JP7717081B2 - Endoscopy band with visual indicator to assist placement - Patent Application 20070122997 - Google Patents

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62/978,797, entitled "Endoscopy Band With Visual Indicator to Assist Placement," filed February 19, 2020, the contents of which are expressly incorporated herein by reference in their entirety.

Colonoscopy is the examination of the large intestine, or colon, with the use of a colonoscope, a flexible, tubular examination device with a camera at its tip. Colonoscopy is performed for a variety of medical reasons, including the detection of inflamed tissue, ulcers, abnormal growths or polyps, and colon cancer. Colonoscopy is increasingly being used as a screening tool to detect colon cancer.

During a colonoscopy, a colonoscope is inserted into the patient's rectum and advanced to the beginning of the colon (the area known as the cecum) to examine the lining of the large intestine. The efficiency and accuracy of this procedure depend heavily on the ease with which the colonoscope can be advanced. During the procedure, the colon can become over-distended or awkwardly oriented, forming loops that impede the advancement of the colonoscope, resulting in patient discomfort, extended examination times, and potentially inaccurate or incomplete screening.

Currently, the difficulty of advancing the scope is addressed by technicians applying manual pressure to manually support the patient's colon. Applying manual pressure is time-consuming and varies depending on the strength, technique, endurance, and training of a particular technician. To apply differential pressure, technicians may roll the patient onto their left side into a supine or prone position, which can be a difficult task for sedated patients. Applying manual pressure and moving the patient to support the patient's colon and advance the colonoscope during the procedure places a physical strain on the technician.

In one aspect of the present disclosure, methods and devices are provided for applying pressure to a patient's abdomen to facilitate the passage of an endoscope during procedures used to examine the intestines, including colonoscopy, sigmoidoscopy, and enteroscopy. The aspects presented herein apply both widespread, uniform hypogastric pressure and additional, location-specific pressure to the sigmoid colon with the objectives of preventing and reducing bowel looping, eliminating the need for manual pressure application, improving patient safety, comfort, and satisfaction, and preventing musculoskeletal injuries for endoscopy professionals.

Aspects include a primary wrap sized for placement around the subject's lower abdomen and at least one secondary strap extending from the primary wrap, extending across at least a portion of the primary wrap, and configured to fasten to a third portion of the primary wrap to adjust the amount of pressure applied by the endoscopic support device. Visual guides are provided on the primary wrap and/or at least one secondary strap to provide visual assistance to the technician in properly positioning the device on the patient and adjusting focal support using the secondary strap.

Additional advantages and novel features of embodiments of the present invention will be set forth in part in the description that follows, and in part will become more apparent to those skilled in the art upon examination of the following or learning by practice thereof.

1 is a schematic diagram of a colon with an endoscope (also known as a colonoscope for a colonoscopy procedure) partially inserted therein. FIG. 1 is a schematic diagram of a colon in which a sigmoid loop has occurred due to an attempt to advance an endoscope against an unsupported colon wall. FIG. 1 is a schematic diagram of the colon showing manual pressure being applied to the colon to facilitate insertion of the endoscope. FIG. 1 is a diagram of an unfastened endoscopic band device having elastic secondary straps stretched and fastened to the primary wrap, capable of holding tension and exerting directional force on the colon, including the sigmoid colon, transverse colon, and cecal regions. 3 is a perspective view of the endoscopy band device depicted in FIG. 2 as it would appear when applied to a patient, according to an embodiment of the present invention. 10 illustrates the use of an endoscopy band device having elastic secondary straps that can hold tension and exert a directional force for an endoscopy procedure. 10 shows a portion of an endoscopy band showing a tapered secondary strap. 10 shows a portion of an endoscopy band including a visual guide for adjusting the directional force on the secondary strap. 1 shows the inside of an endoscopy band including a visual guide for placement of the band on the patient. 10 shows an endoscopy band having multiple secondary straps with visual guides for adjusting the directional force on the secondary straps. 1 is a flowchart of an example method of using an endoscopy band as described herein. 10 shows an endoscopy band having multiple secondary straps with visual guides for adjusting the directional force on the secondary straps. 10 shows an endoscopy band having multiple secondary straps with visual guides for adjusting the directional force on the secondary straps. 10 shows an endoscopy band having multiple secondary straps with visual guides for adjusting the directional force on the secondary straps.

The detailed description set forth below in connection with the accompanying drawings is intended as a description of various configurations and is not intended to represent the only configurations in which the concepts described herein may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the various concepts. However, it will be apparent to those skilled in the art that these concepts may be practiced without these specific details.

The embodiment presented herein includes a primary abdominal wrap that is secured around the patient's lower abdomen and secondary straps that provide directional force and support for the sigmoid colon. Once the device is securely secured, the secondary straps can be adjusted to act as a centralized support or "splint" for the sigmoid colon. The device further includes visual guides or indicators that provide visual reference marks and guidance for positioning the device on the patient and/or adjusting the directional force using the secondary straps.

1A-1C illustrate the sequential steps of a colonoscopy. In FIG. 1A, a colonoscope 2 is inserted into the patient's rectum and advanced through the length of the colon. As the operator passes the colonoscope through the sigmoid region of the colon 4, the colonoscope can impinge, causing distension and looping of the anatomy, as shown in FIG. 1B. This distension can cause discomfort to the patient and increase the time required for the colonoscopy. To reduce the distended or looped area, the technician may apply manual pressure to the patient's abdomen. Among other examples, the technician may be a nurse, assistant, or other staff member. For example, pressure may be applied by a nurse or surgical assistant, as shown in FIG. 1C.

