Drilling device and method for manufacturing the same

Abstract

To provide a puncture device which is excellent in durability on a coupling part of a plurality of metal tubes.SOLUTION: A puncture device comprises: a first resin tube; a first metal tube which is arranged in a lumen of the first resin tube; a metal member which is arranged on a distal end part of the first metal tube; a metal chip which is arranged on a distal end part of the metal member; a channel which is provided between an inner surface of the first metal tube and an outer surface of the metal member; and a second metal tube which includes a proximal end part of the first metal tube. The first resin tube has an opening for communicating the channel with an external part of the first resin tube, the second resin tube has a second penetration part which penetrates from the inner surface toward the outer surface, and on at least the second penetration part, the puncture device is coupled to the first metal tube by a second fastening body.SELECTED DRAWING: Figure 5

Description

Technical Field

[0001] The present invention relates to a puncture device and a method for manufacturing the same.

Background Art

[0002] Catheters having electrodes are used in the examination and treatment of arrhythmias such as atrial fibrillation (AF) and atrioventricular reentrant tachycardia (AVRT). During examination, an operator inserts an electrode catheter into the heart chamber, measures intracardiac potential, and identifies abnormal sites in the heart that cause arrhythmia. During treatment, the operator performs so-called ablation surgery, in which energy including high-frequency current is supplied from the electrode of the catheter to the myocardium causing the arrhythmia, and the source of the arrhythmia is necrosed to be electrically isolated from the heart. In addition, when atrial fibrillation occurs spontaneously during these examinations or treatments, or when atrial fibrillation is induced to identify abnormal sites in the heart, the operator applies electrical stimulation to the heart from the electrode of the catheter to perform defibrillation.

[0003] When performing ablation surgery, in order to deliver a catheter from the right atrium side to the left atrium side, the Brockenbrough method, which is a puncture method that uses a Brockenbrough needle (transseptal puncture needle) to puncture the fossa ovalis in the septal portion of the atrium from the right atrium and open an insertion path for the catheter, is used.

[0004] In the Brockenbrough method, while confirming the position of the device and the fossa ovalis by intracardiac echocardiography or X-ray irradiation, the tip of the transseptal puncture needle is pressed against the fossa ovalis, and the transseptal puncture needle is energized to cauterize and penetrate the fossa ovalis. With the fossa ovalis penetrated by the transseptal puncture needle, a liquid such as physiological saline or a contrast agent is flowed from the tip of the transseptal puncture needle, and it is confirmed using intracardiac echocardiography or X-ray irradiation that the liquid has flowed into the left atrium side, thereby checking whether there is 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] In the past, when forming catheters with electrodes used in the ablation surgery described above, it was sometimes necessary to connect multiple tubes with different outer diameters in the longitudinal direction to reduce the distal diameter of the catheter. When such catheters are inserted into body tissue, stress is placed on the connection points of the multiple tubes, so there was a need to improve the durability of these connection points. Furthermore, the inventors' research revealed that stress is particularly likely to be placed on the connection points of multiple metal tubes.

[0008] The present invention has been made in view of the above circumstances, and its object is to provide a puncture device with excellent durability at the joint of multiple metal tubes. Another object is to provide a method for manufacturing the above puncture device. [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 first 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 first 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, A second metal tube enclosing the proximal end of the first metal tube, Equipped with, The first resin tube is provided with an opening that connects the flow path to the outside of the first 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. A puncture device comprising a second metal tube having a second penetration portion that extends from the inner surface to the outer surface, and being coupled to the first metal tube at least at the second penetration portion by a second fixing body.

[0010] Conventionally, when forming a catheter used in ablation surgery, if multiple tubes such as a first tube and a second tube located proximal to the first tube are joined longitudinally, the proximal end of the first tube is inserted into the second tube, and the proximal end of the first tube and the distal end of the second tube are joined. The inventors' research has shown that when these tubes are metal tubes, the distal end of the second tube in particular is more susceptible to external stress than other parts. Further research by the inventors has shown that, as described in [1] above, by providing a second penetration in the second metal tube and joining the second metal tube to the first metal tube at the second penetration with an adhesive, the durability of the joint can be improved compared to joining the distal end of the second metal tube to the first metal tube.

