JP2013208355A - Medical device and method of manufacturing medical device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To suppress separation of the interface of a resin layer and a wire coil of a medical device having the wire coil composed of a wire of a non-circular cross-section such as a flat wire.SOLUTION: A medical device (catheter 10, for instance) includes an elongated and flexible medical device body 300 to be inserted into a body cavity. The medical device body 300 includes an elongated resin tube (sheath 16), and a wire coil 50 constituted by helically winding a wire 52 whose cross-sectional shape is non-circular and embedded in the resin tube coaxially with the resin tube. In a vertical cross-section of the wire 52, when the thickness of the wire 52 is defined as T and the maximum height difference from the axis of the medical device body 300 to the outer side surface 52a of the wire is defined as H, the value of H/T is different depending on a position in the longitudinal direction of the medical device body 300.

Description

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

  In general, catheters have poor kink resistance. When the guide wire is pulled out of the catheter after the catheter is inserted into the body cavity and bent along the guide wire, the lumen of the catheter (main lumen) is crushed. For this reason, a catheter has been proposed in which a wire coil is disposed on the outer periphery of a resin-made inner tube to improve kink resistance (see, for example, Patent Document 1).

  The catheter described in Patent Document 1 includes a wire coil formed by winding a ribbon-like wire (so-called flat wire) on the outer periphery of an inner resin layer (the inner tube in the same document). The wire coil of the catheter described in Patent Document 1 is wound so that the flat surface of the wire is in contact with the outer peripheral surface of the inner resin layer in parallel. An outer resin layer (outer tube of the same document) is laminated around the inner resin layer, and the wire coil is covered with the outer resin layer. A catheter provided with a wire coil is improved in kink resistance due to the shape retention of the wire coil while maintaining good bendability. In addition, by using a flat wire as the wire, it is possible to expect a reduction in the thickness of the wire coil as compared to the case of using a round wire, and as a result, it can be expected that a sufficient sectional area of the lumen is secured. Such a catheter can be suitably used for surgery of a blood vessel bent in multiple directions, such as a renal artery.

Special table 2003-527226 gazette

  Here, when the catheter inserted into the body cavity is pulled out, a resistance force acts on the catheter. This resistance force is applied to the interface between the inner resin layer and the wire coil and the interface between the outer resin layer and the wire coil.

  As described above, since the wire coil of the catheter described in Patent Document 1 is wound so that the flat surface of the wire is in parallel with the outer peripheral surface of the inner resin layer, the inner peripheral surface and the outer periphery of the wire are wound. The plane is parallel to the catheter axis. For this reason, interface peeling between the wire coil and the inner resin layer and interface peeling between the wire coil and the outer resin layer may occur due to resistance when the catheter is pulled out.

  As described above, in a catheter having a wire coil made of a flat wire, it has been difficult to ensure excellent adhesion between layers.

  This invention is made | formed in view of the said subject, has a wire coil which consists of a wire of non-circular cross sections, such as a flat wire, and can suppress peeling in the interface of a wire coil and a resin layer. An object is to provide a medical device and a method for manufacturing the medical device.

The present invention has a long and flexible medical device body that is inserted into a body cavity,
The medical device body is
A long resin tube,
A wire coil that is configured by spirally winding a wire having a non-circular cross-sectional shape, and is embedded in the resin tube coaxially with the resin tube;
Have
In the longitudinal section of the wire, assuming that the thickness of the wire is T and the maximum height difference from the axis of the medical device body to the outer surface of the wire is H, the value of H / T is the longitudinal length of the medical device body. Provided is a medical device that is different depending on a position in a direction.

  According to this medical device, the value of H / T varies depending on the position in the longitudinal direction of the medical device body. Here, the larger the value of H / T, the greater the anchor effect of the wire with respect to the resin tube per unit thickness of the wire. Therefore, in the longitudinal direction of the medical device main body, by increasing the value of H / T at a position where it is desired to partially increase the anchor effect of the wire to the resin tube, the wire coil and the resin tube (that is, the resin layer) Separation at the interface can be suppressed.

In addition, the present invention has a process of creating a medical device body that is long and flexible, and is inserted into a body cavity,
The step of creating the medical device body includes
Forming a long inner resin tube;
Forming a wire coil by spirally winding a wire having a non-circular cross-sectional shape;
Arranging the wire coil around the inner resin tube;
Forming a long outer resin tube around the wire coil, and embedding the wire coil in a resin tube including the outer resin tube and the inner resin tube;
Have
In the longitudinal section of the wire, if the thickness of the wire is T, and the maximum height difference from the axis of the medical device body to the outer surface of the wire is H,
In the step of forming the wire coil, there is provided a method for manufacturing a medical device, wherein the wire coil is formed so that the value of H / T varies depending on the position in the longitudinal direction of the medical device body.

  ADVANTAGE OF THE INVENTION According to this invention, the peeling in the interface of the wire coil and resin layer of a medical device which has a wire coil which consists of a wire of non-circular cross sections, such as a flat wire, can be suppressed.

It is a typical longitudinal section of the medical equipment main part of the medical equipment concerning a 1st embodiment. It is a schematic diagram which shows the example of the cross-sectional shape of a wire. It is AA sectional drawing of FIG. It is a typical top view of the medical device concerning a 1st embodiment. It is a typical longitudinal cross-sectional view of the medical device main body of the medical device which concerns on 2nd Embodiment. It is a typical longitudinal cross-sectional view of the medical device main body of the medical device which concerns on 3rd Embodiment. It is a typical longitudinal section of the medical equipment main part of the medical equipment concerning a 4th embodiment. It is a typical longitudinal cross-sectional view of the medical device main body of the medical device which concerns on 5th Embodiment. It is a typical longitudinal cross-sectional view of the medical device main body of the medical device which concerns on 6th Embodiment.

