JP7532280B2 - Lancing Device - Google Patents

Description

The present invention relates to a puncture device for puncturing biological tissue such as the atrial septum.

Catheters with electrodes are used in the examination and treatment of arrhythmias such as atrial fibrillation (AF) and atrioventricular reentrant tachycardia (AVRT). During examination, the surgeon inserts the electrode catheter into the cardiac cavity and measures the intracardiac potential to identify the abnormal part of the heart that is causing the arrhythmia. During treatment, the surgeon passes energy including high-frequency current from the catheter electrode to the myocardium that is causing the arrhythmia, causing necrosis of the source of the arrhythmia and electrically isolating it from the heart, a so-called ablation surgery. Furthermore, if atrial fibrillation occurs naturally during these examinations or treatments, or if atrial fibrillation is induced to identify the abnormal part of the heart, the surgeon applies an electrical stimulus to the heart from the catheter electrode to defibrillate it.

When performing ablation surgery, in order to deliver a catheter from the right atrium to the left atrium, a Brockenbrough needle (septal puncture needle) is used to puncture the fossa ovalis in the atrial septum from the right atrium, opening a path for catheter insertion. This is called the Brockenbrough technique.

In the Brockenbrough technique, the tip of the septal needle is pressed against the fossa ovalis while the position of the device and the fossa ovalis are confirmed by intracardiac echo and X-ray irradiation, and electricity is passed through the septal needle to cauterize and penetrate the fossa ovalis. With the fossa ovalis pierced by the septal needle, a liquid such as saline or contrast agent is poured from the tip of the septal needle, and intracardiac echo and X-ray irradiation are used to confirm that the liquid has flowed into the left atrium, to check for the presence or absence of a perforation of the fossa ovalis.

As an example of a septal puncture needle used in the Brockenbrough method, Patent Document 1 describes an electrode catheter comprising a catheter shaft, an insulating irrigation member, and a tip electrode, in which the insulating irrigation member has a plurality of irrigation openings arranged at equal angular intervals for irrigating the surface of the tip electrode with a liquid to be supplied, a liquid storage space and a branch flow path formed inside the insulating irrigation member, a liquid guide groove formed at the tip of the insulating irrigation member, and a liquid guide groove formed at the base end of the tip electrode. Patent Document 2 describes a medical device comprising a flexible elongated member and a support spine extending proximally from the distal end within the distal portion of the lumen, the proximal end of the support spine being disposed within the distal portion of the lumen. Patent Document 3 describes a high-frequency treatment instrument comprising a sheath, an electrode member, a tip member, and a liquid delivery means, in which the electrode member comprises a rod-shaped electrode portion and a large-diameter portion made of an insulating material and having an electrode hole, and a buffer member between the tip member and the large-diameter portion. Patent Document 4 describes an electrosurgical device that includes an elongated member that defines a lumen for a fluid, a distal portion having an electrode and a distal surface, the distal surface defining an opening and including a non-cutting portion and a cutting portion configured to deliver energy to puncture tissue, the distal surface of the electrode forming the cutting portion, a portion of the cutting portion forming a leading portion that partially surrounds the periphery of the opening, and at least one outer diameter of the distal portion of the electrosurgical device or the electrode decreases toward the distal end of the electrosurgical device.

JP 2012-135338 A Special table 2016-509942 publication International Publication No. 2016/203977 JP 2019-177150 A

After the fossa ovalis is punctured with the puncture needle, a liquid such as saline or contrast agent is poured into the left atrium from the opening at the tip of the puncture needle, and penetration of the fossa ovalis is confirmed using an ultrasound diagnostic device or an X-ray fluoroscopy device. In this case, with the puncture needles such as those in Patent Documents 1 to 4, the visibility of the saline or contrast agent liquid using intracardiac echo or X-ray irradiation is poor, making it difficult to confirm penetration of the fossa ovalis.

The present invention was made in consideration of the above circumstances, and its purpose is to provide a puncture device that can inject liquids such as saline or contrast agent over a wide area within the left atrium, thereby improving visibility in intracardiac echo and X-ray irradiation.

The puncture device that has been able to solve the above problem comprises a resin tube having a distal end and a proximal end and extending in the longitudinal direction, a metal tube disposed in the lumen of the resin tube, a metal member having a lumen that opens at least on the proximal side and disposed at the distal end of the metal tube, and a metal tip disposed at the distal end of the metal member, the resin tube being between the inner surface of the resin tube and the outer surface of the metal member and having a flow path that communicates with the lumen of the metal tube, the metal member being provided with a large diameter portion and a small diameter portion that is disposed distal to the large diameter portion and has an outer diameter smaller than that of the large diameter portion, the metal member being provided with a hole that communicates the space between the inner surface of the resin tube and the outer surface of the metal member with the lumen of the metal tube, and the distal end of the resin tube being provided distal to the hole.

In the puncture device of the present invention, it is preferable that a transition section that narrows in diameter toward the distal side is provided distal to the large diameter section and proximal to the small diameter section, and the hole is located in the transition section.

In the puncture device of the present invention, the cross-sectional shape perpendicular to the longitudinal direction of the metal member is preferably polygonal.

In the puncture device of the present invention, it is preferable that the metal member has a recess extending in the longitudinal direction of the metal member.

In the puncture device of the present invention, it is preferable that the metal member has a portion of its outer surface in contact with the inner surface of the resin tube.

In the puncture device of the present invention, it is preferable that the large diameter portion of the metal member has a portion where the outer surface of the large diameter portion is in contact with the inner surface of the metal tube.

In the puncture device of the present invention, it is preferable that the cross-sectional area of the metal member is larger than the cross-sectional area of the flow path in a cross section perpendicular to the longitudinal direction of the metal member.

In the puncture device of the present invention, it is preferable that the distal end of the resin tube is located closer to the proximal end of the metal tip.

In the puncture device of the present invention, it is preferable that the metal tip has a surface at the proximal end of the metal tip that faces the opening at the distal end of the resin tube.

In the puncture device of the present invention, the metal tip preferably has a surface at the proximal end of the metal tip that faces the opening at the distal end of the resin tube, and the metal tip preferably has a tapered recess on the facing surface that tapers from the proximal side to the distal side.

In the puncture device of the present invention, it is preferable that the metal tip has an expanding portion at the proximal end of the metal tip, the expanding portion expanding in diameter from the proximal side to the distal side.

In the puncture device of the present invention, it is preferable that the resin tube has a reinforcing material distal to the distal end of the metal tube.

In the puncture device of the present invention, the reinforcing material is a metallic tubular member, and it is preferable that the reinforcing material is disposed on the inner surface of the resin tube.

