JP6343965B2 - Method for manufacturing tip deflection movable catheter, method for manufacturing ring with wire, and jig for manufacturing ring with wire - Google Patents

Description

  The present invention relates to a method for manufacturing a tip deflection movable catheter capable of freely deflecting a tip portion, a method for manufacturing a ring with wire, and a jig for manufacturing a ring with wire.

  For catheters (including electrode catheters, ablation catheters, and catheter sheaths) that are inserted through blood vessels, body cavities, or body lumens to target tissues such as various organs (for example, the heart). In order to facilitate access to the tissue, etc., the direction of the distal end (tip) of the catheter to be inserted into the body is set to the operation portion provided at the proximal end (base end) of the catheter arranged outside the body. A distal deflection movable catheter that can be deflected by operation is known (see Patent Document 1 and Patent Document 2).

  The portion to be deflected of the distal end portion of the catheter tube is set to have a stepwise lower hardness, for example, as it goes to the distal end. The distal ends of the pair of wires are connected to each other at 180 ° opposite positions, and at the proximal ends of the pair of wires, one wire (first wire) is pulled, and the other wire (second wire) is connected. By slackening, the direction of the tube tip can be controlled.

  In order to manufacture such a tip deflection movable catheter, it is necessary to connect the distal ends of each of a pair of wires to a 180 ° facing position of a ring member (pull ring). Conventionally, the distal ends of the wires are welded alternately to the ring one by one. For this reason, at the time of the second welding, there is a possibility that the heat for the welding is transmitted to the first welded portion through the ring and the first welded portion is peeled off.

JP 2005-230471 A Special table 2009-537244 gazette

  The present invention has been made in view of such a situation, and an object of the present invention is to manufacture a wire-attached ring excellent in bonding strength of the distal end of the wire to the ring member, and to manufacture a tip deflection movable catheter having the wire-attached ring. It is to provide a method and a jig for manufacturing a wire ring.

To achieve the above object, a method for manufacturing a tip deflection movable catheter according to the present invention includes:
A catheter tube;
A ring member provided at the distal end of the catheter tube;
A first wire and a second wire having respective distal ends connected to the ring member;
A method of manufacturing a tip deflection movable catheter having an operation portion provided at a proximal end of the catheter tube,
The ring member is heated to melt the brazing material in a state where the distal ends of the first wire and the second wire are in contact with the ring member via the brazing material, and the first wire and the first wire are melted. A manufacturing method of a tip deflection movable catheter which has the process of joining simultaneously the distal end of two wires to the ring member, respectively.

  In the manufacturing method of the tip deflection movable catheter according to the present invention, the distal ends of the first wire and the second wire are simultaneously joined to the ring member. For this reason, unlike the conventional manufacturing method, the heating by the second welding does not adversely affect the first welding, and the strength of the joint portion between the distal end of each wire and the ring member is improved. Therefore, the direction of the tube tip can be controlled well by pulling one wire (first wire) and loosening the other wire (second wire).

Preferably, the method of the present invention is detachable so that the distal ends of the first wire and the second wire protrude from the distal ends of the jigs in the mounting grooves respectively provided on both side surfaces of the jig. Attaching process;
So that each distal end of the first wire and the second wire protruding from the distal end of the jig protrudes through the through hole while contacting the inner peripheral surface of the through hole of the ring member; And a step of detachably attaching the ring member to the distal end of the jig. According to such a method, it becomes easy to attach a flux or brazing material to the distal end of the wire.

Preferably, the method of the present invention includes attaching the brazing material to distal ends of the first wire and the second wire protruding from the ring member;
Drawing the distal ends of the first wire and the second wire, to which the brazing material is adhered, into the ring member and contacting the inner peripheral surface of the ring member with the brazing material, respectively. . According to such a method, it becomes easy to position the brazing material between the inner peripheral surface of the ring member and the distal end of the wire.

