JP2013192797A - Medical instrument and method for manufacturing the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical instrument having a structure in which the strength of a manipulation wire is prevented from being reduced.SOLUTION: A medical instrument (e.g. catheter 10) has a medical instrument body (sheath 16), a manipulation wire 40, and a fixing member 80. The medical instrument body is long and flexible, and to be inserted into the body cavity. The manipulation wire 40 is embedded in the medical instrument body. The manipulation wire 40 bends the medical instrument body upon performing an operation for pulling the manipulation wire 40 to the base end side of the medical instrument body. The fixing member 80 is equipped on the distal end of the medical instrument body. The fixing member 80 has a plurality of parts. The manipulation wire 40 passes through the plurality of parts of the fixing member 80, is guided from the base end side to the distal end side, and is frictionally fixed to the plurality of parts of the fixing member 80.

Description

  The present invention relates to a medical device and a method for manufacturing the medical device.

  Various medical devices have been developed that are formed in a long shape and configured to be able to change the direction of entry into a body cavity by performing an operation of bending a tip (hereinafter referred to as a “distal end”). As a typical example, for example, a catheter is known.

  Patent Document 1 describes a catheter having an operation line (flat wire of the same document) for performing an operation of bending the distal end portion. The distal end of the operation line is fixed by laser welding to a member (pull ring in the same document) provided at the distal end portion of the catheter. The distal end portion of the catheter can be bent by pulling the operation line to the proximal end side.

Special table 2009-537244 gazette

The present inventor has found the following problems in the technique of Patent Document 1.
In the technique of Patent Document 1, the operation line is fixed by laser welding to a member (pull ring) provided at the distal end portion of the catheter. In this case, the operation line deteriorates due to heat during welding, and the tensile strength (breaking strength) of the operation line decreases. According to the inventor's study, the tensile strength of the operation line is reduced to, for example, about 1/3 of the original by welding.

  This invention is made | formed in view of said subject, and provides the manufacturing method of the medical device of the structure where the strength reduction of the operation line was suppressed, and the strength reduction of the operation line.

The present invention is a long and flexible medical device body inserted into a body cavity,
An operation line embedded in the medical device body, and an operation line for bending the medical device body when an operation of pulling the operation line to the proximal end side of the medical device body is performed,
A fixing member provided at a distal end portion of the medical device body;
Have
The fixing member has a plurality of portions,
The operation line passes between the plurality of portions, is guided from the proximal end side to the distal end side, and is frictionally fixed to the plurality of portions.

  According to this medical device, the operation line passes between the plurality of portions of the fixing member, is guided from the proximal end side to the distal end side, and is frictionally fixed to the plurality of portions of the fixing member. Therefore, the tip of the operation line can be fixed to the fixing member without using a welding technique such as laser welding. For this reason, it is possible to avoid deterioration of the operation line due to heat during welding. Therefore, it is possible to realize a medical device having a structure in which the strength reduction of the operation line is suppressed.

In addition, the present invention bends the medical device body when an operation of pulling the medical device body that is long and flexible and is inserted into a body cavity to the proximal end side of the medical device body is performed. A process of burying operation lines;
Fixing the tip of the operation line to a fixing member having a plurality of portions;
Providing the fixing member at the distal end of the medical device body;
Have
In the step of fixing the distal end portion of the operation line to the fixing member, the operation line is guided between the plurality of portions from the proximal end side to the distal end side, and is fixed to the plurality of portions by friction. A method of manufacturing a medical device is provided.

  According to the present invention, the medical device can have a structure in which a decrease in strength of the operation line is suppressed.

It is a typical top view which shows the front-end | tip part of the medical device which concerns on 1st Embodiment. It is typical sectional drawing which shows the front-end | tip part of the medical device which concerns on 1st Embodiment. It is typical sectional drawing which shows the front-end | tip part of the medical device which concerns on 1st Embodiment. It is II sectional drawing of FIG. It is II-II sectional drawing of FIG. It is a typical top view of the medical device concerning a 1st embodiment. It is typical sectional drawing which shows the modification of the positional relationship between an operation line and several parts of a fixing member. It is a schematic diagram which shows the example of the cross-sectional shape of an operation line. It is a schematic diagram which shows the front-end | tip part of the medical device which concerns on 2nd Embodiment. It is a schematic diagram which shows the front-end | tip part of the medical device which concerns on 3rd Embodiment. It is a schematic diagram which shows the front-end | tip part of the medical device which concerns on 4th Embodiment. It is a schematic diagram which shows the front-end | tip part of the medical device which concerns on 5th Embodiment. It is a schematic diagram which shows the attachment structure of the operation line with respect to the fixing member of the medical device which concerns on 6th Embodiment. It is a schematic diagram which shows the attachment structure of the operation line with respect to the fixing member of the medical device which concerns on 7th Embodiment. It is a schematic diagram which shows the structure of the 1st part and 2nd part of the fixing member of the medical device which concerns on 7th Embodiment. It is a typical cross section which shows the structure of the fixing member of the medical device which concerns on 8th Embodiment.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same components are denoted by the same reference numerals, and description thereof will be omitted as appropriate.

[First Embodiment]
FIG. 1 is a schematic plan view showing a distal end portion of a catheter 10 (FIG. 6) as an example of a medical device according to the first embodiment.
2 and 3 are schematic cross-sectional views showing the distal end portion of the catheter 10. FIG. 3 shows a wider range than FIG.
4 is a sectional view taken along the line II in FIG. 3, and FIG. 5 is a sectional view taken along the line II-II in FIG. In FIG. 5, the coil 50 is not shown.
FIG. 6 is a schematic plan view of the catheter.

The catheter 10 as a medical device according to the present embodiment includes a medical device main body (sheath 16), an operation line 40, and a fixing member 80. The medical device body is long and flexible, and is inserted into a body cavity. The operation line 40 is embedded in the medical device body. The operation line 40 bends the medical device body when an operation of pulling the operation line 40 to the proximal end side of the medical device body is performed. The fixing member 80 is provided at the distal end portion of the medical device main body. The fixing member 80 has a plurality of parts (for example, a first part 81a, a second part 81b, and a tongue piece 82). The operation line 40 passes between a plurality of portions of the fixing member 80 and is guided from the proximal end side to the distal end side, and is frictionally fixed to the plurality of portions of the fixing member 80.
The plurality of portions of the fixing member 80 are separated from each other. However, in the present embodiment, the plurality of portions of the fixing member 80 are integrated with each other via other portions (for example, the third portion 81c) of the fixing member 80.
Details will be described below.

  As shown in FIG. 6, the catheter 10 includes a sheath 16 and an operation mechanism for performing a bending operation of the distal end portion of the sheath 16.

  The operation mechanism includes an operation line 40 (FIGS. 3 and 5) and an operation unit 70 for performing an operation of pulling the operation line 40. The operation line 40 is embedded in the sheath 16 along the longitudinal direction of the sheath 16. The operation unit 70 is provided at the proximal end portion of the sheath 16. A proximal end portion of the operation line 40 is connected to the operation portion 70, and the distal end portion of the sheath 16 can be bent by operating the operation portion 70.

  The sheath 16 as the main body of the catheter 10 is long and flexible, and is used by being inserted into a body cavity.

  The catheter 10 is a suitable example that is an intravascular catheter used by being inserted into a blood vessel. More specifically, the sheath 16 of the catheter 10 is a suitable example in which the sheath 16 is sized to allow the sheath 16 to enter any of the eight sub-regions of the liver.