According to the puncture device of the present invention, the resin tube is between the inner surface of the resin tube and the outer surface of the metal member, and has a flow path communicating with the inner cavity of the metal tube, the metal member has a large diameter portion and a small diameter portion that is disposed distal to the large diameter portion and has an outer diameter smaller than that of the large diameter portion, the metal member has a hole that communicates the space between the inner surface of the resin tube and the outer surface of the metal member with the inner cavity of the metal tube, and the distal end of the resin tube is distal to the hole, thereby widening the flow path while maintaining the rigidity of the distal end of the puncture device for ease of inserting the puncture device into a biological lumen such as a blood vessel and for ease of perforating the fossa ovalis, and increasing the amount of liquid such as physiological saline or contrast agent that flows through the flow path and is discharged from the puncture device. This makes it possible to inject the liquid over a wide area in the left atrium, and improves visibility in intracardiac echo and X-ray irradiation.

1 shows a plan view of a pricking device according to one embodiment of the present invention; 2 illustrates a plan view of the distal end of the puncture device shown in FIG. 1 . 3 shows a longitudinal cross-sectional view of the pricking device shown in FIG. 2; 4 shows a cross-sectional view of the pricking device shown in FIG. 2 taken along line IV-IV. 3 shows a cross-sectional view of the pricking device shown in FIG. 2 taken along the line VV. 13 shows a plan view of the distal end of a puncture device according to another embodiment of the present invention. 7 shows a longitudinal cross-sectional view of the pricking device shown in FIG. 6 . 1A-1D show plan views of the distal end of a puncture device according to different embodiments of the present invention; 9 shows a longitudinal cross-sectional view of the pricking device shown in FIG. 8 .

The present invention will be described in more detail below based on the following embodiment, but the present invention is not limited to the following embodiment, and can of course be modified as appropriate within the scope of the above and below, all of which are included in the technical scope of the present invention. In addition, hatching and component symbols may be omitted in each drawing for convenience, but in such cases, reference should be made to the specification or other drawings. Furthermore, the dimensions of various components in the drawings may differ from the actual dimensions, as priority is given to contributing to an understanding of the features of the present invention.

1 is a plan view of a puncture device 1 according to an embodiment of the present invention, FIG. 2 is a plan view of the distal end of the puncture device 1, FIG. 3 is a cross-sectional view along the longitudinal direction of the puncture device 1, and FIG. 4 and FIG. 5 are cross-sectional views perpendicular to the longitudinal direction of the puncture device 1. The longitudinal direction of the puncture device 1 can be rephrased as the approach-retraction direction of the puncture device 1. The radial direction of the resin tube 10 in the puncture device 1 is a direction perpendicular to the longitudinal axis of the resin tube 10, and is the radial direction of the resin tube 10. The circumferential direction of the resin tube 10 in the puncture device 1 is the direction around the circumference of the resin tube 10.

The puncture device 1 of the present invention comprises a resin tube 10 having a distal end and a proximal end and extending in the longitudinal direction, a metal tube 20 disposed in the lumen of the resin tube 10, a metal member 30 having a lumen and disposed at the distal end of the metal tube 20, and a metal tip 40 disposed at the distal end of the metal member 30. The resin tube 10 is provided with a flow path 50 between the inner surface of the resin tube 10 and the outer surface of the metal member 30 and communicating with the lumen of the metal tube 20. The metal member 30 is provided with a large diameter portion 33 and a small diameter portion 34 disposed distal to the large diameter portion 33 and having a smaller outer diameter than the large diameter portion 33. The metal member 30 is provided with a hole 32 that communicates the space between the inner surface of the resin tube 10 and the outer surface of the metal member 30 with the lumen of the metal tube 20. The distal end 10d of the resin tube 10 is distal to the hole 32.

The puncture device 1 is used, for example, to puncture the fossa ovalis, which is the septal part of the atrium, and open an insertion path for delivering a catheter used in ablation surgery or the like from the right atrium to the left atrium.

In the present invention, the proximal side refers to the side of the user's hand in the extension direction of the puncture device 1, and the distal side refers to the opposite side of the proximal side, i.e., the side to be treated. The extension direction of the puncture device 1 is also referred to as the longitudinal direction. In FIG. 1, the lower side of the figure is the proximal side and the upper side of the figure is the distal side, and in FIG. 2 and FIG. 3, the right side of the figure is the proximal side and the left side of the figure is the distal side.

As shown in Figs. 1 and 2, the puncture device 1 has a shaft 2 including a resin tube 10, a metal tube 20, a metal member 30, and a metal tip 40, and may have a handle 3 at the proximal end of the shaft 2. The handle 3 preferably has a syringe port 4 for feeding a liquid such as saline or a contrast agent into the flow path 50 through the shaft 2. By having the handle 3 have the syringe port 4, it is possible to feed a liquid into the flow path 50 by connecting a syringe or the like to the syringe port 4, and it becomes easier to inject a liquid into the body from the tip of the puncture device 1 to check for the presence or absence of perforation of the fossa ovalis.

The handle 3 preferably has a connector 6 for passing electricity through the shaft 2 via a cable 5. Since the handle 3 has the cable 5 and connector 6, the metal tube 20, metal member 30, and metal tip 40 of the shaft 2 can be electrically connected by connecting the connector 6 to a power source for passing high-frequency current. This makes it possible to pass electricity from the metal tip 40 to the counter electrode plate, making it easier to perforate the fossa ovalis.

The shaft 2 preferably has a bent portion 12 at the distal end where the shaft 2 is bent. By having the bent portion 12 at the distal end of the shaft 2, it becomes easier to insert the puncture device 1 into the heart. The angle of bending of the shaft 2 at the bent portion 12 can be made to suit the shape and condition of the body lumen and the heart. The bent portion 12 may be located proximal to the proximal end of the metal member 30. The bent portion 12 may also be provided in the portion where the metal member 30 is located. By providing the bent portion 12 at the distal end of the shaft 2, the operability of the puncture device 1 can be improved.

The resin tube 10 before being assembled into the puncture device 1 may have multiple internal cavities, but preferably has one. By having the resin tube 10 have one internal cavities, the cross-sectional area of the internal cavities in the direction perpendicular to the longitudinal direction can be increased while the outer diameter of the resin tube 10 is reduced. This makes it easier to place the metal tube 20 in the internal cavity of the resin tube 10, and facilitates the manufacture of the puncture device 1.

2 and 3, the resin tube 10 has a distal end and a proximal end and extends in the longitudinal direction. The material constituting the resin tube 10 is preferably an insulating material, for example, polyolefin resins such as polyethylene and polypropylene, polyamide resins such as nylon, polyester resins such as PET, aromatic polyether ketone resins such as PEEK, polyether polyamide resins, polyurethane resins, polyimide resins, fluorine resins such as PTFE, PFA, and ETFE, and synthetic resins such as polyvinyl chloride resins. The resin tube 10 may be made of one type of synthetic resin or may contain multiple types of synthetic resins. Since the material constituting the resin tube 10 is an insulating material, the metal tube 20 and the metal member 30 can be insulated by the resin tube 10 when the metal tip 40 is energized. Among them, the material constituting the resin tube 10 preferably contains a fluorine resin, and more preferably contains PTFE. By including a fluorine-based resin in the material that constitutes the resin tube 10, the slipperiness of the outer surface of the resin tube 10 can be increased, resulting in a puncture device 1 that is easy to insert.