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

In the present specification, the “longitudinal section of a medical device” refers to a cross section of a medical device (a catheter in each embodiment) cut through the central axis in parallel with the longitudinal direction. The “cross section of the medical device” refers to a cross section obtained by cutting the medical device parallel to the radial direction. The same applies to longitudinal sections of a medical device body, a wire coil, an inner layer, and the like, which are members of a catheter. The “cross-sectional shape in the longitudinal section” of the “coiled wire” refers to the cross-sectional shape of the wire in the longitudinal section of the medical device in a state where the wire is wound in a coil shape.
On the other hand, the cross-sectional shape of a wire having a “non-circular cross-sectional shape” refers to a long wire before being coiled in the width direction of the wire (a direction orthogonal to the wire extending direction). The cross-sectional shape when cut.

[First Embodiment]
FIG. 1 is a schematic longitudinal sectional view of a medical device main body 300 of a catheter 10 as a preferred example of a medical device according to the first embodiment. Among these, FIG. 1A shows a tip portion (distal end portion 15), and FIG. 1B shows an intermediate portion 18 adjacent to the proximal end side of the distal end portion 15. The left side in FIG. 1 corresponds to the distal end side of the catheter, and the right side corresponds to the proximal side (proximal end side).
FIG. 2 is a schematic view showing an example of the cross-sectional shape and posture (inclined or non-inclined) of the wire 52. FIG. 2 (a) shows the cross-sectional shape and posture at the distal end portion 15 in FIG. ) Shows the cross-sectional shape and posture at the intermediate portion 18, respectively.
3 is a cross-sectional view taken along the line AA in FIG. In addition, illustration of the wire coil 50 is abbreviate | omitted in FIG.
FIG. 4 is a schematic plan view of the catheter. 4A shows a state in which the distal end portion of the medical device main body 300 is not bent, and FIG. 4B shows an operation in which the distal end portion of the medical device main body 300 is bent in one direction. FIG. 4C shows a state where an operation of bending the distal end portion of the medical device main body 300 in the opposite direction is performed.

The medical device (for example, the catheter 10) according to the present embodiment has a medical device body 300 that is long and flexible and is inserted into a body cavity. The medical device main body 300 is configured by winding a long resin tube (sheath 16) and a wire 52 having a non-circular cross-sectional shape in a spiral shape, and is embedded in the resin tube coaxially with the resin tube. And a coil 50. In the longitudinal section of the wire 52, when the thickness of the wire 52 is T and the maximum height difference from the axis of the medical device body 300 to the outer surface 52 a of the wire is H, the value of H / T is the longitudinal length of the medical device body 300. It depends on the position in the direction.
Details will be described below.

  As shown in FIG. 4, the catheter 10 includes a medical device main body 300 and an operation mechanism for performing a bending operation of the distal end portion of the medical device main body 300.

  The operation mechanism includes an operation line 40 (FIGS. 1 and 3) and an operation unit 70 for performing an operation of pulling the operation line 40. The operation line 40 is embedded in the medical device main body 300 along the longitudinal direction of the medical device main body 300. The operation unit 70 is provided at the proximal end portion of the medical device main body 300. A proximal end portion of the operation line 40 is connected to the operation unit 70, and the distal end portion of the medical device main body 300 can be bent by operating the operation unit 70.

  The medical device main body 300 as the main body of the catheter 10 is long and flexible, and is used by being inserted into a body cavity.

  The catheter 10 is a suitable example that is an intravascular catheter used by being inserted into a blood vessel. More specifically, it is a preferable example that the medical device main body 300 of the catheter 10 is formed to a size that allows the medical device main body 300 to enter any of the eight sub-regions of the liver. .

  In the present specification, the predetermined length region including the distal end (tip) DE of the catheter 10 (and the medical device main body 300) is referred to as the distal end portion 15 of the catheter 10 (and the medical device main body 300). That's it. Similarly, the predetermined length region including the proximal end (proximal end) (not shown) of the catheter 10 (and the medical device main body 300) is referred to as the proximal end portion (as well as the catheter 10 (and the medical device main body 300)). This is referred to as a proximal end portion 17 (FIG. 4). A predetermined length region adjacent to the proximal end side of the distal end portion 15 in the longitudinal direction of the catheter 10 (and the medical device main body 300) is referred to as an intermediate portion 18. The intermediate portion 18 is located on the distal end side with respect to the proximal end portion 17.

  As shown in FIGS. 1 and 3, a main lumen 20 and a sub-lumen 30 are formed inside the medical device main body 300. The main lumen 20 and the sub-lumen 30 extend along the longitudinal direction (the left-right direction in FIG. 1) of the medical device main body 300 (the catheter 10). The main lumen 20 is disposed, for example, in the center of the cross section (cross section orthogonal to the longitudinal direction) of the medical device main body 300, 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. In the example of FIGS. 1 and 3, the number of sub-lumens 30 is two, and the sub-lumens 30 are arranged around the main lumen 20 at intervals of 180 degrees.

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

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

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

  In addition to flexible metal wires such as low carbon steel (piano wire), stainless steel (SUS), titanium or titanium alloy, the material of the wire constituting the operation wire 40 (or the fine wire 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. 1 and 3, a hollow tube 32 formed in advance is embedded in an outer layer 60 (described later) along the longitudinal direction of the medical device body 300, and the hollow tube The 32 lumens are referred to as sublumen 30. That is, in these examples, the sublumen 30 is configured by the lumen of the hollow tube 32 embedded in the medical device main body 300.

  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 medical device main body 300 in the outer layer 60 (described later).