  In this specification, the predetermined length region including the distal end (tip) DE of the catheter 10 (and the sheath 16) is referred to as the distal end portion 15 of the catheter 10 (and the sheath 16). Similarly, the predetermined length region including the proximal end (proximal end) (not shown) of the catheter 10 (and the sheath 16) is referred to as the proximal end portion (proximal end portion) of the catheter 10 (and the sheath 16). 17 (FIG. 6).

  As shown in FIGS. 3 and 5, a main lumen 20 and a sub-lumen 30 are formed inside the sheath 16. The main lumen 20 and the sub-lumen 30 extend along the longitudinal direction (the left-right direction in FIG. 3) of the sheath 16 (the catheter 10). For example, the main lumen 20 is disposed at the center of the transverse cross section (cross section orthogonal to the longitudinal direction) of the sheath 16, and the sub-lumen 30 is disposed around the main lumen 20. More specifically, for example, in the cross section, the sub-lumens 30 are arranged at rotationally symmetric positions with respect to the center of the main lumen 20.

  The catheter 10 has a plurality of sub-lumens 30, for example. Each sub-lumen 30 has a smaller diameter than the main lumen 20.

  The sub-lumens 30 and the main lumen 20 and the sub-lumen 30 are arranged separately from each other. For example, the plurality of sub-lumens 30 are distributed around the main lumen 20. 3 and 5, the number of sub-lumens 30 is two, and the sub-lumens 30 are arranged around the main lumen 20 at intervals of 180 degrees.

  The operation lines 40 are respectively inserted into the sub-lumens 30. That is, the catheter 10 has, for example, two operation lines 40.

  The operation line 40 is movable relative to the sub-lumen 30 in the longitudinal direction of the sub-lumen 30 by sliding with respect to the peripheral wall of the sub-lumen 30. That is, the operation line 40 is slidable in the longitudinal direction of the sub-lumen 30.

The operation wire 40 may be formed of a single wire, but may be a stranded wire formed by twisting a plurality of thin wires.
The number of fine wires constituting one stranded wire is not particularly limited, but is preferably 3 or more. A suitable example of the number of thin wires is three or seven.
As shown in FIG. 8A, when the number of the fine lines 43 constituting the operation line 40 is three, the three fine lines are arranged point-symmetrically in the cross section. As shown in FIG. 8B, when the number of the fine wires 43 constituting the operation line 40 is seven, the seven fine wires are arranged symmetrically in a honeycomb shape in the cross section.
The outer dimension of the operation wire 40 (diameter of the circumscribed circle of the stranded wire) can be set to 25 to 55 μm, for example.

  In addition to flexible metal wires such as low carbon steel (piano wire), stainless steel (SUS), titanium or titanium alloy, the material of the wire constituting the operation wire 40 (or the fine wire 43 constituting the stranded wire) , Poly (paraphenylene benzobisoxazole) (PBO), polyether ether ketone (PEEK), polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), polyimide (PI) or polytetrafluoroethylene (PTFE), boron fiber, etc. The polymer fiber can be used.

  Here, examples of the structure of the sublumen 30 include the following two structures.

  In the first structure, as shown in FIGS. 3 and 5, a preformed hollow tube 32 is embedded in an outer layer 60 (described later) along the longitudinal direction of the sheath 16, and the hollow tube 32 is The lumen is sublumen 30. That is, in these examples, the sub-lumen 30 is constituted by the lumen of the hollow tube 32 embedded in the sheath 16.

  The hollow tube 32 can be made of, for example, a thermoplastic resin. Examples of the thermoplastic resin include low friction resins such as polytetrafluoroethylene (PTFE) and polyetheretherketone (PEEK).

  In the second structure, the sub-lumen 30 is formed by forming a long hollow along the longitudinal direction of the sheath 16 in the outer layer 60 (described later).

  More specifically, the sheath 16 includes, for example, an inner layer 21, an outer layer 60 formed by laminating around the inner layer 21, and a coat layer 64 formed around the outer layer 60.

  The inner layer 21 is made of a tubular resin material. A main lumen 20 is formed at the center of the inner layer 21.

  The outer layer 60 is made of the same or different resin material as the inner layer 21. The sub-lumen 30 is formed inside the outer layer 60.

Examples of the material of the inner layer 21 include a fluorine-based thermoplastic polymer material. Specifically, the fluorine-based thermoplastic polymer material is, for example, polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), or perfluoroalkoxy fluororesin (PFA).
By configuring the inner layer 21 with such a fluorine-based resin, the delivery property when supplying a contrast medium or a drug solution to the affected area through the main lumen 20 is improved.

  The material of the outer layer 60 (the outer layer main body 61 and the coating resin 62) is, for example, a thermoplastic polymer. As this thermoplastic polymer, polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), nylon elastomer, polyurethane (PU), ethylene-vinyl acetate resin (EVA) And polyvinyl chloride (PVC) or polypropylene (PP).

  The sheath 16 is made of, for example, a resin material. That is, the sheath 16 includes the outer layer 60 and the inner layer 21 made of a resin material.

In other words, the sheath 16 has a hollow resin layer including the outer layer 60 and the inner layer 21.
This resin layer is disposed coaxially with the coil 50 and covers the coil 50. That is, the coil 50 is embedded in this resin layer.

  The resin material constituting the sheath 16 may contain an inorganic filler. For example, as the resin material constituting the outer layer 60 that occupies most of the thickness of the sheath 16, a material containing an inorganic filler can be used.

  Examples of the inorganic filler include barium sulfate and bismuth subcarbonate. By mixing such an inorganic filler in the outer layer 60, the X-ray contrast property is improved.

The coat layer 64 constitutes the outermost layer of the catheter 10 and is made of a hydrophilic material. The coat layer 64 may be formed only in a region extending over a part of the distal end portion 15 of the sheath 16, or may be formed over the entire length of the sheath 16.
The coat layer 64 is made hydrophilic by molding it with a hydrophilic resin material such as polyvinyl alcohol (PVA) or polyvinyl pyrrolidone. The coat layer 64 may be formed by subjecting the outer surface of the outer layer 60 to lubrication so that at least the outer surface of the outer layer 60 is hydrophilic.

For example, the catheter 10 further includes a coil 50 wound around the inner layer 21. The coil 50 is configured, for example, by bending one or more wire rods 52 formed of an elastic body in a spiral shape. As a material of the wire 52 constituting the coil 50, for example, a metal is preferably used. However, the material is not limited to this example, and any other material may be used as long as the material has higher rigidity and elasticity than the inner layer 21 and the outer layer 60. (For example, resin) may be used. Specifically, for example, stainless steel (SUS), nickel titanium alloy, steel, titanium, or copper alloy can be used as the metal material of the wire 52. Although the cross-sectional shape of the wire 52 is not particularly limited, for example, a rectangular shape or a circular shape is a preferable example.
The coil 50 is included in the outer layer 60.
In the present embodiment, the sub-lumen 30 is formed outside the coil 50 inside the outer layer 60.

  The catheter 10 may have a blade layer (not shown) instead of the coil 50. The blade layer is formed by knitting (knitting) a wire in a mesh shape, and is disposed at the same position as the coil 50.

