrates a method of deploying a connected intragastric device, where one wire mesh structure is almost fully deployed and the other wire mesh structure is still deflated within the catheter.

FIG. 38B illustrates a method of pulling back or removing a connected intragastric device, where one wire mesh structure is partially deflated within the catheter and the other wire mesh structure is not yet deflated. Or in an expanded state.

FIG. 38C illustrates a method of pulling back or removing a connected intragastric device, when one wire mesh structure is fully contracted within the catheter, the other wire mesh structure is compressed within the catheter. To be arranged or oriented.

FIG. 38D shows that as the fully compressed wire mesh structure is further pulled back into the catheter, the deployed or oriented wire mesh structure begins to contract or compress into the catheter for removal.

  In one aspect, the present description relates to a dynamic weight intragastric device used in obese patients to induce weight loss. In various embodiments, the intragastric device includes a porous three-dimensional structure having a pre-deployment shape and a post-deployment shape. In one aspect, the porous three-dimensional structure is a non-expandable wire mesh structure, or a spherical, elliptical, kidney bean, or any predetermined shape having a significant volume after deployment from a compressed cylindrical shape before deployment. It is a helical structure made of a shape memory metal or shape memory polymer that changes to the shape of In other embodiments, the intragastric device is made of a plastic material or polymer (eg, polyetheretherketone (PEEK) or polyester), or a bioabsorbable material. This device changes between pre-deployment and post-deployment shapes with minimal mechanical force and / or temperature changes from the pre-deployment shape at room temperature to the post-deployment shape at body temperature. To do. This device is delivered to the stomach using an endoscopic instrument with a catheter. The device may be placed through the endoscope, over the endoscope, or over a guide wire with guidance or assistance through the endoscope or fluoroscopy.

  The device has a compressed shape prior to deployment to facilitate insertion and an expanded shape after deployment that remains in the gastric lumen. The volume after deployment of this device is considerably larger than the volume before deployment. In one aspect, the volume of the device after deployment is at least 100 ml. The deployed device occupies a large volume in the stomach, thereby reducing the volume of stomach available for storing digested food. This limits the food intake, induces a feeling of fullness and suppresses appetite. In one aspect, the device is designed to intermittently delay or prevent the passage of food from the stomach to the small intestine with gastric peristalsis, thereby delaying gastric emptying. In various embodiments, the device is also capable of creating a duodenal switch by either digested food bypassing the spleen secretion or spleen secretion bypassing the digested food.

  In one aspect, the device includes a shape memory metal and, once deployed, self-expands from a pre-deployment shape to a post-deployment shape. In another aspect, the device includes a temperature sensitive metal that is cooled in a pre-deployment shape and self-expands to a post-deployment shape when exposed to human body temperature. In another aspect, an expander is used to change the shape of the device from a pre-deployment shape to a post-deployment shape with minimal mechanical force. In other embodiments, the intragastric device is constructed using plastic, polymer, carbon fiber, or bioabsorbable material.

  In one aspect, the metal wire structure includes different weight materials to assist in proper positioning in the stomach. In one aspect, the light weight material is located on top of the metal wire structure proximate the top opening and the heavy material is located on the bottom of the structure proximate the bottom opening. This different material weight ensures that the device is properly positioned within the stomach and achieves the intended effect of delaying gastric emptying. Further, when the weights of the materials are different, positioning in the stomach is appropriately performed without physically fixing the wire mesh structure to the stomach wall. The characteristic of different weight can also be brought about by the digested food material entering this device. The food material is pulled by gravity and easily accumulates selectively towards the bottom of the device. Different weights can also be achieved using different amounts of material in the upper and lower halves. The wire mesh structure moves freely in the stomach, but is pulled by gravity to easily maintain the correct alignment from top to bottom.

  In one aspect, the apparatus includes a wire mesh structure with a mesh opening between the metal wires of the mesh structure in a deployed configuration. In one aspect, the mesh opening is greater than 1 mm in diameter. In one aspect, the metal wire of the wire mesh structure is coated with a corrosion resistant material. The corrosion resistant material prevents the metal wire of the deployed wire mesh structure from being exposed to the acidic contents in the stomach and deteriorating. The corrosion resistant material completely covers the metal wire of the wire mesh but does not cover the mesh opening. In one aspect, the corrosion resistant material comprises parylene. Parylene has an advantage as a coating film because it has durability, may reduce nickel ion elution, and has a small thickness (becomes thin when applied). In various embodiments, the corrosion resistant material comprises silicone, polyester, polyetheretherketone (PEEK), medical grade epoxy, ceramics, additional metals, or any other suitable flexible corrosion resistant material. . In one aspect, the coating metal is tantalum. Tantalum is difficult to corrode and does not transmit radiation. In one aspect, the coating film is ceramic. This ceramic coating film has a thickness of several angstroms. In various embodiments, any one or a combination of the above corrosion resistant materials is used to coat the metal of the wire mesh structure.

  In one aspect, the mesh openings are constructed to different sizes to regulate the flow of food in and out of the mesh. In one aspect, the at least one opening in the lower half of the device is larger than any of the openings in the upper half of the device, so that food that enters the net will be released without further reducing the size of the food material. Can go.

  In other aspects, the intragastric device further includes an anti-migration member or ring coupled to a portion of its distal end. Similar to the wire mesh of the intragastric device, the anti-movement member is adapted to change between a first compressed configuration for delivery and a second expanded configuration once deployed. The anti-movement member functions as a physical fastener that prevents the intragastric device from passing through the pylorus. In various aspects, the anti-migration member has a diameter that is greater than the diameter of the relaxed pylorus. In one aspect, the anti-migration member includes an expansion of the wire mesh structure of the intragastric device. In another aspect, the anti-migration member is a separate wire mesh piece attached to a portion of the distal end of the intragastric device. In various aspects, the anti-movement member has a shape similar to a shock absorber, quasi-buffer, disk, saucer, etc. that prevents the device from moving through the pylorus, or any other shape. . In general, the anti-migration ring has a dimension such as 1) a diameter or length that is larger than the diameter of the distal opening of the wire mesh structure, and 2) is attached to the wire mesh structure distal to the distal opening. Or formed integrally therewith. In one aspect, the diameter or length ranges from 10 mm to 300 mm.

  In other embodiments, the sleeve may be attached to the intragastric device. The sleeve extends from the stomach into the empty duodenum or through the duodenum into the jejunum. In one aspect, the sleeve has the function of passing the isolated fold directly from the wire mesh structure to the center of the duodenum or the center of the jejunum. In other embodiments, the sleeve is coupled to the intragastric device, but does not receive food directly from the intragastric device. In this embodiment, the proximal end of the sleeve is distal to the intragastric device and receives food directly from either the stomach or the duodenum. Food entering the sleeve exits the distal end and enters the duodenum or jejunum, bypassing a portion of the small intestine.

  Thus, the sleeve acts to bypass a portion of the gastrointestinal (GI) tract to limit the absorption of certain materials in the intestine. The benefits provided by the sleeve are similar to the benefits provided by Rouy's gastric bypass surgery, or an improvement in weight loss and type II diabetes.

  After implantation, the gastrointestinal device herein, particularly the annulus, is always in physical contact with the patient's anatomy without actually being physically attached to the patient's anatomy. This is accomplished by pulling the sleeve down due to small bowel movements. As the sleeve is pulled down, the annulus of the wire mesh structure contacts the stomach on the proximal side of the pylorus. The sleeve is always in physical contact with the pylorus. However, constant contact with this pylorus does not impede the passage of food. The opening of the wire mesh structure and the lumen of the sleeve do not block food anywhere in the pylorus, and food can pass through the pylorus and enter the intestines. The intragastric device herein does not completely occlude food anywhere in the stomach and physically engages the gastric drainage area. The intragastric device herein functions as a variable drainage tube and does not act as a stop for the passage of food.

  The gastrointestinal device herein is designed to maximize the amount of food that is captured and flows through the sleeve into the intestine, rather than minimizing the amount of food that flows into the intestine. The intragastric device is designed to prevent food from passing around and out of the intragastric device by being in constant contact with the pylorus and stomach. In various embodiments, at least 10% of the food coming out of the patient's stomach passes through the device rather than around the device. In one aspect, at least 50% of food coming out of the patient's stomach passes through the device rather than around the device. In various aspects, food that enters the intragastric device and passes through the sleeve does not contact the patient's duodenum, which can thereby function as a true pyloric bypass.

In one aspect, the intragastric device is an inflatable balloon with a sleeve attached. The balloon is not in fluid communication with the lumen of the sleeve and only serves to hold the sleeve in place without stopping or securing the sleeve to the gastrointestinal wall. Balloons can be inflated and deflated with fluid and are designed to be present in a person's stomach. The sleeve is flexibly attached to the balloon and has a proximal opening and a distal opening. The proximal opening is designed to be proximal to the patient's bulge and the distal opening is designed to be distal to the patient's bulge. Partially digested food enters the proximal opening and exits the distal opening, bypassing the vast area. The sleeve is not locked or secured to any part of the gastrointestinal wall.
Wire mesh structure

  In various embodiments, the intragastric device includes a porous three-dimensional structure having a pre-deployment shape and a post-deployment shape. In one aspect, in a post-deployment configuration, the intragastric device includes a three-dimensional wire mesh structure that defines an internal volume and has a proximal end and a distal end.

  In various aspects, the wire mesh structure comprises a free end or “knot” that includes a bend or bend in the metal wire of the wire mesh structure. These bends are not supported and are not joined to any other part of the wire mesh. In some embodiments, the wire mesh structure comprises two groups of knots. The first group of knots is located at the proximal end of the wire mesh structure and the second group of knots is located at the distal end of the wire mesh structure. When the wire mesh structure is compressed to its undeployed configuration, the first and second groups of knots are brought together and “bunched” together at the proximal and distal ends of the wire mesh structure, respectively. This provides a larger cross-sectional area (or diameter) at the proximal and distal ends of the wire mesh structure as compared to the cross-sectional area of the wire mesh structure compressed between the proximal and distal ends. As the cross-sectional area increases, the compressed wire mesh structure becomes more difficult to deploy through a narrow delivery device or catheter. This delivery problem can be addressed in at least two ways. In various ways, the number of knots is reduced for each group of knots. Reducing the number of knots in each group makes it easier to compress the wire mesh structure and reduces the cross-sectional area of the proximal and distal ends of the wire mesh structure. This reduces the force applied to the delivery catheter by the compressed wire mesh structure, thereby making it easier to pass the compressed wire mesh structure through the catheter. In various embodiments, a portion of one or both knots of the first and second groups is moved from the ends of the wire mesh structure and disposed along the body of the wire mesh structure to provide additional groups of knots. Form. This “displacement” of the knot reduces the cross-sectional area at any point of the compressed wire mesh structure and distributes the force applied to the delivery catheter by the compressed wire mesh structure, which is also delivered. It is easier to pass the structure through the catheter. In various embodiments, the number of knots in each group is reduced to displace the knots across multiple groups of the entire wire mesh structure, and the force applied to the delivery catheter by the compressed wire mesh structure is reduced and dispersed. When the force is reduced and distributed, delivery is easier and delivery catheters with smaller diameters can be used. The smaller and dispersed force can create a larger network structure that can be compressed to smaller dimensions.

  In various aspects, each group of knots comprises 10-100 individual knots. In one aspect, each group of knots comprises 44 knots. In other embodiments, each group of knots comprises 36 knots. In various aspects, the wire mesh structure comprises 2-60 groups of knots distributed in the latitude direction at different locations along its length. In one aspect, the knots are staggered so that at least 10% of the total knot of the wire mesh structure is located at the proximal and distal ends. In various embodiments, less than 75% of the total number of knots is placed in any one of the knot groups. In various aspects, the knots are distributed in at least three different lateral groups along the length of the wire mesh structure.

The compressibility of the wire mesh structure also depends on the flexibility of the mesh. The flexibility depends on the thickness of the metal wire, the crossing angle of the metal wires, and the number of metal wire intersections, among other variables. Regarding the crossing angle of the metal wires, the wire mesh structure becomes more flexible as the arrangement of the metal wires of the wire mesh structure becomes more parallel. In various aspects, the wire mesh structure in a form before deployment has a total length of 5 to 50 cm, and the thickness of each metal wire is in the range of 0.1 to 1 mm. In one aspect, the thickness of each metal wire is 0.44 mm. The metal wire of the wire mesh structure has a bending strain that determines how it behaves as the wire mesh structure is compressed. In various embodiments, the metal line includes a shape memory metal, and in one embodiment includes, for example, nitinol. Shape memory metals have a specific bending strain rate beyond which they lose the ability to accurately return to their original shape. This strain rate (%) can be defined by the following equation.
Strain% = 2t / R × 100
In the formula, t is the thickness of the metal wire, and R is the bending radius. In one aspect, once the strain rate reaches 8%, a permanent change is introduced into the shape memory metal that can no longer fully return to its original shape. This factor becomes important when the wire mesh structure is compressed into a pre-deployed shape for delivery. In various aspects, the wire mesh structure includes a ring, or an annular extension of the wire mesh, at the distal end that functions as an anti-migration member. This ring must be folded distally during compression so that the compressed wire mesh structure fits in the delivery device or catheter. Since the ring is folded during compression, the metal mesh structure can “bulge”. If the strain rate is less than 8%, the bulge that can be formed in the compressed wire mesh structure is reduced, and the compressed wire mesh structure can be easily passed through the delivery catheter. Accordingly, in various embodiments, the wire mesh structure is configured such that the ring has a metal wire thickness and bend radius such that the strain rate of the ring is 20% or less, preferably less than 8%. In various embodiments, the radius of the ring is less than 10 times the thickness of the metal line. In various embodiments, the strain rate is in the range of 0.1-20%. In various embodiments, the thickness of the metal wire of the wire mesh is 0.1 to 1.0 mm and the bending radius of the ring is 0.013 to 20 cm. In one aspect, the thickness of the metal wire of the wire mesh is 0.4 mm. In various aspects, the thickness and bend radius of the metal line is such that it satisfies the following description.
2t <R <2000t
In the formula, t is the thickness of the metal wire, and R is the bending radius.

In various embodiments, the metal wire ends of the wire mesh structure have been treated in a manner that minimizes the potential for traumatic damage to body tissue during delivery and retrieval and during deployment. In some embodiments, the wire mesh structure includes a single metal wire folded into a three-dimensional structure. In another aspect, the wire mesh structure includes a structure in which two or more metal wires are folded together to form a three-dimensional structure. In various embodiments, the free ends or metal wires of the metal wires are joined by crimping a titanium tube or nitinol (or other shape memory metal) tube over the free ends. In another aspect, the free ends of the metal wires or the metal wires are joined by spot welding together with the free ends. In one aspect, the intersection of the metal wires is not welded. In another aspect, the intersections of the metal wires are welded.
sleeve

  In various aspects, the intragastric device herein further includes a flexible sleeve member coupled to the wire mesh structure. In a plurality of embodiments, any of the wire mesh structures described above is connected to any of the sleeve members described below. The sleeve member includes an elongate tubular body having a proximal end, a distal end, and an inner lumen.

  In one aspect, the sleeve has a constant diameter over its entire length. In other aspects, the sleeve includes a funnel shape proximate the proximal end. The diameter of the sleeve is large at the first opening at the proximal end of the sleeve body, gradually decreases as the sleeve extends distally, and reaches a minimum diameter proximal to the middle portion of the sleeve length. And the diameter remains constant distally along the rest of the sleeve length.

  In various aspects, the wire mesh structure includes a ring at the distal end, and the proximal end of the sleeve is attached to the bottom surface of the ring by one of the means described above. In various aspects, when the device is compressed to its pre-deployed configuration, the sleeve body is pulled down to assist in folding the ring. When the proximal end of the sleeve is attached to the bottom surface of the annulus as described above, the annulus will not be completely straight when folded, allowing a large bulge to the annulus when the device is in its undeployed configuration. . This bulge has a large diameter including twice the thickness of the wire mesh structure and the thickness of the sleeve. Thus, in a preferred embodiment, the proximal end of the sleeve is attached to the free end or knot of the ring by a plurality of loose seams. The sleeve is stitched to each knot in the same way that an umbrella cloth is attached to the end of each bone of the umbrella. When the umbrella is closed, the fabric is deflated and can be compressed. The intragastric device herein functions similarly. In various aspects, the distal end of the sleeve is pulled down as the wire mesh structure is compressed for mounting on a delivery device. When the sleeve is attached to the knot of the wire mesh with a loose seam, the sleeve can move relative to the wire mesh so that the annulus is pulled distally and extends more linearly. If attached in this way, it is avoided that a large bulge is formed in the ring in the form before deployment. When the sleeve body is pulled down during compression, the ring is more fully folded and the resulting bulge diameter is smaller, including only the thickness of the wire mesh structure. In various aspects, when the intragastric device is in the pre-deployment configuration, the overlap between the ring and the sleeve is minimal to zero. Upon deployment, the shape memory characteristics of the wire mesh structure cause the ring to pull the sleeve toward the ring as the wire mesh structure expands so that the cloth spreads when the umbrella is opened.

  In various embodiments, each knot at the distal end of the wire mesh structure (or ring) is attached to the proximal end of the sleeve via a seam. This may lead to swelling when the wire mesh structure is attached to the sleeve. Thus, in another aspect, fewer knots are sewn to the sleeve. For example, in one embodiment, every other knot is sewn to the sleeve to reduce the number of suture knots and reduce bulges. Moreover, even if an adhesive and a plurality of rings are included in each of the stitches of the stitches, it may lead to swelling of the attachment point with the sleeve of the wire mesh structure. As such, in various aspects, each suture knot is limited to a single loop without the use of an adhesive. When the sleeve is stitched to the knot, the knot of the suture slides along the length of the metal line including the knot, and as a result, the sleeve may move unintentionally with respect to the wire mesh structure. In order to prevent sliding, in various manners, each suture knot is disposed at a first joint of a metal wire proximal to each knot. Actually, since each seam is disposed across two metal lines, it cannot slide along one or the other metal line. In order to remove excessive bulges, fewer than all the first metal wire joints are stitched to the sleeve in various ways. For example, in one aspect, every other first metal wire joint is sewn to the sleeve.

  In various aspects, if the wire mesh and / or the metal wire of the sleeve has sharp edges, such ends can be crimped into a ring or formed outwardly to form the sleeve in the intestine. It acts as a pulling point for moving or connecting the sleeve to the wire mesh structure.

  The distal end of the sleeve may be designed to be weighted to retain an elongated shape that extends through a portion of the duodenum. In one aspect, the sleeve comprises a small weight attached to the distal end. In another aspect, the second opening at the distal end of the sleeve body is disposed along the sleeve body at the distal end, the distal end of the sleeve body further including a pouch without an outlet. A pouch without an outlet has the function of intermittently capturing small amounts of food or fluid in it. The captured food or fluid pushes down the distal end of the sleeve body with a weight, thereby keeping the sleeve member elongated. In one aspect, the distal end of the sleeve is reinforced with at least a second layer to keep the distal end positioned downward and prevent it from collapsing.

  In one aspect, the sleeve includes a wire mesh configuration having a plurality of knots similar to the configuration described for the wire mesh structure.

In another aspect, the sleeve member includes a membrane that is flexible and compressible by contraction of the small intestine. In one aspect, the sleeve includes a minimal structure that imparts a minimal amount of structural strength to the sleeve and retains function against buckling due to gastrointestinal forces. In one aspect, the minimal structure includes a single structure that extends along at least 10% of the length of the sleeve to provide linear strength to the sleeve. In various embodiments, this single structure is a straight metal wire, a spiral metal wire, or a wire mesh. In one aspect, the membrane sleeve member includes a plurality of horizontal and / or vertical support elements along the length of the sleeve body. In one aspect, the horizontal support element includes metal wire rings spaced along the length of the sleeve body. In various embodiments, the rings are spaced from 2 inches to 24 inches. In one aspect, the rings are spaced 6 inches apart. In one aspect, the vertical support element includes an elongated metal wire. In various aspects, the length of these metal lines is 2 to 60 inches. In one aspect, the length of the metal wire is 6 inches. In another aspect, the membrane sleeve member includes a helical metal wire extending along its length. The helical metal wire supports the sleeve member and maintains its long shape. In various embodiments, the helical metal wire includes a shape memory metal such as nitinol. Once the sleeve is compressed for delivery, the helical metal wire twists and the sleeve cannot restore its full shape. In various embodiments, the helical metal wire of the sleeve has a thickness of 0.1 to 1.0 mm. In one aspect, the helical metal wire of the sleeve has a thickness of 0.2 mm. As described above with reference to the bend radius of the ring, the bend radius of the helical metal wire of the sleeve must be made so that the strain rate is in the range of 0.1-20%, preferably less than 8%. I must. In various embodiments, the strain rate (%) of the helical metal wire can be defined by the following equation:
Where d is the diameter of the metal wire, Rf is the final bend radius, and Ri is the initial bend radius. Thus, in various aspects, the helical metal wire has a pitch in the range of 5-150 mm. In one aspect, the helical metal wire has a pitch of 60 mm. In various aspects, the sleeve comprises two or more helical metal wires to provide greater support while preventing permanent twisting. In one aspect, the sleeve comprises three helical metal wires, each individual metal wire having a pitch of 60 mm. These metal wires are spaced apart so that the pitch of the two individual metal wires is 20 mm. In another aspect, the sleeve comprises six helical metal wires and structurally supports the sleeve. In various embodiments, the membrane of the sleeve member extends to the proximal side of the lower portion of the wire mesh structure and covers all or part of the lower portion.

  The sleeve is flexible and compressible so that it can be retained at the distal end of the delivery device in a compressed form upon delivery. In one aspect, the sleeve is nested to shorten its length to facilitate delivery. Also, when the intragastric device is in a pre-deployment configuration, the sleeve may be folded to shorten the length of the sleeve to assist in placement on the delivery device or catheter. In various aspects, the sleeve is folded 2-10 and folded and wrapped along a delivery device or catheter for delivery. In one aspect, the sleeve is supplied coaxially over the guide wire or delivery device or catheter. In other embodiments, the sleeve is folded along the side or circumference of the delivery device or catheter. This helps prevent the sleeve from sticking to the guide wire and / or delivery device / catheter when retracting the guide wire and / or delivery device / catheter. This sticking may occur when the sleeve is delivered coaxially over the guide wire or delivery device / catheter.

  In another aspect, some intragastric devices of the present embodiment include a sleeve having a length shorter than the length described above. In various aspects, the short sleeve has a total length of 100-120 mm. In various aspects, the sleeve has a funnel shape or a conical shape. In some embodiments, the short sleeve includes a metal wire formed in a braid having a wire mesh structure or a plurality of knots, similar to the configuration described above for the wire mesh structure. In one aspect, the braid is formed using a single metal wire. In one aspect, the metal wire comprises a shape memory metal. In one aspect, the shape memory metal is nitinol. In another aspect, the braid is formed by mechanically braiding a plurality of metal wires. In some embodiments, the pitch or distance between knots is uniform. In other embodiments, the pitch is non-uniform. The ends of the braid are designed not to damage the tissue. In one aspect, the end is not sharp. In other embodiments, the ends are covered with a soft polymer tip. In some embodiments, a portion of the short sleeve is covered with a cover. In some embodiments, the covered portion includes a floating knot. In one aspect, the covering is silicone. In various aspects, the diameter of the proximal end of the sleeve is approximately equal to the outer diameter of the anti-migration ring at the distal end of the wire mesh structure. In such an embodiment, the proximal end of the sleeve is placed over or attached to the anti-migration ring. In another aspect, the diameter of the proximal end of the sleeve is smaller than the outer diameter of the anti-migration ring and is approximately equal to the diameter of the neck of the ring that joins the ring and the wire mesh structure. In these embodiments, the proximal end of the sleeve is attached to the neck of the ring.

  In one aspect, the number of knots is uniform throughout the braid. In one aspect, the number of knots is 24. In other embodiments, the number of knots is non-uniform throughout the braid. For example, in various aspects, the short sleeve braid comprises 24 knots at the proximal end and 18 or 12 knots at the distal end. In these embodiments, the knots comprising different numbers (eg, 6 or 12) of knots at the two ends are floating knots and are placed along the short sleeve body.

  Once the intragastric device with a short sleeve is deployed, the short sleeve is not secured to the pylorus and intermittently engages the patient's pylorus to occlude the pylorus. This prevents food from passing through the pylorus and forces food to pass from the stomach through the short sleeve into the duodenum, thereby regulating outflow from the stomach. In various embodiments, the opening at the distal end of the short sleeve is 1-30 mm in diameter. The size of this diameter determines the outflow rate from the stomach. In one aspect, the opening may be 0 mm when engaged with the pylorus, thereby completely inhibiting outflow from the stomach. Thus, food can enter the duodenum from the stomach only when the pylorus is not engaged or only partially engaged.

  In various aspects, the sleeve has a higher coefficient of friction than a conventional sleeve. In various aspects, the sleeve has a coefficient of friction ranging from 0.01 to 0.45. In one aspect, the sleeve has a coefficient of friction of 0.10 or less. In the case of a relatively smooth sleeve, when the sleeve sticks to the inside of the delivery catheter during deployment, or when the sleeve itself sticks and a force is applied to release the sleeve, the sleeve is destroyed. Thus, a sleeve having a rough outer surface can be more easily supplied and deployed by a delivery device or catheter. In various embodiments, the sleeve has a matte outer surface. In other embodiments, a particulate or relatively coarse material (eg, corn starch or biocompatible powder) is applied to the outer surface of the sleeve prior to mounting and deployment of the sleeve on the delivery device.

In various aspects, the sleeve has one or more radiopaque markers to ensure proper placement of the sleeve using x-ray contrast. In various aspects, the radiopaque marker includes a plurality of individual markings along the outer surface of the sleeve body. In other aspects, the radiopaque marker includes a single line extending along the outer surface of the sleeve body. A single spiral line indicates the twist of the sleeve. In yet another aspect, the radiopaque marker includes a plurality of individual markers and a single line extending along the outer surface of the sleeve body. In other embodiments, the thickness of the metal line of the sleeve support element is large enough for x-ray contrast, so no radiopaque label is required.
Collection mechanism

In various aspects, a wire mesh structure or a wire mesh structure coupled to a sleeve member comprises one or more recovery mechanisms, wherein at least one recovery mechanism is proximate to at least one opening at a proximal end of the wire mesh structure. Located. In one aspect, the retrieval mechanism includes a retrieval seam having a breaking strength of 80 pounds.
Movement prevention member

  In various embodiments, a wire mesh structure coupled to a wire mesh structure or sleeve member includes one or more anti-migration members or rings. In one aspect, the anti-movement member includes a metal. In one aspect, the metal is a shape memory metal such as nitinol. The movement preventing member is preferably located at the distal end of the wire mesh structure (in the embodiment of the intragastric device having a sleeve, the junction between the sleeve member and the wire mesh structure). Once deployed, the device will remain proximal to the pylorus. The movement preventing member functions to prevent the wire mesh structure or the entire intragastric device from passing through the pylorus. The movement prevention member rotates a semicircle around an axis that extends through the center of the wire mesh (spherical or elliptical) device or the center of the opening of the wire mesh device in a three-dimensional space. It is the form of the rotation surface made to let it.

  In various aspects, the various components of the intragastric device, including the wire mesh structure, the retrieval mechanism, and / or the anti-migration member, are coated with a therapeutic drug that enhances the function of the intragastric device.

In various aspects, the wire mesh structure, hooks, and / or anti-migration members comprise radiopaque markers for radiography that facilitate delivery and retrieval. In various aspects, the wire mesh structure, hook, and / or anti-migration member comprises an ultrasound marker for ultrasound that facilitates delivery and retrieval.
Delivery device

  The present specification also discloses various aspects of the delivery device used to deploy an intragastric device within the gastrointestinal tract of a patient. The intragastric device is pre-mounted on the delivery device and is used to deliver the intragastric device wire mesh into the stomach and the intragastric device sleeve into the proximal small intestine.

  In one aspect, the delivery device includes an elongate tubular body having a coaxial plunger, a catheter, and a plurality of handles. The handle is operated to deploy the intragastric device sleeve and wire mesh structure in multiple stages. In one aspect, the tubular body includes a trigger that controls movement of various components of the delivery device to activate deployment of the intragastric device.

  In various embodiments, the intragastric device may be retrieved using standard overtubes, endoscopes, and grasping members.

  The present invention relates to multiple aspects. The following disclosure is provided for the purpose of enabling the person skilled in the art to practice the invention. The terminology used herein should not be construed as a general denial of any one of the specific embodiments, and is intended to limit the claims beyond the meaning of the terms used herein. Should not be used. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the present invention. Also, the terminology and expressions used are for the purpose of describing exemplary embodiments and should not be considered limiting. Accordingly, the present invention is consistent with the widest scope including numerous changes, modifications, and equivalents consistent with the disclosed principles and features. For purposes of clarity, details regarding technical materials known in the technical fields related to the present invention have not been described in detail so as not to unnecessarily obscure the present invention.

