JP5957966B2 - Medical device and method for manufacturing medical device - Google Patents

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 long, flexible, and inserted into a body cavity. As a typical example, for example, a catheter is known.

  The distal end of the catheter (hereinafter referred to as “distal end”) is required to be formed flexibly so that it can be easily bent along the shape of the body cavity. On the other hand, the proximal end portion of the catheter (hereinafter referred to as “proximal end portion”) needs to have high torsional rigidity because it requires high torque transferability and pushability transferability in the body cavity. Yes.

Patent Document 1 describes a catheter in which the distal end is set to be less rigid than the proximal end so that the distal end can be easily bent.
More specifically, the catheter of Patent Document 1 has a tubular main body configured by winding a flat wire in a coil shape. Patent Document 1 describes that the bending pitch at the distal end of the catheter is enhanced by setting the winding pitch of the wire at the distal end wider than the winding pitch of the wire at the proximal end. Has been. That is, in patent document 1, the winding pitch of a wire is set to two steps, a proximal end portion and a distal end portion.

JP 2003-144554 A

The present inventor has found the following problems in the technique of Patent Document 1.
As described above, in the catheter of Patent Document 1, the winding pitch of the wire is set in two stages: a proximal end portion and a distal end portion. For this reason, the torsional rigidity changes sharply at the boundary between the proximal end portion and the distal end portion. That is, a torsional rigidity discontinuity occurs at the boundary between the proximal end and the distal end. For this reason, when torque is transmitted from the proximal end to the distal end, the twist concentrates near the boundary between the proximal end and the distal end, resulting in a decrease in torque transmission efficiency and response speed. There is concern about the decline.

  The present invention has been made in view of the above-described problems, and when transmitting torque from a proximal end portion to a distal end portion in a long medical device such as a catheter, high transmission efficiency and high response speed can be obtained. A medical device and a method for manufacturing the medical device are provided.

The present invention has a long and flexible tubular body that is inserted into a body cavity,
The tubular body has a first tubular portion and a second tubular portion that are adjacent to each other in the longitudinal direction of the tubular body,
The torsional rigidity of the first tubular part is smaller than the torsional rigidity of the second tubular part,
The tubular body further includes a reinforcing portion that reinforces the first tubular portion,
The first tubular portion is configured by winding a wire in a spiral shape,
The reinforcing portion extends in the circumferential direction of the first tubular portion, and adjacent winding portions in the circumferential direction of the first tubular portion are welded or bonded together,
The medical device is characterized in that the torsional rigidity of the tubular main body in the region where the reinforcing portion is formed increases toward the boundary between the first tubular portion and the second tubular portion.

  According to this medical device, the tubular body has a reinforcing portion that reinforces the first tubular portion, and the torsional rigidity of the tubular body in the region where the reinforcing portion is formed is directed toward the boundary between the first tubular portion and the second tubular portion. Is getting bigger. Therefore, the change rate of the torsional rigidity from the second tubular portion to the first tubular portion can be moderated. That is, it can suppress that the torsional rigidity of the tubular body changes sharply at the boundary between the first tubular portion and the second tubular portion. Thereby, when transmitting torque from the second tubular portion to the first tubular portion, high transmission efficiency and high response speed can be obtained.

  Further, as the torsional rigidity of the tubular body in the region where the reinforcing part is formed increases toward the boundary between the first tubular part and the second tubular part, the bending rigidity of the tubular body in the region where the reinforcing part is formed is It increases toward the boundary between the first tubular portion and the second tubular portion. Therefore, the change rate of the bending rigidity from the second tubular portion to the first tubular portion can be made moderate. That is, it can suppress that the bending rigidity of a tubular main body changes abruptly in the boundary of a 1st tubular part and a 2nd tubular part. Thereby, generation | occurrence | production of the kink of the tubular main body in the vicinity of the boundary of a 1st tubular part and a 2nd tubular part (Tube body breaks and the lumen | bore (lumen) obstruct | occludes) can be suppressed.

In addition, the present invention has a step of forming a tubular body that is long and flexible and is inserted into a body cavity,
The tubular body has a first tubular portion and a second tubular portion that are adjacent to each other in the longitudinal direction of the tubular body, and the torsional rigidity of the first tubular portion is greater than the torsional rigidity of the second tubular portion. small,
Forming the tubular body comprises:
Forming a reinforcing portion for reinforcing the first tubular portion in the first tubular portion;
The first tubular portion is configured by winding a wire in a spiral shape,
In the step of forming the reinforcing portion, the reinforcing portion extending in the circumferential direction of the first tubular portion is formed by welding or bonding adjacent winding portions in the circumferential direction of the first tubular portion. ,
In the step of forming the reinforcing portion, the reinforcing portion is formed such that the torsional rigidity of the tubular body in the region where the reinforcing portion is formed increases toward the boundary between the first tubular portion and the second tubular portion. A method of manufacturing a medical device is provided.

  According to the present invention, when torque is transmitted from the second tubular portion to the first tubular portion, high transmission efficiency and high response speed are obtained, and the tubular portion in the vicinity of the boundary between the first tubular portion and the second tubular portion is obtained. Generation of kinks in the main body can be suppressed.

It is a top view which shows the tubular main body of the catheter as a medical device which concerns on 1st Embodiment. It is a figure which shows the ring-shaped end surface of a 1st tubular part and a 2nd tubular part. It is a top view which shows an example of a 1st tubular part. It is a top view which shows the process of the manufacturing method of the medical device which concerns on 1st Embodiment. It is a top view which shows the process of the manufacturing method of the medical device which concerns on 1st Embodiment. It is a top view which shows the process of the manufacturing method of the medical device which concerns on 1st Embodiment. It is a top view which shows the process of the manufacturing method of the medical device which concerns on 1st Embodiment. It is a top view which shows the catheter as a medical device which concerns on 1st Embodiment. It is a longitudinal cross-sectional view which shows the front-end | tip part of the catheter as a medical device which concerns on 1st Embodiment. It is II-II sectional drawing of FIG. It is a top view which shows the tubular main body of the catheter as a medical device which concerns on 2nd Embodiment. It is a top view which shows the tubular main body of the catheter as a medical device which concerns on 3rd Embodiment. It is a top view which shows the tubular main body of the catheter as a medical device which concerns on 4th Embodiment. It is a top view which shows the tubular main body of the catheter as a medical device which concerns on 5th Embodiment. It is a figure which shows the variation of the shape and arrangement | positioning of the division part of the reinforcement part in 1st Embodiment. It is a top view which shows the modification 1 of a tubular main body. It is a top view which shows the modification 2 of a tubular main body. It is a top view which shows the modification 3 of a tubular main body.

  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 plan view showing a tubular main body 300 of a catheter 10 (FIG. 8) as an example of a medical device according to the first embodiment. FIG. 1 shows a boundary 90 between the first coil (first tubular portion) 310 and the second coil (second tubular portion) 320 of the tubular main body 300 and the vicinity thereof. In addition, in FIG. 1, in order to show the formation area of the division parts 81-85 of the reinforcement part 80 clearly, the formation area of the division parts 81-85 is hatched.
FIG. 2A is a diagram illustrating a ring-shaped end surface of the first coil 310, and FIG. 2B is a diagram illustrating a ring-shaped end surface of the second coil 320.
FIG. 3 is a plan view showing an example of the first coil 310.

A catheter 10 as a medical device according to the present embodiment is long and flexible, and has a tubular body 300 that is inserted into a body cavity. The tubular body 300 includes a first tubular portion (for example, the first coil 310) and a second tubular portion (for example, the second coil 320) that are adjacent to each other in the longitudinal direction of the tubular body 300. The torsional rigidity of the first tubular part is smaller than the torsional rigidity of the second tubular part. The tubular main body 300 has a reinforcing portion 80 that reinforces the first tubular portion. That is, the first tubular portion is formed with a reinforcing portion 80 that reinforces the first tubular portion. The torsional rigidity of the tubular body 300 in the region where the reinforcing portion 80 is formed increases toward the boundary 90 between the first tubular portion and the second tubular portion.
Details will be described below.

  FIG. 8 is a plan view showing the catheter 10 as a medical device according to the first embodiment. FIG. 9 is a longitudinal sectional view showing the distal end portion (distal end portion) of the sheath 16 of the catheter 10. 10 is a cross-sectional view taken along the line II-II in FIG. In addition, in FIG. 10, illustration of the tubular main body 300 is abbreviate | omitted.

