JP2014138756A - Medical instrument - Google Patents

Abstract

PROBLEM TO BE SOLVED: To make it possible to easily determine the optimal timing for bending operation in a medical instrument which has an operating wire for a traction operation embedded therein.SOLUTION: A medical instrument (for example, a catheter 10) comprises a medical instrument body (sheath 16), an operating wire, a first marker 66, and a second marker 67. The first marker 66 and the second marker 67 are disposed in a distal end section 15 of the medical instrument body. The second marker 67 is disposed in a section on the proximal end side of the medical instrument body in relation to the first marker 66. The tip part of the operating wire is fixed to a section on the distal end side of the medical instrument in relation to the second marker 67.

Description

  The present invention relates to a medical device.

  2. Description of the Related Art A medical device such as a catheter that is long and flexible and is used by being inserted into a body cavity is known.

  In general, a distal end portion of such a medical device is provided with a marker made of a material that does not transmit radiation such as X-rays. By performing radiography during the operation, the arrangement of the medical device in the body cavity can be confirmed with reference to the position of the marker.

Some types of catheters are configured such that a distal end portion can be bent by pulling an operation line embedded therein (Patent Document 1, etc.).
In a type of catheter in which an operation line for traction operation is embedded, a marker is usually provided only at the most distal end of the catheter, as shown in FIG. That is, the marker is provided only at one place in the longitudinal direction of the catheter.

  As a special example of a catheter of a type in which an operation line for towing operation is embedded inside, there is one shown in FIG. The distal end of this catheter is provided with a bent shaping part, markers are provided at the distal end and the proximal end of the shaping part, respectively, and the tip of the operation line is at the proximal end of the shaping part. It is connected. The shaping part is kept in a predetermined bent shape during a series of treatments. In this catheter, the portion bent by pulling the operation line is a portion closer to the proximal end than the tip of the operation line, that is, a portion closer to the proximal end than the shaping portion.

International Publication No. 2010/073646 Pamphlet

  As described above, in a medical device such as a catheter of a type in which an operation line for traction operation is embedded therein, a marker is usually provided only at the most distal end portion of the catheter. This marker is effective as an index for recognizing the position of the most distal end of the catheter during the treatment.

  In order to allow this type of medical device to enter a desired direction at the branch point of the body cavity, the distal end of the catheter is bent after the marker has passed the branch point of the body cavity by a certain distance. Need to enter in the desired direction. It may be difficult for a skilled practitioner to know how much distance the marker should pass through the branch point of the body cavity at which stage the bending operation should be performed.

  In view of the above problems, an object of the present invention is to make it possible to more easily determine the timing at which a bending operation should be performed in a medical device in which an operation line for traction operation is embedded.

  The present invention is a long and flexible medical device main body that is inserted into a body cavity, and an operation line that is embedded in the medical device main body and extends along the longitudinal direction of the medical device main body. An operation line that bends the medical device body by a pulling operation with respect to the operation line, the medical device having a radiopaque material provided at a distal end portion of the medical device body. A first marker and a second marker made of a radiopaque material provided at a portion closer to the proximal end than the first marker at the distal end of the medical device body, The tip of the wire provides a medical device that is fixed to a portion on the distal end side of the second marker in the medical device.

According to this medical device, the first marker and the second marker located on the proximal end side of the first marker are provided at the distal end portion of the medical device body. Therefore, the optimal timing for performing the bending operation of the medical device body can be easily determined by using the positions of the two markers, the first marker and the second marker, as indices.
In addition, the front-end | tip part of the operation line is being fixed to the part more distal than the 2nd marker in a medical device. For this reason, the part at the distal end side of the second marker in the medical device body is bent by the bending operation. Therefore, the medical device can be easily entered into a desired branch of the body cavity by performing a bending operation at a timing when the distal end side of the second marker in the medical device reaches the bent portion of the body cavity.

  According to the present invention, it is possible to easily determine the optimal timing for performing the bending operation of the medical device body.

It is a typical top view which shows the distal end part of the catheter as a medical device which concerns on embodiment, and the part of the vicinity. It is a typical longitudinal cross-sectional view of the catheter along the AA line of FIG. It is a typical cross-sectional view of the catheter along the BB line of FIG. It is a typical cross-sectional view of the catheter along the CC line of FIG. It is a typical cross-sectional view of the catheter along the DD line of FIG. It is a typical cross-sectional view of the catheter along the EE line of FIG. (A) to (c) is a schematic plan view of a catheter according to an embodiment. It is a mimetic diagram for explaining an example of operation of a catheter concerning an embodiment.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. However, the present invention is not limited to the following embodiments. In all the drawings, the same components are denoted by the same reference numerals, and description thereof will be omitted as appropriate.

[First Embodiment]
FIG. 1 is a schematic plan view showing a distal end portion of a catheter 10 as a medical device according to the embodiment and a portion in the vicinity thereof. FIG. 2 is a schematic longitudinal sectional view of the catheter 10 taken along line AA of FIG. FIG. 3 is a schematic cross-sectional view of the catheter 10 taken along line BB in FIG. FIG. 4 is a schematic cross-sectional view of the catheter 10 taken along line CC in FIG. FIG. 5 is a schematic cross-sectional view of the catheter 10 taken along the line DD of FIG. FIG. 6 is a schematic cross-sectional view of the catheter 10 taken along line EE in FIG. FIGS. 7A to 7C are schematic plan views of the catheter 10.

The catheter 10 according to the present embodiment includes a medical device body (sheath 16), an operation line 40, a first marker 66, and a second marker 67. The first marker 66 and the second marker 67 are provided at the distal end portion 15 of the medical device body. The second marker 67 is provided at a portion closer to the proximal end of the medical device body than the first marker 66. The distal end portion 41 (FIG. 2) of the operation line 40 is fixed to a portion on the distal end DE (FIGS. 1 and 2) side of the catheter 10 with respect to the second marker 67.
Details will be described below.