Here, the typical dimension of each component of the catheter 10 of this embodiment is demonstrated.
The radius of the main lumen 20 is about 200 to 300 μm, the thickness of the inner layer 21 is about 10 to 30 μm, the thickness of the outer layer 60 is about 50 to 150 μm, the outer diameter of the coil 50 is 500 to 860 μm, and the inner diameter of the coil 50 is the diameter. It can be 420-660 micrometers.
The radius (distance) from the axial center of the catheter 10 to the center of the sublumen 30 is about 300 to 450 μm, and the inner diameter (diameter) of the sublumen 30 is 40 to 100 μm. And the thickness of the operation line 40 shall be about 30-60 micrometers.
The outermost diameter (radius) of the catheter 10 is about 350 to 490 μm, that is, the outer diameter is less than 1 mm in diameter. Thereby, the catheter 10 of the present embodiment can be inserted into a blood vessel such as a celiac artery.

  A fixing member 80 is provided at the distal end 15 of the sheath 16 of the catheter 10. The distal end portion of the operation line 40 is frictionally fixed to the fixing member 80 at the distal end portion 15 of the sheath 16 (details will be described later).

  The sublumen 30 is open at least on the proximal end 17 side of the catheter 10. The base end portion of each operation line 40 protrudes from the opening of the sub-lumen 30 to the proximal end side. A proximal end portion of each operation line 40 is connected to an operation portion 70 provided at the proximal end portion 17 of the sheath 16.

  As illustrated in FIG. 6, the operation unit 70 includes, for example, a main body case 700 and a wheel operation unit 760 provided to be rotatable with respect to the main body case 700.

  A proximal end portion of the sheath 16 is introduced into the main body case 700. A hub 790 is attached to the rear end portion of the main body case 700. The proximal end of the sheath 16 is fixed to the front end portion of the hub 790.

  The hub 790 is a cylindrical body in which a hollow that penetrates the hub 790 forward and backward is formed. The hollow of the hub 790 communicates with the main lumen 20 of the sheath 16.

  An injector (syringe) (not shown) can be inserted into the hub 790 from behind. By injecting a liquid such as a chemical solution into the hub 790 with this injector, the liquid is supplied to the distal end of the sheath 16 via the main lumen 20, and the liquid is supplied from the distal end of the sheath 16 into the body cavity of the patient. can do.

  For example, the operation line 40 and the hollow tube 32 are branched from the sheath 16 (a portion of the sheath 16 excluding the operation line 40 and the hollow tube 32) at the front end portion of the main body case 700.

  The hollow tube 32 is open at the base end, and the base end of the operation line 40 protrudes proximally from the opening of the base end of the hollow tube 32.

  The base end portion of each operation line 40 is directly or indirectly connected to the wheel operation portion 760. By rotating the wheel operation portion 760 in either direction, the operation lines 40 are individually pulled toward the proximal end side, and the distal end portion 15 of the catheter 10 (the distal end portion 15 of the sheath 16) is bent. It can be made to.

  As shown in FIG. 6B, when the wheel operation unit 760 is rotated in one direction around the rotation axis, one operation line 40 is pulled to the proximal end side. Then, a tensile force is applied to the distal end portion 15 of the catheter 10 through the one operation line 40. As a result, the distal end portion 15 of the sheath 16 bends toward the sub-lumen 30 through which the one operation line 40 is inserted, with the axis of the sheath 16 as a reference. That is, the distal end portion 15 of the sheath 16 bends in one direction.

  Further, when the wheel operation unit 760 is rotated in the other direction around the rotation axis as shown in FIG. 6C, the other operation line 40 is pulled to the proximal end side. Then, a tensile force is applied to the distal end portion 15 of the catheter 10 through the other operation line 40. As a result, the distal end portion 15 of the sheath 16 bends toward the sub-lumen 30 through which the other operation line 40 is inserted with the axis of the sheath 16 as a reference. That is, the distal end portion 15 of the sheath 16 bends in the other direction.

  Here, the bending of the sheath 16 includes a mode in which the sheath 16 bends in a “shape” and a mode in which the sheath 16 is bent like a bow.

  Thus, by selectively pulling the two operation lines 40 by the operation of the operation unit 70 with respect to the wheel operation unit 760, the distal end portion 15 of the catheter 10 is moved in the first direction and the opposite direction. It can be bent in a certain second direction. The first direction and the second direction are included in the same plane.

It is possible to freely control the direction of the distal end DE of the catheter 10 by performing a combination of a torque operation for rotating the entire catheter 10 and a pulling operation.
Furthermore, the amount of bending of the distal end DE of the catheter 10 can be adjusted by adjusting the pulling amount of the operation line 40.
For this reason, the catheter 10 of this embodiment can be made to approach in a desired direction, for example with respect to body cavities, such as a branching blood vessel.
That is, by performing an operation for bending the distal end portion 15, the direction of entry into the body cavity can be changed.

Next, the structure of the fixing member 80 and the structure for fixing the operation line 40 to the fixing member 80 will be described with reference to FIGS. 1 to 4.
1 and 2, the illustration of the coat layer 64 is omitted. Further, in FIG. 1A, illustration of a coating resin 62 (described later) constituting the surface layer portion of the outer layer 60 of the sheath 16 is omitted.

  In the case of the present embodiment, the fixing member 80 is formed in an annular shape (ring shape) coaxial with the sheath 16, for example, as shown in FIGS. The fixing member 80 is provided, for example, around the main lumen 20 and inside the outer layer 60.

  The fixing member 80 has a plurality of portions as described below. The operation line 40 passes between a plurality of portions of the fixing member 80 and is guided from the proximal end side to the distal end side, and is frictionally fixed to the plurality of portions of the fixing member 80.

  As shown in FIG. 1, in the case of this embodiment, the fixing member 80 includes, for example, a main body portion 81 and a tongue piece 82.

  The main body 81 includes a first portion 81a, a second portion 81b, and a third portion 81c that connects the first portion 81a and the second portion 81b.

  The tongue piece 82 is located between the first portion 81a and the second portion 81b in the axial direction of the sheath 16 (the left-right direction in FIGS. 1 and 2). The tongue piece 82 is a peninsular portion whose one end is connected to the third portion 81c.

  The first portion 81 a and the tongue piece 82 are separated from each other in the axial direction of the sheath 16 through the first slit 83. Similarly, the tongue piece 82 and the second portion 81 b are separated from each other in the axial direction of the sheath 16 via the second slit 84.

  When the fixing member 80 is annular as described above, the first portion 81a, the first slit 83, the tongue piece 82, the second slit 84, and the second portion 81b are respectively in the circumferential direction of the fixing member 80 (the sheath 16). Is also the circumferential direction). In this case, one end of the tongue piece 82 in the circumferential direction is connected to the third portion 81c.

  More specifically, the fixing member 80 is formed with a slit 85 that connects the first slit 83 and the second slit 84. The 1st slit 83, the 2nd slit 84, and the slit 85 are C shape as a whole.

  In the present embodiment, the plurality of portions of the fixing member 80 include a first portion 81a, a tongue piece 82, and a second portion 81b. Therefore, in this embodiment, the fixing member 80 has three or more portions as a plurality of portions.

  The first portion 81a, the tongue piece 82, and the second portion 81b are separated from each other in the axial direction of the sheath 16 via slits (first slit 83 and second slit 84) formed in the fixing member 80. Yes. In other words, the first portion 81 a, the tongue piece 82 and the second portion 81 b are arranged along the axial direction of the sheath 16. The operation line 40 passes through a slit formed in the fixing member 80 and is guided from the proximal end side to the distal end side. More specifically, the operation line 40 passes through the first slit 83 and the second slit 84 in this order, and is guided from the proximal end side to the distal end side.

  For example, as shown in FIG. 1A, the operation line 40 guided from the proximal end side to the distal end side with respect to the fixing member 80 passes through the inside of the first portion 81 a and passes through the first slit 83. The fixing member 80 is guided from the inside to the outside, passes through the outside of the tongue piece 82, is guided from the outside to the inside of the fixing member 80 through the second slit 84, passes through the inside of the second portion 81 b, and then is fixed. It is led to the tip side from 80.