  As shown in FIG. 8, 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. 9 and 10) and an operation unit 70 for 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 is a main body portion of the catheter 10. The sheath 16 is long and flexible, and is used by being inserted into a body cavity. The sheath 16 includes a tubular main body 300. The tubular body 300 is also long and flexible, and is 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. 8).

  As shown in FIGS. 9 and 10, 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. 9) 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. 9 and 10, 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 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. When the number of fine lines is 3, the three fine lines are arranged point-symmetrically in the cross section. When the number of fine lines is seven, the seven fine lines are arranged point-symmetrically in a honeycomb shape in the cross section.

  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 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. Polymer fibers 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. 9 and 10, a previously formed hollow tube 32 is embedded in an outer layer 60 (described later) along the longitudinal direction of the sheath 16, and 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 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.
The resin layer is disposed coaxially with the tubular main body 300 and covers the tubular main body 300. That is, the tubular main body 300 is embedded in this resin layer.
In the layer structure of the sheath 16, the first coil 310 (first tubular portion) and the second coil 320 (second tubular portion) of the tubular main body 300 are located in the same 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.

The tubular body 300 is disposed around the inner layer 21.
The tubular body 300 is enclosed in the outer layer 60.
In the present embodiment, the sublumen 30 is formed outside the tubular body 300 inside the outer layer 60.

  The distal end portion 15 of the catheter 10 is provided with a ring-shaped marker 66 made of a material that does not transmit radiation such as X-rays. Specifically, the marker 66 is made of a metal material such as platinum. For example, the marker 66 is provided around the main lumen 20 and inside the outer layer 60.

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 tubular body 300 is 500 to 860 μm, and the inner diameter of the tubular body 300 Can have a diameter of 420-660 μm.
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.

  The distal end portion 41 of the operation line 40 is fixed to the distal end portion 15 of the sheath 16. A mode in which the tip 41 of the operation line 40 is fixed to the distal end 15 is not particularly limited. For example, the tip 41 of the operating line 40 may be welded or fastened to the marker 66, welded to the distal end 15 of the sheath 16, or the distal end of the marker 66 or the sheath 16 with an adhesive. 15 may be adhered and fixed.

  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. 8, 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 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. 8B, 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, as shown in FIG. 8C, when the wheel operation unit 760 is rotated in the other direction around the rotation axis, 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 tubular main body 300 will be described with reference to FIG.

  As described above, the tubular body 300 is long and flexible, and is inserted into a body cavity. The tubular body 300 includes, for example, a first coil 310 and a second coil 320 that are adjacent to each other in the longitudinal direction of the tubular body 300 (that is, the longitudinal direction of the sheath 16). The 1st coil 310 is comprised by winding the wire 311 (refer FIG. 3 thru | or FIG. 7) helically. Similarly, the 2nd coil 320 is comprised by winding the wire 321 (refer FIG. 4 thru | or FIG. 7) helically.

The wire rods 311 and 321 are each made of an elastic body.
For example, the wires 311 and 321 are preferably made of metal, for example. Examples of the metal constituting the wire materials 311 and 321 include stainless steel (SUS), nickel titanium alloy, steel, titanium, or copper alloy.
Note that the wires 311 and 321 may be made of an elastic material (for example, a resin material) other than metal.
The cross-sectional shape of the wire materials 311 and 321 is not particularly limited, and examples thereof include a rectangular shape and a circular shape.

  The rigidity of the first coil 310 is smaller than the rigidity of the second coil 320. More specifically, the torsional rigidity of the first coil 310 is smaller than the torsional rigidity of the second coil 320. The bending rigidity of the first coil 310 in the direction intersecting the axis of the first coil 310 is smaller than the bending rigidity of the second coil 320 in the direction intersecting the axis of the second coil 320.

  For example, the rigidity of the first coil 310 is constant in the longitudinal direction, and similarly, the rigidity of the second coil 320 is constant in the longitudinal direction.

  However, the rigidity of at least one of the first coil 310 and the second coil 320 may not be constant in the longitudinal direction. When it is not constant, the magnitude relationship between the torsional rigidity between the first coil 310 and the second coil 320 means the magnitude relation between the torsional rigidity in the vicinity of the joint (near the boundary 90).

  The distal end 15 of the catheter 10 is required to be flexible so that it can be bent easily. Therefore, for example, of the first coil 310 and the second coil 320, the first coil 310 is disposed on the distal end side, and the second coil 320 is disposed on the proximal end side.

  For example, the wire 311 constituting the first coil 310 is thinner than the wire 321 constituting the second coil 320, whereby the rigidity of the first coil 310 is set smaller than the rigidity of the second coil 320. .

For example, the outer diameter of the first coil 310 is smaller than the outer diameter of the second coil 320.
However, the outer diameter of the first coil 310 is preferably larger than the inner diameter of the second coil 320 so that the first coil 310 and the second coil 320 can be easily joined.
The inner diameter of the second coil 320 may be the same as the inner diameter of the first coil 310 or may be larger than the inner diameter of the first coil 310.

  In the present embodiment, the tubular body 300 includes a reinforcing portion 80 that reinforces the first coil 310 in order to moderate the rate of change in rigidity of the tubular body 300 from the second coil 320 to the first coil 310. Yes. That is, the first coil 310 is formed with a reinforcing portion 80 that reinforces the first coil 310.

The reinforcing ability of the first coil 310 by the reinforcing portion 80 (the ability to reinforce the first coil 310 by the reinforcing portion 80) per unit length in the longitudinal direction of the tubular body 300 is the first coil 310, the second coil 320, and the like. It gradually becomes larger toward the boundary 90. That is, the reinforcing portion 80 reinforces the first coil 310 more strongly as the portion is closer to the boundary 90.
For this reason, the rigidity (including torsional rigidity) of the tubular main body 300 in the region where the reinforcing portion 80 is formed increases toward the boundary 90 between the first coil 310 and the second coil 320.
In other words, the rigidity of the tubular body 300 in the region where the reinforcing portion 80 is formed increases toward one end of the first coil 310.

  In the case of the present embodiment, the reinforcing portion 80 has a plurality of divided portions that are spaced apart from each other in the longitudinal direction of the tubular main body 300 and reinforce the first coil 310. As an example, in the case of FIG. 1, the reinforcing portion 80 has five divided portions 81, 82, 83, 84, 85. These divided portions 81 to 85 are gradually arranged at a narrow pitch toward the boundary 90. As a result, the torsional rigidity and bending rigidity of the tubular body 300 in the region where the reinforcing portion 80 is formed increase toward the boundary 90.

  Therefore, the change rate of the torsional rigidity from the second coil 320 to the first coil 310 can be moderated. That is, it is possible to suppress the torsional rigidity of the tubular body 300 from changing sharply at the boundary 90 between the first coil 310 and the second coil 320. Thereby, stress concentration in the vicinity of the boundary 90 between the first coil 310 and the second coil 320 can be relaxed, and high transmission efficiency and high response speed can be obtained when torque is transmitted from the second coil 320 to the first coil 310. can get.

  At the same time, the rate of change in bending stiffness from the second coil 320 to the first coil 310 can be made moderate. That is, it is possible to prevent the bending rigidity of the tubular body 300 from changing sharply at the boundary 90 between the first coil 310 and the second coil 320. Thereby, generation | occurrence | production of the kink of the tubular main body 300 in the vicinity of the boundary 90 (the tubular main body 300 is broken and the main lumen 20 is closed) can be suppressed.

  In the case of this embodiment, it is mentioned as an example that the reinforcement capability of the 1st coil 310 by each divided part 81-85 is mutually equal. The widths of the divided parts 81 to 85 are the same, and the surface areas of the divided parts 81 to 85 are the same. The width of each divided portion 81 to 85 is preferably smaller than ½ of the outer diameter of the first coil 310.

For example, each of the divided portions 81 to 85 extends in the circumferential direction (axial direction) of the first coil 310. Here, extending in the circumferential direction of the first coil 310 means that the dimensions of the divided portions 81 to 85 in the circumferential direction of the first coil 310 are divided in the axial direction of the first coil 310. It means that it is larger than the dimension (width) of 81-85.
More specifically, for example, each of the divided portions 81 to 85 is formed in a ring shape that circulates the first coil 310 around its axis.

  In the case of this embodiment, the reinforcement part 80 is formed by welding adjacent winding parts of the first coil 310, for example. That is, the divided portions 81 to 85 are formed by welding adjacent winding portions of the first coil 310. In other words, in the reinforcement part 80 (each divided part 81-85), the adjacent winding part of the 1st coil 310 is solidified integrally after welding.