The application of manual pressure is time-consuming and physically demanding for the technician. The effectiveness of manual pressure varies depending on the strength, technique, endurance, and training of a particular technician. To apply differential pressure, technicians may roll the patient onto their left side into a supine or prone position, which can be difficult for sedated patients. Applying manual pressure and moving the patient to support the patient's colon and advance the colonoscope during the procedure can even result in technician injury.

Many patients undergo colonoscopy while in the left lateral decubitus position on a stretcher or operating table. Additional information regarding the use of such manual pressure can be found in Prechel JA, Hucke R. Safe and effective abdominal pressure during colonoscopy: forearm versus open hand technique. Gastroenterol Nurs 2009;32:27-30; quiz 31-2, the entire contents of which are incorporated herein by reference. When applying manual pressure, the technician may reach over the patient from the opposite side of the operating table, place their hand on the patient's sigmoid colon to apply pressure, and then lean backward using their body weight as leverage to apply the force. While these methods are generally effective in generating pressure, they have been implicated as a cause of high rates of occupational injuries among endoscopy nurses and staff. Physicians performing colonoscopies are also particularly susceptible to musculoskeletal injuries. The most frequent site of physician injury is the right upper extremity, which experiences peak torque forces while attempting to advance the scope through the (looped) sigmoid colon. Additional details can be found in Spanarkel M, Hathorn JP. Looping During Colonoscopy: A Major, Implied Cause of Injury Among Endoscopy Healthcare Providers and a Proposed Solution, 2013, the entire contents of which are incorporated herein by reference.

The aspects described herein may be similarly applied to other endoscopic procedures, such as sigmoidoscopy and retrograde enteroscopy procedures. Sigmoidoscopy examines only the lower portion of the colon, from the anus to the descending colon. An endoscope is inserted into the lower portion of the large intestine. Enteroscopy is an examination of the small intestine. During retrograde enteroscopy, an endoscope is inserted into the anus and passed through the large intestine, the cecum, and into the small intestine. Successful navigation through the sigmoid colon region, which is prone to looping, is necessary to complete both sigmoidoscopy and retrograde enteroscopy; therefore, the aspects described herein can be used to help facilitate colonoscopy, sigmoidoscopy, retrograde enteroscopy, and other endoscopic procedures.

Figure 2 shows an exemplary device including a primary elongated band or wrap 10 of sufficient length to be placed around a patient's lower abdomen. Closure mechanisms 12 may be provided at the ends of the primary band to secure the device around the patient to provide the desired amount of general support and compression. Handles 14 may be sewn to the outside of one or both ends of the primary wrap to aid in fastening and closure. Figure 5 shows a portion of an exemplary wrap 10 with handles 502 provided at the ends of the wrap 10. The handles can be used by a technician to stretch the primary wrap 10 to apply the desired amount of compression when fastening the wrap around the patient.

The primary wrap 10 may have a circumferential length between approximately 15 and 75 inches to accommodate various patient abdominal circumferences. The width of the primary wrap 10 may be between 6 and 10 inches, although variations having widths between 3 and 20 inches may be used depending on the patient's size and to accommodate special situations such as abdominal hernias or large pannus. For example, the primary wrap may be configured to have a width that allows it to be fastened around the patient's lower abdomen, with the upper edge of the wrap just below or near the navel and the lower edge of the wrap along or close to the pubic line. The width of the primary wrap may be selected so that the upper edge is not so large as to obscure the navel and additional abdominal areas above the navel. This configuration may be made to avoid compression of the diaphragm or stomach during a colonoscopy, which can increase the risk of oxygen deprivation and aspiration events, respectively, due to the patient's typically sedated state during the procedure. The primary wrap 10 may comprise, in whole or in part, flexible biocompatible foam, rubber, neoprene, polyester, nylon, nonwoven or woven fabric, mesh fabric, synthetic fabric, microfiber fabric, silicone or vinyl plastic, or any other material commonly known for use in medical fabrics and articles. The primary wrap 10 may be constructed from both elastic and non-elastic materials. In one example, the primary wrap 10 may include multiple laminated layers. For example, the primary wrap 10 may include a neoprene layer and an outer fabric layer laminated onto the neoprene layer. The fabric layer may allow for removably fastening secondary straps along the length of the primary wrap and may also allow for visual indicators to be printed on the fabric, such as nylon loop fabric. The primary wrap may also include an inner layer laminated onto the neoprene. The inner layer may include fabric or other material selected for skin sensitivity. For example, the inner layer may include a fabric or other material that is latex-free, biocompatible, and/or skin-sensitive. The inner layer may be the layer that is applied against the patient's skin. In some embodiments, the primary wrap may include a 3D spacer fabric that may provide compressive properties, elasticity, cushioning, breathability, air permeability, thermal insulation, temperature regulation, flexibility with resistance to bending/rolling, good draping, tunable vapor transport, excellent aging qualities, surface and wash durability, sterilization capabilities, and versatile surface design capabilities. The 3D spacer fabric may include a man-made textile structure in which two fabric layers are connected by a layer of pile yarn, sometimes referred to as pile yarn.

