Puncture device

Abstract

To provide a puncture device excellent in liquid feeding properties and durability.SOLUTION: A puncture device includes: a resin tube which has a distal end and a proximal end and extends in a longitudinal direction; a first metal tube arranged in a lumen of the resin tube; a metal member arranged in a distal end part of the first metal tube; a metal chip arranged in the distal end part of the metal member; a flow passage between an inner surface of the first metal tube and an outer surface of the metal member; and a first fixed body combining the metal member and the first metal tube. The resin tube is provided with an opening communicating the flow passage and an outside of the resin tube. The opening is located on a side more distal than a distal end of the first metal tube and located on a side more proximal than a proximal side of the metal chip. The first metal tube has a first penetration part penetrating from the inner surface to the outer surface and is combined with the metal member by the first fixed body at least in the first penetration part. At least in a part of the flow passage, the first fixed body does not exist.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001] The present invention relates to a puncture device.

Background Art

[0002] In the examination and treatment of arrhythmias such as atrial fibrillation (AF) and atrioventricular reentrant tachycardia (AVRT), a catheter having an electrode is used. During examination, the operator inserts the electrode catheter into the heart cavity, measures the intracardiac potential, and identifies the abnormal site of the heart that causes the arrhythmia. During treatment, the operator performs a so-called ablation operation in which energy including a high-frequency current is passed from the electrode of the catheter to the myocardium that causes the arrhythmia, and the origin of the arrhythmia is necrotized to electrically isolate it from the heart. Further, when atrial fibrillation naturally occurs during these examinations or treatments, or when atrial fibrillation is generated to identify an abnormal part of the heart, the operator gives an electrical stimulus from the electrode of the catheter to the heart to perform defibrillation.

[0003] When performing an ablation operation, in order to deliver the catheter from the right atrium side to the left atrium side, the Brockenbrough method, which is a puncture method using a Brockenbrough needle (septum puncture needle) to puncture the fossa ovalis of the atrial septum from the right atrium to open the insertion path of the catheter, is used.

[0004] 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 septum puncture needle is pressed against the fossa ovalis, and the septum puncture needle is energized to cauterize and penetrate the fossa ovalis. In a state where the fossa ovalis is penetrated by the septum puncture needle, a liquid such as physiological saline or a contrast agent is flowed from the tip of the septum puncture needle, and it is confirmed by using intracardiac echo or X-ray irradiation that the liquid flows into the left atrium side to examine the presence or absence of perforation of the fossa ovalis.

[0005] As a septal puncture needle used in the Brockenbrough method, 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 angles for irrigating the surface of the tip electrode with supplied liquid, a liquid storage space and branched channels formed inside the insulating irrigation member, a liquid guide groove formed at the tip of the insulating irrigation member, and a liquid guide groove formed at the proximal end of the tip electrode. Patent Document 2 describes a medical device comprising a flexible, elongated member and a support spine extending from the distal end to the proximal end within the distal part of the lumen, with the proximal end of the support spine positioned within the distal part of the lumen. Patent Document 3 describes a high-frequency treatment instrument comprising a sheath, an electrode member, a tip member, and a fluid delivery means, wherein the electrode member comprises a rod-shaped electrode portion and a large-diameter portion made of insulating material and having an electrode hole, and a buffer member is provided 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 and a distal portion having an electrode and a distal surface, wherein the distal surface defines an opening and includes a non-cutting portion and a cutting portion configured to deliver energy for puncturing tissue, the distal surface of the electrode constitutes the cutting portion, a portion of the cutting portion forms a leading portion partially surrounding the opening, and the outer diameter of at least one of the distal portion of the electrosurgical device or the electrode decreases toward the distal end of the electrosurgical device. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] Japanese Patent Publication No. 2012-135338 [Patent Document 2] Special Publication No. 2016-509942 [Patent Document 3] International Publication No. 2016 / 203977 [Patent Document 4] Japanese Patent Publication No. 2019-177150 [Overview of the project] [Problems that the invention aims to solve]

[0007] After puncturing the fossa ovale with a puncture needle, a fluid such as saline solution or contrast agent is sometimes injected into the left atrium through the opening at the tip of the needle, and the penetration of the fossa ovale is confirmed using an ultrasound or X-ray fluoroscopy device. In recent years, there has been a demand for improved fluid passability within the puncture device to facilitate the injection of such fluids. Furthermore, there is also a demand for improved durability of the puncture device.

[0008] The present invention has been made in view of the above circumstances, and its purpose is to provide a puncture device with excellent fluid delivery and durability. [Means for solving the problem]

[0009] The puncture device according to an embodiment of the present invention that can solve the above problems is as follows. [1] A resin tube having a distal end and a proximal end and extending in the longitudinal direction, A first metal tube is disposed inside the lumen of the resin tube, A metal member located at the distal end of the first metal tube, A metal tip is positioned at the distal end of the aforementioned metal member, A flow path between the inner surface of the first metal tube and the outer surface of the metal member, The device comprises a first fixing body that connects the metal member and the first metal tube, The resin tube has an opening that connects the flow path to the outside of the resin tube, The opening is located distal to the distal end of the first metal tube and proximal to the proximal end of the metal tip. The first metal tube has a first through-hole that penetrates from the inner surface to the outer surface, and is bonded to the metal member by the first fixing body at least at the first through-hole. A puncture device in which the first fixed body is not present in at least a portion of the flow path.

[0010] As described above, by placing at least a portion of the first fixing body at the first penetration of the first metal tube, the amount of the first fixing body can be increased. As a result, the bonding force between the first metal tube and the metal member by the first fixing body is improved, thus improving the durability of the puncture device. Due to this improved durability, it becomes unnecessary to bond the first metal tube and the metal member with the fixing body or the like on the flow path side between the inner surface of the first metal tube and the outer surface of the metal member. In other words, the first fixing body can be omitted on the flow path side, or the amount of the first fixing body on the flow path side can be reduced, thus ensuring a wider flow path. As a result, the fluid delivery performance of the puncture device is improved.

[0011] The puncture device according to the embodiment is preferably one of the following [2] to

[17] . [2] The puncture device according to [1], wherein the distal end of the resin tube is located between the distal and proximal ends of the metal tip. [3] The puncture device according to [1] or [2], wherein the first through portion is a slit, a through hole, or a combination thereof. [4] The puncture device according to [1] or [2], wherein the first penetration portion is a slit extending in the longitudinal direction. [5] The puncture device according to any one of [1] to [4], wherein the first fixing body is located proximal to the distal end of the first metal tube. [6] The first fixation body is a weld metal, an adhesive, or a combination thereof, as described in any one of the [1] to [5] paragraphs. [7] The puncture device according to any one of the items [1] to [6], wherein the metal member extends in the longitudinal direction, and the cross-sectional shape of the metal member in a direction perpendicular to the longitudinal direction is polygonal, cruciate, H-shaped, U-shaped, V-shaped, Y-shaped, or a combination thereof. [8] The puncture device according to any one of [1] to [7], wherein the metal member extends in the longitudinal direction and has a recess extending in the longitudinal direction. [9] In a cross-section perpendicular to the longitudinal direction of the metal member, the cross-sectional area of the metal member is larger than the cross-sectional area of the flow path. The puncture device according to any one of [1] to [8].

