WO2021192168A1

WO2021192168A1 - Catheter

Info

Publication number: WO2021192168A1
Application number: PCT/JP2020/013767
Authority: WO
Inventors: 雄輝丹羽
Original assignee: 日本ライフライン株式会社
Priority date: 2020-03-26
Filing date: 2020-03-26
Publication date: 2021-09-30
Also published as: JPWO2021192168A1; JP7214922B2; TW202202097A

Abstract

Provided is a catheter capable of preventing separation of a resin outer layer tube covering a metal tube from the metal tube.　A catheter 2 is provided with a catheter body 80 having: a metal tube 100 in which a feed path 121 for transferring a cooling medium into a hollow part and a return path 123 are formed; a distal end electrode 101 formed on a distal end portion of the metal tube; an outer layer tube 50 made of a resin and covering the outer surface of a predetermined portion in the axial direction of the metal tube excluding the distal end electrode; and an adhesive 51 for bonding the outer layer tube and the metal tube at at least a distal end portion of the outer layer tube. The metal tube has, at a portion to which the adhesive adheres, a roughened surface section 70 in which a projection-recess pattern 71 is formed. The anchoring effect of the projection-recess pattern prevents separation of the outer layer tube from the metal tube.

Description

catheter

The present invention relates to a catheter having improved adhesiveness between a metal member and a resin outer layer tube covering the metal member.

As a catheter that is inserted into the body via a blood vessel, a catheter having a metal member and a resin outer layer tube that covers the metal member is known.

Patent Document 1 describes a catheter including a tubular shaft main body portion and a covering portion that covers the shaft main body portion. Metal or resin is used for the shaft main body as a material having relatively high rigidity. A polymer material or a mixture thereof is used for the covering portion as a material having an insulating property.

In Patent Document 1, when the shaft main body is made of metal, the shaft main body and the covering portion are a combination of different materials such as metal and polymer material. Generally, the adhesiveness between a metal and a polymer material (adhesiveness between different materials) is lower than the adhesiveness between polymer materials (adhesiveness between homogeneous materials). Therefore, when the shaft main body is made of metal, the problem is how to prevent the coating from being peeled off from the shaft main body.

International Publication No. 2014/174662

The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a catheter capable of preventing a resin outer layer tube covering a metal member from peeling off from the metal member.

In order to solve the above problems, the present invention presents a metal tube in which a flow path for transporting a cooling medium is formed in the hollow portion, a tip electrode formed at the tip of the metal tube, and the tip electrode. A resin outer layer tube that covers the outer surface of a predetermined axial portion of the metal tube excluding the above, and an adhesive that adheres the outer layer tube and the metal tube at at least the tip of the outer layer tube. The metal tube is characterized by including a roughened surface processed portion on which an uneven pattern is formed at a portion to which the adhesive is attached.

According to the present invention, it is possible to prevent the resin outer layer tube that covers the metal member from peeling off from the metal member.

It is a top view which shows the schematic structure of the catheter which concerns on 1st Embodiment of this invention. FIG. 3 is a cross-sectional view taken along the line CC of the catheter body shown in FIG. FIG. 2 is a cross-sectional view taken along the line DD of the catheter body shown in FIG. (A) to (c) are schematic views showing an example of a concavo-convex pattern formed in a roughened surface processed portion. It is a top view which shows the schematic structure of the catheter which concerns on 2nd Embodiment of this invention. FIG. 5A is a cross-sectional view taken along the line EE of the catheter body shown in FIG. 5, and FIG. 5B is a cross-sectional view taken along the line FF. It is a figure which shows the structure of the catheter tip part, (a) is a partially enlarged view, (b) is the GG cross-sectional view of FIG. 6 (b).

Hereinafter, the present invention will be described in detail using the embodiments shown in the figure. However, unless otherwise specified, the components, types, combinations, shapes, relative arrangements, etc. described in this embodiment are merely explanatory examples, not the purpose of limiting the scope of the present invention to that alone. ..

[First Embodiment]
FIG. 1 is a plan view showing a schematic configuration of a catheter according to the first embodiment of the present invention. FIG. 2 is a cross-sectional view taken along the line CC of the catheter body shown in FIG. FIG. 3 is a cross-sectional view taken along the line DD of the catheter body shown in FIG.

Hereinafter, the present embodiment will be described based on an example of an electrode catheter for diagnosis, but the present invention can be applied to catheters other than electrode catheters such as ablation catheters and defibrillation catheters.

The electrode catheter (hereinafter simply referred to as "catheter") 1 shown in FIG. 1 is inserted into the heart through a blood vessel and is used for mapping the electrical activity state in the heart and measuring the electrocardiographic potential after ablation (catheter) of the inner wall of the heart. It is an instrument.

The catheter 1 is attached to a catheter main body 10 extending in the axial direction, a handle 20 attached to a proximal end portion 10b (proximal end side) of the catheter main body 10, and a distal end portion 10a (distal end side) of the catheter main body 10. The tip tip electrode (tip electrode) 31 and a plurality of ring-

shaped electrodes

41, 41 ... Are provided.