The primary wrap may include two or more sections made of different types of material. In one example, a first set of one or more sections may be constructed from a soft, elastic or semi-elastic, medium-weight, latex-free neoprene with a thin layer of polyester or nylon bonded to its interior and exterior sides. This material, among other things, may be capable of providing broad, firm, yet comfortable support to the patient's abdominal region. Another set of one or more sections of the primary wrap 10 may include a relatively inelastic material, such as a woven fabric. The inelastic sections may be located in or beneath an insert. Upon deployment of the device, the inelastic sections may be positioned in the patient's left lower quadrant, above the sigmoid colon.

For the primary wrap to provide adequate overall compression and support, it may be important that the wrap remain flat against the body when fastened around the abdomen. This is noteworthy because certain materials and designs have a tendency to roll up when stretched or wrapped around the abdomen, particularly when the device is applied to patients with large pannus. To prevent roll-up from occurring, embodiments of the present invention may include reinforcements to ensure that the primary abdominal wrap remains flat against the body when used on patients of various body sizes. This may be achieved by applying a surge stitch along the edges of the primary abdominal band.

The primary wrap may also accommodate inserts or attachments that provide specific support to one or more regions of the colon, including the sigmoid, transverse, and large intestine regions, and the splenic and hepatic flexures. Once the device is secured, the secondary straps, inserts, or both can be pushed, pulled, or otherwise tucked into the body in a manner that serves to support or "splint" one or more regions of the colon, including the sigmoid, transverse, and large intestine regions, and the splenic and hepatic flexures. The embodiments described herein can be designed to provide broad lower abdominal support and additional direct force to one or more regions of the colon, including the sigmoid, transverse, and large intestine regions, and the splenic and hepatic flexures, of a patient undergoing a colonoscopy.

The primary wrap 10 may be placed around the patient's lower abdomen and secured using a closure mechanism 12 consisting of a strip of VELCRO® or hook material 13 positioned on the inside of the wrap 10 near the location of the opposing handle 14. This hook strip 13 may be fastened to the outer side of the opposing end of the primary wrap 10.

The edges of the hook strip 13 may not extend to the edges of the primary wrap 10. This structure may be designed to minimize the chance of the hook strip 13 coming into contact with the patient's skin or the gloves of the nurse or assistant deploying the device, as there is a small but known risk that VELCRO® or hook and pile materials can tear medical gloves.

An additional feature designed to reduce the likelihood of patient and provider contact with the hook material. In embodiments incorporating this feature, a thin layer of material may be applied to the hook strips incorporated into the device before the device is packaged. This layer may include, for example, paper, plastic, cloth, silicone, or any other biocompatible material typically used in healthcare products. Additionally, this layer may be lightly adhered to the hook strips so that they remain in place until easily removed and discarded by the end user immediately prior to application of the device to the patient. This feature may be useful in the use of secondary straps 72, as it may be useful for the secondary straps 72 to remain unfastened until the primary wrap 10 is fastened and properly positioned. Having a layer covering the hook strips 75 of the secondary straps 72 helps ensure that the secondary straps are not accidentally fastened while the user is securing the primary wrap 10 around the patient's abdomen.

Adding one or more attachments to the outside of the primary wrap facilitates, for example, the application of additional directional force without requiring adjustment of the primary wrap. The attachments may include one or more straps attached on one side to one or more edges of the inelastic section. Figures 2-4 show an example with a single secondary strap. Figure 8 shows an example with multiple secondary straps 72a, 72b. The free ends of these straps may have closure mechanisms, such as 74a, 74b. The closure mechanisms may include handles or loops near the ends of the straps, which may provide greater ease or additional security for the technician when pulling the elastic straps to apply additional targeted compression. The straps 72a, 72b may be pulled horizontally along the outside of the primary wrap and fastened using a closure mechanism securely enough to maintain tension. The one or more straps may comprise an elastic material configured to be stretched and fastened to the primary wrap to apply targeted compression through elastic contraction of the material. The amount of targeted compression may be adjusted through adjustment of the location where the removable end is coupled to the primary wrap, such as via a Velcro fastener. In some examples, straps may be secured to the inelastic section of the primary wrap, and tension created by fastening these straps may cause additional compression of the inelastic section and/or insert toward the patient's body.

As depicted in FIG. 4, the secondary straps 72 may allow nurses and technicians to easily adjust and readjust the force on specific areas of the patient's abdomen, such as the sigmoid colon and/or transverse colon, from the procedure room or operating room locations typically occupied by these staff in conjunction with the manner in which patients are often positioned during endoscopy procedures. The endoscopy compression devices described herein further eliminate the need for nurses or assistants to perform manual abdominal compressions, thereby reducing the risk of musculoskeletal injury. Additional manual compression may be applied in conjunction with compression from the device. The device is designed for quick and easy removal, should the need arise.

The secondary strap 72 may be attached, e.g., sewn, to a portion of the wrap configured to be placed over the left side of the patient's lower abdomen. The portion of the secondary strap 72 attached to the primary wrap may be referred to as a fixed end and may be permanently attached to the strap, e.g., sewn or formed as an extension of the primary wrap material. The strap may be configured to be pulled from left to right, e.g., stretching across the lower abdomen and/or left lower abdomen from the left to right side of the patient's body. This placement of the secondary strap 72 may allow for easy adjustment of compression when the patient is lying on their left side during a procedure. As the strap is pulled from left to right across the lower abdomen, additional leverage and compression may be generated by the patient's body when the strap is in place. Because the strap extends from left to right across the patient's abdomen, the level of compression generated by the device can be easily adjusted during a procedure, e.g., while the patient is lying on their left side.