  Thereby, the rigidity of the 1st coil 310 is large in the formation area of reinforcement part 80 (each division part 81-85). That is, the first coil 310 can be reinforced in the region where the reinforcing portion 80 (each divided portion 81 to 85) is formed.

  The first coil 310 and the second coil 320 are joined to each other at the boundary 90. That is, the joint portion 110 that joins the first coil 310 and the second coil 320 is formed at the boundary 90. The first coil 310 and the second coil 320 are connected to each other in the longitudinal direction of the tubular main body 300.

The first coil 310 and the second coil 320 are joined to each other by welding.
For example, at one end of the first coil 310, a ring-shaped portion (hereinafter referred to as a joining ring 312) formed by welding adjacent winding portions of the first coil 310 is formed in advance (FIG. 2 (a)). Similarly, a ring-shaped portion (hereinafter referred to as a joining ring 322) formed by welding adjacent winding portions of the second coil 320 is formed in one end portion of the second coil 320 in advance. The first coil 310 and the second coil 320 are joined by welding the joining ring 312 and the joining ring 322 to each other. That is, at the boundary between the bonding ring 312 and the bonding ring 322, the materials of the wire materials 311 and 321 are solidified integrally after being melted. The joining part 110 is constituted by a joining ring 312 and a joining ring 322, for example.

  For this reason, the rigidity of the tubular body 300 is increased at the joint 110. However, in the present embodiment, as described above, the torsional rigidity of the tubular main body 300 in the region where the reinforcing portion 80 is formed increases toward the boundary 90. For this reason, the change rate of the torsional rigidity from the joint part 110 to the first coil 310 can be moderated. Thereby, stress concentration in the vicinity of the boundary between the joint 110 and the first coil 310 can be alleviated, and high transmission efficiency and high response speed can be obtained when torque is transmitted from the joint 110 to the first coil 310. In addition, the rate of change in bending rigidity from the joint 110 to the first coil 310 can be moderated. Thereby, generation | occurrence | production of the kink of the tubular main body 300 in the vicinity of the boundary of the junction part 110 and the 1st coil 310 can be suppressed.

  The reinforcing portion 80 is formed only at the distal end portion of the tubular main body 300, for example. FIG. 1 shows, for example, the distal end portion of the tubular main body 300.

  Here, the first coil 310 may be configured by spirally winding one wire 311 or may be configured by spirally winding a plurality of wires 311. good. That is, the first coil 310 may be a multi-strand coil. Similarly, the second coil 320 may also be a multi-strand coil configured by spirally winding a plurality of wire rods 321.

  With reference to FIG. 3, the case where the 1st coil 310 is a multi-strand coil is demonstrated.

  In this case, the first coil 310 is spirally wound around the plurality of wires 311 in a parallel state in which the plurality of wires 311 are aligned in the winding axis direction (that is, the axial direction of the first coil 310). It is constituted by. In other words, the plurality of wires 311 are wound around the axis of the first coil 310 so as to translate spirally. Hereinafter, such a method of winding the wire 311 is referred to as “multiple winding”.

FIG. 3 shows an example in which the number (the number of strips) of the wire 311 constituting the first coil 310 is 12 (the 12 strips). That is, the first coil 310 shown in FIG. 3 includes a total of 12 (12 strips) of wire rods 311 (wire rods W1, W2, W3, W4, W5, W6, W7, W8, W9, W10, W11, W12). It is configured by winding.
As shown in FIG. 3, the wire rods W1, W2, W3, W4, W5, W6, W7, W8, W9, W10, W11, W12 are in the direction of their winding axes (axial center direction of the first coil 310). Are arranged in this order. In the winding axis direction, the wire W1 is wound again next to the wire W12, and thereafter, W2 to W12, W1 are repeatedly wound next to each other sequentially.

When each of the first coil 310 and the second coil 320 is a multi-strand coil, the number (the number) of the wire rods 321 constituting the second coil 320 and the number of the wire rods 311 constituting the first coil 310 are: It is different from each other.
The multi-strand coil has higher torsional stiffness and bending stiffness as the number of the strips increases. For this reason, for example, among the first coil 310 and the second coil 320, the number of strips (for example, the second coil 320) disposed on the proximal end side of the catheter 10 can be set to a larger number. Can be mentioned.

  4 to 7 are plan views showing the steps of the manufacturing method of the medical device according to the first embodiment.

The method for manufacturing a medical device according to the present embodiment includes a step of forming a tubular body 300 that is long and flexible and is inserted into a body cavity. The tubular body 300 includes a first tubular portion (for example, the first coil 310) and a second tubular portion (for example, the second coil 320) that are adjacent to each other in the longitudinal direction of the tubular body 300, and the first tubular portion is twisted. The rigidity is smaller than the torsional rigidity of the second tubular portion. The step of forming the tubular main body 300 includes the step of forming the reinforcing portion 80 for reinforcing the first tubular portion in the first tubular portion. In the step of forming the reinforcing portion 80, the reinforcing portion 80 is formed so that the torsional rigidity of the tubular main body 300 in the region where the reinforcing portion 80 is formed increases toward the boundary 90 (FIG. 7B).
Details will be described below.

  Hereinafter, with reference to FIG. 4 thru | or FIG. 7, the process of producing the tubular main body 300 is demonstrated.

First, the first coil 310 and the second coil 320 are prepared. The first coil 310 is formed by winding a wire 311 spirally around a core wire (not shown).
Similarly, the second coil 320 is formed by winding a wire 321 around a core wire (not shown).

  After the first coil 310 is formed, the core wire in the first coil 310 is replaced with a core wire (not shown) having a size that fits the inner diameter of the first coil 310. Similarly, the core wire in the second coil 320 is also replaced with a core wire (not shown) having a size that fits the inner diameter of the second coil 320. For example, it is assumed that the inner diameters of the first coil 310 and the second coil 320 are equal to each other.

  Next, as shown in FIG. 4, the reinforcing portion 80 and the ring forming weld portion 313 are formed on the first coil 310. Also, a ring forming weld 323 is formed in the second coil 320. A part or the whole of the ring forming welded portion 313 later becomes the bonding ring 312. Similarly, a part or the whole of the ring forming welded portion 323 later becomes the bonding ring 322.

  In the case of this embodiment, the reinforcement part 80 has the some division part 81-85 as mentioned above.

  In order to form the divided portion 81, for example, adjacent winding portions of the first coil 310 are welded together by irradiating the first coil 310 with laser light. By irradiating the laser beam in this way, each of the adjacent winding portions of the first coil 310 can be partially melted and solidified integrally. Thereby, the position shift of adjacent winding parts is suppressed. That is, the first coil 310 is made highly rigid by the divided portion 81 (the first coil 310 is reinforced).

In addition, when the 1st coil 310 is a multi-strand coil (FIG. 3) comprised by winding the some wire 311, welding the adjacent winding parts of the 1st coil 310 means that It means that adjacent wires 311 among a plurality of wires 311 are welded.
Further, when the first coil 310 is configured by winding one wire 311, welding adjacent winding portions of the first coil 310 means that adjacent windings of the wire 311 are welded. It means that the parts are welded together.

  Here, by scanning the laser beam in the circumferential direction of the first coil 310, it is possible to form the divided portion 81 having a shape extending in the circumferential direction of the first coil 310.

  Scanning with laser light means that the position of the laser spot irradiated to the first coil 310 is moved on the surface of the first coil 310. At this time, the laser beam and the first coil 310 may be relatively moved. The laser irradiation apparatus that irradiates the laser light may be moved while the first coil 310 is fixed, the first coil 310 may be moved while the laser irradiation apparatus is fixed, or the first coil You may move both 310 and a laser irradiation apparatus.

  Irradiation of the laser beam to the first coil 310 may be performed intermittently by irradiating the laser beam in a pulsed manner, or may be performed continuously. In both cases where the laser beam irradiation is performed intermittently and continuously, the locus of the laser beam irradiation position with respect to the first coil 310 extends in the circumferential direction of the first coil 310 (specifically, Is a ring around the axis of the first coil 310).

  When laser beam irradiation is performed intermittently, the divided portion 81 is formed by an assembly of spot-like welding spots 121 (FIG. 5) formed by laser irradiation.

  In the case of the present embodiment, for example, a laser beam is scanned so as to circulate the first coil 310 about the axis, thereby forming a ring-shaped divided portion 81 that circulates the first coil 310 about the axis. The width (thickness) of the divided portion 81 is, for example, a width (thickness) equivalent to the diameter of the laser spot.