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

[21] . [2] The puncture device according to [1], wherein the second penetration portion is a slit, a through hole, or a combination thereof. [3] The puncture device according to [1] or [2], wherein the second penetration portion is a slit extending in the longitudinal direction. [4] The puncture device according to any one of [1] to [3], wherein the second fixing body extends along the edge of the second penetration portion. [5] The puncture device according to [4], wherein the circumferential extension distance of the second metal tube is shorter than the longitudinal extension distance in the section from the starting point to the ending point of the extension. [6] A puncture device according to any one of [1] to [5], wherein a second resin tube is located outside the second metal tube, the second metal tube and the second resin tube are bonded together by an adhesive, and the longitudinal bonding length between the second metal tube and the second resin tube by the adhesive is 180 mm or more and 500 mm or less. [7] A puncture device according to any one of [1] to [6], wherein the second metal tube has a second resin tube outside the second metal tube, the second metal tube and the second resin tube are bonded together by an adhesive, and at least a portion of the adhesive penetrates into the interior of the second penetration. [8] A puncture device according to any one of [1] to [7], wherein the second metal tube has a second resin tube outside the second metal tube, the second metal tube and the second resin tube are bonded together by an adhesive, the distal end of the adhesive is distal to the distal end of the second resin tube, and the distal end of the adhesive is tapered toward the distal end. [9] The puncture device according to any one of [1] to [8], wherein the second fixing body is located proximal to the distal end of the second metal tube.

[10] The puncture device according to any one of [1] to [9], wherein the second fixation body is weld metal, adhesive, or a combination thereof.

[11] Furthermore, it has a first fastener that connects the metal member and the first metal tube, The puncture device according to any one of [1] to

[10] , wherein the first metal tube has a first penetration portion that extends 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 penetration portion, and the first fixing body is not present in at least a portion of the flow path.

[12] The distal end of the first resin tube is located between the distal and proximal ends of the metal tip. [1] to

[11] The puncture device according to any one of these.

[13] The puncture device according to

[11] or

[12] , wherein the first penetration is a slit, a through hole, or a combination thereof.

[14] The puncture device according to any one of [1] to

[13] , wherein the first through portion is the slit extending in the longitudinal direction.

[15] The puncture device according to any one of

[11] to

[14] , wherein the first fixing body is located on a proximal side relative to the distal end of the first metal tube.

[16] The puncture device according to any one of

[11] to

[15] , wherein the first fixing body is weld metal, an adhesive, or a combination thereof.

[17] The puncture device according to any one of [1] to

[16] , wherein the metal member extends in the longitudinal direction, and a cross-sectional shape of the metal member in a direction perpendicular to the longitudinal direction is a polygon, a cross shape, an H shape, a U shape, a V shape, a Y shape, or a combination thereof.

[18] The puncture device according to any one of [1] to

[17] , wherein the metal member extends in the longitudinal direction and has a recess extending in the longitudinal direction.

[19] The puncture device according to any one of [1] to

[18] , wherein in a cross section of the metal member perpendicular to the longitudinal direction, a cross-sectional area of the metal member is larger than a cross-sectional area of the flow path.

[20] The puncture device according to any one of [1] to

[19] , wherein the first resin tube has a diameter-expanded portion on a distal side relative to the opening, an outer diameter of the diameter-expanded portion increasing toward the distal side.

[21] The puncture device according to any one of [1] to

[20] , wherein the metal tip generates heat by a high-frequency current.

[0012] A manufacturing method according to an embodiment of the puncture device is as follows.

[22] A method for manufacturing the puncture device according to any one of [1] to

[21] above, comprising: (1) a first step of joining a first metal tube and a second metal tube enclosing a proximal end portion of the first metal tube with a second fixing body at a second through portion penetrating from an inner surface to an outer surface of the second metal tube; (2) a second step of arranging an adhesive on the second through portion of the second metal tube and an outer surface of the second metal tube; (3) a third step of disposing a second resin tube outside the second metal tube; A method for manufacturing a puncture device, comprising the above steps in this order.

Effects of the Invention

[0013] According to the present invention, a puncture device excellent in durability at a joint portion of a plurality of metal tubes can be provided. Furthermore, a method for manufacturing the above puncture device can be provided.