[10] The resin tube has a diameter-expanded portion whose outer diameter expands toward the distal side on the distal side of the opening. The puncture device according to any one of [1] to [9].

[11] Further, it has a second metal tube, and the proximal end portion of the first metal tube is disposed in the inner cavity of the second metal tube. The puncture device according to any one of [1] to

[10] .

[12] Further, it includes a second fixing member that connects the first metal tube and the second metal tube. The second metal tube has a second through portion that penetrates from the inner surface to the outer surface, and is connected to the first metal tube by the second fixing member at least in the second through portion. The puncture device according to

[11] .

[13] The second through portion is a slit, a through hole, or a combination thereof. The puncture device according to

[12] .

[14] The second through portion is a slit extending in the longitudinal direction. The puncture device according to

[12] .

[15] The second fixing member is located on the proximal side of the distal end of the second metal tube. The puncture device according to any one of

[12] to

[14] .

[16] The second fixing member is a welding metal, an adhesive, or a combination thereof. The puncture device according to any one of

[12] to

[15] .

[17] The metal tip generates heat by high-frequency current. The puncture device according to any one of [1] to

[16] . [Effect of the Invention]

[0012] According to the present invention, a puncture device excellent in liquid feeding property and durability can be provided. [Brief Description of the Drawings]

[0013] [Figure 1]FIG. 1 is a plan view of a puncture device in an embodiment. [Figure 2] FIG. 2 is a plan view of the distal end portion of the puncture device of FIG. 1. [Figure 3] FIG. 3 is a view in the direction of arrow X in FIG. 2. [Figure 4] FIG. 4 is a cross-sectional view taken along line A-A of the puncture device of FIG. 3. [Figure 5] FIG. 5 is a cross-sectional view taken along line B-B of the puncture device of FIG. 3. [Figure 6] FIG. 6 is a cross-sectional view taken along line C-C of the puncture device of FIG. 2. [Figure 7] FIG. 7 is a cross-sectional view taken along line D-D of the puncture device of FIG. 2. [Figure 8] FIG. 8 is a perspective view of a first metal tube included in the puncture device of FIG. 1. [Figure 9] FIG. 9 is a perspective view of a modified example of the first metal tube of FIG. 8. [Figure 10] FIG. 10 is a cross-sectional view taken along line C-C of a modified example of the puncture device of FIG. 6. [Figure 11] FIG. 11 is a cross-sectional view taken along line C-C of a modified example of the puncture device of FIG. 6. [Figure 12] FIG. 12 is a cross-sectional view taken along line C-C of a modified example of the puncture device of FIG. 6.

DETAILED DESCRIPTION OF THE INVENTION

[0014] Hereinafter, the present invention will be described more specifically based on the following embodiments. However, the present invention is not limited by the following embodiments, and it is of course possible to appropriately modify and implement the invention within the scope that conforms to the gist of the foregoing and following descriptions, and all of them are included in the technical scope of the present invention. In each drawing, for convenience, component symbols and the like may be omitted, but in such a case, reference shall be made to the specification and other drawings. Also, the dimensions of various components in the drawings may differ from the actual dimensions because priority is given to facilitating understanding of the features of the present invention.

[0015] A puncture device according to an embodiment of the present invention comprises a resin tube having a distal end and a proximal end and extending in the longitudinal direction; a first metal tube disposed in the lumen of the resin tube; a metal member disposed at the distal end of the first metal tube; a metal tip disposed at the distal end of the metal member; a flow path between the inner surface of the first metal tube and the outer surface of the metal member; and a first fixing body connecting the metal member and the first metal tube. The resin tube has an opening that connects the flow path to the outside of the resin tube, the opening being distal to the distal end of the first metal tube and proximal to the proximal end of the metal tip; the first metal tube has a first penetration portion that penetrates from the inner surface to the outer surface, and is connected to the metal member by a first fixing body at least at the first penetration portion, and the first fixing body is absent in at least a part of the flow path.

[0016] As described above, by placing at least a portion of the first fixing body at the first penetration of the first metal tube, the amount of the first fixing body can be increased. As a result, the bonding force between the first metal tube and the metal member by the first fixing body is improved, thus improving the durability of the puncture device. Due to this improved durability, it becomes unnecessary to bond the first metal tube and the metal member with the fixing body or the like on the flow path side between the inner surface of the first metal tube and the outer surface of the metal member. In other words, the first fixing body can be omitted on the flow path side, or the amount of the first fixing body on the flow path side can be reduced, thus ensuring a wider flow path. As a result, the fluid delivery performance of the puncture device is improved.

[0017] The following describes a puncture device according to an embodiment, with reference to Figures 1 to 12. Figure 1 is a plan view of the puncture device in the embodiment. Figure 2 is a plan view of the distal end of the puncture device in Figure 1. Figure 3 is a view taken along the arrow X in Figure 2. Figure 4 is a cross-sectional view of AA in Figure 3. Figure 5 is a cross-sectional view of BB in Figure 3. Figure 6 is a cross-sectional view of CC in Figure 2. Figure 7 is a cross-sectional view of DD in Figure 2. Figure 8 is a perspective view of the first metal tube included in the puncture device in Figure 1. Figure 9 is a perspective view of a modified example of the first metal tube in Figure 8. Figure 10 is a cross-sectional view of CC of a modified example of the puncture device in Figure 6. Figure 11 is a cross-sectional view of CC of a modified example of the puncture device in Figure 6. Figure 12 is a cross-sectional view of CC of a modified example of the puncture device in Figure 6.

[0018] As shown in Figure 1, the puncture device 1 according to the embodiment preferably has a shaft 2 and a handle 3 connected to the proximal end of the shaft 2.

[0019] As shown in Figures 2, 4, 5, and 6, the puncture device 1 comprises a resin tube 10, a first metal tube 20, a metal member 30, a metal tip 40, a flow path 50, and a first fixing body 60. Specifically, it is preferable that the shaft 2 of the puncture device 1 comprises the resin tube 10, the first metal tube 20, the metal member 30, the metal tip 40, the flow path 50, and the first fixing body 60.