  As described above, the operation line 40 is guided from the proximal end side to the distal end side so as to sew between a plurality of portions of the fixing member 80. More specifically, the operation line 40 is guided from the proximal end side to the distal end side through the inside and outside of the fixing member 80 alternately in the radial direction of the fixing member 80.

  For example, the operation line 40 is in contact with each of the first portion 81a, the tongue piece 82, and the second portion 81b, and is frictionally fixed to the first portion 81a, the tongue piece 82, and the second portion 81b. ing.

  Here, the outer layer 60 includes an outer layer main body 61 and a coating resin 62. The outer layer main body 61 is located near the center of the sheath 16, and the coating resin 62 is located near the outer periphery of the sheath 16. The fixing member 80 is provided at the distal end portion of the sheath 16 by, for example, caulking and fixing around the inner layer 21. The coating resin 62 collectively covers the operation line 40 and the fixing member 80. The coating resin 62 may be formed only at the distal end portion of the sheath 16 or may be formed over the entire longitudinal direction of the sheath 16. For example, the thickness of the coating resin 62 is thinner than the thickness of the outer layer main body 61. The outer layer main body 61 and the coating resin 62 are made of, for example, the same kind of resin material and are fused and integrated with each other.

  Since the operation line 40 and the fixing member 80 are collectively covered with the coating resin 62, the integrity of the operation line 40 and the fixing member 80 is enhanced, and the operation line 40 is more firmly fixed to the fixing member 80. be able to.

A part of the coating resin 62 enters the first slit 83 and the second slit 84, fills the operation line 40 in the first slit 83, and in the second slit 84. The operation line 40 is filled. Note that the coating resin 62 also enters the slit 85.
In this way, a part of the coating resin 62 enters the slits (the first slit 83 and the second slit 84) and fills the operation line 40, so that the operation line 40 is indirectly covered by the coating resin 62. The fixing member 80 is frictionally fixed to the first portion 81a, the tongue piece 82, and the second portion 81b.

  Here, the slits (the first slit 83 and the second slit 84) extend in the circumferential direction of the sheath 16, and the dimension of the slit in the circumferential direction of the sheath 16 is twice the outer dimension of the operation line 40. The above is preferable. By doing so, the coating resin 62 can be easily filled in the slit.

  Here, the thickness of the fixing member 80 in the direction orthogonal to the axis of the sheath 16 is t, and the outer diameter of the operation line 40 is φ. Note that the thickness of the fixing member 80 may or may not be constant over the entire fixing member 80, for example. In the latter case, the wall thickness t means the average wall thickness of the portion of the fixing member 80 that overlaps the operation line 40.

As described above, the operation line 40 passes inside and outside the fixing member 80. Therefore, if the positions of the first portion 81a, the tongue piece 82, and the second portion 81b in the direction orthogonal to the axis of the sheath 16 are the same, the sheath occupied by the operation line 40 and the fixing member 80 The thickness in the direction orthogonal to the 16 axis is (2φ + t). That is, the total thickness of the operation line 40 and the fixing member 80 is (2φ + t).
However, the sheath 16 is required to have a small diameter so that the sheath 16 can be easily inserted into a thinner blood vessel.

Therefore, in the present embodiment, the tongue piece 82 has the axial center of the sheath 16 so that the thickness of the region occupied by the operation line 40 and the fixing member 80 in the direction orthogonal to the axial center of the sheath 16 is less than (2φ + t). Is displaced relative to the main body 81 in a direction orthogonal to the main body 81.
For example, as shown in FIG. 2, the tongue piece 82 is displaced toward the center of the sheath 16 relative to the first portion 81 a and the second portion 81 b of the main body portion 81. As a result, the thickness of the region occupied by the operation line 40 and the fixing member 80 in the direction perpendicular to the axis of the sheath 16 is less than (2φ + t). That is, the total thickness of the operation line 40 and the fixing member 80 is less than (2φ + t).

  More specifically, for example, as shown in FIG. 2, the tongue piece 82 is φ relative to the first portion 81 a and the second portion 81 b of the body portion 81 in the direction orthogonal to the axis of the sheath 16. Is only displaced towards the center. In this case, the first portion 81a and the second portion 81b are substantially flush with the operation line 40 on the outer peripheral side of the sheath 16, and the tongue piece 82 and the operation line 40 are substantially flush also on the inner peripheral side of the sheath 16. It will be the same. In this case, the thickness of the region occupied by the operation line 40 and the fixing member 80 is approximately (φ + t) in the direction perpendicular to the axis of the sheath 16 (becomes the minimum value).

  The displacement amount of the tongue piece 82 with respect to the first portion 81a and the second portion 81b of the main body 81 may exceed φ as shown in FIG. 7A, for example, or as shown in FIG. Thus, it may be less than φ. However, in any case, the thickness of the region occupied by the operation line 40 and the fixing member 80 is set to be less than (2φ + t) in the direction perpendicular to the axis of the sheath 16.

  The displacement of the tongue piece 82 relative to the main body 81 as described above may be realized by plastic deformation of the tongue piece 82 or may be realized by elastic deformation of the tongue piece 82. In the latter case, the operation line 40 can be frictionally fixed to the fixing member 80 more firmly. That is, in the latter case, the operation line 40 and the tongue piece 82 are firmly engaged by the restoring force (spring force) of the tongue piece 82.

  The fixing member 80 includes a first portion 81a, a tongue piece 82, and a second portion 81b for each operation line 40. The first part 81a, the tongue piece 82, and the second part 81b to which one of the two operation lines 40 is fixed, and the first part 81a, the tongue piece to which the other operation line 40 is fixed. 82 and the second portion 81 b are arranged at an interval of 180 ° in the circumferential direction of the fixing member 80.

  The fixing member 80 is preferably made of metal in terms of strength.

The fixing member 80 is made of, for example, a material that is opaque to specific radiation such as X-rays (a material that does not transmit specific radiation). For this reason, for example, the position of the fixing member 80, that is, the position of the distal end portion of the sheath 16 can be easily recognized when X-ray imaging is performed. That is, the fixing member 80 also functions as a marker.
Specifically, the fixing member 80 is made of a metal material such as platinum. Note that the entire fixing member 80 may be made of a material opaque to specific radiation, or only a part of the fixing member 80 may be made of a material opaque to specific radiation. good.

  The distal end of the hollow tube 32 is located on the proximal end side with respect to the fixing member 80, for example. The operation line 40 protrudes to the tip side from the hollow tube 32. In the operation line 40, a portion protruding to the tip side from the hollow tube 32 is friction fixed to the fixing member 80.

  It should be noted that the axial direction component of the operation line 40 includes the axial component of the sheath 16 at any position near the distal end of the sheath 16. In other words, the axial direction of the operation line 40 is not orthogonal to the axial direction of the sheath 16 at any position near the distal end portion of the sheath 16. This is because, for example, when the operation line 40 is bent at a steep angle and turned back, an excessive load (stress) is locally applied to the operation line 40 and the operation line 40 is disconnected.

Next, a method for manufacturing a medical device according to this embodiment will be described.
This manufacturing method includes the following steps.
1) An operation line that bends a medical device body when the medical device body (sheath 16) that is long and flexible and is inserted into a body cavity is pulled toward the proximal end of the medical device body 2) Step of fixing the distal end portion of the operation line 40 to a fixing member 80 having a plurality of portions 3) Step of providing the fixing member 80 at the distal end portion of the medical device main body In the step 2), the operation is performed. The line 40 is guided between the plurality of portions of the fixing member 80 and guided from the base end side to the distal end side, and is fixed to the plurality of portions of the fixing member 80 by friction.