As shown in FIG. 2, the catheter main body 10 is located at the tip portion 10a in the axial direction, a metal member 30 having a tip tip electrode 31 exposed to the outside, and a proximal end side in the axial direction of the metal member 30. It is provided with a resin outer layer tube 50 that covers the outer surface of the non-exposed portion 33, and an adhesive 51 that adheres the outer layer tube 50 and the non-exposed portion 33 of the metal member 30 at at least the tip portion 50a of the outer layer tube 50. .. The metal member 30 is characterized in that the rough surface processed portion 70 on which the uneven pattern 71 (71A to 71C: see FIG. 4) is formed is provided on the portion (surface) to which the adhesive 51 is attached.

<Operation unit>
As shown in FIG. 1, the handle 20 of the catheter 1 is rotatably arranged closer to the catheter body 10 than the grip portion 21 gripped by the operator of the catheter 1 and the grip portion 21, and the tip portion 10a is shown in the drawing. It includes a rotary plate 22 that deflects (or bends and deforms) in the directions of arrows B1-B2, and a rotary knob 23 that rotates the rotary plate 22.

When the rotating plate 22 is rotated in the direction of the arrow A1 in the drawing, the tip portion 10a is deflected in the direction of the arrow B1 in the drawing by an amount corresponding to the rotation angle of the rotating plate 22. When the rotating plate 22 is rotated in the direction of the arrow A2 in the drawing, the tip portion 10a is deflected in the direction of the arrow B2 in the drawing by an amount corresponding to the rotation angle of the rotating plate 22.

<Catheter body>
As shown in FIG. 3, the catheter body 10 includes a hollow tubular outer layer tube 50 and a plurality of hollow tubular lumen tubes 61 (61A to 61D), 65 (65A,) housed in the hollow portion of the outer layer tube 50. 65B) and. The lumen tubes 61 and 65 are fixed to the outer layer tube 50 by, for example, an adhesive or melt bonding.

The catheter body 10 has at least one lumen inside. The catheter body 10 shown in this example has a plurality of lead lumens 62 (62A to 62D) extending along the axial direction thereof and a plurality of operating lumens 66 (66A, 66B) in the hollow portion of the outer layer tube 50. Be prepared. The lead lumen 62 is formed in the hollow portion of the lumen tube 61, and the operating lumen 66 is formed in the hollow portion of the lumen tube 65.

A lead wire (not shown) conducting with the tip tip electrode 31 and each ring-shaped electrode 41 is inserted into each lead lumen 62.

The operation wire 25 (25A, 25B) is inserted through the operation lumen 66 (66A, 66B). The operation wire 25A deflects the tip portion 10a of the catheter body 10 in the direction of arrow B1 in the drawing. The operation wire 25B deflects the tip portion 10a of the catheter body 10 in the direction of arrow B2 in the drawing. Each operation wire 25 is inserted into each operation lumen 66 so as to be slidable in the axial direction thereof.

The base end portion of each operation wire 25 is fixed at an appropriate position on the rotating plate 22 (see FIG. 1). Each operating wire 25 slides in the operating lumen 66 in the axial direction by an amount corresponding to the rotation angle of the rotating plate 22. As shown in FIG. 3, the tip end portion of each operation wire 25 is fixed to the tip tip electrode 31 by soldering or the like.

The outer layer tube 50 and the lumen tubes 61 and 65 are made of a flexible material. Specifically, synthetic resins such as polyolefin, polyamide, polyether polyamide, polyurethane, nylon and PEBAX (registered trademark. Substance name: polyether blockamide) can be used for these tubes.

The axial length of the catheter body 10 is preferably 600 to 1500 mm, more preferably 700 to 1200 mm.

The inner diameter of the lead lumen 62 is preferably 0.05 to 0.20 mm, more preferably 0.07 to 0.15 mm. The axial length of the lead lumen 62 is preferably 600 to 1500 mm, more preferably 700 to 1200 mm.

The inner diameter of the operating lumen 66 is preferably 0.15 to 0.35 mm, more preferably 0.20 to 0.30 mm. The axial length of the operating lumen 66 is preferably 600 to 1500 mm, more preferably 700 to 1200 mm.

<Electrode>
The metal member 30 provided with the tip tip electrode 31 and the ring-shaped electrode 41 shown in FIG. 2 and the like are made of a metal having good electrical conductivity, such as aluminum, copper, stainless steel, gold, and platinum. The metal member 30 and the ring-shaped electrode 41 are preferably made of platinum or an alloy thereof in order to have good contrast with X-rays.

The outer diameters of the tip tip electrode 31 and the ring-shaped electrode 41 are not particularly limited, but are preferably about the same as the outer diameter of the catheter body 10, and are usually about 0.5 to 3 mm.

As shown in FIG. 2, the metal member 30 is fixed to the outer layer tube 50 by the adhesive 51.