  Preferably, an induction heating coil is disposed around the ring member in a state where the distal ends of the first wire and the second wire are in contact with the ring member via a brazing material, respectively, and the ring member is heated. Then, the brazing material is melted, and the distal ends of the first wire and the second wire are simultaneously joined to the ring member. According to such a method, the operation | work which joins the distal end of a 1st wire and a 2nd wire to a ring member simultaneously becomes easy.

  In the method for manufacturing a ring with a wire according to the present invention, the brazing material is melted by heating the ring member in a state where the distal ends of the first wire and the second wire are in contact with the ring member via the brazing material, And simultaneously joining the distal ends of the first wire and the second wire to the ring member, respectively.

  In the method for manufacturing a ring with wire according to the present invention, the distal ends of the first wire and the second wire are simultaneously joined to the ring member. For this reason, unlike the conventional manufacturing method, the heating by the second welding does not adversely affect the first welding, and the strength of the joint portion between the distal end of each wire and the ring member is improved.

A manufacturing jig for a ring with a wire according to the present invention is:
A mounting jig for manufacturing a ring with a wire provided with mounting grooves on both side surfaces, and provided with mounting projections for detachably mounting a ring member on the distal end,
In the mounting groove, the distal ends of the first wire and the second wire can be moved in the axial direction and detachably mounted,
So that each distal end of the first wire and the second wire protruding from the distal end of the jig protrudes through the through hole while contacting the inner peripheral surface of the through hole of the ring member; The ring member is detachably attached to the attachment convex portion of the jig.

  By using the manufacturing jig for the ring with wire according to the present invention, it becomes easy to simultaneously join the distal ends of the first wire and the second wire to the ring member, and the ring with wire having excellent bonding strength can be obtained. Can be manufactured easily.

FIG. 1 is a plan view showing an external configuration of a tip deflection movable catheter according to an embodiment of the present invention. 2 is a cross-sectional view taken along line II-II shown in FIG. FIG. 3 is a sectional view taken along line III-III shown in FIG. 4 is a cross-sectional view taken along line IV-IV shown in FIG. FIG. 5 is a sectional view taken along line VV shown in FIG. FIG. 6 is a perspective view of a jig for manufacturing a ring with wire according to an embodiment of the present invention. FIG. 7 is a partial perspective view showing a manufacturing process of the distal deflection movable catheter according to the embodiment of the present invention. FIG. 8 is a partial perspective view showing a step subsequent to FIG. FIG. 9 is a partial perspective view showing a step subsequent to FIG. FIG. 10 is a partial perspective view showing a step subsequent to FIG. FIG. 11 is a partial perspective view showing a continuation process of FIG. FIG. 12 is a cross-sectional view of a ring with a wire showing details of a connecting portion of the wire.

Hereinafter, the present invention will be described based on embodiments shown in the drawings.
The catheter sheath (tip deflection movable catheter) as the distal deflection movable catheter of the present embodiment is, for example, a sheath for guiding an electrode catheter for detecting an electrocardiogram during arrhythmia treatment and an ablation catheter for excising myocardium. And other uses. Other applications include a sheath for guiding a catheter (stent delivery catheter) for introducing a stent into the bile duct.

  As shown in FIG. 1, the catheter sheath 1 of the present embodiment includes a sheath body 2 as a catheter tube, and an operation portion 3 and a grip portion 4 provided at the proximal end of the sheath body 2.

  As shown in FIGS. 2 and 3, the sheath body 2 includes a hollow tube 20 having a main lumen 21. The hollow tube 20 of the present embodiment is configured by a multilayer tube having an inner tube 22 and an outer tube 24. A blade layer 26 made of a net-like reinforcing wire (for example, a metal wire such as stainless steel) is embedded in the outer tube 24 to impart kink resistance to the sheath body 2.

  Inside the blade layer 26 of the outer tube 24, wire lumen tubes 28, 29 in which wire lumens are formed along the axial direction are embedded at positions facing about 180 ° with respect to the central axis of the sheath body 2. Yes. A first wire 30 and a second wire 31 are inserted into the wire lumens of the tubes 28 and 29 so as to be movable in the axial direction.