  FIG. 1 is a diagram of the upper gastrointestinal system. When the food is swallowed, the food quickly reaches the stomach 112 through the esophagus 111. The food is digested in the stomach for a predetermined time, mixed with gastric juice and ground to dilute to an isotonic concentration. The stomach 112 relaxes to accommodate the digested food volume. When the stomach 112 is filled with food, the stomach wall stretch receptors cause a feeling of fullness and the person stops eating. Isotonic food, known as sputum, then passes through the pylorus 113 and into the duodenum 114. As the sputum enters the duodenum 114, the pancreas 115 releases enzyme-enriched spleen secretion and the liver 116 releases bile salt-rich bile secretion. Bile secretions pass through a common bile duct 117. Here, the bile secretions are combined with the spleen secretions that have passed through the pancreatic duct 118, and these two ducts merge to form the ferter enormous portion 119. The bile pancreatic duct (farter) enormous part 119 acts as an entrance for supplying these secretions into the duodenum 114. In jejunum 120, spleen and bile secretions are mixed with sputum to digest proteins, lipids, and carbohydrates and are absorbed into the blood.

  FIG. 2A is a wire mesh of an intragastric device in a deployed form having a proximally inclined anti-movement disc or anti-movement ring 204 extending from or attached to the distal end in accordance with an aspect of the present specification. FIG. The wire mesh structure 201 includes a three-dimensional porous structure having an internal volume. The wire mesh structure 201 has an elliptical shape and includes a recovery mechanism 203. In one aspect, the recovery mechanism is a silk seam loop. In one aspect, the recovery mechanism is an 80 pound recovery seam. The movement prevention ring 204 is inclined to the proximal side, and the distal end of the wire mesh structure 201 is bent so that the distal end of the wire mesh structure 201 faces the proximal end of the wire mesh structure 201. Including parts. In other aspects, the ring 204 includes a structure that does not damage any curved / tissue located around the distal end of the wire mesh structure 201. The ring 204 helps prevent the wire mesh structure 201 from entering and passing through the pylorus. In one aspect, the wire mesh structure 201 comprises a bulbous, primarily spherical, or oval proximal end and an expanded distal end. In one aspect, the distal half of the wire mesh structure is covered with a membrane that prevents food from leaving the wire mesh structure 201 and the food is directed through the distal opening. In one aspect, the wire mesh structure 201 has an optional check valve at the proximal end and any other valve at the distal end. The valve at the distal end serves to control the flow of phlegm or partially digested food from the inside of the wire mesh structure 201 to the outside of the wire mesh structure 201.

  FIG. 2B is a view of a deployed form of wire mesh structure 210 having a non-migration loop 214 formed at the distal end and curved proximally, in accordance with an aspect of the present specification. The wire mesh structure 210 is oval with a proximal end and a distal end. The wire mesh structure 210 includes a first opening 211 at the proximal end and a second opening 219 at the distal end. The wire mesh structure 210 includes offset knots 216, 218 that facilitate compression for delivery and removal. The wire mesh structure 210 also includes a set of staggered knots 217 at the proximal end. The proximal end offset knot 217 provides a place for capture, which further facilitates retrieval. The movement prevention ring 214 is continuously formed from the metal wire of the wire mesh structure 210 at the distal end. The movement prevention ring 214 is bent proximally and toward the main body side of the wire mesh structure 210, and its end 215 is rounded so as not to damage the body tissue. In various aspects, the wire mesh structure 210 does not have sharp edges and prevents scuffing. Also, the radial force is large enough to prevent large or permanent deformation due to stomach contraction and pyloric passage, but not so much that the mesh structure 210 is too rigid. This allows the wire mesh structure 210 to be affected by stomach contraction to an extent sufficient for food to easily move through the wire mesh structure 210. In some embodiments, the wire mesh structure can withstand contraction forces up to 200 mmHg without being fully compressed. The movement prevention ring 214 is defined by a rotation surface formed by rotating a semicircle around an axis extending through the center of the second opening 219 in the lower part of the wire netting device in a three-dimensional space. The ring 214 is also defined by a diameter of 25 mm or more.

  FIG. 2C is another view of a wire mesh structure in accordance with an aspect of the present description. In various aspects, the length from the proximal end 222 of the wire mesh structure to the distal end 224 of the anti-migration ring 214 ranges from 169 mm to 180 mm. In some aspects, the length from the proximal end 222 to the distal end 226 of the elliptical structure is about 141 mm, and the length from the proximal end 228 of the anti-movement ring 214 to the distal end 224 of the anti-movement ring 214. Is in the range of 31 mm to 36 mm. In one aspect, the length of the middle portion 230 of the elliptical structure is about 109 mm from the distal end of the proximal set of knots 233 to the proximal end of the distal set of knots 239; The length of the portion 232 from the proximal end of the proximal set of knots 233 to the distal end of the distal set of knots 239 is 117 mm. Also, in one aspect, the length of the proximal portion 234 extending from the proximal end 222 to the proximal end of the proximal set of knots and the distal end of the distal set of knots 239 The length of the distal portion 236 extending from the elliptical structure to the distal end 226 of the elliptical structure is 12 mm. In other aspects, the length of the portion 232 ranges from 114 mm to 129 mm, and the length of the proximal portion 234 and the distal portion 236 of the elliptical structure ranges from 8 mm to 12 mm, 7 mm to 14 mm, respectively. In embodiments, the inner diameter 238 of the anti-migration ring 214 that defines the opening of the distal end 224 of the intragastric device ranges from 27 mm to 35 mm, and the outer diameter 240 that defines the outer boundary of the anti-movement ring 214 ranges from 58 mm to The range is 77 mm. Furthermore, in some embodiments, the wire mesh structure diameter at the widest portion of the center of the elliptical structure is in the range of 116 mm to 123 mm. In some embodiments, the diameter of the circular opening 250 at the proximal end 222 ranges from 17 mm to 20 mm.

  As described with reference to FIGS. 2A and 2B, the wire mesh structure includes a plurality of openings or notches 242 forming a mesh. In some embodiments, the notch 242 has a diamond shape as a result of assembling the metal lines of the wire mesh structure into a cross pattern. In one aspect, the width 244 of the notch 242 of the intermediate portion 230 of the mesh ranges from 9.6 mm to 9.7 mm and the length 246 is 16 mm. In various aspects, individual pieces of metal wire, eg, metal wire pieces 248, are joined using methods such as riveting or crimping to form a wire mesh structure. In some embodiments, the length of the metal wire strip 248 ranges from 5 mm to 5.5 mm and has a diameter of about 1 mm.

  In several aspects, as described with reference to FIGS. 3D and 3E, the wire mesh structure includes a proximal end 222 of the mesh, a distal end 224 of the anti-migration ring 214, and a distal end of the elliptical structure. It includes a plurality of rings formed on 236 metal wires. In some embodiments, for example, the thickness of a metal wire forming a ring, such as the metal wire ring 252 shown in FIG. 2C, is about 0.4 mm, and the diameter of the circular portion 254 of the metal wire ring 252 is about 2 mm. . Moreover, the thickness 256 of the ring 252 is about 1 mm. In one aspect, the distal end 224 of the anti-migration ring 214 includes nine rings (eg, a metal wire ring 252 shown in FIG. 2C).

  FIG. 3A is a diagram illustrating a plurality of free ends or knots 301, 302 located at the proximal and distal ends of a wire mesh structure in accordance with an aspect of the present description. The knot 301 is located at the proximal end of the wire mesh structure, and the knot 302 is located at the distal end of the wire mesh structure. These knots include metal wire bends or curves in the wire mesh structure that are not supported or bonded to other parts of the wire mesh. In other words, these knots are rings or bends that include the free ends at each end of the wire mesh structure. Each wire mesh structure includes at least two groups of knots, or a group of knots 301 at the proximal end and at least one group of knots 302 at the distal end. Other wire mesh structure embodiments, such as the embodiments described with reference to FIGS. 3B and 3C below, include three or more groups of knots that provide greater compressibility to the wire mesh structure. Such a wire mesh structure comprises a free end or knot at each end of the structure and a free end or knot located at a side location along the length of the structure body.

  FIG. 3B is a diagram illustrating a plurality of overlapping knots 303 located at one end of a wire mesh structure in accordance with an aspect of the present description. As shown in FIG. 3B, all the knots 303 are located at the same side surface. Thereby, when the wire mesh structure is compressed to the form before deployment, the side surface portion is swollen. This bulge creates traction on the delivery device or catheter during delivery of the wire mesh structure. FIG. 3C is a diagram illustrating a first group of knots 304 located at one end of the wire mesh structure and a second group of knots 305 located proximal to the first group of knots 304 in accordance with an aspect of the present description. is there. These two groups of knots 304, 305 are offset across two different side locations in FIG. 3C. Shifting the knot reduces the bulge that is created when the wire mesh structure is compressed to its pre-deployed shape and reduces the traction force applied to the delivery device or catheter, thus making delivery and retrieval of the wire mesh structure easier.

  FIG. 3D is a diagram of a first group of knots 306 and a second group of knots 307 at one end of the wire mesh structure, according to one aspect of the present specification, formed on a metal wire of the first group of knots 306. 308 is shown. As shown in FIG. 3D, the ring 308 extends in a direction toward the center of the wire mesh structure. In another aspect, the ring extends outward in a direction away from the center of the wire mesh structure. In some aspects, as further described with reference to FIGS. 4B and 4C, the annulus 308 serves as an attachment point for other components (eg, sleeve members) of the intragastric device.

  FIG. 3E is a diagram of a first group of knots 316 and a second group of knots 317 at one end of a wire mesh structure, according to one aspect of the present specification, formed on a metal wire of a second group of knots 317. 318 is shown. FIG. 3F is a diagram of a first group of knots 310 and a second group of knots 319 at one end of a wire mesh structure, according to one embodiment of the present specification, wherein the first group of knots 310 and the second group of knots 319. The rings 313 and 314 formed alternately on both the metal wires are shown. The metal wire ring embodiment shown in FIGS. 3D-3F merely discloses various options for the knot ring and is not intended to be limiting. In various embodiments, any number or percentage of metal wires of either or both of the first group of knots, the second group of knots, or both may be a ring. For example, in one aspect, only the outermost knot with respect to the center of the wire mesh structure is a ring. In other embodiments, only the proximal knot is looped relative to the outermost knot. Depending on the mode, 0 to 100% of the knot is a ring. In one aspect, 50% of the knot is a ring. In other embodiments, 30% of the knots are looped.

  FIG. 3G illustrates a wire mesh structure 315 having a first group of knots 311 at the proximal end and a second group of knots 312 at the distal end, in accordance with an aspect of the present description. The wire mesh structure 315 of FIG. 3G includes the smallest possible number (2) of knots and allows maximum bulge at the proximal and distal ends when compressed to the pre-deployed configuration. FIG. 3H has a first group of knots 321 and a second group of knots 322 at the proximal and distal ends, respectively, along the surface thereof, according to one embodiment of the present specification. It is a figure of the wire-mesh structure 320 in which the knot 324 of the 4th group is distributed. As the number of knot groups increases, the number of individual knots located at the side portions of each knot group can be reduced. In this way, when compressed, the wire mesh structure includes a bulge at each side location of each knot group, each bulge being a proximal end formed when the wire mesh structure shown in FIG. 3G is compressed and Less than the bulge diameter at the distal end. Accordingly, the compressed pre-deployment configuration of the wire mesh structure of FIG. 3H reduces traction on the delivery device or catheter and is easier to deploy. In the wire mesh structure 320 of FIG. 3H, four groups of knots 321, 322, 323, and 324 are shown, but the wire mesh structure may have three groups or five or more groups of knots. In various embodiments, the wire mesh structure comprises 2-60 knot groups located at different side locations.

  FIG. 3I is a diagram illustrating various possible knot shapes, in accordance with aspects herein. Possible knot shapes include, but are not limited to, a narrow bend 331, a thick bend 332, a sharp bend 333, a circular bend 334, and a shape similar to the end of the safety pin 335 (the end of the knot And a metal wire ring 345).

  FIG. 4A is a detailed view of the anti-migration ring 414 that does not damage the tissue of the wire mesh structure 410 of the intragastric device 400 according to one aspect of the present description. The anti-migration ring 414 has an annular valve shape and includes a rounded end 415 extending proximally of the wire mesh structure 410. The rounded end 415 is designed not to damage body tissue. As described above, in some embodiments, the ends 415 are individually knotted to prevent bundles of metal wires during compression. A bundle of metal wires can cause drooling. The major axis of the ring 412 is curved at an angle 413 that is greater than 90 ° relative to the major axis of the mesh 411 so that the rounded end 415 faces the wire mesh structure 410.

  FIG. 4B is a detailed view of the anti-migration ring 424 that does not damage the tissue of the wire mesh structure 421 of the intragastric device 420 according to another aspect of the present description. The anti-movement ring 424 has an annular valve shape and includes a rounded end 425 extending toward the proximal side of the wire mesh structure 421. The rounded end 425 is designed not to damage body tissue. In some embodiments, the ends 425 are individually knotted 427l, 427s to prevent bundles of metal wires during compression. A bundle of metal wires can cause drooling. These knots comprise a long knot 427l and a short knot 427s. The long knot 427l extends further back toward the upper part of the wire mesh structure 421 than the short knot 427s. In some embodiments, ring 424 comprises nine long knots 427l and nine short knots 427s. The free end of the long knot 427l includes a metal ring 428 for sewing the proximal end of the sleeve member. An annulus 428 extends outward from the free end of the long knot 427l. In one aspect, the annulus 428a is formed in an annulus shape by twisting the free end of the long knot 427l. In another aspect, the annulus 428b includes a separate metal wire annulus that is sewn to the free end of the long knot 427l. In some embodiments, once the sleeve is attached, it is provided at the joint of an additional suture knot twisted metal wire ring or individual metal wire ring to prevent the sleeve from being misaligned.

  FIG. 4C is a detailed view of the anti-migration ring 434 that does not damage the tissue of the wire mesh structure 431 of the intragastric device 430 according to yet another aspect of the present description. The anti-movement ring 434 has an annular valve shape and includes a rounded end 435 extending proximally toward the wire mesh structure 431. The rounded end 435 is designed not to damage body tissue. In some embodiments, the end 435 is a variety of individual knots 437l, 437s to prevent the metal wires from being bundled during compression. A bundle of metal wires can cause drooling. These knots include a long knot 437l and a short knot 437s. The long knot 437 l extends in the proximal direction toward the upper part of the wire mesh structure 431 than the short knot 717 s. In some embodiments, ring 434 includes nine long knots 437l and nine short knots 437s. The free end of the long knot 437 l comprises a metal ring 439 for sewing the proximal end of the sleeve member. The metal ring 439 extends inward toward the curve at the distal end of the wire mesh structure 431. In one aspect, the metal ring 439a is formed in a metal ring shape with the free end of the long knot 437l as a ring. In another aspect, the annulus 439b includes individual metal wire annulus sewn to the free end of the long knot 437l. In some embodiments, once the sleeve is attached, an additional stitching knot is provided at the joint of the annulus or individual metal wire ring to prevent the sleeve from slipping.

  In some embodiments, the sleeve member is attached to the distal end of the wire mesh structure or the ring of the intragastric device. In various embodiments, the sleeve members herein can be polytetrafluoroethylene (PTFE), polyethylene, molded PTFE (eg, Teflon), fluorinated ethylene propylene (FEP), or PTFE, PFA having a perfluoroalkoxy (PFA) coating. Made of extruded FEP and extruded PFA, extruded PTFE, fluoropolymer, or silicone. In one aspect, the silicone sleeve is manufactured by manual injection and braiding. In other embodiments, the silicone sleeve is manufactured by mechanical braiding. In various aspects, the length of the sleeve member has a range of 6 inches to 6 feet or more. In one aspect, the length of the sleeve member is 24 inches. In another aspect, the length of the sleeve member is 30 inches. In various embodiments, the diameter of the sleeve member ranges from 1 cm to 10 cm. In one aspect, the diameter of the sleeve member is 3 cm.

  FIG. 5A is a partial view of a sleeve member 500 of a deployed intragastric device, according to one aspect of the present specification, with a single metal wire support 501 spirally wound along the sleeve 500 body. Indicates. The metal wire must have a tightly wound helical shape sufficient to support it, but it must be wound so tight that it cannot be twisted back to its original shape once the sleeve is compressed for delivery. Don't go too far. As shown in FIG. 5A, the helical metal wire 501 has a pitch indicated by a length l, which is equal to 60 mm. When the thickness of the metal wire is 0.1 to 1 mm, this pitch gives the helical metal wire a strain rate of 20% or less, preferably less than 8%.

FIG. 5B is a partial view of a sleeve member 505 of a deployed intragastric device, according to one aspect of the present specification, with a plurality of metal wire supports 506 spirally wound along the sleeve 505 body, 507 and 508 are shown. The sleeve includes two or more helical metal wires to provide greater support and prevent permanent twisting. As shown in Figure 5B, each individual metal lines 506, 507, 508 has a pitch indicated by the length _{l 1,} the pitch is equal to 60 mm. The metal wires 506, 507, 508 are spaced so that the length l ₂ between the two individual metal wires is equal to 20 mm.

  FIG. 5C is an illustration of a sleeve member 510 having a funnel shape of an intragastric device in a deployed configuration, according to one aspect of the specification, wherein the spiral metal wire ring supports 511, 513 on the surface of the sleeve 510 are shown. Show. In the embodiment shown in FIG. 5C, the sleeve 510 includes two sets of metal wire ring supports 511, 513. Each set of metal wire ring supports 511, 513 includes a ring containing two individual metal wires, and a total of four metal wires are provided on the sleeve 510. Each of the metal wire ring supports 511, 513 is finished with a non-pointed end 515 so as not to damage the body tissue. Metal wire ring supports 511 and 513 are spirally wound. Further, it forms a ring along the length of the sleeve 510. In one aspect, the pitch or distance between rings 511 and 513 (and between the metal lines of rings 511 and 513) is defined by length l and is about 15 mm.

  FIG. 5D is an illustration of a sleeve member 520 of the intragastric device in a deployed configuration, according to one aspect of the specification, showing an opening 521 having a funnel shape at the proximal end of the sleeve. An opening 521 having a funnel shape is an annulus located at the distal end of some wire mesh structures of the intragastric device aspects herein, as described in detail with reference to FIGS. 11C and 11D below. Fits to attach to the knot.

  FIG. 5E is an illustration of a sleeve member 525 having a funnel shape of an intragastric device in a deployed configuration, according to one aspect of the specification, showing a plurality of indicia 527 on the outer surface of the sleeve body. Marker 527 is radiopaque and its radiography helps to properly position the sleeve during delivery of the device.

  FIG. 5F is an illustration of a sleeve member 530 having a funnel shape of an intragastric device in a deployed configuration, according to one aspect of the specification, and a marker line 533 extending along the length of the sleeve 530 on the outer surface of the sleeve body. Indicates. Marker line 533 is radiopaque and its radiography aids in proper positioning of the sleeve during delivery of the device. Also, if the marker line is spiraling or rotating around the central axis of the sleeve, it may indicate that the sleeve is twisted.

  FIG. 5G is an illustration of a sleeve member 535 having a funnel shape of an intragastric device in a deployed configuration, according to one aspect of the specification, and a plurality of markers extending along the length of the sleeve 535 on the outer surface of the sleeve body. 537 and a labeled line 538 are shown. Markers 537 and mark lines 538 are radiopaque and their x-ray contrast helps to position the sleeve during delivery of the device and help detect the twist of sleeve 535.

FIG. 6A is a cross-sectional view of a sleeve member 600 having a funnel shape of an intragastric device in a deployed configuration, according to one aspect of the present specification, showing a plurality of sleeve layers 606, 607, 608, 609. In one aspect, the sleeve layers 606, 607, 608, 609 include PTFE. The sleeve 600 includes an innermost first layer 606. This layer is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve. The first layer 606 extends over the entire length of the sleeve 600. The sleeve 600 includes a second layer 607 that overlies the first layer 606. The second layer has a thickness of about 0.06 mm and extends only along the proximal portion 616 of the sleeve 600 and the distal portion 618 of the sleeve 600. In one aspect, the proximal portion 616 includes a funnel portion 601 and additional portions. This additional part has a length _{l 1,} and extends approximately 30~40mm distally beyond the funnel portion 601. In one aspect, the sleeve 600 comprises a distal end having a length l ₂ of about 20-30 mm. Distal portion 618 includes only a portion having a most proximal length l ₂ of about 10 mm. In one aspect, the second layer 607 extends in a configuration along the width of the sleeve 600. The sleeve 600 includes a second layer 607 and a third layer 608 that overlies the central portion 617 of the first layer 606. The third layer 608 is approximately 0.06 mm thick and extends in a configuration along the width of the sleeve 600. The sleeve 600 includes a fourth layer 609 that overlies the third layer 608. The fourth layer is about 0.06 mm thick and extends in a configuration along the length of the sleeve 600. 6A, the sleeve 600 includes four layers at the proximal portion 616, three layers at the central portion 617, and four layers at the distal portion 618. The sleeve layers 606, 607, 608, 609 can be joined across the layers or used in different configurations (configurations along the width versus configurations along the length of the sleeve 600) of the sleeve. Increase durability. In one aspect, the sleeve 600 is further metal between the second layer 607 and the third layer 608 (or between the first layer 606 and the third layer 608 in the center 617 of the sleeve 600). A line support 605 is provided to provide structural support. In one aspect, the sleeve includes a stitch point 619 for connection with the wire mesh structure.

FIG. 6B is a cross-sectional view of a sleeve member 620 having a funnel shape of an intragastric device in a deployed configuration, according to other aspects herein, showing a plurality of sleeve layers 626, 627, 628, 629, 630. . In various embodiments, the sleeve layers 626, 627, 628, 629, 630 are made of polytetrafluoroethylene (PTFE), low density polyethylene (LDPE), high density polyethylene (HDPE), and ultra high molecular weight polyethylene (UHMWPE). Any one or a combination thereof is included. In one aspect, the sleeve 620 includes an innermost first PTFE layer 626. This layer is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve. The first PTFE layer 626 extends over the entire length of the sleeve 620. The sleeve 620 includes a second PTFE layer 627 that overlies the first PTFE layer 626. The second PTFE layer is about 0.06 mm thick and extends only along the proximal portion 636 of the sleeve 620 and the distal portion 638 of the sleeve 620. In one aspect, the proximal portion 636 includes a funnel portion 621 and an additional portion. This additional part has a length _{l 1,} and extends approximately 30~40mm distally beyond the funnel portion 621. In one aspect, the sleeve 620 includes a distal end having a length l ₂ of about 20-30 mm. Distal portion 638 includes only a portion having a most proximal length l ₂ of about 10 mm. In one aspect, the second PTFE layer 627 extends in a configuration along the width of the sleeve 620. The sleeve 620 includes a third PTFE layer 628 overlying the central portion 637 of the second PTFE layer 627 and the first PTFE layer 626. The third PTFE layer 628 has a thickness of about 0.06 mm and extends in a configuration along the width of the sleeve 620. The sleeve 620 includes a fourth PTFE layer 629 that overlies the third PTFE layer 628. The fourth PTFE layer has a thickness of about 0.06 mm and extends in a configuration along the length of the sleeve 620. In one aspect, the sleeve further includes a fifth PFTE layer 630 sandwiched between a third PTFE layer 628 and a fourth PTFE layer 629. In one aspect, the fifth PTFE layer 630 is about 0.06 mm thick and extends in a configuration along the length of the sleeve 620. 6B, the sleeve 620 includes a total of five layers at the proximal portion 636, a total of four layers at the central portion 637, and a total of five layers at the distal portion 638. In various aspects, the layers 626, 627, 628, 629, 630 may be joined across the layers or in different configurations (configurations along the width versus configurations along the length of the sleeve 620). Used to increase the durability of the sleeve. In one aspect, the sleeve 620 is between the second PTFE layer 627 and the third PTFE layer 628 (or between the first PTFE layer 626 and the third PTFE layer 628 in the central portion 637 of the sleeve 620). Further, a metal wire support 625 is provided to provide structural support. In one aspect, the sleeve includes a stitch point 639 for connection with the wire mesh structure.

FIG. 6C is a cross-sectional view of a sleeve member 640 having a funnel shape of a post-deployment form of an intragastric device, according to one aspect of the specification, wherein a plurality of sleeve layers 643, 644, 646, 647, 648, 649, 650 is shown. In various aspects, the sleeve layers 643, 644, 646, 647, 648, 649, 650 are made of polytetrafluoroethylene (PTFE), low density polyethylene (LDPE), high density polyethylene (HDPE), and ultra high molecular weight polyethylene. Any one of (UHMWPE) or a combination thereof. In one aspect, the sleeve 640 includes an innermost first PTFE layer 643. This layer is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve. The first PTFE layer 643 extends along the entire length of the sleeve 640. The sleeve 640 includes a second PTFE layer 644 that overlies the first PTFE layer 643. The second PTFE layer is about 0.06 mm thick and extends only along the proximal portion 656 of the sleeve 640 and the distal portion 658 of the sleeve 640. In one aspect, the proximal portion 656 includes a funnel portion 641 and an additional portion. This additional part has a length _{l 1,} and extends approximately 30~40mm distally beyond said funnel portion 641. In one aspect, the sleeve 640 includes a distal end having a length l ₂ of about 20-30 mm. Distal portion 658 includes a portion having a most proximal length l ₂ of about 10 mm. In one aspect, the second PTFE layer 644 extends in a configuration along the width of the sleeve 640. The sleeve 640 includes a third PTFE layer 646 overlying the central portion 657 of the second PTFE layer 644 and the first PTFE layer 643. The third PTFE layer 646 has a thickness of about 0.06 mm and extends in a configuration along the width of the sleeve 640. The sleeve includes a first intermediate PFTE layer 648 and a second intermediate PFTE layer 649 sandwiched between a second PTFE layer 644 and a third PTFE layer 646. In one aspect, the first intermediate PFTE layer 648 and the second intermediate PFTE layer 649 are both about 0.06 mm thick. In one aspect, both the first intermediate PFTE layer 648 and the second intermediate PFTE layer 649 extend in a configuration along the length of the sleeve 640. In other embodiments, both the first intermediate PFTE layer 648 and the second intermediate PFTE layer 649 extend in a configuration along the width of the sleeve 640. In other embodiments, the first intermediate PFTE layer 648 extending in a configuration along the length of the sleeve 640 and the second intermediate PFTE layer 649 extends in a configuration along the width of the sleeve 640. In yet another aspect, the first intermediate PFTE layer 648 extends in a configuration along the width of the sleeve 640 and the second intermediate PFTE layer 649 extends in a configuration along the length of the sleeve 640. The sleeve 640 includes a fourth PTFE layer 647 that overlies the third PTFE layer 646. The fourth PTFE layer has a thickness of about 0.06 mm and extends in a configuration along the length of the sleeve 640. The sleeve further includes a third intermediate PFTE layer 650 sandwiched between a third PTFE layer 646 and a fourth PTFE layer 647. In one aspect, the third intermediate PFTE layer 650 is about 0.06 mm thick and extends in a configuration along the length of the sleeve 640. Thus, in the embodiment shown in FIG. 6C, the sleeve 640 includes a total of seven layers at the proximal portion 656, a total of six layers at the central portion 657, and a total of seven layers at the distal portion 658. In various aspects, the layers 643, 644, 646, 647, 648, 649, 650 can be joined across the layers or in different configurations (width relative to configurations along the length of the sleeve 640). To increase the durability of the sleeve. In one aspect, the sleeve 640 further includes a metal wire support 645 between the first intermediate PFTE layer 648 and the second intermediate PFTE layer 649 to provide structural support. In one aspect, the sleeve includes a stitch point 659 for connection with the wire mesh structure.

  6A-6C illustrate sleeves having multiple PTFE layers, these configurations are not intended to be limiting, other sleeve embodiments including more or fewer PTFE layers, or individual Other sleeve embodiments are contemplated, including layers comprising other materials with various layers of various layers.

FIG. 6D is a cross-sectional view of a sleeve member 660 having the funnel shape of the intragastric device in a deployed configuration, according to yet another aspect of the present specification, showing a plurality of sleeve layers. The sleeve includes a cylindrical portion 660c and a funnel-shaped portion 660f. In some embodiments, the cylindrical portion 660c has a length l _c of about 500 mm and the funnel portion has a length l _f of about 100 mm. The sleeve member 660 of FIG. 6D includes a single machine braided metal wire 661 sandwiched between a plurality of sleeve layers. In one aspect, the single machine braided metal wire 661 is configured to extend in the axial direction. A single machine braided metal wire 661 extends only along the proximal portion of the cylindrical portion 660c of the sleeve 660. In one aspect, about 450 mm of the proximal portion of the cylindrical portion 660 c of the sleeve 660 includes a single machine braided metal wire 661 and at least 50 mm of the distal end of the sleeve 660 does not include a metal wire. In one aspect, the distal end of the sleeve 660 includes a distal opening 682 having a diameter of about 24.5 mm. The funnel portion 660 f includes a metal wire support 671 that terminates proximally of the plurality of knots 672. In one aspect, the sleeve 660 includes a total of 18 knots that are equidistant from each other. These knots include alternating long and short knots as described above. In some embodiments, the sleeve layer extends proximally at a distance of at least 5 mm beyond the long knot. In one aspect, the proximal end of the sleeve 660 includes a proximal opening 681 having a diameter of about 63 mm. In various aspects, the single machine braided metal wire 661 and the metal wire support 671 each include a metal wire having a diameter in the range of 0.100 to 0.150 mm. In one aspect, the single machine braided metal wire 661 and the metal wire support 671 each include a metal wire having a diameter of 0.127 mm. In another aspect, the single machine braided metal wire 661 and the metal wire support 671 each comprise a metal wire having a diameter of 0.140 mm.

