JP2022127670A - lancing device - Google Patents

Abstract

[Problem] To provide a puncture device capable of injecting saline, contrast medium, etc. over a wide area in the left atrium, and improving visibility in intracardiac echo and X-ray irradiation. [Solution] A puncture device 1 comprising a resin tube 10 having a distal end 10d 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 an inner lumen opening at least on the proximal side 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 metal member 30 having 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 having 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, and the distal end 10d of the resin tube 10 being distal to the hole 32. [Selected Figure] Figure 3

Description

The present invention relates to a puncture device for puncturing a living tissue such as the septal portion of the atria.

Catheters having electrodes are used in the examination and treatment of arrhythmias such as atrial fibrillation (AF) and atrioventricular reentry tachycardia (AVRT). During the examination, the operator inserts the electrode catheter into the heart chamber, measures the intracardiac potential, and identifies the abnormal site of the heart causing the arrhythmia. At the time of treatment, the operator conducts so-called ablation surgery, in which energy including high-frequency current is passed from the electrodes of the catheter to the myocardium causing the arrhythmia, and the source of the arrhythmia is necrotized to electrically isolate it from the heart. . In addition, if atrial fibrillation occurs spontaneously during these examinations or treatments, or if atrial fibrillation is caused to identify an abnormal part of the heart, the operator should apply electrical current from the electrodes of the catheter. Defibrillate by stimulating the heart.

In order to deliver the catheter from the right atrium side to the left atrium side when performing ablation surgery, a Brockenbrough needle (septal puncture needle) is used to puncture the fossa ovalis in the septal portion of the atrium from the right atrium, The Brockenbrough method, which is a puncture method for opening the catheter insertion path, is used.

In the Brockenbrough method, while confirming the position of the device and the fossa ovalis by intracardiac echo or X-ray irradiation, the tip of the septal puncture needle is pressed against the fossa ovalis, and the septal puncture needle is energized to penetrate the fossa ovalis. Cauterize and penetrate. While the fossa ovalis is pierced by the septal puncture needle, a liquid such as saline or a contrast agent is flowed from the tip of the septal puncture needle, and intracardiac echo or X-ray irradiation is used to move the needle to the left atrium side. Check for perforation of the fossa ovalis by confirming fluid flow.

As a septal puncture needle used in the Brockenbrough method, for example, Patent Document 1 discloses a catheter shaft, an insulating irrigating member, and a tip electrode. A plurality of irrigation openings for irrigating the surface of the insulated irrigation member are arranged at equal angular intervals, a liquid storage space and a branch channel are formed inside the insulated irrigation member, and a liquid An electrode catheter is described in which a guide channel is formed in the tip electrode and a liquid guide channel is formed in the proximal end of the tip electrode. U.S. Patent No. 6,000,000 includes a flexible elongated member and a support spine extending proximally from a distal end within a distal portion of a lumen, the proximal end of the support spine being disposed within the distal portion of the lumen. A medical device is described. In Patent Document 3, a sheath, an electrode member, a tip member, and liquid feeding means are provided, and the electrode member includes a rod-shaped electrode portion and a large diameter portion made of an insulating material and having an electrode hole. A high-frequency treatment instrument having a buffer member between is described. U.S. Patent No. 6,000,000 includes an elongated member defining a lumen for fluid and a distal portion having an electrode and a distal surface, the distal surface defining an opening and penetrating the non-cutting portion and tissue. a cutting portion configured to deliver energy for the electrode, the distal surface of the electrode forming the cutting portion, a portion of the cutting portion forming a leading portion partially surrounding the opening, and the electrical An electrosurgical device is described in which the outer diameter of at least one of the distal portions or electrodes of the surgical device decreases toward the distal end of the electrosurgical device.

JP 2012-135338 A Japanese Patent Publication No. 2016-509942 WO2016/203977 JP 2019-177150 A

After puncturing the fossa ovalis with a puncture needle, a liquid such as saline or a contrast medium is injected into the left atrium through the opening at the tip of the puncture needle, and the fossa ovalis is examined using an ultrasound diagnostic device or an X-ray fluoroscope. Check the penetration of At this time, with the puncture needles as in Patent Documents 1 to 4, the visibility of liquids such as physiological saline and contrast media in intracardiac echo or X-ray irradiation is poor, making it difficult to confirm penetration of the fossa ovalis. There was a problem.

The present invention has been made in view of the above circumstances, and its object is to be able to inject a liquid such as a physiological saline solution or a contrast agent over a wide area in the left atrium, and to perform intracardiac echo or X-ray imaging. To provide a puncture device capable of enhancing visibility in irradiation.

A puncture device capable of solving the above-described problems comprises a resin tube extending longitudinally and having a distal end and a proximal end; a metal tube disposed in the lumen of the resin tube; A resin tube having a metal member having a proximally open lumen and disposed at the distal end of the metal tube, and a metal tip disposed at the distal end of the metal member; is between the inner surface of the resin tube and the outer surface of the metal member and has a passageway in communication with the lumen of the metal tube, the metal member having a large diameter portion and a a small-diameter portion disposed on the side and having an outer diameter smaller than that of the large-diameter portion; The resin tube has a hole communicating with and, and the distal end of the resin tube is located on the distal side of the hole.

The puncture device of the present invention has a transition portion distal to the large diameter portion and proximal to the small diameter portion, the transition portion decreasing in diameter toward the distal side, and the hole is located in the transition portion. preferably.

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

In the puncture device of the present invention, the metal member preferably has a concave portion extending in the longitudinal direction of the metal member.

In the puncture device of the present invention, the metal member preferably has a portion where a portion of the outer surface of the metal member is in contact with the inner surface of the resin tube.

In the puncture device of the present invention, the large-diameter portion of the metal member preferably 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, the cross-sectional area of the metal member in a cross section perpendicular to the longitudinal direction of the metal member is preferably larger than the cross-sectional area of the channel.