The medical device main body 300 includes, for example, a sheath 16 configured to include 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 sheath 16 is made of, for example, a resin material. That is, the sheath 16 includes an outer layer 60 and an inner layer 21 each made of a resin material. In other words, the sheath 16 is a hollow resin layer or resin tube including the outer layer 60 and the inner layer 21.
The resin tube is disposed coaxially with the wire coil 50 (described later) and covers the wire coil 50. The resin tube is attached to the wire coil 50.

  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 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 medical device main body 300 and is made of a hydrophilic material. Note that the coat layer 64 may be formed only in a region extending over a part of the distal end portion 15 of the medical device main body 300 or may be formed over the entire length of the medical device main body 300.
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 a lubrication treatment to make at least the outer surface of the outer layer 60 hydrophilic.

The catheter 10 further includes a wire coil 50 wound around the inner layer 21. The wire coil 50 is configured by, for example, winding a single wire or a plurality of wires (wires) 52 formed of an elastic body in a spiral shape. As a material of the wire 52 constituting the wire coil 50, for example, a metal is preferably used. However, the material is not limited to this example, and any material having higher rigidity and elasticity than the inner layer 21 and the outer layer 60 may be used. Other materials (for example, resin) may be used. Specifically, for example, stainless steel (SUS), nickel titanium alloy, steel, titanium, or copper alloy can be used as the metal material of the wire 52. An example of the cross-sectional shape of the wire 52 will be described later.
The wire coil 50 is included in the outer layer 60.
In the present embodiment, the sub-lumen 30 is formed outside the wire coil 50 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 wire coil 50 is 500 to 860 μm, and the inner diameter of the wire coil 50 Can have a diameter of 420-660 μm.
The radius (distance) from the axial center of the medical device main body 300 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 medical device main body 300 is about 350 to 490 μm, that is, the outer diameter is less than 1 mm in diameter. Thereby, the medical device main body 300 of this embodiment can be inserted into blood vessels such as the celiac artery.

  The distal end portion 15 of the medical device main body 300 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.

  The distal end portion 41 of the operation line 40 is fixed to the distal end portion 15 of the medical device main body 300. 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 operation line 40 may be welded or fastened to the marker 66, welded to the distal end 15 of the medical device main body 300, or the marker 66 or the medical device main body 300 with an adhesive. The distal end portion 15 may be adhesively 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 base end portion of each operation line 40 is connected to an operation portion 70 provided at the proximal end portion 17 of the medical device main body 300.

  As illustrated in FIG. 4, 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.

  The proximal end portion of the medical device main body 300 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 medical device main body 300.

  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 medical device main body 300 via the main lumen 20, and the liquid is supplied from the distal end of the medical device main body 300 to the patient. It can be supplied into a body cavity.

  For example, the operation line 40 and the hollow tube 32 are branched from the sheath 16 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 unit 760 in any direction, the operation line 40 can be individually pulled to the proximal end side, and the distal end portion 15 of the medical device main body 300 can be bent. Yes.

  As shown in FIG. 4B, when the wheel operation unit 760 is rotated in one direction around the rotation axis, one operation line 40 is pulled toward the base end side. Then, a tensile force is applied to the distal end portion 15 of the medical device main body 300 through the one operation line 40. Thereby, the distal end portion 15 of the medical device main body 300 bends toward the sub-lumen 30 through which the one operation line 40 is inserted, with the axis of the medical device main body 300 as a reference. That is, the distal end portion 15 of the medical device main body 300 bends in one direction.

  Further, as shown in FIG. 4C, 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 medical device main body 300 through the other operation line 40. Thereby, the distal end portion 15 of the medical device main body 300 is bent toward the sub-lumen 30 through which the other operation line 40 is inserted, with the axis of the medical device main body 300 as a reference. That is, the distal end portion 15 of the medical device main body 300 is bent in the other direction.

  Here, the bending of the medical device main body 300 includes a mode in which the medical device main body 300 bends in a “shape” and a mode in which the medical device main body 300 is bent in a bow shape.

  As described above, by selectively pulling the two operation lines 40 by the operation of the operation unit 70 on the wheel operation unit 760, the distal end 15 of the medical device main body 300 is moved in the first direction and vice versa. The second direction, which is the direction, can be bent. 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 medical device main body 300 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 medical device main body 300 can be adjusted by adjusting the pulling amount of the operation line 40.
For this reason, the medical device main body 300 of the catheter 10 of the present embodiment can be advanced in a desired direction with respect to a body cavity 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 medical device main body 300 will be described in more detail with reference to FIGS. 1 and 2.

  The wire 52 constituting the wire coil 50 has a non-circular cross-sectional shape. In the case of this embodiment, the wire 52 is a so-called flat wire having a rectangular shape with a flat cross-sectional shape, for example. In the cross-sectional shape of the wire 52, the width dimension corresponding to the major axis dimension is longer than the thickness dimension corresponding to the minor axis dimension. The ratio of the width dimension to the thickness dimension, ie, the width dimension when the thickness dimension is 1, is preferably 1.1 or more, 5 or less, more preferably 1.5 or more and 4 or less, and further preferably 2 or more and 4 or less. The actual width of the wire 52 is 1 mm or less, preferably 0.5 mm. The wire 52 is wound so that the cross-sectional shape of the wire 52 in the longitudinal cross section of the medical device main body 300 is thinner than the width.

Note that when the wire 52 is wound in a spiral shape, by winding the wire 52 with an appropriate tension and an appropriate angle, the cross-sectional shape and the vertical cross-sectional shape of the wire 52 are curved, for example, FIG. The concave shape as shown in FIG.
Here, this shape will be described in more detail. For example, as shown in FIG. 2, the outer surface 52a is a concave curved surface, and the inner surface 52b is a convex curved surface. Moreover, it is mentioned that the end surfaces 52c and 52d of the front end side and the base end side are convex curved surfaces that protrude to the front end side and the base end side, respectively.

