Lancing Device

Abstract

The present invention provides a puncturing device (1) having a resin tube (10) that has a distal end (10d) and a proximal end and that extends in the longitudinal direction, a metal tube (20) disposed in the lumen of the resin tube (10), a metal member (30) disposed at the distal end part of the metal tube (20), and a metal tip (40) disposed at the distal end part of the metal member (30). The resin tube (10) is provided with a channel (50) that is located between the inner surface of the resin tube (10) and the outer surface of the metal member (30) and that communicates with the lumen of the metal tube (20). The distal end (10d) of the resin tube (10) is located between the distal end (40d) and the proximal end (40p) of the metal tip (40). The resin tube (10) is provided with an opening (11) communicating the channel (50) and the outside of the resin tube (10) to each other. The opening (11) is located at a position on the distal side relative to the distal end (20d) of the metal tube (20) and on the proximal side relative to the proximal end (40p) of the metal tip (40).

Description

[Technical Field]

[0001] The present invention relates to a puncture device for puncturing biological tissue such as the atrial septum. [Background technology]

[0002] Catheters with electrodes are used in the examination and treatment of arrhythmias such as atrial fibrillation (AF) and atrioventricular reentrant tachycardia (AVRT). During examinations, surgeons insert the electrode catheter into the cardiac chamber and measure intracardiac potentials to identify the abnormal area of ​​the heart causing the arrhythmia. During treatment, surgeons perform ablation surgery, in which they pass energy, including high-frequency current, from the catheter's electrodes to the myocardium causing the arrhythmia, causing necrosis of the source of the arrhythmia and electrically isolating it from the heart. Furthermore, if atrial fibrillation occurs naturally during these examinations or treatments, or if atrial fibrillation is induced to identify the abnormal area of ​​the heart, surgeons defibrillate the heart by applying electrical stimulation from the catheter's electrodes.

[0003] When performing ablation surgery, a catheter is delivered from the right atrium to the left atrium using a Brockenbrough needle (septal puncture needle), which punctures the fossa ovalis in the atrial septum from the right atrium, opening a path for catheter insertion. This is called the Brockenbrough technique.

[0004] In the Brockenbrough technique, the tip of a septal needle is pressed against the fossa ovalis while the position of the device and fossa ovalis is confirmed using intracardiac echocardiography and X-rays, and electricity is passed through the needle to cauterize and penetrate the fossa ovalis. With the fossa ovalis penetrated by the needle, saline or a contrast agent or other liquid is injected from the tip of the needle, and intracardiac echocardiography and X-rays are used to confirm that the liquid has flowed into the left atrium, and the presence or absence of a perforation of the fossa ovalis is checked.

[0005] As for septal puncture needles used in the Brockenbrough technique, for example, Patent Document 1 describes an electrode catheter comprising a catheter shaft, an insulating irrigation member, and a tip electrode, wherein the insulating irrigation member has multiple irrigation openings arranged at equal angular intervals for irrigating the surface of the tip electrode with a supplied liquid, a liquid storage space and branched flow paths formed within 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, wherein 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 comprising an elongated member defining 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 for puncturing tissue, the distal surface of the electrode constituting the cutting portion, a portion of the cutting portion forming a leading portion that partially surrounds the periphery of the opening, and the outer diameter of at least one of the distal portion of the electrosurgical device or the electrode decreasing toward the distal end of the electrosurgical device. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Japanese Patent Application Laid-Open No. 2012-135338 [Patent Document 2] Special Publication No. 2016-509942 [Patent Document 3] International Publication No. 2016 / 203977 [Patent Document 4] Japanese Patent Application Publication No. 2019-177150 Summary of the Invention [Problem to be solved by the invention]

[0007] After the fossa ovalis is punctured with a puncture needle, a liquid such as saline or a 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 described in Patent Documents 1 to 4, the visibility of the liquid such as saline or a contrast agent using intracardiac echography or X-ray irradiation is poor, making it difficult to confirm penetration of the fossa ovalis.

[0008] The present invention has been 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 echocardiography and X-ray irradiation. [Means for solving the problem]

[0009] The first puncture device that can 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 arranged in the lumen of the resin tube, a metal member arranged at the distal end of the metal tube, and a metal tip arranged at the distal end of the metal member, wherein 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 lumen of the metal tube, the distal end of the resin tube is between the distal end and proximal end of the metal tip, and the resin tube has an opening that communicates the flow path with the outside of the resin tube, and the opening is located distal to the distal end of the metal tube and proximal to the proximal end of the metal tip.

[0010] The second puncture device that can 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 arranged in the lumen of the resin tube, a metal member arranged at the distal end of the metal tube, and a metal tip arranged at the distal end of the metal member, wherein the resin tube has a flow path that is between the inner surface of the resin tube and the outer surface of the metal member and communicates with the lumen of the metal tube, and further wherein the resin tube has an opening that communicates the flow path with the outside of the resin tube, and the opening is located distal to the distal end of the metal tube and proximal to the proximal end of the metal tip.

[0011] In the puncture device of the present invention, the metal member has an inner cavity that opens at least on the proximal side, and the metal member has a large diameter portion and a small diameter portion that is located distal to the large diameter portion and has an outer diameter smaller than that of the large diameter portion, and it is preferable that the metal member has a hole that connects the space between the inner surface of the resin tube and the outer surface of the metal member to the inner cavity of the metal tube.

[0012] In the puncture device of the present invention, the opening is preferably arranged on a surface perpendicular to the longitudinal direction of the resin tube.

[0013] In the pricking device of the present invention, the opening is preferably an opening facing the distal side, and the fluid discharged from the opening is preferably discharged in contact with the proximal end of the metal tip.

[0014] In the puncture device of the present invention, the opening is also preferably an opening facing the proximal side.

[0015] In the pricking device of the present invention, the metal member preferably has a recess extending in the longitudinal direction of the metal member.

[0016] In the pricking device of the present invention, the cross section of the metal member perpendicular to the longitudinal direction is preferably polygonal.

[0017] In the pricking 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 flow channel.

[0018] In the puncture device of the present invention, the metal member preferably has a portion where at least a part of the outer surface of the metal member is in contact with the inner surface of the resin tube.

[0019] In the puncture device of the present invention, it is preferable that the metal member does not have a portion in contact with the inner surface of the resin tube distal to the distal end of the metal tube.

[0020] In the puncture device of the present invention, the resin tube preferably has a surface facing the opening, located proximal to the proximal end of the metal tip.

[0021] In the puncture device of the present invention, the resin tube preferably has a constricted portion proximal to the opposing surface, the constricted portion having an outer diameter smaller than the outer diameter of the portion proximal to the opening.