In some embodiments, the fixed end of the strap 72 may be connected to the wrap 10 so that the fixed end of the strap is underneath the patient during the procedure.

As shown in FIGS. 2-4, the device may include a primary wrap 10 with a closure mechanism 12 and at least one handle 14 that assists in fastening the primary wrap around the patient's lower abdomen. The device may also include a secondary strap 72 attached to an outer side 78 of the primary wrap 10, the secondary strap 72 including a closure mechanism 74 that allows the strap to be fastened, for example, to the outer side 78 of the primary wrap 10. In one aspect, the closure mechanism 74 of the secondary strap 72 may include a hook strip 75 on the interior of the secondary strap 72 that can be fastened anywhere along the outer side 78 of the primary wrap 10. In this example, the outer side 78 of the primary wrap 10 may include a hook-compatible material to which the hook strip 75 can be fastened and that can remain fastened while the secondary strap is stretched and under tension. The secondary strap 72 may be constructed of an elastic or semi-elastic material that can be stretched horizontally and retain tension when fastened to the outer side 78 of the primary wrap 10 using the closure mechanism 74. The secondary strap 72 may comprise the same material as that included in the primary wrap 10, or it may comprise a different material. The secondary strap 72 may comprise one or more layers of material. In one example, the secondary strap 72 may comprise an elastic strap whose total length is approximately twice the intended length of the secondary strap 72. As shown, the secondary strap may be tapered along the length of the strap 72. In the example of FIGS. 2-4, the elastic strap may be doubled, with both ends sewn to the exterior 78 of the primary wrap 10 along the same vertical line 73, creating a horizontal "V" appearance for the secondary strap 72. Doubling the material comprising the secondary strap serves to increase the width and force generated by the secondary strap while avoiding the additional material costs that may be associated with using a taller, single-layer strap instead. The midpoint of the secondary strap, when stretched and fastened, may be positioned approximately over the patient's left lower abdomen. In other examples, such as those shown in FIGS. 5, 6, and 8, the secondary strap 72 may be a unitary piece having at least one tapered edge.

FIG. 6 illustrates an example in which a visual guide 60 may be provided on a secondary strap 72 to assist in adjusting the targeted compression or splinting by the secondary strap. A first indicator 62 may indicate the direction in which the secondary strap may be pulled to apply focused compression to the transverse colon. The indicator 62 may include an image, such as an arrow, indicating the direction in which the secondary strap 72 may be stretched, pulled, or moved to apply focused compression to the transverse colon. The indicator 62 may include text identifying the area of compression or text providing additional assistance in applying focused compression. In FIG. 6, the indicator 62 includes an arrow and the word "Transverse," providing a simple way for the technician to stretch the secondary strap across the patient's abdomen and secure it to the primary wrap 10 to apply focused compression to the transverse colon. More than one indicator may be provided. For example, FIG. 6 illustrates a second indicator 64 indicating a different direction in which the secondary strap may be pulled to apply focused compression to the sigmoid colon. The indicator 64, like the indicator 62, may include an image and/or text. The indicators 62 and 64 in FIG. 6 are merely examples for illustrating the concept, and other images or textual descriptions may be used. While specific examples have been provided for indicators 62 and 64 for targeted compression or splinting adjustment of the transverse and/or sigmoid colon, indicators may be provided that provide visual images and/or descriptions to assist in positioning secondary straps 72 to apply compression to other areas involved in endoscopic procedures, such as the splenic flexure, hepatic flexure, etc.

As described above, multiple secondary straps may be provided on the device. FIG. 8 illustrates an example in which indicators 62 and 64 are provided on different secondary straps. For example, the device may include two secondary straps, as shown in FIG. 8. A first elastic strap 72b may extend from left to right from the primary wrap for applying targeted compression to a first abdominal region (e.g., the sigmoid colon region) of the subject. A second elastic strap may extend from left to right from the primary wrap for applying targeted compression to a second abdominal region of the subject. The primary wrap may include an upper edge for placement against the subject's umbilical line (e.g., as shown at 172) and a lower edge for placement below the subject's umbilical line. The first elastic strap and the second elastic strap may extend from the primary wrap at the same location along the length of the primary wrap. For example, the two secondary straps may be sewn (or otherwise fastened or extending) from the same location along the length of the straps. The first strap may be positioned below the second strap along the width of the primary wrap. For example, as shown in FIG. 8 , a first elastic strap can extend from a first location along the width of the primary wrap, and a second elastic strap can extend from a second location along the width of the primary wrap, the second location being closer to the superior rim than the first location. Using multiple secondary straps allows a user to simultaneously apply targeted compression to different abdominal regions, such as different regions of the colon (such as the sigmoid and/or transverse regions), during an endoscopy procedure. Similarly, having multiple secondary straps allows for adjustment of targeted compression for one abdominal region while maintaining targeted compression for another abdominal region. For example, a technician can apply targeted compression using first and second straps. During an endoscopy procedure, the technician can adjust the first strap without removing or readjusting the second strap.