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

  In this specification, the predetermined length region including the distal end (tip) DE of the catheter 10 (and the sheath 16) is referred to as the distal end (tip portion) 15 of the catheter 10 (and the sheath 16). That's it. Similarly, the predetermined length region including the proximal end (proximal end) (not shown) of the catheter 10 (and the sheath 16) is referred to as the proximal end portion (proximal end portion) of the catheter 10 (and the sheath 16). 17 (see FIGS. 7A to 7C).

  The catheter 10 is a suitable example of an intravascular catheter that is used by inserting the sheath 16 into the blood vessel. More specifically, it is a preferable example that the sheath 16 is formed to have a size that allows the sheath 16 to enter any of the eight sub-regions of the liver.

  As shown in FIGS. 2 and 4 to 6, a main lumen 20 and a sub-lumen 30 are formed inside the sheath 16. The main lumen 20 and the sub-lumen 30 each extend along the longitudinal direction (the left-right direction in FIG. 2) of the sheath 16 (the catheter 10).

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. In other words, the main lumen 20 having a larger diameter than the sub-lumen 30 is formed in the sheath 16 along the longitudinal direction of the sheath 16.
The sublumen 30 extends from the proximal end of the sheath 16 to the vicinity of the first marker 66.

  As shown in FIGS. 4 to 6, in the cross section of the sheath 16, the sub-lumens 30, and the main lumen 20 and the sub-lumens 30 are arranged separately from each other.

  The main lumen 20 is disposed, for example, at the center of the transverse cross section (cross section perpendicular to the longitudinal direction) of the sheath 16.

  For example, the plurality of sub-lumens 30 are distributed around the main lumen 20. In the case of this embodiment, for example, 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 line 40 is inserted into the sub-lumen 30 and extends along the longitudinal direction of the sub-lumen 30. That is, the operation line 40 is embedded in the sheath 16 and extends along the longitudinal direction of the sheath 16. In the case of this embodiment, the catheter 10 has two operation lines 40, for example.

  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 can slide 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 preferable example of the number of thin wires is seven or three.
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.

As the material of the operation wire 40 (or the fine wire constituting the operation wire 40), in addition to a flexible metal wire such as low carbon steel (piano wire), stainless steel (SUS), titanium or titanium alloy, tungsten, etc. (Paraphenylene benzobisoxazole) (PBO), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), polyimide (PI) or polytetrafluoroethylene (PTFE), high boron fiber, etc. Molecular fibers can be used.
An outer diameter dimension of the operation wire 40 (for example, a diameter of a circumscribed circle with respect to the stranded wire) can be set to 25 to 55 μm, for example.

  The sheath 16 can be bent in a direction intersecting the axial center direction of the sheath 16 by a pulling operation with respect to the operation line 40.

Here, FIG. 1 shows a state where the distal end portion 15 of the sheath 16 is bent by a pulling operation with respect to the operation line 40.
As shown in FIG. 1, in the distal end portion 15 of the sheath 16, the portion having the maximum curvature when the traction operation is performed (hereinafter referred to as the maximum bending portion 15 a) is, for example, the first marker 66 and the second marker 16. It is located between the marker 67 and closer to the second marker 67 than the first marker 66. The curvature here is the curvature of bending in the crossing direction with respect to the axial direction of the sheath 16. However, the maximum bent portion 15 a may be located closer to the first marker 66 than the second marker 67.

  In addition, as a structure of the sublumen 30, the following two types of structures can be illustrated, for example.

In the first structure, as shown in FIGS. 2, 4 to 6, a preformed resin hollow tube 32 is embedded in the outer layer 60 (described later) along the longitudinal direction of the sheath 16, The lumen of the hollow tube 32 is a sub-lumen 30. That is, in this structure, the sub-lumen 30 is constituted by the lumen of the hollow tube 32 embedded in the sheath 16.
The hollow tube 32 can be made of, for example, a thermoplastic resin. Examples of the thermoplastic resin include low friction resins such as polytetrafluoroethylene (PTFE) and polyetheretherketone (PEEK).

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

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

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

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

Examples of the material of the inner layer 21 include a fluorine-based 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 fluororesin, the delivery property when supplying a contrast medium, a drug solution, a device (described later) and the like through the main lumen 20 to the affected area 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), polyamide elastomer (PAE), nylon elastomer, polyurethane (PU), ethylene- Mention may be made of vinyl acetate resin (EVA), polyvinyl chloride (PVC) or polypropylene (PP).

  The sheath 16 is made of, for example, a resin material. More specifically, the sheath 16 has a hollow resin layer including the outer layer 60 and the inner layer 21 each made of a resin material. A first reinforcing layer 50 and a second reinforcing layer 51 described later are embedded in the resin layer.

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

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

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

  As shown in FIG. 2, the catheter 10 further includes, for example, a first reinforcing layer 50 and a second reinforcing layer 51 each formed in a tubular shape. The first reinforcing layer 50 and the second reinforcing layer 51 are configured so that their axial directions extend along the axial direction of the sheath 16 (for example, parallel to the axial direction of the sheath 16). And the sheath 16 is reinforced.

  The first reinforcement layer 50 is disposed inside the second reinforcement layer 51. That is, at least a double reinforcing layer (first reinforcing layer 50 and second reinforcing layer 51) is embedded in the sheath 16, and the second reinforcing layer 51 surrounds the first reinforcing layer 50. The second reinforcing layer 51 is disposed away from the first reinforcing layer 50 in the entire circumferential direction and longitudinal direction.

  For example, the first reinforcing layer 50 and the second reinforcing layer 51 are arranged coaxially with the sheath 16. The 1st reinforcement layer 50 and the 2nd reinforcement layer 51 are arrange | positioned around the inner layer 21, for example. The first reinforcing layer 50 and the second reinforcing layer 51 are embedded in the outer layer 60, for example.