[0022] In the puncture device of the present invention, the resin tube preferably has a contact portion that contacts the metal member, and the opening is preferably located proximal to the contact portion.

[0023] In the puncture device of the present invention, it is also preferable that the resin tube has a contact portion that contacts the metal member, and the opening is located distal to the contact portion.

[0024] In the puncture device of the present invention, it is preferable that the resin tube has a constricted portion proximal to the opposing surface whose outer diameter is smaller than the outer diameter proximal to the opening, and that the constricted portion has a tapered portion whose outer diameter decreases from the proximal side to the distal side.

[0025] In the puncture device of the present invention, it is preferable that the resin tube has a constricted portion proximal to the opposing surface whose outer diameter is smaller than the outer diameter proximal to the opening, and that the constricted portion has an expanding portion whose outer diameter expands from the proximal side to the distal side.

[0026] 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.

[0027] In the puncture device of the present invention, the reinforcing material is preferably a metallic tubular member, and the reinforcing material is preferably disposed on the inner surface of the resin tube. [Effects of the Invention]

[0028] According to the first puncture device of the present invention, a resin tube is disposed between the inner surface of the resin tube and the outer surface of the metal member, and includes a flow path communicating with the lumen of the metal tube, the distal end of the resin tube is disposed between the distal and proximal ends of the metal tip, and the resin tube further includes an opening communicating the flow path with the outside of the resin tube, the opening being distal to the distal end of the metal tube and proximal to the proximal end of the metal tip. This allows the flow path and the opening to be enlarged 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 perforation of the fossa ovalis. This allows liquids such as saline or contrast agent to be released over a wide area within the left atrium, improving visibility in intracardiac echocardiography and X-ray irradiation. [Brief explanation of the drawings]

[0029] [Figure 1] 1 shows a plan view of a first lancing device according to an embodiment of the present invention. [Figure 2] 2 illustrates a plan view of the distal end of the lancing device shown in FIG. 1. [Figure 3] 3 shows a longitudinal cross-sectional view of the pricking device shown in FIG. 2. [Figure 4] 4 shows a cross-sectional view of the pricking device shown in FIG. 2 taken along line IV-IV. [Figure 5] 3 shows a VV cross-sectional view of the lancing device shown in FIG. 2. [Figure 6] 10 shows a plan view of the distal end of a first lancing device according to another embodiment of the present invention. [Figure 7] 7 shows a longitudinal cross-sectional view of the pricking device shown in FIG. 6. [Figure 8] 8 shows a cross-sectional view of the pricking device shown in FIG. 6 taken along line VIII-VIII. [Figure 9] 9 is a cross-sectional view of the pricking device shown in FIG. 6 taken along line IX-IX. [Figure 10] 10 shows a plan view of the distal end of a first pricking device according to yet another embodiment of the present invention. [Figure 11] 11 shows a longitudinal cross-sectional view of the pricking device shown in FIG. 10. [Figure 12] 12 shows a cross-sectional view of the pricking device shown in FIG. 10 taken along line XII-XII. [Figure 13] 13 shows a cross-sectional view of the pricking device shown in FIG. 10 taken along line XIII-XIII. [Figure 14] 1 shows an enlarged view of the distal end of a first lancing device according to a different embodiment of the present invention. [Figure 15] 10 shows an enlarged view of the distal end of a first lancing device according to yet another embodiment of the present invention. [Figure 16] 10 shows a plan view of the distal end of a second lancing device in one embodiment of the present invention. [Figure 17] 17 shows a longitudinal cross-sectional view of the pricking device shown in FIG. 16. [Figure 18] 10 shows a plan view of the distal end of a second lancing device according to another embodiment of the present invention. [Figure 19] 19 shows a longitudinal cross-sectional view of the pricking device shown in FIG. 18. DETAILED DESCRIPTION OF THE INVENTION

[0030] The present invention will be described in more detail below based on the following embodiments. However, the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. For convenience, hatching and component symbols may be omitted in the drawings. In such cases, reference should be made to the specification or other drawings. The dimensions of various components in the drawings may differ from actual dimensions, as priority is given to helping understand the features of the present invention.

[0031] First, the first pricking device of the present invention will be described.

[0032] Fig. 1 is a plan view of a first 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 Figs. 4 and 5 are cross-sectional views perpendicular to the longitudinal direction of the puncture device 1. The longitudinal direction of the puncture device 1 can also be rephrased as the direction from the longitudinal 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.

[0033] The first puncture device 1 of the present invention comprises a resin tube 10 having a distal end 10d and a proximal end and extending in the longitudinal direction, a metal tube 20 arranged in the lumen of the resin tube 10, a metal member 30 arranged at the distal end of the metal tube 20, and a metal tip 40 arranged at the distal end of the metal member 30, the resin tube 10 having 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 distal end 10d of the resin tube 10 being between the distal end 40d and the proximal end 40p of the metal tip 40, and the resin tube 10 having an opening 11 communicating the flow path 50 with the outside of the resin tube 10, the opening 11 being distal to the distal end 20d of the metal tube 20 and proximal to the proximal end 40p of the metal tip 40.

[0034] 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.

[0035] In the present invention, the proximal side refers to the side closer to the user in the extending direction of the puncture device 1, and the distal side refers to the side opposite the proximal side, i.e., the side to be treated. The extending 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 Figs. 2 and 3, the right side of the figure is the proximal side and the left side of the figure is the distal side.

[0036] 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 channel 50 through the shaft 2. By having the handle 3 have the syringe port 4, it becomes possible to feed a liquid into the flow channel 50 by connecting a syringe or the like to the syringe port 4, and this makes it easier to inject a liquid into the body from the tip of the puncture device 1 to check for perforation of the fossa ovalis.

[0037] The handle 3 preferably has a connector 6 for supplying electricity to the shaft 2 via a cable 5. Since the handle 3 has the cable 5 and the connector 6, the metal tube 20, the metal member 30, and the metal tip 40 of the shaft 2 can be electrically connected by connecting the connector 6 to a power source for supplying high-frequency current. This makes it possible to supply electricity from the metal tip 40 to the counter electrode plate, facilitating perforation of the fossa ovalis.

[0038] It is preferable that the shaft 2 has a bent portion 12 at its 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 adjusted 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 30p 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.

[0039] The resin tube 10 before being assembled into the puncture device 1 may have multiple lumens, but preferably has one. By having the resin tube 10 have one lumen, the cross-sectional area of ​​the lumen 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 lumen of the resin tube 10, and facilitates the manufacture of the puncture device 1.