FIG. 7 illustrates an example in which visual guides or indicators may be provided on the primary wrap 10 to assist in placement of the primary wrap on a patient. FIG. 7 illustrates a portion of the primary wrap 10 on the side configured for placement on a patient, e.g., what may be referred to as the medial side of the wrap 10. In FIG. 7, a first indicator 172 provides a visual indicator to the technician that proper placement of the device to assist in an endoscopy procedure involves aligning the upper edge of the primary wrap 10 with the patient's umbilical line. The indicator 172 may include an image, such as one or more arrows, indicating the edge of the wrap 10 that should be aligned with the patient's umbilical line and/or may include text explaining the alignment to the technician. For example, in FIG. 7, the text indicates "align upper edge with umbilical line." The illustrative indicator 172 in FIG. 7 is merely an example to illustrate the concept, and other images or text may be used to provide guidance regarding placement of the primary wrap on a patient. FIG. 7 also shows an indicator 174 that provides guidance regarding placement of the primary wrap 10 on the patient so that the secondary straps are positioned to provide targeted compression to the sigmoid colon, transverse colon, etc. The indicator 174 may include a graphic, such as one or more arrows, indicating the portion of the wrap 10 to align with the patient's left hip joint and/or text explaining the alignment to the technician. For example, in FIG. 7 , the text indicates "green line on left hip joint." The visual indicator may be used in combination with a visual indicator on the end of the secondary strap 172 that is secured to the opposite side of the primary wrap 10. As shown in FIG. 7 , the stitching 176 securing the end of the secondary strap may use a contrasting color to the primary wrap 10 so that the stitching provides a visual reference for placement of that section of the primary wrap relative to the patient's left hip joint. The illustrative indicator 174 in FIG. 7 is merely an example to illustrate the concept, and other graphics or text may be used to provide guidance regarding placement of the primary wrap relative to the patient.

A stretch and compression indicator mechanism, such as those described herein, may be provided so that the device includes a visual indication of the amount of force being applied, such as a "Logo" marking 80 that stretches and deforms when the secondary strap 72 is stretched and fastened. This mechanism allows the user to compare the deformed marking with photographs or illustrations included in the product instructions or packaging to determine if the device has been applied correctly.

FIG. 10 shows an additional view of device 1000 including a primary wrap and two elastic secondary straps 72a and 72b. FIG. 10 illustrates that each of secondary straps 72a and 72b may have a tapered shape and may include a dual-elastic layer, fold-over design, similar to the single strap 72 shown in FIG. 4. Alternatively, the two elastic secondary straps 72 and 72b may have a single-elastic layer design, such as that shown for the single strap in FIG. 5. FIG. 10 illustrates an example in which each elastic strap 72a and 72b may include visual indicators indicating and/or describing the direction of stretch to apply compression to multiple abdominal regions of the patient, similar to the example for the single strap shown in FIG. 6. For example, first strap 72a may include a first indicator 62a indicating the direction of targeted compression to the transverse colon region and a second indicator 64a indicating the direction of targeted compression to the sigmoid colon region. Similarly, the second strap 72b may include a first indicator 62b indicating the direction of targeted compression in the transverse colon region and a second indicator 64b indicating the direction of targeted compression in the sigmoid colon region. Figure 10 also shows stitches 1004a and 1004b indicating placement for Velcro fasteners at the movable ends of the two straps 72a, 72b. The closure mechanisms 74a, 74b may correspond to handles that allow the operator to more easily stretch and fasten the elastic straps 72a, 72b. In some aspects, the Velcro fasteners may be located on the inner side of the edge 1008 of the primary wrap or may be configured for the outer side of the opposing end 1010 of the primary wrap. Thus, the end 1010 may be wrapped under the end 1008 to fasten the primary wrap. A handle 502 may be provided on the portion of the primary wrap near end 1010 and may be used by the technician to pull end 1010 further under end 1008 to apply a higher level of primary compression through elastic compression of the primary wrap 10. A visual indicator 1002 may indicate the top edge of the wrap to assist in orienting placement relative to the patient's abdomen.

FIG. 11 shows a view 1100 of the inside of the primary wrap 10, e.g., the side of the primary wrap configured for placement on a patient. In addition to the visual indicator 1002, the primary wrap 10 may further include a visual indicator indicating the bottom or bottom side/edge of the wrap. The top/bottom indicator may help avoid applying the primary wrap in the wrong direction. If the bottom edge is applied higher than the top edge, the secondary straps 72a, 72b may extend in the wrong direction and may not provide targeted compression to the appropriate area of the patient's abdomen. Additionally, a visual indicator 1104 may be provided to indicate correct placement along the width of the primary band. In the example of FIG. 11, a line is provided as a visual indicator for the patient's left hip joint. The indicator may further include one or more arrows and lettering. While the example of FIG. 11 uses a green line, the concepts may also apply to indicators of different colors, dashed lines, double lines, visual markers other than lines, etc. The visual indicators can assist the technician in properly positioning the primary wrap on the patient, ensuring that the secondary straps are in the proper position to apply targeted compression to specific areas of the abdomen, such as the sigmoid or transverse colon regions. FIG. 12 shows a lateral view 1200 of a portion of a primary wrap, illustrating that visual indicators 1202 can be provided on the exterior of the wrap. In FIG. 12, the visual indicators 1202 assist the technician in positioning the primary wrap with its upper edge near the umbilical line. The visual indicators may be positioned to line up with the anterior abdominal region of the primary wrap when the wrap is properly positioned (e.g., according to the visual indicators on the interior of the primary wrap), allowing the technician to see, for example, the alignment of the visual indicators with the patient's navel before or when fastening the closure of the primary wrap. FIG. 12 also illustrates that the straps 72a, 72b can be coupled to the primary wrap at the same location along the length of the primary wrap 10. For example, FIG. 12 shows stitching 1204 attaching the fixed ends of the straps 72a, 72b to the primary wrap 10.