  A part of the resin constituting the sheath 16 (for example, the outer layer 60 of the sheath 16) is filled between the first reinforcing layer 50 and the second reinforcing layer 51 (the first reinforcing layer 50 and the second reinforcing layer 51). Between them.) The hollow tube 32 is disposed between the first reinforcing layer 50 and the second reinforcing layer 51 inside the portion of the resin constituting the sheath 16 (for example, the outer layer 60 of the sheath 16).

  Of the resin constituting the sheath 16 (for example, the outer layer 60 of the sheath 16), the first reinforcing layer 50 and the second reinforcing layer 51 are impregnated with the other part continuous with the above-described part containing the hollow tube 32. ing. That is, as will be described later, the radial gap between the first reinforcing layer 50 and the second reinforcing layer 51, which are coil or mesh blade layers, is filled with the other part of the resin constituting the sheath 16. Therefore, high integrity between the sheath 16 and the first reinforcing layer 50 and the second reinforcing layer 51 can be obtained, and the reinforcement of the sheath 16 by the first reinforcing layer 50 and the second reinforcing layer 51 can be performed more reliably.

  Still another part of the resin constituting the sheath 16 (for example, the outer layer 60 of the sheath 16) covers the periphery of the second reinforcing layer 51.

At least one of the first reinforcing layer 50 and the second reinforcing layer 51 is arranged from the region closer to the proximal end than the region where the second marker 67 is disposed in the catheter 10 to the region where the second marker 67 is disposed in the catheter 10. It is arrange | positioned over the area | region of a more distal end side.
In the case of this embodiment, each of the first reinforcing layer 50 and the second reinforcing layer 51 is formed from the region closer to the proximal end than the region where the second marker 67 is disposed in the catheter 10. It arrange | positions over the area | region of a distal end side rather than an arrangement | positioning area | region.

The 2nd reinforcement layer 51 has the proximal end side part 51a and the distal end side part 51b adjacent to the distal end side of the proximal end side part 51a.
The distal end side portion 51b is disposed, for example, in a portion on the distal end side of the catheter 10 with respect to the second marker 67.
The proximal end side portion 51 a is disposed, for example, in a region where the second marker 67 is disposed and a portion closer to the proximal end than the second marker 67.

  The bending rigidity of the distal end side part 51b in the direction intersecting with the axial direction of the sheath 16 is smaller than the bending rigidity of the proximal end side part 51a in the same direction. That is, a portion (distal end side portion 51b) on the distal end side with respect to the second marker 67 in the second reinforcing layer 51 is a portion on the proximal end side with respect to the second marker 67 in the second reinforcing layer 51 (for example, Compared with a portion of the proximal end side portion 51a), the bending rigidity in the direction intersecting the axial direction of the sheath 16 is small.

  As described above, at least one of the first reinforcing layer 50 and the second reinforcing layer 51 (for example, the second reinforcing layer 51) is located closer to the proximal end side than the arrangement region of the second marker 67 in the catheter 10. The bending rigidity decreases from the region toward the region closer to the distal end than the arrangement region. Thereby, the bending rigidity of the portion of the catheter 10 closer to the distal end than the second marker 67 can be reduced, and sufficient flexibility of the portion can be ensured.

  Specifically, for example, the outer diameter of the wire constituting the distal end side portion 51b is set smaller than the outer diameter of the wire constituting the proximal end side portion 51a. As a result, the second reinforcing layer 51 has a bending rigidity that decreases from a region closer to the distal end than the region where the second marker 67 is disposed in the catheter 10 toward a region closer to the distal end than the region where the second marker 67 is disposed. .

  For example, the outer diameter of the portion of the catheter 10 on the distal end side of the second marker 67 is smaller than the outer diameter of the portion of the catheter 10 on the proximal end side of the second marker 67.

  The distal end of the first reinforcing layer 50 reaches, for example, a region where the first marker 66 is disposed. That is, the distal end of the first reinforcing layer 50 is located closer to the distal end DE side of the sheath 16 than the proximal end of the arrangement region of the first marker 66, and the first end in the longitudinal direction of the catheter 10 The first reinforcing layer 50 also exists in the arrangement area of the marker 66. Specifically, for example, the distal end of the first reinforcing layer 50 is located in the vicinity of the distal end of the first marker 66.

  On the other hand, the distal end of the second reinforcing layer 51 is positioned closer to the proximal end side of the catheter 10 than the arrangement region of the first marker 66, for example. That is, for example, in the longitudinal direction of the catheter 10, the second reinforcing layer 51 does not exist in the arrangement region of the first marker 66. Specifically, for example, the distal end of the second reinforcing layer 51 is located between the first marker 66 and the second marker 67 and closer to the first marker 66 than the second marker 67. .

  Thus, for example, at least one distal end of the first reinforcing layer 50 and the second reinforcing layer 51 reaches the arrangement region of the first marker 66. Thereby, generation | occurrence | production of the kink in the vicinity of the proximal end of the 1st marker 66 can be suppressed.

The distal end of the inner layer 21 is located at the distal end DE of the sheath 16, for example. However, the distal end of the inner layer 21 may be located closer to the proximal end side than the distal end DE of the sheath 16. For example, the distal end of the inner layer 21 may be located closer to the proximal end side of the catheter 10 than the region where the first marker 66 is disposed, and in this way, the catheter 10 is attached to the first marker 66. It becomes possible to bend more flexibly in the vicinity.
In addition, the distal end of the inner layer 21 may be located between the first marker 66 and the second marker 67 and closer to the first marker 66 than the second marker 67, for example.
Alternatively, the distal end of the inner layer 21 may be located between the first marker 66 and the second marker 67 and closer to the second marker 67 than the first marker 66.

  Note that the proximal ends of the first reinforcing layer 50 and the second reinforcing layer 51 are located at the proximal end of the sheath 16, for example. That is, the proximal ends of the first reinforcing layer 50 and the second reinforcing layer 51 are located, for example, inside a hub 790 described later.