  Sleeve 660 includes an innermost first PTFE layer 662 that extends in a configuration along the width of sleeve 660. The first PTFE layer 662 extends along the entire length of the sleeve 660. In one aspect, the first PTFE layer 662 has a thickness of about 0.06 mm. A single machine braided metal wire 661 overlies the first PTFE layer 662 along the proximal portion of the cylindrical portion 660c, and the metal wire support 671 is a first along the funnel portion 660f of the sleeve 660. It overlaps with the PTFE layer 662. The proximal intermediate PFTE layer 663p overlaps the metal wire support 671 along the funnel portion 660f and distally over the single mechanical braided metal wire 661 of the cylindrical portion 660c of the sleeve 660 about 5-7 mm. It extends to. The distal intermediate PFTE layer 663d is proximal to overlap the first PFTE layer 662 at the distal end of the sleeve and cover a single mechanical braided metal wire 1601 of the cylindrical portion 660c of the sleeve 660 about 5-7 mm. Extends to the side. The plurality of cylindrical intermediate PFTE layers 663 c overlap a single machine braided metal wire 661 along the cylindrical portion of the sleeve 660. In some aspects, the sleeve 660 includes three cylindrical intermediate PFTE layers 663c, each having a length of about 3-5 mm, from each other proximal proximal and distal ends of the sleeve, respectively. The intermediate PFTE layer 663p and the distal intermediate PFTE layer 663d are spaced from each other by 70 to 80 mm. Sleeve 660 includes an outermost second PTFE layer 664. This layer is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve 660.

  In some embodiments, the sleeve 660 further includes at least one marker for visualization during an x-ray examination to determine an appropriate position after delivery. As shown in FIG. 6D, the sleeve includes three markers 665, each close to the proximal end of a single machine braided metal wire 661, close to the center of a single machine braided metal wire 661. And close to the distal end of a single machine braided metal wire. In one aspect, each marker 665 is secured in place by a piece of PTFE 666 having a length of about 5 mm, a width of about 5 mm, and a thickness of about 0.06 mm. In one aspect, the markers 665 are spaced apart from each other at a distance of about 145 mm to 155 mm. In one aspect, every other marker 665 is positioned on the cylindrical intermediate PFTE layer 663c. In one aspect, the marker 665 is located on one side of the sleeve 660. In one aspect, marker 665 is a tantalum marker.

  As shown in FIGS. 6A-6D, in various embodiments, a sleeve layer made of PTFE is also made of polyethylene (PE), low density polyethylene (LDPE), high density polyethylene (HDPE), and ultra high molecular weight polyethylene (UHMWPE). May be included. As an alternative to bonding, the sleeve layer may be stitched.

  FIG. 6E is a cross-sectional view of a sleeve member 690 having a funnel shape of an intragastric device in a deployed configuration, according to yet another aspect of the specification. As shown in FIG. 6E, the sleeve 690 includes a proximal funnel-shaped portion 690p and a distal cylindrical portion 690d. The proximal portion 690p includes a hand-knitted braided Nitinol wire mesh 691 covered with PTFE. Distal portion 690d includes machine-knitted braided Nitinol wire mesh 692 covered with PTFE. The distal portion 690d also includes at least one fluoropolymer band 695 for improving the adhesion of the nitinol wire mesh and PTFE. At least one radiopaque marker band 693 is also included in the distal portion 690d.

  FIG. 6F is an illustration of a stent support 680 for a sleeve member of an intragastric device, according to one aspect of the present description. In the illustrated embodiment, the stent support 680 includes a plurality of rings 683 formed from a “Z” shaped portion of a metal wire. In another aspect, the stent support includes a continuous helical metal wire support, the metal wire of the helix being “Z” shaped. In one aspect, the stent support 680 has a shape similar to the pattern 2033 shown in FIG. 20F. Returning to FIG. 6F, in one aspect, each ring 683 is connected by a straight metal wire 684 such that a space 685 exists between each ring 683 and includes only the remaining layers of the sleeve member. In some embodiments, each ring 683 has a length in the range of 1-2 cm. In some embodiments, each connecting straight metal line 684 has a length in the range of 1-2 inches, and each space 685 also has a length in the range of 1-2 inches. In one aspect, the proximal end of the stent support 680 includes a funnel-shaped annular portion 686. In one aspect, the funnel-shaped ring portion 686 includes a coupling portion 687 sewn with a first distal ring 683a. In various embodiments, the funnel-shaped ring portion 686 has a diameter that matches the diameter of the anti-migration member at the distal end of the attached wire mesh structure.

  FIG. 6G is an illustration of the sleeve member 688 of the intragastric device having the stent support 680 of FIG. 6F. Stent support 680 includes an annulus 683 joined by straight metal lines 684. Other layers 689 such as PTFE of the sleeve member 688 are shown between each set of rings 683. “Z” shaped stent support 680 provides structural integrity such that sleeve member 688 is flexible enough to fit the curve of the gastrointestinal tract but does not collapse as a result of bowel contraction A sleeve member 688 having the following is obtained.

  In one aspect, the sleeve and wire mesh of the intragastric wire mesh device of the present invention may be covered with a woven fabric so that the sleeve portion is flexible and torsion resistant, while at the same time controlling the porosity of the device. . In one aspect, the woven fabric is made by electrospun forming PTFE into very fine polymer fibers ranging from 0.10 nanometers to 100 microns. Electrospinning allows the material to maintain superior mechanical properties while increasing the surface to weight and volume ratio. This woven fabric has properties similar to expanded PTFE, but has a smaller basis weight than expanded PTFE and has chemical resistance and temperature resistance comparable to expanded PTFE. Even if the strand of the woven fabric breaks, it can be easily repaired. In one aspect, the first woven fabric layer is formed in a spider web shape to cover the sleeve of the intragastric device. A scaffold material is then placed over the first woven fabric layer, followed by a second woven fabric layer, thereby sealing the nitinol or polymer scaffold material.

  In one aspect, the mesh device herein may include braided sleeves or bag knitting for aerospace, automotive, and medical markets made using stretchable, flexible drawn fibers. Good. The braid protects the skin from abrasion and provides additional chemical wear resistance and flexibility to the sleeve of the wire mesh device of the present invention. In several embodiments, the drawn fiber comprises perfluoroalkoxy (PFA) drawn fiber, fluorinated ethylene propylene (FEP) drawn fiber, ethylene tetrafluoroethylene (ETFE) drawn fiber, polyetheretherketone (PEEK) drawn fiber, polyfluorinated Vinylidene (PVDF) drawn fiber or ethylene chlorotrifluoroethylene (ECTFE) drawn fiber may be used. In one aspect, a high temperature resistant nanofiber membrane having the ability to trap particles larger than 0.1 microns may be used to cover the wire mesh device herein. FIG. 6H illustrates a portion 603 of a wire mesh device sleeve covered with a nanofiber membrane 605 in accordance with an aspect of the present description.

  FIG. 7 is an illustration of a funnel shaped sleeve 700 for an intragastric device, according to one aspect of the present description. The sleeve 700 has a funnel shape with a diameter that decreases as the sleeve extends from the first opening 713 at the proximal end to the second opening 719 at the distal end. The sleeve 700 includes at least one metal wire 702 that is folded into a funnel shape having a cross-cross weave pattern. As the sleeve 700 extends distally, its diameter decreases and the intersection of the metal lines of the cruciform weave gradually approaches. Sleeve 700 includes curved or free ends at the proximal and distal ends. The free end is designed not to damage body tissue. In some embodiments, the first opening 713 has a diameter that is substantially the same or somewhat larger than the diameter of the anti-migration ring of the wire mesh structure. The sleeve 700 is slid over the anti-movement ring and then secured in place by stitching the free end 714 at the proximal end of the sleeve to the knot containing the anti-movement ring. A free end 718 at the distal end of the sleeve 700 surrounds the second opening 719. In various aspects, the sleeve 700 is a short sleeve having an overall length in the range of 1 cm to 120 cm. In one aspect, the sleeve 700 is a short sleeve having a total length of 10 cm. In the illustrated embodiment, the conical funnel portion occupies 100% of the sleeve length.

  FIG. 8 is an illustration of a funnel-shaped sleeve 800 for an intragastric device according to another aspect of the present description. The sleeve includes a proximal end having a first opening 813 and a distal end having a second opening 819. Sleeve 800 further includes a proximal portion 811 and a distal portion 816. Both the proximal portion 811 and the distal portion 816 of the sleeve 800 are funnel shaped and decrease in diameter as each portion 811, 816 extends distally. The diameter of the proximal portion 811 is largest at the proximal end of the sleeve 800, or at the location of the first opening 813, with the proximal portion 811 extending distally and the sleeve 800 to the distal portion 816 at the transition point 803. It will get smaller until it moves. At the transition point 803, the diameters of the proximal portion 811 and the distal portion 816 are equal. As the distal portion 816 extends distally, the diameter of the distal portion 816 decreases. In other aspects, the diameter of the distal portion remains the same along its length. In yet another aspect, the diameter of the distal portion increases as it extends distally. The distal portion 816 of the sleeve 800 ends with a second opening 819 at the distal end of the intragastric device 800. The proximal portion includes a first metal wire 802 folded into a funnel shape having a first cross-cross weave pattern. The distal portion includes a second metal wire 812 folded into a funnel shape having a second cross-cross weave pattern. In some embodiments, the second metal line 812 is an extension of the first metal line 802. In other embodiments, the first metal line 802 and the second metal line 812 are separate metal lines that are joined at a transition point 803. In one aspect, these individual metal wires are spot welded. As the portions 811, 816 extend distally and the funnel shape narrows, the intersection of the metal lines in both the proximal portion 811 and the distal portion 816 is such that each weave pattern is the distal end of each portion 811, 816. And get closer to each other to become denser. In one aspect, the proximal portion 811 has the same weave pattern as the distal portion 816. In other aspects, the weave pattern of the proximal portion 811 is denser than the weave pattern of the distal portion 816. In other aspects, the weave pattern of the distal portion 816 is denser than the weave pattern of the proximal portion 811.

  In one aspect, the length of the proximal portion 811 is equal to the length of the distal portion 816. In other aspects, the length of the proximal portion 811 is shorter than the length of the distal portion 816. In other aspects, the length of the proximal portion 811 is longer than the length of the distal portion 816. Sleeve 800 includes curved or free ends at its proximal and distal ends. The free end is designed not to damage body tissue. In some embodiments, the first opening 813 has a diameter that is substantially equal to or slightly smaller than the diameter of the neck of the anti-migration ring of the wire mesh structure. The sleeve 800 is inserted into the neck of the anti-movement ring, and the free end 814 at the proximal end of the sleeve is sewn to the intersection of the metal lines of the neck of the anti-movement ring and fixed in place. A free end 818 at the distal end of the sleeve 800 surrounds the second opening 819. In various aspects, the sleeve 800 is a short sleeve having an overall length in the range of 1 cm to 120 cm. In one aspect, the sleeve 800 is a short sleeve having a total length of 10 cm. In the embodiment shown, the conical funnel portion occupies 100% of the sleeve length.

  FIG. 9A is a view of a wire mesh structure 930 with a sleeve member 944 attached, in an undeployed configuration, according to one aspect of the specification, with the wire mesh support not pointed toward the proximal end of the sleeve 944. An end 952 is shown. The sleeve 944 is connected to the anti-migration ring 942 at the distal end of the wire mesh structure 930 and does not damage the proximally curved tissue, and includes a proximal portion 945 having four layers and a central portion having three layers. 955.

  FIG. 9B is an illustration of a wire mesh structure 957 with the proximal portion of the sleeve member 959 attached, in a deployed configuration, in accordance with an aspect of the present specification, showing the delivery catheter 969 located within the wire mesh structure 957. Show. The sleeve 959 is attached to a movement preventing member 958 that is curved proximally.

  FIG. 10A is an illustration of a short braided sleeve member 1000 having a funnel shape in a deployed configuration, according to one aspect of the specification. Sleeve 1000 includes a braided structure formed of a metal wire having a plurality of knots 1001 at the proximal and distal ends of sleeve 1000. The knot 1001 is a structure similar to the structure described with reference to FIG. 3A above, and includes a free bend that is not supported by the metal wire of the braided structure. In one aspect, the number of knots is uniform so that the number of knots at the proximal end of the sleeve 1000 and the number of knots at the distal end of the sleeve 1000 are the same. In one aspect, the number of uniform knots is 24 at both ends. In other aspects, the number of knots can be varied so that the number of knots at the proximal end of the sleeve 1000 and the number of knots at the distal end of the sleeve 1000 are different. If there is no knot at the distal end of the sleeve, it is offset into the sleeve body. For example, in one aspect, the sleeve includes 24 knots at the proximal end and 18 knots at the distal end. The remaining six knots are offset from the sleeve body. In another aspect, the sleeve includes 24 knots at the proximal end and 12 knots at the distal end. The remaining 12 knots are offset from the sleeve body. Different embodiments include different numbers of staggered knots. In one aspect, the distal portion of the sleeve includes a covering 1002. In various aspects, about 30-60 mm of the distal end is covered with a coating 1002. In one aspect, the coating 1002 is silicone. In one aspect, the staggered knot is located at the distal portion having the covering 1002 and is covered to eliminate the traumatic surface.

The sleeve 1000 shown in FIG. 10A includes a funnel-like portion 1005 at the proximal end and a cylindrical portion 1006 at the distal end. In one aspect, the funnel portion 1005 includes a proximal portion having a length l ₁ and a distal portion. In one aspect, the length l ₁ is about 30 mm. Entire funnel portion has a length l _2, in one embodiment is about 60 mm. Cylindrical portion 1006 is the length _{l 3,} in one embodiment is about 60 mm. Thus, in one aspect, the total length l _t of the sleeve 1000 is about 120 mm. The sleeve 1000 has a first opening 1003 at the proximal end having a diameter _{d 1.} In one aspect, the diameter d ₁ is about 75 mm. The sleeve has a second opening 1004 at the distal end. In various aspects, the diameter d2 of the _second opening 1004 is 1-30 mm.

  FIG. 10B is an illustration of a short braided sleeve member 1010 having a funnel shape with a conical distal end 1017 in a deployed configuration, according to one aspect of the specification. In various aspects, the sleeve 1010 includes a metal wire braid structure having a plurality of knots 1011, the knot groups being uniform or variable as described with reference to FIG. 10A. In one aspect, the distal portion of the sleeve includes a covering 1012. In various aspects, about 30-60 mm of the distal end is covered with a coating 1012. In one aspect, the coating 1012 is silicone. In one aspect, the staggered knot is located at the distal portion having the covering 1012 and is covered to eliminate the traumatic surface.

The sleeve 1010 shown in FIG. 10B includes a funnel-shaped portion 1015 at the proximal end and a conical portion 1017 at the distal end. In one aspect, the funnel portion 1015 includes a proximal portion having a length l ₁ and a distal portion. In one aspect, the length l ₁ is about 30 mm. Entire funnel portion has a length l _2, in one embodiment is about 60 mm. Conical portion 1787 has a length l ₃ and in one aspect is about 55 mm. In one aspect, the short straight portion 1016 of the sleeve is located between the funnel portion 1015 and the conical portion 1017. In one aspect, the short straight portion 1016 has a length of 5 mm. Accordingly, in one aspect, the total length l _{t of the} sleeve 1010 is about 120 mm. The sleeve 1010 has a first opening 1013 at the proximal end having a diameter _{d 1.} In one aspect, the diameter d ₁ is about 75 mm. The sleeve has a second opening 1014 at the distal end having a diameter d _2. In one embodiment, the diameter _{d 2} is about 10 mm.

FIG. 10C is an illustration of a short braided sleeve member 1020 having a conical shape, in a deployed configuration, according to one aspect of the specification. In various aspects, the sleeve 1020 includes a metal wire braid structure having a plurality of knots 1021, wherein the knot groups are uniform or non-uniform as described with reference to FIG. 10A. In one aspect, the distal portion of the sleeve includes a covering 1022. In various aspects, about 30-60 mm of the distal end is covered with a coating 1022. In one aspect, the coating 1022 is silicone. In one aspect, the staggered knot is located at the distal portion having the covering 1022 and is covered to eliminate the traumatic surface. In one aspect, the overall length l of the sleeve 1020 is about 120 mm. The sleeve 1020 has a first opening 1023 at the proximal end having a diameter _{d 1.} In one aspect, the diameter d ₁ is about 75 mm. The sleeve has a second opening 1024 at the distal end having a diameter _{d 2.} In one embodiment, the diameter _{d 2} is about 10 mm.

FIG. 10D is an illustration of a short braided sleeve member 1020 having the conical shape of FIG. 10C attached to a wire mesh structure 1030 in accordance with an aspect of the present description. Referring to FIG. 10C and FIG. 10D at the same time, the diameter d ₁ of the first opening 1023 of the sleeve 1020 is as large as the diameter of the anti-movement ring 1034 of the wire mesh structure 1030. In order to attach the wire mesh structure 1030 and the sleeve 1020, the sleeve 1020 is attached to the movement preventing ring 1034 as indicated by a broken line 1035. Since the wire mesh structure 1030 and the sleeve 1020 include first openings having similar diameters, the sleeve 1000 and the sleeve 1010 of FIGS. 10A and 10B are each attached to the wire mesh structure in the same manner as the sleeve 1020 of FIG. 10C. . In other words, the sleeves 1000 and 1010 are placed on the movement prevention ring of the wire mesh structure.

FIG. 10E is an illustration of a short braided sleeve member 1040 having a conical shape in a deployed configuration, according to another aspect of the specification. The sleeve 1040 is similar to the sleeve 1020 of FIG. 10C except that the sleeve 1040 has a smaller first opening 1043. As shown in FIG. 10E, in various aspects, the sleeve 1040 includes a metal wire braided structure having a plurality of knots 1041, wherein the knot groups are uniform or variable as described with reference to FIG. 10A. In one aspect, the distal portion of the sleeve includes a covering 1042. In various aspects, about 30-60 mm of the distal end is covered with a coating 1042. In one aspect, the coating 1042 is silicone. In one aspect, the staggered knot is located at the distal portion having the covering 1042 and is covered to eliminate the traumatic surface. In one aspect, the overall length l of the sleeve 1040 is about 120 mm. The sleeve 1040 has a first opening 1043 at the proximal end having a diameter d ₁ . In one aspect, the diameter d ₁ is about 30 mm. The sleeve has a second opening 1044 at the distal end having a diameter _{d 2.} In one embodiment, the diameter _{d 2} is about 10 mm.

FIG. 10F is an illustration of a short braided sleeve member 1040 having the conical shape of FIG. 10E attached to a wire mesh structure 1050 in accordance with an aspect of the present description. Referring to FIGS. 10E and 10F simultaneously, the diameter d ₁ of the first opening 1043 of the sleeve 1040 is as large as the diameter of the neck 1052 of the anti-movement ring 1054 of the wire mesh structure 1050. The outer diameter of the movement preventing ring 1054 itself is larger than the diameter _{d 1.} Accordingly, to attach the wire mesh structure 1050 and the sleeve 1040, the sleeve 1040 is inserted into the anti-movement ring 1054 and attached to the neck 1052 of the ring, as shown by the dashed line 1055.

10G and 10H are views of a short braided sleeve member 1060, 1065 having a conical shape with a distal tip 1062, 1067 that does not damage tissue in a deployed configuration, according to aspects herein. Referring to FIGS. 10G and 10H simultaneously, the metal lines 1061, 1066 of the sleeve members 1060, 1065 do not extend to the distal tips 1062, 1067. The distal tips 1062, 1067 only include a more flexible sleeve layer, such as PTFE, so as not to damage the gastrointestinal mucosal tissue. In some embodiments, the distal tips 1062, 1067 have a diameter d _{1 of} about 10 cm and a length in the range of 5-15 cm. In some embodiments, the sleeve members shown in FIGS. 10A-10F each include a distal tip that does not harm tissue similar to that described with reference to FIGS. 10G and 10H.

  FIG. 11A is a cross-sectional view illustrating one embodiment of the intragastric device 1100 with the sleeve 1102 attached, in a deployed configuration. Device 1100 includes a wire mesh structure 1101 having an annulus 1103 located at a distal end. The sleeve 1102 has a cylindrical body with a proximal end attached to the bottom surface of the ring 1103. FIG. 11B is a cross-sectional view showing the intragastric device 1100 of FIG. 11A in a form before deployment. When the device 1100 is compressed into the undeployed configuration, the body of the sleeve 1102 is pulled to assist in folding the ring 1103 of the wire mesh structure 1101. The ring 1103 must be folded so that the device 1100 has a sufficiently small diameter to fit within the delivery device or catheter. As shown in FIG. 11B, the proximal end of the sleeve 1102 is attached to the bottom surface of the annulus 1103 so that when the annulus 1103 is folded, it is twice the annulus thickness 1103 ′ and the sleeve thickness 1102 ′, 1102 ″. Bulges including the thickness of

  FIG. 11C is a cross-sectional view showing another embodiment of the intragastric device 1110 with the sleeve 1112 attached, in a deployed state. Device 1110 includes a wire mesh structure 1111 having an annulus 1113 located at the distal end. The sleeve 1112 has a cylindrical body with a funnel-shaped proximal end attached to the knot or free end at the distal end of the ring 1113. The sleeve 1112 is attached to the ring 1113 via a plurality of seams 1117. FIG. 11D is a cross-sectional view showing the intragastric device of FIG. 11C in a form before deployment. When the device 1110 is compressed to its pre-deployment configuration, the body of the sleeve 1112 is pulled to assist in folding the ring 1113 of the wire mesh structure 1111. The seam 1117 that joins the sleeve 1112 to the ring 1113 is loosely secured, allowing some minimal movement between the sleeve 1112 and the ring 1113. Thus, as shown in FIG. 11D, when the annulus 1113 is folded, the funnel portion of the sleeve 1112 and the annulus 1113 move relative to each other so that the bulge made in the compressed device includes only the annulus thickness 1113 '. This reduces the cross-sectional area or diameter of the compressed device and makes it easier to deploy through the delivery device or catheter.

  In addition, the ring 1113 shown in FIG. 11C has fewer sharp bends (rounder) than the ring 1103 shown in FIG. 11A. When there are few sharp bends in the ring, the ring is less traumatic to body tissue. Moreover, since the distortion rate is low, the shape can be maintained.

  FIG. 12A is an illustration of a plurality of knots 1205 located at the distal end of a wire mesh structure 1202 coupled to the proximal end of a funnel-shaped sleeve in accordance with an aspect of the present description. As shown in FIGS. 11C and 11D, the knot 1205 is located at the distal end of the wire mesh structure or the distal end of the ring. As shown in FIG. 12A, each knot 1205 is attached to the sleeve 1202 by a seam 1208. As described with reference to FIGS. 11C and 11D, the seam is loosely secured and the sleeve 1202 can move somewhat relative to the wire mesh structure.

  FIG. 12B is an illustration of a plurality of knots 1215 located at the distal end of a wire mesh structure 1212 coupled to the proximal end of a funnel-shaped sleeve, according to another aspect of the specification. As shown in FIG. 12B, every other knot 1215 is attached to the sleeve via a seam 1218. Although the wire mesh structure is fixedly attached to the sleeve 1212, the number of seams 1218 is reduced as compared with the embodiment shown in FIG. 12A. This causes the bulges that can be made in the compressed undeployed form of the device to have a smaller diameter. Such compressed devices pass through the delivery device or catheter more easily.

  If the seam is secured directly to the most distal end of the knot, the seam may slide along the metal line of each knot and the sleeve may move excessively relative to the wire mesh structure. FIG. 12C is an illustration of a plurality of knots 1225 located at the distal end of a wire mesh structure 1222 coupled to the proximal end of a funnel-shaped sleeve, in accordance with another aspect of the present description. Rather than providing a seam at the most distal end of each knot 1225, a seam 1228 is provided around the intersection 1229 of the metal lines of two adjacent knots 1225. This prevents the seam from slipping excessively along any one of the metal lines and allows the sleeve 1222 to move relative to the wire mesh structure during compression.

  FIG. 12D is an illustration of a plurality of knots 1235 located at the distal end of a wire mesh structure 1232 coupled to the proximal end of a funnel-shaped sleeve, according to another aspect of the specification. As shown in FIG. 12D, every other intersection 1239 of the metal lines of adjacent knots 1235 is attached to the sleeve via a seam 1238. The wire mesh structure is securely attached to the sleeve 1232 and the number of seams 1238 is reduced compared to the embodiment shown in FIG. 12C. This causes the bulges that can be made in the compressed undeployed form of the device to have a smaller diameter. Such compressed devices pass through the delivery device or catheter more easily.

  FIG. 12E is an illustration of a plurality of knots 1245 located at the distal end of a wire mesh structure 1242 coupled to the proximal end of a funnel-shaped sleeve, according to another aspect of the specification. Each knot 1245 is located at the distal end of the wire mesh structure or the distal end of the anti-migration ring and includes a ring 1246 formed from the metal wire of the knot 1245 and extending in the direction toward the center of the wire mesh structure. The loop 1246 of each knot 1205 is attached to the sleeve 1242 by a seam 1248.

  FIG. 12F is a diagram of a plurality of knots 1255 located at the distal end of a wire mesh structure 1252 coupled to the proximal end of a funnel-shaped sleeve, according to yet another aspect of the specification. Each knot 1255 is positioned at the distal end of the wire mesh structure or the distal end of the anti-migration ring and includes a ring 1256 formed from the metal wire of the knot 1255 and extending in the direction toward the center of the wire mesh structure. The loop 1256 of each knot 1255 is attached to the sleeve 1252 by a seam 1258. As shown in FIG. 12F, the knot 1255 is attached to the sleeve by every other seam 1258. The wire mesh structure is securely attached to the sleeve 1252 and has fewer seams 1258 compared to the embodiment shown in FIG. 12E. This causes the bulges that can be made in the compressed undeployed form of the device to have a smaller diameter. Such compressed devices pass through the delivery device or catheter more easily.

  FIG. 13A is an illustration of a plurality of knots 1305 located at the distal end of a wire mesh structure 1302 coupled to the proximal end of a funnel-shaped sleeve, according to one aspect of the specification. As shown in FIG. 13A, the intersection 1309 of adjacent knots 1305 and the end 1304 of the knot 1305 are both sewn to a sleeve 1302 having a knot 1308.

  In one aspect, the distal end of the wire mesh structure is connected to the proximal end of the sleeve at nine independent connection points. Each connection point includes a “8” -shaped knot, and is further fixed with an adhesive and a heat-shrinkable tube. In one aspect, each knot is comprised of a suture knitted from ultra high molecular weight polyethylene (UHMWPE) having a 30 pound breaking strength to securely connect the wire mesh and the sleeve. FIG. 13B is a diagram of a distal end of a wire mesh structure 1320 and a proximal end of a funnel-shaped sleeve connected to the distal end and covered with a heat shrink tube 1326 according to one aspect of the specification. .

  FIG. 14 is an illustration of an intragastric device 1400 having a funnel-shaped sleeve 1410 in a deployed configuration, according to one aspect of the specification. The intragastric device 1400 includes a wire mesh structure 1405 having a proximal end and a distal end, and the wire mesh structure 1405 has a detent ring 1420 formed at the distal end. The sleeve 1410 includes a proximal end and a distal end, and is attached to the anti-migration ring 1420 via the proximal end.

  The wire mesh structure 1405 includes at least one metal line folded to form a cross-cross weave pattern having a plurality of curved free ends or knots along the structure. In the expanded and expanded form, the wire mesh structure 1405 has an elliptical shape. The wire mesh structure 1405 includes a plurality of staggered knots 1406, 1407, 1408, 1409 along its length to facilitate optimal expansion and compression for ease of delivery and removal. A first set of staggered knots 1406 is located at the proximal end of the wire mesh structure 1405 and surrounds the first opening 1401. In one embodiment, each knot of the first set of staggered knots 1406 is bent upward and extends in a direction opposite to the interior of the wire mesh structure 1405. The knots of the first set of staggered knots 1406 are used as grip points for the retrieval device when the intragastric device 1400 is removed. The wire mesh structure 1405 includes a second set of staggered knots 1407 on the distal side of the first set of staggered knots 1406 and proximate to the midpoint of the wire mesh structure 1405. A third set of staggered knots 1408 are located proximal to the distal end of the wire mesh structure 1405 distal to the midpoint. A fourth set of staggered knots 1409 is located at the distal end of the wire mesh structure 1405 and includes the free end of the anti-movement member 1420. All curves, including the knots in each set of staggered knots 1406, 1407, 1408, 1409 are designed to have bends that do not harm body tissue. These knots are staggered so that when the metal structure is compressed into the form before deployment, the bending points of the metal wires are bundled so that the wire mesh structure is not bulky. Once the knot is distributed along the length of the wire mesh structure, the diameter of the entire device once compressed can be reduced.