In the puncture device of the present invention, the distal end of the resin tube is preferably closer to the proximal side than the proximal end of the metal tip.

In the puncture device of the present invention, the metal tip preferably has a facing 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 has a surface facing the opening of the distal end of the resin tube at the proximal end of the metal tip, and the metal tip has a surface facing the opening of the distal end of the resin tube. It preferably has a reduced diameter recess that tapers distally.

In the puncture device of the present invention, the metal tip preferably has an enlarged diameter portion at the proximal end of the metal tip, the diameter of which increases from the proximal side to the distal side.

In the puncture device of the present invention, the resin tube preferably has a reinforcing material on the distal side of the distal end of the metal tube.

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

According to the puncture device of the present invention, the resin tube is provided 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 lumen of the metal tube, and the metal member has 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, wherein the metal member is between the inner surface of the resin tube and the outer surface of the metal member. A hole that communicates the space with the lumen of the metal tube is provided, and the distal end of the resin tube is located on the distal side of the hole. Liquids such as physiological saline and contrast medium that are released from the puncture device by widening the flow path while maintaining the rigidity of the distal end of the puncture device for facilitating the puncture of the fossa ovalis. can increase the amount of Therefore, it becomes possible to inject the liquid over a wide area in the left atrium, and the visibility in intracardiac echo or X-ray irradiation can be improved.

1 shows a plan view of a puncture device according to an embodiment of the present invention; FIG. Figure 2 represents a plan view of the distal end of the puncture device shown in Figure 1; Figure 3 shows a cross-sectional view along the longitudinal direction of the puncture device shown in Figure 2; Figure 3 shows a IV-IV cross-sectional view of the puncture device shown in Figure 2; 3 represents a VV cross-sectional view of the puncture device shown in FIG. 2; FIG. Fig. 10 shows a plan view of the distal end of a puncture device according to another embodiment of the present invention; Figure 7 shows a cross-sectional view along the longitudinal direction of the puncture device shown in Figure 6; Figures 7A-7C show plan views of the distal end of the puncture device in different embodiments of the present invention; Figure 9 shows a cross-sectional view along the longitudinal direction of the puncture device shown in Figure 8;

Hereinafter, the present invention will be described in more detail based on the following embodiments, but the present invention is not limited by the following embodiments, and can be modified appropriately within the scope of the above and later descriptions. It is of course possible to carry out in addition, and all of them are included in the technical scope of the present invention. In each drawing, for the sake of convenience, hatching, member numbers, etc. may be omitted. In such cases, the specification and other drawings shall be referred to. In addition, the dimensions of various members in the drawings may differ from the actual dimensions, since priority is given to helping to understand 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 portion of the puncture device 1, and FIG. 3 is a cross-sectional view along the longitudinal direction of the puncture device 1. , and FIGS. 4 and 5 are sectional views perpendicular to the longitudinal direction of the puncture device 1. FIG. Note that the longitudinal direction of the puncture device 1 can be rephrased as the far-near direction of the puncture device 1 . The radial direction of the resin tube 10 in the puncture device 1 is the 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 has a distal end and a proximal end, a resin tube 10 extending in the longitudinal direction, a metal tube 20 arranged in the lumen of the resin tube 10, and a a metal member 30 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 a resin tube 10 and the outer surface of the metal member 30 with a channel 50 in communication with the lumen of the metal tube 20, the metal member 30 having a large diameter portion 33 and a a small-diameter portion 34 disposed further distally and having an outer diameter smaller than that of the large-diameter portion 33, and the metal member 30 is between the inner surface of the resin tube 10 and the outer surface of the metal member 30. A hole 32 that communicates the space with the inner lumen of the metal tube 20 is provided, and the distal end 10 d of the resin tube 10 is on the distal side of the hole 32 .

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

In the present invention, the proximal side refers to the user's hand side with respect to the extending direction of the puncture device 1, and the distal side refers to the side opposite to the proximal side, that is, the treatment target side. Also, the extending direction of the puncture device 1 is referred to as the longitudinal direction. 1, the lower side of the drawing is the proximal side and the upper side of the drawing is the distal side. In FIGS. 2 and 3, the right side of the drawing is the proximal side and the left side of the drawing is the distal side. is.

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 a handle 3 at the proximal end of the shaft 2. may have The handle 3 also preferably has a syringe port 4 for feeding liquids such as saline and contrast medium through the shaft 2 into the channel 50 . Since the handle 3 has the syringe port 4, by connecting a syringe or the like to the syringe port 4, it becomes possible to send the liquid into the flow path 50, and the puncture is performed to confirm whether or not the fossa ovalis is perforated. The operation of injecting liquid into the body from the tip of the device 1 becomes easier.

The handle 3 preferably has a connector 6 via a cable 5 for energizing the shaft 2 . Since the handle 3 has a cable 5 and a connector 6, the metal tube 20, the metal member 30 and the metal tip 40 of the shaft 2 are electrically connected by connecting the connector 6 to a power source for applying high frequency current. can do. Therefore, it becomes possible to conduct electricity from the metal tip 40 to the counter electrode plate, which facilitates perforation of the fossa ovalis.

The shaft 2 preferably has at its distal end a bend 12 in which the shaft 2 is bent. Having the bent portion 12 at the distal end of the shaft 2 makes it easier to insert the puncture device 1 into the heart. The bending angle of the shaft 2 at the bending portion 12 can be adapted to the shape and condition of the lumen of the body and the heart. The bent portion 12 may be positioned closer to the proximal side than the proximal end of the metal member 30 . Also, the bent portion 12 may be provided at a portion where the metal member 30 is arranged. By providing the bending portion 12 at the distal end of the shaft 2, the operability of the puncture device 1 can be improved.