As shown in FIG. 1A, for example, at the distal end portion 15 of the medical device main body 300, the wire 52 is inclined with respect to the longitudinal direction of the medical device main body 300. That is, as shown in FIG. 2A, in the longitudinal section of the wire 52, the maximum width direction W in the sectional shape of the wire 52 is inclined with respect to the longitudinal direction X of the medical device main body 300. The inclination angle of the maximum width direction W with respect to the longitudinal direction X is greater than 0 degree and less than 45 degrees. Preferably they are 5 degree | times or more and 30 degrees or less.
The outer surface 52a and the inner surface 52b of the wire 52 are also inclined with respect to the longitudinal direction X.

Examples of a method for winding the wire 52 so that the maximum width direction W is inclined with respect to the longitudinal direction X include the following methods.
(1) Method of winding wire 52 while twisting wire 52 so that wire 52 is deformed around the axis of wire 52 in a direction inclined with respect to longitudinal direction X. As an example of this method, wire 52 is plastically deformed. A method of winding the wire 52 by applying a twist as described above can be mentioned. Another example of this method is a method in which the wire 52 is wound while being twisted so that the wire 52 is elastically deformed, and then the shape of the wire 52 is stabilized to the shape after elastic deformation by heat treatment. .
(2) Method of winding wire coils 50 adjacent to each other so that the winding portions adjacent to each other partially overlap each other in the longitudinal direction of medical device main body 300 Note that the original shape of wire 52 before winding is the longitudinal direction. The shape having an inclined surface with respect to X, in particular, the outer surface 52a may be inclined with respect to the longitudinal direction X.

  On the other hand, as shown in FIG. 1B, for example, in the longitudinal direction of the medical device main body 300, in the intermediate portion 18 adjacent to the proximal end side of the distal end portion 15, the wire 52 is connected to the medical device main body 300. It is parallel to the longitudinal direction. That is, as shown in FIG. 2B, in the longitudinal section of the wire 52, the maximum width direction W in the sectional shape of the wire 52 is parallel to the longitudinal direction X of the medical device main body 300.

  As shown in FIG. 2, the thickness of the wire 52 is T, and the maximum height difference from the axis of the medical device main body 300 to the outer surface 52a of the wire 52 is H. The maximum height difference H means a difference between the longest and shortest distances from the axis of the medical device main body 300 to the outer surface 52a. In the case of this embodiment, the value of H / T varies depending on the position of the medical device main body 300 in the longitudinal direction. That is, in the present embodiment, the H / T value at the distal end portion 15 of the medical device main body 300 is larger than the H / T value at the intermediate portion 18 of the medical device main body 300.

As a result, the anchor effect of the wire 52 on the sheath 16 with respect to the shape factor of the wire 52 and the anchor effect per unit thickness of the wire 52 (hereinafter referred to as the shape factor unit anchor effect) is the medical device main body 300. It depends on the position in the longitudinal direction. That is, in the present embodiment, the shape factor unit anchor effect at the distal end portion 15 of the medical device main body 300 is larger than the shape factor unit anchor effect at the intermediate portion 18 of the medical device main body 300.
Here, the shape factor means a factor including the shape and posture of the wire 52 (inclination with respect to the sheath 16). The shape factor unit anchor effect is increased due to the shape or posture of the wire 52 compared to the case where the wire 52 has a shape such as a rectangular cross section and is not inclined with respect to the longitudinal direction of the medical device main body 300. This is an anchor effect for the relative movement in the longitudinal direction of the medical device main body 300 between the wire 52 and the sheath 16 per unit thickness of 52. The higher the anchor effect, the better the peeling between the wire coil 50 and the sheath 16 (particularly the outer layer 60) can be suppressed when the medical device body 300 is removed from the body cavity.

Here, for example, when the thickness of the wire 52 in the distal end portion 15 and the thickness of the wire 52 in the intermediate portion 18 are equal to each other, the value of H is different depending on the position of the medical device main body 300 in the longitudinal direction. That is, in this case, the value of H at the distal end portion 15 of the medical device main body 300 is larger than the value of H at the intermediate portion 18 of the medical device main body 300.
As a result, the anchor effect of the wire 52 with respect to the sheath 16 (hereinafter referred to as the shape factor anchor effect) of the shape factor of the wire 52 varies depending on the position of the medical device main body 300 in the longitudinal direction. That is, in the present embodiment, the shape factor anchor effect at the distal end portion 15 of the medical device main body 300 is larger than the shape factor anchor effect at the intermediate portion 18 of the medical device main body 300.
The shape factor anchor effect is increased due to the shape or posture of the wire 52 as compared to the case where the wire 52 has a shape such as a rectangular cross section and is not inclined with respect to the longitudinal direction of the medical device main body 300. This is an anchor effect for the relative movement of the medical device main body 300 in the longitudinal direction between the sheath 16 and the sheath 16.

In the case of this embodiment, as shown in FIG. 2A, the axis of the medical device main body 300 is formed on the outer surface 52a of the wire 52 in both cases of FIG. 2A and FIG. The apex P located farthest from the heart is displaced from the center position C of the wire 52 in the longitudinal direction of the medical device main body 300.
However, since the wire 52 is inclined at the distal end portion 15, as shown in FIG. 2A, the top portion P is based on the center position C of the wire 52 in the longitudinal direction of the medical device main body 300. It exists only on one side.

As shown in FIG. 1A, at the distal end portion 15, the winding portions adjacent to each other of the wire coil 50 partially overlap each other in the longitudinal direction of the medical device main body 300.
On the other hand, as shown in FIG. 1B, in the intermediate portion 18, the winding portions adjacent to each other of the wire coil 50 do not overlap each other.
Thereby, the value of H / T and the value of H in the distal end portion 15 are larger than the value of H / T and the value of H in the intermediate portion 18.
That is, in the partial section (for example, the distal end portion 15) in the longitudinal direction of the medical device main body 300, the winding portions adjacent to each other of the wire coil 50 partially overlap in the longitudinal direction. Then, the H / T value and the H value in the partial section (for example, the distal end portion 15) are the same as the H / T value and the H in the section (for example, the intermediate section 18) adjacent to the partial section. Greater than the value.