In some examples, one vertical side of the secondary strap may be secured to the primary wrap, and the other side may be removably secured to the primary wrap, such as via a Velcro closure. In other examples, the secondary strap 72 may be completely removable from the primary wrap and may have fastening mechanisms on both ends that allow the strap to be secured to the outer sides of the primary wrap. The secondary strap in this embodiment may be reusable or disposable, and may be capable of being stretched to maintain tension when secured to the primary band, or may use another mechanism for exerting a compressive force. The strap in this example may not be wrapped completely around the patient, but instead may be stretched directly around the location on the patient's body where force is desired. The strap may include fastening mechanisms on both ends, for example, to allow the strap to be attached directly to the patient's body.

Improving patient comfort and reducing complications both during and after endoscopic procedures is extremely important. The embodiments presented herein reduce patient discomfort and complications by helping to prevent and reduce sigmoid colon looping, which can be a major cause of patient pain and discomfort.

After changing into clothing, such as the hospital gown typically worn during an endoscopic procedure, patients can often become cold or uncomfortably chilled. Many patients request and are provided with blankets, and some facilities offer electrically heated blankets or pre-warmed blankets. Heated blankets not only provide physical warmth, but also tend to relax the patient and alleviate any anxiety or discomfort the patient may be experiencing. The embodiments presented herein can also help patients feel warm and comfortable during the procedure.

The devices shown in Figures 10-12 may include any of the additional aspects described in connection with Figures 1-8.

FIG. 9 illustrates an embodiment of a method for applying pressure and support to a patient's abdomen during advancement of an endoscope during an endoscopic-type procedure.

At 902, the method includes wrapping a primary wrap around the patient's abdomen between the patient's hip joints and navel, as described in connection with FIGS. 2-4. The primary wrap may include any of the aspects described in connection with FIGS. 1-8 and/or 10-12.

At 904, the method includes securing the primary wrap after wrapping the primary wrap around the patient's abdomen by attaching a first end of the primary wrap to a second portion of the primary wrap.

At 906, the method includes adjusting compression applied to the patient's abdomen by pulling at least one strap extending from the primary wrap over at least a portion of the primary wrap and fastening the strap to at least a third portion of the primary wrap, as shown in FIG. 4. The at least one strap may include any of the aspects described in connection with FIGS. 1-8 and/or 10-12. The amount of compression applied to the patient's abdomen may be adjusted at 906 by pulling a strap extending from the primary wrap over at least a portion of the primary wrap and fastening the strap to the primary wrap. The strap may be coupled to a portion of the primary wrap configured to be positioned over the left side of the subject's lower abdomen, thereby utilizing the patient's own body weight to adjust the compression provided by the strap. The strap may be configured to be pulled in a direction toward the right side of the subject's lower abdomen to adjust the amount of pressure applied by the endoscopic support device. A combination of visual indicators may enable correct placement of the device on the patient and assist in applying targeted compression through adjustment of the at least one strap. The at least one visual indicator may include any of the aspects described in connection with FIGS. 1-8 and/or 10-12.

The primary wrap is positioned against the patient's abdomen and/or the straps are stretched using at least one visual indicator. The at least one visual indicator may include a visual indication of the direction to stretch the at least one elastic band to apply additional targeted force to the subject's sigmoid colon region, as described in connection with the examples of FIGS. 6 and 8. The visual indication may include a directional arrow and/or lettering indicating the sigmoid colon region. Thus, at 906, the method may include adjusting the straps to apply the targeted force to the subject's sigmoid colon using the visual indication.

The at least one visual indicator may include a visual indication of a direction to stretch the at least one elastic band to apply additional targeted force to the transverse colon region of the subject, as described in connection with the examples of FIGS. 6 and 8. The visual indication may include a directional arrow and/or text indicating the transverse colon region. Thus, at 906, the method may include adjusting the straps to apply the targeted force to the transverse colon of the subject using the visual indication.

The at least one visual indicator may include a visual indication on the primary wrap indicating placement of the primary wrap relative to the subject's abdomen, as described in connection with FIG. 7. Thus, at 902, the method may include placing the primary wrap relative to the subject's abdomen using the visual indication.

The visual indication may indicate that an edge extending the length of the primary wrap is to be placed at the subject's navel line, as described in connection with FIG. 7. The visual indication may include an arrow indicating the edge of the wrap and/or text indicating and explaining that the edge is for placement at the subject's navel line. Thus, at 902, the method may include using the visual indication to align and position the edge of the primary wrap relative to the subject's navel line.

The at least one visual indication may include a visual indication on the primary wrap indicating placement of the primary wrap relative to the subject's left hip joint, as described in connection with FIG. 7. For example, the visual indication may indicate alignment of the fixed ends of the secondary straps with the subject's left hip joint. The visual indication may include an arrow indicating the fixed ends of the secondary straps, contrasting stitching securing the fixed ends of the secondary straps to the primary wrap, and/or text indicating and describing placement relative to the subject's left hip joint. Thus, at 902, the method may include using the visual indication to position an edge of the primary wrap relative to the subject's left hip joint.