The number of lumens that the resin tube 10 has before being assembled as the puncture device 1 may be plural, but is preferably one. Since the resin tube 10 has one lumen, the cross-sectional area of the lumen in the direction perpendicular to the longitudinal direction can be increased while reducing the outer diameter of the resin tube 10 . Therefore, it becomes easier to dispose the metal tube 20 in the lumen of the resin tube 10, and the manufacturing of the puncture device 1 becomes easier.

As shown in FIGS. 2 and 3, resin tube 10 has a distal end and a proximal end and extends longitudinally. The material constituting the resin tube 10 is preferably an insulating material, and examples thereof include polyolefin resins such as polyethylene and polypropylene, polyamide resins such as nylon, polyester resins such as PET, and aromatic polyethers such as PEEK. Ketone-based resins, polyether polyamide-based resins, polyurethane-based resins, polyimide-based resins, fluorine-based resins such as PTFE, PFA, and ETFE, synthetic resins such as polyvinyl chloride-based resins, and the like. The resin tube 10 may be made of one kind of synthetic resin, or may contain a plurality of kinds of synthetic resins. Since the material forming 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 others, the material forming the resin tube 10 preferably contains a fluororesin, and more preferably contains PTFE. Since the material forming the resin tube 10 contains a fluororesin, the lubricating property of the outer surface of the resin tube 10 can be improved, and the puncture device 1 can be provided with good insertability.

The length of the resin tube 10 in the longitudinal direction can be selected appropriately 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, and the puncture device 1 can be easily inserted into a blood vessel. Also, 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. Therefore, the less invasiveness of the puncture device 1 can be improved.

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, insulation can be achieved by the resin tube 10 when the metal tip 40 is energized. Therefore, cauterization of an unintended site in the body can be prevented. Also, 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, and the puncture device 1 becomes less invasive.

As shown in FIGS. 2 to 5, the metal tube 20 is arranged in the lumen of the resin tube 10. As shown in FIG. That is, the resin tube 10 is arranged outside the metal tube 20 . The number of lumens that the metal tube 20 has may be plural, but preferably one. Since the metal tube 20 has one lumen, the cross-sectional area of the lumen in the direction perpendicular to the longitudinal direction can be increased, and the flow rate of the liquid sent to the channel 50 can be increased. .

Examples of materials that constitute the metal tube 20 include metals such as stainless steel, carbon steel, and nickel-titanium alloys. The material forming the metal tube 20 is preferably stainless steel. Since the metal tube 20 is made of stainless steel, the rigidity of the metal tube 20 is increased, and as a result, the pushability of the puncture device 1 is improved, and the puncture of the fossa ovalis can be facilitated.

The length of the metal tube 20 in the longitudinal direction can be selected appropriately 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, it is possible to increase the rigidity of the metal tube 20, improve the pushability of the puncture device 1, and facilitate perforation of the fossa ovalis. becomes. Also, 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 to the above range, it is easy to secure a sufficient cross-sectional area of the lumen in the cross section perpendicular to the longitudinal direction of the metal tube 20, and the amount of liquid fed into the flow channel 50 can be 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. Therefore, the pushability of the puncture device 1 can be improved, and the puncture of the fossa ovalis can be facilitated. Also, 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, the diameter of the puncture device 1 can be reduced. .

As shown in FIG. 3 , metal member 30 has a lumen that opens at least proximally and is joined to the distal end of metal tube 20 . Methods for joining the metal member 30 to the distal end portion of the metal tube 20 include, for example, welding, brazing such as soldering, bonding, connection by caulking, etc., press-fitting the metal member 30 into the metal tube 20, metal tube 20 and the metal member 30, connection of the metal tube 20 and the metal member 30 via another component, and the like. The method of joining the metal member 30 to the distal end of the metal tube 20 is preferably fixing such as welding, brazing, or adhesion, and more preferably welding. By fixing the distal end portion 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 bends, the metal member 30 is less likely to come off from the metal tube 20 .

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

The diameter of the circumscribed 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 . The diameter of the circumscribed circle of the cross-sectional shape at the proximal end of the metal member 30 is smaller than the inner diameter of the distal end of the metal tube 20, so that the proximal end of the metal member 30 is attached to the distal end of the metal tube 20. It can be inserted, and the bonding strength between the metal tube 20 and the metal member 30 can be increased.

As shown in FIGS. 2 and 3, metal tip 40 is disposed at the distal end of metal member 30 . The metal tip 40 may be formed by directly bonding a separate member constituting the metal tip 40 to the distal end portion of the metal member 30, or via an intermediate member or the like which is a separate part different from the metal member 30 or the metal tip 40. and indirectly bonded to the distal end of metal member 30 . The metal tip 40 is arranged at the distal end of the metal member 30, and the metal tip 40 and the metal member 30 need only be integrated, and may or may not be connected. good. The metal tip 40 can be bonded to the metal member 30 to position the metal tip 40 at the distal end of the metal member 30 .

Specific methods for joining the metal tip 40 to the distal end portion of the metal member 30 include, for example, welding, brazing such as soldering, bonding, connection by caulking, etc., press-fitting the metal member 30 into the metal tip 40, Fitting between the metal member 30 and the metal tip 40, connection between the metal member 30 and the metal tip 40 via a separate part, and the like can be mentioned. The method of joining the metal tip 40 to the distal end portion of the metal member 30 is preferably fixing such as welding, brazing, or adhesion, and more preferably welding. By fixing the distal end portion of the metal member 30 and the metal tip 40 , the metal tip 40 can be firmly joined to the metal member 30 . Therefore, when the metal tip 40 is pressed against the fossa ovalis when puncturing the fossa ovalis, the metal tip 40 is less likely to fall off from the metal member 30, and the puncture device 1 with high durability can be provided.