Brief Description of Drawings

[0014] [Figure 1] FIG. 1 is a plan view of the puncture device according to the embodiment. [Figure 2] FIG. 2 is a plan view of a distal end portion of the puncture device of FIG. 1. [Figure 3] FIG. 3 is a view as seen from arrow X in FIG. 2. [Figure 4] FIG. 4 is a cross-sectional view along line A-A of the puncture device of FIG. 3. [Figure 5] FIG. 5 is a cross-sectional view along line B-B of the puncture device of FIG. 3. [Figure 6] FIG. 6 is a cross-sectional view along line C-C of the puncture device of FIG. 2. [Figure 7] FIG. 7 is a cross-sectional view 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 along line C-C of a modified example of the puncture device of FIG. 6. [Figure 11] FIG. 11 is a cross-sectional view along line C-C of a modified example of the puncture device of FIG. 6. [Figure 12] FIG. 12 is a cross-sectional view along line C-C of a modified example of the puncture device of FIG. 6. [Figure 13] FIG. 13 is a perspective view of a second metal tube included in the puncture device of FIG. 1. [Figure 14]Figure 14 is a perspective view of a modified example of the second metal tube in Figure 13. [Figure 15] Figure 15 is a plan view of the joint between the first and second metal tubes in Figure 1 and its surrounding area. [Figure 16] Figure 16 is a modified example of the joint shown in Figure 15 and a perspective view of its surrounding area. [Modes for carrying out the invention]

[0015] The present invention will be described in more detail below based on the embodiments described below, but the present invention is not limited by the embodiments described below and will be within the scope of what is appropriate for the spirit described above and below. It is certainly possible to implement the invention with appropriate modifications, and all such modifications fall within the technical scope of the present invention. Note that, for convenience, some component reference numerals may be omitted in the drawings; in such cases, refer to the specification or other drawings. Furthermore, the dimensions of various components in the drawings may differ from the actual dimensions, as priority is given to facilitating an understanding of the features of the present invention.

[0016] A puncture device according to an embodiment of the present invention comprises a first 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 first 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 second metal tube enclosing the proximal end of the first metal tube. The first resin tube has an opening that connects the flow path to the outside of the first 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 second metal tube has a second penetration portion that penetrates from the inner surface to the outer surface, and is coupled to the first metal tube by a second fixing body at least at the second penetration portion.

[0017] Conventionally, when forming a catheter used in ablation surgery, if multiple tubes such as a first tube and a second tube located proximal to the first tube are joined longitudinally, the proximal end of the first tube is inserted into the second tube, and the proximal end of the first tube and the distal end of the second tube are joined. Through the inventors' research, it was found that when these tubes are metal tubes, the distal end of the second tube in particular is more susceptible to external stress than other parts. Further research by the inventors revealed that, as described above, by providing a second penetration in the second metal tube and joining the second metal tube to the first metal tube at the second penetration with an adhesive, the durability of the joint can be improved compared to joining the distal end of the second metal tube to the first metal tube.

[0018] The following describes a puncture device according to an embodiment, with reference to Figures 1 to 16. 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. Figure 13 is a perspective view of the second metal tube included in the puncture device in Figure 1. Figure 14 is a perspective view of a modified example of the second metal tube in Figure 13. Figure 15 is a plan view of the joint portion of the first and second metal tubes in Figure 1 and its surrounding area. Figure 16 is a modified example of the joint shown in Figure 15 and a perspective view of its surrounding area.

[0019] 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.

[0020] As shown in Figures 2, 4, and 5, the puncture device 1 comprises a first resin tube 10, a first metal tube 20, a metal member 30, a metal tip 40, a flow path 50, and a second metal tube 70. Specifically, it is preferable that the shaft 2 of the puncture device 1 comprises the first resin tube 10, the first metal tube 20, the metal member 30, the metal tip 40, the flow path 50, and the second metal tube 70.

[0021] As shown in Figures 2, 4, and 5, the first 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 first 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 second metal tube 70 encloses the proximal end 20p of the first metal tube 20.

[0022] As shown in Figures 5 and 7, the second metal tube 70 has a second penetration portion 70t that extends from the inner surface 70i to the outer surface 70o, and is joined to the first metal tube 20 by a second fixing body 80 at least at the second penetration portion 70t. By joining the second metal tube 70 to the first metal tube 20 by the second fixing body 80 at the second penetration portion 70t in this way, the durability of the joint between the metal tubes 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. The parts of the puncture device 1 will be described in more detail below.

[0023] As shown in Figures 1, 2, 4, and 5, the first 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 first 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 first 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] The distal end 10d of the first resin tube 10 is preferably located between the distal end 40d and the proximal end 40p of the metal tip 40. Having the distal end 10d of the first 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 first 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 first resin tube 10 may contain one type of synthetic resin, or it may contain multiple types of synthetic resins. The insulating material allows at least the first metal tube 20 to be insulated by the first resin tube 10 when the metal tip 40 is energized. At least a part of the metal member 30 may be insulated by the first resin tube 10. In particular, the first resin tube 10 preferably contains a fluororesin, and more preferably contains PTFE. The fluororesin improves the slipperiness of the outer surface of the first resin tube 10, thereby improving the insertion of the puncture device 1.