The longitudinal length of the resin tube 10 can be selected to be appropriate for treatment, and can be, for example, 500 mm or more and 1200 mm or less.

The outer diameter of the resin tube 10 is preferably 0.3 mm or more, more preferably 0.5 mm or more, and even more preferably 0.6 mm or more. By setting the lower limit of the outer diameter of the resin tube 10 within the above range, the rigidity of the resin tube 10 can be increased, resulting in a puncture device 1 with good insertability into blood vessels. In addition, the outer diameter of the resin tube 10 is preferably 2 mm or less, more preferably 1.8 mm or less, and even more preferably 1.5 mm or less. By setting the upper limit of the outer diameter of the resin tube 10 within the above range, the outer diameter of the puncture device 1 can be reduced. This improves the minimal invasiveness of the puncture device 1.

The thickness of the resin tube 10 is preferably 30 μm or more, more preferably 50 μm or more, and even more preferably 100 μm or more. By setting the lower limit of the thickness of the resin tube 10 within the above range, the resin tube 10 can insulate the metal tip 40 when electricity is applied. This makes it possible to prevent cauterization of unintended locations inside the body. In addition, the thickness of the resin tube 10 is preferably 350 μm or less, more preferably 300 μm or less, and even more preferably 250 μm or less. By setting the upper limit of the thickness of the resin tube 10 within the above range, the outer diameter of the resin tube 10 is prevented from becoming too large, making the puncture device 1 less invasive.

As shown in Figures 2 to 5, the metal tube 20 is disposed in the lumen of the resin tube 10. In other words, the resin tube 10 is disposed outside the metal tube 20. The metal tube 20 may have multiple lumens, but preferably has one. By having one lumen in the metal tube 20, the cross-sectional area of the lumen in the direction perpendicular to the longitudinal direction can be increased, making it possible to increase the flow rate of liquid sent to the flow path 50.

Examples of the material constituting the metal tube 20 include metals such as stainless steel, carbon steel, and nickel-titanium alloy. The material constituting the metal tube 20 is preferably stainless steel. By using stainless steel as the material constituting the metal tube 20, the rigidity of the metal tube 20 is increased, thereby improving the pushability of the puncture device 1 and making it easier to puncture the fossa ovalis.

The longitudinal length of the metal tube 20 can be selected to be appropriate for treatment, and can be, for example, 500 mm or more and 1200 mm or less.

The outer diameter of the metal tube 20 is preferably 0.5 mm or more, more preferably 0.7 mm or more, and even more preferably 1 mm or more. By setting the lower limit of the outer diameter of the metal tube 20 within the above range, the rigidity of the metal tube 20 is increased, improving the pushability of the puncture device 1 and making it easier to perforate the fossa ovalis. The outer diameter of the metal tube 20 is preferably 2 mm or less, more preferably 1.8 mm or less, and even more preferably 1.5 mm or less. By setting the upper limit of the outer diameter of the metal tube 20 within the above range, it is easy to ensure a sufficient cross-sectional area of the lumen in a cross section perpendicular to the longitudinal direction of the metal tube 20, and the amount of liquid sent to the flow path 50 can be made sufficient.

The thickness of the metal tube 20 is preferably 100 μm or more, more preferably 150 μm or more, and even more preferably 200 μm or more. By setting the lower limit of the thickness of the metal tube 20 within the above range, the rigidity of the metal tube 20 is increased. This improves the pushability of the puncture device 1 and makes it easier to puncture the fossa ovalis. The thickness of the metal tube 20 is preferably 350 μm or less, more preferably 300 μm or less, and even more preferably 250 μm or less. By setting the upper limit of the thickness of the metal tube 20 within the above range, the outer diameter of the metal tube 20 is prevented from becoming excessively large, and as a result, it is possible to reduce the diameter of the puncture device 1.

As shown in FIG. 3, the metal member 30 has an inner cavity that opens at least on the proximal side, and is joined to the distal end of the metal tube 20. Methods for joining the metal member 30 to the distal end of the metal tube 20 include, for example, welding, brazing with solder or the like, bonding, crimping, etc., pressing the metal member 30 into the metal tube 20, fitting the metal tube 20 and the metal member 30, and connecting the metal tube 20 and the metal member 30 via a separate part. The method for joining the metal member 30 to the distal end of the metal tube 20 is preferably fixing by welding, brazing, bonding, etc., and more preferably welding. By fixing the distal end of the metal tube 20 and the metal member 30, the bonding strength between the metal tube 20 and the metal member 30 is increased. Therefore, even if the puncture device 1 is curved, the metal member 30 is less likely to come off the metal tube 20.

Examples of materials constituting the metal member 30 include metals such as stainless steel, carbon steel, and nickel-titanium alloy. The material constituting the metal member 30 is preferably stainless steel. By using stainless steel as the material constituting the metal member 30, it is possible to increase the rigidity of the metal member 30. Therefore, the rigidity of the distal end portion of the puncture device 1 is also increased, making it easier to puncture the fossa ovalis.

The diameter of the circumscribing circle of the cross-sectional shape perpendicular to the longitudinal direction of the metal member 30 at the proximal end of the metal member 30 is preferably smaller than the inner diameter of the metal tube 20 at the distal end of the metal tube 20. By making the diameter of the circumscribing circle of the cross-sectional shape at the proximal end of the metal member 30 smaller than the inner diameter of the distal end of the metal tube 20, the proximal end of the metal member 30 can be inserted into the distal end of the metal tube 20, and the bonding strength between the metal tube 20 and the metal member 30 can be increased.

2 and 3, the metal tip 40 is disposed at the distal end of the metal member 30. The metal tip 40 may be directly bonded to the distal end of the metal member 30 by a separate member constituting the metal tip 40, or may be indirectly bonded to the distal end of the metal member 30 via an intermediate member or the like that is a separate part different from the metal member 30 and the metal tip 40. The metal tip 40 is disposed at the distal end of the metal member 30, and the metal tip 40 and the metal member 30 may be integral with each other, and may or may not have a joint. In order to dispose the metal tip 40 at the distal end of the metal member 30, the metal tip 40 can be bonded to the metal member 30.

Specific methods for joining the metal tip 40 to the distal end of the metal member 30 include, for example, welding, soldering, bonding, caulking, etc., pressing the metal member 30 into the metal tip 40, fitting the metal member 30 and the metal tip 40, and connecting the metal member 30 and the metal tip 40 via a separate part. The method for joining the metal tip 40 to the distal end of the metal member 30 is preferably fixing by welding, brazing, bonding, etc., and more preferably welding. By fixing the distal end of the metal member 30 and the metal tip 40, it is possible to firmly bond the metal tip 40 to the metal member 30. Therefore, when the metal tip 40 is pressed against the fossa ovalis when piercing the fossa ovalis, the metal tip 40 is less likely to fall off the metal member 30, and a highly durable puncture device 1 can be obtained.