Examples of materials forming the metal tip 40 include metals such as stainless steel, carbon steel, and nickel-titanium alloys. The material forming the metal tip 40 is preferably the same as the material forming the metal member 30 . Since the material forming the metal tip 40 is the same as the material forming the metal member 30, the metal member 30 and the metal tip 40 are easily joined together, and the joint strength between the metal member 30 and the metal tip 40 is increased. can increase

As shown in FIGS. 2 and 3, the distal end of metal tip 40 preferably has a curved surface shape. Since the distal end portion of the metal tip 40 has a curved shape, it is possible to make the body lumen less likely to be damaged when the metal tip 40 comes into contact with a body lumen such as a blood vessel. As a result, the metal tip 40 is less likely to damage or perforate unintended locations.

As described above, the metal tube 20 and the metal member 30 of the shaft 2 and the metal member 30 and the metal tip 40 are respectively joined, so that the three members of the metal tube 20, the metal member 30 and the metal tip 40 are electrically connected. can be connected to each other and can be energized.

As shown in FIG. 4 , the resin tube 10 has a channel 50 between the inner surface of the resin tube 10 and the outer surface of the metal member 30 and communicating with the inner lumen of the metal tube 20 . The number of flow paths 50 may be one or plural.

As shown in FIGS. 2 and 3 , the metal member 30 has a large diameter portion 33 and a small diameter portion 34 arranged distally of the large diameter portion 33 and having an outer diameter smaller than that of the large diameter portion 33 . , and the metal member 30 includes 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 inner lumen of the metal tube 20, and the distal end of the resin tube 10 End 10 d is distal to hole 32 . Hole 32 may be provided in small diameter portion 34 . One hole 32 may be provided, or a plurality of holes may be provided. When there are a plurality of holes 32 , they can be provided in the longitudinal direction and circumferential direction of the metal member 30 . A plurality of holes 32 may be provided in the 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 .

By providing the metal member 30 with the large-diameter portion 33, the rigidity of the proximal side of the metal member 30, which is the portion where the large-diameter portion 33 exists, is increased, thereby improving the pushability of the puncture device 1 and the fossa ovalis. Ease of drilling can be improved. Since the metal member 30 has the small diameter portion 34, the space between the distal outer surface of the metal member 30 and the inner surface of the resin tube 10, which is the portion where the small diameter portion 34 exists, is large. As a result, the channel 50 can be widened. Therefore, the flow rate of the liquid discharged from the puncture device 1 can be increased, and the visibility in intracardiac echo or X-ray irradiation can be improved.

As shown in FIG. 3, the lumen of metal member 30 has an opening at least proximally. The proximal end of the lumen of metal member 30 communicates with the lumen of metal tube 20 . The distal end of the lumen of metal member 30 may coincide with the distal end of metal member 30 and may be medial to the distal end of metal member 30, i.e., proximal to the distal end of metal member 30. may be Considering the flow of liquid in the puncture device 1, the distal end of the lumen of the metal member 30 preferably coincides with the proximal end of the small diameter portion 34 of the metal member 30, as shown in FIG.

In the puncture device 1 , the liquid in the flow path 50 flows through the lumen of the metal tube 20 , the lumen 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 . is discharged to the outside of the resin tube 10 through . Since the inner diameter of the hole 32 is smaller than the inner diameter of the metal member 30, the flow velocity of the liquid increases when the liquid passes through the hole 32, and as a result, the liquid can be vigorously discharged to the outside of the resin tube 10 over a wide range. As a result, it is possible to improve the visibility in intracardiac echo or 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, the outer diameter of the small-diameter portion 34. is more preferable, and 1.5 times or more is even more preferable. By setting the lower limit value 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 proximal side of the metal member 30 where the large diameter portion 33 exists. The rigidity is sufficiently increased, and the space between the distal outer surface of the metal member 30 where the small diameter portion 34 is present and the inner surface of the resin tube 10 can be sufficiently secured. . The outer diameter of the large-diameter portion 33 is preferably 2 times or less the outer diameter of the small-diameter portion 34, more preferably 1.8 times or less, and even more preferably 1.6 times or less. . By setting the upper limit of the ratio between the outer diameter of the large diameter portion 33 and the outer diameter of the small diameter portion 34 within the above range, the outer diameter of the distal end portion of the puncture device 1 is prevented from becoming excessively large, Minimal invasiveness can be enhanced.

The resin tube 10 may be a single tube extending from the distal end to the proximal end, or may be composed of a plurality of tubes. When it is composed of a plurality of tubes in the longitudinal direction, each tube must be joined to form one tube. In that case, the boundary of the joint may not be clear. Although not shown, when the resin tube 10 is composed of a plurality of tubes, the resin tube 10 has a distal side resin tube and a proximal side resin tube. A metal member 30 may be arranged in the cavity, and a metal tube 20 may be arranged in the lumen of the proximal resin tube. Further, 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 the distal side resin tube and the proximal side resin tube, the size and material of the distal side resin tube are suitable for the metal member 30, and the proximal side resin tube is the metal tube 20. It is possible to make the size and material suitable for As a result, the process of arranging the metal tube 20 and the metal member 30 in the lumen of the resin tube 10 is facilitated.

When the resin tube 10 has a distal side resin tube and a proximal side resin tube, although not shown, the proximal end of the distal side resin tube is positioned further than the distal end of the proximal side resin tube. is also proximal. Since the proximal end of the distal resin tube is 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 overlaps with Therefore, when the puncture device 1 is inserted into the body lumen, liquid such as blood is less likely to enter the lumen of the resin tube 10 through the gap between the distal side resin tube and the proximal side resin tube. be able to.

The length of the portion where the proximal end portion of the distal resin tube and the distal end portion of the proximal resin tube overlap is determined by considering the influence on the outer diameter of the resin tube 10 and the bonding strength. can be selected. As a method for joining the proximal end of the distal resin tube and the distal end of the proximal resin tube, for example, the proximal end of the distal resin tube and the distal end of the proximal resin tube Heating the ends, adhering, drawing and the like can be mentioned.