[0026] The length of the first resin tube 10 in the longitudinal direction 10X is preferably 3 mm or more and 18 mm or less. The outer diameter of the first resin tube 10 is preferably 0.5 mm or more, more preferably 0.6 mm or more, and even more preferably 0.7 mm or more. This improves the rigidity of the first resin tube 10. Furthermore, the outer diameter of the first resin tube 10 is preferably 1.8 mm or less, more preferably 1.5 mm or less, and even more preferably 1.2 mm or less. By reducing the outer diameter in this way, the invasiveness can be reduced.

[0027] The thickness of the first 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 first resin tube 10 easier to insulate. Furthermore, the thickness of the first 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 first resin tube 10 to be reduced, thereby reducing its invasiveness.

[0028] Although not shown in the diagram, the first 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 first 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 first 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] As shown in Figures 4, 5, and 6, the first metal tube 20 is positioned in the lumen 10l of the first resin tube 10. The first metal tube 20 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 widening the flow path 50.

[0030] As shown in Figures 5 and 6, it is preferable that the first metal tube 20 has a first penetration portion 20t that extends from the inner surface 20i to the outer surface 20o. Furthermore, it is preferable that the first metal tube 20 is bonded to the metal member 30 by a first fixing body 60 at least at the first penetration portion 20t. By arranging 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. Furthermore, this makes it possible to reduce the outer diameter of the shaft 2 compared to when the first fixing body 60 is arranged between the first metal tube 20 and the metal member 30.

[0031] The number of first penetrations 20t is preferably one or more, and more preferably two or more. This increases the number of connections between the first metal tube 20 and the metal member 30 by the first fixing body 60. On the other hand, the number of first penetrations 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 penetrations 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 through-hole 20t is preferably a slit, a through-hole, or a combination thereof, and more preferably a slit. The closer the shape of the first through-hole 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.

[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 first 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 first 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. Furthermore, the contact area between the metal member 30 and the first fixing body 60 can be improved. 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 can improve 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. The use of 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. 30 may contain one type of metal or may contain 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 first 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 first 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 first 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 of the first metal tube 20 distal to the distal end 20d.

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

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

[0056] The first fixing body 60 is preferably positioned on at least a portion of the first penetration portion 20t, and may be positioned on the entire first penetration portion 20t so as to fill it. Furthermore, the first fixing body 60 is preferably 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 is more preferably fixed to the outer surface 20o of the first metal tube 20 as well. 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 other methods. For details, please refer to the description of the manufacturing method of the puncture device 1 below.

[0061] 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.

[0062] 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.

[0063] Specific methods for joining the metal tip 40 to the distal end 30D of the metal member 30 include, for example, welding, soldering or other 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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. This makes it easier to confirm the position of the metal tip 40 within the body. Preferably, the X-ray opaque marker 41 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. The shape of the X-ray opaque marker 41 can be spherical, cylindrical, polygonal tubular, C-shaped with a notch in the cross-section, coil shape with a wire wound around it, cylindrical, polygonal prism, etc.

[0068] 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.

[0069] 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.

[0070] As shown in Figures 4 and 6, it is preferable that the first fixing body 60 is not present in at least a portion of the flow path 50. As shown in Figures 4, 6, and 10, it is even more preferable that the first fixing body 60 is not present in the entire flow path 50. As described above, by arranging at least a portion of the first fixing body 60 in the first penetration portion 20t, the bonding force between the first metal tube 20 and the metal member 30 is improved, so it is not necessary to bond 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 weld 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 by not exposing the first fixing body 60 in the flow path 50, it becomes easier to avoid a reduction in the liquid flow velocity. As a result, the liquid delivery performance of the puncture device 1 is improved. This allows for the efficient release of fluids such as saline solution or contrast agent into the left atrium, improving visibility during intracardiac echocardiography and X-ray irradiation. Therefore, it is preferable that the first fixed body 60 is not present throughout the entire flow path 50.

[0071] As shown in Figure 11, a portion of the first fixing body 60 may be exposed in the flow path 50. In this case, the ratio of the exposed area of ​​the first fixing body 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 fixing body 60.

[0072] 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 first resin tube 10 and the outer surface 30o of the metal member 30.