[0020] As shown in Figures 1, 2, 4, and 5, the resin tube 10 has a distal end 10d and a proximal end 10p and extends in the longitudinal direction 10X. The first metal tube 20 is located in the lumen 10l of the resin tube 10. The metal member 30 is located at the distal end 20D of the first metal tube 20. The metal tip 40 is located at the distal end 30D of the metal member 30. The flow path 50 is located between the inner surface 20i of the first metal tube 20 and the outer surface 30o of the metal member 30. The first fixing body 60 connects the metal member 30 and the first metal tube 20.

[0021] As shown in Figures 5 and 6, the first metal tube 20 has a first penetration portion 20t that extends from the inner surface 20i to the outer surface 20o, and is bonded to the metal member 30 by the first fixing body 60 at least at the first penetration portion 20t. By placing at least a portion of the first fixing body 60 at the first penetration portion 20t of the first metal tube 20 in this way, the amount of the first fixing body 60 can be increased. As a result, the bonding force between the first metal tube 20 and the metal member 30 by the first fixing body 60 is improved, and the durability of the puncture device 1 is improved. This makes it easier to perform, for example, perforation from the right atrium of the heart to the fossa ovale in the atrial septum using the puncture device 1.

[0022] Furthermore, as shown in Figures 4 and 6, the first fixing body 60 is not present in at least a portion of the flow path 50. As described above, durability is improved by placing at least a portion of the first fixing body 60 in the first penetration portion 20t, so it is not necessary to connect the first metal tube 20 and the metal member 30 from the flow path 50 side with a fixing body or the like. Therefore, a wide flow path 50 can be secured. Furthermore, if the first fixing body 60 is welded metal or adhesive, the surface of the first fixing body 60 usually has minute irregularities, so by reducing the amount of first fixing body 60 present in the flow path 50 or not exposing the first fixing body 60 to the flow path 50, it becomes easier to avoid a reduction in the fluid flow velocity. As a result, the fluid delivery performance of the puncture device 1 is improved. This makes it possible to efficiently release fluids such as physiological saline or contrast agent into the left atrium, and improves visibility during intracardiac echocardiography and X-ray irradiation. For this reason, it is preferable that the first fixing body 60 is not present in the entire flow path 50. The following provides a more detailed description of each part of the puncture device 1.

[0023] As shown in Figures 1, 2, 4, and 5, the resin tube 10 has a distal end 10d and a proximal end 10p, and extends in the longitudinal direction 10X. It is preferable that the lumen 10l of the resin tube 10 extends in the longitudinal direction 10X. There may be multiple lumen 10l, but it is preferable that there is one. This makes it possible to reduce the outer diameter of the resin tube 10 while increasing the cross-sectional area of ​​the lumen 10l in the direction perpendicular to the longitudinal direction 10X. As a result, it becomes easier to position the first metal tube 20, and the manufacturing of the puncture device 1 becomes easier.

[0024] It is preferable that 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. Having the distal end 10d of the resin tube 10 located between the distal end 40d and the proximal end 40p of the metal tip 40 makes it easier to improve the rigidity between them.

[0025] The resin tube 10 preferably contains an insulating material, and more preferably is made of an insulating material. Examples of insulating materials include polyolefin resins such as polyethylene and polypropylene, polyamide resins such as nylon, polyester resins such as PET, aromatic polyetherketone resins such as PEEK, polyetherpolyamide resins, polyurethane resins, polyimide resins, fluororesins such as PTFE, PFA, and ETFE, and polyvinyl chloride resins. The resin tube 10 may contain one type of synthetic resin or multiple types of synthetic resins. The insulating material allows at least the first metal tube 20 to be insulated by the resin tube 10 when the metal tip 40 is energized. At least a part of the metal member 30 may be insulated by the resin tube 10. In particular, the resin tube 10 preferably contains a fluororesin, and more preferably contains PTFE. The fluororesin improves the slipperiness of the outer surface of the resin tube 10, thereby improving the insertion of the puncture device 1.

[0026] The length of the resin tube 10 in the longitudinal direction 10X is preferably 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. This improves the rigidity of the resin tube 10. Furthermore, the outer diameter of the resin tube 10 is preferably 2.0 mm or less, more preferably 1.8 mm or less, and even more preferably 1.5 mm or less. By reducing the outer diameter in this way, the invasiveness can be reduced.

[0027] 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. This makes the resin tube 10 easier to insulate. 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. This allows the outer diameter of the resin tube 10 to be reduced, thereby reducing its invasiveness.

[0028] Although not shown in the figures, the resin tube 10 may have a reinforcing material distal to the distal end 20d of the first metal tube 20. This reinforces the distal end of the resin tube 10, increasing its rigidity. Examples of reinforcing materials include cylindrical members. The cylindrical member may be made by arranging or braiding single or stranded wires in a specific pattern. The reinforcing material can be placed on the outer surface of the peripheral wall of the resin tube 10, on the inner surface of the peripheral wall, or within the peripheral wall. Examples of materials for the reinforcing material include metals such as stainless steel, titanium, nickel-titanium alloy, cobalt-chromium alloy, and tungsten alloy, and synthetic resins such as polyarylate resins, aramid resins, and polyolefin resins such as ultra-high molecular weight polyethylene. The reinforcing material may be composed of one type of material or multiple types of materials.

[0029] The resin tube 10 may consist of a single tube extending from the proximal end to the distal end, or it may have multiple tubes extending from the proximal end to the distal end. Preferably, the multiple tubes are connected in the distal direction.

[0030] As shown in Figures 4, 5, and 6, the first metal tube 20 is positioned in the lumen 10l of the resin tube 10. Preferably, the first metal tube 20 has a lumen extending in the longitudinal direction 10X. The number of lumen extending in the longitudinal direction 10X may be multiple, but it is preferable that there be one. This makes it possible to increase the cross-sectional area of ​​the lumen in the direction perpendicular to the longitudinal direction 10X, thereby widening the flow path 50.

[0031] As shown in Figures 5, 6, and 8, the first metal tube 20 has a first penetration portion 20t that penetrates from the inner surface 20i to the outer surface 20o. The first penetration portion 20t allows for a larger amount of the first fixing body 60 to be fixed to the first metal tube 20. Furthermore, this allows for a smaller outer diameter of the shaft 2 compared to when the first fixing body 60 is placed between the first metal tube 20 and the metal member 30. The number of first penetration portions 20t is preferably one or more, and more preferably two or more. This improves durability. On the other hand, the number of first penetration portions 20t is preferably four or less, and more preferably three or less. This reduces thermal stress on the first metal tube 20 when fixing the first fixing body 60 to the first penetration portions 20t.