[0040] As shown in FIGS. 2 and 3 , the resin tube 10 has a distal end and a proximal end and extends longitudinally. The resin tube 10 is preferably made of an insulating material, such as polyolefin resins (e.g., polyethylene, polypropylene, etc.), polyamide resins (e.g., nylon, etc.), polyester resins (e.g., PET, etc.), aromatic polyetherketone resins (e.g., PEEK, etc.), polyetherpolyamide resins, polyurethane resins, polyimide resins, fluorine-based resins (e.g., PTFE, PFA, ETFE, etc.), and synthetic resins (e.g., polyvinyl chloride resins). The resin tube 10 may be made of one type of synthetic resin or may contain multiple types of synthetic resins. The insulating material used to make the resin tube 10 can insulate the metal tube 20 and the metal member 30 when electricity is applied to the metal tip 40. The material used to make the resin tube 10 preferably contains a fluorine-based resin, and more preferably PTFE. The fluorine-based resin used to make the resin tube 10 enhances the slipperiness of the outer surface of the resin tube 10, resulting in a puncture device 1 with good insertability.

[0041] The longitudinal length of the resin tube 10 can be selected to be a length appropriate for treatment, and can be, for example, 500 mm or more and 1200 mm or less.

[0042] 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 that is easy to insert into a blood vessel. Furthermore, 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 minimal invasiveness of the puncture device 1 can be improved.

[0043] 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 it is energized. This prevents cauterization of unintended locations inside the body. Furthermore, 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. Setting the upper limit of the thickness of the resin tube 10 within the above range prevents the outer diameter of the resin tube 10 from becoming too large, making the puncture device 1 minimally invasive.

[0044] 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, and the flow rate of the liquid sent to the flow channel 50 can be increased.

[0045] Examples of materials that can be used to form the metal tube 20 include metals such as stainless steel, carbon steel, and nickel-titanium alloy. The material that can be used to form the metal tube 20 is preferably stainless steel. Using stainless steel as the material for the metal tube 20 increases the rigidity of the metal tube 20, thereby improving the pushability of the puncture device 1 and facilitating perforation of the fossa ovalis.

[0046] 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.

[0047] 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, which makes it possible to improve the pushability of the puncture device 1 and to facilitate perforation of the fossa ovalis. Furthermore, 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 a sufficient amount of liquid can be sent to the flow path 50.

[0048] 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 perforate the fossa ovalis. Furthermore, 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.

[0049] As shown in FIG. 3 , the metal member 30 is joined to the distal end of the metal tube 20. Examples of methods for joining the metal member 30 to the distal end of the metal tube 20 include welding, brazing (e.g., soldering), bonding, crimping, etc., press-fitting the metal member 30 into the metal tube 20, fitting the metal tube 20 and the metal member 30 together, and connecting the metal tube 20 and the metal member 30 via a separate part. Among these, methods for joining the metal member 30 to the distal end of the metal tube 20 are preferably fixing by welding, brazing, bonding, etc., and more preferably welding. Fixing the distal end of the metal tube 20 to the metal member 30 increases the bonding strength between the metal tube 20 and the metal member 30. Therefore, even if the puncture device 1 is bent, the metal member 30 is less likely to come off the metal tube 20.

[0050] Examples of materials that constitute the metal member 30 include metals such as stainless steel, carbon steel, and nickel-titanium alloy. The material that constitutes the metal member 30 is preferably stainless steel. Using stainless steel as the material that constitutes the metal member 30 makes it possible to increase the rigidity of the metal member 30. This also increases the rigidity of the distal end portion of the puncture device 1, making it easier to perforate the fossa ovalis.

[0051] The diameter of a circumscribing circle of the cross-sectional shape of the metal member 30 perpendicular to the longitudinal direction at the proximal end 30p of the metal member 30 is preferably smaller than the inner diameter of the metal tube 20 at the distal end 20d of the metal tube 20. By making the diameter of the circumscribing circle of the cross-sectional shape of the metal member 30 at the proximal end 30p smaller than the inner diameter of the distal end 20d 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.

[0052] As shown in FIGS. 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.

[0053] Specific methods for joining the metal tip 40 to the distal end of the metal member 30 include, for example, welding, brazing (e.g., soldering), bonding, caulking, etc., press-fitting the metal member 30 into the metal tip 40, fitting the metal member 30 and the metal tip 40 together, and connecting the metal member 30 and the metal tip 40 via a separate part. Among these, the method for joining the metal tip 40 to the distal end of the metal member 30 is preferably fixation (e.g., welding, brazing, bonding), and more preferably welding. Fixing the distal end of the metal member 30 to the metal tip 40 allows the metal tip 40 to be firmly joined to the metal member 30. Therefore, when the metal tip 40 is pressed against the fossa ovalis during drilling the fossa ovalis, the metal tip 40 is less likely to fall off the metal member 30, resulting in a puncture device 1 with high durability.

[0054] Examples of materials that constitute the metal tip 40 include metals such as stainless steel, carbon steel, and nickel-titanium alloy. The material that constitutes the metal tip 40 is preferably the same as the material that constitutes the metal member 30. By using the same material that constitutes the metal tip 40 as the material that constitutes 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.

[0055] 2 and 3, the distal end of the metal tip 40 preferably has a curved surface shape. The curved distal end of the metal tip 40 makes it less likely for the metal tip 40 to damage a body lumen such as a blood vessel when it comes into contact with the body lumen. As a result, the metal tip 40 is less likely to damage or perforate an unintended location.

[0056] As described above, by joining the metal tube 20 of the shaft 2 to the metal member 30, and the metal member 30 to the metal tip 40, respectively, the three members, the metal tube 20, the metal member 30, and the metal tip 40, are electrically connected, allowing electricity to flow between them.

[0057] As shown in Figures 3 and 4, the resin tube 10 has a flow path 50 located 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, and as shown in Figures 2 and 3, the distal end 10d of the resin tube 10 is located between the distal end 40d and the proximal end 40p of the metal tip 40.

[0058] Furthermore, as shown in Figure 3, the resin tube 10 has an opening 11 that connects the flow path 50 to the outside of the resin tube 10, and the opening 11 is located distal to the distal end 20d of the metal tube 20 and proximal to the proximal end 40p of the metal tip 40.

[0059] The distal end 10d of the resin tube 10 is located between the distal end 40d and the proximal end 40p of the metal tip 40, and the opening 11 is located distal to the distal end 20d of the metal tube 20 and proximal to the proximal end 40p of the metal tip 40, so that the width of the flow path 50 can be increased while the rigidity of the distal end of the puncture device 1 is maintained by the metal member 30. This improves the pushability of the puncture device 1 and the ease of perforating the fossa ovalis, and further makes it possible to release a large amount of liquid such as physiological saline or contrast agent, thereby improving visibility in intracardiac echocardiography and X-ray irradiation.