[0073] As shown in Figure 4, the first resin tube 10 is provided with an opening 11 that connects the flow path 50 with the outside 10o of the first 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 first 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 first resin tube 10 via the other flow path described above.

[0074] The shape of the opening 11 on the outer surface of the first 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.

[0075] The first 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 enlarges in a tapered, stepped, uneven, or wavy shape from the proximal to distal end, and more preferably enlarges in a tapered shape. This makes it easier for the liquid released from the opening 11 to diffuse radially and distally.

[0076] As shown in Figures 4 and 5, the second metal tube 70 encloses the proximal end 20p of the first metal tube 20. This increases the rigidity of the proximal side of the shaft 2.

[0077] As shown in Figures 5 and 7, the second metal tube 70 has a second penetration portion 70t that extends from the inner surface 70i to the outer surface 70o. Furthermore, the second metal tube 70 is joined to the first metal tube 20 by a second fixing body 80 at least at the second penetration portion 70t. By joining the second metal tube 70 to the first metal tube 20 by the second fixing body 80 at the second penetration portion 70t in this way, the durability of the joint between the metal tubes is improved.

[0078] The number of second penetrations 70t is preferably one or more, and more preferably two or more. This improves the bonding strength. On the other hand, the number of second penetrations 70t is preferably four or less, and more preferably three or less. This reduces thermal stress on the second metal tube 70 when the second fixing body 80 is fixed to the second penetrations 70t.

[0079] 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.

[0080] 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 the bonding strength.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] The distal end of the second penetration portion 70t is preferably located at the distal end 70d of the second metal tube 70, as shown in Figure 13. 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 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. On the other hand, as shown in Figure 14, the distal end of the second penetration portion 70t may be located proximal to the distal end 70d of the second metal tube 70.

[0085] As shown in Figure 15, it is preferable that the second fixing body 80 be 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.

[0086] 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.

[0087] 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.

[0088] The second metal tube 70 and the first metal tube 20 can be joined by welding, adhesive, or other methods. For details, please refer to the description of the manufacturing method of the puncture device 1 below.

[0089] As shown in Figures 4 and 5, it is preferable that the second metal tube 70 is placed in the lumen 90l of the second resin tube 90. It is preferable that the second metal tube 70 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.

[0090] 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.

[0091] 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.

[0092] 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 first resin tube 10 to be reduced, thereby reducing invasiveness.

[0093] As shown in Figures 15 and 16, the second fixing body 80 is positioned on at least a portion of the second penetration portion 70t. Preferably, the second fixing body 80 is positioned to cover the second penetration portion 70t, as shown in Figure 15. Alternatively, the second fixing body 80 may be positioned over the entire second penetration portion 70t so as to fill it. This increases the contact area between the second fixing body 80 and the first metal tube 20. Preferably, the second fixing body 80 is fixed to at least the outer surface 20o of the first metal tube 20 and the inner wall of the second metal tube 70 that constitutes the second penetration portion 70t, and more preferably, it is also fixed to the outer surface 70o of the second metal tube 70. This improves the bonding strength between the first metal tube 20 and the second metal tube 70.

[0094] As shown in Figure 16, it is preferable that the second fixing body 80 extends along the edge 70u of the second penetration portion 70t. The connection between the first metal tube 20 and the second metal tube 70 by the second fixing body 80 along the edge 70u makes it difficult for the connection to come undone.

[0095] As shown in Figure 16, it is preferable that the extension distance of the second metal tube 70 in the circumferential direction 70c is shorter than the extension distance in the longitudinal direction 10X in the section from the starting point 80a to the ending point 80b of the extension of the second fixing body 80. This improves the durability against loads applied in the longitudinal direction 10X. Furthermore, when the first metal tube 20 and the second metal tube 70 are joined by welding, for example, this configuration can reduce thermal stress in the circumferential direction 70c of the second metal tube 70, making it easier to maintain the durability of the second metal tube 70.

[0096] As shown in Figures 4 and 5, it is preferable that the puncture device 1 has a second resin tube 90 outside the second metal tube 70. By enclosing the second metal tube 70 within the second resin tube 90 in this way, the second metal tube 70 can be protected. Furthermore, it is preferable that the second metal tube 70 and the second resin tube 90 are bonded together with an adhesive 100. The adhesive 100 can reduce the occurrence of wrinkles that occur when the second resin tube 90 is bent.