[0032] When there are multiple first penetrations 20t, it is preferable that at least two of them are positioned opposite each other, as shown in Figures 6 and 8. Furthermore, when there are multiple first penetrations 20t, it is preferable that each first penetration 20t is positioned at equal intervals in the circumferential direction of the first metal tube 20. For example, as shown in Figure 11, when there are three first penetrations 20t, it is preferable that each first penetration 20t is positioned at 120-degree intervals in the circumferential direction of the first metal tube 20. This improves durability against pressure from multiple directions.

[0033] The shape of the first penetration portion 20t is preferably a slit, a through hole, or a combination thereof, with a slit being more preferable. The closer the shape of the first penetration portion 20t is to a slit, the higher the ratio of the contact area with the first metal tube 20 to the total surface area of ​​the first fixing body 60 can be, thus improving durability.

[0034] The first penetration portion 20t is preferably a slit extending in the longitudinal direction 10X. This improves durability against loads applied in the longitudinal direction 10X, making it easier to puncture with the puncture device 1.

[0035] When the shape of the first penetration portion 20t is a slit, the shape of the slit on the outer surface 20o of the first metal tube 20 is preferably linear, wavy, zigzag, arc-shaped, spiral, or a combination thereof, more preferably linear, wavy, zigzag, or a combination thereof, and even more preferably linear. Furthermore, it is preferable that these slits extend in the longitudinal direction 10X.

[0036] When the shape of the first through-hole 20t is a through-hole, the shape of the through-hole on the outer surface 20o of the first metal tube 20 is preferably round, elliptical, polygonal, or a combination thereof, more preferably elliptical, polygonal, or a combination thereof, and even more preferably elliptical. As for the polygonal shape, it is preferably triangular, quadrilateral, pentagonal, or hexagonal, more preferably quadrilateral, and even more preferably rectangular. The polygon may also have a rounded corner shape, where at least one corner is rounded.

[0037] The distal end of the first penetration portion 20t is preferably located at the distal end 20d of the first metal tube 20, as shown in Figure 8. In this structure where the distal end of the first penetration portion 20t is open, heat can be easily dissipated when the first metal tube 20 and the metal member 30 are joined, for example, by welding, thus reducing thermal stress on the first metal tube 20. In this open structure, when the first metal tube 20 and the metal member 30 are joined, for example, by adhesive, the adhesive is more easily exposed to air and hardens more easily, thus improving manufacturing efficiency. On the other hand, as shown in Figure 9, the distal end of the first penetration portion 20t may be located proximal to the distal end 20d of the first metal tube 20.

[0038] As shown in Figure 12, it is preferable that a portion of the metal member 30 is positioned at the first penetration portion 20t of the first metal tube 20. This makes it difficult for the metal member 30 to move in the circumferential direction of the first metal tube 20. Such an arrangement can be manufactured, for example, by positioning a portion of the metal member 30 at the first penetration portion 20t of the first metal tube 20, crimping it, and then welding, bonding, etc., to the first penetration portion 20t and its vicinity to join the first metal tube 20 and the metal member 30 with the first fixing body 60.

[0039] The first metal tube 20 preferably contains a metal, and more preferably is made of a metal. Examples of metals include stainless steel, carbon steel, and nickel-titanium alloy, with stainless steel being preferred. Stainless steel increases the rigidity of the first metal tube 20, thereby improving the pushability of the puncture device 1. The first metal tube 20 may contain one type of metal or multiple types of metals.

[0040] The length of the first metal tube 20 in the longitudinal direction 10X is preferably 5 mm or more and 20 mm or less. The outer diameter of the first metal tube 20 is preferably 0.4 mm or more, more preferably 0.5 mm or more, and even more preferably 0.6 mm or more. This increases the rigidity of the first metal tube 20 and improves the pushability of the puncture device 1. Furthermore, the outer diameter of the first metal tube 20 is preferably 1.5 mm or less, more preferably 1.2 mm or less, and even more preferably 1.0 mm or less. This allows the outer diameter of the resin tube 10 to be reduced, thereby reducing invasiveness.

[0041] The thickness of the first metal tube 20 is preferably 50 μm or more and 150 μm or less. This allows the rigidity of the first metal tube 20 to be maintained and the outer diameter of the resin tube 10 to be reduced, thereby reducing invasiveness.

[0042] As shown in Figures 2, 4, 5, and 6, the metal member 30 is positioned at the distal end 20D of the first metal tube 20. The metal member 30 can improve the rigidity between the metal tip 40 and the first metal tube 20. Preferably, the metal member 30 has a portion positioned in the lumen of the distal end 20D of the first metal tube 20, and more preferably, it has a portion located distal to the distal end 20d of the metal tube 20. It is also preferable to deliver the liquid by allowing it to flow along the outer surface 30o of the metal member 30.

[0043] The metal member 30 extends in the longitudinal direction 10X, and the cross-sectional shape of the metal member 30 in the direction perpendicular to the longitudinal direction 10X is preferably a polygon, a cross, an H-shape, a U-shape, a V-shape, a Y-shape, or a combination thereof, more preferably a polygon or a Y-shape, and even more preferably a polygon. These shapes make it easier to secure multiple flow paths 50 and improve the contact area between the metal member 30 and the first fixing body 60. As for the polygon, a triangle, a quadrilateral, a pentagon, or a hexagon is preferred, a quadrilateral is more preferred, and a rectangle is even more preferred. This improves the rigidity of the metal member 30. The polygon may also have a rounded corner shape, where at least one corner is rounded.

[0044] As shown in Figure 10, it is preferable that the metal member 30 extends in the longitudinal direction 10X and has recesses 31 that extend in the longitudinal direction 10X. This allows for a wider flow path 50. The number of recesses 31 may be one, but it is preferable that there be multiple recesses.

[0045] Although not shown in the figures, the cross-sectional shape of the metal member 30 in the direction perpendicular to the longitudinal direction 10X may change as the metal member 30 moves from the proximal end to the distal end in the longitudinal direction 10X. For example, the cross-sectional shape may change from a hexagon to a quadrilateral as the metal member 30 moves from the proximal end to the distal end in the longitudinal direction 10X. It is preferable that the number of sides of the polygon in the cross-section of the metal member 30 decreases as the metal member moves from the proximal end to the distal end. This improves the pushability of the puncture device 1.

[0046] Preferably, the cross-sectional area of ​​the metal member 30 in the direction perpendicular to the longitudinal direction 10X is constant from the proximal end to the distal end of the metal member 30. This constant cross-sectional area improves the rigidity of the metal member 30. A constant cross-sectional area means that the cross-sectional area is within ±5% of the average value.

[0047] It is preferable that the metal member 30 does not have a cavity. That is, it is preferable that the metal member 30 is made of a solid material. This improves the rigidity of the metal member 30.