[0060] 4, it is preferable that the resin tube 10 has a plurality of flow paths 50. When the resin tube 10 has a plurality of flow paths 50, the liquid can be easily discharged over a wide range in the radial direction of the resin tube 10 when it is discharged to the outside from the opening 11. As a result, it becomes easier to confirm the presence or absence of a perforation of the fossa ovalis using intracardiac echocardiography or X-ray irradiation.

[0061] The resin tube 10 may be a single tube extending from the distal end to the proximal end, or may be comprised of multiple tubes. When the resin tube 10 is comprised of multiple tubes in the longitudinal direction, the individual tubes must be joined together to form a single tube. In this case, the boundary between the joined portions does not need to be clearly defined. Although not shown, when the resin tube 10 is comprised of multiple tubes, the resin tube 10 may have a distal resin tube and a proximal resin tube, with the metal member 30 disposed in the lumen of the distal resin tube and the metal tube 20 disposed in the lumen of the proximal resin tube. An additional tube may be disposed to cover the joint between the metal tube 20 and the metal member 30. By having the distal resin tube and the proximal resin tube, the resin tube 10 can be made of a size and material suitable for the metal member 30, and the proximal resin tube can be made of a size and material suitable for the metal tube 20. This facilitates the process of disposing the metal tube 20 and the metal member 30 in the lumen of the resin tube 10.

[0062] When the resin tube 10 has a distal resin tube and a proximal resin tube, the proximal end of the distal resin tube is preferably located closer to the proximal side than the distal end of the proximal resin tube (not shown). By having the proximal end of the distal resin tube located 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 a lumen in the body, it is possible to prevent liquids such as blood from entering the lumen of the resin tube 10 through a gap between the distal resin tube and the proximal resin tube.

[0063] The length of the overlapping portion between 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 joining strength. 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.

[0064] Furthermore, it is preferable that the proximal end of the distal-side resin tube is disposed in the lumen of the proximal-side resin tube. By disposing the proximal end of the distal-side resin tube in the lumen of the proximal-side resin tube, the distal end of the proximal-side resin tube can be brought into close contact with the outer surface of the distal-side 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 from between the distal-side resin tube and the proximal-side resin tube.

[0065] The proximal end of the distal resin tube is preferably joined without any gaps to the distal end of the proximal resin tube. By joining the proximal end of the distal resin tube to the proximal resin tube without any gaps, when electricity is applied to the metal tip 40 via the metal tube 20, it is possible to prevent current traveling through the metal tube 20, the metal member 30, the metal tip 40, etc. from leaking out through the gap between the distal resin tube and the proximal resin tube.

[0066] 2 and 3, the outer diameter of the resin tube 10 at the portion where the distal end 20d 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. By making the outer diameter of the resin tube 10 at the portion where the distal end 20d of the metal tube 20 is located larger than the outer diameter of the resin tube 10 at the portion where the distal end of the metal member 30 is located, it is possible to form a small diameter portion 34 on the distal side and a large diameter portion 33 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, by configuring the small diameter portion 34 so that only the small diameter portion 34 is exposed from the dilator, it is possible to easily control the length of the puncture device 1 exposed from the dilator.

[0067] Fig. 6 is a plan view of the distal end of a puncture device 1 in another embodiment of the present invention, Fig. 7 is a cross-sectional view along the longitudinal direction of this puncture device 1, and Figs. 8 and 9 are cross-sectional views perpendicular to the longitudinal direction of this puncture device 1. In Figs. 6 and 7, the right side of the figure is the proximal side and the left side of the figure is the distal side.

[0068] As shown in FIGS. 6 and 7 , the metal member 30 has an inner cavity that opens at least proximally. The metal member 30 includes 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 preferably includes 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 with the inner cavity of the metal tube 20. The hole 32 may be provided in the small-diameter portion 34. There may be one or more holes 32. When there are multiple holes 32, they may be provided in the longitudinal and circumferential directions of the metal member 30. At the opening 11 at the distal end 10d of the resin tube 10, multiple holes 32 may be provided in the circumferential direction of the metal member 30 to release liquid from the entire periphery of the resin tube 10.

[0069] The large-diameter portion 33 of the metal member 30 increases the rigidity of the proximal side of the metal member 30 where the large-diameter portion 33 is present, improving the pushability of the puncture device 1 and the ease of perforating the fossa ovalis. The small-diameter portion 34 of the metal member 30 increases the space between the outer surface of the distal side of the metal member 30 where the small-diameter portion 34 is present and the inner surface of the resin tube 10, widening the flow path 50. This increases the flow rate of the liquid released from the puncture device 1, making it possible to improve visibility in intracardiac echocardiography and X-ray irradiation.

[0070] As shown in Fig. 7, the lumen of the metal member 30 has an opening at least on the proximal side. The proximal end of the lumen of the metal member 30 communicates with the lumen of the metal tube 20. The distal end of the lumen of the metal member 30 may coincide with the distal end of the metal member 30, or may be located inside the distal end of the metal member 30, i.e., on the proximal side of 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 lumen 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. 7.

[0071] In the puncture device 1 in which the metal member 30 is provided with a large diameter portion 33, a small diameter portion 34, and a hole 32, 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 it 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 echocardiography and X-ray irradiation.

[0072] The outer diameter of the large-diameter portion 33 is preferably at least 1.1 times, more preferably at least 1.3 times, and even more preferably at least 1.5 times the outer diameter of the small-diameter portion 34. 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, where the large-diameter portion 33 is located, is sufficiently increased, and a sufficient space can be secured between the outer surface of the distal side of the metal member 30, where the small-diameter portion 34 is located, and the inner surface of the resin tube 10. Furthermore, the outer diameter of the large-diameter portion 33 is preferably at most 2 times, more preferably at most 1.8 times, and even more preferably at most 1.6 times 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, thereby improving minimal invasiveness.

[0073] Next, a second lancing device of the present invention will be described. In the description of the second lancing device, parts that overlap with the above description will be omitted.

[0074] Fig. 16 is a plan view of the distal end of a second puncturing device 1 in an embodiment of the present invention, and Fig. 17 is a cross-sectional view along the longitudinal direction of the puncturing device 1. Fig. 18 is a plan view of the distal end of a second puncturing device 1 in another embodiment of the present invention, and Fig. 19 is a cross-sectional view along the longitudinal direction of the puncturing device 1.

[0075] The second puncture device 1 of the present invention comprises a resin tube 10 having a distal end 10d and a proximal end and extending in the longitudinal direction, a metal tube 20 arranged in the inner cavity of the resin tube 10, a metal member 30 arranged at the distal end of the metal tube 20, and a metal tip 40 arranged at the distal end of the metal member 30, the resin tube 10 having a flow path 50 located between the inner surface of the resin tube 10 and the outer surface of the metal member 30 and communicating with the inner cavity of the metal tube 20, and further having an opening 11 connecting the flow path 50 with the outside of the resin tube 10, the opening 11 being located distal to the distal end 20d of the metal tube 20 and proximal to the proximal end 40p of the metal tip 40.