Also, the proximal end of the distal resin tube is preferably arranged in the lumen of the proximal resin tube. By arranging 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. When the liquid is fed into the lumen of the metal tube 20 and passes through the flow path 50, the liquid in the flow path 50 flows from between the distal resin tube and the proximal resin tube to the outside. can be prevented from leaking out.

The proximal end of the distal side resin tube is preferably joined to the distal end of the proximal side resin tube without a gap. Since the proximal end of the distal resin tube is joined to the proximal resin tube without a gap, when the metal tip 40 is energized through the metal tube 20, the distal resin tube and the proximal resin tube are connected together. It is possible to make it difficult for the electric current transmitted through the metal tube 20, the metal member 30, the metal tip 40, and the like to leak outside from the gap with the tube.

As shown in FIGS. 2 and 3, the outer diameter of the portion of the resin tube 10 where the distal end of the metal tube 20 is located is larger than the outer diameter of the portion of the resin tube 10 where the distal end of the metal member 30 is located. Large is preferred. The outer diameter of the portion of the resin tube 10 where the distal end of the metal tube 20 is located is larger than the outer diameter of the portion of the resin tube 10 where the distal end of the metal member 30 is located. At the end, a small diameter portion 34 can be formed distally and a large diameter portion 33 proximal to the small diameter portion 34 can be formed. Therefore, for example, when using a dilator when inserting the puncture device 1 into a body lumen, only the small-diameter portion 34 is exposed from the dilator so that the puncture device 1 is exposed from the dilator. can be easily controlled.

As shown in FIGS. 2 and 3, distal to the large diameter portion 33 and proximal to the small diameter portion 34, there is a transition portion 35 that tapers distally to provide a bore. 32 is preferably located at transition 35 . Since the hole 32 is located in the transition portion 35 , the liquid in the inner cavity of the large diameter portion 33 of the metal member 30 flows through the hole 32 to the inner surface of the resin tube 10 and the small diameter portion 34 of the metal member 30 . can be efficiently sent into the space between the outer surface of a certain portion. When the space between the outer surface of the small diameter portion 34 and the inner surface of the resin tube 10 is made wider than the space between the outer surface of the large diameter portion 33 and the inner surface of the resin tube 10, the flow The flow of liquid in channel 50 becomes smooth, and a large amount of liquid can be easily discharged from puncture device 1 .

The transition section 35 may vary in inner diameter from the proximal end of the transition section 35 to the distal end of the transition section 35 in a tapered, stepped, undulating, or wavy shape, in whole or in part. Above all, it is preferable that the transition portion 35 is tapered from the proximal end to the distal end of the transition portion 35 as a whole. Since the transition portion 35 is tapered from the proximal end to the distal end, resistance is less likely to occur when the liquid that has passed through the hole 32 contacts the outer surface of the transition portion 35 . Therefore, 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, the pressure loss of the liquid can be reduced. Flow rate can be increased.

As shown in FIG. 3, the large diameter portion 33 and the transition portion 35 preferably have bores and the small diameter portion 34 does not have a bore. In other words, it is preferable that the inner lumen of the metal member 30 be closer to the proximal side than the small diameter portion 34 . Since the large-diameter portion 33 and the transition portion 35 have a bore, it is possible to increase the flow rate of the liquid from the bore of the metal tube 20 to the hole 32 while securing a certain amount of liquid flow rate. Become. In addition, since the small diameter portion 34 does not have a lumen, it is a portion where the small diameter portion 34 is present while ensuring the width of the space between the outer surface of the small diameter portion 34 and the inner surface of the resin tube 10. It becomes possible to increase the rigidity of the distal end of the resin tube 10 . As a result, it is easy to perforate the fossa ovalis with good pushability, and it is possible to release a large amount of liquids such as saline and contrast medium over a wide range, resulting in good visibility in intracardiac echo and X-ray irradiation. device 1;

As shown in FIG. 4, the shape of the cross section perpendicular to the longitudinal direction of the metal member 30 is preferably polygonal. The puncture device 1 in which the metal member 30 is present while maintaining the strength of the metal member 30 while increasing the cross-sectional area of the flow path 50 because the shape of the cross section perpendicular to the longitudinal direction of the metal member 30 is polygonal. can maintain the stiffness of the distal end of the

In addition, the polygon in the present invention includes a polygon with clear corner vertices and straight sides, a polygon with rounded corners, a so-called rounded polygon, Polygons in which at least part of the sides are curved are also included. 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 any case, the material and hardness of the resin tube 10 are selected 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. is preferred. When the cross section perpendicular to the longitudinal direction of the metal member 30 is polygonal, the flow path 50 can be formed between the resin tube 10 and the metal member 30 by providing the resin tube 10 with appropriate hardness. .

The shape of the cross section perpendicular to the longitudinal direction of the metal member 30 may be circular, elliptical, polygonal, cross-shaped, H-shaped, U-shaped, mountain-shaped, or a combination thereof. More preferably, the shape of the cross section perpendicular to the longitudinal direction of the metal member 30 is a quadrangle. Since the shape of the cross section of the metal member 30 perpendicular to the longitudinal direction is square, it is possible to ensure both the strength of the metal member 30 and the size of the flow path 50 .