  For example, as will be described below, the catheter 10 is manufactured by separately creating each part of the catheter 10 and combining them.

The outer layer main body 61 of the outer layer 60 is produced, for example, by extruding a resin material as a molding material with an extrusion molding apparatus (not shown). In this extrusion molding, a resin material that will be the outer layer main body 61 is attached around the core wire by extruding a core wire (mandrel) together with the resin material.
Although the material of a core wire is not specifically limited, As an example, copper or a copper alloy, alloy steels, such as carbon steel and SUS, nickel, or a nickel alloy can be mentioned.
A release treatment may optionally be performed on the surface of the core wire. As the mold release treatment, optical or chemical surface treatment may be performed in addition to the application of a release agent such as fluorine or silicon.

Here, in each of the positions where the sub-lumen 30 is formed by burying the hollow tube 32 later in the outer layer main body 61, for example, at that position, a long hollow along the longitudinal direction is formed. Extrusion molding while supplying fluid such as gas. The hollow inner diameter is larger than the outer diameter of the hollow tube 32. This is to facilitate the process of later inserting the hollow tube 32 into the hollow.
After the extrusion molding, the hollow outer layer body 61 can be formed by pulling out the core wire. The core diameter used for forming the outer layer main body 61 is larger than the outer diameter of the coil 50. This is to facilitate the process of covering the outer layer main body 61 around the coil 50 (and the inner layer 21) later.

  The inner layer 21 is created by extruding a resin material with an extrusion molding apparatus (not shown) different from the extrusion molding apparatus for creating the outer layer main body 61. At the time of this extrusion molding, a core material (a core wire different from that for forming the outer layer main body 61) is extruded together with the resin material, thereby adhering the resin material to be the inner layer 21 around the core wire. The diameter of the core wire corresponds to the diameter of the main lumen 20. The inner layer 21 may be formed by a dispersion forming apparatus.

  The coil 50 is produced through a process of winding a wire rod in a spiral around the core wire (core wire different from that for creating the inner layer 21 and the outer layer body 61). Thereafter, the core wire in the coil 50 is pulled out.

  Thereafter, the coil 50 is placed around the inner layer 21 with the core wire. Accordingly, at this stage, the core wire is still inserted into the inner layer 21.

  The hollow tube 32 is formed by extruding a resin material by an extrusion molding apparatus (not shown) separate from the extrusion molding apparatus for creating the inner layer 21 and the extrusion molding apparatus for creating the outer layer main body 61. Create by. Here, a hollow is formed at the center of the hollow tube 32 by performing extrusion molding while discharging a fluid such as gas from a discharge tube disposed at the center of the extrusion port (nozzle) of the extrusion molding apparatus.

  In addition, a dummy core wire inserted into the hollow tube 32 is separately prepared, and the dummy core wire is inserted into the hollow tube 32.

After forming the outer layer main body 61 and covering the coil 50 around the inner layer 21, the outer layer main body 61 is covered around the coil 50. As a result, the core wire (used for forming the inner layer 21), the inner layer 21, the coil 50, and the outer layer main body 61 are arranged concentrically in order from the center side.
Next, the hollow tube 32 (with a dummy core wire) is inserted into each hollow of the outer layer main body 61.

  Next, a heat shrinkable tube (not shown) is placed around the outer layer main body 61. Next, the heat-shrinkable tube is contracted by heating, and the outer layer main body 61 is tightened from the periphery, and the outer layer main body 61 is melted. The heating temperature is higher than the melting temperature of the outer layer main body 61 and lower than the melting temperature of the inner layer 21. By this heating, the outer layer main body 61 and the inner layer 21 are joined by welding. At this time, the resin material constituting the outer layer main body 61 encloses the coil 50, and the resin material impregnates the coil 50. Moreover, the outer layer main body 61 and the hollow tube 32 are joined by welding.

  Next, the heat-shrinkable tube is removed from the outer layer main body 61 by making a cut in the heat-shrinkable tube and tearing the heat-shrinkable tube.

  Next, the dummy core wire is pulled out from the hollow tube 32, and the operation wire 40 is inserted into the hollow tube 32.

  Separately, the fixing member 80 is prepared.

  As described above, the distal end portion of the operation line 40 is guided from the proximal end side to the distal end side so as to sew between the first portion 81a, the tongue piece 82, and the second portion 81b of the fixing member 80, and the distal end of the operation line 40 The part is fixed to the fixing member 80. This operation is performed for each operation line 40.

  Next, the fixing member 80 is fixed to the distal end portion of the sheath 16. For this purpose, for example, the outer layer main body 61 at the distal end portion of the sheath 16 is excised, and the inner layer 21 is exposed at the distal end portion of the sheath 16. At this time, the hollow tube 32 is also cut out together with the outer layer main body 61. Next, let the front-end | tip part of the operation line 40 be the state protruded from the front-end | tip side of the hollow tube 32 to the front end side.

  Next, the fixing member 80 is extrapolated around the inner layer 21 at the distal end portion of the sheath 16, and the fixing member 80 is caulked and fixed to the periphery of the inner layer 21.

  Next, the periphery of the distal end portion of the sheath 16 is covered with a coating resin 62 formed in a cylindrical shape in advance, and the coating resin 62 is applied to the outer layer main body 61 and the inner layer 21 using a heat shrinkable tube different from the heat shrinkable tube. On the other hand, it joins by welding. Thus, the outer layer 60 composed of the outer layer main body 61 and the coating resin 62 is formed. At this time, the operation line 40 and the fixing member 80 are collectively covered with the coating resin 62. The outer layer main body 61 and the coating resin 62 are, for example, melted and integrated with each other. The front end surface of the fixing member 80 is also covered with the melted outer layer 60.

  Next, the hub 790 is connected to the proximal end portion of the sheath 16.

  Next, the core wire in the inner layer 21 is pulled out. The core wire is pulled out in a state where the core wire is reduced in diameter by pulling both ends in the longitudinal direction of the core wire. As a result, a hollow serving as the main lumen 20 is formed at the center of the inner layer 21.

  Next, the base end part of the operation line 40 is connected directly or indirectly to the wheel operation part 760 of the operation part 70 created separately. Further, the main body case 700 of the operation unit 70 and the wheel operation unit 760 are assembled, and the hub 790 is attached to the main body case 700.

  Thus, the sheath 16 is bent by a pulling operation with respect to the operation line 40.

  Next, the coat layer 64 is formed.

  In this way, the catheter 10 having the structure shown in FIGS. 3 to 6 can be manufactured.

  According to the first embodiment as described above, a long and flexible sheath 16 to be inserted into a body cavity, and an operation line 40 embedded in the sheath 16, the operation line 40 being the sheath. 16 includes an operation line 40 for bending the sheath 16 when an operation of pulling the base 16 toward the proximal end is performed, and a fixing member 80 provided at the distal end portion of the sheath 16. The fixing member 80 has a plurality of parts (for example, a first part 81a, a tongue piece 82, and a second part 81b). The operation line 40 passes between a plurality of portions of the fixing member 80 and is guided from the proximal end side to the distal end side, and is frictionally fixed to the plurality of portions of the fixing member 80.