[0076] The distal end 10d of the resin tube 10 may be located between the distal end 40d and the proximal end 40p of the metal tip 40, as shown in Figures 2 and 3, or may be located proximal to the proximal end 40p of the metal tip 40, as shown in Figures 16 to 19. Furthermore, when the distal end 10d of the resin tube 10 is located proximal to the proximal end 40p of the metal tip 40, as shown in Figures 16 and 17, it is preferable that the distal end of the flow path 50 coincides with the distal end 10d of the resin tube 10. By having the distal end 10d of the resin tube 10 located proximal 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 liquid such as physiological saline or contrast agent in the flow path 50 is released from the distal end 10d of the resin tube 10 to the outside of the resin tube 10. That is, 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 that is 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, thereby improving visibility in intracardiac echocardiography and X-ray irradiation. The liquid flows through the flow path 50 along 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 opposing surface 41 changes the flow direction of the liquid to the radial direction of the resin tube 10.

[0077] 18 and 19, when the metal member 30 has a hole 32, the distal end 10d of the resin tube 10 is preferably located distal to the hole 32. By having the distal end 10d of the resin tube 10 located distal to the hole 32, the liquid that passes through the lumen of the metal tube 20 and the metal member 30 and is released from the hole 32 moves into the lumen of the resin tube 10 and is released from the distal end 10d of the resin tube 10. As a result, the liquid in the flow path 50 can be diffused over a wide range in the radial direction of the resin tube 10, which makes it possible to improve visibility in intracardiac echocardiography and X-ray irradiation.

[0078] 7, the metal member 30 has a transition section 35, which tapers distally, 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 via the hole 32 to the space between the inner surface of the resin tube 10 and the outer surface of the portion 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, making it easier to release a large amount of liquid from the pricking device 1.

[0079] 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 manner. Among these, it is preferable that the transition section 35 tapers in diameter from the proximal end to the distal end of the transition section 35. Tapering the diameter of the transition section 35 from the proximal end to the distal end of the transition section 35 as a whole reduces resistance when the liquid passing through the hole 32 comes into contact with the outer surface of the transition section 35. This reduces the pressure loss of the liquid as it passes through the space between the inner surface of the resin tube 10 and the outer surface of the metal member 30, thereby increasing the flow velocity and flow rate of the liquid released from the resin tube 10.

[0080] As shown in FIG. 7 , it is preferable that the large-diameter section 33 and the transition section 35 have lumens, while the small-diameter section 34 does not. In other words, it is preferable that the lumen of the metal member 30 is located proximal to the small-diameter section 34. The large-diameter section 33 and the transition section 35 have lumens, which allows the flow rate of the liquid from the lumen of the metal tube 20 to the hole 32 to be increased while maintaining a certain level of liquid flow rate. Furthermore, the small-diameter section 34 does not have a lumen, which allows the rigidity of the distal end of the resin tube 10, where the small-diameter section 34 is located, to be increased while maintaining a sufficient space between the outer surface of the small-diameter section 34 and the inner surface of the resin tube 10. As a result, the puncture device 1 can be made to have good pushability, facilitate perforation of the fossa ovalis, and be capable of discharging a large amount of liquid, such as saline or contrast agent, over a wide area, resulting in good visibility in intracardiac echocardiography and X-ray irradiation.

[0081] 3 and 7, the opening 11 is preferably arranged on a plane perpendicular to the longitudinal direction of the resin tube 10. By arranging the opening 11 on a plane perpendicular to the longitudinal direction of the resin tube 10, the liquid in the flow path 50 can be released in a direction along the longitudinal direction of the resin tube 10. In other words, it becomes possible to release a liquid such as saline or a contrast agent toward the distal or proximal side, allowing the liquid to be released over a wide area and improving visibility in intracardiac echocardiography and X-ray irradiation.

[0082] As shown in FIG. 3 , the opening 11 is an opening facing the distal side, and the liquid discharged from the opening 11 preferably comes into contact with the proximal end 40p of the metal tip 40. When the liquid discharged from the opening 11 comes into contact with the proximal end 40p of the metal tip 40, some of the liquid discharged from the opening 11 bounces off the proximal end 40p of the metal tip 40, discharging the liquid not only to the distal side but also to the proximal side. As a result, the liquid can be dispersed over a wider area, improving visibility in intracardiac echocardiography and X-ray irradiation. Note that, as shown in FIG. 3 , if the proximal end 40p of the metal tip 40 is covered with another member, such as a resin tube 10, indirect contact of the liquid discharged from the opening 11 with the proximal end 40p of the metal tip 40 via the other member is also included in the term "contact of the liquid discharged from the opening 11 with the proximal end 40p of the metal tip 40."

[0083] As shown in Fig. 7, it is also preferable that the opening 11 faces the proximal side. By having the opening 11 face the proximal side, the liquid discharged from the opening 11 can be discharged toward the proximal side. This allows the liquid, such as saline or contrast agent, to be diffused over a wide area including the proximal side, improving visibility in intracardiac echocardiography and X-ray irradiation.

[0084] Fig. 10 is a plan view of the distal end of a puncture device 1 in yet another embodiment of the present invention, Fig. 11 is a cross-sectional view along the longitudinal direction of this puncture device 1, and Figs. 12 and 13 are cross-sectional views perpendicular to the longitudinal direction of this puncture device 1. In Figs. 10 and 11, the right side of the figure is the proximal side and the left side of the figure is the distal side.

[0085] 10 to 13, the metal member 30 preferably has a recess 31 extending in the longitudinal direction of the metal member 30. When the metal member 30 has the recess 31 extending in the longitudinal direction, it is easy to form a flow path 50 between the inner surface of the resin tube 10 and the outer surface of the metal member 30, and it is also possible to ensure a sufficient cross-sectional area of ​​the flow path 50. Therefore, the amount of liquid released from the opening 11 can be increased.

[0086] In a cross section perpendicular to the longitudinal direction, the maximum distance between the recess 31 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 31 and the inner surface of the resin tube 10 to the maximum length of the metal member 30 within the above range, the cross-sectional area of ​​the flow channel 50 in a cross section perpendicular to the longitudinal direction can be ensured, and a sufficient amount of liquid can pass through the flow channel 50. Furthermore, in a cross section perpendicular to the longitudinal direction, the maximum distance between the recess 31 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 31 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.