[0048] The metal member 30 preferably contains a metal, and more preferably is made of a metal. Examples of metals include stainless steel, carbon steel, and nickel-titanium alloy, with stainless steel being preferred. Stainless steel increases the rigidity of the metal member 30, which in turn increases the rigidity of the distal end of the puncture device 1, thereby improving the pushability of the puncture device 1 and facilitating perforation of the fossa ovalis. The metal member 30 may contain one type of metal or multiple types of metals.

[0049] The length of the metal member 30 in the longitudinal direction 10X is preferably 0.5 mm or more and 3.0 mm or less, and more preferably 1.0 mm or more and 2.0 mm or less. This improves the rigidity near the opening 11.

[0050] Although not shown in the figures, the metal member 30 may have a large-diameter portion and a small-diameter portion located distal to the large-diameter portion and having a smaller outer diameter than the large-diameter portion. Furthermore, the metal member 30 may have a transition portion located distal to the large-diameter portion and proximal to the small-diameter portion, which decreases in diameter toward the distal side.

[0051] In a cross-section perpendicular to the longitudinal direction 10X of the metal member 30, it is preferable that the cross-sectional area of ​​the metal member 30 is larger than the cross-sectional area of ​​the flow path 50. This increases the rigidity of the portion where the metal member 30 is located. As a result, the insertion of the puncture device 1 is improved. Specifically, 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, than the cross-sectional area of ​​the flow path 50. On the other hand, 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, than the cross-sectional area of ​​the flow path 50. This allows for a wider flow path 50.

[0052] As shown in Figure 4, it is preferable that the metal member 30 has a portion that does not contact the inner surface of the resin tube 10 in the circumferential direction. This makes it easier to deliver liquid to the opening 11. Furthermore, as shown in Figure 5, it is more preferable that the metal member 30 has a portion that contacts the inner surface of the resin tube 10 in the circumferential direction. This protects the metal member 30.

[0053] As shown in Figure 5, it is preferable that the metal member 30 has a portion that is in contact with the inner surface of the resin tube 10 along the longitudinal direction 10X, distal to the distal end 20d of the first metal tube 20. This makes it possible to improve the strength of the portion distal to the distal end 20d of the first metal tube 20.

[0054] Preferably, the metal member 30 has multiple portions that are in planar contact with the inner surface of the resin tube 10 in a cross section perpendicular to the longitudinal direction 10X. This makes it easier to form multiple openings 11.

[0055] The first fixing body 60 connects the metal member 30 and the first metal tube 20. Furthermore, the metal member 30 is connected to the first metal tube 20 by the first fixing body 60 which is positioned at least at the first penetration portion 20t of the first metal tube 20.

[0056] The first fixing body 60 may be placed in at least a portion of the first penetration portion 20t, or it may be placed in the entire first penetration portion 20t so as to fill the first penetration portion 20t. Furthermore, it is preferable that the first fixing body 60 is fixed to at least the outer surface 30o of the metal member 30 and the inner wall of the first metal tube 20 that constitutes the first penetration portion 20t, and it is even more preferable that it is fixed to the outer surface 20o of the first metal tube 20. This improves the bonding strength between the first metal tube 20 and the metal member 30.

[0057] The first fixing body 60 is not particularly limited as long as it can connect the metal member 30 and the first metal tube 20 at least at the first penetration portion 20t of the first metal tube 20, but it is preferably weld metal, adhesive, or a combination thereof.

[0058] The weld metal is preferably a brazing material, a metal contained in the first metal tube 20, a metal contained in the metal member 30, or a mixture thereof, and more preferably a metal contained in the metal member 30. Examples of brazing materials include soft brazing materials with a melting point of less than 450°C, or hard brazing materials with a melting point of 450°C or higher, with hard brazing materials being preferred. Preferred hard brazing materials include brass brazing materials, copper brazing materials, silver brazing materials, gold brazing materials, aluminum brazing materials, nickel brazing materials, phosphorus copper brazing materials, or alloys thereof. Examples of soft brazing materials include so-called solder. Soft brazing materials are preferably those containing zinc, lead, tin, or alloys thereof.

[0059] The adhesive is preferably an epoxy adhesive, acrylic adhesive, cyano-based adhesive, polyurethane adhesive, silicone adhesive, or a mixture thereof, with epoxy adhesive or acrylic adhesive being more preferred. This improves the bonding strength between the metal member 30 and the first metal tube 20. The adhesive may be one-component or two-component, but one-component is preferred. The adhesive may also be room-temperature curing or heat-curing.

[0060] The metal member 30 and the first metal tube 20 can be joined by welding, adhesive, or the like. In the case of welding, for example, it is preferable to place at least the proximal end of the metal member 30 inside the lumen of the first metal tube 20, then crimp the first metal tube 20 as necessary, and then melt one of the metal member 30 or the first metal tube 20 near the first penetration portion 20t by arc welding, laser welding, or the like and attach it to the other, and it is more preferable to melt the metal member 30 near the first penetration portion 20t by arc welding, laser welding, or the like and attach it to the first metal tube 20, and then weld it. Alternatively, after placing at least the proximal end of the metal member 30 inside the lumen of the first metal tube 20 and crimping the first metal tube 20, welding may be performed by heating and melting a brazing material and attaching it to the first penetration portion 20t. In this case, it is preferable to melt the metal member 30.

[0061] For bonding, for example, the metal member 30 can be bonded by first placing at least its proximal end into the lumen of the first metal tube 20, then crimping the first metal tube 20 as necessary, applying adhesive to the first penetration portion 20t, and then allowing it to stand or heat-cur to cure at room temperature.

[0062] The first fixing body 60 is preferably located proximal to the distal end 20d of the first metal tube 20. For example, when welding the metal member 30 and the first metal tube 20, if the heated and molten weld metal does not come into contact with the distal end 20d of the first metal tube 20, the thermal stress on the distal end 20d can be reduced. As a result, it is easier to maintain the strength of the area near the distal end 20d of the first metal tube 20 after welding. Consequently, it is easier to avoid damage to the area near the distal end 20d of the first metal tube 20 during puncture with the puncture device 1, etc.

[0063] As shown in Figure 2, the metal tip 40 is positioned at the distal end 30D of the metal member 30. The metal tip 40 may be directly connected to the distal end 30D of the metal member 30 by another component constituting the metal tip 40, or it may be indirectly connected to the distal end 30D of the metal member 30 via an intermediate component or the like, which is a separate part from the metal member 30 and the metal tip 40. The metal tip 40 is positioned at the distal end 30D of the metal member 30, and the metal tip 40 and the metal member 30 may be a single unit, and may be connected at a joint or without a joint.