  Therefore, the distal end portion of the operation line 40 can be fixed to the fixing member 80 without using a welding technique such as laser welding. For this reason, deterioration of the operation line 40 due to heat during welding can be avoided. Therefore, the catheter 10 having a structure in which the strength reduction of the operation line 40 is suppressed can be realized.

  Since the operation line 40 is guided from the base end side to the distal end side so as to sew between a plurality of portions of the fixing member 80, a large frictional resistance between the plurality of portions of the fixing member 80 and the operation line 40 is obtained. The operation line 40 can be firmly fixed to the fixing member 80 without welding.

  Since the fixing member 80 has three or more portions as a plurality of portions, a larger frictional resistance between the plurality of portions of the fixing member 80 and the operation line 40 can be obtained.

  Further, the tongue piece 82 is positioned in the direction orthogonal to the axis of the sheath 16 so that the thickness of the region occupied by the operation line 40 and the fixing member 80 in the direction orthogonal to the axis of the sheath 16 is less than (2φ + t). It is displaced relative to the part 81. Accordingly, it is possible to prevent the sheath 16 from becoming thinner.

Further, since the catheter 10 has the coating resin 62 that collectively covers the operation line 40 and the fixing member 80, the operation line 40 can be fixed to the fixing member 80 more firmly by friction.
In particular, a part of the coating resin 62 enters the slits (the first slit 83 and the second slit 84) and fills the operation line 40, thereby fixing the operation line 40 to the fixing member 80 more firmly. can do.

  Further, since the operation line 40 is in contact with each of the plurality of portions of the fixing member 80, a larger frictional resistance between the operation line 40 and the plurality of portions of the fixing member 80 can be obtained.

  At any position in the vicinity of the distal end portion of the sheath 16, the axial direction component of the operation line 40 includes the axial direction component of the sheath 16, so that stress applied to the operation line 40 can be suppressed. .

  Further, since the operation line 40 is a stranded wire formed by twisting a plurality of thin wires 43, the operation line 40 and a plurality of portions of the fixing member 80 are compared with the case where the operation line 40 is a round wire or the like. Greater frictional resistance can be obtained.

  In addition, since the slits (the first slit 83 and the second slit 84) extend in the circumferential direction of the sheath 16, the extending direction of the edge of the slit and the extending direction of the operation line 40 are different. Nearly orthogonal. For this reason, a large frictional resistance between the sheath 16 and the edge of the slit is obtained.

[Second Embodiment]
FIG. 9 is a schematic diagram showing a distal end portion of a catheter as a medical device according to the second embodiment. 9A is a plan view and FIG. 9B is a cross-sectional view. In FIG. 9, illustration of the coat layer 64 is omitted. Further, in FIG. 9A, illustration of the coating resin 62 is omitted.

The catheter according to the second embodiment is different from the first embodiment (FIGS. 1 and 2) only in the configuration of the fixing member 80. In the present embodiment, the fixing member 80 is not formed with the slit 85. The fixing member 80 has a third portion 86 instead of the tongue piece 82. Both ends of the third portion 86 are connected to the main body portion 81. The first portion 81 a and the third portion 86 are separated from each other in the axial direction of the sheath 16 through the first slit 83. Similarly, the third portion 86 and the second portion 81 b are separated from each other in the axial direction of the sheath 16 via the second slit 84. Similarly to the operation line 40 being frictionally fixed to the first portion 81a, the tongue piece 82, and the second portion 81b in the first embodiment, the first portion 81a, the third portion 86, and the second portion. It is fixed to the friction with respect to 81b.
According to the second embodiment as described above, the same effect as that of the first embodiment can be obtained.

[Third Embodiment]
FIG. 10 is a schematic diagram showing a distal end portion of a catheter as a medical device according to the third embodiment. 10A is a plan view, and FIG. 10B is a cross-sectional view. In FIG. 10, the coat layer 64 is not shown. Further, in FIG. 10A, illustration of the coating resin 62 is omitted.

The catheter according to the third embodiment is different from the first embodiment (FIGS. 1 and 2) only in the configuration of the fixing member 80. In 3rd Embodiment, the 1st part 81a and the 2nd part 81b are also tongue pieces shape, and the fixing member 80 is E-shaped.
The catheter may have a fixing member 80 for each operation line 40, and a first portion 81a, a tongue piece 82, and a second portion 81b are provided at both ends in the circumferential direction of one fixing member 80, respectively. May be formed.
According to the third embodiment, the same effect as that of the first embodiment can be obtained. In addition, since one end of each of the slits 83 and 84 is open, the operation line 40 can be easily attached to the fixing member 80.

[Fourth Embodiment]
FIG. 11 is a schematic diagram showing a distal end portion of a catheter as a medical device according to the fourth embodiment. 11A is a plan view, and FIG. 11B is a cross-sectional view. In FIG. 11, illustration of the coat layer 64 is omitted. Further, in FIG. 11A, illustration of the coating resin 62 is omitted.

The catheter according to the fourth embodiment is different from the second embodiment (FIG. 9) only in the configuration of the fixing member 80. In the present embodiment, the fixing member 80 does not have the third portion 86. Further, the first slit 83 and the second slit 84 are not formed in the fixing member 80.
In the case of the present embodiment, the first portion 81 a and the second portion 81 b are separated from each other in the axial direction of the sheath 16 through the slit 87.
For example, the operation line 40 passes through the outside of the first portion 81 a, passes through the slit 87, enters the inside of the fixing member 80, passes through the inside of the second portion 81 b, and is guided to the tip side from the fixing member 80. Yes.
According to the fourth embodiment, the same effect as that of the second embodiment can be obtained.
However, the operation line 40 can be fixed to the fixing member 80 more firmly in the second embodiment than in the fourth embodiment.

[Fifth Embodiment]
FIG. 12 is a schematic diagram showing a distal end portion of a catheter as a medical device according to the fifth embodiment. 12A is a plan view, and FIG. 12B is a cross-sectional view. In FIG. 12, the coating layer 64 is not shown. Further, in FIG. 12A, illustration of the coating resin 62 is omitted.

  The catheter according to the fifth embodiment is different from the first embodiment (FIGS. 1 and 2) only in the configuration of the fixing member 80.

  In the case of this embodiment, the fixing member 80 is formed with round holes (for example, round holes 91, 92, 93) that penetrate the fixing member 80 in the thickness direction. The round holes 91, 92, 93 are circular or elliptical. Of the round holes 91, 92, 93, the round hole 91 is disposed on the most proximal side, the round hole 93 is disposed on the most distal side, and the round hole 92 is disposed between the round hole 91 and the round hole 93. ing.

The plurality of portions of the fixing member 80 include, for example, a first portion 94, a second portion 95, a third portion 96, and a fourth portion 97. The first portion 94 is a portion closer to the proximal end than the round hole 91 in the fixing member 80. The second portion 95 is a portion between the round hole 91 and the round hole 92 in the fixing member 80. The third portion 96 is a portion between the round hole 92 and the round hole 93 in the fixing member 80. The fourth portion 97 is a portion on the distal end side of the round hole 93 in the fixing member 80.
As described above, the plurality of portions of the fixing member 80 include a portion closer to the proximal end than the round holes 91, 92, 93 in the fixing member 80 and a portion closer to the distal end than the round holes 91, 92, 93 in the fixing member 80. And part.

  The operation line 40 is led from one side of the fixing member 80 to the other side, or from the other side to one side in a direction orthogonal to the axial center of the sheath 16 through the round holes 91, 92, 93. . Specifically, for example, the operation line 40 guided from the portion on the proximal end side to the distal end side with respect to the fixing member 80 passes through the inside of the first portion 94 and passes through the round hole 91 to the outside from the inside of the fixing member 80. To the inside of the fixing member 80 through the round hole 92, to pass through the inside of the third portion 96, and through the round hole 93 from the inside to the outside of the fixing member 80. To the distal end side of the fixing member 80 through the outside of the fourth portion 97.