The ring-shaped electrode 41 is fixed to the outer peripheral surface of the outer layer tube 50 by crimping a metal ring having a diameter larger than the outer diameter of the outer layer tube 50 but being larger than the outer diameter of the outer layer tube 50, for example. The number of ring-shaped electrodes 41 is not particularly limited. The number of ring-shaped electrodes 41 is appropriately set according to the number of lead wires that can be inserted into the catheter body 10.

<Metal parts>
The metal member 30 has a bottomed cylinder shape in which the tip end side is closed and the base end side is open.
The metal member 30 includes an exposed portion arranged on the tip end side to form the tip end electrode 31, and a non-exposed portion 33 arranged on the proximal end side and covered with the outer layer tube 50. The outer shape of the metal member 30 on which the tip tip electrode 31 is formed on the tip side is hemispherical.

<< Rough surface processing part >>
The tip portion 50a of the outer layer tube 50 is adhered to the outer surface of the non-exposed portion 33 by the adhesive 51.
A rough surface processed portion 70 is formed on the outer surface of the non-exposed portion 33. The rough surface processed portion 70 is a portion where the surface is subjected to uneven processing according to a predetermined pattern. The rough surface processing portion 70 is arranged on the entire axial direction of the non-exposed portion 33, or at least on the tip end side portion of the non-exposed portion 33. The rough surface processing portion 70 is formed on the entire non-exposed portion 33 in the circumferential direction.

<< Concavo-convex pattern >>
4 (a) to 4 (c) are schematic views showing an example of a concavo-convex pattern formed on the rough surface machined portion.
The uneven pattern 71 is formed by, for example, blasting, laser processing, electric discharge machining, chemical etching, cutting, or the like. The uneven pattern 71 may be formed by a method other than this.

The uneven pattern 71 (71A to 71C) is a pattern having a predetermined uneven shape formed on the surface of the non-exposed portion 33. The uneven pattern 71 is a pattern for obtaining an anchor effect for improving the adhesive force of the adhesive 51 to the non-exposed portion 33. In particular, the uneven pattern 71 improves the adhesive force between different materials such as metal and resin.

For example, the rough surface processing portion 70 may include a concave-convex pattern 71A in which a large number of concave portions 72 (or convex portions) are randomly arranged as shown in FIG. 4A. When the concave-convex pattern 71A is formed by blasting, the shape of the concave portion 72 (or the convex portion) constituting the concave-convex pattern 71A is the particle size, hardness, projection speed, etc. of the projection material that collides with the surface of the non-exposed portion 33. It is adjusted according to the processing conditions at the time of blasting including.

Further, the rough surface processing portion 70 may include a concavo-convex pattern 71B in which a plurality of

grooves

73 and 74 are geometrically (or regularly) arranged as shown in FIG. 4 (b).
The concavo-convex pattern 71B shown is a pattern in which a plurality of grooves 73 extending in the first direction and a plurality of grooves 74 extending in the second direction intersecting the first direction are arranged so as to intersect each other.
The inclination angles (spiral angles) of the

grooves

73 and 74 with respect to the axial direction of the metal member 30 can be set to any angle such as 0 degree, 30 degree, 45 degree, 60 degree, 90 degree and the like.

Here, when the outer layer tube 50 is peeled from the metal member 30, the peeling tends to occur from the place where the adhesive force between the two is the weakest. Therefore, it is desirable that the uneven pattern 71 is a pattern capable of exerting a uniform adhesive force over the entire area of the rough surface processed portion 70.

From this point of view, the rough surface machined portion 70 has a plurality of

grooves

73, 74 geometrically (or) rather than forming a concavo-convex pattern 71A in which a large number of recesses 72 (or protrusions) are randomly arranged. It is desirable to form an arranged pattern (concavo-convex pattern 71B, etc.). The geometric pattern facilitates the formation of uniform unevenness over the entire surface of the roughened surface machined portion 70. Since the geometric pattern tends to exert a uniform adhesive force over the entire area of the rough surface processed portion 70, a higher peeling prevention effect can be obtained.

In order to obtain a uniform adhesive force over the entire surface of the rough surface machined portion 70, the width and depth of the

grooves

73 and 74, the internal shape of the grooves, and the like are set to be the same, and the

grooves

73 and 73 are connected to each other. It is desirable to set the spacing and the spacing between the

grooves

74 and 74 to be the same.

It is desirable that the

grooves

73 and 74 are inclined with respect to both the direction along the axis Ax of the metal member 30 (axial direction) and the direction orthogonal to the axis Ax (circumferential direction).

Here, when guiding the catheter 1 into the body, an external force is applied to the tip edge 50b of the outer layer tube 50 in the direction opposite to the insertion direction of the catheter 1 (the direction from the tip to the proximal end along the axis Ax). This external force tends to peel off the outer layer tube 50.

However, if the

grooves

73 and 74 that are inclined with respect to both the axis Ax (the direction of the force to be peeled off) and the direction orthogonal to the axis Ax are formed, they extend in parallel with each of the axial direction and the circumferential direction. A higher peeling prevention effect can be obtained than forming a groove. In this case, it is preferable that the angles of the

grooves

73 and 74 are inclined by 45 degrees with respect to the axis Ax of the metal member 30.