  Sleeve 1410 includes a proximal portion 1411 and a distal portion 1416 joined at a transition point 1415 along the body of sleeve 1410. Both the proximal portion 1411 and the distal portion 1416 of the sleeve 1410 are funnel-shaped and the diameter decreases as the portions 1411 and 1416 extend distally, respectively. In one aspect, the diameter of the proximal portion 1411 is substantially the same as the diameter of the anti-migration ring 1420 at the proximal end of the proximal portion 1411. The diameter of the proximal portion 1411 decreases until the proximal portion 1411 extends distally and the sleeve 1410 transitions to the distal portion 1416. At this point, the diameter of the proximal portion 1411 and the diameter of the distal portion 1416 are equal. Thereafter, the diameter of the distal portion 1416 decreases as the distal portion 1416 extends distally. The distal portion 1416 of the sleeve 1410 ends with a second opening 1419 at the distal end of the intragastric device 1400. In one aspect, the length of the proximal portion 1411 is shorter than the length of the distal portion 1416. In various aspects, the funnel-shaped sleeve 1410 includes at least one metal wire support. In some embodiments, the at least one metal wire support includes the same metal wire in both the proximal portion 1411 and the distal portion 1416. In other aspects, the proximal portion 1411 and the distal portion 1416 include separate metal wire supports that are joined at the distal end of the proximal portion 1411 and the proximal end of the distal portion 1416. Has been. In one aspect, the individual metal wires are spot welded. The metal wire is folded to form a cross-cross weave pattern on the sleeve 1410. In both the proximal portion 1411 and the distal portion 1416, as the portions 1411, 1416 extend distally and the funnel shape narrows, the crossover portion of the metal wire has a woven pattern at the distal end of each portion 1411, 1416. It gets closer to each other to become denser. The sleeve 1410 includes curved or free ends at the proximal and distal ends, similar to the knot of the wire mesh structure 1405. These free ends are designed not to damage body tissue. The proximal free end of the sleeve 1410 is attached to the knot of the fourth set of staggered knots 1409 of the wire mesh structure 1405 by one or more seams 1422. The free end of the distal end of the sleeve 1410 surrounds the second opening 1419. In various aspects, the sleeve 1410 is a short sleeve having an overall length in the range of 5 cm to 120 cm. In one aspect, the sleeve 1410 is a short sleeve having a total length of 60 cm. In one aspect, the sleeve 1410 includes a tip 1430 that does not harm tissue at the distal end. The tip 1430 does not include a metal wire. This tip is included to prevent the mucous membrane from being damaged by the sleeve tip.

  When the sleeve 1410 is attached to the wire mesh structure 1405, the proximal end of the proximal portion 1411 of the sleeve 1410 is prevented from moving so that the proximal portion 1411 of the sleeve 1410 covers the opening of the distal end of the wire mesh structure. Cover and cover at least part of 1420. With this arrangement, the inside of the wire mesh structure 1405 and the inside of the sleeve 1410 can be in fluid communication, enter the inside of the wire mesh structure 1405 through the first opening 1401, pass through the inside of the sleeve 1410, and then A food path out of the opening 1419 is established.

  FIG. 15 is an illustration of an intragastric device 1500 having a cylindrical sleeve 1510 in a deployed configuration, according to one aspect of the specification. The intragastric device 1500 includes a wire mesh structure 1505 having a proximal end and a distal end, and a detent ring 1520 is formed at the distal end. The sleeve 1510 includes a proximal end and a distal end and is attached to the anti-migration ring 1520 via the proximal end. In one aspect, the sleeve 1510 includes a soft tip 1530 that does not harm tissue at the distal end. The tip portion 1530 does not include a metal wire. This tip is included to prevent the mucous membrane from being damaged by the sleeve tip.

  The wire mesh structure 1505 is similar to the structure 1405 described with reference to FIG. 14, with an oval shape having a cross-cross weave pattern, a plurality of staggered knots 1506, 1507, 1508, 1509, and proximal ends. A first opening 1501 is included. All curves, including the knots in each set of staggered knots 1506, 1507, 1508, 1509 are designed to have bends that do not harm body tissue.

  The sleeve 1510 includes a proximal portion 1511 and a distal portion 1516 that are joined at a transition point 1515 along the body of the sleeve 1510. The proximal portion 1511 of the sleeve 1510 is funnel-shaped and its diameter decreases as the portion 1511 extends distally. In one aspect, the diameter of the proximal portion 1511 is substantially the same as the diameter of the anti-migration ring 1520 at the proximal end of the proximal portion 1511. The diameter of the proximal portion 1511 decreases until the proximal portion 1511 extends distally and the sleeve 1510 transitions to the distal portion 1516. At this point, the diameter of the proximal portion 1511 and the diameter of the distal portion 1516 are equal. Thereafter, the diameter of the distal portion 1516 remains the same as the distal portion 1516 extends distally, and the distal portion 1516 is substantially cylindrical. The distal portion 1516 of the sleeve 1510 ends with a second opening 1519 at the distal end of the intragastric device 1500. In one aspect, the length of the proximal portion 1511 is shorter than the length of the distal portion 1516.

  In various aspects, the funnel-shaped proximal portion 1511 of the sleeve 1510 includes at least one metal wire support. The metal wire is folded to form a cross-cross weave pattern on the sleeve 1510. As the portion 1511 extends distally and the funnel shape narrows, the metal wire intersections become closer together so that the weave pattern is denser at the distal end of the proximal portion 1511. In various aspects, the distal portion 1516 includes at least one helical wire support member that extends along the length of the cylinder. The helical wire support member has a constant pitch such that the resulting helical woven structure has the same pattern along the length of the distal portion 1516 of the sleeve 1510. In some embodiments, the helical wire support member of the distal portion 1516 is an extension of at least one metal wire support of the proximal portion 1511. In other aspects, proximal portion 1511 and distal portion 1516 include separate metal wire supports that are joined at the distal end of proximal portion 1511 and the proximal end of distal portion 1516. ing. In one aspect, these individual metal wires are spot welded. The sleeve 1510 includes curved or free ends at the proximal and distal ends, similar to the knot of the wire mesh structure 1505. The free end is designed not to damage body tissue. The free end at the proximal end of the sleeve 1510 is attached to the knot of the fourth set of staggered knots 1509 of the wire mesh structure 1505 by one or more seams 1522. The free end of the distal end of the sleeve 1510 surrounds the second opening 1519. In various aspects, the sleeve 1510 is a short sleeve having an overall length in the range of 5 cm to 120 cm. In one aspect, the sleeve 1510 is a short sleeve having a total length of 60 cm. The funnel shaped cone can vary from 1% to 100% of the total length of the sleeve.

  When the sleeve 1510 is attached to the wire mesh structure 1505, the proximal end of the proximal portion 1511 of the sleeve 1510 is prevented from moving so that the proximal portion 1511 of the sleeve 1510 covers the opening at the distal end of the wire mesh structure. Cover the member 1520. With this arrangement, the inside of the wire mesh structure 1505 and the inside of the sleeve 1510 can be in fluid communication, enter the inside of the wire mesh structure 1505 through the first opening 1501, pass through the inside of the sleeve 1510, and then A food path out of opening 1519 is established.

  FIG. 16A is a detailed view of a funnel-shaped sleeve 1602 attached to a detent ring 1604 of the wire mesh structure 1605 of the intragastric device 1600 according to one aspect of the present description. The sleeve 1602 is attached to the movement prevention ring 1604 by a plurality of seams 1608.

  FIG. 16B is a detailed view of a funnel-shaped sleeve 1612 attached to a detent ring 1614 of the wire mesh structure 1615 of the intragastric device 1610 according to another aspect of the present description. Sleeve 1612 is attached to anti-shift ring 1614 by a plurality of seams 1618 and includes a plurality of frayed ends 1611 at the proximal end. This prevents the end of the sleeve from damaging body tissue.

  FIG. 16C is an illustration of an intragastric device 1620 that includes a wire mesh structure 1625 and a sleeve 1622 attached thereto, according to one aspect of the specification. The metal mesh structure 1625 includes a metal wire end portion that has no fixed portion and does not damage the tissue. In one embodiment, the wire mesh structure 1625 is made of nitinol. The wire mesh structure 1625 includes a movement prevention ring 1624, and a sleeve 1622 is attached to the movement prevention ring 1624. In some aspects, the wire mesh structure 1625 includes a retrieval pull string located proximate its proximal end, as shown in FIG. 16E. The sleeve 1622 includes an impermeable fluoropolymer liner without an anchor designed to extend to the small intestine, particularly the proximal portion of the middle duodenum. In various aspects, the sleeve 1622 includes a nitinol stent structure embedded within the polymer layer so that the sleeve 1622 does not damage tissue and no portion of nitinol contacts the small intestine. In one aspect, the sleeve 1622 includes a radiopaque marker to assist in proper delivery and placement.

  The metal mesh structure 1625 does not have a fixing portion and occupies a space in the stomach. The wire mesh structure 1625 floats freely inside the stomach, and exerts an elastic force on the stomach portion that is intermittently gentle and does not damage the tissue while in contact with the inner wall of the stomach. The stretching force induces a feeling of fullness for the patient. The anti-movement ring 1624 is appropriately shaped to receive the attached sleeve 1622. The contents of the stomach enter the wire mesh structure 1625 via the first opening 1621 at the proximal end of the wire mesh structure 1625 or the opening 1629 between the metal wires of the wire mesh structure 1625 and are directed into the attached sleeve 1622. . The stomach contents then pass through the sleeve 1622 and out of the second opening 1623 at the distal end of the sleeve 1622 and enter the duodenum or jejunum depending on the length of the sleeve 1622. The sleeve 1622 is attached in advance to the movement prevention ring 1624 of the wire mesh structure 1625. The Nitinol stent structure embedded in the sleeve 1622 supports the sleeve 1622 and prevents twisting or more of the sleeve due to the action of intestinal musculature. The Nitinol stent structure also applies a gentle radial stretching force to the small intestine wall to induce a fullness of the patient and prevent the heel from passing around the sleeve 1622.

FIG. 16D is an illustration of the intragastric device 1620 of FIG. 16C with a sleeve 1622. Device 1620 is straightened to show dimensions relative to the surrounding anatomy. The sleeve 1622 includes a proximal funnel or conical portion 1622p attached to the anti-migration ring of the wire mesh structure 1625 and a distal cylindrical portion 1622d extending distally from the proximal portion 1622p. Wire mesh structure 1625 and a proximal portion 1622p of the sleeve 1622 has a maximum outer diameter and the length l ₁ of which is configured to remain in the stomach of a patient, together about 8 inches. In some embodiments, the length l ₁ is about 10 inches. In some embodiments, the fully deployed wire mesh structure 1625 has a volume of about 1 liter. The proximal portion 1622p of the sleeve 1622 and the distal portion 1622d of the sleeve 1620 meet at a junction 1622j. This junction is located at the patient's pylorus. The distal portion 1622d of the sleeve 1620, the patient's small intestine, specifically configured to remain within the duodenum and has a maximum outer diameter and the length _{l 2} of about 1.0 inch. In some embodiments, the length l ₂ is about 10-25 inches. In some embodiments, the length l ₂ of the distal portion 1622d is such that the distal end of the sleeve 1622 is located in the duodenum and the contents of the stomach enter the duodenum directly from the stomach through the device 1620 to bypass the pylorus. It is like that. In another aspect, the length l ₂ is such that the distal end of the sleeve 1622 is located in the jejunum and the contents of the stomach enter the jejunum directly from the stomach through the device 1620 and bypass the pylorus and duodenum. ing. In another aspect, the wire mesh structure has a maximum diameter of 18 inches, a maximum length of 24 inches, and a maximum volume of 2.5 liters.

  FIG. 16E is an illustration of the wire mesh structure 1635 and sleeve 1632 of the intragastric device 1630 in accordance with an aspect of the present specification, showing the recovery straps 1637, 1638 on the surface of the wire mesh structure 1635. FIG. The sleeve 1632 is attached to an anti-migration ring 1634 at the distal end of the wire mesh structure 1635. In some aspects, the anti-migration ring 1634 includes a ring on the metal line of the knot at the distal end of the knot as shown in FIG. 4C. The sleeve 1632 is stitched to the anti-movement ring 1634 at these rings. In the illustrated embodiment, a pair of recovery pull cords 1637, 1638 are disposed on a wire mesh structure 1635 proximate to the proximal end. The first withdrawal cord 1637 is located at the proximal end of the wire mesh structure 1635 and the second withdrawal cord 1638 is distal to the first withdrawal cord 1637, but the proximal end of the wire mesh structure 1635. Located close to. The recovery drawstrings 1637 and 1638 pass through the metal wire openings of the wire mesh structure 1635. At the time of recovery, the free ends of the recovery strings 1637 and 1638 may be pulled using a gripping member, and the wire mesh structure 1635 may be contracted so that the outer diameter becomes smaller, and then removed from the patient through the endoscope. In one aspect, the two withdrawal strings 1637, 1638 are interlocked so that when one withdrawal string is squeezed, the other withdrawal strings are simultaneously squeezed.

  FIG. 16F is a view of the wire mesh structure 1645 and sleeve 1642 of the intragastric device 1640 according to one aspect of the present specification, showing a single withdrawal string 1648 on the surface of the wire mesh structure 1645. The sleeve 1642 is attached to the anti-movement ring 1644 at the distal end of the wire mesh structure 1645. In some aspects, the anti-migration ring 1644 includes a knot metal wire ring at the distal end of the knot, as shown in FIG. 4C. The sleeve 1642 is stitched to the anti-movement ring 1644 at these rings. In the illustrated embodiment, a single withdrawal cord 1648 is disposed on the wire mesh structure 1645 proximate the proximal end. This single drawstring passes through the opening between the metal wires of the wire mesh structure 1645. At the time of collection, the free end of the collection pulling string 1648 may be pulled using a gripping member, and the wire mesh structure 1645 may be contracted so that the outer diameter becomes small, and then removed from the patient through the endoscope. In the illustrated embodiment, a single withdrawal pullstring 1648 may include two groups of knots 1647, 1649 of wire mesh structure 1645, or a first group of knots 1647 at the proximal end of wire mesh structure 1645 and collection pullstring 1648. It is sufficient to squeeze the second group of knots 1649 in position. In another aspect, a single drawstring is sufficient to squeeze more than two groups of wire mesh structures.

  In some embodiments, the sleeve includes a metal wire support, and the end of the metal wire or the metal wire is designed not to injure body tissue. In various embodiments, the end of the metal wire is not sharp and is folded or welded to the end of another metal wire. In another aspect, the distal end of the sleeve includes components designed such that the distal end does not harm body tissue. FIG. 17A is a cross-sectional view of the distal end of the sleeve 1705 showing one embodiment of a component 1710 designed such that the distal end does not damage body tissue. Component 1710 has a cylindrical shape and has a proximal end 1711, a distal end 1719, and an inner lumen 1716. The two ends 1711, 1719 of the component 1710 are open. The lumen 1716 of the component 1710 is in fluid communication with the lumen 1706 of the sleeve 1705 so that food can pass through the wire mesh of the intragastric device, the sleeve 1705, and the component 1710. The distal end 1719 is rounded to an unsharp shape that does not harm body tissue. The outer surface of component 1710 includes a groove 1713 adapted to receive an annular member or O-ring 1714. To attach the component 1710 to the sleeve 1705, the distal end of the sleeve 1705 is coaxially over the proximal end 1711 of the component 1710 such that a portion of the sleeve 1705 is disposed over the groove 1713. Next, the O-ring 1714 is put on the sleeve 1705 and fitted in the groove 1713. Thereby, the sleeve 1705 and the component 1710 are firmly connected. The distal sleeve end 1707 is then folded proximally toward the sleeve 1705 body. In one aspect, component 1710 includes an annular flange 1712 that extends outwardly from the outer surface of component 1710 and then proximally. The flange 1712 acts to cover any sharpened ends of the folded distal sleeve end 1707 and further protect body tissue from trauma. In various aspects, the component 1710 has a length ranging from 5 mm to 500 mm, an outer diameter ranging from 3 mm to 30 mm, and an inner diameter ranging from 0.5 to 50 mm.

  FIG. 17B is a cross-sectional view of the distal end of the sleeve 1705 showing another aspect of a component 1720 designed such that the distal end does not damage body tissue. Component 1720 has a cylindrical shape and has a proximal end 1721, a distal end 1729, and an inner lumen 1726. The two ends 1721, 1729 of the component 1720 are open. The lumen 1726 of the component 1720 is in fluid communication with the lumen 1706 of the sleeve 1705 so that food can pass through the wire mesh of the intragastric device, the sleeve 1705, and the component 1720. The distal end 1729 is rounded to a non-pointed shape that does not harm body tissue. The outer surface of component 1720 includes a groove 1723 adapted to receive an annular member or O-ring 1724. To attach the component 1720 to the sleeve 1705, the distal end of the sleeve 1705 is coaxially over the proximal end 1721 of the component 1720 such that a portion of the sleeve 1705 is disposed over the groove 1723. An O-ring 1724 is placed over the sleeve 1705 and fitted into the groove 1723. The distal sleeve end is then folded proximally toward the sleeve 1705 body. A heat shrink tube 1725 is then placed over the distal sleeve end and the O-ring 1724. Heat is applied to the heat shrink tube 1725 to shrink the tube 1725 so that the sleeve 1705 and the component 1720 are securely connected. The sharp end of the distal sleeve end is contained under the heat shrink tube 1725 and is not exposed to body tissue.

  FIG. 17C is a cross-sectional view of the distal end of the sleeve 1705 showing another aspect of a component 1730 designed such that the distal end does not damage body tissue. Component 1730 has a cylindrical shape and has a proximal end 1731, a distal end 1739, and an inner lumen 1736. The two ends 1731, 1739 of the component 1730 are open. The lumen 1736 of the component 1730 is in fluid communication with the lumen 1706 of the sleeve 1705 so that food can pass through the wire mesh of the intragastric device, the sleeve 1705, and the component 1730. The distal end 1739 is rounded to a non-pointed shape that does not harm body tissue. The outer surface of component 1730 includes a groove 1733 adapted to receive an annular member or O-ring 1734. In order to attach the component 1730 to the sleeve 1705, the sleeve 1705 is first turned upside down. The distal end of the sleeve 1705 is then placed coaxially over the distal end 1739 of the component 1730 so that a portion of the sleeve 1705 covers the groove 1733. An O-ring 1734 is placed over the sleeve 1705 and fitted into the groove 1733. The sleeve 1705 is then folded proximally over the O-ring 1734 and the proximal end 1731 of the component 1730, thereby firmly connecting the sleeve 1705 and the component 1730. Connecting the sleeve 1705 to the component 1730 in this manner ensures that the distal sleeve end 1707 is positioned within the sleeve lumen 1706. The pointed end of the distal sleeve end 1707 is contained within the sleeve lumen 1706 and is not exposed to body tissue.

  FIG. 18 is a view of the distal end of a sleeve 1805 with a positioning tail 1810 attached in accordance with an aspect of the present description. A positioning tail 1810 is attached to the distal end of a short sleeve 1805 having a length of 5 mm to 500 mm. The positioning tail 1810 includes ribbon material that extends from the distal end of the sleeve 1805 into the patient's duodenum and is used to help maintain the proper orientation of the sleeve 1805 relative to the patient's pylorus. In various aspects, the positioning tail 1810 has a length l in the range of 5 mm to 500 mm. In one aspect, the positioning tail 1810 has a length l of 25 mm. In one aspect, the distal end of the positioning tail 1810 includes beads 1815 for hanging the distal end with weight. In another aspect, the distal end of the positioning tail includes a plurality of individual free ends resembling a horse tail. In another aspect, the distal end of the positioning tail includes any mechanism or component designed to add additional weight to or pull the distal end, and pulling the tail to It can be surely pointed in the right direction. In one aspect, the distal end of the positioning tail does not include additional components.

  FIG. 19A is an illustration of a distal end of a sleeve 1905 that includes a plurality of tufts 1907 joined to an annulus 1908 in accordance with an aspect of the present description. In various aspects, the distal end of the sleeve 1905 includes two or more tufts 1907. In one aspect, the distal end of the sleeve 1905 includes four tufts 1907. Each tuft 1907 includes a portion of sleeve material that is separate from the adjacent tuft 1907. The tufts 1907 are separated from each other by a space 1906, which allows food to pass through the intragastric device and out of the sleeve 1905. In various aspects, each tuft 1907 has a length in the range of 5 mm to 500 mm and a width in the range of 1 mm to 15 mm. In some embodiments, the width of each tuft 1907 becomes narrower as the tuft 1907 extends distally. Tuft 1907 is connected to ring 1908 at the most distal end of sleeve 1905. Ring 1908 includes a central opening 1909 for passing food. In some embodiments, the ring 1908 is semi-rigid. In various embodiments, the ring 1908 has an outer diameter in the range of 1 mm to 30 mm and an inner diameter in the range of 1 mm to 30 mm. In various aspects, an annulus 1908 is attached to each tuft 1907 by stitching, gluing, gluing, or any other attachment method. An annulus 1908 joins the tuft 1907 and acts to cause the distal end of the sleeve 1905 to hang down with a weight, thereby assisting the device in the proper orientation. The surface of the ring 1908 is not sharp and does not damage body tissue. In some embodiments, the tuft 1907 and the ring 1908 are parabolic.

  FIG. 19B is a view of the distal end of a sleeve 1910 that includes a plurality of tufts 1912 joined to a ball 1913 in accordance with one aspect of the present specification. In various aspects, the distal end of sleeve 1910 includes two or more tufts 1912. In one aspect, the distal end of the sleeve 1910 includes four tufts 1912. Each tuft 1912 includes a portion of sleeve material separate from the adjacent tuft 1912. The tufts 1912 are separated from each other by a space 1911 so that food can leave the sleeve 1910 through the intragastric device. In various aspects, each tuft 1912 has a length in the range of 5 mm to 500 mm and a width in the range of 1 mm to 15 mm. In some embodiments, the width of each tuft 1912 becomes narrower as the tuft 1912 extends distally. Tuft 1912 is connected to ball 1913 at the distal most end of sleeve 1910. In various aspects, the ball 1913 has a diameter in the range of 2 mm to 30 mm. In various aspects, balls 1913 are glued or glued to each tuft 1907. Ball 1913 joins tuft 1912 and acts to hang down the distal end of sleeve 1910 with a weight, thereby assisting the device to point in the proper direction. Since the ball 1913 is spherical, it has no sharp edges and does not damage body tissue. In other embodiments, the distal most end of the tuft 1912 is tied into a single knot to form a ball 1913, and no additional ball members are required. In some embodiments, the tuft 1912 and the ball 1913 are parabolic.

  In one aspect, as shown in FIG. 19C, the ball 1913 includes a lumen 1933 through which a guide wire can pass. In another aspect, the ball 1913 has a groove or recess 1932 that receives the plunger of the inner pusher catheter or delivery device. In one aspect, the ball is designed to be in the outer catheter of the delivery device.

  FIG. 19D is a view of the distal end of the sleeve 1915 according to one aspect of the specification. A plurality of seams 1917 extend therefrom and are joined to the ball 1918. In various aspects, the sleeve 1915 includes two or more seams 1917. In one aspect, the sleeve 1915 includes six seams 1917. In various aspects, the seam 1917 has a length in the range of 5 mm to 500 mm. In one aspect, the seam 1917 is made of nylon. The proximal end of each seam 1917 is attached to the distal end of sleeve 1915, and the distal end of each seam 1917 is attached to ball 1918. In various aspects, balls 1918 are glued to each seam 1917. In various aspects, the ball has a diameter in the range of 3 mm to 30 mm. Ball 1918 is designed to apply a weight to the distal end of sleeve 1915 and pull sleeve 1915 in the proper implantation direction. Since ball 1918 is spherical, it has no sharp edges and does not damage body tissue. The food exits the distal end of the sleeve 1915 and passes through the space 1916 between the seams 1917. In one aspect, the ball 1918 includes a central opening 1919 for passing a guide wire therethrough. In various aspects, the ball 1918 is replaced by an annulus or similarly designed component, which hangs the sleeve 1915 with a weight to ensure that the device is oriented properly. In some embodiments, the seam 1917 and ball 1918 are parabolic.

  FIG. 19E is an illustration of a distal end of a sleeve 1920 having at least one seam 1922 extending therefrom, according to one aspect of the specification. A seam ring or bead 1923 is attached to the seam. In one aspect, the sleeve 1920 includes six seams 1922. In various aspects, the seam 1922 has a length in the range of 5 mm to 500 mm. In one aspect, the seam 1922 comprises UHMWPE. The proximal end of each seam 1922 is attached to the distal end of sleeve 1920, and the distal end of each seam 1922 is attached to a seam ring or bead 1923. The loop or bead 1923 of the seam is designed to weight the distal end of the sleeve 1920 to pull the sleeve 1920 and face the appropriate implantation direction. Since each loop or bead 1923 is spherical, it has no sharp edges and does not harm body tissue.

  FIG. 20A is a view of the distal end of the sleeve 2005, showing at least one crease 2007 in the sleeve wall 2006, according to one aspect of the specification. In one aspect, the sleeve 2005 includes three folds 2007 in the wall 2006. The crease 2007 is formed along the longitudinal axis of the sleeve 2005. In various aspects, the folds 2007 are located equidistant from each other. As shown in FIG. 20A, the sleeve 2005 is folded twice so that three layers of the sleeve wall 2006 are provided in each fold line 2007. These sleeve layers are bonded at each fold 2007. In one aspect, the sleeve layer is heat sealed. When the sleeve wall 2006 is folded, a pleat effect is created, giving the sleeve 2005 structure and stability. This additional structure maintains the sleeve 2005 in the proper orientation relative to the patient's pylorus and helps prevent deformation of the sleeve 2005 by the action of the patient's gastrointestinal tract.

  FIG. 20B is a view of the distal end of the sleeve 2010, showing at least one channel 2012 and support structure 2013 in the sleeve wall 2011, in accordance with an aspect of the present description. In one aspect, the sleeve 2010 includes four channels 2012 in the wall 2011 and each channel 2012 includes a support structure 2013 on its inside. In various aspects, the support structure 2013 includes a tube or bead. In various aspects, the support structure 2013 is sized to fit snugly into the channel 2012. The channel 2012 extends along the longitudinal axis of the sleeve 2010. In one aspect, the channel 2012 extends along the entire length of the sleeve 2010. In other aspects, the channel extends only along the distal end portion of the sleeve 2010. In various aspects, the channels 2012 are equidistant from each other. Inclusion of the channel 2012 and support structure 2013 provides structure and stability to the sleeve 2010. This additional structure keeps the sleeve 2010 in the proper orientation relative to the patient's pylorus and helps prevent deformation of the sleeve 2010 by the action of the patient's gastrointestinal tract. In one aspect, the channel 2012 is a hollow groove that can be filled or inflated with a fluid, such as water or air, to provide the sleeve 2010 with rigidity and / or structure.

  FIG. 20C is an illustration of a portion of sleeve 2015 according to one aspect of the present specification, showing a corrugated sleeve wall. The sleeve 2015 includes a plurality of annular grooves 2016 and ridges 2017 extending alternately along its length. In one aspect, the entire sleeve 2015 is corrugated. In other aspects, only the distal end portion of the sleeve 2015 is corrugated. In various embodiments, the corrugated portion of the sleeve 2015 is made of fluoropolymer or polyethylene (PE). As shown in FIG. 20C, in one aspect, the portion of the corrugated structure of the sleeve 2015 is cylindrical and has a constant diameter along its entire length. In another aspect, the corrugated portion of the sleeve is funnel-shaped and decreases in diameter as the sleeve extends distally. In various aspects, the distal end of the corrugated sleeve 2015 is curled and soft so as not to damage body tissue. The corrugated structure maintains sleeve 2015 in the proper orientation relative to the patient's pylorus and helps prevent deformation of sleeve 2015 by the action of the patient's gastrointestinal tract.

  FIG. 20D depicts a braided sleeve wall, with an illustration of a portion of a sleeve 2020, according to one aspect of the specification. Sleeve 2020 includes a braided metal line pattern 2021 that extends along its length. In one aspect, the entire sleeve 2020 is a braid. In other aspects, only certain portions of the sleeve 2020 are braided, for example, only the distal end. As shown in FIG. 20D, in one aspect, the braided portion of the sleeve 2020 is cylindrical and has a constant diameter along its entire length. In various aspects, the diameter of the sleeve 2020 ranges from 1 cm to 10 cm. In one aspect, the diameter of the sleeve is 25 mm and the length is 500 mm. In other embodiments, the braided portion of the sleeve is funnel-shaped and decreases in diameter as the sleeve extends distally. In various aspects, the distal end of the braided sleeve 2020 is soft and rounded so as not to damage body tissue. The braided structure helps maintain the sleeve 2020 in the proper orientation with respect to the patient's pylorus and helps prevent deformation of the sleeve 2020 due to the action of the patient's gastrointestinal tract. The braided structure provides a structurally complete sleeve 2020 and prevents the sleeve 2020 from twisting, bending or clogging. In various aspects, the sleeve 2020 has a radial force. This radial force is high enough to prevent deformation of the gastrointestinal tract due to wrinkling, but low enough to compress the sleeve 2020 and allow food to spread into the sleeve 2020. Also, the radial force is sufficiently low and the rigidity of the sleeve is not so great as to cause trauma (including scratches) to the gastrointestinal tract. In one aspect, the braided structure of the sleeve 2020 functions similarly to a stent and keeps the sleeve 2020 in place in the patient's small intestine.