Each of the 1st reinforcement layer 50 and the 2nd reinforcement layer 51 is a blade layer or a coil, for example. That is, the first reinforcing layer 50 and the second reinforcing layer 51 may each be a blade layer, the first reinforcing layer 50 and the second reinforcing layer 51 may each be a coil, or the first reinforcing layer 50. One of the second reinforcing layer 51 may be a blade layer and the other may be a coil. The blade layer is formed in a tubular shape by braiding a plurality of wire rods in mesh directions in different directions. The coil is formed in a tubular shape by winding a single wire or a plurality of wire rods spaced apart from each other in the circumferential direction in a spiral manner.
In this embodiment, the 1st reinforcement layer 50 and the 2nd reinforcement layer 51 are comprised by winding helically by the arrangement | positioning coaxial with the sheath 16 arrange | positioned spaced apart in the circumferential direction. Each of the first reinforcing layer 50 and the second reinforcing layer 51 shown in FIGS. 2 to 5 is wound in a spiral manner with a total of 16 wires each having 8 sets spaced apart in the circumferential direction in a coaxial arrangement with the sheath 16. It has been done. In addition, the number of the wire which comprises the 1st reinforcement layer 50 and the 2nd reinforcement layer 51 is not limited to this.
As a preferred example, the first reinforcing layer 50 or the second reinforcing layer is prepared by preparing a plurality of sets of a plurality of wire rods that are spaced apart in the circumferential direction and winding the sets in a spiral manner in different directions. 51 can be a mesh blade layer. Moreover, the 1st reinforcement layer 50 or the 2nd reinforcement layer 51 can be made into a multi-strand coil by winding the several wire rod spaced apart in the circumferential direction helically in the same direction. .

  As a material of the wire constituting the first reinforcing layer 50 and the second reinforcing layer 51, for example, a metal is preferably used. However, the material is not limited to this example, and is more rigid and elastic than the inner layer 21 and the outer layer 60. Other materials (for example, a resin or the like) may be used as long as they have a material. Specifically, for example, tungsten (W), stainless steel (SUS), nickel titanium alloy, steel, titanium, or copper alloy can be used as the metal material of the wire. The cross-sectional shape of the wire is not particularly limited, but for example, a rectangular shape or a circular shape is a preferable example.

  As an example, the first reinforcing layer 50 can be made of tungsten, for example. Moreover, the 2nd reinforcement layer 51 can be comprised by stainless steel, for example. For example, the outer diameter of the wire constituting the first reinforcing layer 50 and the outer diameter of the wire constituting the second reinforcing layer 51 can be the same.

  Here, various properties such as contrast and rigidity during X-ray imaging differ depending on the type of metal material. For this reason, by making the material of the first reinforcing layer 50 and the material of the second reinforcing layer 51 different from each other, various properties such as contrast and rigidity can be finely adjusted.

  As an example, for example, the first reinforcing layer 50 can be a blade layer. Further, for example, the proximal end side portion 51a of the second reinforcing layer 51 can be a blade layer, and the distal end side portion 51b of the second reinforcing layer 51 can be a coil or a blade layer.

  The first reinforcing layer 50 is arranged on the radially inner side of the sheath 16 with respect to the arrangement region of the hollow tube 32 in the sheath 16. The second reinforcing layer 51 is arranged on the outer side in the radial direction of the sheath 16 with respect to the arrangement region of the hollow tube 32 in the sheath 16 (which can also be regarded as the arrangement region of the sublumen 30 or the arrangement region of the operation line 40). Yes. The hollow tube 32, the sublumen 30 and the operation line 40 pass through the layer between the first reinforcing layer 50 and the second reinforcing layer 51 in the sheath 16 and are second from the region proximal to the second marker 67. The region is guided to the distal end side of the marker 67.

For example, when the first reinforcing layer 50 is regarded as a tube, the outer peripheral surface of the first reinforcing layer 50 is in contact with the hollow tube 32. Similarly, when the second reinforcing layer 51 is regarded as a tube, the inner peripheral surface of the second reinforcing layer 51 is in contact with the hollow tube 32.
Further, when the first reinforcing layer 50 is regarded as a pipe, the inner peripheral surface of the first reinforcing layer 50 is in contact with the outer peripheral surface of the inner layer 21.

Whether the first reinforcing layer 50 is a blade layer or a coil, the pitch angle of the wire constituting the first reinforcing layer 50 is gradually reduced from the proximal end side toward the distal end side. Can do.
Similarly, the pitch angle of the wire constituting the second reinforcing layer 51 can be gradually decreased from the proximal end side toward the distal end side.
By doing so, the bending rigidity of the distal end portion 15 of the catheter 10 can be gradually reduced toward the distal end DE side.

  The first marker 66 and the second marker 67 are made of a material that does not transmit specific radiation such as X-rays (radiation opaque material). A material that does not transmit specific radiation does not necessarily mean a material that does not transmit specific radiation at all, but is a material that is opaque to specific radiation, that is, has a contrast property when irradiated with specific radiation. Mean good material. Specifically, for example, the first marker 66 and the second marker 67 are made of a metal material such as platinum.

  Each of the first marker 66 and the second marker 67 is formed in, for example, an annular (ring shape) shape, and is fixed to the sheath 16 in a coaxial arrangement with the sheath 16. Each of the first marker 66 and the second marker 67 is provided, for example, around the main lumen 20, on the first reinforcing layer 50 or the second reinforcing layer 51, and inside the outer layer 60.

  For example, the first marker 66 is arranged on the outer side in the radial direction of the sheath 16 with respect to the arrangement region of the first reinforcing layer 50 in the sheath 16. That is, the first marker 66 is disposed so as to surround the periphery of the first reinforcing layer 50. More specifically, for example, the inner peripheral surface of the first marker 66 is in contact with the first reinforcing layer 50 (FIG. 3). Thereby, it can suppress that the outer diameter of the 2nd marker 67 becomes large too much, and approach of the catheter 10 to a body cavity can be performed smoothly.