Examples of materials constituting the metal tip 40 include metals such as stainless steel, carbon steel, and nickel-titanium alloy. The material constituting the metal tip 40 is preferably the same as the material constituting the metal member 30. By using the same material constituting the metal tip 40 as the material constituting the metal member 30, it becomes easier to join the metal member 30 and the metal tip 40, and the joining strength between the metal member 30 and the metal tip 40 can be increased.

As shown in Figures 2 and 3, the distal end of the metal tip 40 preferably has a curved surface shape. By making the distal end of the metal tip 40 curved, it is possible to make it less likely for the metal tip 40 to damage an internal lumen such as a blood vessel when it comes into contact with the internal lumen. As a result, it is less likely for the metal tip 40 to cause damage or perforation in unintended locations.

As described above, the metal tube 20 and metal member 30 of the shaft 2, and the metal member 30 and metal tip 40 are joined together, so that the three components of the metal tube 20, metal member 30, and metal tip 40 are electrically connected and can pass electricity.

As shown in FIG. 4, the resin tube 10 has a flow path 50 between the inner surface of the resin tube 10 and the outer surface of the metal member 30, which is in communication with the inner cavity of the metal tube 20. The number of flow paths 50 may be one or more.

2 and 3, the metal member 30 has a large diameter portion 33 and a small diameter portion 34 that is located distal to the large diameter portion 33 and has a smaller outer diameter than the large diameter portion 33. The metal member 30 has a hole 32 that connects the space between the inner surface of the resin tube 10 and the outer surface of the metal member 30 to the inner cavity of the metal tube 20, and the distal end 10d of the resin tube 10 is distal to the hole 32. The hole 32 may be provided in the small diameter portion 34. There may be one hole 32, or multiple holes 32 may be provided. When there are multiple holes 32, multiple holes 32 can be provided in the longitudinal direction and circumferential direction of the metal member 30. In order to release liquid from the entire circumference of the resin tube 10 at the opening 11 at the distal end of the resin tube 10, multiple holes 32 can be provided in the circumferential direction of the metal member 30.

By providing the metal member 30 with the large diameter portion 33, the rigidity of the proximal side of the metal member 30 where the large diameter portion 33 exists is increased, and the pushability of the puncture device 1 and the ease of perforating the fossa ovalis can be improved. By providing the metal member 30 with the small diameter portion 34, the space between the outer surface of the distal side of the metal member 30 where the small diameter portion 34 exists and the inner surface of the resin tube 10 is increased, and the flow path 50 can be widened. Therefore, the flow rate of the liquid discharged from the puncture device 1 can be increased, and visibility in intracardiac echo and X-ray irradiation can be improved.

As shown in FIG. 3, the inner cavity of the metal member 30 has an opening at least on the proximal side. The proximal end of the inner cavity of the metal member 30 is connected to the inner cavity of the metal tube 20. The distal end of the inner cavity of the metal member 30 may coincide with the distal end of the metal member 30, or may be inside the distal end of the metal member 30, i.e., proximal to the distal end of the metal member 30. Considering the flow of liquid within the puncture device 1, it is preferable that the distal end of the inner cavity of the metal member 30 coincides with the proximal end of the small diameter portion 34 of the metal member 30, as shown in FIG. 3.

In the puncture device 1, the liquid in the flow path 50 passes through the inner cavity of the metal tube 20, the inner cavity of the metal member 30, the hole 32, and the space between the inner surface of the resin tube 10 and the outer surface of the metal member 30, and is discharged to the outside of the resin tube 10. Because the inner diameter of the hole 32 is smaller than the inner diameter of the metal member 30, the flow rate of the liquid increases as the liquid passes through the hole 32, and as a result, the liquid can be forcefully discharged over a wide area to the outside of the resin tube 10, improving visibility in intracardiac echo and X-ray irradiation.

The outer diameter of the large diameter portion 33 may be more than 1 times the outer diameter of the small diameter portion 34, but is preferably 1.1 times or more, more preferably 1.3 times or more, and even more preferably 1.5 times or more. By setting the lower limit of the ratio of the outer diameter of the large diameter portion 33 to the outer diameter of the small diameter portion 34 within the above range, the rigidity of the proximal side of the metal member 30, which is the portion where the large diameter portion 33 exists, is sufficiently increased, and the space between the outer surface of the distal side of the metal member 30, which is the portion where the small diameter portion 34 exists, and the inner surface of the resin tube 10 can be sufficiently secured. In addition, the outer diameter of the large diameter portion 33 is preferably 2 times or less, more preferably 1.8 times or less, and even more preferably 1.6 times or less, the outer diameter of the small diameter portion 34. By setting the upper limit of the ratio of the outer diameter of the large diameter portion 33 to the outer diameter of the small diameter portion 34 within the above range, the outer diameter of the distal end of the puncture device 1 can be prevented from becoming excessively large, and the low invasiveness can be improved.

The resin tube 10 may be a single tube from the distal end to the proximal end, or may be composed of multiple tubes. When composed of multiple tubes in the longitudinal direction, each tube must be joined to form a single tube. In that case, the boundary of the joint portion does not need to be clear. Although not shown, when the resin tube 10 is composed of multiple tubes, the resin tube 10 may have a distal resin tube and a proximal resin tube, a metal member 30 may be arranged in the inner cavity of the distal resin tube, and a metal tube 20 may be arranged in the inner cavity of the proximal resin tube. In addition, another tube may be arranged to cover the joint portion between the metal tube 20 and the metal member 30. Since the resin tube 10 has a distal resin tube and a proximal resin tube, it is possible to make the distal resin tube a size and material suitable for the metal member 30, and the proximal resin tube a size and material suitable for the metal tube 20. As a result, the process of arranging the metal tube 20 and the metal member 30 in the inner cavity of the resin tube 10 is easy to perform.

When the resin tube 10 has a distal resin tube and a proximal resin tube, it is preferable that the proximal end of the distal resin tube is closer to the proximal side than the distal end of the proximal resin tube, although this is not shown. By having the proximal end of the distal resin tube closer to the proximal side than the distal end of the proximal resin tube, the proximal end of the distal resin tube and the distal end of the proximal resin tube overlap. Therefore, when the puncture device 1 is inserted into the body lumen, it is possible to make it difficult for liquids such as blood to enter the lumen of the resin tube 10 through the gap between the distal resin tube and the proximal resin tube.

The length of the overlapping portion of the proximal end of the distal resin tube and the distal end of the proximal resin tube can be selected taking into consideration the effect on the outer diameter of the resin tube 10 and the strength of the joint. Methods for joining the proximal end of the distal resin tube and the distal end of the proximal resin tube include, for example, heating, gluing, drawing, etc. the proximal end of the distal resin tube and the distal end of the proximal resin tube.

In addition, it is preferable that the proximal end of the distal resin tube is disposed in the lumen of the proximal resin tube. By disposing the proximal end of the distal resin tube in the lumen of the proximal resin tube, the distal end of the proximal resin tube can be brought into close contact with the outer surface of the distal resin tube, and when liquid is fed into the lumen of the metal tube 20 and passes through the flow path 50, it is possible to prevent the liquid in the flow path 50 from leaking out between the distal resin tube and the proximal resin tube.