  As shown in FIG. 2, the blade layer 26 is embedded in the outer tube 24 so as to have an elliptical cross section, and the first wire 30 and the first wire 30 are arranged in the major axis direction of the elliptical blade layer 26. Two wires 31 are arranged. In the minor axis direction of the elliptical blade layer 26, the blade layer 26 is embedded in the outer tube 24 near the inner tube 22, and in the major axis direction of the elliptical blade layer 26, the blade layer 26 is embedded. Is embedded in the outer tube 24 close to the outer periphery.

  The main lumen 21 formed along the axial direction on the inner peripheral surface of the inner tube 22 includes an electrode catheter, an ablation catheter, a stent delivery catheter, a catheter for other uses, a guide wire, and other medical devices. It can be inserted freely in the direction. The inner peripheral surface of the main lumen 21 preferably has good sliding characteristics, and the inner tube 22 is made of, for example, polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene · It is made of a fluororesin such as hexafluoropropylene copolymer (FEP), tetrafluoroethylene / ethylene copolymer (ETFE), and polyvinylidene fluoride (PVDF).

  The outer tube 24 is preferably formed of a resin. For example, a polyamide-based elastomer such as a polyether block amide copolymer, polyamide, polyimide, polyamideimide, polyethylene terephthalate, polyethylene, polypropylene, polyurethane, ethylene-vinyl acetate copolymer Consists of polyvinyl chloride and the like. The wire lumen tubes 28 and 29 are preferably formed of a resin having good sliding characteristics. For example, polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoro It is made of a fluororesin such as ethylene / hexafluoropropylene copolymer (FEP), tetrafluoroethylene / ethylene copolymer (ETFE), or polyvinylidene fluoride (PVDF). The first wire 30 and the second wire 31 are made of a metal such as stainless steel, and may be a stranded wire or a single wire.

  As shown in FIG. 1, the distal end of the sheath body 2 is a deflecting portion 2a that can be arbitrarily deflected in directions opposite to each other by 180 °, as indicated by arrows α and β. The deflection directions α and β of the deflection unit 2a correspond to the mounting positions of the wire lumen tubes 28 and 29 facing each other at 180 °. In the deflection part 2a, it is preferable that the hardness is set lower (softer) than the remaining part, and further, in the deflection part, the hardness is set to be gradually or stepwise reduced toward the tip. May be.

  As shown in FIG. 4, a ring 35 with a wire having an annular pull ring (ring member) 32 is embedded in the distal end of the sheath body 2 (near the tip of the deflecting portion 2 a). The distal ends of the first wire 30 and the second wire 31 are connected and fixed at a position opposed to the central axis of the sheath body 2 on the inner peripheral surface of the pull ring 32 by 180 °. A manufacturing method for connecting and fixing the distal ends of the first wire 30 and the second wire 31 to the pull ring 32 will be described in detail later.

  In order to embed the wire ring 35 at the distal end of the sheath body 2, the distal end of the outer tube 24 has a stepped tip inserted into the through-hole of the pull ring 32, as shown in FIGS. The part 24a is formed by means such as cutting. The outer peripheral surface of the stepped tip portion 24 a is cut into a cylindrical outer peripheral surface shape in accordance with the inner peripheral surface shape of the through hole of the pull ring 32. Therefore, as shown in FIGS. 3 and 5, the blade layer 26 may remain inside the ring 32 in the minor axis direction of the blade layer 26 having an elliptical cross section.

  Further, as shown in FIGS. 3 and 4, in the major axis direction of the blade layer 26 having an elliptical cross section, a part of the blade layer 26 is also removed, and part of the wire lumen tubes 28 and 29 are also removed. Removed, the wire lumen is open inside the ring 32. At the position where the wire lumen is opened inside the ring 32, the distal ends of the wires 30 and 31 are connected and fixed to the inner peripheral surface of the ring 32.

  4 and 5, at the distal end of the deflecting portion 2a, the outer periphery of the ring 32, the outer periphery of the stepped tip 24a, the outer periphery of the inner tube 22, and the distal end of the inner tube 22 are distal. It is covered and integrated by the end coating resin 34. The distal end coating resin 34 may partially enter the distal end lumen of the wire lumen tubes 28, 29, but does not prevent the wires 30, 31 from moving in the axial direction in the wire lumen. It has become.