  For example, the second marker 67 is arranged on the outer side in the radial direction of the sheath 16 with respect to the arrangement region of the second reinforcing layer 51 in the sheath 16. That is, the second marker 67 is disposed so as to surround the periphery of the second reinforcing layer 51. More specifically, for example, the inner peripheral surface of the second marker 67 is in contact with the second reinforcing layer 51 (FIG. 5).

  The first marker 66 is fixed by caulking, for example, around the distal end portion of the first reinforcing layer 50. For example, the second marker 67 is fixed by caulking around the distal end portion of the proximal end side portion 51 a of the second reinforcing layer 51.

  The second marker 67 is formed with a larger diameter than the first marker 66. That is, the dimension of the second marker 67 in the radial direction of the sheath 16 is larger than the dimension of the first marker 66 in the radial direction of the sheath 16.

  As described above, the second marker 67 is formed in a ring shape from a metal material such as platinum. For this reason, the arrangement region of the second marker 67 in the catheter 10 is reinforced by the second marker 67. And the bending rigidity of the arrangement | positioning area | region of the 2nd marker 67 in the catheter 10 is an area | region adjacent to the distal end side and proximal end side of the arrangement | positioning area | region of the 2nd marker 67 in the catheter 10, respectively (1st adjacency shown in FIG. 1). It is greater than the bending stiffness of region 18 and second adjacent region 19).

  A distal end portion 41 (FIG. 2) of the operation line 40 is fixed to the distal end portion 15 of the catheter 10. More specifically, the distal end portion 41 of the operation line 40 is fixed to the first marker 66 (for example, fixed to the proximal end portion of the first marker 66). Alternatively, the distal end portion 41 of the operation line 40 is fixed to a portion of the sheath 16 in the vicinity of the first marker 66 (a portion closer to the first marker 66 than the second marker 67 at the distal end portion 15 of the sheath 16). Yes.

  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 portion 41 may be welded or fastened to the first marker 66, the tip portion 41 may be welded to the distal end portion 15 of the sheath 16, or the tip portion 41 is bonded to the first marker with an adhesive. 66 or the distal end 15 of the sheath 16 may be adhesively fixed.

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 5 to 30 μm, the thickness of the outer layer 60 is about 10 to 200 μm, the inner diameter of the first reinforcing layer 50 is about 410 to 660 μm, and the first reinforcing layer The outer diameter of 50 can be about 450 to 740 μm, the inner diameter of the second reinforcing layer 51 can be about 560 to 920 μm, and the outer diameter of the second reinforcing layer 51 can be about 600 to 940 μm.
The inner diameter of the first marker 66 is about 450 to 740 μm, the outer diameter of the first marker 66 is about 490 to 820 μm, the inner diameter of the second marker 67 is about 600 to 940 μm, the outer diameter of the second marker 67 is about 640 to 980 μm, The length of the first marker 66 in the longitudinal direction of the sheath 16 can be about 0.3 to 2.0 mm, and the length of the second marker 67 in the longitudinal direction of the sheath 16 can be about 0.3 to 2.0 mm. .
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 about 40 to 100 μm. And the thickness of the operation line 40 shall be about 30-60 micrometers.
The outermost diameter (radius) of the catheter 10 is about 350 to 490 μm, that is, the outer diameter is less than 1 mm in diameter. Thereby, the catheter 10 of the present embodiment can be inserted into a blood vessel such as a celiac artery.

  The sublumen 30 is open at least on the proximal end 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.

  As shown in FIGS. 7A to 7C, the catheter 10 has an operation unit 70 provided at the proximal end portion of the sheath 16. The operation unit 70 constitutes an operation mechanism for performing the bending operation of the distal end portion 15 of the sheath 16 together with the operation line 40 (FIGS. 2, 4 to 6).

  The operation unit 70 includes, for example, a main body case 700 and a wheel operation unit 760 provided to be rotatable with respect to the main body case 700.

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

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

  An injector (syringe) (not shown) can be inserted into the hub 790 from behind. By injecting a liquid such as a chemical solution into the hub 790 with this injector, the liquid is supplied to the distal end DE of the sheath 16 via the main lumen 20, and the liquid is supplied from the distal end of the sheath 16 to the body cavity of the patient. Can be fed in. That is, the main lumen 20 is open at the distal end DE of the sheath 16, and liquid can be supplied from the proximal end to the distal end of the sheath 16 via the main lumen 20. The supply supplied from the proximal end to the distal end of the sheath 16 via the main lumen 20 is not limited to a liquid. For example, a device such as NBCA (n-butyl-2-cyanoacrylate) used as an embolic coil, a bead (emboli globular material), an instantaneous adhesive, etc. is connected to the distal end from the proximal end of the sheath 16 via the main lumen 20. It is also possible to supply

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

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

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

  As shown in FIG. 7B, 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 via the one operation line 40. As a result, the distal end portion 15 of the sheath 16 bends toward the sub-lumen 30 through which the one operation line 40 is inserted, with the axis of the sheath 16 as a reference. That is, the distal end portion 15 of the sheath 16 bends in one direction.

  Further, as shown in FIG. 7C, 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 via the other operation line 40. As a result, the distal end portion 15 of the sheath 16 bends toward the sub-lumen 30 through which the other operation line 40 is inserted with the axis of the sheath 16 as a reference. That is, the distal end portion 15 of the sheath 16 bends in the other direction.

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

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

It is possible to freely control the direction of the distal end DE of the catheter 10 by performing a combination of a torque operation for rotating the entire catheter 10 and a pulling operation.
Furthermore, the amount of bending of the distal end portion 15 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.