Specifically, in the example of FIG. 1A, among the winding portions adjacent to each other of the wire coil 50, the winding on the proximal end side is arranged on the outer peripheral side of the rear portion (base end portion) of the winding portion on the distal end side. The front part (tip part) of the turning part rides up. Thereby, at the distal end portion 15, the wire 52 is inclined in a direction in which the distal end side of the wire 52 moves away from the axis of the medical device main body 300 in the longitudinal section.
However, the inclination direction of the wire 52 may be the opposite direction to FIG. That is, in the longitudinal section of the wire 52, the proximal end side of the wire 52 may be inclined in a direction away from the axis of the medical device main body 300.

  As shown in FIG. 1, the wire coil 50 is configured by, for example, winding a plurality of wires 52 (a plurality of wires 52) spirally so as to be in a parallel state aligned in the winding axis direction. It is mentioned that it is a multi-strip coil. In FIG. 1, an example is shown in which the number of wires 52 constituting the wire coil 50 is four (four), but the number of wires 52 constituting the wire coil 50 is a plurality other than four. It may be a book.

  In the case of this embodiment, the value of H / T is, for example, larger toward the distal end side of the medical device main body 300. Further, for example, the value of H is also larger toward the distal end side of the medical device main body 300, for example.

  Next, a method for manufacturing a medical device according to this embodiment will be described.

This manufacturing method has a step of creating a medical device main body 300 that is long and flexible and is inserted into a body cavity.
This process has the following processes.
1) Step of forming a long inner resin tube (inner layer 21) 2) Step of forming a wire coil 50 by spirally winding a wire 52 having a non-circular cross-sectional shape 3) Inner resin tube (inner layer) 21) Step of disposing wire coil 50 around 4) Resin tube (sheath 16) including a long outer resin tube (outer layer 60) formed around wire coil 50 and including an outer resin tube and an inner resin tube In the longitudinal section of the wire 52, the thickness of the wire 52 is T, and the maximum height difference from the axis of the medical device main body 300 to the outer surface of the wire 52 is H.
In the step of forming the wire coil 50, the wire coil 50 is formed so that the value of H / T varies depending on the position in the longitudinal direction of the medical device main body 300.
Details will be described below.

  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. As the mold release treatment, optical or chemical surface treatment may be performed in addition to the application of a release agent such as fluorine or silicon.

Here, in 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. The wire diameter of the core wire used for forming the outer layer 60 is larger than the outer diameter of the wire coil 50. This is to facilitate the process of covering the outer layer 60 around the wire coil 50 (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 material of the core wire is not particularly limited as long as it is an elastic body having sufficient tensile strength, but as an example, copper or copper alloy, alloy steel such as carbon steel or SUS, nickel or nickel alloy (such as nickel-titanium alloy) is used. Can be mentioned.
A release treatment may optionally be performed on the surface of the core wire. As the mold release treatment, optical or chemical surface treatment may be performed in addition to the application of a release agent such as fluorine or silicon.

  Separately, a hollow tube 32 is prepared. 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.

  Moreover, the wire coil 50 is created separately.

  The wire coil 50 is configured, for example, by connecting a plurality of wire coils having different bending rigidity and torsional rigidity in the longitudinal direction.

  Each of the plurality of wire coils includes a step of spirally winding the wire 52 using a winding machine around a core wire (core wire different from that for creating the inner layer 21 and the outer layer 60). After that, create it separately. Thereafter, the core wire in each wire coil is pulled out. Further, thereafter, in a state where the wire coils are extrapolated to a common core wire, the wire coils are joined by laser welding or the like and connected in the longitudinal direction, thereby creating the wire coil 50. Thereafter, the core wire in the wire coil 50 is pulled out.

Here, as described above, the inclination of the wire 52 varies depending on the position of the medical device main body 300 in the longitudinal direction. Specifically, for example, in the distal end portion 15, the maximum width direction W of the wire 52 is inclined with respect to the longitudinal direction of the medical device main body 300, whereas in the intermediate portion 18, The maximum width direction W is parallel to the longitudinal direction of the medical device main body 300.
For this reason, about the wire coil arrange | positioned at the distal end part 15, the wire 52 is wound so that the maximum width direction W of the wire 52 may incline with respect to the longitudinal direction of the medical device main body 300. For the wire coil disposed in the intermediate portion 18, the wire 52 is wound so that the maximum width direction W of the wire 52 is parallel to the longitudinal direction of the medical device main body 300.

  Here, if the thickness of the wire 52 is T and the maximum height difference from the axis of the medical device main body 300 to the outer surface 52a of the wire 52 is H, the value of H / T is the position in the longitudinal direction of the medical device main body 300. Different depending on. Specifically, the value of H / T in the wire coil arranged at the distal end portion 15 is made larger than the value of H / T in the wire coil arranged in the intermediate portion 18.

  As an example, the value of H is made different depending on the position of the medical device main body 300 in the longitudinal direction. Specifically, the value of H in the wire coil arranged at the distal end portion 15 is made larger than the value of H in the wire coil arranged in the intermediate portion 18.

For example, for the wire coil disposed at the distal end portion 15, the wire 52 is wound so that the adjacent winding portions of the wire coil partially overlap each other in the longitudinal direction of the medical device body 300. To do.
On the other hand, about the wire coil arrange | positioned at the intermediate part 18, the wire 52 is wound so that the mutually adjacent winding parts of the wire coil may not mutually overlap.