As the uneven pattern formed on the rough surface processed portion 70, the optimum uneven pattern is selected based on the ease of forming the unevenness, the obtained anchor effect, and the like. For example, in the uneven pattern formed on the rough surface processed portion 70 of the diagnostic catheter having the outer diameter of the catheter body 10 of 1 Fr (0.33 mm) or less, the

grooves

73 and 74 extending in two directions are 45 degrees with respect to the axis Ax, respectively. The uneven pattern 71B extending in the direction of is preferable.

The concavo-convex pattern 71B shown is a so-called twill pattern (diamond pattern) in which two types of

grooves

73 and 74 extending in different directions intersect each other, but the concavo-convex pattern has three or more types of grooves extending in different directions. It may be a crossed pattern.
Instead of forming a large number of linear grooves, a large number of wavy grooves may be formed in the rough surface processed portion 70.

Further, the rough surface processing portion 70 may include a concave-convex pattern 71C in which a plurality of concave portions 75 (or convex portions) are geometrically (or regularly) arranged as shown in FIG. 4 (c). good. The pattern shown is a pattern in which the dot-shaped (hemispherical) recesses 75 are aligned so as to extend linearly in the first direction and the second direction intersecting the first direction. The concavo-convex pattern 71C is a grid-like pattern in which the recesses 75 are arranged at positions corresponding to the intersections of the

grooves

73 and 74 in the concavo-convex pattern 71B.

<Adhesive>
As the adhesive 51, a biocompatible adhesive is used. For example, as the adhesive 51, a reactive adhesive such as an ultraviolet / visible light curable acrylic type, a cyanoacrylate type, or an ultraviolet / visible light curable silicon type, and a thermoplastic resin that melts by heating and cures by cooling (melting). Resin) etc. can be used. As the adhesive 51 which is a thermoplastic resin, a polyether block amide copolymer resin (PEBAX (registered trademark)) can be exemplified.

<Effect>
As described above, according to the present embodiment, since the uneven surface processed portion 70 is formed with the uneven surface pattern 71, the adhesive force between the rough surface processed portion 70 and the adhesive 51 can be improved by the anchor effect. Even if the materials to be bonded are different materials, such as the relationship between the rough surface processed portion 70 made of a metal material and the adhesive 51 made of a resin material, good adhesive force is obtained due to the anchor effect. Can be obtained. Therefore, it is possible to prevent the outer layer tube 50 from peeling off from the metal member 30.

[Second Embodiment]
FIG. 5 is a plan view showing a schematic configuration of a catheter according to a second embodiment of the present invention. FIG. 6A is a cross-sectional view taken along the line EE of the catheter body shown in FIG. 5, and FIG. 6B is a cross-sectional view taken along the line FF. 7A and 7B are views showing the structure of the tip of the catheter, FIG. 7A is a partially enlarged view, and FIG. 7B is a cross-sectional view taken along the line GG of FIG. 6B.

Hereinafter, the present invention will be described with reference to an example of an ablation catheter that heats and cauterizes a target tissue in a specific range using high frequency waves (radio waves). In the following description, the same components as those in the first embodiment are designated by the same reference numerals, and the description thereof will be omitted as appropriate.

The ablation catheter (hereinafter simply referred to as "catheter") 2 is attached to a catheter body 80 having at least one lumen (feed path 121, return path 123, guide wire lumen 125) inside and a proximal end portion 80b of the catheter body 80. The handle 90 is provided. The illustrated catheter is an over-the-wire catheter.

As shown in FIGS. 6 and 7, the catheter body 80 is composed of a metal tube 100 in which a flow path (feed path 121, return path 123) for transporting a cooling medium is formed in a hollow portion, and a metal tube 100. A resin outer layer tube 50 that covers the outer surface of a predetermined axial portion (insulation coating portion 106) of a metal tube 100 excluding the tip electrode 101 and a tip electrode 101 formed on the tip portion 100a, and an outer layer tube 50. An adhesive 51 for adhering the outer layer tube 50 and the metal tube 100 at least at the tip portion 50a is provided.

The metal tube 100 includes a rough surface processed portion 70 in which an uneven pattern 71 is formed at a portion to which the adhesive 51 is attached. The metal tube 100 is flexible in which slits 104 extending along the direction intersecting the axial direction are formed in at least a part of the axial direction located on the proximal end side in the axial direction with respect to the roughened surface machined portion 70. A portion 103 is provided.

<Metal tube>
Examples of the metal material constituting the metal tube 100 include stainless steel, NiTi, β-titanium, platinum iridium and the like.

The outer diameter of the metal tube 100 is, for example, 0.55 to 3.0 mm, preferably 0.7 to 2.0 mm. The inner diameter of the metal tube 100 is, for example, 0.25 to 2.8 mm, preferably 0.6 to 1.9 mm. The length of the metal tube 100 is, for example, 200 to 2200 mm, preferably 600 to 1000 mm.