  The distal end coating resin 34 is formed by, for example, a dipping method, and a resin such as a polyamide-based elastomer such as a polyether block amide copolymer, polyamide, polyethylene, polypropylene, polyurethane, an ethylene-vinyl acetate copolymer, or polyvinyl chloride. It consists of

  The ring 32 is made of, for example, a metal such as stainless steel, and a contrast ring may be attached to the distal end thereof. The contrast ring is made of a metal that can be easily detected by X-rays, for example, gold, platinum, iridium, tungsten, or the like. In addition, you may comprise the whole ring 32 with a contrast ring.

  Proximal ends of the first wire 30 and the second wire 31 are connected to an operation unit 3 provided at the proximal end of the sheath body 2 shown in FIG. The operation unit 3 is provided on the tip (distal end) side of the grip unit 4. The operation unit 3 is provided with, for example, a rotary knob. By operating the rotary knob in the first rotation direction, the first wire 30 shown in FIGS. 2 to 5 is pulled, and the deflection unit 2a at the tip is shown in FIG. It is deflected as shown by arrow α. Further, by operating the rotary knob in the second rotation direction opposite to the first rotation direction, the second wire 31 shown in FIGS. 2 to 5 is pulled, and the tip deflection unit 2a is moved to the arrow β in FIG. Deflection as shown.

  Next, a method for manufacturing the catheter sheath 1 according to the present embodiment will be described. However, a method for manufacturing the sheath body 2 itself, the operation portion 3 itself, and the grip portion 4 itself, and a joining method thereof are known methods. Detailed description thereof will be omitted, and portions different from the conventional manufacturing method will be described in detail.

  In the present embodiment, the manufacturing method of the catheter sheath 1 shown in FIG. 1 is particularly characterized in the manufacturing method of the ring with wire 35 shown in FIG. 4 has a pull ring 32, and the distal end of the first wire 30 and the distal end of the second wire 31 are connected and fixed to the inner peripheral surface of the pull ring 32.

  The wire-attached ring 35 is manufactured by the method described below, and before the distal end coating resin 34 shown in FIGS. 4 and 5 is formed, the wires 30, 29 are placed in the lumens of the wire lumen tubes 28, 29. 31 is inserted, and the stepped tip portion 24a shown in FIG. Thereafter, a distal end coating resin 34 is formed, and at the distal end of the deflecting portion 2a, the outer periphery of the ring 32, the outer periphery of the stepped tip 24a, the outer periphery of the inner tube 22, and the distal end of the inner tube 22 Are covered and integrated by the distal end coating resin 34.

  In order to manufacture the ring 35 with a wire, first, a jig 40 for manufacturing a ring with a wire shown in FIG. 6 is prepared. As shown in FIG. 6, the jig 40 has a jig body 42 having a rectangular cross section and being elongated in the axial direction. At both ends in the axial direction of the jig main body 42, large size portions 42a having a larger cross-sectional size than the central portion are formed. The cross-sectional shape of the large size portion 42a is a rectangle and its corners are chamfered.

  At the end of the large size portion 42a formed at the end in the axial direction of the jig main body 42, a mounting projection 46 is formed to protrude. In addition, on both opposing side surfaces of the jig main body 42, mounting grooves 44 and 45 are formed which are continuous in a straight line in the axial direction. These mounting grooves 44 and 45 are also formed so as to extend to the large size portions 42a and 42a, and the bottom portions of these mounting grooves 44 and 45 are formed at the center portion of the jig body 42 and the large size portion 42a. It is designed to be substantially flush with each other.

  As will be described later, the first wire 30 and the second wire 31 can be inserted in the mounting grooves 44 and 45 so as to be movable in the axial direction and detachable. Therefore, the groove widths of these mounting grooves 44 and 45 are configured to be equal to or slightly larger than the wire diameters of the wires 30 and 31.