  For example, the divided portions 81 are preferably formed in a continuous manner. For example, the divided portions 81 can be formed in a single line by scanning the laser beam in a single stroke. In this case, the division part 81 can be easily formed, and the integrity of the adjacent winding parts by the division part 81 can be enhanced. In addition, when irradiating laser light intermittently, as shown in FIG. 5, the division part 81 can be formed in a row by making adjacent welding spots 121 overlap.

  In the example of FIG. 5, the laser beam is scanned only once around the axis of the first coil 310. Thereby, the division | segmentation part 81 is formed so that the row | line | column of the several welding spot 121 may make the 1st coil 310 1 round around the axis | shaft.

The other divided portions 82 to 85 are formed in the same manner as the divided portion 81. However, the interval (pitch) between the adjacent divided portions is set so that the divided portions 81 to 85 are gradually arranged at a narrow pitch toward the boundary 90 (that is, toward the portion that becomes the boundary 90 later). .
In the example of FIG. 1, among the divided portions 81 to 85, the divided portion 81 is closest to the boundary 90 and gradually moves away from the boundary 90 in the order of the divided portions 82, 83, 84, and 85. In this case, the interval between the divided portion 81 and the divided portion 82 is made the shortest, the interval between the divided portion 82 and the divided portion 83 is shortened second, and the interval between the divided portion 83 and the divided portion 84 is shortened third. The interval between the divided portion 84 and the divided portion 85 is made the longest.

  The interval between the divided portion 81 and the boundary 90 that is closest to the boundary 90 is preferably shorter than the interval between the divided portion 81 and the divided portion 82.

  In addition, the order which forms the division parts 81-85 is not ask | required. The divided portions 81 to 85 may be formed in parallel.

  The ring forming welded portion 313 can also be formed in the same manner as the divided portions 81 to 85.

However, in the example of FIG. 5, the laser light is sequentially shifted in the axial direction of the first coil 310, and scanning is performed so as to go around a plurality of times in the circumferential direction of the first coil 310. For this reason, the row | line | column of the several welding spot 121 has made the 1st coil 310 circulate around the axis | shaft several times. Therefore, the width dimension of the ring forming welded portion 313 (the width dimension in the axial direction of the first coil 310) is made larger than the diameter of the laser spot (for example, twice or three times the diameter of the laser spot). be able to.
In this case, as shown in FIG. 5, each of the ring-forming welds 313 includes a plurality of ring-shaped portions that circulate around the first coil 310 in the circumferential direction (for example, the first portion 313a and the second portion 313b). Composed of). In other words, a plurality of ring forming welds (for example, the first portion 313 a and the second portion 313 b) are formed at positions shifted from each other in the axial direction of the first coil 310.

  In addition, the order which forms the 1st part 313a and the 2nd part 313b is not ask | required. The first portion 313a and the second portion 313b may be formed in parallel.

  Moreover, the order which forms the reinforcement part 80 (divided part 81-85) and the welding part 313 for ring formation does not ask | require. You may form the reinforcement part 80 and the welding part 313 for ring formation in parallel.

  Next, the first coil 310 is cut so that the bonding ring 312 (FIGS. 1 and 7A) is exposed at the end of the first coil 310 (FIGS. 6 and 7A).

  For example, the first coil 310 is cut at the cutting position 122 shown in FIG. That is, for example, the first coil 310 is cut such that the ring forming weld 313 is divided in the axial direction of the first coil 310.

Here, when the ring-forming weld 313 is composed of a plurality of portions (for example, the first portion 313a and the second portion 313b) arranged in the axial center direction of the first coil 310 as described above, It is a preferable example that the joining ring 312 is exposed at the end of the first coil 310 by cutting the first coil 310 at the position (for example, the position between the first portion 313a and the second portion 313b). is there.
By cutting the first coil 310 at such a position, the first coil 310 can be prevented from being crushed during the cutting, and the cutting can be easily performed. This is because there are portions (for example, the first portion 313a and the second portion 313b) that have become highly rigid by being welded to both sides of the cut portion.
In this case, a bonding ring 312 is formed, which is composed of a part of the ring forming welded portion 313 (for example, the second portion 313b).

  The first coil 310 may be cut at the cutting position 123 shown in FIG. That is, you may cut | disconnect the 1st coil 310 in the interface of the welding part 313 for ring formation, and the part adjacent to it.

  In the first coil 310, the cut removing portion 124, which is a portion located on the end side of the first coil 310 with respect to the cut portion, is removed and does not remain in the tubular body 300. For this reason, it is preferable to form the ring forming weld 313 near the end of the first coil 310 so that as many portions of the first coil 310 as possible remain in the tubular body 300.

As a result of cutting the first coil 310, the joining ring 312 is exposed at the end of the first coil 310 as shown in FIG. An end surface of the ring-shaped joining ring 312 (see FIG. 2A) is an end surface of the first coil 310.
Further, the end surface of the bonding ring 312 is flattened by polishing or the like.

  The ring forming weld 323 (FIGS. 4 and 5) is formed on the second coil 320 in the same manner as the ring forming weld 313 is formed on the first coil 310. The ring forming welded portion 323 includes, for example, a first portion 323a and a second portion 323b similar to the first portion 313a and the second portion 313b of the ring forming welded portion 313 (FIGS. 4 and 5). . Further, in the same manner as cutting the first coil 310 so that the bonding ring 312 is exposed at the end of the first coil 310, the second ring so that the bonding ring 322 is exposed at the end of the second coil 320. The coil 320 is cut. Further, the end face of the bonding ring 322 is polished and flattened.

  In addition, a ring forming weld 313 is formed on the first coil 310 to form the joining ring 312, and the end surface of the joining ring 312 is flattened, and the ring forming weld is attached to the second coil 320. The order in which the part 323 is formed, the joining ring 322 is formed, and the end face of the joining ring 322 is flattened is not limited. These steps may be performed in parallel.

Next, as shown in FIG. 7B, the first coil 310 and the second coil 320 are joined to each other. That is, the end face of the first coil 310 (end face of the joining ring 312) and the end face of the second coil 320 (end face of the joining ring 322) are abutted and joined. In this way, the joining part 110 formed by joining the joining ring 312 and the joining ring 322 to each other at the boundary 90 between the first coil 310 and the second coil 320 is formed. The first coil 310 and the second coil 320 are joined by, for example, laser welding. At this time, since the end faces of the bonding rings 312 and 322 are ring-shaped end faces as shown in FIG. 2, the end face of the second coil 320 is easily and sufficiently strong with respect to the end face of the first coil 310. Can be joined.
In addition, before joining the 1st coil 310 and the 2nd coil 320, the core wire in the 1st coil 310 is extracted, the core wire in the 2nd coil 320 is extracted, and the 2nd coil 320 from the inside of the 1st coil 310 is extracted. It is preferable that one core wire 315 (FIG. 1) is inserted therethrough. Accordingly, the end surfaces of the first coil 310 and the second coil 320 can be easily butted and joined using the core wire as a guide.

  Thus, the tubular body 300 can be created. That is, for example, the tubular main body 300 is obtained by connecting the first coil 310 and the second coil 320 having the same inner diameter to each other coaxially.

  In addition, after joining the 1st coil 310 and the 2nd coil 320, you may form a part or whole of the reinforcement part 80. FIG.

  Next, the manufacturing process of the catheter 10 as described above will be described in detail.

  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 60 is formed by, for example, extruding a resin material as a molding material with an extrusion molding apparatus (not shown). At the time of this extrusion molding, a core material (mandrel) is extruded together with the resin material, thereby adhering the resin material to be the outer layer 60 around the core wire.
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. The release treatment, addition of the release agent coating such as fluorine series or silicon series, yet good I line optical or chemical surface treatment.

Here, in order to form a long hollow along the longitudinal direction at each of the positions where the sub-lumen 30 is formed by the hollow tube 32 being embedded later in the outer layer 60, for example, gas at that position. Extruding while supplying fluid such as. 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 60 can be formed by drawing the core wire. Note that the wire diameter of the core wire used for forming the outer layer 60 is larger than the outer diameter of the tubular body 300. This is to facilitate the process of covering the outer layer 60 around the tubular body 300 (and the inner layer 21) later.

  The inner layer 21 is created by extruding a resin material with an extrusion molding device (not shown) different from the extrusion molding device for creating the outer layer 60. At the time of this extrusion molding, a core material (a core wire different from that for forming the outer layer 60) 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 tubular main body 300 is created by the process described above. As described above, one core wire 315 is inserted from the first coil 310 to the second coil 320. After creating the tubular body 300, the core wire 315 is pulled out from the tubular body 300.