After the inner layer 21 with the core wire is created and the wire coil 50 is created, the wire coil 50 is extrapolated to the inner layer 21 with the core wire.
Further, the outer layer 60 is extrapolated to the wire coil 50.
Thereby, the core wire, the inner layer 21, the wire coil 50, 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 is put around the outer layer 60. Next, the heat-shrinkable tube is contracted by heating to tighten the outer layer 60 from the surroundings, and the outer layer 60 is heated. 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 is melted, and the outer layer 60 is attached to the wire coil 50 and the inner layer 21 (joined by welding). At this time, the resin material constituting the outer layer 60 encloses the wire coil 50, and the resin material impregnates the wire coil 50.
Thus, the outer layer 60 can be attached to the wire coil 50 in a tubular shape coaxial with the wire coil 50.

Thereafter, the outer layer 60 is cooled and solidified. Thereafter, 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 is prepared, and each operation line 40 is fixed to the marker 66.

  Next, the marker 66 is fixed to the distal end portion of the medical device main body 300. For this purpose, for example, the outer layer 60 at the distal end portion of the medical device main body 300 is excised, and the inner layer 21 is exposed at the distal end portion of the medical device main body 300. At this time, the hollow tube 32 is also excised together with the outer layer 60. Next, let the front-end | tip part of the operation line 40 be the state protruded from the front-end | tip side of the hollow tube 32 to the front end side.

  Next, the marker 66 is extrapolated around the inner layer 21 at the distal end portion of the medical device main body 300, and the marker 66 is caulked and fixed to the periphery of the inner layer 21.

  Next, the periphery of the distal end portion of the medical device main body 300 is covered with a coating resin (not shown) molded in advance into a cylindrical shape, and the coating resin is coated with the outer layer 60 and the heat shrinkable tube using a heat shrinkable tube different from the heat shrinkable tube. The inner layer 21 is joined by welding. The outer layer 60 and the coating resin are, for example, melted and integrated with each other. Note that the tip-side surface of the marker 66 is also covered with the melted outer layer 60 or coating resin.

  Next, the hub 790 is connected to the proximal end portion of the medical device main body 300.

  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 until the core wire is plastically deformed 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 medical device main body 300 is bent by the pulling operation with respect to the operation line 40.

  Next, a thin coat layer 64 is formed.

  Thus, the catheter 10 can be manufactured.

According to the first embodiment as described above, the value of H / T varies depending on the position of the medical device main body 300 in the longitudinal direction. Here, the greater the value of H / T, the greater the anchor effect of the wire 52 on the sheath 16 (particularly the outer layer 60) per unit thickness of the wire 52. Therefore, in the longitudinal direction of the medical device main body 300, by increasing the value of H / T at a position where the anchor effect of the wire 52 with respect to the sheath 16 is to be partially increased, the interface between the wire coil 50 and the outer layer 60 is increased. Peeling can be suppressed.
Specifically, as described above, the value of H / T can be increased at the distal end portion 15. Thereby, when the catheter 10 is extracted from the body cavity, peeling of the wire coil 50 and the outer layer 60 of the sheath 16 at the distal end portion 15 can be suppressed.
In addition, since the thickness of the arrangement region of the wire coil 50 can be suppressed in the intermediate portion 18, the increase in diameter of the medical device main body 300 and the securing of a sufficient lumen area of the main lumen 20 can be achieved in the intermediate portion 18. realizable.

  As an example, the value of H may be different depending on the position of the medical device main body 300 in the longitudinal direction. For example, by making the value of H at the distal end portion 15 larger than the value of H at the intermediate portion 18, peeling at the interface between the wire coil 50 and the sheath 16 at the distal end portion 15 can be further suppressed. Further, the thickness of the arrangement region of the wire coil 50 can be further suppressed in the intermediate portion 18, and further increase in the diameter of the medical device main body 300 can be further suppressed in the intermediate portion 18, and a further sufficient lumen area of the main lumen 20 can be achieved. Secure.

[Second Embodiment]
FIG. 5 is a schematic longitudinal sectional view of the medical device main body 300 of the catheter 10 according to the second embodiment. 5A shows the distal end portion 15 and FIG. 5B shows the intermediate portion 18. The left side of FIG. 5 corresponds to the distal end side of the catheter, and the right side corresponds to the proximal side (proximal end side).

  The catheter 10 according to the present embodiment is different from the first embodiment only in the points described below, and is configured in the same manner as the first embodiment in other points.

  In the case of this embodiment, the inclination of the wire 52 at the distal end portion 15 and the inclination of the wire 52 at the intermediate portion 18 are reversed from those in the first embodiment. That is, as shown in FIG. 5A, for example, at the distal end portion 15, the wire 52 is parallel to the longitudinal direction of the medical device main body 300. On the other hand, as shown in FIG. 5B, in the intermediate portion 18, the wire 52 is inclined with respect to the longitudinal direction of the medical device main body 300.

  In the case of this embodiment, the value of H / T at the distal end portion 15 of the medical device main body 300 is smaller than the value of H / T at the intermediate portion 18 of the medical device main body 300.

  As an example, the value of H at the distal end portion 15 of the medical device main body 300 is smaller than the value of H at the intermediate portion 18 of the medical device main body 300.

As shown in FIG. 5A, at the distal end portion 15, the winding portions adjacent to each other of the wire coil 50 do not overlap each other.
On the other hand, as shown in FIG. 5B, in the intermediate portion 18, the winding portions adjacent to each other of the wire coil 50 partially overlap each other in the longitudinal direction of the medical device main body 300.
Thereby, the value of H / T and the value of H in the distal end portion 15 are smaller than the value of H / T and the value of H in the intermediate portion 18.
That is, in the partial section (intermediate portion 18) in the longitudinal direction of the medical device main body 300, the winding portions adjacent to each other of the wire coil 50 partially overlap in the longitudinal direction. And the value of H / T and the value of H in the partial section (intermediate portion 18) are based on the values of H / T and H in the section adjacent to the partial section (distal end portion 15). Is also big.