[0087] The cross-sectional shape of the metal member 30 perpendicular to the longitudinal direction may be, for example, a circle, an ellipse, a polygon, a star, a cross, an H-shape, a U-shape, a mountain shape, or a combination thereof. Furthermore, the cross-sectional shape of the metal member 30 is preferably a shape having a notch formed therein for forming the flow path 50. The notch on the cross-sectional shape corresponds to the recess 31 extending in the longitudinal direction of the metal member 30. When the inner surface of the resin tube 10 and a portion of the outer surface of the metal member 30 are configured to be in planar contact with each other, the flow path 50 can be easily formed by forming a cross-section of the metal member 30 with a notch formed therein for forming the flow path 50. When the inner surface of the resin tube 10 and the outer surface of the metal member 30 are configured to be in point contact with each other in the cross-section, the cross-sectional shape of the metal member 30 perpendicular to the longitudinal direction is 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 metal member 30 are not in contact with each other, the cross-sectional shape of the metal member 30 perpendicular to the longitudinal direction can be any shape.

[0088] 12 and 13, the metal member 30 preferably has a plurality of recesses 31. By having a plurality of recesses 31 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 range in the radial direction of the resin tube 10.

[0089] 4 and 8, the cross section perpendicular to the longitudinal direction of the metal member 30 preferably has a polygonal shape. By having the cross section perpendicular to the longitudinal direction of the metal member 30 have a polygonal shape, 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.

[0090] In the present invention, the term "polygon" refers to polygons with clearly defined corners 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 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 to form a flow path 50 between the resin tube 10 and the metal member 30.

[0091] It is particularly preferable that the cross-sectional shape perpendicular to the longitudinal direction of the metal member 30 is rectangular. By making the cross-sectional shape perpendicular to the longitudinal direction of the metal member 30 rectangular, it is possible to achieve both the strength of the metal member 30 and the size of the flow path 50.

[0092] As shown in Figures 7 to 9, the cross-sectional shape of the metal member 30 perpendicular to the longitudinal direction is preferably circular for the large-diameter portion 33 and polygonal for the small-diameter portion 34. By having the large-diameter portion 33 and the small-diameter portion 34 circular and polygonal for the large-diameter portion 33, the large-diameter portion 33 of the metal member 30 conforms to the inner diameter of the metal tube 20, increasing the bonding strength between the metal member 30 and the metal tube 20. Furthermore, 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 channel 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 notch in the cross-sectional shape described above to form the flow channel 50. In a configuration in which the inner surface of the resin tube 10 and a portion of the outer surface of the small diameter portion 34 of the metal member 30 are in planar contact with each other, the cross section of the small diameter portion 34 can be shaped to have a notch for forming the flow path 50, thereby making it easy to form the flow path 50. In a configuration in which the inner surface of the resin tube 10 and the outer surface of the small diameter portion 34 are in contact at a point 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 a configuration in which 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.

[0093] 8 and 12, 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, it is possible to increase the rigidity of the portion of the distal end of the pricking device 1 where the metal member 30 is present. This improves the insertability of the pricking device 1.

[0094] 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. Furthermore, 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.

[0095] 3, 4, 11 and 12, it is preferable that the metal member 30 has a portion where at least a part of the outer surface of the metal member 30 is in contact with the inner surface of the resin tube 10. When the metal member 30 has a portion where at least a part of the outer surface of the metal member 30 is in contact with the inner surface of the resin tube 10, the rigidity of the distal end portion of the puncture device 1 where the metal member 30 is present can be increased by the metal member 30, and the puncture device 1 can have good insertability.

[0096] It is preferable that a part 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 part 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 contacting part becomes the part that maintains the strength of the distal end of the puncture device 1.

[0097] When at least a portion of the outer surface of the metal member 30 is in contact with the inner surface of the resin tube 10, it is preferable that the metal member 30 be in planar contact with the inner surface of the resin tube 10 at multiple locations in a cross section perpendicular to the longitudinal direction of the metal member 30, as shown in Fig. 12. When the metal member 30 is in planar contact with the inner surface of the resin tube 10 at multiple locations, multiple flow paths 50 are present, and when the liquid is discharged to the outside from the opening 11, the liquid can be easily discharged over a wide range in the radial direction of the resin tube 10.

[0098] 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 resin tube 10 is preferably 10% or more, more preferably 20% or more, and even more preferably 30% or more of the length of the outer surface of the metal member 30. By setting the lower limit of the ratio of the length of the metal member 30 in planar contact with the inner surface of the resin tube 10 to the length of the outer surface of the metal member 30 within the above range, the length of the contact portion between the resin tube 10 and the metal member 30 in the cross section perpendicular to the longitudinal direction can be made sufficient. As a result, liquid fed into the flow path 50 is prevented from flowing between the resin tube 10 and the metal member 30 in a portion other than the flow path 50, thereby ensuring the amount of liquid discharged from the distal end 10d of the resin tube 10. Furthermore, 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 resin tube 10 is preferably 50% or less, more preferably 45% or less, and even more preferably 40% or less of the length of the outer surface of the metal member 30. By setting the upper limit of the ratio between the length of the metal member 30 that is in planar contact with the inner surface of the resin tube 10 and the length of the outer surface of the metal member 30 within the above range, the cross-sectional area of ​​the flow path 50 in a cross section perpendicular to the longitudinal direction can be increased, making it possible to increase the amount of liquid released from the distal end 10d of the resin tube 10.

[0099] 7 and 8, 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, thereby increasing the flow rate of the liquid passing through the flow path 50.

[0100] 9, the metal member 30 is preferably in planar contact with the inner surface of the metal tube 20. By having the metal member 30 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 lumen in the body. The length of the metal member 30 in planar contact with the inner surface of the metal tube 20 in a cross section perpendicular to the longitudinal direction of the metal member 30 can be selected in consideration of the bonding strength between the metal tube 20 and the metal member 30 and the flow rate of the flow path 50.

[0101] 2, 3, 6, 7, 10, and 11, the resin tube 10 preferably has an opposing surface 14 that faces the opening 11, on the proximal side of the proximal end 40p of the metal tip 40. By having the opposing surface 14, the liquid in the flow path 50 that is released from the opening 11 easily comes into contact with the opposing surface 14. The liquid that comes into contact with the opposing surface 14 bounces back, making it possible to release the liquid over a wide area, and improving visibility in intracardiac echocardiography and X-ray irradiation.

[0102] 2 and 3, the resin tube 10 preferably has a constricted portion 15 proximal to the opposing surface 14, the constricted portion 15 having an outer diameter smaller than the outer diameter proximal to the opening 11. By having the resin tube 10 have the constricted portion 15, the liquid in the flow path 50 released from the opening 11 can easily come into contact with the opposing surface 14, and most of the liquid can be bounced off by the opposing surface 14, allowing the liquid to be dispersed over a wide area. As a result, it is possible to improve visibility in intracardiac echocardiography and X-ray irradiation.