[0097] The length of the bond between the second metal tube 70 and the second resin tube 90 in the longitudinal direction 10X by the adhesive 100 is preferably 180 mm or more and 500 mm or less. By bonding the second metal tube 70 and the second resin tube 90 with the adhesive 100 in this way, the occurrence of wrinkles that occur when the second resin tube 90 is bent can be reduced. The bond length is more preferably 200 mm or more and 400 mm or less.

[0098] Preferably, at least a portion of the adhesive 100 penetrates into the interior of the second penetration portion 70t. Because a portion of the adhesive 100 penetrates into the interior of the second penetration portion 70t, the adhesive 100 has an anchoring effect, making it difficult for the adhesive 100 to detach from the second metal tube 70.

[0099] As shown in Figures 4 and 5, it is preferable that the distal end 100D of the adhesive 100 is distal to the distal end 90d of the second resin tube 90. By exposing the distal end 100D of the adhesive 100 from the second resin tube 90 in this way, damage to internal tissue by the distal end 90d of the second resin tube 90 can be reduced. Furthermore, as shown in Figures 4 and 5, it is preferable that the distal end 100D of the adhesive 100 tapers toward the distal end. This makes it easier to insert the second resin tube 90 into internal tissue.

[0100] It is preferable that the distal end 100D of the adhesive 100 is attached to the outer surface of the first resin tube 10. This makes it difficult for the distal end 100D of the adhesive 100 to peel off.

[0101] The second resin tube 90 preferably extends in the longitudinal direction 10X. The lumen 90l of the second resin tube 90 preferably extends in the longitudinal direction 10X. There may be multiple lumen 90l, but it is preferable that there be one. This makes it possible to reduce the outer diameter of the second resin tube 90 while increasing the cross-sectional area of ​​the lumen 90l in the direction perpendicular to the longitudinal direction 10X. As a result, it becomes easier to position the second metal tube 70, and the manufacturing of the puncture device 1 becomes easier.

[0102] Preferably, the distal end 90d of the second resin tube 90 is distal to the distal end 70d of the second metal tube 70 and proximal to the distal end of the adhesive 100. This allows for a larger amount of adhesive 100 to adhere near the distal end 90d of the second resin tube 90, making the second resin tube 90 less likely to peel off.

[0103] The second resin tube 90 preferably contains an insulating material, and more preferably consists of an insulating material. For details of the insulating material, please refer to the description of the first resin tube 10.

[0104] The length of the second resin tube 90 in the longitudinal direction 10X is preferably 500 mm or more and 1200 mm or less. The outer diameter of the second resin tube 90 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 second resin tube 90. Furthermore, the outer diameter of the second resin tube 90 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.

[0105] The thickness of the second resin tube 90 is preferably 10 μm or more, more preferably 20 μm or more, and even more preferably 30 μm or more. This makes the second resin tube 90 easier to insulate. Furthermore, the thickness of the second resin tube 90 is preferably 350 μm or less, more preferably 150 μm or less, and even more preferably 50 μm or less. This allows the outer diameter of the second resin tube 90 to be reduced, thereby reducing its invasiveness.

[0106] The adhesive 100 is preferably an epoxy adhesive, acrylic adhesive, cyano-based adhesive, polyurethane adhesive, silicone adhesive, or a mixture thereof, more preferably an epoxy adhesive or an acrylic adhesive, and even more preferably an epoxy adhesive. This reduces the occurrence of wrinkles when the second resin tube 90 is bent. The adhesive may be one-component or two-component, but two-component is preferred. The adhesive may also be room-temperature curing or heat-curing.

[0107] The puncture device 1 may have resin tubes other than the first resin tube 10 and the second resin tube 90. These tubes are preferably connected in the longitudinal direction 10X.

[0108] 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.

[0109] 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.

[0110] 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.

[0111] The following describes a method for manufacturing a puncture device according to an embodiment. The method for manufacturing the puncture device 1 according to the embodiment includes, in this order: (1) a first step of joining a first metal tube and a second metal tube enclosing the proximal end of the first metal tube with a second adhesive at a second penetration portion that penetrates from the inner surface to the outer surface of the second metal tube; (2) a second step of placing an adhesive at the second penetration portion of the second metal tube and on the outer surface of the second metal tube; and (3) a third step of placing a second resin tube outside the second metal tube. Each step will be described below with reference to the figures.