The proximal end of the distal resin tube is preferably joined to the distal end of the proximal resin tube without any gaps. By joining the proximal end of the distal resin tube to the proximal resin tube without any gaps, when electricity is passed through the metal tip 40 via the metal tube 20, the current passing through the metal tube 20, the metal member 30, the metal tip 40, etc. is less likely to leak out from the gap between the distal resin tube and the proximal resin tube.

2 and 3, the outer diameter of the resin tube 10 at the portion where the distal end of the metal tube 20 is located is preferably larger than the outer diameter of the resin tube 10 at the portion where the distal end of the metal member 30 is located. Since the outer diameter of the resin tube 10 at the portion where the distal end of the metal tube 20 is located is larger than the outer diameter of the resin tube 10 at the portion where the distal end of the metal member 30 is located, a small diameter portion 34 can be formed on the distal side and a large diameter portion 33 can be formed on the proximal side of the small diameter portion 34 at the distal end of the puncture device 1. Therefore, for example, when a dilator is used to insert the puncture device 1 into a lumen in the body, the length of the puncture device 1 exposed from the dilator can be easily controlled by configuring the small diameter portion 34 to be exposed only from the dilator.

2 and 3, the transition section 35 is located distal to the large diameter section 33 and proximal to the small diameter section 34, and the hole 32 is preferably located in the transition section 35. By locating the hole 32 in the transition section 35, the liquid in the lumen of the large diameter section 33 of the metal member 30 can be efficiently sent through the hole 32 to the space between the inner surface of the resin tube 10 and the outer surface of the part of the metal member 30 where the small diameter section 34 is located. If the space between the outer surface of the small diameter section 34 and the inner surface of the resin tube 10 is made wider than the space between the outer surface of the large diameter section 33 and the inner surface of the resin tube 10, the flow of liquid in the flow path 50 becomes smoother, and it becomes easier to release a large amount of liquid from the puncture device 1.

The inner diameter of the transition section 35 may change entirely or partially from the proximal end of the transition section 35 to the distal end of the transition section 35 in a tapered, stepped, uneven, or wavy shape. In particular, it is preferable that the transition section 35 tapers in diameter from the proximal end to the distal end of the transition section 35. By the transition section 35 tapers in diameter from the proximal end to the distal end, resistance is less likely to occur when the liquid that has passed through the hole 32 comes into contact with the outer surface of the transition section 35. Therefore, the pressure loss of the liquid can be reduced when the liquid passes through the space between the inner surface of the resin tube 10 and the outer surface of the metal member 30, and the flow rate and flow rate of the liquid discharged from the resin tube 10 can be increased.

As shown in FIG. 3, it is preferable that the large diameter portion 33 and the transition portion 35 have a lumen, and the small diameter portion 34 does not have a lumen. In other words, it is preferable that the lumen of the metal member 30 is closer to the proximal side than the small diameter portion 34. Since the large diameter portion 33 and the transition portion 35 have a lumen, it is possible to increase the flow rate of the liquid from the lumen of the metal tube 20 to the hole 32 while securing a certain amount of liquid flow rate. In addition, since the small diameter portion 34 does not have a lumen, it is possible to increase the rigidity of the distal end portion of the resin tube 10, which is the portion where the small diameter portion 34 is located, while securing the width of the space between the outer surface of the small diameter portion 34 and the inner surface of the resin tube 10. As a result, it is possible to provide a puncture device 1 that has good pushability, is easy to puncture the fossa ovalis, and can release a large amount of liquid such as saline or contrast agent over a wide area, and has good visibility in intracardiac echo and X-ray irradiation.

As shown in FIG. 4, the cross-sectional shape perpendicular to the longitudinal direction of the metal member 30 is preferably polygonal. By having a polygonal cross-sectional shape perpendicular to the longitudinal direction of the metal member 30, the cross-sectional area of the flow path 50 can be increased while maintaining the strength of the metal member 30 and maintaining the rigidity of the distal end of the puncture device 1 where the metal member 30 is present.

In addition, the polygon in the present invention includes polygons with clear corner vertices and straight sides, as well as polygons with rounded corners, so-called rounded polygons, and polygons with at least some curved sides. When the cross section perpendicular to the longitudinal direction of the metal member 30 is polygonal, the vertices of the polygon may or may not be in contact with the inner surface of the resin tube 10. In either case, it is preferable to select the material and hardness of the resin tube 10 so that the inner surface of the resin tube 10 does not form a portion in close contact with the entire circumference of the outer surface of the metal member 30 in the cross section perpendicular to the longitudinal direction. When the cross section perpendicular to the longitudinal direction of the metal member 30 is polygonal, the resin tube 10 has an appropriate hardness, so that a flow path 50 can be formed between the resin tube 10 and the metal member 30.

The shape of the cross section perpendicular to the longitudinal direction of the metal member 30 may be, for example, a circle, an ellipse, a polygon, a cross, an H-shape, a U-shape, a mountain shape, or a combination of these. It is more preferable that the shape of the cross section perpendicular to the longitudinal direction of the metal member 30 is a rectangle. By having the shape of the cross section perpendicular to the longitudinal direction of the metal member 30 be a rectangle, it is possible to achieve both the strength of the metal member 30 and the size of the flow path 50.

It is preferable that the large diameter portion 33 of the metal member 30 is circular in cross section perpendicular to the longitudinal direction, and the small diameter portion 34 is polygonal. Since the large diameter portion 33 of the metal member 30 is circular in cross section perpendicular to the longitudinal direction, and the small diameter portion 34 of the metal member 30 is polygonal in cross section, the large diameter portion 33 of the metal member 30 is shaped along the inner diameter of the metal tube 20, increasing the joining strength between the metal member 30 and the metal tube 20, and the small diameter portion 34 of the metal member 30 increases the rigidity of the resin tube 10 while ensuring the cross-sectional area of the flow path 50, resulting in a puncture device 1 that is easy to push and to puncture the fossa ovalis. The small diameter portion 34 may have a shape in which a notch is provided to form the flow path 50 in the above-mentioned cross-sectional shape. In the case where the inner surface of the resin tube 10 and a part of the outer surface of the small diameter portion 34 of the metal member 30 are in contact with each other in a planar manner, the cross section of the small diameter portion 34 can be shaped to have a notch for forming the flow path 50, so that the flow path 50 can be easily formed. In the case where the inner surface of the resin tube 10 and the outer surface of the small diameter portion 34 are in contact with each other in a point-like manner in the cross section, the cross section of the small diameter portion 34 perpendicular to the longitudinal direction of the metal member 30 has a shape with a vertex such as a polygon or a star. In the case where the inner surface of the resin tube 10 and the outer surface of the small diameter portion 34 are not in contact with each other, the cross section of the small diameter portion 34 perpendicular to the longitudinal direction of the metal member 30 can have any shape.