According to the fifth embodiment, the same effect as that of the first embodiment can be obtained.
However, in the first embodiment in which slits (for example, the first slit 83 and the second slit 84) are formed in the fixing member 80, the coating resin 62 enters the slit, so that the fifth embodiment is different from the fifth embodiment. In comparison, the operation line 40 can be fixed to the fixing member 80 more firmly.

[Sixth Embodiment]
FIG. 13 is a schematic diagram showing a structure for attaching the operation line 40 to a fixing member 80 of a catheter as a medical device according to the sixth embodiment. 13A is a plan view, FIG. 13B is a cross-sectional view, and FIG. 13C is a front view when the base end side is viewed from the distal end side. In FIGS. 13A and 13B, the coat layer 64 is not shown. In FIG. 13A, illustration of the coating resin 62 is omitted. In FIG. 13C, only the fixing member 80, the operation line 40, and the fastener 110 are shown.

  The catheter according to the sixth embodiment is different from the first embodiment (FIGS. 1 and 2) only in the configuration of the fixing member 80.

  In the present embodiment, the plurality of portions of the fixing member 80 include an annular first portion 120 and an annular second portion 130 having a smaller diameter than the first portion 120. For example, the first portion 120 and the second portion 130 are each formed in an annular shape. The second portion 130 is attached to the first portion 120 by fitting with the first portion 120. That is, in the present embodiment, the fixing member 80 has a plurality of parts separated from each other.

  The operation line 40 passes between the inner edge (for example, the inner peripheral surface 121) of the first portion 120 and the outer edge (for example, the outer peripheral surface 131) of the second portion 130, and is guided from the proximal end side to the distal end side. .

The inner diameter of the first portion 120 is slightly larger than the outer diameter of the second portion 130. The difference between the inner diameter (diameter) of the first portion 120 and the outer diameter (diameter) of the second portion 130 is smaller than twice the outer dimension of the operation wire 40 (for example, the diameter of the circumscribed circle of the stranded wire).
For this reason, the operation line 40 is sandwiched between the inner peripheral surface 121 of the first portion 120 and the outer peripheral surface 131 of the second portion 130 and is held in a compressed state. That is, the operation line 40 passes between a plurality of portions (the first portion 120 and the second portion 130) of the fixing member 80 and is guided from the proximal end side to the distal end side, and is fixed to the plurality of portions by friction. Has been.

  Note that a fastener 110 having a diameter larger than that of the operation line 40 is caulked and fixed to the tip of the operation line 40. The fastener 110 is located on the tip side of the first portion 120 and the second portion 130 of the fixing member 80. Accordingly, the operation line 40 is restricted by the fastener 110 from moving to the proximal side relative to the first portion 120 and the second portion 130. That is, the operation line 40 is prevented from coming off from the first portion 120 and the second portion 130.

  According to the sixth embodiment, the same effect as that of the first embodiment can be obtained.

[Seventh Embodiment]
FIG. 14 is a schematic diagram showing a structure for attaching the operation line 40 to a fixing member 80 of a catheter as a medical device according to the seventh embodiment. 14A is a front view when the base end side is viewed from the distal end side, FIG. 14B is a side view, and FIG. 14C is a cross-sectional view taken along line AA in FIG. 14 (d) is a cross-sectional view taken along line BB in FIG. 14 (a). In FIG. 14, only the fixing member 80, the operation line 40, and the fastener 110 are shown.
FIG. 15 is a schematic diagram illustrating the structure of the first portion 120 and the second portion 130 of the fixing member 80 according to the seventh embodiment. 15A is a front view of the first portion 120 when the base end side is viewed from the distal end side, FIG. 15B is a side view of the first portion 120, and FIG. 15C is FIG. FIG. 15A is a cross-sectional view taken along the line AA in FIG. 15A, and FIG. 15D is a cross-sectional view taken along the line BB in FIG. 15 (e) is a front view of the second portion 130 when viewed from the distal end side to the proximal end side, FIG. 15 (f) is a side view of the second portion 130, and FIG. 15 (g) is FIG. FIG. 15E is a cross-sectional view taken along the line AA in FIG. 15E, and FIG. 15F is a cross-sectional view taken along the line BB in FIG.

  The catheter according to the seventh embodiment is different from the sixth embodiment (FIG. 13) only in the points described below.

  As shown in FIGS. 15A to 15D, in the case of the present embodiment, a concave portion 122 is formed on the tip-side surface of the annular first portion 120. The inner diameter of the inner peripheral surface 123 of the first portion 120 is smaller than the inner diameter of the recess 122.

  In the first portion 120, a portion adjacent to the proximal end side of the recess 122 is referred to as a small diameter portion 127. In the first portion 120, a portion located around the recess 122 is referred to as an outer peripheral portion 128.

  A number of slits 124 corresponding to the operation line 40 are formed in the small diameter portion 127. The slit 124 penetrates the small diameter portion 127 from the proximal end side to the distal end side. The slit 124 is formed from the inner peripheral side end to the outer peripheral side end in the small diameter portion 127. The outer peripheral end of the slit 124 reaches the inner peripheral end 125 of the outer peripheral portion 128.

  A number of semi-cylindrical recesses 126 corresponding to the operation lines 40 are formed on the front end surface of the outer peripheral portion 128. The recess 126 opens to the inner peripheral side of the outer peripheral portion 128. As shown in FIG. 15A, the recess 126 and the slit 124 are adjacent to each other in a front view.

  As shown in FIGS. 15 (e) to 15 (h), a semi-cylindrical recess 136 is formed on the tip-side surface of the annular second portion 130 having a smaller diameter than the first portion 120. The recess 136 opens to the outer peripheral side of the second portion 130.

  For example, the inner diameter of the inner peripheral surface 133 of the second portion 130 and the inner diameter of the inner peripheral surface 123 of the first portion 120 are equal to each other.

  In the case of this embodiment, the operation line 40 is frictionally fixed to the fixing member 80 as follows.

The operation line 40 is inserted through the slit 124 and guided from the proximal end side to the distal end side of the first portion 120.
The second portion 130 is fitted into the recess 122 from the distal end side of the first portion 120. As a result, the operation line 40 passes between the inner edge of the first portion 120 (for example, the inner peripheral side end 125 of the outer peripheral portion 128) and the outer edge (for example, the outer peripheral surface 131) of the second portion 130, and is on the proximal end side. To the tip side.

Further, the recess 126 of the first portion 120 and the recess 136 of the second portion 130 are combined to form a recess 116 capable of accommodating the fastener 110 on the front surface side of the fixing member 80 (see FIG. 14).
The fastener 110 is accommodated in the recess 116. For this reason, the fastener 110 is restricted in movement to the proximal end side by the fixing member 80. That is, the operation line 40 is prevented from being detached from the fixing member 80.

  According to the seventh embodiment as described above, the same effect as in the sixth embodiment can be obtained.

[Eighth Embodiment]
FIG. 16 is a schematic cross-sectional view showing the structure of the fixing member 80 of the catheter 10 according to the eighth embodiment.