[0112] For example, as shown in Figure 15, in the first step, when joining the first metal tube 20 and the second metal tube 70 with the second fixing body 80, the joining can be done by welding, adhesive, or other methods. These methods may be combined. In the case of welding, it is preferable to place at least the proximal end 20p of the first metal tube 20 into the lumen of the second metal tube 70, crimp the second metal tube 70 as necessary, and then melt and weld the second metal tube 70 and / or the first metal tube 20 near the second penetration portion 70t by arc welding, laser welding, or the like. In this case, it is preferable to melt the first metal tube 20. Alternatively, after placing at least the proximal end 20p of the first metal tube 20 into the lumen of the second metal tube 70, crimp the second metal tube 70 as necessary, and then welding may be performed by heating and melting brazing material and adhering it to the second penetration portion 70t. On the other hand, in the case of bonding, for example, after placing at least the proximal end 20p of the first metal tube 20 into the lumen of the second metal tube 70, and crimping the second metal tube 70 as necessary, adhesive can be applied to the second penetration portion 70t, and then bonded by leaving it to stand at room temperature or by heating and curing.

[0113] In the first step, when joining the first metal tube 20 and the second metal tube 70 with the second fixing body 80, it is preferable to leave a portion of the second penetration portion 70t exposed without filling it with the second fixing body 80, as shown in Figures 15 and 16. This allows the adhesive 100 to penetrate into the second penetration portion 70t in the second step. It is preferable that the exposed portion includes at least the distal end of the second penetration portion 70t.

[0114] In the second step, when placing the adhesive 100 on the second penetration portion 70t and the outer surface 70o of the second metal tube 70, the adhesive 100 may be placed by methods such as coating or spraying. When placing the adhesive 100, it is preferable to also place the adhesive 100 on the outer surface of the second fixing body 80. Furthermore, it is preferable to place the adhesive 100 such that a portion of the adhesive 100 reaches a region distal to the distal end 70d of the second metal tube 70. In this case, it is preferable to place the distal end 100D of the adhesive 100 on the outer surface of the first resin tube 10 in a region distal to the distal end 70d of the second metal tube 70.

[0115] In the third step, when positioning the second resin tube 90 outside the second metal tube 70, it is preferable to position the second metal tube 70 inside the lumen of the second resin tube 90 before the adhesive 100 hardens. In this case, it is preferable to insert the second metal tube 70 into the lumen of the second resin tube 90 by sliding the second resin tube 90 proximal to the second metal tube 70. Furthermore, in this case, it is preferable to slide the second resin tube 90 proximal to the second metal tube 70 such that the distal end 90d of the second resin tube 90 is located proximal to the distal end of the adhesive 100. This allows the distal end 100D of the adhesive 100 to be exposed from the second resin tube 90, as shown in Figures 4 and 5, and to create a tapered shape.

[0116] The manufacturing method for the puncture device 1 preferably includes a step before the first step of joining the first metal tube 20 and the distal end 20D of the first metal tube 20 with a first fixing body 60 at a first penetration portion 20t that penetrates from the inner surface 20i to the outer surface 20o of the first metal tube 20. This joining can be done by welding, bonding, or other methods. These methods may be combined. In the case of welding, for example, it is preferable to place at least the proximal end of the metal member 30 into the lumen of the first metal tube 20, crimp the first metal tube 20 as necessary, and then melt and weld the metal member 30 and / or the first metal tube 20 near the first penetration portion 20t by arc welding, laser welding, etc. It is more preferable to melt the metal member 30 near the first penetration portion 20t by arc welding, laser welding, etc., and weld it by adhering it to the first metal tube 20. Alternatively, the metal member 30 may be welded by placing at least its proximal end inside the lumen of the first metal tube 20, crimping the first metal tube 20, and then heating and melting a brazing material to adhere to the first penetration portion 20t. In this case, it is preferable to melt the metal member 30.

[0117] 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.

[0118] The metal tip 40 may be attached to the metal member 30 before joining the metal member 30 and the distal end 20D of the first metal tube 20 with the first fixing body 60, or the metal tip 40 may be attached to the metal member 30 after joining them with the first fixing body 60.