[0064] Specific methods for joining the metal tip 40 to the distal end 30D of the metal member 30 include, for example, welding, soldering or brazing, bonding, crimping, 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 methods for joining the metal tip 40 to the distal end 30D of the metal member 30, fixing by welding, brazing, or bonding is preferred, and welding is more preferred. By fixing the distal end 30D of the metal member 30 and the metal tip 40, it becomes possible to firmly bond the metal tip 40 to the metal member 30. Therefore, when the metal tip 40 is pressed against the fovea ovale, such as when drilling the fovea ovale, the metal tip 40 is less likely to fall off the metal member 30.

[0065] The metal chip 40 preferably contains a metal, and more preferably is made of a metal. Examples of metals include stainless steel, carbon steel, and nickel-titanium alloy. The metal chip 40 may contain one type of metal or multiple types of metal. It is preferable that the material constituting the metal chip 40 is the same as the material constituting the metal member 30. This makes it easier to bond the metal member 30 and the metal chip 40, and also increases the bonding strength between the metal member 30 and the metal chip 40.

[0066] The metal tip 40 preferably generates heat due to the high-frequency current. This facilitates perforation of the fossa ovalis in the septal portion of the heart. This also allows the puncture device 1 to be used as an ablation catheter. An example of an ablation catheter is one in which the distal end generates heat due to the high-frequency current, and a portion of the heart, an aneurysm, or a varicose vein is cauterized. The high-frequency current can be supplied to the metal tip 40, for example, via the first metal tube 20, metal member 30, etc.

[0067] The distal portion of the metal tip 40 preferably has a hemispherical or semi-ellipsoidal shape. This makes the distal end 40d of the metal tip 40 and its vicinity curved, making it less likely for the metal tip 40 to damage the internal lumen, such as a blood vessel, when it comes into contact with it. The hemispherical or semi-ellipsoidal portion may have an internal lumen.

[0068] Preferably, the metal tip 40 has a lumen and an X-ray opaque marker 41 is placed inside the metal tip 40. By placing the X-ray opaque marker 41 inside the lumen of the metal tip 40, the contrast-enhancing properties of the metal tip 40 to X-rays can be enhanced. 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.

[0069] The radiopaque marker 41 preferably contains an X-ray opaque material such as lead, barium, iodine, tungsten, gold, platinum, iridium, platinum-iridium alloy, stainless steel, titanium, palladium, cobalt-chromium alloy, or alloys thereof. Among these, the radiopaque material is preferably a platinum-iridium alloy. This enhances contrast enhancement and makes it easier to confirm the position of the metal tip 40 by X-ray irradiation.

[0070] The shape of the radiopaque marker 41 can be spherical, cylindrical, polygonal, C-shaped with a notch in the tube, coiled with a wire wound around it, cylindrical, polygonal prism, etc. The radiopaque marker 41 may be placed in a location other than the lumen of the metal tip 40. The number of radiopaque markers 41 may be one or multiple. The metal tip 40 and the metal member 30 may be connected via the radiopaque marker 41.

[0071] As shown in Figures 4 and 6, the channel 50 is located between the inner surface 20i of the first metal tube 20 and the outer surface 30o of the metal member 30. Liquids such as physiological saline and contrast agents can be supplied to the opening 11 through the channel 50.

[0072] The number of flow channels 50 may be one, but it is preferable to have multiple channels. This makes it easier to supply liquid to multiple openings 11 and to discharge the liquid over a wide area. As a result, it becomes easier to confirm whether or not there is perforation of the fossa ovale using intracardiac echocardiography or X-ray irradiation.

[0073] At least a portion of the flow path 50 does not contain the first adsorbent 60. As shown in Figures 4, 6, and 10, it is preferable that the entire flow path 50 does not contain the first adsorbent 60. Since the surface of the first adsorbent 60 usually has minute irregularities, reducing the amount of first adsorbent 60 present in the flow path 50 or preventing the first adsorbent 60 from being exposed in the flow path 50 makes it easier to avoid a reduction in the liquid flow velocity. As shown in Figure 11, a portion of the first adsorbent 60 may be exposed in the flow path 50. In this case, the ratio of the exposed area of ​​the first adsorbent 60 to the 100% surface area of ​​the inner wall constituting the flow path 50 is preferably 5% or less, more preferably 3% or less, and even more preferably 1% or less. The surface of the inner wall corresponds to the inner surface 20i of the first metal tube 20, the outer surface 30o of the metal member 30, and the exposed surface of the first adsorbent 60.

[0074] Although not shown in the figures, there may be other flow channels distal to the distal end 20d of the first metal tube 20 that communicate with the flow channel 50 in the longitudinal direction 10X. Preferably, the other flow channels are located between the inner surface of the resin tube 10 and the outer surface 30o of the metal member 30.

[0075] As shown in Figure 4, the resin tube 10 is provided with an opening 11 that connects the flow path 50 with the outside 10o of the resin tube 10. The opening 11 is located distal to the distal end 20d of the first metal tube 20 and proximal to the proximal end 40p of the metal tip 40. By positioning the opening 11 distal to the distal end 20d of the first metal tube 20 that forms the flow path 50, the flow velocity of the liquid from the flow path 50 to the opening 11 is less likely to decrease. Note that the opening 11 of the resin tube 10 does not include the opening of the first metal tube 20. The opening 11 may also connect the flow path 50 with the outside 10o of the resin tube 10 via the other flow path described above.

[0076] The shape of the opening 11 on the outer surface of the resin tube 10 is preferably round, elliptical, polygonal, or a combination thereof, more preferably elliptical, polygonal, or a combination thereof, and even more preferably elliptical. The polygonal shape is preferably triangular, quadrilateral, pentagonal, or hexagonal, more preferably quadrilateral, and even more preferably rectangular. The polygon may also have rounded corners, with at least one corner being rounded. Furthermore, the opening 11 is preferably extended in the longitudinal direction 10X. The distance of the opening 11 in the longitudinal direction 10X is preferably 0.1 mm or more and 1.0 mm or less.

[0077] The resin tube 10 preferably has an enlarged diameter section 13 distal to the opening 11, where the outer diameter increases toward the distal end. The enlarged diameter section 13 preferably expands in a tapered, stepped, uneven, or wavy shape from the proximal to distal end, and more preferably expands in a tapered shape. This facilitates the diffusion of the liquid released from the opening 11 radially and distally.

[0078] Preferably, the puncture device 1 further includes a second metal tube 70, and the proximal end 20P of the first metal tube 20 is positioned in the lumen 70l of the second metal tube 70. This allows the shaft 2 to be reinforced.

[0079] Preferably, the puncture device 1 further comprises a second fixing body 80 that connects the first metal tube 20 and the second metal tube 70. Furthermore, preferably, the second metal tube 70 has a second penetration portion 70t that penetrates from the inner surface 70i to the outer surface 70o. Furthermore, preferably, the second metal tube 70 is connected to the first metal tube 20 by the second fixing body 80 at least at the second penetration portion 70t.