According to the first embodiment as described above, the distal end portion 15 of the sheath 16 has the first marker 66 and the second marker 67 located closer to the proximal end side than the first marker 66. Is provided. Therefore, by using the positions of the two markers of the first marker 66 and the second marker 67 as an index, the optimum timing for performing the bending operation of the sheath 16 can be easily determined.
Note that the distal end portion 41 of the operation line 40 is fixed to a portion on the distal end side of the second marker 67 in the catheter 10. Therefore, a portion on the distal end side of the second marker in the sheath 16 is bent by the bending operation.

For example, as shown in FIG. 8, the timing for performing the bending operation can be easily determined using the position of the first marker 66, the position of the second marker 67, the position of the branch point 81 of the blood vessel (body cavity) 80, etc. as indices. Therefore, the distal end DE of the sheath 16 can be easily advanced to the desired branch 82 side of the blood vessel 80.
For example, the distance between the first marker 66 and the branch point 81, the distance between the second marker 67 and the branch point 81, the distance between the first marker 66 and the second marker 67, and the relationship between the distance and the thickness of the blood vessel 80. Therefore, it is possible to easily determine the timing for performing the bending operation of the sheath 16 as compared with the case where there is only one marker. Similarly, the amount of bending required by the bending operation can be easily determined.

  In particular, the distal end portion 41 of the operation line 40 is fixed to the first marker 66, or is fixed to a portion closer to the first marker 66 than the second marker 67 at the distal end portion 15 of the sheath 16. Thus, the portion between the first marker 66 and the second marker 67 can be bent greatly by the pulling operation of the operation line 40. That is, the first marker 66 can be an indicator of the distal end of the main bent portion of the catheter 10, and the second marker 67 can be an indicator of the proximal end of the main bent portion of the catheter 10. Therefore, by using the positions of the two markers of the first marker 66 and the second marker 67 as an index, the optimal timing for performing the bending operation of the sheath 16 can be determined with higher accuracy.

  In particular, at the distal end portion 15 of the sheath 16, the maximum bending portion 15 a having the maximum curvature when the pulling operation is performed is between the first marker 66 and the second marker 67 and from the first marker 66. Since the sheath 16 can be bent sharply in the vicinity of the second marker 67 when the second marker 67 is positioned near the second marker 67, the second marker 67 is positioned in the immediate vicinity of the branch point 81. The distal end DE can be made to enter the desired branch 82 by performing a bending operation at an appropriate timing.

  Here, the bending rigidity of the arrangement region of the second marker 67 in the catheter 10 is a region adjacent to the distal end side and the proximal end side of the arrangement region of the second marker 67 in the catheter 10 (the first region shown in FIG. 1). By adopting a configuration that is larger than the bending rigidity of the adjacent region 18 and the second adjacent region 19), a structure in which the portion near the second marker 67 in the catheter 10 becomes the maximum bent portion 15a can be easily realized.

  In addition, since each of the first marker 66 and the second marker 67 is formed in an annular shape and is arranged coaxially with the sheath 16, each of the first marker 66 and the second marker 67 has good visibility. Become. In addition, since the axial centers of the first marker 66 and the second marker 67 coincide with the axial center of the sheath 16, the arrangement of the sheath 16 can be easily recognized based on the positions of the first marker 66 and the second marker 67.

  Further, the dimension of the second marker 67 in the radial direction of the sheath 16 is larger than the dimension of the first marker 66 in the radial direction of the sheath 16. Thereby, the visibility of the 2nd marker 67 can further be improved, and the 1st marker 66 and the 2nd marker 67 can be distinguished visually easily.

  The catheter 10 further includes a first reinforcing layer 50 and a second reinforcing layer 51 that are embedded in the sheath 16 such that the axial center direction extends along the axial direction of the sheath 16. Among these, the first reinforcing layer 50 is disposed inside the second reinforcing layer 51. And at least any one of the 1st reinforcement layer 50 and the 2nd reinforcement layer 51 is a distal end rather than the said arrangement | positioning area | region from the area | region of the proximal end rather than the arrangement | positioning area | region of the 2nd marker 67 in the catheter 10. The bending rigidity decreases toward the side region. As a result, a rigidity discontinuity point or a rigidity changing region in which the rigidity decreases toward the distal end side can be formed on the distal end side of the second marker 67 in the catheter 10. Therefore, the flexibility of the region on the distal end side of the second marker 67 in the catheter 10 can be sufficiently ensured.

  Further, specifically, for example, each of the first reinforcing layer 50 and the second reinforcing layer 51 is configured so that the second marker in the catheter 10 is from a region proximal to the arrangement region of the second marker 67 in the catheter 10. It arrange | positions over the area | region of a distal end side rather than 67 arrangement | positioning area | regions. Accordingly, the first reinforcing layer 50 extends from a region closer to the distal end than the region where the second marker 67 is disposed in the catheter 10 to a region closer to the distal end than the region where the second marker 67 is disposed in the catheter 10. The sheath 16 can be reinforced by the second reinforcing layer 51. Therefore, the occurrence of kinking of the catheter 10 in the vicinity of the second marker 67 can be suppressed.

  In addition, the operation line 40 (specifically, the hollow tube 32 containing the sub-lumen 30 and the operation line 40) passes through the layer between the first reinforcement layer 50 and the second reinforcement layer 51 in the sheath 16, and passes through the sheath. 16, the region closer to the distal end than the second marker 67 is guided from the region closer to the distal end than the second marker 67 in the sheath 16. In other words, the first reinforcing layer 50 is disposed on the radially inner side of the sheath 16 with respect to the arrangement region of the operation line 40 (the hollow tube 32 including the sub-lumen 30 and the operation line 40) in the sheath 16, and the second reinforcing layer 51 is arranged on the outer side in the radial direction of the sheath 16 with respect to the arrangement region of the operation line 40 in the sheath 16 (specifically, the hollow tube 32 containing the sub-lumen 30 and the operation line 40). Accordingly, the operation line 40 (the hollow tube 32 including the sub-lumen 30 and the operation line 40) can be protected by the first reinforcement layer 50 and the second reinforcement layer 51, and the first reinforcement layer 50 and the second reinforcement layer 51 can be protected. Interference of the operation line 40 (the hollow tube 32 containing the sub-lumen 30 and the operation line 40) with respect to the reinforcing layer 51 can be suppressed.