  Thereafter, the tubular body 300 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 with 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 60. create. 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 60 and covering the tubular body 300 around the inner layer 21, the outer layer 60 is covered around the tubular body 300. Accordingly, the core wire (used for forming the inner layer 21), the inner layer 21, the tubular main body 300, and the outer layer 60 are arranged concentrically in order from the center side.
Next, a hollow tube 32 (with a dummy core wire) is inserted into each hollow of the outer layer 60.

  Next, a heat shrinkable tube (not shown) is placed around the outer layer 60. Next, the heat shrinkable tube is contracted by heating, and the outer layer 60 is tightened from the surroundings, and the outer layer 60 is melted. The heating temperature is higher than the melting temperature of the outer layer 60 and lower than the melting temperature of the inner layer 21. By this heating, the outer layer 60 and the inner layer 21 are joined by welding. At this time, the resin material constituting the outer layer 60 encloses the tubular body 300, and the resin material impregnates the tubular body 300. Further, the outer layer 60 and the hollow tube 32 are joined by welding. Further, the inner layer 21 is attached to the inner peripheral side of the tubular main body 300.

  Next, the heat shrinkable tube is removed from the outer layer 60 by cutting 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, a marker 66 that is an annular metal member is prepared.

  Next, fixation of the distal end portion of the operation line 40 to the marker 66 and caulking fixation of the marker 66 to the periphery of the distal end portion of the outer layer 60 are performed.

  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. 8 to 10 can be manufactured.

  According to the first embodiment as described above, the catheter 10 has the tubular body 300 that is long and flexible and is inserted into the body cavity. The tubular body 300 has a first coil 310 and a second coil 320 that are adjacent to each other in the longitudinal direction of the tubular body 300. The torsional rigidity of the first coil 310 is smaller than the torsional rigidity of the second coil 320. The tubular main body 300 has a reinforcing portion 80 that reinforces the first coil 310. That is, the first coil 310 is formed with a reinforcing portion 80 that reinforces the first coil 310. The torsional rigidity of the tubular main body 300 in the region where the reinforcing portion 80 is formed increases toward the boundary 90 between the first coil 310 and the second coil 320. Therefore, the change rate of the torsional rigidity from the second coil 320 to the first coil 310 can be made gentle and smooth. That is, the torsional rigidity of the tubular body 300 can be prevented from changing sharply at the boundary 90 between the first coil 310 and the second coil 320. As a result, stress concentration near the boundary between the first coil 310 and the second coil 320 can be alleviated, and high transmission efficiency and high response speed can be obtained when torque is transmitted from the second coil 320 to the first coil 310. .

  Further, as the torsional rigidity of the tubular body 300 in the region where the reinforcing part 80 is formed increases toward the boundary 90, the bending rigidity of the tubular body 300 in the region where the reinforcing part 80 is formed also increases toward the boundary 90. It has become. Therefore, the rate of change in bending rigidity from the second coil 320 to the first coil 310 can be made moderate. That is, it is possible to prevent the bending rigidity of the tubular body 300 from changing sharply at the boundary 90. Thereby, generation | occurrence | production of the kink of the tubular main body 300 in the vicinity of the boundary 90 can be suppressed.

  Further, since the reinforcing portion 80 is formed on the first coil 310, the tubular body 300 (and the sheath 16) has a long length while ensuring the high flexibility of the tubular body 300 and thus the sheath 16 at the distal end portion 15. The distribution of rigidity (bending rigidity and torsional rigidity) in the direction can be easily set to a desired distribution.

  The reinforcing portion 80 includes a plurality of divided portions 81 to 85 that are arranged apart from each other in the longitudinal direction of the tubular body 300 and reinforce the first coil 310, respectively. It is arrange | positioned gradually toward narrow pitch. Thereby, it is possible to easily realize a structure in which the torsional rigidity of the tubular main body 300 in the region where the reinforcing portion 80 is formed increases toward the boundary 90.

  In addition, each of the divided portions 81 to 85 extends in the circumferential direction of the first coil 310. Thereby, the torsional rigidity of the tubular body 300 in the region where the reinforcing portion 80 is formed can be increased toward the boundary 90 while maintaining the balance of rigidity in the circumferential direction of the first coil 310.

  In addition, since each of the divided portions 81 to 85 is formed in a ring shape, the reinforcing ability of the first coil 310 by each of the divided portions 81 to 85 can be further enhanced.

  The first coil 310 is formed by winding a wire 311 in a spiral shape, and the reinforcing portion 80 is formed by welding adjacent winding portions of the first coil 310. Such a reinforcing portion 80 can reinforce the first coil 310 while suppressing an increase in the radial dimension of the first coil 310.

  The reinforcing portion 80 is formed only at the distal end portion of the tubular main body 300. That is, a configuration in which the boundary 90 between the first coil 310 and the second coil 320 is disposed at the distal end portion of the tubular main body 300 and the first coil 310 having a low rigidity is disposed further on the distal end side thereof. can do. Therefore, the distal end portion 15 of the catheter 10 can be easily bent along the shape of the body cavity.

  In the first embodiment, the example in which the number of the divided parts of the reinforcing portion 80 is five has been described. However, the number of the divided parts is not limited to five, and any number (preferably three or more). It is. When the number of the divided parts is two, the interval between the boundary 90 and the divided part closer to the boundary 90 is made shorter than the interval between the divided parts in the axial direction of the tubular body 300.

  FIG. 15 is a diagram showing variations in the shape and arrangement of the divided portions (the divided portions 81 to 83 are shown in FIG. 15) of the reinforcing portion 80 in the first embodiment. Each drawing of FIG. 15 shows a shape when the first coil 310 is developed in the circumferential direction.

  FIG. 15A shows a case where each of the divided portions 81 to 85 is formed in a ring shape as described above. That is, each divided portion 81 to 85 is formed over the entire 360 ° circumference in the circumferential direction of the first coil 310.

FIG. 15B and FIG. 15C show an example in which each of the divided portions 81 to 85 exists only in a partial region in the circumferential direction of the first coil 310. In FIG. 15B and FIG. 15C, for example, each of the divided portions 81 to 85 is formed in an angular range over 180 ° in the circumferential direction of the first coil 310.
Among these, FIG. 15B shows an example in which the arrangement of the divided portions 81 to 85 in the circumferential direction of the first coil 310 is the same.
Among these, FIG. 15C shows an example in which the arrangement of the divided portions 81 to 85 in the circumferential direction of the first coil 310 is different.
The configuration of FIG. 15C has a better balance of rigidity of the first coil 310 than the configuration of FIG.

  In addition, each division | segmentation part 81-85 is not restricted to the shape extended in the circumferential direction of the 1st coil 310, For example, the circular part comprised by welding the adjacent winding part of the 1st coil 310, The portion may extend in the axial direction of the first coil 310.

[Second Embodiment]
FIGS. 11A and 11B are plan views showing a tubular main body 300 of a catheter as a medical device according to the second embodiment. In FIG.11 (b), the example of the more detailed structure of each division part 81-84 of the reinforcement part 80 is shown typically. In FIG. 11A, in order to show the formation regions of the divided portions 81 to 84 of the reinforcing portion 80 in an easily understandable manner, the formation regions of the divided portions 81 to 84 are hatched. In the present embodiment, the number of divided portions is arbitrary, but FIG. 11 shows an example in which the reinforcing portion 80 has four divided portions 81 to 84.

  The catheter according to the second embodiment is different from the catheter 10 according to the first embodiment only in the structure of the reinforcing portion 80 formed in the first coil 310 of the tubular main body 300. It is comprised similarly to the catheter 10 which concerns on this embodiment.

  In the first embodiment, the example in which the plurality of divided portions 81 to 85 are gradually arranged at a narrow pitch toward the boundary 90 has been described.

On the other hand, in 2nd Embodiment, the capability to reinforce the 1st coil 310 is so large that the division part near the boundary 90 among the some division parts 81-84. That is, the first coil 310 is reinforced more strongly as the divided portion is closer to the boundary 90.
Thereby, the torsional rigidity and the bending rigidity of the tubular main body 300 in the region where the reinforcing portion 80 is formed increase toward the boundary 90.

  More specifically, for example, among the plurality of divided portions 81 to 84, the divided portion closer to the boundary 90 has a larger area, so that the divided portion closer to the boundary 90 has a higher ability to reinforce the first coil 310. ing.