Although not shown, it is preferable that the metal member 30 has a recess extending in the longitudinal direction of the metal member 30. By having the metal member 30 have a recess extending in the longitudinal direction, the cross-sectional area of the flow path 50 formed between the inner surface of the resin tube 10 and the outer surface of the metal member 30 can be increased. This makes it possible to ensure that the amount of liquid released from the resin tube 10 is sufficient.

In a cross section perpendicular to the longitudinal direction, the maximum distance between the recess and the inner surface of the resin tube 10 is preferably 20% or more, more preferably 25% or more, and even more preferably 30% or more of the maximum length of the metal member 30 connecting two points on the outer periphery of the metal member 30 (hereinafter, simply referred to as the "maximum length of the metal member 30"). By setting the lower limit of the ratio of the maximum distance between the recess and the inner surface of the resin tube 10 and the maximum length of the metal member 30 to the above range, the cross-sectional area of the flow path 50 in the cross section perpendicular to the longitudinal direction can be secured, and the amount of liquid passing through the flow path 50 can be made sufficient. In addition, in a cross section perpendicular to the longitudinal direction, the maximum distance between the recess and the inner surface of the resin tube 10 is preferably 70% or less, more preferably 60% or less, and even more preferably 50% or less of the maximum length of the metal member 30. By setting the upper limit of the ratio between the maximum distance between the recess and the inner surface of the resin tube 10 and the maximum length of the metal member 30 within the above range, the strength of the metal member 30 can be maintained, and the rigidity of the distal end of the puncture device 1 where the metal member 30 is located can be ensured.

It is preferable that the metal member 30 has multiple recesses. By having multiple recesses in the metal member 30, the cross-sectional area of the flow path 50 in a cross section perpendicular to the longitudinal direction can be increased, and when the liquid is discharged to the outside from the opening 11, it is easier to discharge the liquid over a wide radial range of the resin tube 10.

Although not shown, it is preferable that the metal member 30 has a portion where a part of the outer surface of the metal member 30 is in contact with the inner surface of the resin tube 10. By having the metal member 30 have a portion where a part of the outer surface of the metal member 30 is in contact with the inner surface of the resin tube 10, the metal member 30 can increase the rigidity of the distal end of the puncture device 1 where the metal member 30 is present, resulting in a puncture device 1 with good insertability.

It is preferable that a portion of the outer surface of the metal member 30 contacts the inner surface of the resin tube 10 along the longitudinal direction in the section where the flow path 50 exists. The portion where the outer surface of the metal member 30 and the inner surface of the resin tube 10 do not contact becomes the flow path 50, and the contact portion becomes the portion that maintains the strength of the distal end of the puncture device 1.

When a portion of the outer surface of the metal member 30 is in contact with the inner surface of the resin tube 10, as shown in FIG. 4, in a cross section perpendicular to the longitudinal direction of the metal member 30, the metal member 30 is preferably in planar contact with the inner surface of the resin tube 10 at multiple locations. By having the metal member 30 in planar contact with the inner surface of the resin tube 10 at multiple locations, multiple flow paths 50 can be secured. The presence of multiple flow paths 50 makes it easier to release liquid over a wide radial range of the resin tube 10 when the liquid is released to the outside from the opening 11 at the distal end 10d of the resin tube 10.

As shown in FIG. 3, it is also preferable that the metal member 30 does not have a portion in contact with the inner surface of the resin tube 10 distal to the distal end 20d of the metal tube 20. Since the metal member 30 does not have a portion in contact with the inner surface of the resin tube 10 distal to the distal end 20d of the metal tube 20, the flow path 50 can be secured, and the size of the flow path 50 can be widened to increase the flow rate of the liquid passing through the flow path 50.

As shown in Figures 3 and 5, it is preferable that the large diameter portion 33 of the metal member 30 has a portion where the outer surface of the large diameter portion 33 is in contact with the inner surface of the metal tube 20. Since the large diameter portion 33 has a portion where the outer surface of the large diameter portion 33 is in contact with the inner surface of the metal tube 20, the liquid in the lumen of the metal tube 20 can easily flow into the lumen of the metal member 30. As a result, the liquid in the lumen of the metal member 30 passes through the hole 32, which increases the flow rate of the liquid released from the resin tube 10 and allows a large amount of liquid to be released over a wide area of the left atrium, improving visibility in intracardiac echo and X-ray irradiation.

3 and 5, the metal member 30 is preferably in planar contact with the inner surface of the metal tube 20. By the metal member 30 being in planar contact with the inner surface of the metal tube 20, the area of contact between the metal tube 20 and the metal member 30 can be increased. This makes it possible to increase the bonding strength between the metal tube 20 and the metal member 30, and makes it difficult for the metal member 30 to come off the metal tube 20 even when the puncture device 1 is inserted into a curved body lumen. In a cross section perpendicular to the longitudinal direction of the metal member 30, the length of the metal member 30 in planar contact with the inner surface of the metal tube 20 can be selected taking into consideration the bonding strength between the metal tube 20 and the metal member 30 and the flow rate of the flow path 50.

As shown in FIG. 5, it is more preferable that the large diameter portion 33 of the metal member 30 has a portion where the entire circumference of the outer surface of the large diameter portion 33 is in contact with the inner surface of the metal tube 20. By having the large diameter portion 33 have a portion where the entire circumference of the outer surface of the large diameter portion 33 is in contact with the inner surface of the metal tube 20, all of the liquid flowing through the lumen of the metal tube 20 can easily enter the lumen of the metal member 30, and the flow rate of the liquid released from the resin tube 10 can be further increased, making it possible to further improve visibility in intracardiac echo and X-ray irradiation.

As shown in FIG. 4, in a cross section perpendicular to the longitudinal direction of the metal member 30, the cross-sectional area of the metal member 30 is preferably larger than the cross-sectional area of the flow path 50. By making the cross-sectional area of the metal member 30 larger than the cross-sectional area of the flow path 50, the rigidity of the portion where the metal member 30 is present at the distal end of the puncture device 1 can be increased. This improves the insertability of the puncture device 1.

In a cross section perpendicular to the longitudinal direction of the metal member 30, the cross-sectional area of the metal member 30 is preferably 1.1 times or more, more preferably 1.3 times or more, and even more preferably 1.5 times or more, the cross-sectional area of the flow channel 50. By setting the lower limit of the ratio of the cross-sectional area of the metal member 30 to the cross-sectional area of the flow channel 50 within the above range, the rigidity of the distal end of the puncture device 1 in which the metal member 30 is disposed can be sufficiently increased. In addition, the cross-sectional area of the metal member 30 is preferably 5 times or less, more preferably 4 times or less, and even more preferably 3 times or less, the cross-sectional area of the flow channel 50. By setting the upper limit of the ratio of the cross-sectional area of the metal member 30 to the cross-sectional area of the flow channel 50 within the above range, the outer diameter of the distal end of the puncture device 1 can be prevented from becoming too large while ensuring the cross-sectional area of the flow channel 50.