<< Flexible part >>
The slit 104 formed in the flexible portion 103 penetrates the metal tube 100 in the inner and outer diameter directions. As shown in FIGS. 5 and 7 (a), the slit 104 is formed continuously in a spiral shape. By forming the slit 104, the flexible portion 103 is freely curved and deformed without kinking with a curvature corresponding to the width and pitch of the slit 104.

The pitch (spacing in the axial direction) of the slit 104 gradually narrows from the base end side to the tip end side of the metal tube 100. As a result, the rigidity of the catheter body 80 gradually decreases toward the distal end side. Therefore, the flexible portion 103 can be made to follow the shape of the blood vessel. The catheter body 80 can be a catheter having particularly excellent operability when it is introduced into the treatment target site. In the present invention, the pitch of the slit 104 may be the same in the axial direction.

The axial length from the handle 90 to the flexible portion 103 is 100 to 700 mm, preferably 300 to 500 mm. The axial length of the flexible portion 103 is 50 to 800 mm, preferably 100 to 600 mm. The axial length from the flexible portion 103 to the tip edge is 5 to 15 mm, preferably 7 to 13 mm.

The width of the slit 104 is 0.01 to 0.1 mm, preferably 0.02 to 0.04 mm. The distance between the slits 104 (the distance between the metal tubes 100 in the axial direction) is 0.3 to 20 mm.

The slit 104 is formed by, for example, laser processing, electric discharge machining, chemical etching, cutting, or the like. The slit 104 may be formed by any other method.

The slit 104 may have a shape other than the spiral shape as long as it can impart flexibility to the metal tube 100. For example, the metal tube 100 may include a plurality of slits extending in the circumferential direction in the flexible portion 103. Each of such slits is arranged, for example, in different axial positions and is formed independently (discontinuously) from each other.

<< Exposed part, Insulation coating part >>
As shown in FIG. 5, the catheter body 80 includes a tip electrode 101 formed by exposing the outer surface of the metal tube 100 to the axial tip 80a. Further, the remaining portion of the catheter body 80 in the axial direction is an insulating coating portion 106 whose outer surface is insulated and coated by the outer layer tube 50 and the adhesive 51.

The axial length of the insulating coating portion 106 is 150 to 1100 mm, preferably 800 to 1000 mm. The axial length of the tip electrode 101 (length L in FIG. 7A) is 2 to 10 mm, preferably 4 to 8 mm.

The outer layer tube 50 covers at least the entire flexible portion 103. The outer layer tube 50 is made of a heat-shrinkable resin tube having an insulating property. The outer layer tube 50 formed by heating the heat-shrinkable resin tube to reduce its diameter is in close contact with the outer surface of the metal tube 100.

The outer layer tube 50 is made of, for example, a polyether block amide copolymer resin (PEBAX (registered trademark)) or polyethylene terephthalate (PET). The film thickness of the outer layer tube 50 is, for example, 10 to 100 μm, preferably 20 to 40 μm.

The tip electrode 101 and the insulating coating 106 are inserted into the patient's body via blood vessels.
High-frequency power is supplied to the tip electrode 101 of the catheter 2 from the high-frequency power supply device via the lead wire 127. Since the metal tube 100 is exposed in the tip electrode 101, a high frequency current flows between the tip electrode 101 and the counter electrode connected to the high frequency power supply device. The tissue around the tip electrode 101 is cauterized by the generated Joule heat.

Since the insulating coating portion 106 is insulated and coated, a high frequency current does not flow between the insulating coating and the counter electrode connected to the high frequency power supply device.

<Lumen>
The catheter body 80 includes, as lumens in the hollow portion of the metal tube 100, a feed path 121 and a return path 123 for transporting a cooling medium for cooling the tip electrode 101, and a guide wire lumen 125 through which a guide wire is inserted (FIG. FIG. 6).

The feed path 121 and the guide wire lumen 125 are formed in the hollow portions of the flexible

resin lumen tubes

122 and 126, respectively, which are inserted into the hollow portions of the metal tube 100.

The return path 123 is formed between the inner surface of the metal tube 100 and the outer surface of the

lumen tubes

122 and 126. According to such a method of forming the return path 123, the number of lumen tubes accommodated in the metal tube 100 can be reduced, so that the diameter of the catheter body 80 can be reduced.

The cooling medium feed path 121 may be formed between the inner surface of the metal tube 100 and the outer surfaces of the

lumen tubes

122 and 126, and the return path 123 may be formed in the hollow portion of the lumen tube 122.

The guide wire lumen 125 is arranged so as to penetrate the catheter body 80. The guide wire lumen 125 is independent of the feed path 121 and the return path 123.

Lumen tubes

122 and 126 are composed of, for example, polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE) or polyimide (PI).

<< Cooling medium and its flow path >>
The flow paths for transporting the cooling medium include a feeding path 121 for transporting the cooling medium from the proximal end side to the distal end side of the catheter body 80 and a return path 123 for transporting the cooling medium from the distal end side toward the proximal end side. , Is included.