  Further, as will be described later, the mounting convex portion 46 is a portion to which the ring 32 is detachably attached, and is a cylindrical convex portion having an outer diameter equal to or slightly smaller than the inner diameter of the ring 32, and the mounting groove 44. , 45, 45, 45, and 45, 45, 45, 45, 45, 45, 45, 45, 45. The notch surface 46a is substantially flush with the bottom surfaces of the mounting grooves 44 and 45.

  Next, in this embodiment, as shown in FIG. 7, the distal ends 30 a and 31 a of the first wire 30 and the second wire 31 are respectively provided in the mounting grooves 44 and 45 provided on both side surfaces of the jig 40. Is detachably attached so as to protrude from the distal end of the jig 40. Thereafter, as shown in FIG. 8, the distal ends 30 a and 31 a of the first wire 30 and the second wire 31 protruding from the distal end of the jig 40 are formed on the inner peripheral surface of the through hole 32 a of the ring 32. The ring 32 is detachably attached to an attachment projection 46 provided at the distal end of the jig 40 so as to protrude through the through hole 32a while coming into contact.

  Next, the flux is attached to the distal ends 30a and 31a of the first wire 30 and the second wire 31 protruding from the ring 32 shown in FIG. The method for attaching the flux is not particularly limited, and examples thereof include a coating method. Thereafter, as shown in FIG. 9, the silver brazing material 36 is attached to the distal ends 30 a and 31 a of the first wire 30 and the second wire 31 protruding from the ring 32.

  A method for attaching the silver brazing material 36 is not particularly limited. For example, a method of inserting the distal ends 30 a and 31 a of the first wire 30 and the second wire 31 into a container in which the silver brazing material 36 is accommodated. Etc. are exemplified. In addition to the silver brazing material, a copper brazing material, a copper alloy brazing material, a nickel brazing material, or the like may be used as the brazing material. In the present embodiment, since the distal ends 30a and 31a of the wires 30 and 31 protrude from the through-hole 32a of the ring 32, it is easy to attach flux and brazing material.

  Next, as shown in FIG. 10, the wires 30 and 31 are moved in the axial direction along the mounting grooves 44 and 45, and the distal ends 30 a and 31 a of the wires 30 and 31 to which the silver brazing material 36 is attached are moved. Then, it is drawn into the ring 32 and brought into contact with the inner peripheral surface of the ring 32 via the silver brazing material 36. In this embodiment, the wires 30 and 31 are moved only in the axial direction along the mounting grooves 44 and 45, and the far end of the wire to which the silver brazing material 36 is attached to the 180 ° -opposing position of the inner peripheral surface of the ring 32. The distal ends 30a and 31a can be accurately positioned.

  Next, as shown in FIG. 11, an induction heating coil 48 is arranged around the ring 32 with the distal ends 30 a and 31 a of the wires 30 and 31 being in contact with the ring 32 via a silver brazing material 36. . The ring 32 is heated by the induction heating coil 48 to melt the silver brazing material 36. Then, as shown in FIG. 12, by cooling, a semi-bow-shaped silver solder joint 36a is formed, and the distal ends 30a, 31a of the wires 30, 31 are respectively positioned 180 ° opposite to the inner peripheral surface of the ring 32. At the same time.

  In the manufacturing method according to the present embodiment, the distal ends 30 a and 31 a of the first wire 30 and the second wire 31 can be simultaneously bonded to predetermined positions on the inner peripheral surface of the ring 32. For this reason, unlike the conventional manufacturing method, the heating by the second welding does not adversely affect the first welding portion, and the joint portion 36a between the distal ends 30a, 31a of the wires 30, 31 and the ring 32 is eliminated. The strength of is improved. Therefore, as shown in FIGS. 1 and 3, by pulling one wire (first wire 30) and loosening the other wire (second wire 31), the direction of the tube tip is improved in the direction of arrow α. Can be controlled. Further, by pulling the other wire (second wire 31) and loosening one wire (first wire 30), the direction of the tube tip can be controlled well in the arrow β direction.