  FIG. 20E is an illustration of a portion of a sleeve 2025 according to one aspect of the specification, showing a braided sleeve wall and a distal sleeve end having a frayed end 2028. The sleeve 2025 includes a braided metal line pattern 2026 that extends along its length. The frayed end 2028 at the distal end of the sleeve 2025 is less likely to damage body tissue.

  FIG. 20F is an illustration of exemplary sleeve braid patterns 2031, 2032, 2033, 2034, 2035, 2036, 2037 in accordance with various aspects herein.

  FIG. 21A is an illustration of an intragastric device 2130 having an elliptical wire mesh structure 2131 deployed in a patient's gastrointestinal tract, according to one aspect of the specification. In the illustrated embodiment, the device 2130 includes a wire mesh structure 2131 having a movement prevention ring 2134 and having a sleeve 2132 attached thereto. Device 2130 is deployed such that wire mesh structure 2131 is located in stomach 2160, anti-migration ring 2134 is located just proximal to pylorus 2161, and sleeve 2132 extends through pylorus 2161 into duodenum 2170. . The distal end of the sleeve 2132 is located within the duodenum 2170. The anti-migration ring prevents the entire device 2130 from moving through the pylorus 2161 into the duodenum 2170. Device 2130 occupies the volume of stomach 2160 and the entire device does not pass through pylorus 2161. Also, the food bypasses the pylorus 2161 and part of the duodenum 2170. In various aspects, the sleeve 2132 is a short sleeve having a length in the range of 5 cm to 120 cm. In one aspect, the sleeve 2132 is a short sleeve having a total length of 60 cm. In some embodiments, the short sleeve 2132 functions to hang down the wire mesh structure 2131 with a weight and position the wire mesh structure 2131 toward the pylorus 2161 in the correct orientation. Also, in one aspect, the device 2130 with the short sleeve 2132 is free to move within the patient's stomach 2160 after deployment. The short sleeve 2132 can enter and exit the pylorus 2161 without damaging the tissue. With the device 2130 moved so that the short sleeve 2132 is located within the stomach 2160 with the rest of the device 2130 rather than within the pylorus 2161 and duodenum 2170, the short sleeve also impedes the flow of food to the pylorus 2161 and Functions to adjust. This occurs when food enters the device 2130 from the proximal end of the wire mesh structure 2131 and passes through the wire mesh structure 2131 and the sleeve 2132. This slows the progression of food as it passes through the funnel-shaped sleeve 2132. While functioning correctly, the intragastric device is never fixedly or permanently connected to the wall of the gastrointestinal tract. During most of the time that the intragastric device is functioning after deployment, at least some or all of the intragastric device is free to move relative to the stomach or small intestine. As a result of the inclusion of the lumen, the device never completely or permanently blocks the passage of stomach contents into the small intestine for any clinically significant time while functioning normally. Never do. In various aspects, based on the shape of the sleeve, the intragastric device can increase, decrease, or have no effect on gastric emptying.

  FIG. 21B is a diagram of an intragastric device 2140 having an elliptical wire mesh structure 2141 deployed in a patient's gastrointestinal tract, according to another aspect of the present description. The wire mesh structure 2141 is located in the patient's stomach 2160 and includes a detent ring 2144 to which a sleeve 2142 is attached. The sleeve 2142 includes a proximal funnel portion 2142p. The funnel-shaped portion 2142 is just proximal to the pylorus 2161 in the stomach. The sleeve 2142 also includes a distal cylindrical portion 2142d. Cylindrical portion 2142d passes through the end of pylorus 2161, duodenum 2170, and jejunum 2172, where it releases the contents of the stomach that passed through intragastric device 2140. This effectively bypasses the pylorus 2161 and duodenum 2170. In other embodiments, the sleeve is shorter and ends in the duodenum, and the stomach contents that pass through the intragastric device bypass only the pylorus and the proximal portion of the duodenum. While functioning correctly, the intragastric device is never permanently or permanently connected to the wall of the gastrointestinal tract. During most of the time that the intragastric device is functioning after deployment, at least some or all of the intragastric device is free to move relative to the stomach or small intestine. As a result of the inclusion of the lumen, the device never completely or permanently blocks the passage of stomach contents into the small intestine for any clinically significant time while functioning normally. Never do. In various aspects, based on the shape of the sleeve, the intragastric device can increase, decrease, or have no effect on gastric emptying.

FIG. 21C shows several views 2121 showing the open and closed states of the patient's pylorus 2125 with or without the sleeve 2126 of the intragastric device in accordance with some aspects herein. 2122, 2123, 2124. In FIG. 2121 pylorus 2125 is closed and there is no sleeve extending through it. FIG. 2122 shows a closed pylorus 2125 and a sleeve 2126 extending therethrough. 2123 and 2124 show a partially open pylorus 2125 and a fully open pylorus 2125, respectively, with a sleeve 2126 extending therethrough. In various aspects, the sleeve 2126 includes a collapsible tubular reinforcing membrane that faces the inner wall of the pyloric mouth. In various aspects, the maximum inner diameter of the sleeve 2126 ranges from 25 mm to 40 mm and the wall thickness is about 0.2 mm. Any membrane that passes through the pylorus, such as the sleeve 2126, has a very small but finite cross-sectional area. In various aspects, the cross-sectional area of the sleeve 2126 is about 15 mm ² and is equivalent to a plug having a diameter of about 4.4 mm. In other words, the moving area of the pyloric ostium is always reduced by about 15 mm ² when the sleeve 2126 passes through the pyloric ostium.

  FIG. 22 illustrates an expanded wire mesh structure 2201 of the first intragastric device 2200 in the deployed configuration and a second intragastric coupled to the distal end of the infusion catheter 2250 according to one aspect of the present specification. FIG. 22 is a view of the deflated wire mesh structure 2221 of the device 2220. Second intragastric device 2220 also includes a sleeve 2222 coupled to the distal end of wire mesh structure 2221. The wire mesh structure 2221 and sleeve 2222 of the second intragastric device 2220 are compressed and coaxially over the distal end of the infusion catheter 2250. In the illustrated embodiment, the wire mesh structure 2221 and the sleeve 2222 are maintained in a compressed form by seams or threads 2225 wound around both the wire mesh structure 2221 and the sleeve. Once the device 2220 is placed in the patient's stomach and duodenum, the seam line or thread 2225 is unwound and the wire mesh structure 2221 and sleeve 2222 expand to the deployed configuration. As device 2220 expands, device 2220 is released from catheter 2250. The catheter 2250 is then removed from the patient. In other embodiments, the compressed wire mesh structure and sleeve are held in place by a coaxial sheath overlying the infusion catheter. Upon deployment, the device is released by opening, pulling, or tearing the sheath vertically.

  FIG. 23 is an illustration of an intragastric device 2300 according to one aspect of the present specification, having a wire mesh structure 2301 partially constrained to a delivery catheter 2350 surface. The device 2300 is also connected to a sleeve 2302 and a movement preventing member 2304. In the illustrated embodiment, the proximal end of the wire mesh structure 2301 is also contracted with a seam or thread 2340. The sleeve 2302, the anti-movement member 2304, and a portion of the wire mesh structure 2301 are beginning to expand because the shrinking seams or threads have already been removed from these components.

  FIG. 24A is a diagram of a first exemplary delivery device 2450 for intragastric device 2400 according to one aspect of the specification. The intragastric device 2400 includes a compressed wire mesh structure 2401 and a sleeve 2402 that are coaxially disposed about the distal end of the delivery device or catheter 2450. A seam or thread 2440 is wrapped around the intragastric device 2400 to maintain the intragastric device 2400 in a compressed form. Catheter 2450 further includes a ostium 2458 from which the seam or thread 2440 used to compress intragastric device 2400 exits and terminates at the proximal end of catheter 2450. When the physician pulls the seam or free end 2459 of the thread 2440, the intragastric device 2400 is released. In one aspect, the catheter 2450 also includes a locking mechanism 2455 that locks the device 2450 in place.

  24B is a flow diagram illustrating a process that includes delivering an intragastric device using the delivery device of FIG. 24A, according to one aspect of the specification. In step 2410, the compressed intragastric device is coaxially placed over the distal end of the delivery device or catheter. Step 2412 then inserts the catheter into the patient using the endoscopic instrument and advances its distal end to the duodenum. Then, at step 2414, the distal end of the catheter is positioned so that the intragastric device wire mesh structure is in the stomach just proximal to the pylorus and the device sleeve enters the duodenum through the pylorus. In step 2416, the physician pulls the free end of the thread to remove the contracting thread from around the intragastric device and automatically expands the intragastric device. Finally, at step 2418, the catheter is slid back coaxially from the intragastric device and removed from the patient.

  FIG. 25A is a diagram of a second exemplary delivery device 2550 for intragastric device 2500 in accordance with an aspect of the present description. The intragastric device 2500 includes a compressed wire mesh structure 2501 and a sleeve 2502 that are coaxially disposed about the distal end of the delivery device or catheter 2550. A restraining sheath 2541 with a zipper is placed coaxially over the intragastric device 2500 to maintain the intragastric device 2500 in a compressed configuration.

  FIG. 25B is a flow diagram illustrating a process that includes delivering an intragastric device using the delivery device of FIG. 25A, according to one aspect of the specification. At step 2510, the compressed intragastric device is coaxially placed over the distal end of the delivery device or catheter. The catheter is then inserted into the patient using the endoscopic instrument at step 2512 and its distal end is advanced to the duodenum. Then, in step 2514, the distal end of the catheter is positioned so that the intragastric device wire mesh structure is in the stomach just proximal to the pylorus and the device sleeve enters the duodenum through the pylorus. At step 2516, the tool is used to open the restraining sheath around the intragastric device to automatically expand the intragastric device. Finally, at step 2518, the catheter is slid back coaxially from the intragastric device and removed from the patient.

  Alternatively, the sheath 2541 is a standard tubular sheath that, when pulled, releases the intragastric device in the desired position. FIG. 25C is a flow diagram illustrating a process that includes delivering an intragastric device using a delivery device that includes a withdrawal sheath, according to one embodiment of the present specification. At step 2550, the compressed intragastric device is coaxially placed over the distal end of the delivery device or catheter. Step 2552, an endoscopic instrument is then used to insert the catheter into the patient and its distal end is advanced to the duodenum. Then, at step 2554, the distal end of the catheter is positioned so that the wire mesh structure of the intragastric device is in the stomach just proximal to the pylorus and the sleeve of the device enters the duodenum through the pylorus. At step 2556, the tool is used to pull the constraining sheath coaxially around the intragastric device to automatically expand the intragastric device. Finally, at step 2558, the catheter is slid back coaxially from the intragastric device and removed from the patient.

  FIG. 26A is a diagram of a third exemplary delivery device 2650 for intragastric device 2600 according to one aspect of the specification. The intragastric device 2600 includes a compressed wire mesh structure 2601 and a sleeve 2602 and is coaxially disposed about the distal end of the delivery device or catheter 2650. A tear restraining sheath 2642 is coaxially placed over the intragastric device 2600 to maintain the intragastric device 2600 in a compressed configuration.

  FIG. 26B is a flow diagram illustrating a process that includes delivering an intragastric device using the delivery device of FIG. 26A according to one aspect of the specification. In step 2610, the compressed intragastric device is coaxially placed over the distal end of the delivery device or catheter. Step 2612, an endoscopic instrument is then used to insert the catheter into the patient and its distal end is advanced to the duodenum. Then, at step 2614, the distal end of the catheter is positioned so that the wire mesh structure of the intragastric device is in the stomach just proximal to the pylorus and the sleeve of the device enters the duodenum through the pylorus. At step 2616, a tool is used to tear the restraining sheath around the intragastric device to automatically expand the intragastric device. Finally, at step 2618, the catheter is slid back coaxially from the intragastric device and removed from the patient.

  FIG. 26C is a flow diagram illustrating a process that includes delivering an intragastric device using the delivery device of FIG. 26A in accordance with another aspect of the present description. At step 2620, the compressed intragastric device is coaxially placed over the distal end of the delivery device or catheter. Step 2622 then inserts the catheter into the patient using the endoscopic instrument and advances its distal end to the stomach. Then, in step 2624, the distal end of the catheter is positioned so that both the intragastric device wire mesh structure and the sleeve are located proximal to the pylorus. In step 2626, the tool is used to tear the restraining sheath from around the intragastric device and automatically expand the intragastric device. At step 2628, the catheter is slid back coaxially from the intragastric device and removed from the patient. Finally, at step 2630, gastric peristalsis pushes the sleeve of the intragastric device into the pylorus to reach the duodenum.

  FIG. 26D is a flow diagram illustrating a process that includes delivering the wire mesh structure and sleeve separately to assemble the intragastric device within the gastrointestinal tract of the patient. At step 2660, the first catheter delivers the wire mesh structure into the patient's stomach. Then, in step 2662, the second catheter delivers the sleeve into the wire mesh structure. Next, at step 2664, the distal end of the sleeve is extended through the distal opening of the wire mesh structure. Finally, at step 2666, the proximal end of the sleeve is connected to the distal end of the wire mesh structure.

  27A and 27B are views of a fourth exemplary delivery device 2700 for an intragastric device, according to one aspect of the present description. Delivery device 2700 includes a flexible elongate device body or outer catheter 2704 having a proximal end, a distal end, and an inner lumen. The distal end includes an opening 2703 and the proximal end is attached to the first handle 2705. The first handle 2705 is used to position the delivery device 2700 within the patient's gastrointestinal tract. The flexible plunger member 2716 is coaxially disposed within the lumen of the device body 2704 and can move longitudinally. Plunger 2716 includes a proximal end, a distal end, and a lumen therein. The distal tip 2714 of the plunger 2716 includes a mesh holder 2719 that includes a plurality of fins 2715. The fin 2715 firmly holds the wire mesh structure 2701 of the intragastric device, and acts to push and pull the wire mesh structure 2701 when the plunger 2716 moves back and forth within the device body 2704. A second handle 2706 is disposed at the proximal end of the plunger 2716 for moving the plunger 2716 longitudinally within the lumen of the device body 2704. Optionally, in one aspect, plunger 2716 includes a fastener 2718. This fastener prevents the plunger 2716 from going too far in the distal direction. A flexible elongate rod or inner catheter 2717 is coaxially disposed within the lumen of the plunger 2716 and can move longitudinally. Rod 2717 includes a proximal end and a distal end. A first spherical member or olive tip 2708 is disposed on the proximal side of the distal end of the rod 2717, and a second spherical member or olive tip 2709 is disposed on the distal end of the rod 2717. The first spherical member or olive tip 2708 has a diameter that is similar to or greater than the diameter of the second spherical member or olive tip 2709. A third handle 2707 is attached to the proximal end of the rod 2717. A third handle 2707 is used to move the rod 2717 longitudinally within the lumen of the plunger 2716. An intragastric device including a wire mesh structure 2701 and a sleeve 2702 is placed in the delivery device 2700 prior to deployment. The wire mesh structure 2701 is arranged with a side loop around the rod 2717 on the distal side of the tip portion 2714 of the plunger 2716, and a part of the wire mesh structure 2701 is hooked on the fin 2715 of the tip portion 2714. In some embodiments, the rod 2717 passes through at least two openings in the wire mesh structure 2701. These openings are not along the central axis in the longitudinal direction of the wire mesh structure 2701. In one aspect, the wire mesh structure 2701 is compressed to have a compressed length of about 20 cm for placement in the delivery device 2700. The sleeve 2702 is attached to the wire mesh structure 2701 and is disposed on the distal side of the wire mesh structure 2701 and on the proximal side of the first spherical member or olive tip 2708. The sleeve 2702 is folded 2 to 10 times and wound around the rod 2717. In one aspect, the sleeve 2702 has a length of 80 cm and is folded three times and compressed to a length of about 30 cm. The sleeve 2702 covers the rod 2717 but does not penetrate coaxially. One of the first and second ends of the seam loop 2713 is attached to the sleeve 2702 and the other is looped to the rod 2717 at a position distal to the first spherical member or olive tip 2708. It is. The diameter of the seam ring 2713 around the rod is smaller than the diameter of the first spherical member or olive tip 2708 but larger than the diameter of the second spherical member or olive tip 2709. When the rod 2717 is pushed out of the apparatus body 2704, the first spherical member or olive tip 2708 pushes out the seam ring 2713, and the seam ring 2713 pulls the attached sleeve 2702 out of the apparatus body 2704. When the delivery device 2700 with the rod 2717 is removed from the patient's gastrointestinal tract, the second spherical member or olive tip 2709 having a small diameter passes through the seam ring 2713, leaving the intragastric device in the patient's body. it can. In one aspect, the seam ring 2713 is biodegradable and dissolves over time. In other embodiments, the seam ring 2713 is non-biodegradable. In other embodiments, the seam ring 2713 is a biodegradable hook, ring, cone, or umbrella.

  Optionally, in one aspect, the delivery device 2700 further includes a balloon 2710 at the distal end of the device body 2704. The channel 2711 extends along the length of the device body 2704 and includes an inlet 2712 at the proximal end of the device body 2704. Inlet 2712 and channel 2711 are used to inflate balloon 2710 to secure the delivery device within the gastrointestinal tract of the patient. When secured, the delivery device applies a greater traction force and can push and pull the intragastric device during delivery.

  In some embodiments, the delivery device 2700 further includes a water flow mechanism or a water injection mechanism that reduces deployment force during delivery.

  In various aspects, the delivery device or catheter has a stiffness that is not constant along its length. The delivery device is more flexible at the distal end and less flexible along its length towards the proximal end. In some embodiments, the delivery device has three flexible regions, or a proximal region, a central region, and a distal region. In one aspect, the proximal zone has a length of 100 cm and a flexibility of 55D, the central zone has a length of 20 cm and a flexibility of 40D, and the distal zone has a length of 30 cm and a flexibility of 35D. Have Optionally, in one aspect, the distal region is further divided into two regions, including a more distal distal region and a more proximal distal region. The two regions are 15 cm in length, the more proximal distal region flexibility is 35D, and the distal distal region flexibility is 25D. The region is braided and the central and distal regions are coiled.

  The delivery device includes a distal end that does not harm tissue, and the three-handle system of the delivery device reduces the overall length of the device body. In various aspects, as shown in FIG. 27B, the delivery device has the following dimensions: The total length is in the range of 275 cm to 320 cm. The length of the device body or outer catheter 2704 ranges from 100 cm to 150 cm. The length of the plunger 2716 ranges from 120 cm to 150 cm. The length of the rod or inner catheter 2717 ranges from 275 cm to 320 cm. The length of each handle 2705, 2706, 2707 is equal to 10 cm. The distance between the second spherical member or olive chip 2709 and the first spherical member or olive chip 2708 ranges from 15 cm to 30 cm. The distance between the first handle 2705 and the second handle 2706 in the initial form prior to delivery is equal to 60 cm. The distance between the second handle 2706 and the third handle 2707 in the initial configuration prior to delivery is equal to 50 cm. In some embodiments, the outer diameter of the device body or outer catheter 2704 is 10 mm or less. In one aspect, the delivery device can be placed over a 0.035 inch guide wire. In various embodiments, plunger 2716 and rod 2717 are sufficiently flexible to allow guidance without damaging tissue in the intestine. In some embodiments, a stiff outer catheter can be bent up to 80 degrees and can traverse a curved section having a radius of 30-50 mm. In one aspect, if the rigid outer catheter is coiled with a radius of about 50 mm, the sleeve and mesh will twist or will not deploy tightly in place. Thus, as shown in FIG. 27C, in some embodiments, the device body or outer catheter 2704 includes a flexible braided catheter. The flexible braided catheter can be bent or coiled beyond the above limits, without unsuccessful deployment of the sleeve and wire mesh.

  FIG. 27C is a view of the distal end of a delivery device 2700, according to one aspect of the present specification, showing a guiding olive tip or first spherical member 2709 for guidance. Guide olive tip 2709 includes a small sphere with a non-pointed outer surface attached to the rod of delivery device 2700 or the distal end of inner catheter 2717. Guide olive tip 2709 guides device 2700 upon delivery, preventing twisting of device 2700 and trauma to surrounding body tissue. As illustrated in FIG. 27C, a portion of the inner catheter 2717 extending from the outer catheter 2704 includes a guide member. The stiffness of the guide member is less than the stiffness of the distal portion of the outer catheter 2704. In some embodiments, the stiffness of the guide member is not constant, the proximal end stiffness is closer to the distal end stiffness of the outer catheter 2704, and the distal end stiffness is closer to the 0.035 inch guide wire stiffness.

  FIG. 27D is a diagram of a portion of a delivery device 2700 according to one aspect of the present description, showing a net retainer 2719. Net holder 2719 includes a plurality of fins 2715. The fin 2715 holds the wire mesh structure of the intragastric device firmly, and acts to push and pull the wire mesh structure when the plunger 2716 moves back and forth within the device body 2704.

  In one aspect, the sleeve is only partially deployed upon delivery. The wire mesh structure functions as a fixture for keeping the intragastric device in place. As the patient eats, the sleeve expands and is fully deployed by movement of the gastrointestinal tract.

  FIG. 27E is a flow diagram illustrating a process that includes delivering an intragastric device using the delivery device of FIG. 27A, according to one embodiment herein. At step 2720, the delivery device is placed over the guide wire and into place in the patient's gastrointestinal tract. At step 2721, the physician uses the first handle to position the distal end of the delivery device body in the patient's duodenum. Optionally, at step 2722, the physician inflates a balloon at the distal end of the device body to secure the delivery device within the patient's gastrointestinal tract. Next, at step 2723, the physician pushes the second handle to push the plunger member until the sleeve is pushed out of the device body. If necessary, the plunger includes a fastener so that the physician knows when to stop pushing the second handle. At this point, the sleeve has advanced about 20 cm beyond the first spherical member and is located just proximal to the second spherical member. The wire mesh structure is located immediately proximal to the first spherical member and the opening at the distal end of the device body. Then, at step 2724, the physician advances the approximately 60 cm rod within the lumen of the plunger by pushing the third handle until the sleeve is fully deployed and fully extended, or compression is released. At step 2725, the physician retracts the device approximately 5-10 cm and repositions so that the distal end of the funnel portion of the sleeve is in the stomach. Then, at step 2726, the physician pulls back the first handle while holding the second handle firmly to deploy the funnel portion of the sleeve and the wire mesh structure in the stomach. This pulls back the apparatus body while keeping the plunger in place, thereby releasing the wire mesh structure. Step 2727 then removes the delivery device from the patient and leaves the intragastric device deployed in the patient's gastrointestinal tract.

  FIG. 28A is a diagram of a fifth exemplary delivery device 2830 for an intragastric device, according to one aspect of the specification. Delivery device 2830 includes a flexible elongate device body or outer catheter 2834 having a proximal end, a distal end, and an inner lumen. The distal end includes an opening 2833 and the proximal end is attached to the actuation mechanism 2835. Actuating mechanism 2835 includes actuator handle 2849 and actuation trigger 2848 and is used to move the components of the delivery device relative to each other. The actuation mechanism is also used to position the delivery device 2830 within the patient's gastrointestinal tract. The flexible plunger member 2846 is coaxially disposed within the lumen of the device body 2834 and can move longitudinally. Plunger 2846 includes a proximal end, a distal end, and an inner lumen. The distal tip 2844 of the plunger 2846 includes a mesh retainer 2819 that includes a plurality of fins 2845. The fin 2845 firmly holds the wire mesh structure 2831 of the intragastric device, and acts to push and pull the wire mesh structure 2831 when the plunger 2846 moves back and forth within the device body 2834. The proximal end of plunger 2846 is located within the actuation mechanism. Thus, when the actuation trigger 2848 is pulled, the plunger 2846 moves back and forth in the longitudinal direction in the lumen of the apparatus main body 2834. A flexible elongate rod or inner catheter 2847 is placed within the lumen of the plunger 2846. Rod 2847 includes a proximal end and a distal end. A first spherical member or olive tip 2838 is disposed on the proximal side of the distal end of the rod 2847, and a second spherical member or olive tip 2839 is disposed on the distal end of the rod 2847. Olive tips 2838, 2839 include spherical attachments that assist in guiding the delivery of intragastric devices. The diameter of the first spherical member or olive tip 2838 is larger than the diameter of the second spherical member or olive tip 2839. A rod handle 2837 is attached to the proximal end of the rod 2847 and is used to move the rod 2847 longitudinally in the lumen of the plunger 2846. The intragastric device includes a wire mesh structure 2831 and a sleeve 2832 and is disposed within the delivery device 2830 prior to deployment. In various aspects, the sleeve is axially compressed. In other embodiments, the sleeve is not axially compressed. The wire mesh structure 2831 is arranged with a side loop around the rod 2847 on the distal side of the tip 2844 of the plunger 2846, and a part of the wire mesh structure 2831 is hooked on the fin 2845 of the tip 2844. The sleeve 2832 is attached to the wire mesh structure 2831 and is disposed on the distal side of the wire mesh structure 2831 and on the proximal side of the first spherical member or olive tip 2838. The sleeve 2832 is folded 2 to 10 times and wound around the rod 2847. The sleeve 2832 covers the rod 2847 but does not penetrate coaxially. A seam loop 2843 is attached to the sleeve 2832 and is looped to the rod 2847 at a location distal to the first spherical member or olive tip 2838. The diameter of the seam ring 2843 around the rod 2847 is smaller than the diameter of the first spherical member or olive tip 2838, but larger than the diameter of the second spherical member or olive tip 2839. When the rod 2847 is pushed out of the device body 2834, the first spherical member or olive tip 2838 pushes the seam ring 2843, and the seam ring 2843 pulls the attached sleeve 2832 out of the device body 2834. Upon removal of the delivery device 2830 along with the rod 2847 from the patient's gastrointestinal tract, the second spherical member or olive tip 2839 having a small diameter passes through the seam ring 2843 so that the intragastric device can remain in the patient's body. . In one aspect, the seam loop 2843 is biodegradable and dissolves over time. In other embodiments, the seam loop 2843 is a biodegradable hook, ring, cone, or umbrella.

  Optionally, in one aspect, the delivery device 2830 further includes a balloon 2840 at the distal end of the device body 2834. Channel 2841 extends along the length of device body 2834 and includes an inlet 2842 at the proximal end of device body 2834. Inlet 2842 and channel 2841 are used to inflate balloon 2840 to secure the delivery device within the gastrointestinal tract of the patient. When secured, the delivery device applies a greater traction force and can push and pull the intragastric device during delivery.

  FIG. 28B is a flow diagram illustrating a process that includes delivering an intragastric device using the delivery device of FIG. 28A, according to one aspect of the specification. At step 2850, the delivery device is placed over the guide wire and into place in the patient's gastrointestinal tract. At step 2851, the physician uses the actuation mechanism to place the distal end of the delivery device body within the patient's duodenum. Optionally, at step 2852, the physician inflates a balloon at the distal end of the device body to secure the delivery device within the patient's gastrointestinal tract. Next, in step 2853, the physician pulls the actuation trigger until the first lock is applied and pushes the rod handle until the sleeve is pushed out of the device body. If necessary, the plunger includes a fastener so that the physician knows when to stop pushing the second handle. At this point, the sleeve has advanced about 20 cm beyond the first spherical member and is located just proximal to the second spherical member. The wire mesh structure is located immediately proximal to the first spherical member and the opening at the distal end of the device body. If necessary, at step 2854, the physician pulls the trigger and advances the plunger approximately 60 cm until the sleeve is fully deployed and fully extended, or the compression is released. At step 2855, the physician retracts the device approximately 5-10 cm and repositions so that the distal end of the funnel portion of the sleeve is in the stomach. Then, at step 2856, the physician pulls the actuation trigger again until the second lock is applied. This pulls back the device body while keeping the plunger in place, releasing the funnel portion of the sleeve and the wire mesh structure. Then, at step 2857, the delivery device is removed from the patient, leaving the intragastric device deployed in the patient's gastrointestinal tract.