The feed path 121 transports the cooling medium toward the tip electrode 101. The return path 123 transports the cooling medium that has cooled the tip electrode 101 (heat exchanged with the tip electrode 101) to the handle 90 side. The tip opening 122a of the lumen tube 122 forming the feeding path 121 is arranged at an axial position corresponding to the forming position of the tip electrode 101. The cooling medium cools the tip electrode 101 from the inside. The cooling medium that has flowed out of the feed path 121 from the tip opening 122a of the lumen tube 122 flows into the return path 123 and is transported to the handle 90 side.

In this example, since the feed path 121 is formed in the lumen tube 122 and the return path 123 is formed between the lumen tube 122 and the metal tube 100, cooling is performed when the cooling medium is transported to the tip electrode 101. It is possible to prevent the temperature of the medium from rising. Therefore, the cooling efficiency of the tip electrode 101 by the cooling medium is improved.

The cooling medium for cooling the tip electrode 101 may be a liquid or a gas as long as it is a fluid that can flow through the feed path 121 and the return path 123. As the liquid cooling medium, for example, water, physiological saline, saturated saline, ethylene glycol, ethylene glycol aqueous solution and the like can be used. As the gas cooling medium, for example, air can be used. The temperature of the cooling medium is preferably −20 to 10 ° C.

Both the sending path 121 and the returning path 123 are kept liquidtight (airtight) with respect to the external space of the catheter body 80. Therefore, the cooling medium is transported along the axial direction inside the catheter body 80, but does not leak to the outside of the catheter body 80.

In the catheter 2, since the cooling medium does not enter the patient's body, the risk of irrigating the cooling medium into the organ to be treated can be avoided. Further, in the catheter 2, the optimum cooling medium can be selected and used according to the cooling capacity exhibited by each cooling medium.

<Electrical system>
Lead

wires

127 and 127 that energize the tip electrode 101 are soldered to appropriate positions on the outer surface of the metal tube 100. The

lead wires

127 and 127 are covered with an outer layer tube 50.

As another electrical configuration, the catheter body 80 may be provided with a thermocouple for measuring the temperature of the tip electrode 101 inside the metal tube 100.

<Handle>
As shown in FIG. 5, the first to fourth branch pipes 131 to 134 are connected to the base end of the handle 90.

<< First branch pipe >>
The first branch pipe 131 forms a path for introducing the cooling medium into the feed path 121. An injection connector 135, which serves as an injection port for the cooling medium, is attached to the base end of the first branch pipe 131.

The first branch pipe 131 is connected to the lumen tube 122 in the handle 90. In the handle 90, the hollow portion of the first branch pipe 131 communicates with the feed path 121, but does not communicate with other lumens (return path 123, guide wire lumen 125).

<< Second branch pipe >>
The second branch pipe 132 forms a path for discharging the cooling medium from the return path 123. A discharge connector 136, which serves as a discharge port for the cooling medium, is attached to the base end of the second branch pipe 132.
In the handle 90, the hollow portion of the second branch pipe 132 communicates with the return path 123, but does not communicate with other lumens (feed path 121, guide wire lumen 125).

<< Third branch pipe >>
The third branch pipe 133 forms a path for introducing the guide wire into the guide wire lumen 125. An introduction connector 137, which is an introduction port for a guide wire, is attached to the base end portion of the third branch pipe 133.

The third branch pipe 133 is connected to the lumen tube 126 in the handle 90. In the handle 90, the hollow portion of the third branch pipe 133 communicates with the guide wire lumen 125, but does not communicate with other lumens (feed path 121, return path 123).

<< Fourth branch pipe >>
Lead

wires

127 and 127 are inserted into the fourth branch pipe 134. A current-carrying connector 138 that conducts with the

lead wires

127 and 127 is attached to the base end of the fourth branch pipe 134.

<< Handle function >>
In the handle 90, the hollow portions of the branch pipes 131 to 134 are independent of each other. That is, the space for transporting the cooling medium is kept liquidtight (airtight) with other lumens.

The handle 90 has a function as a grip portion for operation. Further, the handle 90 has a function as a hub that integrates the flow path for transporting the cooling medium, the path through which the guide wire is inserted, and the

lead wires

127 and 127 for energization and guides them to the catheter body 80.

<Rough surface processed part / uneven pattern>
As shown in FIG. 7, the rough surface processing portion 70 is a portion where the outer surface of the metal tube 100 is subjected to uneven processing according to a predetermined pattern. The uneven pattern 71 formed on the rough surface processed portion 70 is a pattern formed mainly for the purpose of obtaining an anchor effect for improving the adhesiveness with the adhesive. The uneven surface processing portion 70 can be formed with the unevenness pattern 71 shown in FIGS. 4 (a) to 4 (c), as in the first embodiment.