The second marker 67 is formed in an annular shape and is disposed so as to surround the second reinforcing layer 51. That is, the annular second marker 67 is arranged on the outer side in the radial direction of the sheath 16 with respect to the arrangement region of the second reinforcing layer 51 in the sheath 16. Therefore, since the second marker 67 has a larger diameter than the second reinforcing layer 51, the visibility of the second marker 67 can be improved.
In particular, when the operation line 40 is disposed in a layer between the first reinforcing layer 50 and the second reinforcing layer 51, the second marker 67 is disposed so as to surround the second reinforcing layer 51. Thus, the operation line 40 can be guided from the proximal end side to the distal end side of the second marker 67 without causing the operation line 40 to interfere with the second marker 67.

  In the above, the catheter 10 is exemplified as the medical device. However, the present invention can be applied to other medical devices (for example, endoscopes) having a structure in which a long medical device body is bent by the operation of pulling the operation line 40. Applicable.

In the above, since the bending rigidity of the distal end side portion 51b of the second reinforcing layer 51 is smaller than the bending rigidity of the proximal end side portion 51a, sufficient flexibility of the portion on the distal end side of the catheter 10 is achieved. Although the example to ensure was demonstrated, the 2nd reinforcement layer 51 does not have the distal end side part 51b (the 2nd reinforcement layer 51 does not exist in the distal end side rather than the 2nd marker 67). Thus, sufficient flexibility of the distal end side portion of the catheter 10 may be ensured. As a preferred example, when the second reinforcing layer 51 does not have the distal end side portion 51b, the distal end of the second reinforcing layer 51 is more proximal than the distal end of the second marker 67, and The second marker 67 may be located on the distal end side of the proximal end.
Alternatively, since the first reinforcing layer 50 is not present on the distal end side of the second marker 67, sufficient flexibility of the distal end side portion of the catheter 10 may be ensured.

  In the above description, the example in which the first marker 66 is arranged around the first reinforcing layer 50 has been described. However, the first marker 66 may be arranged inside the first reinforcing layer 50. Alternatively, the distal end of the second reinforcing layer 51 may reach the arrangement area of the first marker 66, and the first marker 66 may be arranged around the second reinforcing layer 51.

  In the above description, the example in which the second marker 67 is arranged around the second reinforcing layer 51 has been described. However, the second marker 67 is arranged inside the second reinforcing layer 51 and around the first reinforcing layer 50. May be. In this case, the second marker 67 may be arranged in a layer between the hollow tube 32 and the second reinforcing layer 51 in the sheath 16, or the second marker 67 may be disposed between the hollow tube 32 and the first reinforcing layer 50 in the sheath 16. It may be arranged in a layer between. Further, the second marker 67 may be disposed inside the first reinforcing layer 50.

  In the above, each of the first reinforcing layer 50 and the second reinforcing layer 51 is located on a region closer to the distal end than the region where the second marker 67 is disposed, from a region closer to the end than the region where the second marker 67 is disposed. Although the example located over the region has been described, one or both of the first reinforcing layer 50 and the second reinforcing layer 51 may terminate in the region where the second marker 67 is disposed. That is, the distal end of the first reinforcing layer 50 or the second reinforcing layer 51, particularly the distal end of the second reinforcing layer 51, is more proximal than the distal end of the second marker 67 and the second marker 67. It may be located on the distal end side with respect to the proximal end. In that case, in the above description, the example in which the entire longitudinal direction of the inner peripheral surface of the second marker 67 is in contact with the second reinforcing layer 51 has been described. It may be in contact with the second reinforcing layer 51.

  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.

Embodiments of the present invention include the following technical ideas.
(1) A long and flexible medical device main body inserted into a body cavity and an operation line embedded in the medical device main body and extending along the longitudinal direction of the medical device main body. A medical device having an operation line for bending the medical device body by a pulling operation with respect to the operation line, wherein the medical device body is provided with a radiopaque material provided at a distal end portion of the medical device body. A marker; and a second marker made of a radiopaque material provided at a portion closer to the proximal end than the first marker at the distal end of the medical device body, and the operation line The tip of the medical device is fixed to a portion of the medical device on the distal end side of the second marker.
(2) The tip of the operation line is fixed to the first marker, or is fixed to a portion closer to the first marker than the second marker at the distal end of the medical device body. The medical device according to (1) above.
(3) The bending rigidity of the arrangement area of the second marker in the medical device is larger than the bending rigidity of areas adjacent to the distal end side and the proximal end side of the arrangement area of the second marker in the medical device. The medical device according to (1) or (2), which is large.
(4) In the distal end portion of the medical device main body, a portion having a maximum curvature when the pulling operation is performed is between the first marker and the second marker, and the first marker. The medical device according to any one of (1) to (3), wherein the medical device is located closer to the second marker.
(5) Each of the first marker and the second marker is formed in an annular shape, and is arranged coaxially with the medical device main body, as described in any one of (1) to (4) above. Medical equipment.
(6) Any one of the above (1) to (5), wherein the size of the second marker in the radial direction of the medical device body is larger than the size of the first marker in the radial direction of the medical device body. Medical device according to item.
(7) A tubular first reinforcing layer and a second reinforcing layer that are embedded in the medical device main body and reinforce the medical device main body such that the axial center direction extends along the axial direction of the medical device main body. The first reinforcing layer is disposed inside the second reinforcing layer, and at least one of the first reinforcing layer and the second reinforcing layer is the first reinforcing layer in the medical device. The bending stiffness is reduced from the region closer to the distal end than the placement region of the two markers toward the region distal to the placement region, or present on the distal end side from the placement region The medical device according to any one of (1) to (6), which is not performed.
(8) The operation line passes through a layer between the first reinforcement layer and the second reinforcement layer in the medical device body, and from a region closer to the end side than the second marker in the medical device body. The medical device according to (7), wherein the medical device body is guided to a region on a distal end side of the second marker in the medical device body.
(9) The medical device according to (7) or (8), wherein the second marker is formed in an annular shape and is disposed so as to surround a periphery of the second reinforcing layer.
(10) Each of the first reinforcing layer and the second reinforcing layer is a blade layer configured by braiding a wire in a mesh shape, or is configured by winding the wire in a spiral shape. The medical device according to any one of (7) to (9), wherein the medical device is a coil.
(11) Any of the above (1) to (10), wherein a lumen is formed in the medical device main body along the longitudinal direction of the medical device main body, and the operation line is inserted into the lumen. The medical device according to one item.
(12) The medical device according to (11), wherein the lumen extends from a proximal end portion of the medical device main body to a vicinity of the first marker.
(13) The lumen according to (11) or (12), wherein the lumen is configured by a lumen of a hollow tube embedded in the medical device body.
(14) The main lumen having a larger diameter than the lumen is formed in the medical device main body along the longitudinal direction of the medical device main body, according to any one of the above (11) to (13). Medical equipment.
(15) The main lumen is open at a distal end of the medical device body, and supplies can be supplied from the proximal end to the distal end of the medical device body through the main lumen. The medical device according to (14), characterized in that it is characterized in that
(16) The medical device according to any one of (1) to (15), wherein the medical device is a catheter.