In the first embodiment (FIGS. 1 and 2), the second embodiment (FIG. 9), the fourth embodiment (FIG. 11), and the fifth embodiment (FIG. 12), the fixing member 80 is Although the example which is cyclic | annular was demonstrated, in these embodiment, the catheter may have the fixing member 80 for each operation line 40, as shown in FIG. That is, one operation line 40 may be fixed to the fixing member 80a, and the other operation line 40 may be fixed to the fixing member 80b. These fixing members 80a and 80b are arranged at intervals of 180 ° in the circumferential direction of the sheath 16, for example.
According to the eighth embodiment, the same effects as those of the first, second, fourth, and fifth embodiments can be obtained.

  In the third embodiment, the plurality of tongue-like portions (the first portion 81a, the tongue piece 82, and the second portion 81b) are arranged side by side in the axial direction of the sheath 16, and the plurality of tongue pieces An example in which the protruding directions of the shaped portions are the same has been described. On the other hand, the protruding directions of the plurality of tongue-like portions arranged in the axial direction of the sheath 16 may be staggered.

  In each of the embodiments described above, an example in which the operation line 40 is in direct contact with the fixing member 80 has been described. However, the operation line 40 may be indirectly frictionally fixed to the fixing member 80. For example, the operation line 40 may be frictionally fixed to the fixing member 80 via the coating resin 62.

  In the fixing member 80, the surface roughness of the surface (for example, the inner peripheral surface of the annular fixing member 80) facing the lumen (for example, the main lumen 20) of the sheath 16 is the opposite surface (for example, the annular fixing member). It is also preferable to make it larger than the surface roughness of the outer peripheral surface of 80). As described above, the inner peripheral side of the fixing member 80 is protected by the thick outer layer main body 61 and is reinforced by the coil 50. For this reason, there is no problem even if the surface roughness of the fixing member 80 is large to some extent. On the other hand, since the outer peripheral side of the fixing member 80 is only covered with the thin coating resin 62 and the coating layer 64, it is preferable to make the surface roughness as small as possible. Note that as the surface roughness of the fixing member 80 increases, the frictional resistance between the operation line 40 and a plurality of portions of the fixing member 80 can be increased.

  In addition, each component in each said form does not necessarily need to exist independently independently. A plurality of components may be formed as a single member, one component may be formed of a plurality of members, or a certain component may be a part of another component. A part of a certain component and a part of another component may overlap.

10 Catheter 15 Distal End 16 Sheath (Medical Device Main Body)
17 Proximal end portion 20 Main lumen 21 Inner layer 30 Sublumen 32 Hollow tube 40 Operation wire 43 Fine wire 50 Coil 52 Wire material 60 Outer layer 61 Outer layer body 62 Coating resin 64 Coat layer 70 Operation portions 80, 80a, 80b Fixing member 81 Body portion 81a first part 81b second part 81c third part 82 tongue piece 83 first slit 84 second slit 85 slit 86 third part 87 slit 91 round hole 92 round hole 93 round hole 94 first part 95 second part 96 Third part 97 Fourth part 110 Fastener 116 Recess 120 First part 121 Inner peripheral surface 122 Recessed part 123 Inner peripheral surface 124 Slit 125 Inner peripheral end 126 Recessed part 127 Small diameter part 128 Outer peripheral part 130 Second part 131 Outer peripheral surface 133 Inner peripheral surface 136 Concave portion 700 Main body case 760 Wheel operation portion 790 Hub DE Distal end

Claims (19)

A long and flexible medical device body inserted into a body cavity;
An operation line embedded in the medical device body, and an operation line for bending the medical device body when an operation of pulling the operation line to the proximal end side of the medical device body is performed,
A fixing member provided at a distal end portion of the medical device body;
Have
The fixing member has a plurality of portions,
The medical device is characterized in that the operation line passes between the plurality of portions, is guided from the proximal end side to the distal end side, and is frictionally fixed to the plurality of portions.   The medical device according to claim 1, wherein the operation line is guided from a proximal end side to a distal end side so as to sew between the plurality of portions.   The medical device according to claim 2, wherein the fixing member has three or more portions as the plurality of portions. The plurality of portions are spaced apart in the axial direction of the medical device body through a slit formed in the fixing member,
The medical device according to claim 2 or 3, wherein the operation line is guided from the proximal end side to the distal end side through the slit. The fixing member is
A main body having a first portion, a second portion, and a third portion connecting the first portion and the second portion;
A tongue piece located between the first part and the second part in the axial direction of the medical device body and having one end connected to the third part;
Have
The first portion and the tongue piece are spaced apart in the axial direction of the medical device body through the first slit,
The tongue piece and the second portion are spaced apart in the axial direction of the medical device body through the second slit,
The medical device according to claim 4, wherein the plurality of portions include the first portion, the tongue piece, and the second portion. When the outer diameter of the operation line is φ, and the thickness of the fixing member in the direction orthogonal to the axis of the medical device body is t,
The tongue piece is displaced relative to the main body portion in the orthogonal direction so that the thickness of the region occupied by the operation line and the fixing member is less than (2φ + t) in the orthogonal direction. The medical device according to claim 5. The fixing member is formed with a round hole that penetrates the fixing member in its thickness direction,
The plurality of portions include a portion closer to the proximal end than the round hole in the fixing member, and a portion closer to the distal end than the round hole in the fixing member.
The operation line is guided from one side of the fixing member to the other side, or from the other side to one side in the direction orthogonal to the axis of the medical device body through the round hole. The medical device according to claim 2 or 3, characterized in that The fixing member is formed in an annular shape coaxial with the medical device body,
8. The operation line according to claim 2, wherein the operation line is guided from the proximal end side to the distal end side alternately through the inside and outside of the fixing member in the radial direction of the fixing member. The medical device according to one item. The plurality of parts include
An annular first portion;
An annular second portion having a smaller diameter than the first portion;
Contains
The second part is attached to the first part by fitting to the first part,
The said operation line passes between the inner edge of the said 1st part, and the outer edge of the said 2nd part, and is guide | induced to the front end side from the base end side. Medical equipment.   The medical device according to claim 1, further comprising a coating resin that collectively covers the operation line and the fixing member. The medical device further includes a coating resin that collectively covers the operation line and the fixing member,
The medical device according to any one of claims 4 to 6, wherein a part of the coating resin enters the slit and fills the operation line.   The medical device according to any one of claims 1 to 11, wherein a fastener having a diameter larger than that of the operation line is caulked and fixed to a distal end of the operation line. A concave portion is formed on the front surface of the fixing member,
The fastener is housed in the recess,
The medical device according to claim 12, wherein movement of the fastener to the proximal end side is restricted by the fixing member.   The medical device according to claim 1, wherein the operation line is in contact with each of the plurality of portions.   The component in the axial direction of the medical device main body is included in the direction component of the axial center of the operation line at any position near the distal end of the medical device main body. The medical device according to any one of the above.   The medical device according to any one of claims 1 to 15, wherein the operation line is a stranded wire formed by twisting a plurality of thin wires.   The medical device according to any one of claims 1 to 16, wherein at least a part of the fixing member is made of a material opaque to specific radiation. Embedding an operation line that bends the medical device body when the operation is pulled to the proximal end side of the medical device body in a long and flexible medical device body that is inserted into a body cavity When,
Fixing the tip of the operation line to a fixing member having a plurality of portions;
Providing the fixing member at the distal end of the medical device body;
Have
In the step of fixing the distal end portion of the operation line to the fixing member, the operation line is guided between the plurality of portions from the proximal end side to the distal end side, and is fixed to the plurality of portions by friction. The manufacturing method of the medical device characterized by the above-mentioned.   The method for manufacturing a medical device according to claim 18, further comprising a step of covering the operation line and the fixing member together with a coating resin.

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