[0103] The minimum outer diameter of the constricted portion 15 is preferably 0.8 times or less, more preferably 0.7 times or less, and even more preferably 0.6 times or less, the maximum outer diameter of the resin tube 10 proximal to the opening 11. By setting the upper limit of the ratio of the minimum outer diameter of the constricted portion 15 to the maximum outer diameter of the resin tube 10 proximal to the opening 11 within the above range, the liquid in the flow path 50 released from the opening 11 is more likely to be released toward the opposing surface 14 without being blocked by the constricted portion 15. Furthermore, the minimum outer diameter of the constricted portion 15 is preferably 0.2 times or more, more preferably 0.25 times or more, and even more preferably 0.3 times or more, the maximum outer diameter of the resin tube 10 proximal to the opening 11. By setting the lower limit of the ratio of the minimum outer diameter of the constricted portion 15 to the maximum outer diameter of the resin tube 10 proximal to the opening 11 within the above range, the strength of the constricted portion 15 can be sufficiently maintained, and the durability of the distal end of the puncture device 1 can be ensured.

[0104] As shown in FIG. 3, the resin tube 10 has a contact portion 16 that contacts the metal member 30, and the opening 11 is preferably located proximal to the contact portion 16. Because the contact portion 16 is the portion where the resin tube 10 contacts the metal member 30, it has a smaller outer diameter than other portions of the resin tube 10. Therefore, by having the opening 11 located proximal to the contact portion 16, when the liquid in the flow path 50 is released from the opening 11, the liquid heading toward the distal side is less likely to come into contact with the contact portion 16, allowing the liquid to be released over a wide area. As a result, the puncture device 1 can be made highly visible in intracardiac echocardiography and X-ray irradiation.

[0105] 11, the resin tube 10 has a contact portion 16 that contacts the metal member 30, and the opening 11 is preferably located distal to the contact portion 16. By having the opening 11 located distal to the contact portion 16, when the liquid in the flow path 50 is released from the opening 11, the liquid moving toward the proximal side is less likely to come into contact with the contact portion 16, making it possible to release the liquid over a wide area, thereby improving visibility in intracardiac echocardiography and X-ray irradiation.

[0106] Figure 14 is an enlarged view of the distal end of a puncture device 1 in a different embodiment of the present invention, and Figure 15 is an enlarged view of the distal end of a puncture device 1 in yet another embodiment of the present invention. In Figures 14 and 15, the right side of the figure is the proximal side and the left side of the figure is the distal side.

[0107] 14, resin tube 10 has, proximal to opposing surface 14, a constricted portion 15 whose outer diameter is smaller than the outer diameter of the portion proximal to opening 11, and constricted portion 15 preferably has a tapered portion 15a whose outer diameter decreases from the proximal side to the distal side. Because constricted portion 15 has tapered portion 15a, more of the liquid in flow path 50 released from opening 11 flows toward opposing surface 14, where it is bounced off opposing surface 14 and diffuses toward the proximal side. As a result, it is possible to release liquid such as saline or contrast agent over a wide area, improving visibility in intracardiac echocardiography and X-ray irradiation.

[0108] The outer diameter of the entire or a portion of the constricted portion 15 in the reduced diameter section 15 may decrease from the proximal side to the distal side in a tapered, stepped, uneven, or wavy manner. It is particularly preferable that the reduced diameter section 15a decrease in diameter in a tapered manner from the proximal end to the distal end of the constricted portion 15. By tapering the diameter of the reduced diameter section 15a from the proximal end to the distal end of the constricted portion 15, most of the liquid released from the opening 11 tends to come into contact with the opposing surface 14, allowing a larger amount of liquid to be diffused over a wider area, improving visibility in intracardiac echocardiography and X-ray irradiation.

[0109] 15, resin tube 10 preferably has, proximal to opposing surface 14, a constricted portion 15 whose outer diameter is smaller than the outer diameter of the portion proximal to opening 11, and constricted portion 15 preferably has an expanding diameter portion 15b whose outer diameter expands from the proximal side to the distal side. Since constricted portion 15 has expanding diameter portion 15b, the opening size of opening 11 can be increased, making it possible to increase the amount of liquid in flow path 50 that is released from opening 11. This allows a large amount of liquid, such as saline or contrast agent, to be released from opening 11, improving visibility in intracardiac echocardiography and X-ray irradiation.

[0110] The outer diameter of the entire or a portion of the constricted portion 15 may increase from the proximal side to the distal side in a tapered, stepped, uneven, or wavy manner. It is particularly preferable that the outer diameter of the entire constricted portion 15 is increased in a tapered manner from the proximal end to the distal end of the constricted portion 15. By increasing the diameter of the entire constricted portion 15 in a tapered manner from the proximal end to the distal end of the constricted portion 15, the size of the opening 11 can be increased while still ensuring a sufficient size of the facing surface 14. This allows the liquid released from the opening 11 to be repelled by the facing surface 14, spreading the liquid over a wide area and improving visibility in intracardiac echocardiography and X-ray irradiation.

[0111] The constricted portion 15 may have either the reduced diameter portion 15a or the expanded diameter portion 15b, or both. When the constricted portion 15 has both the reduced diameter portion 15a and the expanded diameter portion 15b, the reduced diameter portion 15a is preferably located proximal to the expanded diameter portion 15b. The constricted portion 15 has the reduced diameter portion 15a and the expanded diameter portion 15b distal to the reduced diameter portion 15a. This allows the liquid in the flow path 50 released from the opening 11 to flow distally along the reduced diameter portion 15a, with some of the liquid returning to the proximal side via the expanded diameter portion 15b. Therefore, some of the liquid released from the opening 11 flows distally and some flows proximally, allowing the liquid to be dispersed over a wide area. This improves visibility in intracardiac echocardiography and X-ray imaging.

[0112] Although not shown, the metal tip 40 has an inner 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 inner cavity of the metal tip 40, the contrast of the metal tip 40 against X-rays 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.

[0113] The radiopaque marker can be made of a radiopaque substance such as lead, barium, iodine, tungsten, gold, platinum, iridium, platinum-iridium alloy, stainless steel, titanium, palladium, or cobalt-chromium alloy. Among these, a platinum-iridium alloy is preferable. By using a platinum-iridium alloy as the material for the radiopaque marker, the radiopaque contrast can be improved, making it easier to confirm the position of the metal tip 40 by X-ray irradiation.