[0119] The manufacturing method for the puncture device 1 preferably includes a step of positioning the first resin tube 10 outside the first metal tube 20 after the first step and before the second step. This makes it easier to position the first resin tube 10. At this time, it is preferable to insert the first metal tube 20 into the lumen of the first resin tube 10 by sliding the first resin tube 10 proximal to the first metal tube 20. [Explanation of symbols]

[0120] 1: Puncture device 2: Shaft 3: Handle 4: Syringe port 5: Cable 6: Connector 10: First 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 20p: Proximal end 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 70c: Circumferential direction 70d: Distal end 70i: Inner surface 70l: lumen 70o: outer surface 70t: 2nd penetration part 70u: Edge 80: Second fixed body 80a: Starting point 80b: End point 90: Second resin tube 90d: Distal end 90l: lumen 100: Adhesive 100D: Distal end

Claims

1. A first resin tube having a distal end and a proximal end and extending in the longitudinal direction, A first metal tube is placed inside the lumen of the first resin tube, A metal member located at the distal end of the first metal tube, A metal tip for perforating internal tissue 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, A second metal tube enclosing the proximal end of the first metal tube, Equipped with, The first resin tube is provided with an opening that connects the flow path to the outside of the first 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 second metal tube has a second through-port that penetrates from the inner surface to the outer surface, and is bonded to the first metal tube by a second fixing body at least at the second through-port. A drilling device in which the distal end of the second penetration portion is exposed and not filled with the second fixing body.

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

3. The perforation device according to claim 1, wherein the second penetration portion is a slit extending in the longitudinal direction.

4. The drilling device according to claim 1, wherein the second fixing body extends along the edge of the second penetration portion.

5. The perforation device according to claim 4, wherein the circumferential extension distance of the second metal tube is shorter than the longitudinal extension distance in the section from the starting point to the ending point of the extension.

6. The perforation device according to claim 1, wherein a second resin tube is provided outside the second metal tube, the second metal tube and the second resin tube are bonded together by an adhesive, and the longitudinal bonding length between the second metal tube and the second resin tube by the adhesive is 180 mm or more and 500 mm or less.

7. The perforation device according to claim 1, wherein a second resin tube is located outside the second metal tube, the second metal tube and the second resin tube are bonded together by an adhesive, and at least a portion of the adhesive penetrates into the interior of the second penetration portion.

8. The perforation device according to claim 1, further comprising a second resin tube outside the second metal tube, wherein the second metal tube and the second resin tube are bonded together by an adhesive, the distal end of the adhesive is distal to the distal end of the second resin tube, and the distal end of the adhesive tapers toward the distal end.

9. The perforation device according to claim 1, wherein the second fixing body is located proximal to the distal end of the second metal tube.

10. The drilling device according to claim 1, wherein the second fixing body is weld metal, adhesive, or a combination thereof.

11. Furthermore, it has a first fixing body that connects the metal member and the first metal tube, The perforation device according to claim 1, wherein the first metal tube has a first penetration portion that extends 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 penetration portion, and the first fixing body is not present in at least a portion of the flow path.

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

13. The drilling device according to claim 11, wherein the first through portion is a slit, a through hole, or a combination thereof.

14. The perforation device according to claim 11, wherein the first penetration portion is a slit extending in the longitudinal direction.

15. The perforation device according to claim 11, wherein the first fixing body is located proximal to the distal end of the first metal tube.

16. The drilling device according to claim 11, wherein the first fixing body is a weld metal, an adhesive, or a combination thereof.

17. The drilling device according to claim 1, wherein the metal member extends in the longitudinal direction, and at least one location in the longitudinal direction of the metal member has a cross-sectional shape perpendicular to the longitudinal direction that is polygonal, cross-shaped, H-shaped, U-shaped, V-shaped, Y-shaped, or a combination thereof.

18. The drilling device according to claim 1, wherein the metal member extends in the longitudinal direction and has a recess extending in the longitudinal direction.

19. The drilling device according to claim 1, 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.

20. The perforation device according to claim 1, wherein the first resin tube has an enlarged diameter portion distal to the opening, wherein the outer diameter increases toward the distal side.

21. The drilling device according to claim 1, wherein the metal tip generates heat due to a high-frequency current.

22. The perforation device according to claim 1, wherein the proximal end of the opening is located distal to the distal end of the flow path.

23. The perforation device according to claim 1, wherein the distal end of the second penetration portion is located at the distal end of the second metal tube.

24. The drilling device according to claim 1, wherein the second fixing body is fixed to the outer surface of the first metal tube and the inner wall of the second metal tube.

25. A method for manufacturing a perforating device according to any one of claims 1 to 24, (1) A first step of joining a first metal tube and a second metal tube enclosing the proximal end of the first metal tube with a second fixing body at a second penetration portion that penetrates from the inner surface to the outer surface of the second metal tube, (2) A second step of applying adhesive to the second penetration portion of the second metal tube and the outer surface of the second metal tube, (3) A third step of arranging the second resin tube outside the second metal tube, A method for manufacturing a drilling device, comprising the elements in this order.

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