  In the case of the present embodiment, the value of H / T is smaller, for example, toward the distal end side of the medical device main body 300. For example, the value of H is also smaller, for example, toward the distal end side of the medical device main body 300.

  According to the second embodiment as described above, the anchor effect of the wire coil 50 with respect to the sheath 16 can be relatively large at the intermediate portion 18 and relatively small at the distal end portion 15. Thereby, in the distal end part 15, the outer layer 60 and the wire coil 50 can be relatively moved relative to each other, and the mobility of the wire coil 50 and the flexibility of the distal end part 15 are improved.

[Third Embodiment]
FIG. 6 is a schematic longitudinal sectional view of the medical device main body 300 of the catheter 10 according to the third embodiment. 6A shows the distal end portion 15 and FIG. 6B shows the intermediate portion 18. The left side of FIG. 6 corresponds to the distal end side of the catheter, and the right side corresponds to the proximal side (proximal end side).

  The catheter 10 according to the present embodiment is different from the first embodiment only in the points described below, and is configured in the same manner as the first embodiment in other points.

In the case of this embodiment, the thickness (thickness) of the wire 52 at the distal end portion 15 is thinner (thin) than the thickness (thickness) of the wire 52 at the intermediate portion 18.
That is, in a partial section (distal end portion 15) in the longitudinal direction of the medical device main body 300, the winding portions adjacent to each other of the wire coil 50 partially overlap each other in the longitudinal direction of the medical device main body 300. . The value of H / T in the partial section (distal end portion 15) is larger than the value of H / T in the section adjacent to the partial section (intermediate portion 18). The wire 52 is thinner toward the distal end side of the medical device main body 300.

  Note that the number of wires 52 constituting the wire coil 50 (the number of wires) is smaller in the intermediate portion 18 than in the distal end portion 15. For example, in the example of FIG. 6B, the wire coil 50 is configured by pitch winding one (one) wire 52 in the intermediate portion 18.

  According to the third embodiment, since the thickness of the wire 52 at the distal end portion 15 is thin, the bending rigidity of the wire coil 50 at the distal end portion 15 and the medical device main body 300 can be suppressed. Moreover, at the distal end portion 15, the winding portions adjacent to each other of the wire coil 50 partially overlap each other in the longitudinal direction of the medical device main body 300, thereby ensuring the above H / T value. Can do.

[Fourth Embodiment]
FIG. 7 is a schematic longitudinal sectional view of the medical device main body 300 of the catheter 10 according to the fourth embodiment. 7A shows the distal end portion 15 and FIG. 7B shows the intermediate portion 18. The left side of FIG. 7 corresponds to the distal end side of the catheter, and the right side corresponds to the proximal side (proximal end side).

  The catheter 10 according to the present embodiment is different from the second embodiment only in the points described below, and is configured in the same manner as the second embodiment in other points.

In the case of this embodiment, the number (wires) of the wires 52 constituting the wire coil 50 in the intermediate portion 18 is larger than the number (wires) of the wires 52 constituting the wire coil 50 in the distal end portion 15.
That is, in a partial section (intermediate portion 18) in the longitudinal direction of the medical device main body 300, the number of the wires 52 constituting the wire coil 50 is reduced in the section adjacent to the partial section (distal end portion 15). More than the number of wires 52 constituting 50. For example, the number of strips in the intermediate section 18 is 12.

  In the intermediate portion 18, the maximum width direction W in the cross-sectional shape of the wire 52 is easily inclined with respect to the longitudinal direction of the medical device body 300 by increasing the number of the wires 52. That is, the pitch angle α of the wire 52 (the angle formed by the longitudinal direction of the medical device main body 300 and the axial center direction of the wire 52) varies depending on the position in the longitudinal direction of the medical device main body 300, specifically, The pitch angle α in the portion 18 is larger than the pitch angle α in the distal end portion 15. Thereby, in the intermediate portion 18, the maximum width direction W in the cross-sectional shape of the wire 52 is easily inclined with respect to the longitudinal direction of the medical device main body 300.

[Fifth Embodiment]
FIG. 8 is a schematic longitudinal sectional view of the medical device main body 300 of the catheter 10 according to the fifth embodiment. 8A shows the distal end 15 and FIG. 8B shows the proximal end 17. The left side of FIG. 8 corresponds to the distal end side of the catheter, and the right side corresponds to the proximal side (proximal end side).

  The catheter 10 according to the present embodiment is different from the first embodiment only in the points described below, and is configured in the same manner as the first embodiment in other points.

  In the case of the present embodiment, if the thickness of the portion outside the wire coil 50 in the sheath 16 is TP, the value of TP is thinner toward the distal end side of the medical device main body 300. That is, the thickness TP of the outer layer 60 at the distal end 15 is thinner than the thickness TP at the proximal end 17.

  More specifically, for example, the value of H / TP increases toward the distal end side of the medical device main body 300.

  For example, as shown in FIG. 8, the value of H / T at the distal end 15 is larger than the value of H / T at the proximal end 17. In this case, the anchor effect of the wire coil 50 can be sufficiently obtained at the distal end portion 15 with respect to the thin outer layer 60.

  Although not shown, the value of H / T at the distal end 15 may be smaller than the value of H / T at the proximal end 17. In this case, at the distal end portion 15, the thickness of the outer layer 60 can be reduced by having a small H / T value corresponding to the thin outer layer 60.

[Sixth Embodiment]
FIG. 9 is a schematic longitudinal sectional view of the proximal end portion 17 of the medical device main body 300 of the catheter 10 according to the sixth embodiment. The left side of FIG. 9 corresponds to the distal end side of the catheter, and the right side corresponds to the proximal side (proximal end side).

  The catheter 10 according to the present embodiment is different from the first embodiment only in the points described below, and is configured in the same manner as the first embodiment in other points.

  In the case of this embodiment, the outer surface 50 a of the wire coil 50 is flat at the proximal end portion 17. For example, the outer surface 50a (the outer surface 52a of the wire 52) is polished to flatten the outer surface 50a.

  Thereby, the layer thickness of the wire coil 50 in the proximal end part 17 can be suppressed.

  In each of the above embodiments, the example in which the cross-sectional shape of the wire 52 is rectangular has been described, but the cross-sectional shape of the wire 52 is not particularly limited as long as it is non-circular. Here, non-circular shapes include oval, elliptical, semi-circular, fan-shaped (fan-shaped with one arc, or fan-shaped with inner and outer arcs (ground paper shape)), curved ball shape, spindle shape, polka dot Shapes or polygons can be mentioned by way of example. The polygon may be a convex polygon such as a rectangle, a trapezoid, a rhombus or a parallelogram, or a concave polygon having an internal angle exceeding 180 degrees. The non-circular shape may be a shape obtained by combining the above shapes, and specifically, may be a rounded polygon having a side protruding in an arc shape or a concave lens shape having a side recessed in an arc shape. The non-circular shape may have a long side and a short side having different lengths assuming a rectangle with a minimum area circumscribing the non-circular shape. Of the wires 52 having these shapes, the wires 52 having different H / T values may be selected according to the position in the longitudinal direction of the medical device main body 300.

  Moreover, in the above, although the active type catheter 10 which has an operation mechanism was illustrated, this invention is not restricted to this example, It can apply also to the inactive type catheter which does not have an operation mechanism.

DESCRIPTION OF SYMBOLS 10 Catheter 15 Distal end part 16 Sheath 17 Proximal end part 18 Middle part 20 Main lumen 21 Inner layer 30 Sublumen 32 Hollow tube 40 Operation line 41 Tip part 50 Wire coil 50a Outer surface 52 Wire 52a Outer surface 52b Inner surface 52c End surface 52d on the distal end side End surface 60 on the proximal end side 60 Outer layer 64 Coat layer 66 Marker 70 Operation unit 300 Medical device body 700 Body case 760 Wheel operation unit 790 Hub DE Distal end W Maximum width direction X Longitudinal direction TP Thickness P Top portion C Center position

Claims (14)

Long and flexible, having a medical device body inserted into a body cavity,
The medical device body is
A long resin tube,
A wire coil that is configured by spirally winding a wire having a non-circular cross-sectional shape, and is embedded in the resin tube coaxially with the resin tube;
Have
In the longitudinal section of the wire, assuming that the thickness of the wire is T and the maximum height difference from the axis of the medical device body to the outer surface of the wire is H, the value of H / T is the longitudinal length of the medical device body. A medical device characterized by different positions in directions.   2. The medical device according to claim 1, wherein a top portion located farthest from an axis of the medical device main body on the outer surface of the wire is shifted from a center position of the wire in the longitudinal direction.   3. The medical device according to claim 1, wherein, in a longitudinal section of the wire, a maximum width direction in a sectional shape of the wire is inclined with respect to the longitudinal direction.   The medical device according to any one of claims 1 to 3, wherein the value of H varies depending on a position in the longitudinal direction.   The medical device according to any one of claims 1 to 4, wherein the value of the H / T is larger toward a distal end side of the medical device main body.   The medical device according to any one of claims 1 to 4, wherein a value of the H / T is larger toward a proximal end side of the medical device main body. In a partial section in the longitudinal direction of the medical device body, adjacent winding portions of the wire coil partially overlap each other in the longitudinal direction,
The medical device according to claim 5 or 6, wherein a value of the H / T in the partial section is larger than a value of the H / T in a section adjacent to the partial section. In a partial section in the longitudinal direction of the medical device body, adjacent winding portions of the wire coil partially overlap each other in the longitudinal direction,
A value of the H / T in the partial section is larger than a value of the H / T in a section adjacent to the partial section;
The medical device according to claim 5, wherein a thickness of the wire is thinner toward a distal end side of the medical device main body. The number of the wires constituting the wire coil in the partial section is as follows:
9. The medical device according to claim 7, wherein the number of the wires constituting the wire coil is greater than that in the section adjacent to the partial section.   The thickness of the part outside the said wire coil in the said resin pipe is set to TP, The value of TP is so thin that the front end side of the said medical device main body is characterized by the above-mentioned. Medical device as described in.   The medical device according to claim 10, wherein a value of H / TP is larger toward a distal end side of the medical device main body.   The medical device according to any one of claims 1 to 11, wherein a pitch angle of the wire varies depending on a position in a longitudinal direction of the medical device main body.   The medical device according to any one of claims 1 to 12, wherein an outer surface of the wire coil is flat at a proximal end portion of the medical device main body. Having a long and flexible process of creating a medical device body to be inserted into a body cavity;
The step of creating the medical device body includes
Forming a long inner resin tube;
Forming a wire coil by spirally winding a wire having a non-circular cross-sectional shape;
Arranging the wire coil around the inner resin tube;
Forming a long outer resin tube around the wire coil, and embedding the wire coil in a resin tube including the outer resin tube and the inner resin tube;
Have
In the longitudinal section of the wire, if the thickness of the wire is T, and the maximum height difference from the axis of the medical device body to the outer surface of the wire is H,
In the step of forming the wire coil, the wire coil is formed so that the value of H / T varies depending on the position in the longitudinal direction of the medical device main body.

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