  As an example, as shown in FIG. 11, the divided portion 83 located closer to the boundary 90 than the divided portion 84 is wider than the divided portion 84. Similarly, the width of the divided portion 82 is set wider than that of the divided portion 83, and the width of the divided portion 81 is set larger than that of the divided portion 82.

  In order to realize such a configuration, for example, as shown in FIG. 11 (b), the number of rows of the welding spots 121 and the diameter of the welding spots 121 constituting the respective divided portions 81 to 84 are appropriately adjusted. Is mentioned.

  For example, the divided portions 81 to 83 are configured by the welding spots 121 having the same diameter, but the number of rows (for example, 3) of the welding spots 121 constituting the divided portion 81 is the number of the welding spots 121 constituting the divided portion 82. The number of rows (for example, 2) of the welding spots 121 constituting the divided portion 82 is larger than the number of rows (for example, 1) of the welding spots 121 constituting the divided portion 83. Accordingly, among the plurality of divided portions 81 to 83, the closer to the boundary 90, the thicker the width and the greater the ability to reinforce the first coil 310.

  Further, the divided portion 83 and the divided portion 84 are configured by the same number of welding spots 121 as each other, but the diameter of the welding spot 121 constituting the divided portion 84 is the diameter of the welding spot 121 constituting the divided portion 83. Smaller than. Thus, the divided portion 83 is wider than the divided portion 84 and has a greater ability to reinforce the first coil 310.

Here, in the case of this embodiment, the pitch between each divided part 81-84 is not ask | required.
As an example, as shown in FIG. 11, it is possible to arrange the divided portions 81 to 84 at an equal pitch.
However, as in the first embodiment, the plurality of divided portions 81 to 84 may be gradually arranged at a narrow pitch toward the boundary 90.
Further, if the condition that the torsional rigidity of the tubular main body 300 in the region where the reinforcing portion 80 is formed increases toward the boundary 90 is satisfied, the plurality of divided portions 81 to 84 are gradually arranged at a narrower pitch as the distance from the boundary 90 increases. It doesn't matter.

  In addition, although illustration is abbreviate | omitted, when the dimension (length) in the circumferential direction of the 1st coil 310 is large (longer), the division part near the boundary 90 among several division parts 81-84 is large, The divided portion closer to the boundary 90 may have a larger area and a greater ability to reinforce the first coil 310.

  According to the second embodiment as described above, the same effect as in the first embodiment can be obtained.

  In the case of the second embodiment, the reinforcing portions 80 are arranged apart from each other in the longitudinal direction of the tubular main body 300, and have a plurality of divided portions 81 to 84 that reinforce the first coil 310, respectively. Of the portions 81 to 84, the closer to the boundary 90, the greater the ability to reinforce the first coil 310. In the case of the second embodiment, such a configuration can easily realize a structure in which the torsional rigidity of the tubular body 300 in the region where the reinforcing portion 80 is formed increases toward the boundary 90.

  More specifically, among the plurality of divided portions 81 to 84, the divided portion closer to the boundary 90 has a larger area, thereby realizing a configuration in which the divided portion closer to the boundary 90 has a greater ability to reinforce the first coil 310. can do.

[Third Embodiment]
FIGS. 12A and 12B are plan views showing a tubular body 300 of a catheter as a medical device according to the third embodiment. FIG. 12B schematically shows an example of a more detailed structure of each of the divided portions 81 to 84 of the reinforcing portion 80. In FIG. 12A, in order to show the formation regions of the divided portions 81 to 84 of the reinforcing portion 80 in an easy-to-understand manner, the formation regions of the divided portions 81 to 84 are hatched. In the present embodiment, the number of the divided portions is arbitrary, but FIG. 12 shows an example in which the reinforcing portion 80 has four divided portions 81 to 84.

  The catheter according to the third embodiment is different from the catheter according to the second embodiment only in the structure of the reinforcing portion 80 formed in the first coil 310 of the tubular body 300. In other respects, It is comprised similarly to the catheter which concerns on embodiment.

  In the second embodiment, the example in which the area closer to the boundary 90 among the plurality of divided parts 81 to 84 is larger has been described.

In contrast, in the third embodiment, the closer to the boundary 90 among the plurality of divided portions 81 to 84, the greater the rigidity. In other words, the closer to the boundary 90 among the plurality of divided portions 81 to 84, the greater the reinforcing ability per unit area (the ability to reinforce the first coil 310).
Thereby, the capability which reinforces the 1st coil 310 is so large that the division part near boundary 90 among a plurality of division parts 81-84.

  Specifically, for example, as shown in FIG. 12B, among the plurality of divided portions 81 to 84, the closer to the boundary 90, the higher the arrangement density of the welding spots 121, The divided portion closer to 90 has a higher rigidity.

  It should be noted that the rigidity of the divided portion closer to the boundary 90 can be increased by configuring the divided portion closer to the boundary 90 with the welding spot 121 having a larger diameter. In this case, the arrangement density of the welding spots 121 in each of the divided portions 81 to 84 may be constant.

Here, in the case of this embodiment, the area of the formation region of each divided portion 81 to 84 (the area of the region where the envelope of each divided portion 81 to 84 is drawn) does not matter.
As an example, as shown in FIG. 12, the areas of the formation regions of the divided portions 81 to 84 may be the same.
However, as in the second embodiment, the area closer to the boundary 90 among the plurality of divided parts 81 to 84 may be increased.
In addition, among the plurality of divided portions 81 to 84, if the condition that the ability to reinforce the first coil 310 is increased as the divided portion is closer to the boundary 90, the boundary among the plurality of divided portions 81 to 84 is satisfied. The area closer to 90 may be smaller in area.

  According to the third embodiment as described above, the same effect as in the second embodiment can be obtained.

  In the case of the third embodiment, among the plurality of divided portions 81 to 84, the divided portion closer to the boundary 90 has higher rigidity, and thus the divided portion closer to the boundary 90 has a greater ability to reinforce the first coil 310. Can be realized.

[Fourth Embodiment]
FIG. 13 is a plan view showing a tubular main body 300 of a catheter as a medical device according to the fourth embodiment. In FIG. 13, the formation region of the spiral portion 87 of the reinforcement portion 80 is hatched in order to easily show the formation region of the spiral portion 87 of the reinforcement portion 80.

  The catheter according to the fourth embodiment is different from the catheter 10 according to the first embodiment only in the structure of the reinforcing portion 80 formed in the first coil 310 of the tubular main body 300. It is comprised similarly to the catheter 10 which concerns on this embodiment.

  In the first embodiment, the example in which the reinforcing portions 80 are arranged apart from each other in the longitudinal direction of the tubular main body 300 and have a plurality of divided portions 81 to 85 that reinforce the first coil 310 has been described. .

  On the other hand, in the fourth embodiment, the reinforcing portion 80 is formed in a shape spirally wound along the first coil 310 and has a helical portion 87 that reinforces the first coil 310. Yes. In the present embodiment, in the structure having such a spiral portion 87, the condition that the torsional rigidity of the tubular body 300 in the region where the reinforcing portion 80 is formed increases toward the boundary 90 is satisfied.

  The winding direction of the spiral portion 87 is preferably opposite to the winding direction of the wire 311 of the first coil 310. For example, if the wire 311 is turning right, the spiral portion 87 is preferably turning left. Thereby, the adjacent winding parts of the first coil 310 can be more suitably integrated by the spiral portion 87.

In the case of the present embodiment, more specifically, for example, the spiral portion 87 is wound toward the boundary 90 so that the pitch gradually becomes narrower.
In other words, as the boundary 90 is approached, the intersecting angle between the extending direction of the spiral portion 87 and the axial direction of the first coil 310 increases.

  As a result, the torsional rigidity and bending rigidity of the tubular body 300 in the region where the reinforcing portion 80 is formed increase toward the boundary 90.

The spiral portion 87 can be formed, for example, by irradiating the first coil 310 with a laser similarly to forming the divided portions 81 to 85 in the first embodiment. That is, the spiral portion 87 is composed of, for example, a plurality of welding spots 121.
Here, the spiral portion 87 can be formed by scanning the laser on the surface of the first coil 310 in a spiral shape that gradually becomes a narrow pitch toward the boundary 90.

  Although the number of turns of the spiral portion 87 is arbitrary, it is easier to realize a configuration in which winding is performed at a narrow pitch gradually toward the boundary 90 by winding a plurality of turns around the first coil 310.

  According to the fourth embodiment as described above, the same effect as in the first embodiment can be obtained.

  In the case of the fourth embodiment, the first coil 310 can be reinforced by the reinforcing portion 80, that is, the helical portion 87 formed in a shape spirally wound along the first coil 310.