  FIG. 29A is a diagram of another exemplary delivery device 2900 for an intragastric device, according to one aspect of the specification. The delivery device 2900 of FIG. 29A differs from the delivery device 2700 shown in FIG. 27A in that it includes only two handles 2905, 2906, a device body or outer catheter 2904, and a rod or inner catheter 2917. The delivery device 2900 of FIG. 29A does not include a separate plunger with a handle. Instead, the plunger 2916 is integral with the second handle 2906 and is coaxially enclosed in the proximal portion of the inner catheter 2917. Delivery device 2900 includes a flexible elongate device body or outer catheter 2904 having a proximal end, a distal end, and an inner lumen. The distal end includes an opening 2903 and the proximal end is attached to the first handle 2905. The first handle 2905 is used to place the delivery device 2900 in the patient's gastrointestinal tract. In one aspect, the first handle 2905 includes a Y connector. A flexible elongate rod or inner catheter 2917 is coaxially disposed within the lumen of the outer catheter 2904 and can move longitudinally. Rod 2917 includes a proximal end attached to second handle 2906 and a distal end. A flexible plunger member 2916 is provided coaxially over the proximal portion of the inner catheter 2917 and moves longitudinally. Plunger 2916 also includes a proximal end attached to second handle 2906 and a distal end. The distal tip of plunger 2916 includes a mesh retainer 2919 that includes a plurality of fins 2915. The fins 2915 hold the wire mesh structure 2901 of the intragastric device firmly and act to push and pull the wire mesh structure 2901 as the plunger 2916 and inner catheter 2917 move back and forth within the outer catheter 2904. Second handle 2906 is disposed at the proximal end of plunger 2916 and inner catheter 2917 to move plunger 2916 and inner catheter 2917 longitudinally within the lumen of outer catheter 2904. Optionally, in one aspect, the plunger includes a fastener. This fastener prevents the plunger and inner catheter from going too far in the distal direction. The first spherical member or olive tip 2908 is located proximal to the distal end of the inner catheter 2917 and the second spherical member or olive tip 2909 is located at the distal end of the inner catheter 2917. The diameter of the first spherical member or olive tip 2908 is greater than the diameter of the second spherical member or olive tip 2909. The intragastric device includes a wire mesh structure 2901 and a sleeve 2902 and is placed within the delivery device 2900 prior to deployment. The wire mesh structure 2901 is disposed with a side loop around the rod 2917 on the distal side of the tip of the plunger 2916, and a part of the wire mesh structure 2901 is hooked on the fin 2915 of the holding member 2919. In some embodiments, the rod 2917 passes through at least two openings in the wire mesh structure 2901. These openings are not along the longitudinal central axis of the wire mesh structure 2901. In one aspect, the wire mesh structure 2901 is compressed such that the compressed length is about 30 cm because it is disposed within the delivery device 2900. The sleeve 2902 is attached to the wire mesh structure 2901 and is located on the distal side of the wire mesh structure 2901 and proximal to the first spherical member or olive tip 2908. The sleeve 2902 is folded 2-10 and wrapped around the inner catheter 2917. In one aspect, sleeve 2902 has a length of 80 cm and is folded three times and compressed to a length of about 30 cm. The sleeve 2902 covers the inner catheter 2917 but does not penetrate coaxially. One of the first and second ends of the loop 2913 of the seam is attached to the sleeve 2902 and the other is looped at a location distal to the first spherical member or olive tip 2908 to the inner catheter. 2917. The diameter of the seam ring 2913 around the rod is smaller than the diameter of the first spherical member or olive tip 2908 but larger than the diameter of the second spherical member or olive tip 2909. As the inner catheter 2917 is pushed out of the outer catheter 2904, the first spherical member or olive tip 2908 pushes the seam ring 2913, which pulls the attached sleeve 2902 out of the outer catheter 2904. When the delivery device 2900 with the inner catheter 2917 is removed from the patient's gastrointestinal tract, the second bulbous member or olive tip 2909 having a small diameter passes through the seam ring 2913, thus leaving the intragastric device in the patient's body. Can do. In one aspect, the seam loop 2913 is biodegradable and dissolves over time. In other embodiments, the seam ring 2913 is a biodegradable hook, ring, cone, or umbrella.

  Optionally, in one aspect, the delivery device 2900 further includes a balloon at the distal end of the device body. A channel extending along the length of the device body includes an inlet at the proximal end of the device body. The inlet and channel are used to inflate the balloon to secure the delivery device within the patient's gastrointestinal tract. When secured, the delivery device applies a greater traction force and can push and pull the intragastric device during delivery.

  In some embodiments, the delivery device 2900 further includes a water flow mechanism or a water injection mechanism that reduces deployment forces during delivery.

  In various aspects, the stiffness of the delivery device or catheter is not constant along its length. The distal end of the delivery device is more flexible and less flexible along its length towards the proximal end. In some embodiments, the delivery device has three flexible regions, or a proximal region, a central region, and a distal region. In one aspect, the proximal zone has a length of 100 cm and a flexibility of 55D, the central zone has a length of 20 cm and a flexibility of 40D, and the distal zone has a length of 30 cm and a flexibility of 35D. Have Optionally, in one aspect, the distal region is further divided into two regions, including a more distal distal region and a more proximal distal region. The two regions are 15 cm in length, the more proximal distal region flexibility is 35D, and the distal distal region flexibility is 25D. The region is braided and the central and distal regions are coiled.

  The delivery device includes a distal end that does not harm tissue, and the two-handle system of the delivery device shortens the overall length of the device body. In various aspects, the delivery device has the following dimensions: The total length is in the range of 265 cm to 310 cm. The length of the device body or outer catheter 2904 ranges from 100 cm to 150 cm. The length of the plunger 2916 ranges from 120 cm to 150 cm. The length of the rod or inner catheter 2917 ranges from 265 cm to 310 cm. The length of each handle 2905, 2906, 2907 is equal to 10 cm. The distance between the second spherical member or olive chip 2909 and the first spherical member or olive chip 2908 ranges from 15 cm to 30 cm. The distance between the first handle 2905 and the second handle 2906 in the initial configuration prior to delivery is equal to 110 cm. In some embodiments, the outer diameter of the device body or outer catheter 2904 is 10 mm or less. In one aspect, the delivery device can be placed over a 0.035 inch guide wire. In various aspects, the plunger 2916 and the inner catheter 2917 are sufficiently flexible to allow guidance without damaging tissue in the intestine. In some embodiments, a stiff outer catheter can be bent up to 80 degrees and can traverse a curved section having a radius of 30-50 mm. In one aspect, if the rigid outer catheter is coiled with a radius of about 50 mm, the sleeve and mesh will twist or will not deploy tightly in place. Thus, in some embodiments, outer catheter 2904 includes a flexible braided catheter. The flexible braided catheter can be bent or coiled beyond the above limits, without unsuccessful deployment of the sleeve and wire mesh.

  In one aspect, the sleeve is only partially deployed upon delivery. The wire mesh structure functions as a fixture for keeping the intragastric device in place. As the patient eats, the sleeve expands and is fully deployed by movement of the gastrointestinal tract.

  In some embodiments, the outer catheter includes a distal end having a length and a non-constant stiffness along the inner catheter coaxially disposed within the outer catheter, and a lumen that receives the guide device and does not harm tissue. . Prior to delivery, the intragastric device is placed in the space between the inner and outer catheters. The inner catheter further includes a flexible extension having a length of at least 5 cm at the distal end extending beyond the distal end of the outer catheter. In some embodiments, the guidance device is a guidance wire. In another aspect, the guidance device is an endoscope for delivering a delivery article over the tip. In some embodiments, the tip of the distal end that does not harm the tissue of the inner catheter is spherical. In some embodiments, the inner catheter has a stiffness that is not constant along its length. In some variations, the flexible extension includes a proximal end and a distal end and has a non-constant stiffness along its length. The stiffness is different for the guide wire at the distal end and the inner catheter at the proximal end. In other aspects, the rigidity of the flexible extension is constant along its length.

  FIG. 29B is a cross-sectional view of a coaxial arrangement prior to deployment of a sleeve 2935 of an intragastric device disposed within a delivery device 2930, according to one aspect of the specification. Delivery device 2930 includes an inner catheter 2933 coaxially disposed within lumen 2936 of outer catheter 2937. The inner catheter 2933 includes a guide wire port 2932 for inserting a guide wire that assists in guiding the delivery. In various aspects, the guide wire is a super rigid guide wire having a diameter in the range of 0.035 to 0.038 inches. In the arrangement shown in FIG. 29B, the sleeve 2935 is drawn around the inner catheter 2933 such that the inner catheter 2933 is located within the lumen 2934 of the sleeve 2935.

  FIG. 29C is a cross-sectional view of a coaxial arrangement prior to deployment of a sleeve 2935 of an intragastric device positioned within a delivery device 2930 according to another aspect of the present description. Delivery device 2930 includes an inner catheter 2933 coaxially disposed within lumen 2936 of outer catheter 2937. The inner catheter 2933 includes a guide wire port 2932 for inserting a guide wire that assists in guiding delivery. In the arrangement shown in FIG. 29C, the sleeve 2935 is depicted adjacent to the inner catheter 2933 such that the inner catheter 2933 is located outside the lumen 2934 of the sleeve 2935.

  FIG. 29D is a cross-sectional view of a coaxial arrangement prior to deployment of a sleeve 2933 of an intragastric device positioned in a delivery device 2930 over an endoscope 2939 according to one aspect of the present specification. Delivery device 2930 includes an inner catheter 2933 coaxially disposed within lumen 2936 of outer catheter 2937. The inner catheter 2933 includes an endoscope port 2938 that is provided in the endoscope 2939 to assist in the delivery guidance. In the arrangement shown in FIG. 29D, sleeve 2935 is drawn around inner catheter 2933 such that inner catheter 2933 is located within lumen 2934 of sleeve 2935.

  In some embodiments, a system for delivering an intragastric device to a patient's gastrointestinal tract includes a porous network having a first lumen, a sleeve attached to the porous network and having a second lumen. And a coaxial catheter system. The coaxial catheter system includes an outer catheter and an inner catheter. Prior to delivery, the porous mesh structure and the sleeve are constrained in the space between the outer catheter and inner catheter, the outer catheter covering a substantial portion of the intragastric device, and the inner catheter is mostly It passes through the first lumen of the mesh but exits from the main portion of the second lumen of the sleeve. In some embodiments, upon actuation, the inner catheter is manipulated at its distal end so that the inner catheter pushes the sleeve out of the coaxial catheter system and then the inner catheter is removed from the sleeve to deliver the intragastric device into the gastrointestinal tract. Attached to the sleeve.

  FIG. 29E is a flow diagram illustrating a process that includes delivering an intragastric device using the delivery device of FIG. 29A, according to one embodiment herein. In step 2920, the delivery device is placed over the guide wire and into place in the patient's gastrointestinal tract. At step 2921, the physician uses the first handle to position the distal end of the delivery device body within the patient's duodenum. Optionally, at step 2922, the physician inflates a balloon at the distal end of the device body to secure the delivery device within the patient's gastrointestinal tract. Then, in step 2923, the physician pushes the second handle (about 60 cm) to advance the plunger and inner catheter until the sleeve is pushed out of the delivery device body and fully deployed. If necessary, the plunger includes a fastener so that the physician knows when to stop pushing the second handle. At step 2924, the physician retracts the device approximately 5-10 cm and repositions so that the distal end of the funnel portion of the sleeve is in the stomach. Then, at step 2925, the physician pulls back the first handle while holding the second handle firmly to deploy the funnel portion of the sleeve and the wire mesh structure in the stomach. This pulls back the device body while keeping the plunger and inner catheter in place, thereby releasing the wire mesh structure. The delivery device is then removed from the patient at step 2926, leaving the intragastric device deployed in the patient's gastrointestinal tract.

  FIG. 30A is a diagram of a seventh exemplary delivery device 3000, according to one aspect of the specification. Delivery device 3000 includes a coaxial delivery system having a flexible outer catheter 3002 axis and a flexible inner catheter 3001 axis preloaded with an intragastric device. The outer catheter 3002 includes a proximal end, a distal end, and an inner lumen. Inner catheter 3001 is disposed within the lumen of outer catheter 3002 and includes a proximal end, a distal end, and an inner lumen. The lumen of the inner catheter 3001 is adapted to receive a guide wire. In various aspects, the delivery device 3000 is about 3 meters in length. The delivery device 3000 is used to deliver the intragastric device orally into the patient's stomach and duodenum or jejunum. The delivery device 3000 has a non-constant stiffness along its length, provides sufficient flexibility to follow the curvature of the small intestine, and has sufficient pushability to not bend in the stomach. In various aspects, the length of the outer catheter 3002 is about 1.5 meters. In some embodiments, the distal portion of outer catheter 3002 includes a lubricious hydrophilic coating that may be activated immediately prior to delivery to facilitate guidance. In one aspect, the coating covers about 0.65 meters distal of the outer catheter 3002. The proximal end of device 3000 includes the proximal portion of inner catheter 3001 that is not covered by outer catheter 3002. As further described with reference to FIGS. 30E and 30G, a pair of stop mechanisms 3004 and 3006 are disposed on the inner catheter 3001. The first handle 3003 has a proximal end, a distal end, and a lumen adapted to receive a guide wire and is attached to the proximal end of the inner catheter 3001. The second handle 3008 has a proximal end, a distal end, and a lumen adapted to receive the inner catheter 3001 and is attached to the proximal end of the outer catheter 3002. The second handle 3008 is coaxially covered with the inner catheter 3001. When the second handle 3008 is moved proximally and distally relative to the first handle 3003, the outer catheter 3002 moves the outer side of the inner catheter 3001 proximally and distally.

  Guide member 3007 extends distally from the distal end of inner catheter 3001. The guide member includes an elongate superflexible rod having a proximal end and a distal end. The proximal end of the guide member includes a proximal sphere or olive tip, as described with reference to FIGS. 30D and 30E below. The distal end of guide member 3007 includes a distal sphere or olive tip, as further described with reference to FIGS. 30D and 30F below. In some embodiments, the guide member 3007 is also covered with a lubricious hydrophilic coating.

  FIG. 30B is an illustration of an exemplary embodiment outer catheter 3050 used in the delivery device of FIG. 30A. Outer catheter 3050 includes three portions of varying stiffness, or proximal portion 3051, central portion 3052, and distal portion 3053, each having a proximal end, a distal end, and a lumen. Second handle 3054 is attached to the proximal end of proximal portion 3051. A soft tip 3055 is attached to the distal end of the distal portion 3053. Both the second handle 3054 and the soft tip 3055 include a lumen that receives the inner catheter. In one aspect, the outer catheter 3050 includes a first radiopaque marker 3056 at the junction of the soft tip 3055 and the distal portion 3053 and a second radiopaque marker 3057 at the central portion 3052. including. The second radiopaque marker 3057 is located about 4-6 cm from the junction of the central portion 3052 and the proximal portion 3051. In various aspects, the proximal portion 3051 has a length of about 85 cm and a stiffness that is 120% of the stiffness of the central portion 3052. In various aspects, the length of the central portion 3052 ranges from about 52-54 cm. In various aspects, the distal portion 3053 has a length in the range of approximately 11-13 cm and a stiffness that is 80% of the stiffness of the central portion 3052. In various aspects, the overall length of the outer catheter 3050 ranges from 150 to 152 cm, with the exception of the second handle 3054 or the soft tip 3055. In one aspect, the length of the second handle 3054 is 10 cm. In one aspect, the length of the soft tip 3055 is 0.5 cm. Upon delivery, the second handle 3054 is located outside the patient's body. In some embodiments, 50 cm proximal to proximal portion 3051 is located within the esophagus upon delivery. In some embodiments, 35 cm distal to the proximal portion 3051 and 4-6 cm proximal to the central portion 3052 are located in the stomach upon delivery. In some embodiments, approximately 48 cm distal to the central portion 3052 as well as the entire distal portion 3053 and soft tip 3055 are located in the intestine upon delivery.

  FIG. 30C is an illustration of another aspect of the outer catheter 3070 showing the dimensions of the compressed sleeve 3062 of the intragastric device 3060 relative to the dimensions of the outer catheter 3070 and the relative dimensions of the compressed wire mesh structure 3061. The outer catheter 3070 of FIG. 30C includes only a proximal portion 3071 and a distal portion 3073. The distal portion 3073 has a length in the range of 63-67 cm, 59-61 cm is placed in the intestine and 4-6 cm is placed in the stomach. The compressed sleeve 3062 has a length in the range of 54-56 cm and is fully contained within the distal portion 3073 and placed entirely in the intestine. The length of the compressed wire mesh structure 3061 is in the range of about 29-31 cm. The wire mesh structure 3061 drug 9-11 cm is contained in the proximal end of the distal portion 3073, and the wire mesh structure 3061 19-21 cm is contained in the distal end of the proximal portion 3071. About 4-6 cm of the wire mesh structure 3061 is placed in the intestine, and 24-26 cm of the wire mesh structure is placed in the stomach.

  FIG. 30D is a detailed view of the distal end of the delivery device 3000 of FIG. Proximal sphere 3011 is shaped to not damage tissue and includes a radiopaque marker 3012 for x-ray contrast during delivery. The distal sphere 3013 also has a ball tip shape and is designed not to damage body tissue. The design of the guide member 3007, the proximal spherical member 3011, and the distal spherical member 3013 is configured to facilitate easy tracing of the bowel curve without damaging the tissue “over the guide wire” Has been. The stiffness of the guide member 3007 is less than the stiffness of the distal portion of the outer catheter. In some embodiments, the stiffness of the guide member 3007 is not constant, having a stiffness close to that of the distal end of the outer catheter at the proximal end and a stiffness close to that of the 0.035 inch guide wire at the distal end. Have.

  FIG. 30E is a proximal end view of the delivery device of FIG. 30A showing the outer catheter 3002 retracted to the first stop mechanism 3004. During delivery of the intragastric device previously mounted on the delivery device, the user holds the first handle 3003 and holds the inner catheter 3001 in place while using the second handle 3008 to inner catheter 3001. Outside catheter 3002 is retracted or slid proximally. The outer catheter 3002 is retracted until the proximal end of the second handle 3008 contacts the first stop mechanism 3004. The second stop mechanism 3006 is also disposed on the surface of the inner catheter 3001 proximal to the first stop mechanism 3004. In some embodiments, the stop mechanism 3004, 3006 includes a plastic ring that is secured to the inner catheter using wing nuts 3004a, 3006a. In some embodiments, the first handle 3003 includes a first port 3013 for injecting a fluid such as saline or water, or for flushing the lumen of the inner catheter 3001. In some embodiments, the second handle 3008 includes a second port 3018 for injecting fluids such as saline or water, or for flushing the lumen of the outer catheter 3002.

  FIG. 30F is an illustration of one embodiment of a partially deployed intragastric device sleeve 3022 corresponding to the position of the outer catheter 3002 shown in FIG. 30E. Referring to FIGS. 30E and 30F simultaneously, the sleeve 3022 is as shown in FIG. 30F when the outer catheter 3002 is retracted such that the proximal end of the second handle 3008 contacts the first stop mechanism 3004. Partially expanded. The deployed portion of sleeve 3022 is the cylindrical distal portion 1622d described with reference to FIG. 16D. This is the portion of the sleeve 3022 that remains in the patient's small intestine. The outer catheter 3002 has been retracted to the sleeve junction 1622j described in FIG. 16D. In some embodiments, as shown in FIG. 30F, the sleeve 3022 is coaxially wrapped around the inner catheter 3001 of the delivery device. In other words, the inner catheter 3001 does not penetrate the lumen of the sleeve 3022. In one aspect, the distal end of the outer catheter 3002 includes a radiopaque marker 3009 to ensure proper positioning of the delivery device in radiography.

  FIG. 30G is a proximal end view of the delivery device of FIG. 30A, showing the outer catheter 3002 retracted to the second stop mechanism 3006. Since the first stop mechanism is removed, the outer catheter 3002 can be further retracted. While continuing delivery of the intragastric device, the user holds the first catheter 3003 firmly to hold the inner catheter 3001 in place while using the second handle 3008 to the outer catheter 3002 outside the inner catheter 3001. Retreat. The outer catheter 3002 is retracted until the proximal end of the second handle 3008 contacts the second stop mechanism 3006.

  FIG. 30H is a view of one embodiment of a partially deployed intragastric device wire mesh structure 3021 corresponding to the position of the outer catheter 3002 shown in FIG. 30G. Referring to FIGS. 30G and 30H simultaneously, when the outer catheter 3002 is retracted such that the proximal end of the second handle 3008 contacts the second stop mechanism 3006, the wire mesh structure 3021 is moved to FIG. Partially expanded as shown. The movement prevention ring 3024 of the wire mesh structure 3021 is expanded, and as a result of its shape memory characteristics, as shown in FIG. 11D, it is in a state after being unfolded or turned up as shown in FIG. 11D. As shown, the proximal end of this fully deployed sleeve 3022 is attached to a detent ring 3024. As shown in FIG. 30H, in some embodiments, the inner catheter 3001 passes through the space between the metal lines of the wire mesh structure 3021 along the side of the structure 3021. In other words, the inner catheter 3001 does not penetrate the center of the wire mesh structure 3021.

  FIG. 30I is a flow diagram illustrating steps that include delivering an intragastric device using the delivery device of FIG. 30A according to one aspect of the specification. If necessary, at step 3030, the distal end of the delivery device is moistened to activate the lubricious hydrophilic coating. This facilitates insertion and guidance of the delivery device. At step 3032, the delivery device is placed over a guide wire and into place in the patient's gastrointestinal tract. At step 3034, fluoroscopy is used to determine the position of the distal end of the outer catheter to ensure accurate positioning of the delivery device. Step 3036 holds the first handle firmly to hold the inner catheter in place and retracts the outer catheter to the first stop mechanism to pre-load the stomach in the intestinal portion of the patient's gastrointestinal tract. Unfold and position part of the sleeve of the inner device. Step 3038 then retracts the entire delivery device until the distal end of the outer catheter is located just proximal to the pylorus. At step 3040, the first stop mechanism is removed from the inner catheter. In step 3042, the intragastric device is placed in the stomach portion of the patient's gastrointestinal tract while the first catheter is securely held and the inner catheter is held in place while the outer catheter is retracted to the second stop mechanism. A part of the wire mesh structure is developed and positioned. At step 3044, the second stop mechanism is removed from the inner catheter. In step 3046, hold the first handle firmly to hold the inner catheter in place while retracting the outer catheter to the first handle to place the entire wire mesh structure in a portion of the stomach of the patient's gastrointestinal tract. Unfold and position. Then, at step 3048, the delivery device is removed from the patient.

  FIG. 31A is a diagram of a wire mesh structure 3101 of an intragastric device 3100 mounted on a delivery device according to one aspect of the present description. As shown in FIG. 31A, the inner catheter 3131 and guide member 3137 portions of the delivery device are shown. The delivery device includes a proximal sphere 3135 at the transition from the inner catheter 3101 to the guide member 3137. The wire mesh structure 3101 includes a sleeve 3102 attached to the movement prevention ring 3104. When the intragastric device 3100 is mounted on the delivery device, the guide member so that the proximal sphere 3135 is located just distal to the wire mesh structure 3101 and the inner catheter 3131 is in the internal volume of the wire mesh structure 3101. Reference numeral 3137 penetrates the opening of the metal mesh structure 3101 which is off the center between the metal wires.

  FIG. 31B is a diagram of the wire mesh structure 3101 of FIG. 31A further mounted on a delivery device. The proximal end of the wire mesh structure 3101 is compressed and contained within the distal end of the outer catheter 3132 of the delivery device. As the wire mesh structure 3101 advances proximally along the inner catheter 3131, the proximal sphere is no longer visible. As shown in FIG. 31B, the inner catheter exits the wire mesh structure 3101 through an opening off the center of the wire mesh structure 3101. The sleeve is then coaxially wrapped around the inner catheter as described with reference to FIG. 31C. In other embodiments, the inner catheter (and attached guide member) stays within the wire mesh structure and exits through the opening in the side of the funnel-like portion proximal to the sleeve. In other embodiments, the inner catheter remains in the wire mesh structure and exits from the opening in the side of the cylindrical portion distal to the sleeve. In yet another aspect, the inner catheter remains within the wire mesh structure and penetrates the entire sleeve and exits through an opening at the distal end of the sleeve.

  FIG. 31C is a diagram of the wire mesh structure 3101 of FIG. 31A mounted on the delivery device such that only the movement prevention ring 3104 remains unmounted. FIG. 31D is a view of the wire mesh structure of FIG. 31A fully loaded into the delivery device. As shown in FIG. 31D, the wire mesh structure is completely hidden within the distal end of the outer catheter 3132 so that it is not visible. As shown, the sleeve 3102 is coaxially wrapped around the inner catheter 3131.

  FIG. 31E is a view of the sleeve 3102 of the intragastric device of FIG. 31A partially loaded into the delivery device. It can be seen that a portion of the sleeve 3102 coaxially wrapped around the inner catheter 3131 extends from the distal end of the outer catheter 3132. FIG. 31F is a diagram of the intragastric device of FIG. 31A fully loaded into a delivery device. Proximal sphere 3135 is located at the distal end of outer catheter 3132. In one aspect, a plurality of seams 3105 extending from the distal end of the sleeve are tied around the proximal sphere 3135 to maintain the intragastric device in place until ready for delivery. Prior to delivery, seams 3105 are unwound to deploy the intragastric device.

  FIG. 32A is an illustration of a retrieval device 3200 for removing an intragastric device according to another aspect of the present description. The retrieval device 3200 includes a flexible outer tube 3202 that includes an elongate body having a proximal end, a distal end, and an inner lumen. A first handle 3212 is attached to the proximal end. Opening 3222 is located at the distal end of outer tube 3202. A flexible inner member 3204 that includes an elongate body having a proximal end and a distal end is provided within the lumen of the outer tube 3202. In one aspect, the inner member 3204 includes a flexible metal wire. The second handle 3214 is attached to the proximal end and the retrieval mechanism 3224 is formed from the distal end of the inner member 3204. In one aspect, the retrieval mechanism 3224 includes a hook. In one aspect, the hook can be locked.

  FIG. 32B is a flow diagram illustrating a process that includes removing an intragastric device from a patient using the collection device of FIG. 32A according to one aspect of the specification. At step 3232, the physician inserts the retrieval device outer tube into the operating channel of the endoscope inserted into the patient. At this point, the retrieval mechanism at the distal end of the inner member is contained within the distal end of the outer tube. At step 3234, the physician holds the first handle and places the retrieval device in the patient's gastrointestinal tract. Then, at step 3236, the physician pushes the second handle to extend the retrieval mechanism through the opening and beyond the distal end of the outer tube. At step 3238, the physician manipulates the second handle to grasp the proximal end of the intragastric device with the retrieval mechanism. In one aspect, as described for knot 1615 with reference to FIG. 16B, the proximal end of the intragastric device includes a set of staggered knots that facilitate capture with a retrieval mechanism. In step 3240, once the intragastric device is secured with the retrieval mechanism, the physician pulls the second handle to place the retrieval mechanism and at least a portion of the attached intragastric device into the distal end of the outer tube. Pull in. Because the intragastric device is made of shape memory metal, it can be easily compressed to a size that can fit into the outer tube. If necessary, at step 3242, the physician activates a locking mechanism on the collection device to prevent the collection mechanism and attached intragastric device from sliding off the distal end of the outer tube. Finally, at step 3244, the physician removes the retrieval mechanism and attached intragastric device from the patient.

  FIG. 33A is a diagram of one embodiment of an exemplary post-deployment configuration of intragastric device 3300 having a dumbbell shape. Device 3300 includes a first upper wire mesh 3361 at the proximal end and a second lower wire mesh 3362 at the distal end. The internal volumes of the two wire meshes 3361 and 3362 are in fluid communication with each other. In various aspects, the size of the second wire mesh 3362 is the same as or less than the size of the upper wire mesh 3361. Device 3300 includes a first opening 3363 at the proximal end of upper wire mesh 3361 and a second, larger opening 3364 at the distal end of lower wire mesh 3362. Food enters the device 3300 from the first opening 3363, passes through the inner volume of the upper wire mesh 3361, enters the inner volume of the lower wire mesh 3362, and exits from there through the second opening 3364. In one aspect, the wire mesh of the lower wire mesh portion 3362 is an extension of the wire mesh of the upper wire mesh portion 3361. In another aspect, the two wire mesh portions 3361, 3362 comprise separate wire mesh structures and are attached prior to deployment. In the embodiment shown, device 3300 includes a membrane 3367 that covers the entire outer surface of device 3300 except for two openings 3363, 3364.

  FIG. 33B is an illustration of an embodiment of an intragastric device 3320 having a two-stage wire mesh structure, in which the lower wire mesh is formed from an anti-movement member 3324 that is turned up. The device 3320 has a dumbbell-shaped structure similar to the structure of the two-stage network device described in this specification, and functions similar to those devices. The upper wire mesh 3322 is similar to the wire mesh structure 210 of FIG. 2B. The lower mesh structure is similar to the anti-movement ring 214 of FIG. 2B, but the lower mesh structure 3324 is larger and is fully bent up or curved in the proximal direction as shown in FIG. 33B. The difference is that a net structure 3324 is formed. The first wire mesh structure 3322 includes a plurality of free ends extending from the bottom or bottom thereof. The first portion of the plurality of free ends is curved to form a portion 3324 that is turned up to the right, and the second portion of the plurality of free ends is bent to form a portion 3324 that is turned up to the left. Obviously, this turn is formed around the entire circumference of the first metal wire structure, thereby forming an annular body. The annular body may be long, elliptical, or oval.