As shown in FIG. 2 and FIG. 3, the distal end 10d of the resin tube 10 is preferably located closer to the proximal end 40p of the metal tip 40. Since the distal end 10d of the resin tube 10 is located closer to the proximal end 40p of the metal tip 40, the distal end 10d of the resin tube 10 is separated from the proximal end 40p of the metal tip 40, and liquids such as saline and contrast agent in the flow path 50 are discharged from the distal end 10d of the resin tube 10 to the outside of the resin tube 10. In other words, an opening 11 is present at the distal end 10d of the resin tube 10, and the liquid in the flow path 50 is discharged from the opening 11 to the outside of the resin tube 10. Therefore, the liquid in the flow path 50 discharged from the distal end 10d of the resin tube 10 can be diffused in the radial direction of the resin tube 10 and can be discharged over a wide area in the left atrium, thereby improving visibility in intracardiac echo and X-ray irradiation. The liquid flows through the flow path 50 in the longitudinal direction of the resin tube 10, and is discharged from the distal end 10d of the resin tube 10 and flows toward the opposing surface 41, which is the surface of the proximal end of the metal tip 40. The flow direction of the liquid is changed by the opposing surface 41 to the radial direction of the resin tube 10.

Figure 6 is a plan view of the distal end of a puncture device 1 in another embodiment of the present invention, and Figure 7 is a cross-sectional view along the longitudinal direction of this puncture device 1. Also, Figure 8 is a plan view of the distal end of a puncture device 1 in a different embodiment of the present invention, and Figure 9 is a cross-sectional view along the longitudinal direction of this puncture device 1. Note that in Figures 6 to 9, the right side of the figure is the proximal side and the left side of the figure is the distal side.

The proximal end 30p of the metal member 30 may be located proximal to the distal end 20d of the metal tube 20 as shown in Figs. 3 and 9, or may be located distal to the distal end 20d of the metal tube 20 as shown in Fig. 7. By having the proximal end 30p of the metal member 30 located distal to the distal end 20d of the metal tube 20, the rigidity of the distal end of the puncture device 1 can be increased while ensuring a wide flow path 50 in the portion where the metal member 30 is not present. As a result, it is possible to provide a puncture device 1 that has good pushability, is easy to puncture the fossa ovalis, and releases a large amount of liquid such as saline or contrast agent, and has good visibility in intracardiac echo and X-ray irradiation.

As shown in Figures 2, 3 and 6 to 9, the distal end of the metal tip 40 is preferably located distal to the distal end 10d of the resin tube 10. By having the distal end of the metal tip 40 located distal to the distal end 10d of the resin tube 10, the distal end of the metal tip 40 is exposed from the resin tube 10. In other words, the exposed portion of the metal tip 40 functions as an electrode that cauterizes the tissue.

As shown in Figures 2, 3 and 6 to 9, the proximal end of the metal tip 40 is preferably located distal to the distal end 10d of the resin tube 10. By having the proximal end of the metal tip 40 located distal to the distal end 10d of the resin tube 10, the cross-sectional area perpendicular to the longitudinal direction of the opening 11 at the distal end 10d of the resin tube 10 can be increased, making it possible to release a large amount of liquid in the flow channel 50 from the opening 11.

As shown in Figures 2, 3, 6 and 7, the metal tip 40 preferably has an opposing surface 41 at the proximal end of the metal tip 40 that faces the opening 11 at the distal end 10d of the resin tube 10. By having the opposing surface 41 on the metal tip 40, the liquid in the flow path 50 discharged from the opening 11 of the resin tube 10 comes into contact with the opposing surface 41, and the liquid discharged from the opening 11 tends to diffuse in the radial direction of the resin tube 10. As a result, it is possible to discharge the liquid over a wide area in the left atrium, improving visibility by intracardiac echo and X-ray irradiation.

As shown in Figures 6 and 7, the metal tip 40 has an opposing surface 41 at the proximal end of the metal tip 40 that faces the opening 11 of the distal end 10d of the resin tube 10, and the metal tip 40 preferably has a reduced diameter recess 42 on the opposing surface 41 that reduces in diameter from the proximal side to the distal side. By having the reduced diameter recess 42 on the opposing surface 41 of the metal tip 40, the liquid in the flow path 50 discharged from the opening 11 of the resin tube 10 comes into contact with the reduced diameter recess 42 and bounces off, allowing the liquid to be diffused not only in the radial direction of the resin tube 10 but also to the proximal side, making it possible to improve visibility in intracardiac echo and X-ray irradiation.

The diameter of the reduced diameter recess 42 may change entirely or partially from the proximal end of the reduced diameter recess 42 to the distal end of the reduced diameter recess 42 in a tapered, stepped, uneven, or wavy shape. In particular, it is preferable that the reduced diameter recess 42 is tapered entirely from the proximal end to the distal end of the reduced diameter recess 42. By tapering the diameter of the reduced diameter recess 42 entirely from the proximal end to the distal end, the liquid in the flow path 50 that is released from the opening 11 of the resin tube 10 and comes into contact with the reduced diameter recess 42 tends to move toward the proximal side. Therefore, the liquid can be released over a wide area in the left atrium, making it easier to improve visibility by intracardiac echo or X-ray irradiation.

As shown in Figures 8 and 9, it is also preferable that the metal tip 40 has an expanded diameter section 43 at the proximal end of the metal tip 40, which expands in diameter from the proximal side to the distal side. By having the expanded diameter section 43 in the metal tip 40, the liquid in the flow path 50 comes into contact with the expanded diameter section 43 after being released from the opening 11 of the resin tube 10, and moves along the outer surface of the expanded diameter section 43. Therefore, the liquid in the flow path 50 can be diffused not only in the radial direction of the resin tube 10 but also to the distal side, resulting in a puncture device 1 with high visibility by intracardiac echo or X-ray irradiation.

The outer diameter of the expanded portion 43 may change entirely or partially from the proximal end of the expanded portion 43 to the distal end of the expanded portion 43 in a tapered, stepped, uneven, or wavy shape. In particular, it is preferable that the expanded portion 43 is expanded in a tapered shape from the proximal end to the distal end of the expanded portion 43. Since the expanded portion 43 is expanded in a tapered shape from the proximal end to the distal end, when the liquid in the flow path 50 discharged from the opening 11 of the resin tube 10 comes into contact with the expanded portion 43, the liquid is more likely to flow to the distal side. As a result, it is possible to diffuse the liquid over a wide area in the left atrium, improving visibility in intracardiac echo and X-ray irradiation.

Although not shown, the metal tip 40 has an internal cavity, and it is preferable that an X-ray opaque marker is disposed inside the metal tip 40. By disposing an X-ray opaque marker in the internal cavity of the metal tip 40, the X-ray contrast of the metal tip 40 can be improved. Therefore, by using X-rays when using the puncture device 1, it becomes easy to confirm the position of the metal tip 40 inside the body.