In the catheter 2, the axial length of the roughened surface processed portion 70 is, for example, 0.5 to 3.0 mm, preferably 1.0 to 2.0 mm.
When the rough surface processing portion 70 includes the uneven pattern 71B in which a plurality of

grooves

73, 74 are geometrically (or regularly) arranged as shown in FIG. 4B, the depth of the

grooves

73, 74 is deep. The thickness is 5 to 15%, preferably 8 to 12% of the wall thickness of the non-exposed portion 33. The depth of the

grooves

73 and 74 is, for example, 4 to 14 μm, preferably 7 to 11 μm.

The width of the

grooves

73 and 74 is, for example, 0.01 to 0.1 mm, preferably 0.04 to 0.06 mm. The spacing between the

grooves

73 and 73 and the spacing between the

grooves

74 and 74 are, for example, 0.1 to 0.4 mm, preferably 0.2 to 0.3 mm.

<Positional relationship between rough surface processed part and adhesive>
The adhesive 51 adheres to the entire circumferential direction of the rough surface processed portion 70 without any gap, and adheres the rough surface processed portion 70 and the tip portion 50a of the outer layer tube 50.

The axial tip edge 51a of the adhesive 51 is arranged so as to be located at the same axial position as the tip edge 71a of the uneven pattern 71, or preferably located on the proximal end side of the tip edge 71a of the concave-convex pattern 71. .. When the adhesive 51 is peeled from the metal member 30, the tip edge 51a of the adhesive 51 is the starting point of the peeling. Therefore, by fitting the tip edge 51a of the adhesive 51 into the uneven pattern 71, a more reliable peeling prevention effect can be obtained.

Further, the tip edge 50b of the outer layer tube 50 is arranged so as to be located at the same axial position as the tip edge 51a of the adhesive 51, or preferably located on the proximal end side of the tip edge 51a of the adhesive 51. As a result, the adhesive is attached to the tip edge 50b of the outer layer tube 50 to prevent the outer layer tube 50 from peeling off from the roughened surface processed portion 70.

<Effect>
As described above, according to the present embodiment, since the uneven surface processed portion 70 is formed with the uneven surface pattern 71, the adhesive force between the rough surface processed portion 70 and the adhesive 51 can be improved by the anchor effect. Even if the materials to be bonded are different materials, such as the relationship between the rough surface processed portion 70 made of a metal material and the adhesive 51 made of a resin material, good adhesive force is obtained due to the anchor effect. Can be obtained. Therefore, it is possible to prevent the outer layer tube 50 from peeling from the metal tube 100.

If the outer layer tube 50 (and / or the adhesive 51) is peeled off from the metal tube 100 and a part of the covered metal tube 100 is exposed, the exposed part functions as a tip electrode. Due to the increase in the portion that functions as an electrode, there is a risk that tissues other than those to be cauterized will be cauterized. Further, if the outer layer tube 50 (and / or the adhesive 51) peeled off from the metal tube 100 is further torn, fragments of the outer layer tube 50 (and / or the adhesive 51) may remain in the body. There is.

According to the present embodiment, the adhesive force between the rough surface processed portion 70 and the adhesive 51 is improved by the anchor effect, so that the above-mentioned problem caused by the outer layer tube 50 being peeled from the metal tube 100 is prevented from occurring. can.

[Summary of Examples of Embodiments of the Present Invention, Actions, and Effects]
<First embodiment>
The catheter 2 according to this embodiment has a metal tube 100 in which a flow path (feed path 121, return path 123) for transporting a cooling medium is formed in the hollow portion, and a tip electrode 101 formed in the tip portion of the metal tube. A resin outer layer tube 50 that covers the outer surface of a predetermined axial portion of the metal tube excluding the tip electrode, and an adhesive 51 that adheres the outer layer tube and the metal tube at least at the tip of the outer layer tube. The catheter main body 80 is provided. The metal tube is characterized in that a rough surface processed portion 70 on which the uneven pattern 71 is formed is provided at a portion to which the adhesive is attached.

According to this aspect, since the uneven pattern is formed on the rough surface processed portion, the adhesive force between the rough surface processed portion and the adhesive can be improved by the anchor effect. Therefore, it is possible to prevent the outer layer tube from peeling from the metal tube.

In addition, an anchor that exhibits an uneven pattern on a rough surface processed portion made of a metal material, even if the materials to be adhered to each other are different materials, as in the case where the adhesive is made of a resin material. Good adhesive strength can be obtained due to the effect. Therefore, it is possible to prevent the outer layer tube from peeling from the metal tube.

<Second embodiment>
In the catheter 2 according to this aspect, the concave-convex pattern 71 includes a plurality of grooves 73 extending in the first direction and a plurality of grooves 74 extending in the second direction intersecting the first direction. It is characterized by that.

Here, when the outer layer tube 50 is peeled from the metal tube 100, the peeling tends to occur from the place where the adhesive force between the two is the weakest. By forming a plurality of grooves extending in the first and second directions as a concavo-convex pattern in the rough surface processed portion, it becomes easy to make the adhesive force of the adhesive in the rough surface processed portion uniform. Therefore, it is possible to effectively prevent the outer layer tube from peeling from the metal tube.