DESCRIPTION OF SYMBOLS 10 Catheter 15 Distal end part 15a Maximum bending part 16 Sheath 17 Proximal end part 18 1st adjacent area 19 2nd adjacent area 20 Main lumen 21 Inner layer 30 Sublumen 32 Hollow tube 40 Operation line 41 Tip part 50 First reinforcement Layer 51 Second reinforcing layer 51a Proximal end side portion 51b Distal end side portion 60 Outer layer 64 Coat layer 66 First marker 67 Second marker 70 Operation portion 80 Blood vessel (body cavity)
81 Branch point 82 Branch 700 Main body case 760 Wheel operation part 790 Hub DE Distal end

Claims (17)

A long and flexible medical device body inserted into a body cavity;
An operation line embedded in the medical device body and extending along the longitudinal direction of the medical device body, and an operation line for bending the medical device body by a pulling operation with respect to the operation line;
A medical device having
A first marker made of a radiopaque material provided at a distal end of the medical device body;
A second marker made of a radiopaque material provided at a portion closer to the proximal end than the first marker at the distal end of the medical device body;
Further comprising
A medical device in which a tip portion of the operation line is fixed to a portion on a distal end side of the second marker in the medical device.   The tip of the operation line is fixed to the first marker, or is fixed to a portion closer to the first marker than the second marker at the distal end of the medical device body. Item 1. A medical device according to Item 1.   The bending rigidity of the arrangement region of the second marker in the medical device is larger than the bending rigidity of regions adjacent to the distal end side and the proximal end side of the arrangement region of the second marker in the medical device. The medical device according to 1 or 2.   In the distal end portion of the medical device main body, the portion where the curvature when performing the pulling operation is maximized is between the first marker and the second marker, and more than the first marker. The medical device according to claim 1, wherein the medical device is located near the second marker.   Each of the said 1st marker and the said 2nd marker is a medical device as described in any one of the Claims 1 thru | or 4 formed in the cyclic | annular shape, and arrange | positioning coaxially with the said medical device main body.   The medical device according to any one of claims 1 to 5, wherein a size of the second marker in a radial direction of the medical device body is larger than a size of the first marker in a radial direction of the medical device body. . A tubular first reinforcing layer and a second reinforcing layer that are embedded in the medical device main body and reinforce the medical device main body so that the axial direction extends along the axial direction of the medical device main body, respectively. And
The first reinforcing layer is disposed inside the second reinforcing layer;
At least one of the first reinforcing layer and the second reinforcing layer is a region closer to the distal end than the arrangement region of the second marker in the medical device, and a distal end side from the arrangement region. The medical device according to any one of claims 1 to 6, wherein the bending rigidity decreases toward the region, or does not exist on the distal end side of the arrangement region.   The operation line passes through the layer between the first reinforcement layer and the second reinforcement layer in the medical device body, and from the region proximal to the second marker in the medical device body, the medical device The medical device according to claim 7, wherein the medical device is guided to a region on a distal end side of the second marker in the main body.   The medical device according to claim 7 or 8, wherein the second marker is formed in an annular shape and is disposed so as to surround the periphery of the second reinforcing layer.   Each of the first reinforcing layer and the second reinforcing layer is a blade layer formed by braiding a wire in a mesh shape, or a coil formed by winding a wire in a spiral shape. The medical device according to any one of claims 7 to 9.   The sub-lumen is formed in the inside of the medical device main body along the longitudinal direction of the medical device main body, and the operation line is inserted into the sub-lumen. Medical equipment.   The medical device according to claim 11, wherein the sublumen extends from a proximal end portion of the medical device main body to a vicinity of the first marker.   The medical device according to claim 11 or 12, wherein the sublumen is configured by a lumen of a hollow tube embedded in the medical device main body.   The medical device according to any one of claims 11 to 13, wherein a main lumen having a diameter larger than that of the sublumen is formed in the medical device main body along a longitudinal direction of the medical device main body. The main lumen is open at a distal end of the medical device body;
The medical device according to claim 14, wherein a supply can be supplied from a proximal end to a distal end of the medical device body through the main lumen.   The medical device according to any one of claims 7 to 10, wherein the second reinforcing layer is disposed apart from the first reinforcing layer over the entire circumferential direction and longitudinal direction of the second reinforcing layer. machine.   The medical device according to any one of claims 1 to 16, wherein the medical device is a catheter.

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