  In addition, by using the jig 40 according to the present embodiment, the distal ends 30 a and 31 a of the first wire 30 and the second wire 31 can be joined to the predetermined positions on the inner peripheral surface of the ring 32 simultaneously at the same time. It becomes easy and the ring 35 with a wire excellent in joining strength can be manufactured easily.

  The present invention is not limited to the above-described embodiment, and can be variously modified within the scope of the present invention.

  For example, in the above-described embodiment, the tip deflection movable catheter is used as a catheter sheath having the main lumen 21, but the present invention can also be applied to a catheter having no main lumen 21 and other catheters. In the above-described embodiment, the wire lumen is formed by the wire lumen tubes 28, 29. However, the present invention is not limited to this, and the wire lumen is formed on the outer tube 24 itself without providing the tubes 28, 29. Also good. Further, in the embodiment described above, the sheath body 2 is configured by a multilayer tube, but may be configured by a single layer tube.

1 ... tip deflection movable catheter (catheter sheath)
DESCRIPTION OF SYMBOLS 2 ... Sheath main body 2a ... Deflection part 3 ... Operation part 4 ... Grip part 20 ... Hollow tube 21 ... Main lumen 22 ... Inner tube 24 ... Outer tube 26 ... Blade layer 28, 29 ... Wire lumen tube 30 ... First wire 31 ... Second wire 32 ... Pull ring 34 ... Distal end coating resin 35 ... Ring with ring 36 ... Silver brazing material 36a ... Joint portion 40 ... Jig 42 for manufacturing ring with wire ... Jig body 44, 45 ... Installation groove 46 ... Mounting projection

Claims (3)

A catheter tube;
A ring member provided at the distal end of the catheter tube;
A first wire and a second wire having respective distal ends connected to the ring member;
A method of manufacturing a tip deflection movable catheter having an operation portion provided at a proximal end of the catheter tube,
A step of detachably attaching the distal ends of the first wire and the second wire to the mounting grooves respectively provided on both side surfaces of the jig such that the distal ends of the jig protrude from the distal end of the jig;
The distal ends of the first wire and the second wire projecting from the distal end of the jig are projected through the through hole while contacting the inner peripheral surface of the through hole of the ring member. Detachably attaching the ring member to the distal end of the jig;
Attaching a brazing material to the distal ends of the first wire and the second wire protruding from the ring member;
Drawing the distal ends of the first wire and the second wire to which the brazing material is attached into the ring member and bringing the distal ends into contact with the inner circumferential surface of the ring member via the brazing material; ,
Heating said ring member in a state in which the distal end of said first wire and said second wire were contacted respectively through the brazing material to the ring member is fused the brazing material, the first wire and the The manufacturing method of the tip deflection | deviation movable catheter which has the process of joining simultaneously the distal end of a 2nd wire to the said ring member, respectively. An induction heating coil around the ring member a distal end of said first wire and said second wire being in contact respectively via the brazing material to said ring member arranged, by heating said ring member The method of manufacturing a tip deflection movable catheter according to claim 1, wherein the brazing material is melted and the distal ends of the first wire and the second wire are simultaneously joined to the ring member. A step of detachably attaching the distal ends of the first wire and the second wire to the mounting grooves respectively provided on both side surfaces of the jig such that the distal ends of the jig protrude from the distal end of the jig;
So that each distal end of the first wire and the second wire protruding from the distal end of the jig protrudes through the through hole while contacting the inner peripheral surface of the through hole of the ring member; Removably attaching the ring member to the distal end of the jig;
Attaching a brazing material to the distal ends of the first wire and the second wire protruding from the ring member;
Drawing the distal ends of the first wire and the second wire to which the brazing material is attached into the ring member and bringing the distal ends into contact with the inner circumferential surface of the ring member via the brazing material; ,
Heating said ring member in a state in which the distal end of said first wire and said second wire were contacted respectively through the brazing material to the ring member is fused the brazing material, the first wire and the The manufacturing method of the ring with a wire which has the process of joining simultaneously the distal end of a 2nd wire to the said ring member, respectively.

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