[0114] The shape of the radiopaque marker may be a sphere, a cylinder, a polygonal tube, a tube with a slit and a C-shaped cross section, a coil shape formed by winding a wire, a columnar shape, a polygonal prism shape, etc. The radiopaque marker may be disposed in a location other than the lumen of the metal tip 40. Furthermore, the number of radiopaque markers may be one or more.

[0115] 7, the resin tube 10 preferably has a reinforcing member 13 distal to the distal end 20d of the metal tube 20. By having the reinforcing member 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 member 13, increasing its rigidity. This allows the puncture device 1 to have good pushability and to easily puncture the fossa ovalis.

[0116] The reinforcing material 13 may be, for example, a layered tubular member 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.

[0117] Examples of materials constituting the reinforcing material 13 include metals such as stainless steel, titanium, nickel-titanium alloy, cobalt-chromium alloy, and tungsten alloy, and synthetic resins such as polyarylate resin, aramid resin, and polyolefin resin 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.

[0118] The reinforcing member 13 is preferably a tubular metal member, and is disposed on the inner surface of the resin tube 10, as shown in Fig. 7. By disposing the reinforcing member 13 on the inner surface of the resin tube 10, the rigidity of the entire distal end of the resin tube 10 is increased, while the surface of the distal end of the resin tube 10 is made smooth, thereby improving the slidability of the resin tube 10. When the reinforcing member 13, which is a tubular member, is disposed on the inner surface of the resin tube 10, the flow path 50 is located between the inner surface of the reinforcing member 13 and the outer surface of the metal member 30 of the resin tube 10.

[0119] As described above, the puncture device of the present invention includes 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 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 including a flow path communicating with the lumen of the metal tube, the distal end of the resin tube being between the distal and proximal ends of the metal tip, and the resin tube being including an opening communicating the flow path with the outside of the resin tube, the opening being distal to the distal end of the metal tube and proximal to the proximal end of the metal tip. This configuration of the puncture device of the present invention allows the width of the flow path and the size of the opening to be increased while maintaining the rigidity of the distal end of the puncture device, which is necessary for ease of inserting the puncture device into a biological lumen such as a blood vessel and for ease of puncturing the fossa ovalis. This allows liquids such as saline or contrast agents to be released over a wide area within the left atrium, improving visibility during intracardiac echocardiography and X-ray irradiation.

[0120] This application claims the benefit of priority to Japanese Patent Application No. 2021-025788, filed on February 22, 2021. The entire contents of the specification of Japanese Patent Application No. 2021-025788, filed on February 22, 2021, are incorporated herein by reference. [Explanation of symbols]

[0121] 1: Lancing 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 material 14: Opposite surface 15: Waist 15a: Reduced diameter part 15b: Expanded diameter part 16: Contact part 20: Metal tube 20d: Distal end of metal tube 30: Metal parts 30p: Proximal end of metal member 31: Recess 32: Hole 33: Large diameter section 34: Small diameter part 35: Transition part 40: Metal chip 40d: Distal end of metal tip 40p: proximal end of metal tip 41: Opposite surface 50: Flow path

Claims

1. a resin tube extending in a longitudinal direction and having a distal end and a proximal end; a metal tube disposed in the lumen of the resin tube; a metal member 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 communicating with the lumen of the metal tube; the distal end of the resin tube is located between the distal end and the proximal end of the metal tip; Furthermore, the resin tube has an opening that connects the flow path with the outside of the resin tube, A puncture device wherein the opening is distal to the distal end of the metal tube and proximal to the proximal end of the metal tip.

2. a resin tube extending in a longitudinal direction and having a distal end and a proximal end; a metal tube disposed in the lumen of the resin tube; a metal member 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 communicating with the lumen of the metal tube; Furthermore, the resin tube has an opening that connects the flow path with the outside of the resin tube, A puncture device wherein the opening is distal to the distal end of the metal tube and proximal to the proximal end of the metal tip.

3. The metal member has an inner cavity that opens at least to a proximal side, The metal member includes a large diameter portion and a small diameter portion that is disposed distally of the large diameter portion and has an outer diameter smaller than that of the large diameter portion, The puncture device according to claim 1 or 2, wherein the metal member has a hole that connects 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.

4. The puncture device according to any one of claims 1 to 3, wherein the opening is disposed on a surface perpendicular to the longitudinal direction of the resin tube.

5. The puncture device according to any one of claims 1 to 4, wherein the opening is an opening facing the distal side, and the fluid released from the opening is released in contact with the proximal end of the metal tip.

6. The pricking device according to any one of claims 1 to 4, wherein the opening is an opening facing the proximal side.

7. The pricking device according to any one of claims 1 to 6, wherein the metal member has a recess extending in the longitudinal direction of the metal member.

8. The pricking device according to any one of claims 1 to 7, wherein the cross section of the metal member perpendicular to the longitudinal direction has a polygonal shape.

9. The pricking device according to any one of claims 1 to 8, wherein a cross-sectional area of ​​the metal member in a cross section perpendicular to the longitudinal direction of the metal member is larger than a cross-sectional area of ​​the flow channel.

10. The puncture device according to any one of claims 1 to 9, wherein the metal member has a portion where at least a part of the outer surface of the metal member is in contact with the inner surface of the resin tube.

11. The puncture device according to any one of claims 1 to 10, wherein the metal member does not have a portion in contact with the inner surface of the resin tube distal to the distal end of the metal tube.

12. The puncture device according to any one of claims 1 to 11, wherein the resin tube has a surface facing the opening, located proximal to the proximal end of the metal tip.

13. The puncture device according to claim 12, wherein the resin tube has a constricted portion proximal to the opposing surface, the constricted portion having an outer diameter smaller than the outer diameter of the resin tube proximal to the opening.

14. the resin tube has a contact portion that contacts the metal member, The pricking device according to any one of claims 1 to 13, wherein the opening is located proximal to the contact portion.

15. the resin tube has a contact portion that contacts the metal member, The pricking device according to any one of claims 1 to 13, wherein the opening is located distal to the contact portion.

16. the resin tube has a constricted portion proximal to the opposing surface, the constricted portion having an outer diameter smaller than an outer diameter proximal to the opening, The puncture device according to claim 12, wherein the constricted portion has a tapered portion whose outer diameter decreases from the proximal side to the distal side.

17. the resin tube has a constricted portion proximal to the opposing surface, the constricted portion having an outer diameter smaller than an outer diameter proximal to the opening, The puncture device according to claim 12, wherein the constricted portion has an expanding portion whose outer diameter expands from the proximal side to the distal side.

18. The puncture device according to any one of claims 1 to 17, wherein the resin tube has a reinforcing material on a side distal to the distal end of the metal tube.

19. the reinforcing member is a metal tubular member, The puncture device according to claim 18, wherein the reinforcing material is disposed on the inner surface of the resin tube.

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