As for the cross-sectional shape of the metal member 30 perpendicular to the longitudinal direction, the large diameter portion 33 is preferably circular, and the small diameter portion 34 is preferably polygonal. The shape of the cross section perpendicular to the longitudinal direction of the metal member 30 is such that the large diameter portion 33 is circular and the small diameter portion 34 is polygonal. The shape along the inner diameter increases the bonding strength between the metal member 30 and the metal tube 20, and the portion that is the small diameter portion 34 of the metal member 30 secures the cross-sectional area of the flow path 50 while the resin tube 10 The rigidity of the puncture device 1 is increased, and the puncture device 1 can be made pushable and easy to perforate the fossa ovalis. The small-diameter portion 34 may have a shape provided with a notch for forming the flow path 50 in the cross-sectional shape described above. When 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 planar contact, the cross section of the small diameter portion 34 is cut to form the flow path 50. By forming the provided shape, the flow path 50 can be easily formed. When 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 cross section, the cross-sectional shape of the small-diameter portion 34 perpendicular to the longitudinal direction of the metal member 30 is a vertex such as a polygon or a star. It is a shape with When 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-sectional shape of the small diameter portion 34 perpendicular to the longitudinal direction of the metal member 30 can be any shape.

Although not shown, the metal member 30 preferably has a recess extending in the longitudinal direction of the metal member 30 . Since the metal member 30 has a concave portion 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. can. Therefore, the amount of liquid discharged from the resin tube 10 can be made 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 the maximum length of the metal member 30 connecting two points on the outer circumference of the metal member 30 (hereinafter simply referred to as "the maximum length of the metal member 30 length) is preferably 20% or more, more preferably 25% or more, and even more preferably 30% or more. By setting the lower limit value 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 cross-sectional area of the flow channel 50 in the cross section perpendicular to the longitudinal direction can be reduced to can be ensured and the amount of liquid passing through the channel 50 can be 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 70% or less of the maximum length of the metal member 30, more preferably 60% or less. , is more preferably 50% or less. 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 metal member 30 can ensure the rigidity of the distal end of the puncture device 1 with

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

Although not shown, the metal member 30 preferably has a portion where a portion of the outer surface of the metal member 30 is in contact with the inner surface of the resin tube 10 . Since 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, the distal end portion of the puncture device 1 where the metal member 30 exists. can be enhanced by the metal member 30, and the puncture device 1 can be easily inserted.

A part of the outer surface of the metal member 30 is preferably in contact with 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 portion of the puncture device 1 .

When part 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. It is preferable that the inner surface is in planar contact with the inner surface at a plurality of locations. Since the metal member 30 is in planar contact with the inner surface of the resin tube 10 at a plurality of locations, a plurality of flow paths 50 can be secured. Due to the presence of the plurality of flow paths 50, when the liquid is discharged to the outside from the opening 11 at the distal end 10d of the resin tube 10, the liquid is easily discharged over a wide range in the radial direction of the resin tube 10. .

Moreover, 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 on the distal side of the distal end 20 d 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 on the distal side of the distal end 20d of the metal tube 20, the flow path 50 can be secured. The size of 50 can be increased to increase the flow rate of liquid through channel 50 .

As shown in FIGS. 3 and 5 , the large diameter portion 33 of the metal member 30 preferably 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 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 , so that the liquid in the lumen of the metal tube 20 flows into the lumen of the metal member 30 . easier to flow. As a result, the liquid in the lumen of the metal member 30 passes through the hole 32, and the flow rate of the liquid discharged from the resin tube 10 is increased. Visibility in echo or X-ray irradiation can be improved.

As shown in FIGS. 3 and 5, the metal member 30 is preferably in planar contact with the inner surface of the metal tube 20 . Since the metal member 30 is in planar contact with the inner surface of the metal tube 20, the contact area between the metal tube 20 and the metal member 30 can be increased. Therefore, the bonding strength between the metal tube 20 and the metal member 30 can be increased, and the metal member 30 is less likely to come off from the metal tube 20 even when the puncture device 1 is inserted through a curved body lumen. can be done. In the 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 depends on the bonding strength between the metal tube 20 and the metal member 30 and the flow rate of the flow path 50. can be selected in consideration of

As shown in FIG. 5 , it is more preferable that the large-diameter portion 33 of the metal member 30 have a portion where the entire 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 entire 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 is a metal member. It becomes easier to enter the lumen 30, the flow velocity of the liquid discharged from the resin tube 10 is further increased, and the visibility in intracardiac echo or X-ray irradiation can be improved.

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 exists at the distal end of the puncture device 1 can be increased. Therefore, the insertability of the puncture device 1 is enhanced.

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, the cross-sectional area of the flow path 50. More preferably, it is 1.5 times or more. By setting the lower limit of the ratio between the cross-sectional area of metal member 30 and the cross-sectional area of flow path 50 within the above range, the rigidity of the distal end portion of puncture device 1 where metal member 30 is arranged is sufficiently increased. can be enhanced. The cross-sectional area of the metal member 30 is preferably five times or less, more preferably four times or less, and even more preferably three times or less the cross-sectional area of the flow path 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 path 50 within the above range, the cross-sectional area of the flow path 50 is ensured, and the outer portion of the distal end portion of the puncture device 1 is secured. It is possible to prevent the diameter from becoming too large.

As shown in FIGS. 2 and 3, the distal end 10d of the resin tube 10 is preferably closer to the proximal side than the proximal end 40p of the metal tip 40. As shown in FIGS. Since the distal end 10d of the resin tube 10 is closer to the proximal side than 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, Liquid such as physiological saline and a contrast medium in the flow path 50 is discharged from the distal end 10 d of the resin tube 10 to the outside of the resin tube 10 . That is, the resin tube 10 has an opening 11 at the distal end 10 d , and the liquid in the flow path 50 is discharged to the outside of the resin tube 10 through the opening 11 . Therefore, the liquid in the flow path 50 discharged from the distal end 10d of the resin tube 10 can diffuse in the radial direction of the resin tube 10, and can be discharged over a wide area in the left atrium. Visibility in intracavitary echo or X-ray irradiation can be improved. Since the liquid flows along the longitudinal direction of the resin tube 10 in the channel 50 , the liquid is discharged from the distal end 10 d of the resin tube 10 and flows toward the opposing surface 41 that is the surface of the proximal end of the metal tip 40 . The flow direction of the liquid is changed in the radial direction of the resin tube 10 by the facing surface 41 .