At 906, compression may be adjusted for multiple target locations through adjustment of more than one strap. For example, as described in connection with FIG. 8 , a user may adjust compression at a first abdominal region by stretching and fastening a first elastic strap and adjust compression at a second abdominal region by stretching and fastening a second elastic strap. The multiple elastic straps may include visual indicators showing the direction of stretch to apply targeted compression to different regions of the colon, e.g., the sigmoid colon region and/or the transverse colon region. The use of multiple secondary straps allows for simultaneous targeted compression of different abdominal regions, e.g., different regions of the colon, during an endoscopy procedure.

To further enhance patient comfort, certain aspects of the present invention are designed to be single-use and remain in place on the patient during and/or after the procedure. For example, maintaining the compression applied by the device during the withdrawal phase of the procedure and while imaging is taking place may help improve adenoma detection. The device may be maintained on the patient to reduce common post-procedure complications of bloating and abdominal pain caused by bloating. Distension, otherwise known as gas distention, occurs after endoscopic procedures because physicians often use compressed air or carbon dioxide to create pneumoperitoneum in areas of the intestine that are difficult to view or examine. Opening the area allows for more complete visualization and enhances the effectiveness of the procedure. However, gas remains in the patient's body until it is absorbed or expelled. Because absorption is a highly inefficient process, expulsion is the primary gas removal mechanism. Gas distention is a major post-procedure complication and a frequent patient complaint. However, if the wraps described herein remain in place after the procedure, the lower abdominal compression generated by the device allows the intestine to expel trapped gas more quickly by directing excess gas toward the rectum. As a result, the severity and duration of post-procedure bloating and associated abdominal pain may be reduced.

U.S. Patent Application No. 15/256,019, entitled "METHOD AND APPARATUS FOR ENHANCED VISUALIZATION DURING ENDOSCOPY," filed September 2, 2016; U.S. Patent Application No. 13/344,715, entitled "METHOD AND APPARATUS FOR TENSILE COLONOSCOPY COMPRESSION," filed January 6, 2012; and U.S. Patent Application No. 13/344,715, entitled "ENDOSCOPY BAND WITH SIGMOID SUPPORT." U.S. Patent Application No. 14/575,860, filed December 18, 2014, entitled "COLONOSCOPY BAND WITH SIGMOID SPLINT," U.S. Provisional Patent Application No. 61/917,469, filed December 18, 2013, entitled "COLONOSCOPY BAND WITH SIGMOID SUPPORT APPARATUS," U.S. Provisional Patent Application No. 61/944,658, filed February 26, 2014, entitled "ENDOSCOPY BAND WITH SIGMOID SUPPORT APPARATUS," U.S. Provisional Patent Application No. 61/944,658, filed February 26, 2014, entitled "IMPROVED BOWEL STABILITY AND ENHANCED VISUALIZATION DURING The contents of each of U.S. Provisional Patent Application No. 62/214,747, filed September 4, 2015, entitled "ENDOSCOPY," are expressly incorporated herein by reference in their entirety.

Exemplary embodiments of the present invention have been described in accordance with the above advantages. It will be understood that these examples are merely illustrative of embodiments of the present invention. Many variations and modifications will be apparent to those skilled in the art.

It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of example approaches. Based on design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Additionally, some steps may be combined or omitted. The accompanying method claims present elements of the various steps in a sample order, and are not intended to be limited to the specific order or hierarchy presented.

The foregoing description is provided to enable any person skilled in the art to practice the various aspects described herein. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects. Accordingly, the claims are not intended to be limited to the aspects set forth herein, but rather are to be accorded the full scope consistent with the language of the claims, wherein reference to an element in the singular does not mean "only one," unless specifically stated otherwise. The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any aspect described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects. Unless otherwise specified, the term "some" refers to one or more. Combinations such as "at least one of A, B, or C," "at least one of A, B, and C," or "A, B, C, or any combination thereof" include any combination of A, B, and/or C, and may include multiples of A, B, or C. Specifically, combinations such as "at least one of A, B, or C," "at least one of A, B, and C," "A, B, C, or any combination thereof," may refer to A only, B only, C only, A and B, A and C, B and C, or A, B, and C, and any of these combinations may include one or more members of A, B, or C. All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is expressly recited in the claims. No claim element shall be construed as a means plus function unless the element is expressly recited using the phrase "means for."

Claims (20)