The material constituting the radiopaque marker may be, for example, a radiopaque substance such as lead, barium, iodine, tungsten, gold, platinum, iridium, platinum-iridium alloy, stainless steel, titanium, palladium, or cobalt-chromium alloy. Of these, the radiopaque substance is preferably a platinum-iridium alloy. By using a platinum-iridium alloy as the material constituting the radiopaque marker, the contrast of X-rays can be improved, making it easier to confirm the position of the metal tip 40 by X-ray irradiation.

The shape of the radiopaque marker may be a sphere, a cylinder, a polygonal tube, a C-shaped cross section with a notch in the tube, a coil shape made of wound wire, a columnar shape, a polygonal columnar shape, etc. The radiopaque marker may be disposed in a location other than the inner cavity of the metal tip 40. In addition, the number of radiopaque markers may be one or more.

As shown in Figures 6 to 9, the resin tube 10 preferably has a reinforcing material 13 distal to the distal end 20d of the metal tube 20. By having the resin tube 10 have the reinforcing material 13 distal to the distal end 20d of the metal tube 20, the distal end of the resin tube 10 is reinforced by the reinforcing material 13, increasing its rigidity. This allows for a puncture device 1 that has good pushability and is easy to puncture the fossa ovalis.

The reinforcing material 13 may be, for example, a layered tubular member or the like, or may be a single wire or stranded wire arranged or braided in a specific pattern. The reinforcing material 13 may be disposed on the outer surface of the peripheral wall of the resin tube 10, on the inner surface of the peripheral wall, or within the peripheral wall.

Examples of materials constituting the reinforcing material 13 include metals such as stainless steel, titanium, nickel-titanium alloys, cobalt-chromium alloys, and tungsten alloys, and synthetic resins such as polyarylate resins, aramid resins, and polyolefin resins such as ultra-high molecular weight polyethylene. The reinforcing material 13 may be made of one type of material, or may contain multiple types of materials.

The reinforcing material 13 is a metallic tubular member, and as shown in Figs. 7 and 9, it is preferable that the reinforcing material 13 is disposed on the inner surface of the resin tube 10. By disposing the reinforcing material 13 on the inner surface of the resin tube 10 as a metallic tubular member, the rigidity of the entire distal end of the resin tube 10 can be increased while the surface of the distal end of the resin tube 10 can be made smooth, thereby improving the sliding properties of the resin tube 10. When the reinforcing material 13 of the tubular member is disposed on the inner surface of the resin tube 10, the flow path 50 is between the inner surface of the reinforcing material 13 of the resin tube 10 and the outer surface of the metal member 30.

As described above, the puncture device of the present invention comprises a resin tube having a distal end and a proximal end and extending in the longitudinal direction, a metal tube disposed in the inner cavity of the resin tube, a metal member having an inner cavity that opens at least on the proximal side and disposed at the distal end of the metal tube, and a metal tip disposed at the distal end of the metal member, the resin tube being between the inner surface of the resin tube and the outer surface of the metal member and having a flow path communicating with the inner cavity of the metal tube, the metal member being provided with a large diameter portion and a small diameter portion disposed distal to the large diameter portion and having a smaller outer diameter than the large diameter portion, the metal member being provided with a hole that communicates the space between the inner surface of the resin tube and the outer surface of the metal member with the inner cavity of the metal tube, and the distal end of the resin tube being distal to the hole. The puncture device of the present invention has such a configuration, and while maintaining the rigidity of the distal end of the puncture device to facilitate insertion of the puncture device into a biological lumen such as a blood vessel and ease of puncturing the fossa ovalis, the flow path can be widened, and the amount of liquid such as saline or contrast agent flowing through the flow path and released from the puncture device can be increased. This makes it possible to inject the liquid over a wide area within the left atrium, improving visibility in intracardiac echo and X-ray irradiation.

1: Puncture device 2: Shaft 3: Handle 4: Syringe port 5: Cable 6: Connector 10: Resin tube 10d: Distal end of resin tube 11: Opening 12: Bend 13: Reinforcement 20: Metal tube 20d: Distal end of metal tube 30: Metal member 30p: Proximal end of metal member 32: Hole 33: Large diameter section 34: Small diameter section 35: Transition section 40: Metal tip 40p: Proximal end of metal tip 41: Opposing surface 42: Diameter-reducing recess 43: Diameter-expanding section 50: Flow path

Claims (13)

a resin tube having a distal end and a proximal end and extending in a longitudinal direction;
a metal tube disposed in an inner cavity of the resin tube;
a metal member having an inner lumen opening at least to a proximal side and disposed at a distal end of the metal tube;
a metal tip disposed at a distal end of the metal member;
the resin tube has a flow path between an inner surface of the resin tube and an outer surface of the metal member, the flow path being in communication with an inner cavity of the metal tube;
The metal member includes a large diameter portion and a small diameter portion disposed distally of the large diameter portion and having an outer diameter smaller than that of the large diameter portion,
the metal member has a hole that communicates a space between an inner surface of the resin tube and an outer surface of the metal member with an inner cavity of the metal tube;
A puncture device, wherein the distal end of the plastic tube is distal to the hole. a transition section having a diameter that decreases toward the distal side, the transition section being distal to the large diameter section and proximal to the small diameter section;
The puncture device of claim 1 , wherein the hole is located in the transition portion. The puncture device according to claim 1 or 2, wherein the cross-sectional shape perpendicular to the longitudinal direction of the metal member is polygonal. The puncture device according to any one of claims 1 to 3, wherein the metal member has a recess extending in the longitudinal direction of the metal member. The puncture device according to any one of claims 1 to 4, wherein the metal member has a portion of its outer surface in contact with the inner surface of the resin tube. The puncture device according to any one of claims 1 to 5, wherein the large diameter portion of the metal member has a portion where the outer surface of the large diameter portion is in contact with the inner surface of the metal tube. The puncture device according to any one of claims 1 to 6, wherein the cross-sectional area of the metal member in a cross section perpendicular to the longitudinal direction of the metal member is larger than the cross-sectional area of the flow path. The puncture device according to any one of claims 1 to 7, wherein the distal end of the resin tube is closer to the proximal side than the proximal end of the metal tip. The puncture device according to claim 8, wherein the metal tip has a surface at the proximal end of the metal tip that faces the opening at the distal end of the resin tube. The metal tip has a surface at a proximal end thereof facing an opening at a distal end of the resin tube,
The puncture device according to claim 8 or 9, wherein the metal tip has, on the opposing surface, a tapered recess whose diameter tapers from the proximal side toward the distal side. The puncture device according to claim 8 or 9, wherein the metal tip has an expanding portion at the proximal end of the metal tip, the expanding portion expanding from the proximal side to the distal side. The puncture device according to any one of claims 1 to 11, wherein the resin tube has a reinforcing material on the distal side of the distal end of the metal tube. the reinforcing member is a metal tubular member,
The puncture device according to claim 12 , wherein the reinforcing material is disposed on an inner surface of the resin tube.

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