<Third embodiment>
In the catheter 2 according to this embodiment, the groove 73 extending in the first direction and the groove 74 extending in the second direction are inclined in the direction along the axis Ax of the metal tube 100 and in the direction orthogonal to the axis, respectively. It is characterized by doing.

Here, when guiding the catheter into the body, an external force that tries to peel off the outer layer tube 50 acts on the tip edge 50b of the outer layer tube 50 in the direction opposite to the insertion direction of the catheter. However, if the rough surface machined portion 70 is formed with a groove inclined with respect to both the axis Ax (the direction along the external force to be peeled off) and the direction orthogonal to the axis Ax, the outer layer tube 50 is peeled off. A high peeling prevention effect can be obtained even against an external force.

<Fourth embodiment>
In the catheter 2 according to this aspect, the tip edge 51a of the adhesive 51 is located closer to the proximal end side than the tip edge 71a of the uneven pattern 71.

When the adhesive 51 is peeled from the metal tube 100, the tip edge of the adhesive is the starting point of peeling. Therefore, by fitting the tip edge of the adhesive in the uneven pattern, a more reliable peeling prevention effect can be obtained.

<Fifth embodiment>
In the catheter 2 according to this embodiment, the flow paths include a feeding path 121 for transporting the cooling medium from the proximal end side to the distal end side, and a return path 123 for transporting the cooling medium from the distal end side toward the proximal end side. One of the feed path and the return path is formed by a resin tube (lumen tube 122) inserted into the hollow portion of the metal tube 100, and the other of the feed path and the return path is a resin tube and a metal tube. It is characterized in that it is formed between.

In the catheter according to this aspect, the cooling medium cools the tip electrode. Since the cooling medium reciprocates in the catheter, the cooling medium does not enter the patient's body. Therefore, the risk of irrigating the cooling medium into the organ to be treated can be avoided. In addition, the optimum cooling medium can be selected and used according to the cooling capacity exhibited by each cooling medium.

In the catheter according to this aspect, the cooling medium flows directly in the metal tube. Since the number of resin tubes housed in the metal tube can be reduced, the diameter of the catheter can be reduced.

1,2 ... catheter, 10 ... catheter body, 10a ... tip, 10b ... base end, 20 ... handle, 21 ... grip, 22 ... rotating plate, 23 ... rotating knob, 25, 25A, 25B ... operating wire, 30 ... Metallic member, 31 ... Tip tip electrode, 33 ... Non-exposed part, 41 ... Ring-shaped electrode, 50 ... Outer layer tube, 50a ... Tip, 50b ... Tip edge, 51 ... Adhesive, 51a ... Tip edge, 61 , 61A-61D ... Lumen tube, 62, 62A-62D ... Lead lumen, 65, 65A, 65B ... Lumen tube, 66, 66A, 66B ... Operation lumen, 70 ... Rough surface machined part, 71, 71A-71C ... Concavo-convex pattern, 72 ... recess, 73, 74 ... groove, 75 ... recess, 80 ... catheter body, 80a ... tip, 80b ... base end, 90 ... handle, 100 ... metal tube, 100a ... tip, 101 ... Tip electrode, 103 ... Flexible part, 104 ... Slit, 106 ... Insulation coating, 121 ... Feed path, 122 ... Lumen tube, 122a ... Tip edge, 123 ... Return path, 125 ... Guide wire lumen, 126 ... Lumen tube, 127 ... lead wire, 131 ... first branch pipe, 132 ... second branch pipe, 133 ... third branch pipe, 134 ... fourth branch pipe, 135 ... injection connector, 136 ... discharge connector, 137 ... introduction connector 138 ... Energizing connector

Claims

A metal tube having a flow path for transporting a cooling medium in the hollow portion, a tip electrode formed at the tip of the metal tube, and a predetermined axial portion of the metal tube excluding the tip electrode. A catheter body having a resin outer layer tube covering the outer surface and an adhesive for adhering the outer layer tube and the metal tube at at least at the tip of the outer layer tube is provided.
The metal tube is a catheter characterized in that a rough surface processed portion on which an uneven pattern is formed is provided at a portion to which the adhesive is attached.
The first aspect of the present invention is characterized in that the uneven pattern includes a plurality of grooves extending in a first direction and a plurality of grooves extending in a second direction intersecting the first direction. The catheter described.
The groove extending in the first direction and the groove extending in the second direction are each inclined with respect to a direction along the axis of the metal tube and a direction orthogonal to the axis. The catheter according to claim 2.
The catheter according to any one of claims 1 to 3, wherein the tip edge of the adhesive is located on the proximal end side of the tip edge of the uneven pattern.
The flow path includes a feed path for transporting the cooling medium from the proximal end side to the distal end side and a return path for transporting the cooling medium from the distal end side toward the proximal end side.
One of the feed path and the return path is formed by a resin tube inserted into the hollow portion of the metal tube, and the other of the feed path and the return path is between the metal tube and the resin tube. The catheter according to any one of claims 1 to 4, wherein the catheter is formed in.