An endoscopy support device, comprising:
a primary wrap comprising a band of elastic material sized for placement around the subject's lower abdomen ;
a closure mechanism on an end of the primary wrap that removably attaches the end of the primary wrap to a second portion of the primary wrap to secure the primary wrap around the subject's abdomen ; and
at least one elastic strap having a first end secured to the primary wrap and a second end including a coupling mechanism for releasably coupling the second end to the primary wrap, the at least one elastic strap configured to extend in a left-to-right direction across a front abdominal portion of the primary wrap to exert an additional targeted force on a portion of the subject's abdomen ;
at least one visual indicator provided on the primary wrap or the at least one elastic strap to indicate one or more of the placement of the endoscopy support device relative to the subject or the direction of adjustment of the at least one elastic strap for targeted compression ; and
Equipped with
Endoscopy support device. The at least one elastic strap:
a first elastic strap extending in the left-to-right direction from the primary wrap for applying the targeted compression to the sigmoid colon region of the subject, the at least one visual indicator including a first text label and a first arrow indicating a first direction for applying the targeted compression to the sigmoid colon region;
a second elastic strap extending from the primary wrap extending in the left-to-right direction for applying the targeted compression to the transverse colon region of the subject , wherein the at least one visual indicator includes a second text label and a second arrow indicating a second direction for applying the targeted compression to the transverse colon region, the first direction being different from the second direction; and
10. The endoscopy support device of claim 1, comprising: 3. The endoscopy support device of claim 2, wherein at least one elastic strap is configured to extend in the left-to-right direction across an anterior abdominal portion of the primary wrap to position the first end at the subject's left hip joint and to exert the additional targeted force between a first end and a second end of the at least one elastic strap, the additional targeted force being targeted to at least one of a sigmoid colon region or a transverse colon region of the subject's abdomen. The primary wrap is
an upper edge for placement against the subject's umbilical line;
a lower edge for placement below the navel line of the subject;
the first elastic strap and the second elastic strap extend from the primary wrap at the same location along the length of the primary wrap;
the first elastic strap extends from a first location along the width of the primary wrap, and the second elastic strap extends from a second location along the width of the primary wrap, the second location being closer to the top edge than the first location ;
3. The endoscopy support device of claim 2. The at least one visual indicator is:
an edge extending the length of the primary wrap that is positioned at the subject's umbilical line; or
Positioning the primary wrap in alignment with the subject's hip joint.
3. The endoscopy support device of claim 2, further comprising one or more visual indicators on the primary wrap indicating at least one of: 6. The endoscopy support device of claim 5, wherein the one or more visual indicators include one or more of a first letter and a first arrow indicating the edge to be positioned at the subject's umbilical line, or contrasting stitching indicating placement of the primary wrap in alignment with the subject's hip joint. 10. The endoscopy support device of claim 1, wherein the at least one visual indicator comprises a visual indication of a direction to stretch the at least one elastic strap to apply the additional targeted force to the sigmoid colon region of the subject. The endoscopy support device of claim 7 , wherein the visual indication includes an arrow indicating the direction. The endoscopy support device of claim 8 , wherein the visual indication includes letters indicating the sigmoid colon region. 2. The endoscopy support device of claim 1, wherein the at least one visual indicator comprises a visual indication of a direction to stretch the at least one elastic strap to apply the additional targeted force to the transverse colon region of the subject. The endoscopy support device of claim 10 , wherein the visual indication includes an arrow indicating the direction. The endoscopy support device of claim 10 , wherein the visual indication includes letters indicating the transverse colon region. The endoscopy support device of claim 1, wherein the at least one visual indicator includes a visual indication on the primary wrap indicating placement of the primary wrap relative to the subject's abdomen. 14. The endoscopy support device of claim 13 , wherein the visual instructions include letters and arrows that visually indicate to a user one edge extending the length of the primary wrap to be placed at the subject's umbilical line . The endoscopy support device of claim 1, wherein the at least one visual indicator includes a visual indication on the primary wrap indicating placement of the primary wrap relative to the subject's hip joint. 16. The endoscopy support device of claim 15, wherein the visual indication is provided on a first side of the primary wrap to indicate alignment of the subject's hip joint with the first end of the at least one elastic strap secured to a second side of the primary wrap. The endoscopy support device of claim 16, wherein the visual indication includes one or more of an arrow or letter indicating the first end of the at least one elastic strap. The endoscopy support device of claim 16, wherein the visual indication includes contrasting stitching securing the first end of the at least one elastic strap to the primary wrap. The at least one visual indicator is:
a first visual indication on a first side of the primary wrap, the first visual indication including a first letter and a first arrow, visually indicating to a user one edge extending a length of the primary wrap to be placed at the subject's umbilical line;
a second visual indication on the first side of the primary wrap including second letters and lines indicating alignment of the subject's hip joint with the first end of the at least one elastic strap secured to the second side of the primary wrap; and
a third visual indicator on a first elastic strap extending in the left-to-right direction from the primary wrap for applying the targeted compression to the sigmoid colon region, the third visual indicator including a third letter and a second arrow indicating a first direction for extending the first elastic strap to apply the targeted compression to the sigmoid colon region;
a fourth visual indicator on a second elastic strap extending in the left-to-right direction from the primary wrap for applying the targeted compression to the transverse colon region, the fourth visual indicator including a fourth letter and a third arrow indicating a second direction for applying the targeted compression to the transverse colon region, the first direction being different from the second direction;
10. The endoscopy support device of claim 1, comprising: The at least one elastic strap:
a first elastic strap extending in the left-to-right direction from the primary wrap for applying the targeted compression to a first abdominal region of the subject,
The first elastic strap comprises:
a first sigmoid letter label and a first arrow indicating a first direction for applying the targeted compression to the sigmoid colon area via the first elastic strap;
a first transverse letter label and a second arrow indicating a second direction for applying the targeted compression to the transverse colon region via the first elastic strap;
a first elastic strap including:
a second elastic strap extending from the primary wrap extending in the left-to-right direction for applying the targeted compression to a second abdominal region of the subject;
The second elastic strap:
a second sigmoid letter label and a third arrow indicating the first direction for applying the targeted compression to the sigmoid region via the second elastic strap;
a second transverse letter label and a fourth arrow indicating the second direction for applying the targeted compression to the transverse colon region via the second elastic strap;
a second elastic strap including:
10. The endoscopy support device of claim 1, comprising: