JP2013192716A - Medical instrument - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical instrument in which the front end of a tubular body can be bent at a small curvature radius and a kink can be prevented from being formed.SOLUTION: A medical instrument (e.g. catheter 10) has a tubular body 300 to be inserted into a body cavity, and a manipulation wire 40. The tubular body 300 has a tubular body (sheath 16), and a bar-like body 80. The bar-like body 80 is made of an elastic material having rigidity higher than that of the tubular main body, and is embedded in a tube wall portion in the front end of the tubular body and extends in the longitudinal direction of the tubular body 300. The front end of the manipulation wire 40 is fixed to the tubular body 300 at a farther front end than the front end of the bar-like body 80. The tubular body 300 has a high-rigidity region having bending rigidity larger than that of a disposition region R1 of the bar-like body 80 more closely to a base end side than to a disposition region R1, and a low-rigidity region R2 having bending rigidity smaller than that of the disposition region R1 at a position between the front end of the bar-like body 80 and the front end of the manipulation wire 40.

Description

  The present invention relates to a medical device.

  Various medical devices having a long tubular body and configured to change the direction of entry into a body cavity by bending the distal end portion (hereinafter referred to as “distal end portion”) of the tubular body. Has been developed. As a typical example, for example, a catheter is known. In order to ensure torque transmission and push force transmission at the proximal end of the tubular body, and to ensure flexibility at the distal end of the tubular body, the bending rigidity of the tubular body decreases toward the distal end side. Yes.

  In the catheter described in Patent Document 1, a tubular member is provided inside the tubular body. The tubular member is set so that the distal end portion is less rigid than the proximal end portion. A pair of plate-like rods are fixed in a parallel arrangement at the tip of the tubular member. The operation wire for bending the distal end portion of the tubular body has its distal end fixed to the distal end of the tubular member. In the technique of Patent Document 1, the tubular member is provided with a plate-like rod, whereby the bending direction of the tubular body is defined in a direction perpendicular to the line connecting the pair of plate-like rods (two directions).

  Patent Document 2 describes a catheter in which a tubular body is bent in a specific region by forming a plurality of notches (cuts) spaced apart in the longitudinal direction in a specific region in the longitudinal direction of the tubular body. Has been.

JP 2003-144554 A Special Table 2002-512534 gazette

  In a medical device that is used by allowing a tubular body to enter a body cavity, it is required that the tubular body can enter a desired body cavity in a desired approach direction, that is, high direction selectivity. For example, a blood vessel catheter that is used by entering into a blood vessel is required to be able to easily enter a desired branch blood vessel, that is, high blood vessel selectivity.

  If the radius of curvature of the tubular body is large, a sufficient bending angle cannot be secured inside a narrow body cavity (narrow blood vessel or the like), and the distal end of the tubular body may not be allowed to enter the desired body cavity in the desired approach direction. . That is, the direction selectivity is low. For this reason, in order to improve the direction selectivity in the medical device, it is desirable that the distal end portion of the tubular body can be bent with a small curvature radius.

  On the other hand, in general, the smaller the radius of curvature at the bent portion of the tubular body, the easier it is to generate kinks (the tubular body is broken and the lumen is closed).

  In the technique of Patent Document 1, although the distal end portion of the tubular member is set to be less rigid than the proximal end portion of the tubular main body, a plate-like rod is attached to the distal end portion, so that the distal end portion is so-called. It is reinforced. For this reason, it is difficult to sufficiently reduce the radius of curvature of the distal end portion of the tubular member.

  Moreover, in the technique of patent document 2, since the several notch for improving the flexibility of a tubular body is mutually spaced apart in the longitudinal direction of a tubular body, a tubular body bends over a wide range. Therefore, it is difficult to sufficiently reduce the radius of curvature of the tubular body. In addition, the presence of the notch may cause the tubular body to be bent and kink locally at an excessive bending angle, and the tubular body may have insufficient strength.

  The present invention has been made in view of the above problems, and provides a medical device that can bend the distal end portion of a tubular body with a small radius of curvature and can suppress the occurrence of kinks in the tubular body. .

The present invention is a long and flexible tubular body that is inserted into a body cavity;
An operation line embedded in the tubular body, and one or more operation lines for bending the tubular body when the operation line is pulled to the proximal end side of the tubular body;
Have
The tubular body is
A long and flexible tubular body;
A rod-like body made of an elastic body having higher rigidity than the tubular body, embedded in the tube wall portion at the distal end portion of the tubular body, and extending in the longitudinal direction of the tubular body;
Have
The distal end of the operation line is fixed to the tubular body on the distal end side of the distal end of the rod-shaped body,
The tubular body has a high-rigidity region having a higher bending rigidity than a region where the rod-shaped body is disposed in the tubular body on the proximal end side relative to the region where the rod-shaped body is disposed. There is provided a medical device characterized in that a low-rigidity region having a bending rigidity smaller than an arrangement region is provided between the tip of the rod-shaped body and the tip of the operation line.

  ADVANTAGE OF THE INVENTION According to this invention, the front-end | tip part of the elongate tubular body of a medical device can be bent with a small curvature radius, and generation | occurrence | production of the kink in a tubular body can be suppressed.

It is a schematic diagram (perspective view) which shows the front-end | tip part of the medical device which concerns on 1st Embodiment. It is AA sectional drawing (transverse sectional view) of FIG. It is a typical perspective view which shows the front-end | tip part of the medical device which concerns on 1st Embodiment. It is a typical side view (perspective view) which shows the example of the positional relationship of the rod-shaped body of the medical device which concerns on 1st Embodiment, and a reinforcement layer. It is a typical longitudinal cross-sectional view of the front-end | tip part of the medical device which concerns on 1st Embodiment. It is a typical longitudinal cross-sectional view of the front-end | tip part (base end side rather than FIG. 5) of the medical device which concerns on 1st Embodiment. It is BB sectional drawing (transverse sectional view) of FIG. It is a typical top view of the medical device concerning a 1st embodiment. It is a typical cross-sectional view which shows the manufacturing process of the medical device which concerns on 1st Embodiment. It is a schematic diagram which shows the mechanism of operation | movement of the medical device which concerns on 1st Embodiment. It is a schematic diagram which shows the operation example of the medical device which concerns on 1st Embodiment. It is a schematic diagram which shows the modification of arrangement | positioning of the rod-shaped body in the cross section of the medical device which concerns on 1st Embodiment. It is a typical side view (perspective view) which shows the front-end | tip part of the medical device which concerns on 2nd Embodiment. It is a schematic diagram which shows the front-end | tip part at the time of the bending of the medical device which concerns on 2nd Embodiment. It is a typical side view (perspective view) which shows the medical device which concerns on the modification of 1st and 2nd embodiment. It is a typical side view (perspective view) which shows the front-end | tip part of the medical device which concerns on 3rd Embodiment. It is a typical side view (perspective view) which shows the medical device which concerns on the modification of 3rd Embodiment. It is a schematic diagram which shows operation | movement of the medical device which concerns on a comparative example. It is a schematic diagram which shows the mechanism of operation | movement of the medical device which concerns on a comparative example.

  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 (a) and FIG.1 (b) are schematic diagrams which show the front-end | tip part of the catheter 10 as a medical device which concerns on 1st Embodiment. 1A is a plan view and FIG. 1B is a side view. FIG. 1 is a perspective view showing a fixing member 66, a rod-like body 80, and an operation line 40 that are internal configurations of the catheter 10.
2 is a cross-sectional view (transverse cross-sectional view) taken along line AA of FIG.
FIG. 3 is a schematic perspective view showing the distal end portion of the catheter 10.
FIG. 4 is a schematic side view showing an example of the positional relationship between the rod-shaped body 80 of the catheter 10 and the reinforcing layer (for example, the coil 50). FIG. 4 is a perspective view showing the fixing member 66, the rod-like body 80, the operation wire 40, and the coil 50 that are the internal configuration of the catheter 10.
5 and 6 are schematic longitudinal sectional views of the distal end portion of the catheter 10 according to the first embodiment. FIG. 6 shows a portion closer to the base end than FIG.
7 is a cross-sectional view (cross-sectional view) taken along the line BB of FIG.
FIG. 8 is a schematic plan view of the catheter 10 according to the first embodiment.
FIG. 9 is a schematic cross-sectional view showing a manufacturing process of the catheter 10 according to the first embodiment.

The catheter 10 according to the present embodiment has a long and flexible tubular body 300 inserted into a body cavity, and one or more operation lines 40 embedded in the tubular body 300. Yes. The operation line 40 bends the tubular body 300 when an operation of pulling the operation line 40 to the proximal end side of the tubular body 300 is performed. The tubular body 300 has a long and flexible tubular body (sheath 16) and a rod-shaped body 80. The rod-shaped body 80 is made of an elastic body having higher rigidity than the tubular main body. The rod-like body 80 is thinner than the inner diameter of the tubular main body and thinner than the wall thickness of the tube wall portion of the tubular main body. The rod-shaped body 80 is embedded in the tube wall portion at the distal end portion of the tubular main body and extends in the longitudinal direction of the tubular body 300.
The distal end of the operation line 40 is fixed to the tubular body 300 on the distal end side of the distal end of the rod-shaped body 80.
The tubular body 300 has a high-rigidity region R5 (FIG. 4) having a higher bending rigidity than the arrangement region R1 of the rod-like body 80 in the tubular body 300 on the proximal end side with respect to the arrangement region R1. As shown in FIG. 4A, when the high-rigidity region R5 and the arrangement region R1 overlap each other, the magnitude relationship of the bending rigidity between the arrangement region R1 and the high-rigidity region R5 is as follows. This means the size relationship between non-overlapping areas.
Further, the tubular body 300 has a low-rigidity region R2 having a bending rigidity smaller than that of the arrangement region R1 between the distal end of the rod-shaped body 80 and the distal end of the operation line 40.
Details will be described below.

  As shown in FIG. 8, the catheter 10 includes a tubular body 300 and an operation mechanism for performing a bending operation of the distal end portion of the tubular body 300.

  The operation mechanism includes an operation line 40 (FIGS. 1 to 7) and an operation unit 70 for performing an operation of pulling the operation line 40.

  The tubular 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 operation line 40 is embedded in the tubular body 300 along the longitudinal direction of the tubular body 300. More specifically, the operation line 40 is embedded in a tube wall portion of a sheath 16 (tubular body) described later. The distal end of the operation line 40 is fixed to the distal end portion of the tubular body 300. Specifically, as will be described later, the operation line 40 is indirectly fixed to the tubular body 300 by being fixed to the fixing member 66, for example.

  The operation unit 70 is provided at the proximal end of the tubular body 300. A base end portion of the operation line 40 is connected to the operation unit 70. By operating the operation unit 70, the operation line 40 can be pulled toward the proximal end side of the tubular body 300, and the distal end portion of the tubular body 300 can be bent.

  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 tubular body 300 of the catheter 10 is formed to a size that allows the tubular 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 tubular body 300) is referred to as the distal end portion 15 of the catheter 10 (and the tubular body 300). Similarly, a predetermined length region including the proximal end (proximal end) (not shown) of the catheter 10 (and the tubular body 300) is referred to as the proximal end portion (proximal end) of the catheter 10 (and the tubular body 300). Part) 17 (FIG. 8).

  As shown in FIGS. 5 to 7, a main lumen (a lumen of the tubular body 300) 20 and a sub-lumen 30 are formed inside the tubular body 300. The main lumen 20 and the sub-lumen 30 extend along the longitudinal direction (the left and right direction in FIGS. 5 and 6) of the tubular body 300 (the catheter 10).

  The main lumen 20 is open at the tip of the tubular body 300 (see FIG. 3). A liquid such as a chemical solution can be supplied from the proximal end to the distal end of the tubular body 300 via the main lumen 20.

  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 tubular 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. 5 to 7, 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.

  Examples of the structure of the sublumen 30 include the following two structures.

  In the first structure, as shown in FIGS. 5 to 7, a hollow tube 32 formed in advance is embedded in the outer layer 60 (described later) along the longitudinal direction of the tubular body 300, and the hollow tube 32 is embedded. This lumen is called sublumen 30. That is, in these examples, the sublumen 30 is configured by the lumen of the hollow tube 32 embedded in the tubular 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 tubular body 300 in the outer layer 60 (described later).

  As described above, the tubular body 300 has the sheath 16 as a long and flexible tubular body.

  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 configured by molding a resin material into a tubular shape. 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 outer layer 60 includes, for example, (an outer layer main body 61 and a coating resin 62 formed around the outer layer main body 61 (FIG. 9C)). It may be formed only at the distal end, or may be formed over the entire longitudinal direction of the sheath 16. For example, the thickness of the coating resin 62 is thinner than the thickness of the outer layer body 61. The outer layer body 61. The covering resin 62 is made of, for example, the same kind of resin material and is fused and integrated with each other.
The sub-lumen 30 is formed inside the outer layer 60.

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

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

  The tubular body 300 is made of, for example, a resin material. That is, the tubular body 300 includes the outer layer 60 and the inner layer 21 made of a resin material.

  In other words, the tubular body 300 has a hollow resin layer including the outer layer 60 and the inner layer 21. A hollow resin layer including the outer layer 60 and the inner layer 21 is referred to as a tube wall portion of the sheath 16.

  The resin material constituting the tubular body 300 may contain an inorganic filler. For example, as the resin material constituting the outer layer 60 occupying most of the wall thickness of the tubular body 300, 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. Note that the coat layer 64 may be formed only in a region extending over a partial length of the distal end portion 15 of the tubular body 300 or may be formed over the entire length of the tubular 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 tubular body 300 further includes a tubular reinforcing layer having a rigidity higher than that of the resin material constituting the sheath 16. The reinforcing layer is disposed coaxially with the sheath 16 and is embedded in the tube wall portion of the sheath 16. The region where the reinforcing layer is disposed constitutes a highly rigid region R5.

  In the present embodiment, this reinforcing layer is, for example, a coil 50 as shown in FIGS. The coil 50 is wound around the inner layer 21 and embedded (embedded) in the outer layer 60.

The coil 50 is configured by, for example, winding a single or a plurality of wire members 52 formed of an elastic body in a spiral shape. As a material of the wire 52 constituting the coil 50, for example, a metal is preferably used. However, the material is not limited to this example, and any other material may be used as long as the material has higher rigidity and elasticity than the inner layer 21 and the outer layer 60. (For example, resin) may be used. Specifically, for example, stainless steel (SUS), nickel titanium alloy, steel, titanium, or copper alloy can be used as the metal material of the wire 52. Although the cross-sectional shape of the wire 52 is not particularly limited, for example, a rectangular shape or a circular shape is a preferable example.
In the present embodiment, the sub-lumen 30 is formed outside the coil 50 inside the outer layer 60.
As will be described later, flexible coils may also be arranged in the arrangement region R1 and the low-rigidity region R2 of the rod-shaped body 80. That is, the tubular body 300 has a tubular reinforcing layer that is higher in rigidity than the sheath 16 (that is, has higher bending rigidity) and is embedded in the sheath 16 coaxially with the sheath 16 in at least the high rigidity region R5.

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

  The catheter 10 has a fixing member 66 that is higher in rigidity (larger in bending rigidity) than the sheath 16. The fixing member 66 is provided at the distal end portion 15 of the tubular body 300. The distal end of the operation line 40 is fixed to the fixing member 66.

  The fixing member 66 is formed in an annular shape that is coaxial with the tubular body 300, for example. The fixing member 66 is embedded in the sheath 16. The fixing member 66 is provided around the main lumen 20 and inside the outer layer 60.

  The fixing member 66 is made of a material that is opaque to specific radiation such as X-rays. For this reason, for example, the position of the fixing member 66, that is, the position of the distal end portion of the tubular body 300 can be easily recognized when X-ray imaging is performed. That is, the fixing member 66 also functions as a marker. Note that the entire fixing member 66 may be made of a material opaque to specific radiation, or only a part of the fixing member 66 may be made of a material opaque to specific radiation. good.

  The fixing member 66 is made of, for example, a metal material such as platinum.

  A mode of fixing the tip of the operation line 40 to the fixing member 66 is not particularly limited. For example, the tip of the operation line 40 may be welded or fastened to the fixing member 66, or may be bonded and fixed to the fixing member 66 with an adhesive.

  Here, the fixing member 66 is provided at the distal end portion of the tubular body 300 by, for example, caulking and fixing around the inner layer 21.

Here, the typical dimension of each component of the catheter 10 of this embodiment is demonstrated.
The radius of the main lumen 20 is about 200 to 300 μm, the thickness of the inner layer 21 is about 10 to 30 μm, the thickness of the outer layer 60 is about 50 to 150 μm, the outer diameter of the coil 50 is 500 to 860 μm, and the inner diameter of the coil 50 is the diameter. It can be 420-660 micrometers.
The radius (distance) from the axial center of the catheter 10 to the center of the sublumen 30 is about 300 to 450 μm, and the inner diameter (diameter) of the sublumen 30 is 40 to 100 μm. And the thickness of the operation line 40 shall be about 30-60 micrometers.
The outermost diameter (radius) of the tubular body 300 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 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 tubular body 300.

  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 tubular 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 tubular body 300 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 tubular 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 by this injector, the liquid is supplied to the distal end of the tubular body 300 via the main lumen 20, and the liquid is supplied from the distal end of the tubular body 300 into the body cavity of the patient. Can be supplied to.

  For example, the operation line 40 and the hollow tube 32 are branched from the sheath 16 of the tubular body 300 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 either direction, the operation lines 40 are individually pulled to the proximal end side, and the distal end 15 of the catheter 10 (the distal end 15 of the tubular body 300) is moved. It can be bent.

  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. Thereby, the distal end portion 15 of the tubular body 300 is bent toward the sub-lumen 30 side through which the one operation line 40 is inserted, with the axial center of the tubular body 300 as a reference. That is, the distal end portion 15 of the tubular body 300 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. Thereby, the distal end portion 15 of the tubular body 300 is bent toward the sub-lumen 30 side through which the other operation line 40 is inserted, with the axis of the tubular body 300 as a reference. That is, the distal end portion 15 of the tubular body 300 is bent in the other direction.

  Here, the bending of the tubular body 300 includes an aspect in which the tubular body 300 is bent in a “shape” and an aspect in which the tubular body 300 is bent like a bow.

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

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

  Next, the structure of the distal end portion 15 of the tubular body 300 will be described in more detail.

  As shown in FIGS. 1 to 7, the tubular body 300 has a rod-like body 80 at its distal end 15. The rod-shaped body 80 is embedded in the tube wall portion at the distal end portion 15 of the sheath 16 and extends in the longitudinal direction of the tubular body 300.

  Here, “extending in the longitudinal direction” means that the rod-shaped body 80 meanders along the tubular body 300 in addition to the case where the longitudinal direction of the rod-shaped body 80 and the longitudinal direction of the tubular body 300 are parallel to each other. It is also included. However, the case where the rod-shaped body 80 goes around the tubular body 300 one or more times (when it is spiral) is excluded.

  The rod-shaped body 80 may be a hollow tube or a coil in addition to a simple rod, that is, a solid rod (solid rod). The coil is configured by winding a wire rod in a spiral shape. When a coil is used as the rod-shaped body 80, it is particularly preferable to use a closely wound coil.

The rod-like body 80 is preferably one having a certain degree of flexibility in the bending direction, that is, one that can be bent to some extent in the direction intersecting the axial direction. That is, the rod-like body 80 allows bending.
However, the rod-shaped body 80 does not substantially allow axial compression. That is, the rod-shaped body 80 has sufficient rigidity in the axial direction.
Since the rod-shaped body 80 is not substantially deformed (buckled) in the axial compression direction, the rod-shaped body 80 in the tubular body 300 is also pulled when the operation line 40 is pulled to bend the distal end portion 15 of the tubular body 300. The arrangement region R1 is slightly bent.
When the distal end 15 of the tubular body 300 is bent by pulling the operation line 40, the bending of the arrangement region R1 and the proximal end side of the tubular body 300 is restricted. Therefore, in the tubular body 300, a portion on the tip side of the arrangement region R1 (a portion including the low rigidity region R2) is mainly bent. Therefore, the distal end portion 15 of the tubular body 300 can be bent with a small radius of curvature.
The arrangement region R1 is greatly bent as compared with the high-rigidity region R5 on the base end side. Moreover, the arrangement | positioning area | region R1 bends largely, for example toward the front end side.

The sheath 16 is made of the same resin material from at least the arrangement region R1 of the rod-shaped body 80 to the low-rigidity region R2. For this reason, the sheath 16 itself does not have a rigid discontinuity at the boundary between the arrangement region R1 and the low-rigidity region R2. By disposing the rod-like body 80, a rigid discontinuity point is formed at the boundary between the arrangement region R1 and the low-rigidity region R2 (the tip position of the rod-like body 80).
In addition, the sheath 16 is comprised by the same resin material from the base end to the front-end | tip, for example.

  The thickness (diameter) of the rod-shaped body 80 is thinner than the thickness of the tube wall portion of the sheath 16. Note that the cross-sectional shape of the rod-shaped body 80 is, for example, preferably a circular shape, but may be an elliptical shape, a polygonal shape, or other irregular shapes.

The rod-shaped body 80 is constituted by an elastic body having a larger elastic modulus than the resin material constituting the sheath 16, and the bending rigidity of the rod-shaped body 80 is larger than the bending rigidity of the sheath 16. For example, the rod-shaped body 80 is preferably made of metal. As the metal material constituting the rod-like body 80, for example, an elastic metal material such as a nickel-titanium alloy is suitable. The rod-shaped body 80 only needs to have required rigidity and elasticity, and may be made of a material other than metal.
In the case of this embodiment, the rod-shaped body 80 is, for example, a solid rod of an elastic metal material.

  The distal end of the rod-shaped body 80 is located closer to the proximal end side (base end side) than the distal end (tip end) DE of the tubular body 300 and the distal end (tip end) of the sheath 16.

In the tubular body 300, a portion from the distal end DE to the tip of the rod-shaped body 80 is referred to as the most distal end portion 18. For example, the length of the most distal end 18 is preferably about 5 mm.
Moreover, it is a preferable example that the total length of the most distal end portion 18 and the arrangement region R1 is 50 times to 100 times the outer diameter of the tubular body 300, for example.

  The distal end of the operation line 40 is fixed to the tubular body 300 on the distal end side of the tubular body 300 with respect to the distal end of the rod-shaped body 80. Specifically, for example, the tip of the operation line 40 is fixed to the fixing member 66 as described above.

  The tubular body 300 has a low-rigidity region R2 having a bending rigidity smaller than the arrangement region R1 of the rod-shaped body 80 in the tubular body 300 between the distal end of the rod-shaped body 80 and the distal end of the operation line 40. The low rigidity region R2 is a part of the most distal end portion 18.

  In the case of this embodiment, the low rigidity region R <b> 2 is a region from the distal end of the rod-shaped body 80 to the proximal end of the fixing member 66. In the present embodiment, in the low-rigidity region R2, other than the operation line 40 and the hollow tube 32, no component that increases the bending rigidity of the tubular body 300 is provided on the sheath 16. For this reason, the tubular body 300 can be flexibly bent in the low-rigidity region R2.

  When the tubular body 300 is bent by pulling the operation line 40, a portion on the distal end side of the tubular body 300 with respect to the rod-shaped body 80 (a portion including the low rigidity region R2) is mainly bent. Thereby, compared with the case where a tubular body is bent gently over the wide range in the longitudinal direction, the curvature radius of the bending part of the tubular body 300 can be made small.

  The length of the rod-shaped body 80 is preferably equal to or greater than the outer diameter (diameter) of the tubular body 300. Thereby, although mentioned later for details, generation | occurrence | production of the kink in the tubular body 300 can be suppressed suitably. That is, the kink resistance of the tubular body 300 is improved. In addition, since the length of the rod-shaped body 80 is equal to or larger than the outer diameter of the tubular body 300, it is possible to prevent both ends of the rod-shaped body 80 from damaging the sheath 16 when the tubular body 300 is bent.

  The length of the low-rigidity region R2 in the longitudinal direction of the tubular body 300 is preferably equal to or greater than the outer diameter (diameter) of the tubular body 300. Thereby, the flexibility of the tubular body 300 becomes favorable, and the tubular body 300 can be bent at a sufficient bending angle.

  In the circumferential direction of the tubular body 300, the operation line 40 and the rod-shaped body 80 are preferably disposed close to each other (see FIGS. 1 to 3 and FIG. 7). In this case, the rod-shaped body 80 extends along the operation line 40 in the vicinity of the operation line 40. For example, in the cross section of the tubular body 300, the angle formed by the line segment connecting the center of the tubular body 300 and the center of the operation line 40 and the line segment connecting the center of the tubular body 300 and the center of the rod-shaped body 80 is 45 degrees or less or 15 degrees or less.

  Since the operation line 40 and the rod-shaped body 80 are close to each other, the force to bend the sheath 16 by pulling the operation line 40 is alleviated by the presence of the rod-shaped body 80 located in the vicinity of the operation line 40. . As a result, the kink resistance of the tubular body 300 is improved.

  More specifically, for example, as shown in FIG. 1A, FIG. 2, and FIG. 7, the rod-shaped bodies 80 are respectively disposed adjacent to both sides of each operation line 40. That is, a pair of rod-like bodies 80 are arranged with the operation line 40 interposed therebetween. In this case, it is a preferable example that the center of the bending rigidity of the pair of rod-shaped bodies 80 (the stiffness of the pair of rod-shaped bodies 80) coincides with the operation line 40.

  In the case where the operation line 40 is inserted through the hollow tube 32 as in the present embodiment, the rod-shaped body 80 is disposed close to the hollow tube 32.

  The operation line 40 and the rod-shaped body 80 are arranged in the same layer in the sheath 16. Here, the same layer means that the distance from the center of the tubular body 300 is the same as the distance from the center of the tubular body 300 in addition to the case where the distance from the center of the tubular body 300 is completely the same. Including some cases (partly duplicated).

  As described above, in the present embodiment, the tubular body 300 includes the coil 50 as a reinforcing layer in the high-rigidity region R5.

  For example, as shown in FIGS. 4A and 4B, the distal end of the coil 50 is preferably positioned on the proximal end side with respect to the distal end of the rod-shaped body 80. That is, it is preferable that the rod-shaped body 80 is disposed on the distal end side with respect to the coil 50.

  However, the tip of the coil 50 may be located on the tip side of the tip of the rod-shaped body 80. That is, for example, a part of the coil 50 may exist in the low rigidity region R2. If the coil 50 is pitch wound (not tightly wound), it does not hinder the flexibility of the tubular body 300 in the low-rigidity region R2. When a part of the coil 50 is arranged in the low-rigidity region R2, a pitch-wound coil 50 made of a single wire 52 is particularly preferable.

  On the other hand, the base end (portion not shown in FIG. 4) of the coil 50 is located on the base end side with respect to the base end of the rod-shaped body 80. Specifically, the proximal end of the coil 50 is located at the proximal end portion 17 of the tubular body 300, for example.

  As an example, as shown in FIGS. 4A and 6, the distal end of the coil 50 may be located on the distal end side with respect to the proximal end of the rod-shaped body 80. That is, the rod-shaped body 80 and the coil 50 are disposed so as to overlap each other. In this case, the change in bending rigidity of the tubular body 300 from the region closer to the proximal end than the region R1 of the rod-shaped body 80 to the region R1 can be moderated.

  However, the rod-shaped body 80 may be disposed in a region where the coil 50 does not exist over the entire region in the longitudinal direction. For example, as shown in FIG. 4B, the tip of the coil 50 may be located at the base end of the rod-shaped body 80. Although not shown, the distal end of the coil 50 may be located closer to the proximal end than the proximal end of the rod-shaped body 80. That is, the position of the proximal end of the rod-shaped body 80 in the longitudinal direction of the tubular body 300 can be the same as the distal end portion of the coil 50 or the distal end side thereof.

  The bending rigidity of the tubular body 300 in the region where the coil 50 is disposed is larger than the bending rigidity of the tubular body 300 in the region R1 where the rod-shaped body 80 is disposed (particularly, the region where the coil 50 is not disposed). Thereby, at the time of bending operation of the tubular body 300, the bending of the tubular body 300 on the base end side with respect to the rod-shaped body 80 can be suppressed, and the distal end portion 15 of the tubular body 300 can be bent with a small radius of curvature.

Here, the bending rigidity of the sheath 16 is constant at least at the distal end portion 15 regardless of the position in the longitudinal direction. Further, the bending rigidity of the coil 50 is also constant at least at the distal end portion 15 regardless of the position in the longitudinal direction.
Thereby, generation | occurrence | production of the kink in the boundary part of the area | region of the base end side rather than arrangement | positioning area | region R1 of the rod-shaped body 80 and arrangement | positioning area | region R1 can be suppressed. Further, it is possible to suppress the occurrence of kinks at the boundary between the arrangement region R1 of the rod-shaped body 80 and the region on the tip side of the arrangement region R1.

  The coil 50 is configured, for example, by connecting a plurality of coils (for example, the first coil 50a and the second coil 50b shown in FIG. 4) having different bending rigidity in the longitudinal direction. Among these, the coil located on the tip side has a lower bending rigidity. Thereby, the bending rigidity of the tubular body 300 becomes smaller toward the tip side.

  Next, an example of a method for manufacturing the catheter 10 having the above-described configuration will be described.

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

The outer layer main body 61 (FIG. 9A) of the outer layer 60 is created by, for example, extruding a resin material as a molding material with an extrusion molding apparatus (not shown). In this extrusion molding, a resin material that will be the outer layer main body 61 is attached around the core wire by extruding a core wire (mandrel) together with the resin material.
Although the material of a core wire is not specifically limited, As an example, copper or a copper alloy, alloy steels, such as carbon steel and SUS, nickel, or a nickel alloy can be mentioned.
A release treatment may optionally be performed on the surface of the core wire. As the mold release treatment, optical or chemical surface treatment may be performed in addition to the application of a release agent such as fluorine or silicon.

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

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

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

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

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

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

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

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

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

  Next, the dummy core wire is pulled out from the hollow tube 32, and the operation wire 40 is inserted into the hollow tube 32. The state up to this point is shown in FIG.

  Separately, a fixing member 66 is prepared, and each operation line 40 is fixed to the fixing member 66.

  Next, the fixing member 66 is fixed to the distal end portion of the tubular body 300. For this purpose, for example, the outer layer main body 61 at the distal end portion of the tubular body 300 is excised, and the inner layer 21 is exposed at the distal end portion of the tubular body 300. At this time, the hollow tube 32 is also cut out together with the outer layer main body 61. Next, let the front-end | tip part of the operation line 40 be the state protruded from the front-end | tip side of the hollow tube 32 to the front end side.

  Next, the fixing member 66 is extrapolated around the inner layer 21 at the distal end portion of the tubular body 300, and the fixing member 66 is caulked and fixed to the periphery of the inner layer 21.

  Further, as shown in FIG. 9B, the rod-shaped body 80 is temporarily fixed to the outer surface of the outer layer main body 61. This temporary fixing is performed by, for example, welding the rod-shaped body 80 to the outer surface of the outer layer main body 61 (laser welding or the like) or bonding (bonding with an adhesive or the like).

  Next, the periphery of the distal end portion of the tubular body 300 is covered with a coating resin 62 that is formed into a cylindrical shape in advance, and the coating resin 62 is coated with the outer layer main body 61 and the inner layer 21 using a heat shrinkable tube different from the heat shrinkable tube. Bonded by welding. Thus, the outer layer 60 composed of the outer layer main body 61 and the coating resin 62 is formed. At this time, the rod-shaped body 80 is embedded in the coating resin 62 (FIG. 9C). The outer layer main body 61 and the coating resin 62 are, for example, melted and integrated with each other. Note that the surface on the distal end side of the fixing member 66 is also covered with the melted outer layer 60.

  Next, the hub 790 is connected to the proximal end portion of the tubular 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 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 tubular body 300 is bent by the pulling operation with respect to the operation line 40.

  Next, the coat layer 64 is formed.

  Thus, the catheter 10 can be manufactured.

  Next, the operation of the catheter 10 will be described.

  FIG. 10 is a schematic view showing a mechanism of operation of the catheter 10 according to the first embodiment. FIG. 11 is a schematic diagram illustrating an operation example of the catheter 10 according to the first embodiment.

  When the tubular body 300 is bent by pulling the operation line 40 (hereinafter referred to as a bending operation), a portion of the tubular body 300 on the tip side of the rod-shaped body 80 (a portion including the low rigidity region R2) is mainly bent. (See FIG. 10). This is because the rod-like body 80 is not substantially deformed in the axial compression direction as described above, and the arrangement region R1 of the rod-like body 80 is bent only slightly during the bending operation. Therefore, the force that bends the tubular body 300 can be concentrated in the region on the tip side of the arrangement region R1, so that the radius of curvature of the bent portion of the tubular body 300 can be reduced.

  As a result, for example, as shown in FIG. 11, the distal end (distal end DE) of the catheter 10 can easily enter the blood vessel 19 that branches at an acute angle. If the distal end portion 15 has an appropriate rigidity (koshi), the catheter 10 can be advanced into the blood vessel 19 by pushing the catheter 10 as it is.

  In addition, during the bending operation of the tubular body 300, the occurrence of kinks in the tubular body 300 is suppressed for the following reason.

  In the catheter 10, as described above, in the tubular body 300, the portion on the distal end side (the portion including the low rigidity region R <b> 2) of the rod-shaped body 80 is bent with a small radius of curvature. Along with the bending deformation, the resin as the material of the sheath 16 in the arrangement region R1 of the rod-shaped body 80 can move with a certain degree of freedom in the longitudinal direction of the tubular body 300. This is because the rod-like member 80, which is a rod-like member rather than an annular member, is embedded in the sheath 16, so that the restraining action of the sheath 16 by the rod-like member 80 is limited to a specific location in the circumferential direction of the sheath 16. This is because that. That is, the material of the portion of the sheath 16 that is separated from the rod-like body 80 in the circumferential direction can move with a certain degree of freedom in the longitudinal direction of the tubular body 300 when subjected to stress. Therefore, when the tubular body 300 is bent, the material of the sheath 16 in the arrangement region R1 of the rod-shaped body 80 serves as a buffer to relieve stress, so that stress is prevented from concentrating on a specific portion in the longitudinal direction of the tubular body 300. Is done. Thereby, it is suppressed that the tubular body 300 is locally bent and deformed in the longitudinal direction. That is, the occurrence of kinks in the tubular body 300 is suppressed.

  Here, as the arrangement region R1 of the rod-shaped body 80 is longer, the amount of the resin material serving as a buffer for relaxing the stress increases, and the stress relaxation action in the arrangement region R1 increases. It is preferable to have an appropriate length. For example, as described above, the length of the rod-shaped body 80 is preferably equal to or greater than the outer diameter (diameter) of the tubular body 300. The length of the rod-shaped body 80 is preferably, for example, two times or more, or three times or more the outer diameter of the tubular body 300. By doing so, the distal end of the rod-shaped body 80 damages the sheath 16 when bent. The possibility can be reduced.

  However, as described above, during the bending operation of the tubular body 300, the arrangement region R1 is slightly bent, and the amount of bending is bent in the high-rigidity region R5 located on the proximal end side of the arrangement region R1. Greater than the amount. That is, the change in bending rigidity is not excessively steep at the boundary between the high-rigidity region R5, that is, the region where the coil 50 is disposed, and the portion on the distal end side. This also suppresses the occurrence of kinks in the tubular body 300.

FIG. 18 is a schematic diagram showing the operation of the catheter 1000 as a medical device according to a comparative example. This catheter 1000 is different from the catheter 10 of this embodiment only in that it does not have the rod-shaped body 80.
In the case of this catheter 1000, the region corresponding to the arrangement region R1 is also bent during the bending operation. For this reason, as shown in FIG. 18, the tubular body is gently bent over a wide range in the longitudinal direction. That is, it is difficult to reduce the curvature radius of the distal end portion of the tubular body. As a result, it is difficult to allow the distal end of the catheter 1000 to enter the blood vessel 19 that branches at an acute angle.

In addition, the catheter 1000 according to the comparative example is likely to cause a tubular kink for the following reason.
FIG. 19 is a schematic diagram showing a mechanism of operation of the catheter 1000 according to the comparative example.
The kink of the tubular body starts when the side peripheral surface on the inner diameter side (in course) of bending is buckled inward. The region with high bending rigidity does not buckle. That is, for example, the arrangement region of the coil 50 is not buckled. Even in the region where the coil 50 is not disposed, the resin material of the sheath 16 is restrained by the coil 50 in the vicinity of the region where the coil 50 is disposed, so that it is difficult to buckle.
In the case of the comparative example, unlike this embodiment, there is a significant discontinuity in bending rigidity at the boundary position between the region where the coil 50 is disposed and the region on the tip side. For this reason, as shown in FIG. 19, in the tubular body, the kink 1001 is likely to occur at a location slightly away from the arrangement area of the coil 50.

According to the first embodiment as described above, the tube wall portion of the sheath 16 of the tubular body 300 is made of an elastic body having higher rigidity than the sheath 16 and extends in the longitudinal direction of the tubular body 300. 80 is buried. The distal end of the operation line 40 is fixed to the tubular body 300 on the distal end side of the distal end of the rod-shaped body 80. The tubular body 300 has a low-rigidity region R2 having a bending rigidity smaller than the arrangement region R1 of the rod-shaped body 80 in the tubular body 300 between the distal end of the rod-shaped body 80 and the distal end of the operation line 40. .
Therefore, when the tubular body 300 is bent by pulling the operation line 40, the distal end portion (the portion including the low-rigidity region R2) of the tubular body 300 with respect to the rod-shaped body 80 can be mainly bent. That is, the portion of the tubular body 300 that bends according to the bending operation can be substantially limited to a portion on the distal end side of the rod-shaped body 80. Thereby, the curvature radius of the bending part of the tubular body 300 can be made small compared with the case where the tubular body 300 bends gently over the wide range in the longitudinal direction.

  In short, according to the present embodiment, the tip of the tubular body 300 can be bent with a small radius of curvature, and the occurrence of kinks in the tubular body 300 can be suppressed.

  Since the distal end portion of the tubular body 300 can be bent with a small radius of curvature, a sufficient bending angle of the tubular body 300 can be secured even in a narrow body cavity (specifically, a narrow blood vessel), and the tubular body 300 can be formed in a desired shape. It is possible to easily enter a body cavity (desired blood vessel) in a desired approach direction. That is, according to this catheter 10, high direction selectivity (blood vessel selectivity) is obtained. Therefore, for example, the tip of the catheter 10 can be easily advanced even to a blood vessel that branches at an acute angle.

In addition, in the technique of patent document 1, since the plate-shaped rod is provided in the tubular member, the bending direction of the tubular body is limited to only two directions. For this reason, the technique of patent document 1 cannot be applied to the medical device of the type which bends a tubular body to three or more directions by operation, for example.
On the other hand, since the catheter 10 according to the present embodiment does not have components that limit the bending direction of the low-rigidity region R2, the distal end portion 15 of the tubular body 300 is bent in an arbitrary direction. Can be made. Therefore, even if the catheter 10 is a type that bends the tubular body 300 in three or more directions by operation, there is no problem.

  Moreover, in the technique of patent document 2, in order to improve the flexibility of a tubular body, the notch is formed in the tubular body. For this reason, it is difficult to apply the technique of Patent Document 2 to a chemical solution supply type catheter as described in the present embodiment. This is because the presence of the notch may cause insufficient strength (insufficient pressure resistance) of the tubular body.

<Modification of First Embodiment>
FIGS. 12A and 12B are schematic views showing a modified example of the arrangement of the rod-like bodies 80 in the transverse cross section of the catheter 10 according to the first embodiment.
For example, as shown in FIG. 12A, the operation line 40 and the rod-shaped body 80 may be separated from each other in the circumferential direction of the tubular body 300. In the example of FIG. 12A, a rod-like body 80 is disposed at an intermediate position between the two operation lines 40 in the circumferential direction of the tubular body 300.
In addition, as shown in FIG. 12B, when there is one operation line 40 (one hollow tube 32, one sub-lumen 30 and one operation line 40), the operation line 40 is positioned close to the operation line 40. Only the rod-shaped body 80 may be disposed. In this case, in the circumferential direction of the tubular body 300, the thickness of the tube wall portion of the sheath 16 is increased in the portion where the rod-shaped body 80, the hollow tube 32, and the operation line 40 are arranged, and the other portions The wall thickness can be reduced.

[Second Embodiment]
FIG. 13 is a schematic side view showing the distal end portion of the catheter 10 as a medical device according to the second embodiment. FIG. 13 is a perspective view showing the fixing member 66, the rod-shaped body 80, the second rod-shaped body 90, and the operation line 40 that are the internal configuration of the catheter 10. FIG. 14 is a schematic view showing a distal end portion of the catheter 10 according to the second embodiment at the time of bending.

  The catheter 10 according to the second embodiment is different from the first embodiment only in the points described below, and is configured similarly to the first embodiment in other points.

  In the case of this embodiment, the catheter 10 has a second rod-like body 90 similar to the rod-like body 80. That is, the second rod-like body 90 is made of an elastic body having a higher rigidity than the sheath 16, is embedded in the tube wall portion of the distal end portion 15 of the sheath 16, and extends in the longitudinal direction of the tubular body 300. . The second rod-like body 90 is also thinner than the inner diameter of the sheath 16 and the wall thickness of the tube wall portion of the sheath 16.

  The second rod-like body 90 is disposed between the tip of the rod-like body 80 and the tip of the operation line 40. That is, rod-shaped bodies (bar-shaped body 80 and second rod-shaped body 90) are arranged in two or more regions that are separated in the longitudinal direction of the tubular body 300, respectively.

  In the present embodiment, the low-rigidity region R <b> 2 is disposed between the second rod-shaped body 90 and the rod-shaped body 80 in the longitudinal direction of the tubular body 300.

  Furthermore, in the present embodiment, the tubular body 300 has a second low-rigidity region R4 between the tip of the second rod-like body 90 and the tip of the operation line 40. The second low-rigidity region R4 has a lower bending rigidity than the arrangement region R3 of the second rod-like body 90 in the tubular body 300.

  Thus, in the case of this embodiment, the tubular body 300 has two low-rigidity regions (a low-rigidity region R2 and a second low-rigidity region R4) that are separated in the longitudinal direction. For this reason, at the time of bending operation of the tubular body 300, the tubular body 300 is bent with a small radius of curvature at two locations in the longitudinal direction. That is, the tubular body 300 is bent in two stages (see FIG. 14).

  Here, the distal-side second low-rigidity region R4 may be bent first, and then the proximal-side low-rigidity region R2 may be bent. The second low-rigidity region R4 and the low-rigidity region R2 may be bent. It may be bent simultaneously (in parallel). Alternatively, the proximal low-rigidity region R2 may be bent first, and then the distal second low-rigidity region R4 may be bent. Any one of these bending modes can be realized by appropriately setting the magnitude relationship of the bending stiffness between the low stiffness region R2 and the second low stiffness region R4. That is, of the low rigidity region R2 and the second low rigidity region R4, the one having the smaller bending rigidity can be bent first. For example, one of the low-rigidity region R2 and the second low-rigidity region R4 is formed by embedding a flexible coil (not shown) with a pitch winding in the sheath 16 coaxially with the sheath 16 so that the coil is embedded. Flexural rigidity can be increased.

  The length of the second rod-shaped body 90 is preferably equal to or greater than the outer diameter of the tubular body 300. This is due to the same reason that the length of the rod-shaped body 80 is preferably equal to or larger than the outer diameter of the tubular body 300.

  The length of the second low-rigidity region R4 in the longitudinal direction of the tubular body 300 is preferably equal to or greater than the outer diameter of the tubular body 300. This is for the same reason that the length of the low-rigidity region R2 in the longitudinal direction of the tubular body 300 is preferably equal to or larger than the outer diameter of the tubular body 300.

  In the cross section of the tubular body 300, the arrangement of the second rod-shaped body 90 with respect to the operation line 40 is the same as the arrangement of the rod-shaped body 80 with respect to the operation line 40. Therefore, the 2nd rod-shaped body 90 and the rod-shaped body 80 are arrange | positioned in series.

  In the circumferential direction of the tubular body 300, it is preferable that the operation line 40 and the second rod-shaped body 90 are arranged close to each other. This is due to the same reason that the operation line 40 and the rod-shaped body 80 are preferably arranged close to each other in the circumferential direction of the tubular body 300. Moreover, the 2nd rod-shaped body 90 can be arrange | positioned in the vicinity of the both sides of each operation line 40, respectively.

  In the tubular body 300, a portion from the distal end DE to the tip of the rod-shaped body 80 is referred to as the most distal end portion 28. For example, the length of the most distal end portion 28 is preferably about 20 mm, for example. In the tubular body 300, a portion from the distal end DE to the tip of the second rod-shaped body 90 is referred to as a second most distal end portion 29. For example, the length of the second most distal end portion 29 is preferably about 5 mm, for example.

According to the second embodiment as described above, the same effect as in the first embodiment can be obtained.
In addition, since the tubular body 300 is bent in two stages, the direction selectivity (blood vessel selectivity) is further improved as compared with the first embodiment.

<Modification of the first embodiment and the second embodiment>
FIG. 15 is a schematic side view showing a modification of the catheter 10 according to the first and second embodiments. FIG. 15 is a perspective view showing an internal configuration of the catheter 10 (any of the fixing member 66, the rod-like body 80, the second rod-like body 90, the operation line 40, and the connecting members 110 and 120).

  The catheter 10 according to this modification is different from the first embodiment or the second embodiment only in the points described below, and is otherwise the same as the first embodiment or the second embodiment. It is configured.

  In the case of this modification, the fixing member 66 and the rod-shaped body (the rod-shaped body 80 or the second rod-shaped body 90) are coupled to each other via a coupling member (any one of the coupling members 110 and 120). The connecting members 110 and 120 have a bending rigidity smaller than that of the fixing member 66 and the rod-shaped body (the rod-shaped body 80 or the second rod-shaped body 90).

  The connecting members 110 and 120 are, for example, coils configured by winding a wire rod in a spiral shape. The wire can be made of the same material as the wire 52, for example. However, in order to make the bending rigidity of the connecting members 110 and 120 smaller than the bending rigidity of the fixing member 66 and the rod-shaped body, the wire constituting the connecting members 110 and 120 has a diameter smaller than that of the wire 52. That is, the connecting members 110 and 120 are, for example, flexible coils.

  The connecting members 110 and 120 are embedded in the sheath 16 so as to be coaxial with the sheath 16. The connecting members 110 and 120 are located closer to the outer periphery of the sheath 16 than the operation line 40 and do not interfere with the operation line 40. That is, specifically, the connecting members 110 and 120 are positioned closer to the outer periphery of the sheath 16 than the hollow tube 32, for example.

  Of the four embodiments of the catheter 10 shown in FIG. 15, first, the catheter 10 shown in FIG.

  A catheter 10 shown in FIG. 15A includes a connecting member 110 in addition to the configuration of the first embodiment. The fixing member 66 and the rod-shaped body 80 are connected to each other via the connecting member 110. That is, the connecting member 110 is arranged in the low rigidity region R2.

Here, the connection member 110 has a coil corresponding to each of the rod-shaped bodies 80, for example. As described above, in the case where the number of the rod-shaped bodies 80 is four, the connecting member 110 has four coils. The connecting member 110, which is an assembly of these coils, is like a multi-strand coil. The base end of each coil of the connecting member 110 is joined to the tip of the corresponding rod-shaped body 80, and the tip of each coil of the connecting member 110 is joined to the fixing member 66. The joining of each coil and the rod-shaped body 80 and the joining of each coil and the fixing member 66 can be performed by laser welding or adhesion using an adhesive or metal wax.
The connecting member 110 may include a coil (for example, only one coil) that connects any one or more rod-shaped bodies 80 to the fixing member 66.

  According to the catheter 10 shown in FIG. 15A, the connecting member 110 having a bending rigidity smaller than that of the fixing member 66 and the rod-shaped body 80 is disposed in the low-rigidity region R2. It can be moderately (lightly) reinforced. As a result, the occurrence of kinks in the low-rigidity region R2 can be suppressed without inhibiting the flexibility of the low-rigidity region R2. In addition, since the fixing member 66 and the rod-shaped body 80 are coupled by the coupling member 110, it is possible to improve torque transmission from the region R1 where the rod-shaped body 80 is disposed to the region where the fixing member 66 is disposed.

  Next, the catheter 10 shown in FIG. 15B includes a connecting member 110 and a connecting member 120 in addition to the configuration of the second embodiment. The connecting member 110 has a bending rigidity smaller than that of the second rod-shaped body 90 and the rod-shaped body 80. The connecting member 120 has a bending rigidity smaller than that of the fixing member 66 and the second rod-like body 90.

The second rod-shaped body 90 and the rod-shaped body 80 are connected to each other via the connecting member 110. That is, the connecting member 110 is arranged in the low rigidity region R2.
The proximal end of each coil of the connecting member 110 is joined to the distal end of the corresponding rod-shaped body 80, and the distal end of each coil of the connecting member 110 is joined to the proximal end of the corresponding second rod-shaped body 90. Yes. Here, the combination of the rod-shaped body 80 and the second rod-shaped body 90 that are connected via the coil may be arranged in series with each other or not in series arrangement. Also good.
The joining of each coil and the second rod-like body 90 can also be performed by laser welding or adhesion using an adhesive or metal wax.

Further, the fixing member 66 and the second rod-shaped body 90 are connected to each other via the connecting member 120. That is, the connecting member 120 is disposed in the second low rigidity region R4. The connecting member 120 has the same structure as the connecting member 110. The base end of each coil of the connecting member 120 is joined to the tip of the corresponding second rod-shaped body 90, and the tip of each coil of the connecting member 120 is joined to the fixing member 66. The joining of each coil and the second rod-shaped body 90 and the joining of each coil and the fixing member 66 can be performed by laser welding or adhesion using an adhesive or metal wax.
The connecting member 120 may include a coil (for example, only one coil) that connects any one or more second rod-shaped bodies 90 to the fixing member 66.

According to the catheter 10 shown in FIG. 15B, the connecting member 110 having a lower bending rigidity than the second rod-like body 90 and the rod-like body 80 is disposed in the low-rigidity region R2, and therefore the connecting member 110 causes the low-rigidity region to be low. R2 can be moderately (lightly) reinforced. As a result, the occurrence of kinks in the low-rigidity region R2 can be suppressed without inhibiting the flexibility of the low-rigidity region R2. Moreover, since the second rod-like body 90 and the rod-like body 80 are connected by the connecting member 110, torque transmission from the arrangement region R1 of the rod-like body 80 to the arrangement region R3 of the second rod-like body 90 is improved. It can also be increased.
Similarly, since the connecting member 120 having a bending rigidity smaller than that of the fixing member 66 and the second rod-shaped body 90 is disposed in the low rigidity region R4, the low rigidity region R4 is moderately (lightly) reinforced by the connecting member 120. be able to. As a result, the occurrence of kinks in the low rigidity region R4 can be suppressed without hindering the flexibility of the low rigidity region R4. Moreover, since the fixing member 66 and the second rod-like body 90 are connected by the connecting member 120, the torque transmission performance from the arrangement region R3 of the second rod-like body 90 to the arrangement region of the fixing member 66 is improved. You can also.

Next, the catheter 10 shown in FIG. 15C has a configuration in which the connecting member 120 is removed from the catheter 10 shown in FIG. Also in this case, the same effect as that obtained by the presence of the connecting member 110 can be obtained in the catheter 10 shown in FIG.
In the catheter 10 of FIG. 15C, the bending rigidity of the second low-rigidity region R4 can be made smaller than the bending rigidity of the low-rigidity region R2, so that the second low-rigidity region R2 precedes the low-rigidity region R2 during the bending operation. A configuration in which the region R4 is bent can be easily realized.

Next, the catheter 10 shown in FIG. 15 (d) has a configuration in which the connecting member 110 is removed from the catheter 10 shown in FIG. 15 (b). Also in this case, the same effect as that obtained by the presence of the connecting member 120 in the catheter 10 shown in FIG.
In the catheter 10 of FIG. 15D, the bending rigidity of the low-rigidity region R2 can be made smaller than the bending rigidity of the low-rigidity region R4, so that the low-rigidity region R precedes the second low-rigidity region R4 during the bending operation. Can be easily realized.

[Third Embodiment]
FIG. 16 is a schematic side view showing the distal end portion of the catheter 10 as a medical device according to the third embodiment. FIG. 16 is a perspective view showing the fixing member 66, the rod-shaped body 80, the second rod-shaped body 90, and the operation line 40 that are the internal configuration of the catheter 10.

  The catheter 10 according to the third 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 catheter 10 has the 2nd rod-shaped body 90 similarly to 2nd Embodiment. Further, as in the second embodiment, the second rod-shaped body 90 is disposed closer to the distal end side than the distal end of the rod-shaped body 80. Further, similarly to the second embodiment, the low-rigidity region R <b> 2 is disposed between the second rod-shaped body 90 and the rod-shaped body 80 in the longitudinal direction of the tubular body 300.

  However, the second rod-like body 90 is connected to the fixing member 66, and the second rod-like body 90 protrudes from the fixing member 66 to the proximal end side. The second rod-like body 90 is joined to the fixing member 66 by, for example, welding (laser welding or the like) or adhesion (adhesion with an adhesive or solder). For example, as the fixing member 66, a member in which an insertion hole opening on the base end side is formed is used. The second rod-shaped body 90 can be connected to the fixing member 66 by inserting the tip of the second rod-shaped body 90 into the insertion hole and fixing it with an adhesive.

  Since the second rod-shaped body 90 is connected to the fixing member 66, unlike the second embodiment, only one low-rigidity region R2 exists between the tip of the operation line 40 and the tip of the rod-shaped body 80. To do. The operation of the catheter 10 in the case of the third embodiment is closer to that of the first embodiment than in the second embodiment.

  Since the second rod-like body 90 is connected to the fixing member 66, the arrangement region of the fixing member 66 and the arrangement region R3 of the second rod-like body 90 are bent integrally.

Since the second rod-shaped body 90 protrudes to the proximal end side from the fixing member 66, the low-rigidity region R2 is disposed in the arrangement region R3 of the second rod-shaped body 90 on the distal end side and the rod-shaped body 80 on the proximal end side. It is sandwiched between the region R1.
The occurrence of kinks in the low-rigidity region R2 is suppressed by the presence of the arrangement region R3 by the same mechanism that suppresses the generation of kinks in the low-rigidity region R2 due to the presence of the arrangement region R1. Therefore, the occurrence of kinks in the low-rigidity region R2 can be suppressed more suitably than in the first embodiment.

  In addition, before using the catheter 10, the arrangement | positioning area | region R3 of the 2nd rod-shaped body 90 can also be used as a shaping part by making it bend so that the 2nd rod-shaped body 90 may plastically deform.

<Modification of Third Embodiment>
FIG. 17 is a schematic side view showing a catheter 10 according to a modification of the third embodiment. FIG. 17 is a perspective view showing the fixing member 66, the rod-shaped body 80, the second rod-shaped body 90, the operation line 40, and the connecting member 130 that are the internal configuration of the catheter 10.

  In this modification, the second rod-shaped body 90 and the rod-shaped body 80 are connected to each other via the second rod-shaped body 90 and a connecting member 130 having a bending rigidity smaller than that of the rod-shaped body 80. The connecting member 130 is the same as the connecting member 110. The aspect which connects the 2nd rod-shaped body 90 and the rod-shaped body 80 by the connection member 130 is the same as the aspect which connects the 2nd rod-shaped body 90 and the rod-shaped body 80 by the connection member 110 in the example shown in FIG.15 (b). is there.

  According to this modification, an effect obtained by combining the effect of the third embodiment and the effect obtained by the presence of the connecting member 110 in the configuration of FIG.

  In the above description, the example in which the tip of the operation line 40 is fixed to the distal end portion 15 of the tubular body 300 by fixing the tip of the operation line 40 to the fixing member 66 has been described. There is no particular limitation on the manner in which the is fixed to the distal end portion 15. The tip of the operation line 40 may be welded to the distal end portion 15 of the sheath 16 or may be bonded and fixed to the distal end portion 15 of the sheath 16 with an adhesive.

Further, in the above description, an example in which two rod-like bodies 80 are arranged close to each operation line 40 has been described, but one or three or more rod-like bodies 80 are placed close to each operation line 40. May be arranged.
Similarly, the second rod-like bodies 90 are not limited to the example in which two second rod-like bodies 90 are arranged close to each operation line 40, but one or three or more second rod-like bodies 90 are placed near each operation line 40. May be arranged.

Each component in each of the above embodiments does not necessarily have to be an independent entity. 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.
For example, the rod-shaped body (any of the rod-shaped body 80 and the second rod-shaped body 90) and the connecting member (one of the connecting members 110, 120, 130) are formed as one member, or a part of them is formed. It may be duplicated. Similarly, the 2nd rod-shaped body 90 and the fixing member 66 may be formed as one member, or those one part may overlap. Similarly, the connecting members 110 and 120 and the fixing member 66 may be formed as one member, or a part of them may overlap each other.

  In the second embodiment, the example in which the tubular body 300 is configured to be bent in two stages has been described. However, the tubular body 300 may be configured to be bent in three or more stages. That is, a rod-shaped body is disposed in each of three or more regions that are spaced apart in the longitudinal direction of the tubular body 300, and the rod-shaped body and the fixing member that are positioned at the forefront are disposed between the regions where the rod-shaped bodies are disposed. It is good also considering the area | region between these as a low rigidity area | region, respectively.

10 Catheter 15 Distal End 16 Sheath (Tubular Body)
17 proximal end 18 most distal end 19 blood vessel 20 main lumen 21 inner layer 28 most distal end 29 second most distal end 30 sub-lumen 32 hollow tube 40 operation line 50 coil 50a first coil 50b first 2 coil 52 wire 60 outer layer 61 outer layer main body 62 coating resin 64 coat layer 66 fixing member 70 operation part 80 rod-like body 90 second rod-like body 110 connection member 120 connection member 130 connection member 300 tubular body 700 main body case 760 wheel operation part 790 hub 1000 Catheter 1001 Kink DE Distal end R1 Rod-shaped body arrangement area R2 Low-rigid area R3 Second rod-shaped body arrangement area R4 Second low-rigidity area R5 High-rigidity area

Claims (22)

A long and flexible tubular body that is inserted into a body cavity;
An operation line embedded in the tubular body, and one or more operation lines for bending the tubular body when the operation line is pulled to the proximal end side of the tubular body;
Have
The tubular body is
A long and flexible tubular body;
A rod-like body made of an elastic body having higher rigidity than the tubular body, embedded in a tube wall portion at a distal end portion of the tubular body, and extending in a longitudinal direction of the tubular body;
Have
The distal end of the operation line is fixed to the tubular body on the distal end side of the distal end of the rod-shaped body,
The tubular body has a high rigidity region having a higher bending rigidity than a region where the rod-shaped body is disposed in the tubular body on a proximal end side than the region where the rod-shaped body is disposed. A medical device having a low-rigidity region having a bending rigidity smaller than an arrangement region between a tip of the rod-like body and a tip of the operation line.   The length of the said rod-shaped body is more than the outer diameter of the said tubular body, The medical device of Claim 1 characterized by the above-mentioned.   The medical device according to claim 1 or 2, wherein a length of the low-rigidity region in a longitudinal direction of the tubular body is equal to or greater than an outer diameter of the tubular body.   The medical device according to any one of claims 1 to 3, wherein the operation line and the rod-like body are arranged close to each other in a circumferential direction of the tubular body.   The medical device according to claim 4, wherein the rod-like bodies are arranged on both sides of each operation line. The tubular body is
Having a tubular reinforcing layer embedded in the tubular body with higher rigidity than the tubular body and coaxially with the tubular body, at least in the highly rigid region;
The distal end of the reinforcing layer is located on the proximal side with respect to the distal end of the rod-shaped body,
The medical device according to any one of claims 1 to 5, wherein a base end of the reinforcing layer is located on a base end side with respect to a base end of the rod-shaped body.   The medical device according to claim 6, wherein a distal end of the reinforcing layer is located on a distal end side with respect to a proximal end of the rod-shaped body.   The medical device according to claim 6, wherein the position of the proximal end of the rod-shaped body in the longitudinal direction of the tubular body is the same as the distal end portion of the reinforcing layer or a distal end side thereof.   The medical device according to any one of claims 6 to 8, wherein the reinforcing layer is a coil configured by winding a wire rod in a spiral shape.   The medical treatment according to any one of claims 1 to 9, wherein the tubular main body is made of the same resin material from at least the region where the rod-shaped body is disposed to the low-rigidity region. machine. It further has a fixing member that is higher in rigidity than the tubular body and is provided at the tip of the tubular body,
The medical device according to any one of claims 1 to 10, wherein a distal end of the operation line is fixed to the fixing member.   The medical device according to claim 11, wherein the fixing member is formed in an annular shape coaxial with the tubular body.   The medical device according to claim 11 or 12, wherein the fixing member is made of a material opaque to specific radiation. A second rod-like body made of an elastic body having higher rigidity than the tubular body, embedded in the tube wall at the distal end of the tubular body, and extending in the longitudinal direction of the tubular body;
The second rod-shaped body is disposed between the tip of the rod-shaped body and the tip of the operation line,
The medical device according to any one of claims 1 to 13, wherein the low-rigidity region is disposed between the second rod-shaped body and the rod-shaped body in a longitudinal direction of the tubular body. machine.   The tubular body has a second low-rigidity region having a lower bending rigidity than an arrangement region of the second rod-shaped body in the tubular body between the distal end of the second rod-shaped body and the distal end of the operation line. The medical device according to claim 14, wherein the medical device is provided. A second rod-like body made of an elastic body having higher rigidity than the tubular body, embedded in the tube wall at the distal end of the tubular body, and extending in the longitudinal direction of the tubular body;
The second rod-shaped body is disposed between the tip of the rod-shaped body and the tip of the operation line,
In the longitudinal direction of the tubular body, the low rigidity region is disposed between the second rod-shaped body and the rod-shaped body,
The medical device according to any one of claims 11 to 13, wherein the second rod-shaped body is connected to the fixing member and protrudes to the proximal end side from the fixing member.   The medical device according to any one of claims 14 to 16, wherein the second rod-shaped body and the rod-shaped body are arranged in series.   The fixing member and the rod-shaped body are connected to each other via a connecting member having a bending rigidity smaller than that of the fixing member and the rod-shaped body. The medical device described.   The said 2nd rod-shaped body and the said rod-shaped body are mutually connected through the connection member whose bending rigidity is smaller than the said 2nd rod-shaped body and the said rod-shaped body. A medical device according to claim 1.   The medical device according to claim 15, wherein the fixing member and the second rod-shaped body are connected to each other via a connecting member having a bending rigidity smaller than that of the fixing member and the second rod-shaped body. machine.   The medical device according to any one of claims 18 to 20, wherein the connecting member is a coil configured by winding a wire in a spiral shape. The lumen of the tubular body is open at the distal end of the tubular body;
The medical device according to any one of claims 1 to 21, wherein a liquid can be supplied from a proximal end to a distal end of the tubular body through the lumen.

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