FIG. 6 is a plan view of the distal end portion of puncture device 1 according to another embodiment of the present invention, and FIG. 7 is a longitudinal sectional view of puncture device 1. As shown in FIG. 8 is a plan view of the distal end portion of puncture device 1 in a different embodiment of the present invention, and FIG. 9 is a cross-sectional view of puncture device 1 along the longitudinal direction. 6 to 9, the right side of the drawing is the proximal side and the left side of the drawing is the distal side.

The proximal end 30p of the metal member 30 may be proximal to the distal end 20d of the metal tube 20, as shown in FIGS. It may be on the distal side of the distal end 20d. Since the proximal end 30p of the metal member 30 is located on the distal side of the distal end 20d of the metal tube 20, the rigidity of the distal end of the puncture device 1 is increased, and the metal member 30 is not present. The portion can ensure a wide flow path 50 . As a result, the puncture device 1 has good pushability, facilitates perforation of the fossa ovalis, and emits a large amount of liquid such as physiological saline and a contrast medium, and has good visibility in intracardiac echo or X-ray irradiation. It becomes possible to

As shown in FIGS. 2, 3 and 6-9, the distal end of the metal tip 40 is preferably located further distally than the distal end 10d of the resin tube 10. FIG. Since the distal end of the metal tip 40 is on the distal side of the distal end 10 d 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 for cauterizing tissue.

Moreover, as shown in FIGS. 2, 3 and 6 to 9, the proximal end of the metal tip 40 is preferably located further distally than the distal end 10d of the resin tube 10. FIG. Since the proximal end of the metal tip 40 is on the distal side of 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 is increased. It is possible to discharge a large amount of the liquid in the channel 50 from the opening 11 .

As shown in FIGS. 2, 3, 6 and 7, the metal tip 40 has an opposing surface 41 at the proximal end of the metal tip 40 facing the opening 11 of the distal end 10d of the resin tube 10. It is preferable to have Since the metal chip 40 has the facing surface 41, the liquid in the flow path 50 discharged from the opening 11 of the resin tube 10 contacts the facing surface 41, and the liquid discharged from the opening 11 It becomes easier to diffuse in the radial direction of the resin tube 10 . As a result, the liquid can be discharged over a wide area in the left atrium, and the visibility of intracardiac echo and X-ray irradiation can be improved.

As shown in FIGS. 6 and 7, the metal tip 40 has a facing surface 41 at the proximal end of the metal tip 40 facing the opening 11 of the distal end 10d of the resin tube 10. preferably has a diameter-reduced recess 42 on the facing surface 41, the diameter of which decreases from the proximal side to the distal side. Since the metal tip 40 has the diameter-reduced recess 42 on the opposing surface 41, the liquid in the flow path 50 released from the opening 11 of the resin tube 10 contacts the diameter-reduced recess 42 and rebounds, and the resin tube The liquid can be diffused not only in the radial direction of 10 but also in the proximal side, and visibility in intracardiac echo or X-ray irradiation can be improved.

The diameter-reduced recess 42 may have an inner diameter that varies in a tapered, stepped, uneven, or wavy shape, in whole or in part, from the proximal end of the reduced-diameter recess 42 to the distal end of the reduced-diameter recess 42 . . Above all, it is preferable that the diameter of the diameter-reduced recess 42 is reduced in a tapered manner as a whole from the proximal end to the distal end of the diameter-reduced recess 42 . Since the diameter-reduced recess 42 is tapered from the proximal end to the distal end, the liquid in the flow path 50 is released from the opening 11 of the resin tube 10 and contacts the diameter-reduced recess 42 . tend to move proximally. Therefore, the liquid can be discharged over a wide range in the left atrium, and the visibility of intracardiac echo or X-ray irradiation can be easily improved.

Moreover, as shown in FIGS. 8 and 9, the metal tip 40 has an enlarged diameter portion 43 at the proximal end portion of the metal tip 40, the diameter of which increases from the proximal side to the distal side. is also preferred. Since the metal tip 40 has the enlarged diameter portion 43 , the liquid in the flow path 50 comes into contact with the enlarged diameter portion 43 after being discharged from the opening 11 of the resin tube 10 , and spreads out of the enlarged diameter portion 43 . move along the surface. Therefore, the liquid in the flow path 50 can be diffused not only in the radial direction of the resin tube 10 but also in the distal side, and the puncture device 1 can be provided with high visibility by intracardiac echo or X-ray irradiation. .

The diameter-enlarged portion 43 may have an outer diameter that changes in a tapered, step-like, uneven, or wavy shape from the proximal end of the enlarged-diameter portion 43 to the distal end thereof. good. Among them, it is preferable that the diameter-enlarged portion 43 is tapered as a whole from the proximal end to the distal end of the enlarged-diameter portion 43 . Since the enlarged diameter portion 43 is tapered from the proximal end to the distal end, the liquid in the flow path 50 discharged from the opening 11 of the resin tube 10 contacts the enlarged diameter portion 43. This facilitates fluid flow distally. As a result, it becomes possible to diffuse the liquid over a wide area in the left atrium, and the visibility in intracardiac echo or X-ray irradiation can be improved.

Although not shown, the metal tip 40 has a lumen, and preferably a radiopaque marker is placed inside the metal tip 40 . By arranging the X-ray opaque marker in the lumen of the metal tip 40, the contrastability of the metal tip 40 with respect to X-rays can be enhanced. Therefore, by using X-rays when using the puncture device 1, it becomes easier to confirm the position of the metal tip 40 inside the body.