  In various aspects, the overall length of the device 3300 ranges from 50 to 500 mm. In a preferred embodiment, the overall length of the device 3300 is 180 mm. In various aspects, the length of the upper wire mesh 3361 ranges from 30 to 250 mm. In a preferred embodiment, the length of the upper wire mesh 3361 is 140 mm. In various aspects, the length of the lower wire mesh 3362 ranges from 1 to 250 mm. In a preferred embodiment, the length of the lower wire mesh 3362 is 10 mm. In various aspects, the width of the upper wire mesh 3361 ranges from 30 to 300 mm. In a preferred embodiment, the width of the upper wire mesh 3361 is 120 mm. In various aspects, the width of the lower wire mesh 3362 ranges from 10 to 300 mm. In a preferred embodiment, the width of the lower wire mesh 3362 is 60 mm. In various aspects, the diameter of the first opening 3363 ranges from 5 to 50 mm. In a preferred embodiment, the diameter of the first opening 3363 is 20 mm. In various embodiments, the diameter of the second opening 3364 ranges from 10 to 75 mm. In a preferred embodiment, the diameter of the second opening 3364 is 30 mm.

  FIG. 34A is a diagram of another exemplary two-stage wire mesh intragastric device 3400a in a post-deployment configuration, according to one aspect of the specification. The illustrated embodiment includes a first wire mesh structure 3401 disposed on the second wire mesh structure 3411 and a sleeve 3402 coupled to the distal end of the second wire mesh structure 3411. The first movement preventing member 3404 at the bottom of the first wire mesh structure 3401 is inside the second wire mesh structure 3411 and functions to connect the two wire mesh structures 3401 and 3411 together. The first anti-movement member 3404 also helps prevent compression of the second wire mesh structure 3411 due to stomach contraction and holds the device 3400a outside the pylorus. The second movement preventing member 3414 at the bottom of the second wire mesh structure 3411 has an effect of preventing the passage of the pylorus of the entire device 3400a. The food is first isolated in the first wire mesh structure 3401 through the upper opening of the connected intragastric device 3400a. The food then slowly enters the second wire mesh structure 3411 and is isolated. Finally, food is slowly released through the opening in the bottom of the connected intragastric device 3400a and into the sleeve 3402 attached to the distal end of the second wire mesh structure 3411. The second wire mesh structure 3411 bypasses the pylorus and releases food to the small intestine. In one aspect, the sleeve 3402 is not attached and food is released from the bottom opening of the connected intragastric device 3400a back to the stomach. The combined wire mesh structures 3401, 3411 cooperate to occupy a large volume in the patient's stomach and further delay food from passing through the gastrointestinal tract. The combined two wire mesh structures 3401, 3411 also have the effect of inducing a feeling of fullness faster and inducing a feeling of fullness that lasts longer than a single mesh structure device. These two metal wire network structures can move relative to each other and more conform to the shape of the stomach than a single structure. The result is higher tolerance and / or fewer complications.

  FIG. 34B is a diagram of another exemplary two-stage wire mesh intragastric device 3400b in a deployed configuration, according to one aspect of the specification. The illustrated embodiment includes a first wire mesh structure 3421 disposed on a second wire mesh structure 3431. The two wire mesh structures 3421, 3431 work together to occupy a large volume in the patient's stomach and further delay the passage of food through the gastrointestinal tract. These two metal wire network structures can move relative to each other and more conform to the shape of the stomach than a single structure. As a result, it is more tolerated and less susceptible to complications.

  FIG. 34C is a diagram of another exemplary two-stage wire mesh device 3400c in a post-deployment configuration, according to one aspect of the present description. The illustrated embodiment includes a first wire mesh structure 3451 disposed on a second wire mesh structure 3461. The anti-movement member 3464 at the bottom of the second wire mesh structure 3461 acts to prevent the entire device 3400c from passing through the pylorus. The two wire mesh structures 3451, 3461 work together to occupy a large volume in the patient's stomach and further delay food from passing through the gastrointestinal tract. These two metal wire network structures can move relative to each other and more conform to the shape of the stomach than a single structure. As a result, it is more tolerated and less susceptible to complications.

  FIG. 34D is a diagram of another exemplary two-stage wire mesh intragastric device 3400d in a deployed configuration, according to one aspect of the specification. The illustrated embodiment includes a first wire mesh structure 3471 disposed on a second wire mesh structure 3481. The first movement preventing member 3474 at the bottom of the first wire mesh structure 3471 is inside the second wire mesh structure 3481 and functions to connect the two wire mesh structures 3471 and 3481 together. The first anti-movement member 3474 also helps prevent compression of the second wire mesh structure 3481 due to stomach contraction and holds the device 3400d out of the pylorus. A second anti-movement member 3484 at the bottom of the second wire mesh structure 3481 acts to prevent the entire device 3400d from passing through the pylorus. The two wire mesh structures 3471, 3481 cooperate to occupy a large volume in the patient's stomach and further delay the passage of food through the gastrointestinal tract.

  FIG. 34E is a diagram of another exemplary bilevel intragastric device 3400e in a post-deployment configuration, according to one aspect of the specification. The illustrated embodiment includes a first wire mesh structure 3493 disposed on a second wire mesh structure 3495. The movement preventing member 3497 at the bottom of the first wire mesh structure 3493 is inside the second wire mesh structure 3495 and functions to connect the two wire mesh structures 3493 and 3495 together. The anti-migration member 3497 also helps prevent compression of the second wire mesh structure 3495 due to stomach contraction and holds the device 3400e outside the pylorus. The two wire mesh structures 3493, 3495 cooperate to occupy a large volume in the patient's stomach and further delay the passage of food through the gastrointestinal tract.

  In various aspects, any of the two-stage wire mesh intragastric devices of FIGS. 34B-34E includes a sleeve attached to the distal end of the second wire mesh structure. In various aspects, the anti-movement member or ring of the device herein has a length in the range of 1 mm to 100 mm, an outer diameter in the range of 25 mm to 75 mm, and a ratio of length to outer diameter of 0.1 mm. It is the range of 01-4. In one aspect, the length of the anti-movement member or ring is equal to 15 mm, the outer diameter is equal to 60 mm, and the ratio of length to outer diameter is equal to 0.25. In various aspects, the wire mesh of the intragastric device herein is adapted to be fatigue resistant for at least 6 months. Fatigue resistance is defined as fracture resistance in the intended use.

  FIG. 34F is a diagram of another exemplary two-stage wire mesh intragastric device 3400f in a deployed configuration, according to one aspect of the specification. The illustrated embodiment includes a first wire mesh structure 3491 disposed on the second wire mesh structure 3499 and a sleeve 3492 coupled to the distal end of the second wire mesh structure 3499. The anti-movement member 3494 at the bottom of the second wire mesh structure 3499 acts to prevent the entire device 3400f from passing through the pylorus. The two wire mesh structures 3491, 3499 work together to occupy a large volume in the patient's stomach and further delay the passage of food through the gastrointestinal tract.

  FIG. 34G is a diagram of another exemplary two-stage gauze intragastric device 3400g in a post-deployment configuration, according to one aspect of the specification. The illustrated embodiment includes a first wire mesh structure 3403 disposed over the second wire mesh structure 3405 and a sleeve 3407 coupled to the distal end of the second wire mesh structure 3405. The first movement prevention mechanism 3409 at the bottom of the first wire mesh structure 3403 serves to connect the two wire mesh structures 3403 and 3405 together. The first anti-movement mechanism 3409 also helps prevent compression of the second wire mesh structure 3403 due to stomach contraction when the first wire mesh structure 3405 is compressed, so that the entire device 3400f passes through the pylorus. prevent. A second anti-movement member 3413 at the bottom of the second wire mesh structure 3405 acts to prevent the entire device 3400g from passing through the pylorus. The combined wire mesh structures 3403, 3405 occupy a large volume in the patient's stomach and further delay the passage of food through the gastrointestinal tract. In one aspect, the device 3400g is covered with a protective cover, such as a silicone or PTFE sheath. In some embodiments, the first wire mesh structure and the second wire mesh structure 3403, 3405 have a thickness in the range of 0.1 mm to 1.0 mm, more preferably about 0.4 mm, by hand braided nitinol metal wire. Consists of. The sleeve 3407 consists of a machine braided nitinol metal wire having a thickness in the range of 0.05 mm to 0.7 mm, more preferably about 0.127 mm.

  In one aspect, the overall length of the device 3400g is about 100-850 mm. In one embodiment, the central diameter of the first wire mesh 3403 is about 90 mm. In one embodiment, the length of each of the first wire mesh 3403 and the second wire mesh 3405 is about 70 mm, and the second wire mesh 3403 includes the first wire mesh 3403 (including the first anti-movement member 3409) and the second wire mesh 3403. The total length measured to the distal end of the mesh 3405 is about 145 mm. In various aspects, the diameter of the proximal end opening 3425 ranges from about 5 mm to 25 mm, and the diameter of the distal end opening 3423 of the sleeve 3407 ranges from 5 mm to 35 mm. In one embodiment, the width of the first movement preventing member 3409 at the bottom of the first wire mesh structure 3403 is about 5 mm. In one aspect, the diameter of the sleeve 3407 is about 25 mm. Further, in one aspect, the total length of the sleeve is about 505 mm, the length from the proximal point 3415 to the midpoint 3417 is about 137 mm, and the length from the distal point 3419 to the distal end 3423 is about 57 mm. is there.

  FIG. 34H illustrates an intragastric device 3400h having two wire meshes coupled to a detent mechanism according to one aspect of the present description. As shown, the device 3400h includes a first wire mesh structure 3462 disposed on the second wire mesh structure 3472 and a detent ring 3473 coupled to the distal end of the second wire mesh structure 3472. Including. The first movement prevention mechanism 3463 at the bottom of the first wire mesh structure 3462 serves to connect the two wire mesh structures 3462 and 3472. The first anti-movement mechanism 3463 also helps prevent compression due to contraction of the cavity of the first wire mesh structure 3462 when the second wire mesh structure 3472 is compressed, and holds the device 3400h outside the pylorus. . The anti-migration ring 3473 at the bottom of the second wire mesh structure 3472 acts to prevent the entire device 3400g from passing through the pylorus.

  In various aspects, the overall length of the device 3400h ranges from 30 mm to 300 mm. In one aspect, the central diameter of the first wire mesh 3462 is about 90 mm and is in the range of 20-200. In one aspect, the length of each of the first wire mesh 3462 and the second wire mesh 3472 is in the range of 20 mm to 100 mm, more preferably about 70 mm. The measured total length from the proximal end of the first wire mesh 3462 (including the first detent mechanism 3463) to the distal end of the second mesh 3472 is in the range of 30 mm to 200 mm, preferably about 145 mm. . In one aspect, the diameter of the proximal end opening 3465 ranges from 5 mm to 35 mm, and the diameter of the distal end opening 3475 ranges from 5 mm to 60 mm. In one embodiment, the width of the first movement preventing member 3463 at the bottom of the first wire mesh structure 3462 is about 5 mm. In some embodiments, the length of the movement prevention ring 3473 is in the range of 5 mm to 100 mm. In embodiments, the inner diameter 3476 of the anti-movement ring 3473 is in the range of about 10 mm to 30 mm and the outer diameter 3477 is in the range of 25 mm to 77 mm.

  In several aspects, the wire mesh device 3400h (as described with reference to FIGS. 3D and 3E) has a first wire mesh structure at its proximal and distal ends and at the distal end of the anti-migration ring 3473. A plurality of rings formed on the metal wires of the body and second wire mesh structures 3462, 3472. In one aspect, the thickness of the metal wire forming the ring, such as the metal wire ring 3466, is about 0.4 mm, and the diameter of the annular portion 3467 of the metal wire ring 3466 is about 2 mm. In one aspect, the distal end of the anti-migration ring 3473 includes nine rings, for example, a metal wire ring 3466 shown in FIG. 34H. In various aspects, the first anti-movement member 3463 is attached to the first and second wire mesh structures 3462, 3472 by soft PTFE metal wires 3468 having a diameter of about 0.20 mm. In some embodiments, the anti-migration ring 3473 is also attached to the wire mesh 3472 by a soft PTFE metal wire 3438 having a diameter of about 0.20 mm.

  FIG. 35 is an illustration of a single intragastric device 3530 through guide wire 3535 attached to a single intragastric device 3520 that has already been deployed in the stomach 3512. Catheter 3521 is shown passing through esophagus 3511 and entering stomach 3512. Catheter 3521 deploys second single intragastric device 3530 and assists in attaching to already deployed intragastric device 3520. In operation, the catheter 3521 is threaded through the opening of an existing intragastric device 3520, preferably the opening used by the original catheter to deploy the device. The second intragastric device 3530 is then deployed with a portion of the second device (eg, neck, protrusion, or other member) secured to the first intragastric device 3520, thereby The two intragastric devices are fixed together. In other embodiments, these two intragastric devices are pre-attached outside the body and then deployed in the patient's body as a single device.

  FIG. 36 is an illustration of an intragastric device 3600 fully deployed and connected within the stomach 3612. Two single intragastric devices 3620, 3630 are shown. One is mounted on the other and occupies a larger volume in the stomach 3612 than the single intragastric device 3620.

  FIGS. 37A and 37B are side and perspective views, respectively, of another exemplary connection or two-stage wire mesh intragastric device 3700 in a deployed configuration, according to one aspect of the present description. The illustrated embodiment includes a first wire mesh structure 3701 that is flexibly connected, attached, or coupled to a second wire mesh structure 3702 to form a substantially dumbbell or barbell shape. Forming an intragastric device 3700. The first wire mesh structure 3701 has a first volume in a pre-deployment configuration corresponding to a fully compressed or constrained state, and a second in a post-deployment configuration corresponding to a fully expanded or relaxed state. Have a volume. In various embodiments, the first volume is less than the second volume. The second wire mesh structure 3702 has a third volume in a pre-deployment configuration corresponding to a fully compressed or constrained state, and a fourth in a post-deployment configuration corresponding to a fully expanded or relaxed state. Having a volume of In various embodiments, the third volume is smaller than the fourth volume.

  According to a plurality of embodiments, the first wire mesh structure 3701 has a first shape and size or dimension in a form before deployment, and a second shape and size or dimension in a form after deployment. In accordance with embodiments, the second wire mesh structure 3702 has a third shape and size or dimension in the undeployed configuration and a fourth shape and size or dimension in the deployed configuration. In some embodiments, the shape and dimensions after development are the same for the first wire mesh structure 3701 and the second wire mesh structure 3702. In other embodiments, the shape and dimensions after deployment are not the same for the first wire mesh structure 3701 and the second wire mesh structure 3702. In various embodiments, the deployed shape is substantially spherical, elliptical, oblate, kidney bean, oval, or inverted oval.

  In various aspects herein, the first and / or second wire mesh structure 3702 can have a variable volume after deployment so that either or both can be expanded to different dimensions. is there. During deployment, the degree of change in deployment dimensions is used to identify the location of the device and possibly deployment problems. For example, in some embodiments, the device is slowly deployed in the deployment process and checks for proper deployment and location in different processes. In some embodiments, the dimensions after full deployment are constant. In some embodiments, the two wire mesh structures are knitted separately, or the wire mesh design of a single mesh assembly is different, and the two wire mesh structures have different stiffness, compressibility, and dimensions Can do.

  In a preferred embodiment, the deployed shape is substantially spherical or elliptical with similar dimensions.

  In various aspects, the present description provides a wire mesh device as a prosthesis. This prosthesis is small enough to easily deliver the device through the catheter into the patient's body, but large enough that it will not pass through the patient's cavity / pylorus and be injured. The device is also appropriately sized to isolate food and delay gastric emptying. For example, in various aspects, a device with a total volume less than 50 ml after deployment is not effective in isolating food and delaying gastric emptying and may pass through the pylorus. On the other hand, a device with a volume of more than 3,500 ml after deployment is too large and may adversely affect the digestion process. In addition, the wire mesh device is not fixed or permanently attached anywhere in the stomach structure, it acts as a free float and places an optional sleeve in the patient's intestine, and the physician Do not physically attach or fix the sleeve to the gastrointestinal tract. This allows both the mesh and the sleeve structure to move relative to the gastrointestinal tract wall. In various embodiments, these devices move freely in the stomach so that the patient's pylorus is occluded for less than 100% of (use) time. This occlusion also includes less than 100% of the opening defined by the pylorus. In various embodiments, these devices occlude the pylorus for more than 50% of the (use) time, more preferably more than 90%, most preferably more than 95%.

  In various aspects, the wire mesh structure, the single wire mesh structure and the two-stage wire mesh structure of the intragastric devices herein provide several advantages over conventional gastrointestinal space-occupying balloons. Traditional balloons may be deformed by gastric pressure, but the volume of these balloons is substantially constant. The high gastric wall pressure is pushed back by a fixed volume balloon, and water filled balloons can cause pressure ulcers due to gravity and / or inertia. With an air-filled balloon, the patient may feel full. These wire mesh devices avoid these problems because the volume of the wire mesh devices herein varies. Also, with traditional balloons, food cannot enter the balloon, which can cause trauma due to excessive stretching of the stomach wall. The food is intended to pass through the wire mesh device of the present description, and therefore there is no risk of excessive stretching. In addition, the intragastric device of the present specification can delay gastric emptying because food is held in the wire mesh structure. This is an advantage not available from traditional balloons. Also, when the outward pressure of the wire mesh structure is always low, a feeling of fullness is induced, but natural comfort can be obtained by changing the volume and shape.

Table 1 shows the range of diameter, height, volume, and compressed length before deployment of various dual reticuloendothelial devices, according to some embodiments herein. In some embodiments, the largest deployed diameter of the double reticulum device is in the range of 20-200 mm. In some embodiments, the largest deployed diameter of the double reticulum device is more preferably in the range of 50-150 mm, even more preferably 80-100 mm. In one aspect, the deployed diameter of the reticulated intragastric device is 90 mm. In some embodiments, the height after deployment of the double reticulum device ranges from 45 to 400 mm. In some embodiments, the post-deployment height of the double reticulum device is more preferably in the range of 105-300 mm, and even more preferably 145 mm. In some embodiments, the first length of the first wire mesh structure is 75 cm or less, more preferably about 15 cm. In some embodiments, the volume of the first wire mesh structure before deployment is 5 ml or less, more preferably 110 ml or less, and the volume after deployment is 5 ml or more, more preferably 125 ml or more. In some embodiments, the second length of the second wire mesh structure is 70 cm or less. In some embodiments, the volume of the second wire mesh structure before deployment is 5 ml or less, more preferably 100 ml or less, and the volume after deployment is 5 ml or more, more preferably 110 ml or more. In some embodiments, the volume of the first wire mesh structure after deployment is greater than 5 ml and less than 5000 ml. In some embodiments, the volume after deployment of the second wire mesh structure is greater than 20 ml and less than 4000 ml. In some embodiments, the volume after deployment of the double reticulum device (2 nets together) ranges from 8 to 8381 ml. In some embodiments, the volume after deployment of the dual reticulum device (two nets combined) is more preferably in the range of 131-536 ml, and even more preferably 442-826 ml. In one aspect, the volume after deployment of the double reticulum device (2 nets combined) is 657 ml. In some embodiments, the compression length of the double reticulum device before deployment ranges from 63 to 629 mm. The compressed length before deployment refers to the total length of the device when compressed and placed in a catheter for deployment within the subject's body. In some embodiments, the compression length of the double reticulum device before deployment is more preferably in the range of 157-471 mm, even more preferably 236-290 mm. In one aspect, the compressed length of the double reticulum device before deployment is 269 mm.

  The first wire mesh structure 3701 and the second wire mesh structure 3702 are respectively the upper half surface or upper hemisphere, and the lower half surface defined by the shape and size or dimensions of the wire mesh structures 3701 and 3702 after deployment. Or has a lower hemisphere and an internal volume. The first wire mesh structure 3701 is on the upper half surface so that food enters the structure 3701 via at least one first opening 3705 and exits the structure 3701 via at least one second opening 3706. Or at least one first opening (or first opening surface area) 3705 proximate to the upper hemisphere, at least one second opening (or second opening surface area) proximate to the lower half surface or lower hemisphere 3706 is included. The second wire mesh structure 3702 is close to the upper hemisphere so that food enters the structure 3702 via at least one third opening 3707 and exits the structure 3702 via at least one fourth opening 3708. At least one third opening (or third opening surface region) 3707 and at least one fourth opening (or fourth opening surface region) 3708 proximate the lower hemisphere. In various aspects, the deployed shape of the first wire mesh structure is a first plurality defined by an arc determined by a radius in the range of 0.2 cm to 20 cm and a central angle in the range of 5 to 175 degrees. Including curved surfaces. In various aspects, the deployed shape of the second wire mesh structure is a second plurality defined by an arc determined by a radius in the range of 0.1 cm to 15 cm and a central angle in the range of 1 to 179 degrees. Including curved surfaces.

  According to some embodiments, the first wire mesh structure 3701 and the second wire mesh structure 3702 are porous structures. In other embodiments, the first wire mesh structure 3701 and the second wire mesh structure 3702 are substantially covered with a membrane to further inhibit food from exiting the intragastric device 3700. In various embodiments, the membrane can be used in 10% to 3% of device 3700, leaving only at least one first opening, second opening, third opening, and fourth opening 3705, 3706, 3707, 3708. Covering 99%. This directs food to enter the device 3700 via at least one first opening 3705 and exit through at least one fourth opening 3708.

  The first wire mesh structure 3701 includes a first group of free ends or knots disposed in at least one first opening 3705 and a second group of free ends or knots disposed in at least one second opening 3706. Including a knot. The second wire mesh structure 3702 includes a third group of free ends or knots disposed in the at least one third opening 3707 and a fourth group of free ends or knots disposed in the at least one fourth opening 3708. Including a knot. These groups of knots include turns or curves in the metal lines of wire mesh structures 3701, 3702 that are not supported or connected to other parts of the wire mesh. In other words, the knots in the plurality of groups are rings or bends including free ends at the ends of the wire mesh structures 3701 and 3702. According to various embodiments, the first group, the second group, the third group, and the fourth group of knots include a gold ring. In one aspect, these annulus are formed into annulus shape by twisting the free ends of a plurality of groups of knots. In another aspect, the annulus includes individual metal wire annulus sewn to the free ends of multiple groups of knots.

  In various aspects, a plurality of free end portions of the first wire mesh structure defining the second open surface region 3706 and a plurality of second wire mesh structures defining the third open surface region 3707 are provided. A connecting portion is formed between the free end portion. In some embodiments, the connecting portion has a first end attached to a first point of the second open surface area 3706 and a second end attached to the second end of the third open surface area 3707. Includes a first flexible seam attached to the point. In various aspects, the length of this connection is in the range of 0 mm to 200 mm. The lower limit is in the range of 0-2 mm and all its increments. In some embodiments, the connecting portion has a first end attached to a third point of the second open surface region 3706 and a second end attached to a fourth point of the third open surface region 3707. The second point is different from the first point, and the fourth point is different from the second point, including a second flexible seam attached to the point. In various aspects, the length of the connection including the second flexible seam ranges from 0 mm to 300 mm. The lower limit is in the range of 0-2 mm and all its increments. In some embodiments, the connecting portion has a first end attached to a fifth point of the second open surface area 3706 and a second end attached to a sixth point of the third open surface area 3707. The fifth point is different from the first point and the third point, and the sixth point is different from the second point and the fourth point. In various embodiments, the length of this connection, including the third flexible seam, ranges from 0 mm to 300 mm. The lower limit is in the range of 0-2 mm and all its increments. In some embodiments, the connecting portion has a first end attached to a seventh point of the second open surface region 3706 and a second end attached to the eighth open surface of the third open surface region 3707. A fourth flexible seam attached to the point, wherein the seventh point is different from the first point, the third point, and the fifth point, and the eighth point is the second point, It differs from the fourth point and the sixth point. In various aspects, the length of the connection including the second flexible seam ranges from 0 mm to 300 mm. The lower limit is in the range of 0-2 mm and all its increments.

As shown in FIG. 37C, in accordance with one aspect of the present specification, a portion of the second group of knots 3701n of the first wire mesh structure 3701 is second with a plurality of sufficiently loose stitches or stitched knots 3710. The wire net structure 3702 is flexibly connected, connected, or attached to a part of the third group of knots 3702n. Although seams are shown in FIG. 37C, in other embodiments, the flexible connection between the first and second wire mesh structures can be any flexible member (eg, flexible Metal wire or plastic component). In these other aspects, no seams are required. In some embodiments, the plurality of seams 3710 include at least two independent flexible connections or stitching points, and the at least two knots of the second group of knots 3701n of the first wire mesh structure 3701 are second The wire net structure 3702 is flexibly connected to at least two knots of the third group of knots 3702n. In a preferred embodiment, the plurality of seams 3710 include three or four independent flexible connections or stitch points. In various embodiments, the length of the connecting portion between the opening on the lower surface of the first wire mesh structure and the opening on the upper surface of the second wire mesh structure is in the range of 0 mm to 300 mm. In various embodiments, the connection of the second wire mesh structure of the first wire mesh structure can cause the first wire mesh structure to be 1% to 99% of its equator diameter without compressing the second wire mesh structure. More preferably in the range of 40% to 99% and such a length that it can be compressed to its increments. In various aspects, the plurality of seams 3710 are distributed equidistantly around the perimeter of the second and third openings 3706, 3707. FIG. 37E shows two connections or stitching points 3711 used to flexibly connect the first wire mesh structure 3701 and the second wire mesh structure 3702. In one aspect, these two connections or stitch points 3711 are 180 degrees apart from each other.

  In another embodiment, the first wire mesh structure 3701 and the second wire mesh structure 3702 may be provided in place of the second group of knots 3701n of the first wire mesh structure 3701 (instead of using a plurality of stitches or stitches). A part thereof is knitted or meshed with a part of a third group of knots 3702n of the second wire net structure 3702 so as to be flexibly connected.

  In one optional aspect, as shown in FIG. 37D, a sleeve 3725 having a proximal end, a distal end, and a lumen is connected at the proximal end to the lower portion of the second wire mesh structure 3702. The sleeve 3725 includes at its proximal end a first opening 3741 in fluid communication with a fourth opening or fourth opening surface region (3708 in FIG. 37A) of the second wire mesh structure 3702, said distal A second opening 3742 is included at the end. In some embodiments, the sleeve 3725 is connected to the fourth knot group 3702p of the second wire mesh structure 3702 via a plurality of seams. This optionally connected sleeve 3725, when deployed, extends from the patient's stomach into the duodenum and empties the duodenum. Alternatively, in other embodiments, the sleeve 3725 extends through the duodenum and into the jejunum. In one aspect, the sleeve 3725 serves to transfer isolated food / sputum from the intragastric device 3700 directly into the duodenum or jejunum.

  Here, as shown in FIGS. 37A-37C, it will be appreciated that the first wire mesh structure 3701 and the second wire mesh structure 3702 are individually knitted and constructed in various ways, after which the patient It can be flexibly attached or sutured to or from the body (as described above with reference to FIGS. 35 and 36). Of course, the joints of the seams may be cut to separate the two structures 3701, 3702 from the patient's stomach.

  In various aspects, each connection or stitch point may include eight knots and may be further secured with an adhesive and a heat shrink tube. In one aspect, each knot includes a braided seam line of ultra high molecular weight polyethylene (UHMWPE) having a 30 pound break strength, and is a reliable first and second wire mesh structure 3701, 3702. Provides a connecting part.

  In accordance with various aspects herein, a flexible connection or attachment of a first wire mesh structure 3701 and a second wire mesh structure 3702 using a plurality of seams 3710 and the resulting intragastric device 3700 include: Provides various advantages and functions (described below).

  By this connection portion or attachment portion, the first wire mesh structure and the second wire mesh structures 3701 and 3702 can be in fluid communication. Alternatively, the food is first sequestered in the first wire mesh structure 3701 through at least one first opening 3705 at the top of the connected intragastric device 3700. The food then slowly enters the second wire mesh structure 3702 where it is isolated. Finally, food is slowly released through at least one fourth opening 3708 at the bottom of the connected intragastric device 3700 and back to the stomach. The connected wire mesh structures 3701, 3702 work together to occupy a large volume in the patient's stomach and further delay food from passing through the gastrointestinal tract. These two connected wire mesh structures 3701, 3702 also induce a feeling of fullness faster and induce a feeling of satiety that lasts longer than a single mesh structure device.

  By this connection portion or attachment portion, the first wire mesh structure 3701 and the second wire mesh structure 3702 can turn, bend, or move in substantially all directions. As shown in FIG. 37F, the first wire mesh structure 3701 includes the center of the first structure 3701, the center of the first open surface region 3721 at the proximal end of the first structure 3701, and the first The first longitudinal axis 3715 passing through the center of the second open surface area 3722 at the distal end of the structure, the second wire mesh structure 3702 being the center of the second structure 3702, the second structure It has a second longitudinal axis 3716 passing through the center of the third open surface region 3731 at the proximal end of 3702 and the center of the fourth open surface region 3732 at the distal end of the second structure. The relative angles of motion of the two structures 3701, 3702 are shown and are defined by the angular displacement 3717 between the first longitudinal axis 3715 and the second longitudinal axis 3716. In various aspects, the flexible connection point 3711 allows the first wire mesh structure 3701 and the second wire mesh structure 3702 to have a movement angle (or first longitudinal length) of up to 90 degrees relative to each other in all directions. There may be an angular displacement 3717) between the axial direction 3715 and the second longitudinal axis 3716). In some embodiments, the connection of the first wire mesh structure to the second wire mesh structure is less than 10% of the second wire mesh structure when the first wire mesh structure is compressed more than 90%. The first wire mesh structure has a length having an angular displacement.