[0080] Because the second metal tube 70 is connected to the first metal tube 20 by the second fixing body 80 at the second penetration portion 70t, the outer diameter of the shaft 2 can be made smaller than when the second fixing body 80 is placed between the second metal tube 70 and the first metal tube 20.

[0081] The second penetration portion 70t allows for an increased amount of the second fixing body 80 to be fixed to the second metal tube 70. Preferably, there is one or more second penetration portions 70t, and more preferably two or more. This improves durability. On the other hand, preferably, there are four or fewer second penetration portions 70t, and more preferably three or fewer. This reduces thermal stress on the second metal tube 70 when fixing the second fixing body 80 to the second penetration portions 70t.

[0082] When there are multiple second penetrations 70t, it is preferable that at least two of them are positioned opposite each other, as shown in Figure 7. Furthermore, when there are multiple second penetrations 70t, it is preferable that each second penetration 70t is positioned at equal intervals in the circumferential direction of the second metal tube 70. For example, if there are three second penetrations 70t, it is preferable that each second penetration 70t is positioned at 120-degree intervals in the circumferential direction of the second metal tube 70. This improves durability against pressure from multiple directions.

[0083] The second penetration portion 70t is preferably a slit, a through hole, or a combination thereof, and more preferably a slit. The closer the shape of the second penetration portion 70t is to a slit, the higher the ratio of the contact area with the second metal tube 70 to the total surface area of ​​the second fixing body 80 can be, thus improving durability.

[0084] The second penetration portion 70t is preferably a slit extending in the longitudinal direction 10X. This improves durability against loads applied in the longitudinal direction 10X, making it easier to puncture with the puncture device 1.

[0085] When the shape of the second penetration portion 70t is a slit, the shape of the slit on the outer surface 70o of the second metal tube 70 is preferably linear, wavy, zigzag, arc-shaped, spiral, or a combination thereof, more preferably linear, wavy, zigzag, or a combination thereof, and even more preferably linear. Furthermore, it is preferable that these slits extend in the longitudinal direction 10X.

[0086] When the shape of the second through-hole 70t is a through-hole, the shape of the through-hole on the outer surface 70o of the second metal tube 70 is preferably round, elliptical, polygonal, or a combination thereof, more preferably elliptical, polygonal, or a combination thereof, and even more preferably elliptical. As for the polygonal shape, it is preferably triangular, quadrilateral, pentagonal, or hexagonal, more preferably quadrilateral, and even more preferably rectangular. The polygon may also have a rounded corner shape, where at least one corner is rounded.

[0087] Preferably, the distal end of the second penetration portion 70t is located at the distal end 70d of the second metal tube 70. In this structure where the distal end of the second penetration portion 70t is open, heat can be easily dissipated when the second metal tube 70 and the first metal tube 20 are joined, for example, by welding, thus reducing thermal stress on the second metal tube 70. In addition, in this open structure, when the second metal tube 70 and the first metal tube 20 are joined, for example, by adhesive, the adhesive is more easily exposed to air and hardens more easily, thus improving manufacturing efficiency. For details on this open structure, please refer to the explanation of the second penetration portion 20t in Figure 8. On the other hand, the distal end of the second penetration portion 70t may be located proximal to the distal end 70d of the second metal tube 70.

[0088] The second penetration portion 70t is preferably a slit extending in the longitudinal direction 10X. This improves durability against loads applied in the longitudinal direction 10X, making it easier to puncture with the puncture device 1.

[0089] The second fixing body 80 is preferably located proximal to the distal end 70d of the second metal tube 70. When welding the second metal tube 70 and the first metal tube 20, if the heated and molten weld metal does not come into contact with the distal end 70d of the second metal tube 70, the thermal stress on the distal end 70d can be reduced. As a result, it is easier to maintain the strength of the area near the distal end 70d of the second metal tube 70 after welding. Consequently, it is easier to avoid damage to the area near the distal end 70d of the second metal tube 70 during puncture with the puncture device 1.

[0090] The second fixing body 80 is preferably a weld metal, an adhesive, or a combination thereof. The weld metal is preferably a brazing material, a metal contained in the first metal tube 20, a metal contained in the second metal tube 70, or a mixture thereof, and more preferably a metal contained in the first metal tube 20. Examples of brazing materials include soft brazing materials with a melting point of less than 450°C, or hard brazing materials with a melting point of 450°C or higher, with hard brazing materials being preferred. Examples of hard brazing materials include brass brazing materials, copper brazing materials, silver brazing materials, gold brazing materials, aluminum brazing materials, nickel brazing materials, phosphorus copper brazing materials, or alloys thereof. Examples of soft brazing materials include so-called solder. Examples of soft brazing materials include zinc, lead, tin, or alloys thereof.

[0091] The adhesive is preferably an epoxy adhesive, acrylic adhesive, cyanoacrylate adhesive, polyurethane adhesive, silicone adhesive, or a mixture thereof, with epoxy adhesive or acrylic adhesive being more preferred. This improves the bonding strength between the first metal tube 20 and the second metal tube 70. The adhesive may be one-component or two-component, but one-component is preferred. The adhesive may also be room-temperature curing or heat-curing.

[0092] The second metal tube 70 and the first metal tube 20 can be joined by welding, adhesive, or the like. In the case of welding, for example, after placing at least the proximal end of the first metal tube 20 into the lumen of the second metal tube 70, and crimping the second metal tube 70 as necessary, welding may be performed by heating and melting a brazing material and adhering it to the second penetration portion 70t. Alternatively, it is preferable to place at least the proximal end of the first metal tube 20 into the lumen of the second metal tube 70, crimp the second metal tube 70, and then melt one of the second metal tube 70 or the first metal tube 20 near the second penetration portion 70t by arc welding, laser welding, or the like and adhering it to the other. In this case, it is preferable to melt the first metal tube 20.

[0093] For bonding, for example, the first metal tube 20 can be placed in the lumen of the second metal tube 70, the second metal tube 70 can be crimped if necessary, and then adhesive can be applied to the second penetration portion 70t, followed by allowing it to stand at room temperature or heating to cure.

[0094] The second metal tube 70 is preferably placed in the lumen 10l of the resin tube 10. The second metal tube 70 preferably has a lumen extending in the longitudinal direction 10X. The number of lumen extending in the longitudinal direction 10X may be multiple, but it is preferable that there be one. This makes it possible to increase the cross-sectional area of ​​the lumen in the direction perpendicular to the longitudinal direction 10X, thereby enabling the delivery of a large amount of liquid.