  More specifically, the torsional rigidity and the bending rigidity of the tubular body 300 in the region where the reinforcing portion 80 is formed are directed toward the boundary 90 by winding the spiral portion 87 toward the boundary 90 so as to gradually become a narrow pitch. Can be realized.

[Fifth Embodiment]
FIG. 14 is a plan view showing a tubular main body 300 of a catheter as a medical device according to the fifth embodiment. In FIG. 14, the formation region of the spiral portion 87 of the reinforcement portion 80 is hatched in order to easily show the formation region of the spiral portion 87 of the reinforcement portion 80.

  The catheter according to the fifth embodiment is different from the catheter according to the fourth embodiment only in the structure of the reinforcing portion 80 formed in the first coil 310 of the tubular body 300. In other respects, It is comprised similarly to the catheter which concerns on embodiment.

  In the fourth embodiment, the torsional rigidity and the bending rigidity of the tubular body 300 in the region where the reinforcing portion 80 is formed by winding the spiral portion 87 toward the boundary 90 so that the pitch gradually becomes narrower. In the example described above, the value increases toward the boundary 90.

  On the other hand, in the fifth embodiment, the helical portion 87 gradually becomes thicker toward the boundary 90, so that the torsional rigidity and bending rigidity of the tubular body 300 in the region where the reinforcing portion 80 is formed become the boundary 90. It is getting bigger.

The spiral portion 87 can be formed, for example, by irradiating the first coil 310 with a laser similarly to forming the divided portions 81 to 85 in the first embodiment. That is, the spiral portion 87 is composed of, for example, a plurality of welding spots 121.
Here, the diameter of the welding spot 121 constituting the spiral portion 87 is gradually increased toward the boundary 90, or the number of rows of the welding spots 121 constituting the spiral portion 87 is gradually increased toward the boundary 90. By doing so, it is possible to realize a configuration in which the spiral portion 87 gradually becomes thicker toward the boundary 90.

  The number of turns of the spiral portion 87 is arbitrary, but it is easier to realize a configuration in which the spiral portion 87 gradually becomes thicker toward the boundary 90 by winding a plurality of turns around the first coil 310. .

  According to the fifth embodiment as described above, the same effect as in the fourth embodiment can be obtained.

  In the case of the fifth embodiment, the helical portion 87 gradually becomes thicker toward the boundary 90, so that the torsional rigidity and bending rigidity of the tubular body 300 in the region where the reinforcing portion 80 is formed increase toward the boundary 90. Can be realized.

<Modification 1>
FIG. 16 is a plan view showing a first modification of the tubular main body 300.

  In each of the above embodiments, the example in which two tubular parts (for example, the first coil 310 and the second coil 320) are adjacent to each other in the longitudinal direction has been described. The number may be three or more.

  For example, as shown in FIG. 16, the tubular main body 300 may further include a third coil (third tubular portion) 330 adjacent to the proximal end side of the second coil 320.

The rigidity of the second coil 320 is smaller than the rigidity of the third coil 330. More specifically, the torsional rigidity of the second coil 320 is smaller than the torsional rigidity of the third coil 330. The bending rigidity of the second coil 320 in the direction intersecting the axis of the second coil 320 is smaller than the bending rigidity of the third coil 330 in the direction intersecting the axis of the third coil 330.
For example, the outer diameter of the second coil 320 is smaller than the outer diameter of the third coil 330. The outer diameter of the second coil 320 is preferably larger than the inner diameter of the third coil 330 so that the second coil 320 and the third coil 330 can be easily bonded to each other.
The inner diameter of the third coil 330 may be the same as the inner diameter of the second coil 320 or may be larger than the inner diameter of the second coil 320.

  The second coil 320 is formed with a reinforcing portion 280 that reinforces the second coil 320. The torsional rigidity of the tubular main body 300 in the region where the reinforcing portion 280 is formed increases toward the boundary 290 between the second coil 320 and the third coil 330.

  As a result, the rate of change in the torsional rigidity from the second coil 320 to the third coil 330 can be made gentle and smooth, and the torsional rigidity of the tubular body 300 is the boundary 290 between the second coil 320 and the third coil 330. It is possible to suppress abrupt change in. Thereby, stress concentration in the vicinity of the boundary between the second coil 320 and the third coil 330 can be relaxed, and high transmission efficiency and high response speed can be obtained when torque is transmitted from the third coil 330 to the second coil 320. .

  In addition, as the torsional rigidity of the tubular body 300 in the region where the reinforcing portion 280 is formed increases toward the boundary 290, the bending rigidity of the tubular body 300 in the region where the reinforcing portion 280 is formed also toward the boundary 290. It is getting bigger. As a result, the rate of change in bending stiffness from the second coil 320 to the third coil 330 can be made moderate and smooth, and the bending stiffness of the tubular body 300 can be suppressed from changing sharply at the boundary 290. . Thereby, generation | occurrence | production of the kink of the tubular main body 300 in the vicinity of the boundary 290 can be suppressed.

  FIG. 16 shows an example in which the reinforcing portion 280 includes a plurality of divided portions 81 to 85, but the reinforcing portion 280 includes a spiral portion 87 (FIGS. 13 and 14). There may be.

<Modification 2>
FIG. 17 is a plan view showing a second modification of the tubular main body 300.

  In each of the above-described embodiments, the example has been described in which the tubular portions adjacent to each other in the longitudinal direction of the tubular body 300 are joined to each other at their boundaries, but the present invention is not limited to this example.

For example, as shown in FIG. 17, the second coil 320 is extrapolated around the base end side portion of the first coil 310 (hereinafter, the base end side portion 310 a). A structure in which a portion (hereinafter referred to as a distal end side portion 310b) protrudes from the second coil 320 toward the distal end side may be employed. In this case, the distal end side portion 310b of the first coil 310 corresponds to the first tubular portion, and has a double structure (double tube) of the proximal end side portion 310a of the first coil 310 and the second coil 320. The portion corresponds to the second tubular portion. Therefore, the first tubular portion and the second tubular portion are not joined to each other at the boundary 90.
Thus, the rigidity of the first tubular portion can be made smaller than the rigidity of the second tubular portion by adopting a structure in which the second tubular portion has a larger number of layers than the first tubular portion.

  Even in such a structure, the same effect as that of each of the above-described embodiments can be obtained by forming the reinforcing portion 80 similar to the above in the first tubular portion.

<Modification 3>
FIG. 18 is a plan view showing a third modification of the tubular main body 300.

  In each of the above embodiments, the example in which the torsional rigidity of the first coil 310 is smaller than the torsional rigidity of the second coil 320 has been described, but the present invention is not limited to this example.

  For example, as shown in FIG. 18, the torsional rigidity of the first coil 310 and the torsional rigidity of the second coil 320 may be the same. For example, the wire constituting the first coil 310 and the wire constituting the second coil 320 have the same material and the same wire diameter, and these wires are wound with the same winding diameter.

  Here, the rigidity of the tubular main body 300 is increased at the joint 110 where the first coil 310 and the second coil 320 are joined. Further, the joint 110 has a certain size in the axial direction of the tubular main body 300. For this reason, the joint portion 110 can be regarded as the second tubular portion, and the portion of the first coil 310 on the tip side of the joint portion 110 can be regarded as the first tubular portion. By considering in this way, also in the case of the structure of FIG. 18, the tubular body 300 has a first tubular portion and a second tubular portion that are adjacent to each other in the longitudinal direction of the tubular body 300, and the first tubular portion Is less than that of the second tubular portion.

  Therefore, in the case of such a structure, the same effect as that of each of the above embodiments can be obtained by forming the reinforcing portion 80 similar to the above in the first tubular portion.

In the above, when the tubular parts (the first tubular part (first coil 310) and the second tubular part (second coil 320)) are configured by spirally winding the wires 311 and 321, Although the reinforcement parts 80 and 280 demonstrated the example formed by welding the adjacent winding parts of a tubular part, it is not restricted to this example.
When the tubular portion is formed by spirally winding the wires 311 and 321, the reinforcing portions 80 and 280 may be configured by adhering adjacent winding portions of the tubular portion. For example, when the wire rods 311 and 321 constituting the tubular portion are made of metal, adjacent winding portions of the tubular portion may be bonded to each other with metal wax.
The reinforcing portions 80 and 280 are separate members (wire material, plate material, etc.) fixed to the tubular portion (the first tubular portion (first coil 310) and the second tubular portion (second coil 320)). May be.