  In the process of deployment, one of the wire mesh structures, for example, the first wire mesh structure 3701 can be expanded without developing the other wire mesh structure, for example, the second wire mesh structure 3702, by this connection portion or attachment portion. It can be opened almost completely. FIG. 38A shows the process of deployment of the connected intragastric device 3800. As shown, the device 3800 further includes a catheter or sheath 3820. The first wire mesh structure 3801 is substantially or almost completely unfolded, and the second wire mesh structure 3802 connected or attached to the first wire mesh structure 3801 through a plurality of seams 3810 is continuous. In the catheter or barrel 3820 and still constrained. In some variations, the catheter 3820 includes a housing, a lumen extending through the housing. In some embodiments, the lumen diameter is 2 cm or less, more preferably about 0.9 cm. When one of the wire mesh structures (for example, the second wire mesh structure 3702) is compressed and pulled into the cylindrical structure (for example, an outer tube or a catheter) in the process of pulling back or taking out, The wire mesh structure (for example, the first wire mesh structure 3701) can be compressed and drawn into the cylindrical structure. 38B-38D illustrate the pull back or removal process of the coupled intragastric device 3800. As shown in FIG. 38B, when the second wire mesh structure 3802 is pulled back into the catheter 3820 using the gripping member 3822 delivered through an endoscope 3825 (eg), the second wire mesh structure 3802 Although partially compressed, the first wire mesh structure 3801 is not yet constrained or remains in a deployed configuration. As shown in FIG. 38C, when the second wire mesh structure 3802 is fully pulled back into the catheter 3820 and fully compressed, a plurality of seams 3810 compress the first wire mesh structure 3801 for removal and cause the catheter to be removed. Arranged or oriented to be pulled into 3820. Finally, as shown in FIG. 38D, the first wire mesh structure aligned or oriented as the fully compressed second wire mesh structure 3802 is further pulled back into the catheter 3820 using the endoscope 3825. 3801 is constrained or compressed and pulled into catheter 3820 for removal.

  In this manner, one of the wire mesh structures can be compressed, pulled back, released, or deployed independently of the other wire mesh structures by the connection portion or the attachment portion.

  37A to 37F, the plurality of seams 3710 are long enough to allow the two wire mesh structures 3701 and 3702 to turn, bend, or have a relative motion angle. The length should be short enough to transmit compressive force from the body (when pulled back or unfolded) to the other wire mesh structure. In some embodiments (in the embodiment where the first wire mesh structure 3701 and the second wire mesh structure 3702 are substantially spherical), the other wire mesh structure is not compressed in the radial direction. It can be compressed to 99% of its equator diameter, beyond which compression is transmitted. Thereby, even if one of the two wire mesh structures is substantially compressed, the intragastric device 3700 has the tendency to not pass through the completely relaxed pylorus because it is in the form after deployment, and the movement preventing effect is obtained. In various embodiments, the length of the connection or stitching point from one knot of the second group of knots to one knot of the third group of knots is from 1 mm to the diameter of the third opening 3707 of the second wire mesh 3702. The range is up to twice (FIGS. 37A and 37B).

  The connected or double wire mesh intragastric device 3700 herein provides various advantages and advantages over deploying a large single device. First, the coupled intragastric device 3700 provides better protection against the device 3700 moving through the patient's relaxed pylorus. When a large single device is compressed, it can pass through the relaxed pylorus relatively easily. However, both the wire mesh structures 3701, 3702 of the intragastric device 3700 are not accidentally compressed, thereby reducing the risk of movement.

  Secondly, large single devices are relatively inflexible, and at least part of the (use) time, this places excessive pressure on the intima of the patient's stomach. In contrast, the intragastric device 3700 has a sufficiently large structure or occupied volume after deployment, minimizing excessive pressure on the stomach wall (and preventing scuffing of the stomach wall or intima). This is because the intragastric device 3700 bends (by the connection or attachment of two linked wire mesh structures 3701, 3702), moves, and is thereby adapted to the shape of the stomach. Thus, when deployed, the intragastric device 3700 improves or optimizes the balance between the need to increase the occupied volume of the stomach and minimize the pressure on the stomach. In various aspects, the intragastric device 3700, when deployed, occupies 25% to 95% of the stomach volume or the patient's stomach volume.

Of course, the present disclosure is intended to teach some exemplary aspects of the present invention and is not limited to the specific structures disclosed herein. Those skilled in the art will appreciate that other variations of the disclosed embodiments are included in the present application and are further within the scope of the invention as defined in the claims.
Examples of embodiments of the present invention are listed in the following items [1] to [41].
[1]
An intragastric device configured to deploy in a person's stomach,
The intragastric device includes a catheter, a first wire mesh structure, a second wire mesh structure, and a connection portion.
The catheter includes a housing and a lumen having an inner diameter of 2 cm or less extending through the housing;
The first wire mesh structure has a compressed undeployed shape in the lumen of the catheter and an expanded shape in the human stomach, and the undeployed shape is A first volume of 110 ml or less and a first length of 75 cm or less, wherein the unfolded shape is a porous and closed second of 125 ml or more defined by a first plurality of curved surfaces; The first wire mesh structure further includes an upper portion and a lower portion, and the upper portion is configured to receive a material from the outside of the second volume to the inside of the second volume. A first surface region of the opening, and the lower portion has a second surface region of the plurality of openings,
The second wire mesh structure is separated from the first wire mesh structure and has a compressed undeployed shape in the catheter lumen and an expanded in the human stomach. The shape before deployment has a third volume of 100 ml or less and a second length of 70 cm or less, and the shape after deployment is defined by a second plurality of curved surfaces. A fourth volume of 110 ml or more that is porous and closed, and wherein the second wire mesh structure further has an upper part and a lower part, and the upper part is formed from the outside of the fourth volume. A third surface region of a plurality of openings configured to receive material in a volume of the bottom, the lower portion has a fourth surface region of the plurality of openings;
The connection portion flexibly connects the first wire mesh structure and the second wire mesh structure, and the connection portion includes a portion of the first wire mesh structure that defines a second opening surface area. An intragastric device formed between a portion of the second wire mesh structure defining a third open surface area.
[2]
The intragastric device according to item 1, wherein the first wire mesh structure and the second wire mesh structure are continuously disposed in the lumen of the catheter.
[3]
Item 2. The item 1, wherein at least one of the first plurality of curved surfaces is defined by an arc, the arc being determined by a radius in the range of 0.2 cm to 20 cm and a central angle in the range of 5 ° to 175 °. Intragastric device.
[4]
Item 4. The item 3, wherein at least one of the second plurality of curved surfaces is defined by an arc, the arc being determined by a radius in a range of 0.1 cm to 15 cm and a central angle in a range of 1 ° to 179 °. Intragastric device.
[5]
The connection portion includes a plurality of free end portions of the first wire mesh structure that defines the second opening surface region, and a plurality of the second wire mesh structure that defines the third opening surface region. The intragastric device according to item 1, wherein the intragastric device is formed between the free end portion of the device.
[6]
The intragastric device according to item 1, wherein the first wire mesh structure has at least one of a spherical shape and an elliptical shape.
[7]
Item 7. The intragastric device according to Item 6, wherein the second wire mesh structure has at least one of a spherical shape and an elliptical shape.
[8]
The intragastric device according to item 1, wherein the connecting portion includes a plurality of seams.
[9]
The plurality of seams have one end attached to a first point on the second opening surface area and a second end attached to a second point on the third opening surface area 9. The intragastric device according to item 8, comprising a first flexible seam.
[10]
The stomach according to item 1, wherein the length of the connecting portion from the first point of the second opening surface region to the second point of the third opening surface region is in the range of 0.01 mm to 200 mm. Internal device.
[11]
The plurality of seams have a first end attached to a third point of the second opening surface region and a second end attached to a fourth point of the third opening surface region. 10. The intragastric device according to item 9, comprising two flexible seams, wherein the first point is different from the third point and the second point is different from the fourth point.
[12]
Item 12. The intragastric region according to item 11, wherein the length of the connecting portion from the third point of the second opening surface region to the fourth point of the third opening surface region is in the range of 0.01 mm to 300 mm. apparatus.
[13]
12. The intragastric device of item 11, wherein the first flexible seam and the second flexible seam are 180 degrees apart.
[14]
The plurality of seams have one end attached to a fifth point of the second opening surface region and a second end attached to a sixth point of the third opening surface region. Item 11, wherein the fifth point is different from the first point and the third point, and the sixth point is different from the second point and the fourth point. A gastric device according to claim 1.
[15]
Item 15. The intragastric region according to Item 14, wherein the length of the connecting portion from the fifth point of the second opening surface region to the sixth point of the third opening surface region is in the range of 0.01 mm to 300 mm. apparatus.
[16]
The plurality of seams have one end attached to the seventh point of the second opening surface region and the second end attached to the eighth point of the third opening surface region. The fourth point is different from the first point, the third point, and the fifth point, and the eighth point is the second point and the fourth point. The intragastric device according to item 14, which is different from the sixth point.
[17]
Item 17. The intragastric region according to item 16, wherein the length of the connecting portion from the seventh point of the second opening surface region to the eighth point of the third opening surface region is in the range of 0.01 mm to 300 mm. apparatus.
[18]
The first wire mesh structure and the second wire mesh structure have a motion angle relative to each other in all directions, and the motion angle is the center of the first wire mesh structure, the first opening. A center of the surface region and a first longitudinal axis passing through the center of the second open surface region, and the center of the second wire mesh structure, the center of the third open surface region, and the fourth The intragastric device according to item 1, defined by an angular displacement between a second longitudinal axis passing through the center of the open surface area.
[19]
Item 19. The intragastric device according to Item 18, wherein the angular displacement is 90 ° or less.
[20]
The connecting portion of the first wire mesh structure with the second wire mesh structure compresses the first wire mesh structure to 99% of its equator diameter without compressing the second wire mesh structure. 2. The intragastric device of item 1, having a length such that
[21]
The connection part of the first wire mesh structure with the second wire mesh structure is such that when the first wire mesh structure is compressed more than 90%, the second wire mesh structure is the first wire mesh structure. A length having an angular displacement of 10% or less with respect to the body, the angular displacement being the center of the first wire mesh structure, the center of the first opening surface region, and the second A first longitudinal axis through the center of the open surface area and a second through the center of the second wire mesh structure, the center of the third open surface area, and the center of the fourth open surface area. The intragastric device of claim 1, defined by a relative angle between the longitudinal axes.
[22]
Item 2. The intragastric device according to Item 1, wherein the first wire mesh structure and the second wire mesh structure are connected by a connecting portion within the lumen of the catheter.
[23]
Item 2. The intragastric device according to Item 1, wherein the first wire mesh structure and the second wire mesh structure are not connected by a connecting portion within the lumen of the catheter.
[24]
2. The intragastric region according to Item 1, wherein the connection portion is formed by braiding a plurality of free end portions of the second opening surface region and a plurality of free end portions of the third opening surface region. apparatus.
[25]
The intragastric device according to item 1, wherein the second volume and the fourth volume occupy 25% to 95% of the stomach.
[26]
A sleeve having a proximal end, a distal end, and a lumen, the proximal end being coupled to the lower portion of the second wire mesh structure, the distal end being located within a patient's duodenum; The sleeve further includes a first opening in fluid communication with the fourth opening surface region and a second opening at the distal end, the sleeve configured to deliver food from the intragastric device to the duodenum. The intragastric device according to item 1, wherein
[27]
The intragastric device according to item 1, wherein the first wire mesh structure has at least one of a spherical shape and an elliptical shape, and the first wire mesh structure has a volume of more than 5 ml and less than 5000 ml.
[28]
28. The intragastric device according to item 27, wherein the second wire mesh structure has at least one of a spherical shape and an elliptical shape, and the second wire mesh structure has a volume of more than 20 ml and less than 4000 ml.
[29]
An intragastric device configured to deploy in a person's stomach,
The intragastric device includes a first wire mesh structure, a second wire mesh structure, and a plurality of flexible members,
The first wire mesh structure has a compressed undeployed shape in the lumen of the catheter and an expanded shape in the human stomach, and the undeployed shape is Within the lumen of the catheter has a first volume of 110 ml or less and a first length of 75 cm or less, the deployed shape is porous and closed, defined by a first plurality of curved surfaces The first wire mesh structure further includes an upper part and a lower part, and the upper part is filled with material from the outside of the second volume into the second volume. Configured to have a first surface region of a plurality of openings, the lower portion has a second surface region of a plurality of openings;
The second wire mesh structure has a compressed pre-deployment shape in the lumen of the catheter, and an expanded post-expansion shape in the human stomach, and the pre-deployment shape is: A third volume of 100 ml or less and a second length of 70 cm or less, wherein the deployed shape is a porous and closed fourth of 110 ml or more defined by a second plurality of curved surfaces. A first wire mesh structure further comprising an upper portion and a lower portion, wherein the upper portion is configured to allow material to enter the fourth volume from the outside of the fourth volume; The lower surface has a fourth surface region of a plurality of openings;
The plurality of flexible members flexibly connect the first wire mesh structure and the second wire mesh structure, and the plurality of flexible members include the first flexible member and the second flexible member. The first flexible member includes one end attached to a first point of the second opening surface region and a second end of the first opening surface region. The second flexible member is attached at one end to the third point of the second opening surface region, and the second end is attached to the third opening surface region. Wherein the first point is different from the third point and the second point is different from the fourth point.
[30]
Item 29. The length of the first flexible member from the first point of the second opening surface region to the second point of the third opening surface region is in the range of 0.01 mm to 300 mm. A gastric device according to claim 1.
[31]
Item 30. The length of the second flexible member from the third point of the second opening surface region to the fourth point of the third opening surface region is in the range of 0.01 mm to 100 mm. A gastric device according to claim 1.
[32]
30. The intragastric device of item 29, wherein the first flexible member and the second flexible member are 180 degrees apart.
[33]
The plurality of flexible members have one end attached to the fifth point of the second opening surface region and the second end attached to the sixth point of the third opening surface region. A third flexible member, wherein the fifth point is different from the first point and the third point, and the sixth point is different from the second point and the fourth point. 30. The intragastric device according to item 29.
[34]
Item 33, wherein the length of the third flexible member from the fifth point of the second opening surface region to the sixth point of the third opening surface region is in the range of 0.01 mm to 300 mm. A gastric device according to claim 1.
[35]
The plurality of flexible members have one end attached to the seventh point of the second opening surface region and the second end attached to the eighth point of the third opening surface region. A fourth flexible member, wherein the seventh point is different from the first point, the third point, and the fifth point, and the eighth point is the second point, the fourth point, The intragastric device according to item 33, which is different from the sixth point and the sixth point.
[36]
Item 35. The length of the fourth flexible member from the seventh point of the second opening surface region to the eighth point of the third opening surface region is in the range of 0.01 mm to 100 mm. A gastric device according to claim 1.
[37]
The first wire mesh structure and the second wire mesh structure have a relative motion angle in all directions, the motion angle being a center of the first wire mesh structure, the first wire mesh structure, A center of the opening surface region, a first longitudinal axis passing through the center of the second opening surface region, the center of the second wire mesh structure, the center of the third opening surface region, and the fourth 30. The intragastric device according to item 29, defined by an angular displacement with a second longitudinal axis passing through the center of the open surface area.
[38]
38. The intragastric device according to item 37, wherein the angular displacement is 90 ° or less.
[39]
Each of the plurality of flexible members has such a length that the first wire mesh structure can be compressed to 95% of its equator diameter without compressing the second wire mesh structure. 30. The intragastric device according to item 29, comprising:
[40]
Each of the plurality of flexible members has an angular displacement with respect to the first wire mesh structure in which the second wire mesh structure is 10% or less when the first wire mesh structure is compressed more than 90%. A first longitudinal direction passing through the center of the first wire mesh structure, the center of the first opening surface region, and the center of the second opening surface region. An item defined by a relative angle between an axis and a center of the second wire mesh structure, a center of the third opening surface region, and a second longitudinal axis passing through the center of the fourth opening surface region. 2. The intragastric device according to 1.
[41]
An intragastric device configured to deploy in a person's stomach,
The intragastric device includes a catheter, a first wire mesh structure, and a ring,
The catheter includes a housing and a lumen having an inner diameter of 2 cm or less extending through the housing;
The first wire mesh structure has a compressed undeployed shape in the lumen of the catheter and an expanded shape in the human stomach, and the undeployed shape is A first volume of 110 ml or less and a first length of 75 cm or less, the expanded shape is defined by a plurality of first curved surfaces, and is a porous and closed second volume of 125 ml or more. And the first wire mesh structure further includes a first upper portion and a first lower portion, wherein the first upper portion is made of material from the outside of the second volume into the second volume. A first opening configured to enter, wherein the lower portion has a portion of the first plurality of curved surfaces that gradually narrows and fits within a second opening defined by a diameter;
The ring is attached to the lower part and is defined by a rotation surface formed by rotating a semicircle in a three-dimensional space around an axis passing through the center of the second opening, and the ring is defined by a diameter of 25 mm or more. Intragastric device.

Claims (41)

An intragastric device configured to deploy in a person's stomach,
The intragastric device includes a catheter, a first wire mesh structure, a second wire mesh structure, and a connection portion.
The catheter includes a housing and a lumen having an inner diameter of 2 cm or less extending through the housing;
The first wire mesh structure has a compressed undeployed shape in the lumen of the catheter and an expanded shape in the human stomach, and the undeployed shape is A first volume of 110 ml or less and a first length of 75 cm or less, wherein the unfolded shape is a porous and closed second of 125 ml or more defined by a first plurality of curved surfaces; The first wire mesh structure further includes an upper portion and a lower portion, and the upper portion is configured to receive a material from the outside of the second volume to the inside of the second volume. A first surface region of the opening, and the lower portion has a second surface region of the plurality of openings,
The second wire mesh structure is separated from the first wire mesh structure and has a compressed undeployed shape in the catheter lumen and an expanded in the human stomach. The shape before deployment has a third volume of 100 ml or less and a second length of 70 cm or less, and the shape after deployment is defined by a second plurality of curved surfaces. A fourth volume of 110 ml or more that is porous and closed, and wherein the second wire mesh structure further has an upper part and a lower part, and the upper part is formed from the outside of the fourth volume. A third surface region of a plurality of openings configured to receive material in a volume of the bottom, the lower portion has a fourth surface region of the plurality of openings;
The connection portion flexibly connects the first wire mesh structure and the second wire mesh structure, and the connection portion includes a portion of the first wire mesh structure that defines a second opening surface area. An intragastric device formed between a portion of the second wire mesh structure defining a third open surface area.   The intragastric device according to claim 1, wherein the first wire mesh structure and the second wire mesh structure are continuously disposed in a lumen of the catheter.   The at least one of the first plurality of curved surfaces is defined by an arc, the arc being determined by a radius in the range of 0.2 cm to 20 cm and a central angle in the range of 5 ° to 175 °. Intragastric device.   The at least one of the second plurality of curved surfaces is defined by an arc, the arc being determined by a radius in the range of 0.1 cm to 15 cm and a central angle in the range of 1 ° to 179 °. Intragastric device.   The connection portion includes a plurality of free end portions of the first wire mesh structure that defines the second opening surface region, and a plurality of the second wire mesh structure that defines the third opening surface region. The intragastric device according to claim 1, formed between the free end portion of the device.   The intragastric device according to claim 1, wherein the first wire mesh structure has at least one of a spherical shape and an elliptical shape.   The intragastric device according to claim 6, wherein the second wire mesh structure has at least one of a spherical shape and an elliptical shape.   The intragastric device according to claim 1, wherein the connecting portion includes a plurality of seams.   The plurality of seams have one end attached to a first point on the second opening surface area and a second end attached to a second point on the third opening surface area 9. The intragastric device of claim 8, comprising a first flexible seam.   The length of the connection part from the 1st point of said 2nd opening surface area to the 2nd point of said 3rd opening surface area is a range of 0.01 mm-200 mm according to claim 1. Intragastric device.   The plurality of seams have a first end attached to a third point of the second opening surface region and a second end attached to a fourth point of the third opening surface region. 10. The intragastric device of claim 9, comprising two flexible seams, wherein the first point is different from the third point and the second point is different from the fourth point.   The stomach according to claim 11, wherein the length of the connecting portion from the third point of the second opening surface region to the fourth point of the third opening surface region is in the range of 0.01 mm to 300 mm. Internal device.   12. The intragastric device of claim 11, wherein the first flexible seam and the second flexible seam are 180 degrees apart.   The plurality of seams have one end attached to a fifth point of the second opening surface region and a second end attached to a sixth point of the third opening surface region. The fifth point is different from the first point and the third point, and the sixth point is different from the second point and the fourth point. 11. The intragastric device according to 11.   The stomach according to claim 14, wherein the length of the connecting portion from the fifth point of the second opening surface region to the sixth point of the third opening surface region is in the range of 0.01 mm to 300 mm. Internal device.   The plurality of seams have one end attached to the seventh point of the second opening surface region and the second end attached to the eighth point of the third opening surface region. The fourth point is different from the first point, the third point, and the fifth point, and the eighth point is the second point and the fourth point. The intragastric device according to claim 14, which is different from the sixth aspect.   The stomach according to claim 16, wherein the length of the connecting portion from the seventh point of the second opening surface region to the eighth point of the third opening surface region is in the range of 0.01 mm to 300 mm. Internal device.   The first wire mesh structure and the second wire mesh structure have a motion angle relative to each other in all directions, and the motion angle is the center of the first wire mesh structure, the first opening. A center of the surface region and a first longitudinal axis passing through the center of the second open surface region, and the center of the second wire mesh structure, the center of the third open surface region, and the fourth The intragastric device of claim 1, defined by an angular displacement between a second longitudinal axis through the center of the open surface area.   The intragastric device according to claim 18, wherein the angular displacement is 90 ° or less.   The connecting portion of the first wire mesh structure with the second wire mesh structure compresses the first wire mesh structure to 99% of its equator diameter without compressing the second wire mesh structure. 2. The intragastric device of claim 1 having a length such that it is capable of.   The connection part of the first wire mesh structure with the second wire mesh structure is such that when the first wire mesh structure is compressed more than 90%, the second wire mesh structure is the first wire mesh structure. A length having an angular displacement of 10% or less with respect to the body, the angular displacement being the center of the first wire mesh structure, the center of the first opening surface region, and the second A first longitudinal axis through the center of the open surface area and a second through the center of the second wire mesh structure, the center of the third open surface area, and the center of the fourth open surface area. The intragastric device of claim 1, defined by a relative angle between the longitudinal axes.   The intragastric device according to claim 1, wherein the first wire mesh structure and the second wire mesh structure are connected to each other by a connecting portion within a lumen of the catheter.   The intragastric device according to claim 1, wherein the first wire mesh structure and the second wire mesh structure are not connected by a connecting portion within a lumen of the catheter.   The stomach according to claim 1, wherein the connecting portion is formed by braiding a plurality of free end portions of the second opening surface region and a plurality of free end portions of the third opening surface region. Internal device.   The intragastric device according to claim 1, wherein the second volume and the fourth volume occupy 25% to 95% of the stomach.   A sleeve having a proximal end, a distal end, and a lumen, the proximal end being coupled to the lower portion of the second wire mesh structure, the distal end being located within a patient's duodenum; The sleeve further includes a first opening in fluid communication with the fourth opening surface region and a second opening at the distal end, the sleeve configured to deliver food from the intragastric device to the duodenum. The intragastric device according to claim 1.   The intragastric device according to claim 1, wherein the first wire mesh structure has at least one of a spherical shape and an elliptical shape, and the first wire mesh structure has a volume of more than 5 ml and less than 5000 ml.   28. The intragastric device according to claim 27, wherein the second wire mesh structure has at least one of a spherical shape and an elliptical shape, and the second wire mesh structure has a volume of more than 20 ml and less than 4000 ml. An intragastric device configured to deploy in a person's stomach,
The intragastric device includes a catheter, a first wire mesh structure, a second wire mesh structure, and a plurality of flexible members ,
The first wire mesh structure has a compressed undeployed shape in the lumen of the catheter and an expanded shape in the human stomach, and the undeployed shape is Within the lumen of the catheter has a first volume of 110 ml or less and a first length of 75 cm or less, the deployed shape is porous and closed, defined by a first plurality of curved surfaces The first wire mesh structure further includes an upper part and a lower part, and the upper part is filled with material from the outside of the second volume into the second volume. Configured to have a first surface region of a plurality of openings, the lower portion has a second surface region of a plurality of openings;
The second wire mesh structure has a compressed pre-deployment shape in the lumen of the catheter, and an expanded post-expansion shape in the human stomach, and the pre-deployment shape is: A third volume of 100 ml or less and a second length of 70 cm or less, wherein the deployed shape is a porous and closed fourth of 110 ml or more defined by a second plurality of curved surfaces. A first wire mesh structure further comprising an upper portion and a lower portion, wherein the upper portion is configured to allow material to enter the fourth volume from the outside of the fourth volume; The lower surface has a fourth surface region of a plurality of openings;
Wherein the plurality of flexible members is configured to flexibly connecting the second wire mesh structure and the first wire mesh structure, the plurality of flexible members, the first flexible member and second flexible include sexual member, said first flexible member is one end attached to the first point of the second opening surface area, the second end of the third opening surface area The second flexible member is attached at one end to the third point of the second opening surface region, and the second end is attached to the third opening surface region. Wherein the first point is different from the third point and the second point is different from the fourth point. The length of the first flexible member from the first point of the second opening surface region to the second point of the third opening surface region is in the range of 0.01 mm to 300 mm. 30. The intragastric device according to 29. The length of the second flexible member from the third point of the second opening surface region to the fourth point of the third opening surface region is in the range of 0.01 mm to 100 mm. 30. The intragastric device according to 30. 30. The intragastric device of claim 29, wherein the first flexible member and the second flexible member are 180 degrees apart. The plurality of flexible members have one end attached to the fifth point of the second opening surface region and the second end attached to the sixth point of the third opening surface region. A third flexible member , wherein the fifth point is different from the first point and the third point, and the sixth point is different from the second point and the fourth point. 30. The intragastric device according to claim 29. The length of the third flexible member from the fifth point of the second opening surface region to the sixth point of the third opening surface region is in the range of 0.01 mm to 300 mm. 34. The intragastric device according to 33. The plurality of flexible members have one end attached to the seventh point of the second opening surface region and the second end attached to the eighth point of the third opening surface region. A fourth flexible member , wherein the seventh point is different from the first point, the third point, and the fifth point, and the eighth point is the second point, the fourth point, 34. The intragastric device according to claim 33, which is different from the sixth point and the sixth point. The length of the fourth flexible member from the seventh point of the second opening surface region to the eighth point of the third opening surface region is in the range of 0.01 mm to 100 mm. 36. The intragastric device according to 35.   The first wire mesh structure and the second wire mesh structure have a relative motion angle in all directions, the motion angle being a center of the first wire mesh structure, the first wire mesh structure, A center of the opening surface region, a first longitudinal axis passing through the center of the second opening surface region, the center of the second wire mesh structure, the center of the third opening surface region, and the fourth 30. The intragastric device according to claim 29, defined by an angular displacement with a second longitudinal axis passing through the center of the open surface area.   38. The intragastric device according to claim 37, wherein the angular displacement is 90 degrees or less. Each of the plurality of flexible members has such a length that the first wire mesh structure can be compressed to 95% of its equator diameter without compressing the second wire mesh structure. 30. The intragastric device according to claim 29, comprising: Each of the plurality of flexible members, when said first wire mesh structure was supercompressed 90%, the angular displacement relative to said second wire mesh structure first wire mesh structure becomes 10% or less The angular displacement is a first longitudinal axis passing through the center of the first wire mesh structure, the center of the first opening surface region, and the center of the second opening surface region. Defined by a relative angle between a direction axis and a second longitudinal axis passing through a center of the second wire mesh structure, a center of the third opening surface region, and a center of the fourth opening surface region; 30. The intragastric device according to claim 29 . An intragastric device configured to deploy in a person's stomach,
The intragastric device includes a catheter, a first wire mesh structure, and a ring,
The catheter includes a housing and a lumen having an inner diameter of 2 cm or less extending through the housing;
The first wire mesh structure has a compressed undeployed shape in the lumen of the catheter and an expanded shape in the human stomach, and the undeployed shape is A first volume of 110 ml or less and a first length of 75 cm or less, the expanded shape is defined by a plurality of first curved surfaces, and is a porous and closed second volume of 125 ml or more. And the first wire mesh structure further includes a first upper portion and a first lower portion, wherein the first upper portion is made of material from the outside of the second volume into the second volume. A first opening configured to enter, wherein the lower portion has a portion of the first plurality of curved surfaces that gradually narrows and fits within a second opening defined by a diameter;
The ring is attached to the lower part and is defined by a rotation surface formed by rotating a semicircle in a three-dimensional space around an axis passing through the center of the second opening, and the ring is defined by a diameter of 25 mm or more. Intragastric device.