X-ray opaque materials such as lead, barium, iodine, tungsten, gold, platinum, iridium, platinum-iridium alloys, stainless steel, titanium, palladium, cobalt-chromium alloys, etc. should be used for the materials constituting the X-ray opaque markers. can be done. The X-ray opaque material is preferably a platinum-iridium alloy, among others. By using a platinum-iridium alloy as the material for forming the X-ray opaque marker, X-ray contrastability can be enhanced, and the position of the metal tip 40 can be easily confirmed by X-ray irradiation.

Examples of the shape of the X-ray opaque marker include a spherical shape, a cylindrical shape, a polygonal cylindrical shape, a C-shaped cross section with a notch in the cylinder, a coil shape in which a wire is wound, a columnar shape, a polygonal columnar shape, and the like. Radiopaque markers may be placed in locations other than the lumen of the metal tip 40 . Also, the number of X-ray opaque markers may be one or plural.

As shown in FIGS. 6 to 9, the resin tube 10 preferably has a reinforcing member 13 distal to the distal end 20d of the metal tube 20. As shown in FIGS. Since the resin tube 10 has the reinforcing member 13 on the distal side of the distal end 20d of the metal tube 20, the distal end portion of the resin tube 10 is reinforced by the reinforcing member 13 to increase the rigidity. Therefore, it is possible to provide the puncture device 1 that has good pushability and facilitates perforation of the fossa ovalis.

For example, the reinforcing material 13 may be formed in layers such as a cylindrical member, or may be formed by arranging or braiding single wires or twisted wires in a specific pattern. The reinforcing material 13 can be arranged on the outer surface of the peripheral wall of the resin tube 10, the inner surface of the peripheral wall, or within the peripheral wall.

Materials constituting the reinforcing material 13 include, for example, metals such as stainless steel, titanium, nickel-titanium alloys, cobalt-chromium alloys, and tungsten alloys, and polyolefin resins such as polyarylate-based resins, aramid-based resins, and ultrahigh-molecular-weight polyethylene. and synthetic resins such as The reinforcing material 13 may be composed of one type of material, or may include a plurality of types of materials.

The reinforcing member 13 is a metal cylindrical member, and is preferably arranged on the inner surface of the resin tube 10 as shown in FIGS. 7 and 9 . Reinforcement member 13 is a metal tubular member and is arranged on the inner surface of resin tube 10 , thereby increasing the rigidity of the entire distal end portion of resin tube 10 and increasing the rigidity of the distal end portion of resin tube 10 . The surface of the resin tube 10 can be made smooth and the slidability of the resin tube 10 can be improved. In addition, when the reinforcing material 13 of a cylindrical member is arranged on the inner surface of the resin tube 10 , the flow path 50 is formed between the inner surface of the reinforcing material 13 of the resin tube 10 and the outer surface of the metal member 30 . will be between

As described above, the puncture device of the present invention has a distal end and a proximal end, a longitudinally extending resin tube, a metal tube disposed in the lumen of the resin tube, and at least a proximal end. The resin tube includes a metal member having a lumen that is open to 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. a passage between the inner surface of the resin tube and the outer surface of the metal member and in communication with the lumen of the metal tube, the metal member having a large diameter portion and a distal portion of the large diameter portion; and a small diameter portion having an outer diameter smaller than that of the large diameter portion, and the metal member includes a space between the inner surface of the resin tube and the outer surface of the metal member, and a lumen of the metal tube. , and the distal end of the resin tube is distal to the hole. Since the puncture device of the present invention has such a configuration, the rigidity of the distal end portion of the puncture device for the ease of inserting the puncture device into a lumen in a living body such as a blood vessel and the ease of puncturing the fossa ovalis. , the flow path can be widened, and the amount of liquid such as physiological saline or a contrast medium flowing through the flow path and discharged from the puncture device can be increased. Therefore, it becomes possible to inject the liquid over a wide area in the left atrium, and the visibility in intracardiac echo or X-ray irradiation can be improved.

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: Bending portion 13: Reinforcing material 20: Metal tube 20d: Distal end of metal tube 30: Metal member 30p: Proximal end of metal member 32: Hole 33: Large diameter portion 34: Small diameter portion 35: Transition portion 40: Metal tip 40p: Proximal end of metal tip 41: Opposing surface 42: diameter-reduced concave portion 43: diameter-enlarged portion 50: flow path

Claims (13)

a longitudinally extending resin tube having a distal end and a proximal end;
a metal tube arranged in the lumen of the resin tube;
a metal member having a lumen that opens at least proximally and is located at the distal end of the metal tube;
a metal tip positioned at the distal end of the metal member;
The resin tube has a flow path between the inner surface of the resin tube and the outer surface of the metal member and communicating with the inner lumen 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 the inner surface of the resin tube and the outer surface of the metal member with the inner cavity of the metal tube,
The distal end of the resin tube is a puncture device located distally of the hole. having a transition portion distal to the large diameter portion and proximal to the small diameter portion, the transition portion decreasing in diameter toward the distal side;
2. The lancing device of claim 1, wherein said hole is located at said transition. 3. The puncture device according to claim 1, wherein the metal member has a polygonal cross section perpendicular to the longitudinal direction. 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 where a portion of the outer surface of the metal member is 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 is larger than the cross-sectional area of the channel in a cross section perpendicular to the longitudinal direction of the metal member. 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. 9. The puncture device according to claim 8, wherein the metal tip has a facing surface at the proximal end of the metal tip that faces the opening of the distal end of the resin tube. The metal tip has a facing surface at the proximal end of the metal tip that faces the opening at the distal end of the resin tube,
10. The puncture device according to claim 8, wherein the metal tip has a diameter-reduced concave portion on the facing surface, the diameter of which decreases from the proximal side to the distal side. The puncture device according to claim 8 or 9, wherein the metal tip has an enlarged diameter portion at the proximal end of the metal tip, the diameter of which increases 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 member 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 arranged on the inner surface of the resin tube.

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