[0095] The second metal tube 70 preferably contains a metal, and more preferably is made of a metal. Examples of metals include stainless steel, carbon steel, and nickel-titanium alloy, with stainless steel being preferred. Stainless steel increases the rigidity of the first metal tube 20, thereby improving the pushability of the puncture device 1. The second metal tube 70 may contain one type of metal or multiple types of metals.

[0096] The length of the second metal tube 70 in the longitudinal direction 10X is preferably 500 mm or more and 1200 mm or less. The outer diameter of the second metal tube 70 is preferably 0.5 mm or more, more preferably 0.7 mm or more, and even more preferably 1.0 mm or more. This increases the rigidity of the second metal tube 70 and improves the pushability of the puncture device 1. Furthermore, the outer diameter of the second metal tube 70 is preferably 2.0 mm or less, more preferably 1.8 mm or less, and even more preferably 1.5 mm or less. This increases the cross-sectional area of ​​the lumen in the section perpendicular to the longitudinal direction 10X of the second metal tube 70.

[0097] The thickness of the second metal tube 70 is preferably 100 μm or more, more preferably 150 μm or more, and even more preferably 200 μm or more. This increases the rigidity of the second metal tube 70. Furthermore, the thickness of the second metal tube 70 is preferably 350 μm or less, more preferably 300 μm or less, and even more preferably 250 μm or less. This allows the outer diameter of the resin tube 10 to be reduced, thereby reducing invasiveness.

[0098] As shown in Figure 1, the puncture device 1 preferably has a shaft 2 and a handle 3 connected to the proximal end of the shaft 2. The handle 3 preferably has a syringe port 4 for delivering liquid such as saline solution or contrast agent into the flow path 50 through the shaft 2. The presence of the syringe port 4 on the handle 3 makes it easier to deliver liquid into the flow path 50 by connecting a syringe or the like to the syringe port 4.

[0099] The handle 3 preferably has a connector 6 for supplying power to the shaft 2 and a cable 5 connecting the handle 3 and the connector 6. By connecting the connector 6 to a power supply for supplying high-frequency current, the first metal tube 20, the second metal tube 70, the metal member 30, and the metal tip 40 of the shaft 2 can be electrically connected. For example, this makes it possible to supply current from the metal tip 40 to the counter electrode plate.

[0100] It is preferable that the shaft 2 has a bent portion 12 at its distal end. Having a bent portion 12 at the distal end of the shaft 2 makes it easier to insert the puncture device 1 into the heart. The angle of the bend of the shaft 2 at the bent portion 12 can be adjusted to match the shape and condition of the internal lumen and the heart. The bent portion 12 may be located proximal to the proximal end of the metal member 30. Alternatively, the bent portion 12 may be provided in the area where the metal member 30 is located. Providing the bent portion 12 at the distal end of the shaft 2 can improve the operability of the puncture device 1. [Explanation of Symbols]

[0101] 1: Puncture device 2: Shaft 3: Handle 4: Syringe port 5: Cable 6: Connector 10: Resin tube 10d: Distal end 10p: Proximal end 10X: Longitudinal direction 10l: lumen 10o: External 11: Opening 12: Bending section 13: Expanded diameter part 20: First metal tube 20d: Distal end 20D: Distal end 20i: Inner surface 20o: outer surface 20t: 1st penetration part 30: Metal components 30D: Distal end 30o: outer surface 31: Recess 40: Metal tip 40d: Distal end 40p: Proximal end 41: X-ray opaque markers 50: Flow channel 60: First Adhesion Body 70: Second metal tube 70d: Distal end 70i: Inner surface 70l: lumen 70o: outer surface 70t: 2nd penetration part 80: Second fixing body

Claims

1. A resin tube having a distal end and a proximal end, extending in the longitudinal direction, A first metal tube is disposed inside the lumen of the resin tube, A metal member located at the distal end of the first metal tube, A metal tip is positioned at the distal end of the aforementioned metal member, A flow path between the inner surface of the first metal tube and the outer surface of the metal member, The device comprises a first fixing body that connects the metal member and the first metal tube, The resin tube has an opening that connects the flow path to the outside of the resin tube, The opening is located distal to the distal end of the first metal tube and proximal to the proximal end of the metal tip. The first metal tube has a first through-hole that penetrates from the inner surface to the outer surface, and is bonded to the metal member by a first fixing body at least at the first through-hole. A part of the metal member is placed in the first through-hole, A puncture device in which the first fixed body is not present in at least a portion of the flow path.

2. The puncture device according to claim 1, wherein the distal end of the resin tube is located between the distal and proximal ends of the metal tip.

3. The puncture device according to claim 1 or 2, wherein the first through portion is a slit, a through hole, or a combination thereof.

4. The puncture device according to claim 1 or 2, wherein the first penetration portion is a slit extending in the longitudinal direction.

5. The puncture device according to claim 1 or 2, wherein the first fixing body is located proximal to the distal end of the first metal tube.

6. The puncture device according to claim 1 or 2, wherein the first fixing body is a weld metal, an adhesive, or a combination thereof.

7. The puncture device according to claim 1 or 2, wherein the metal member extends in the longitudinal direction, and the cross-sectional shape of the metal member in a direction perpendicular to the longitudinal direction is polygonal, cross-shaped, H-shaped, U-shaped, V-shaped, Y-shaped, or a combination thereof.

8. The puncture device according to claim 1 or 2, wherein the metal member extends in the longitudinal direction and has a recess extending in the longitudinal direction.

9. The puncture device according to claim 1 or 2, wherein in a cross section perpendicular to the longitudinal direction of the metal member, the cross-sectional area of ​​the metal member is greater than the cross-sectional area of ​​the flow path.

10. The puncture device according to claim 1 or 2, wherein the resin tube has an enlarged diameter portion distal to the opening, where the outer diameter increases toward the distal end.

11. Furthermore, the puncture device according to claim 1 or 2, wherein the device further comprises a second metal tube, and the proximal end of the first metal tube is positioned in the lumen of the second metal tube.

12. Furthermore, it includes a second fixing body that connects the first metal tube and the second metal tube, The second metal tube has a second penetration portion that extends from the inner surface to the outer surface. The puncture device according to claim 11, wherein at least the second penetration portion is connected to the first metal tube by the second fixing body.

13. The puncture device according to claim 12, wherein the second through portion is a slit, a through hole, or a combination thereof.

14. The puncture device according to claim 12, wherein the second penetration portion is a slit extending in the longitudinal direction.

15. The puncture device according to claim 12, wherein the second fixing body is located proximal to the distal end of the second metal tube.

16. The puncture device according to claim 12, wherein the second fixing body is a weld metal, an adhesive, or a combination thereof.

17. The puncture device according to claim 1 or 2, wherein the metal tip generates heat due to a high-frequency current.

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