  In the above, each tubular part (the 1st tubular part, the 2nd tubular part, the 3rd tubular part) is constituted by the coil (the 1st coil 310, the 2nd coil 320, the 3rd coil 330), respectively. Although described, it is not limited to this example. Each tubular portion may be, for example, a tubular structure (braided) formed by knitting a plurality of wire rods into a mesh shape (called a blade). When each tubular part is a blade, for example, the tubular parts are joined to each other via another member (for example, an annular metal member). Furthermore, when each tubular part is a blade, the tubular part is reinforced by joining another member (for example, an annular metal member, a wire, a plate, etc.) around the tubular part.

  In the above, the example in which the reinforcing portions 80 and 280 are configured by a plurality of divided portions (divided portions 81 to 85 and the like) or the spiral portion 87 has been described. You may have both the helical parts 87. FIG.

  In addition, each component in the above does not necessarily need to exist 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.

Moreover, in the above, although the catheter was illustrated as a medical device, this invention is not restricted to this example. That is, the present invention can also be applied to other medical devices (for example, endoscopes, guide wires) having a long and flexible tubular body that is inserted into a body cavity.
Hereinafter, examples of the reference form will be added.
1. Long and flexible, having a tubular body inserted into a body cavity,
The tubular body has a first tubular portion and a second tubular portion that are adjacent to each other in the longitudinal direction of the tubular body,
The torsional rigidity of the first tubular part is smaller than the torsional rigidity of the second tubular part,
The tubular body further includes a reinforcing portion that reinforces the first tubular portion,
The medical device according to claim 1, wherein a torsional rigidity of the tubular main body in a region where the reinforcing portion is formed increases toward a boundary between the first tubular portion and the second tubular portion.
2. The reinforcing portion has a plurality of divided portions that are spaced apart from each other in the longitudinal direction and reinforce the first tubular portion, respectively.
The plurality of divided portions are gradually arranged at a narrow pitch toward the boundary. Medical device as described in.
3. Each of the divided portions extends in the circumferential direction of the first tubular portion. Medical device as described in.
4). Each of the divided portions is formed in a ring shape. Or 3. Medical device as described in.
5. The reinforcing portion has a plurality of divided portions that are spaced apart from each other in the longitudinal direction and reinforce the first tubular portion, respectively.
Of the plurality of divided portions, the closer to the boundary, the greater the ability to reinforce the first tubular portion. To 4. A medical device according to any one of the above.
6). 4. The area closer to the boundary is larger in area. Medical device as described in.
7). 4. The torsional rigidity is higher in the divided portion closer to the boundary. Or 6. Medical device as described in.
8). The reinforcing portion is formed in a shape spirally wound along the first tubular portion and has a helical portion that reinforces the first tubular portion. To 7. A medical device according to any one of the above.
9. The spiral portion is wound so as to gradually become a narrow pitch toward the boundary. Medical device as described in.
10. The spiral portion is gradually thickened toward the boundary. Or 9. Medical device as described in.
11. The first tubular portion is configured by winding a wire in a spiral shape,
The reinforcing portion is formed by welding adjacent winding portions of the first tubular portion. To 10. A medical device according to any one of the above.
12 The first tubular portion is configured by winding a wire in a spiral shape,
The reinforcing portion is formed by adhering adjacent winding portions of the first tubular portion. To 10. A medical device according to any one of the above.
13. The reinforcing portion is formed only at the tip of the tubular body. To 12. A medical device according to any one of the above.
14 Forming a tubular body that is elongated and flexible and is inserted into a body cavity;
The tubular body has a first tubular portion and a second tubular portion that are adjacent to each other in the longitudinal direction of the tubular body, and the torsional rigidity of the first tubular portion is greater than the torsional rigidity of the second tubular portion. small,
Forming the tubular body comprises:
Forming a reinforcing portion for reinforcing the first tubular portion in the first tubular portion;
In the step of forming the reinforcing portion, the reinforcing portion is formed such that the torsional rigidity of the tubular body in the region where the reinforcing portion is formed increases toward the boundary between the first tubular portion and the second tubular portion. A method for manufacturing a medical device, comprising: forming a medical device.
15. The first tubular portion is configured by winding a wire in a spiral shape,
15. In the step of forming the reinforcing portion, the reinforcing portion is formed by welding adjacent winding portions of the first tubular portion. A method for producing a medical device according to claim 1.
16. 15. In the step of forming the reinforcing portion, adjacent winding portions of the first tubular portion are welded together by laser irradiation. A method for producing a medical device according to claim 1.

DESCRIPTION OF SYMBOLS 10 Catheter 15 Distal end part 16 Sheath 17 Proximal end part 20 Main lumen 21 Inner layer 30 Sublumen 32 Hollow tube 40 Operation line 41 Tip part 60 Outer layer 64 Coat layer 66 Marker 70 Operation part 80 Reinforcement part 81, 82, 83 , 84, 85 Split portion 87 Spiral portion 90 Boundary 110 Joint portion 121 Welding spot 122 Cutting position 123 Cutting position 124 Cutting removal portion 280 Reinforcement portion 290 Boundary 300 Tubular body 310 First coil (first tubular portion)
310a Base end side portion 310b Tip end side portion 311 (W1, W2, W3, W4, W5, W6, W7, W8, W9, W10, W11, W12) Wire material 312 Bonding ring 313 Ring forming weld portion 313a First portion 313b Second portion 315 Core wire 320 Second coil (second tubular portion)
321 Wire 322 Joining ring 323 Ring forming weld 323a First part 323b Second part 330 Third coil 700 Main body case 760 Wheel operation part 790 Hub DE Distal end

Claims (12)

Long and flexible, having a tubular body inserted into a body cavity,
The tubular body has a first tubular portion and a second tubular portion that are adjacent to each other in the longitudinal direction of the tubular body,
The torsional rigidity of the first tubular part is smaller than the torsional rigidity of the second tubular part,
The tubular body further includes a reinforcing portion that reinforces the first tubular portion,
The first tubular portion is configured by winding a wire in a spiral shape,
The reinforcing portion extends in the circumferential direction of the first tubular portion, and adjacent winding portions in the circumferential direction of the first tubular portion are welded or bonded together,
The medical device according to claim 1, wherein a torsional rigidity of the tubular main body in a region where the reinforcing portion is formed increases toward a boundary between the first tubular portion and the second tubular portion. The reinforcing portion has a plurality of divided portions that are spaced apart from each other in the longitudinal direction and reinforce the first tubular portion, respectively.
The medical device according to claim 1, wherein the plurality of divided portions are gradually arranged at a narrow pitch toward the boundary. The medical device according to claim 2 , wherein each of the divided portions is formed in a ring shape. 4. The medical device according to claim 2 , wherein a divided portion closer to the boundary among the plurality of divided portions has a greater ability to reinforce the first tubular portion. The medical device according to claim 4 , wherein the area closer to the boundary is larger. The medical device according to claim 4 or 5, characterized in that the torsional rigidity as divided portions closer to the boundary is large. The said reinforcement part is formed in the shape wound helically along the said 1st tubular part, and has a helical part which reinforces the said 1st tubular part, The any one of Claim 1 thru | or 6 characterized by the above-mentioned. A medical device according to claim 1. The medical device according to claim 7 , wherein the spiral portion is wound so as to gradually become a narrow pitch toward the boundary. The medical device according to claim 7 or 8 , wherein the spiral portion is gradually thickened toward the boundary. The medical device according to any one of claims 1 to 9 , wherein the reinforcing portion is formed only at a distal end portion of the tubular main body. Forming a tubular body that is elongated and flexible and is inserted into a body cavity;
The tubular body has a first tubular portion and a second tubular portion that are adjacent to each other in the longitudinal direction of the tubular body, and the torsional rigidity of the first tubular portion is greater than the torsional rigidity of the second tubular portion. small,
Forming the tubular body comprises:
Forming a reinforcing portion for reinforcing the first tubular portion in the first tubular portion;
The first tubular portion is configured by winding a wire in a spiral shape,
In the step of forming the reinforcing portion, the reinforcing portion extending in the circumferential direction of the first tubular portion is formed by welding or bonding adjacent winding portions in the circumferential direction of the first tubular portion. ,
In the step of forming the reinforcing portion, the reinforcing portion is formed such that the torsional rigidity of the tubular body in the region where the reinforcing portion is formed increases toward the boundary between the first tubular portion and the second tubular portion. A method for manufacturing a medical device, comprising: forming a medical device. The method for manufacturing a medical device according to claim 11 , wherein in the step of forming the reinforcing portion, adjacent winding portions of the first tubular portion are welded together by laser irradiation.

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