JP2016013344A - Medical instrument - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical instrument that prevents winding of a coil provided between an inner layer and an outer layer provided inside a tubular body from loosened and prevents the tip of the coil from unexpectedly operating.SOLUTION: A medical instrument (catheter 100) comprising a long tubular body 10 including a resin inner layer (inside layer 24) having a main lumen 20 formed inside and a resin outer layer (outside layer 50) encapsulating the inner layer (inside layer 24) includes: a coil (holding coil 70) that is encapsulated by the outer layer (outside layer 50) and is formed by being wound around the outer periphery of the inner layer (inside layer 24) in the axial direction of the tubular body 10; and a bond part 74 that is attached to the outer periphery surface of the inner layer (inside layer 24) and differs from the outer layer (outside layer 50), where the tip of the coil (holding coil 70) is embedded in the bond part 74.

Description

  The present invention relates to a medical device such as a catheter.

  In recent years, in a long medical device such as a catheter, an example has been proposed in which a coil formed by winding a wire in the axial direction of the main body is installed on the inner layer of the long tubular main body. Even if the coil is installed inside the tubular body, the coil does not hinder the bending operation of the medical device and can reinforce the tubular body.

  For example, Patent Document 1 discloses a catheter (hereinafter also referred to as Prior Art 1) provided with a coil having a reinforcing effect (hereinafter also referred to as a reinforcing coil) installed in a flexible tubular catheter body. Is disclosed. More specifically, the prior art 1 has an outer layer and an inner layer, and a reinforcing coil is installed around the inner layer.

  In Patent Document 1, the reinforcing coil can be installed by winding a wire rod for forming a reinforcing coil around the inner layer on the outer periphery of the core material in the longitudinal direction of the inner layer. Has been explained. Then, a hollow tubular body constituting the outer layer is covered with the core material so as to cover the coil, and further, a heat shrinkable tube is placed on the tubular body, and this is heated and thermally contracted. Thereafter, the heat-shrinkable tube is removed, the end portion is cut, and the core material is pulled out, whereby the catheter body of the prior art 1 is formed.

  As in the prior art 1, the strength of the catheter body is reinforced by installing a reinforcing coil wound in the axial direction of the catheter body inside the catheter body. Patent Document 2 will be described later.

JP 2001-218851 A JP 2006-192269 A

However, as represented by the related art 1 including a reinforcing coil, a catheter including a coil installed in a state wound around the outer periphery of the inner layer between the inner layer and the outer layer inside the main body includes the following: There was a problem.
That is, the coil installed while being wound around the inner layer of the catheter body is maintained in a predetermined installation state by being embedded in the outer layer as in the prior art 1, but the installation state is not maintained. It was not enough.

For example, due to the recent increasing demand for catheter diameter reduction, the thickness of the outer layer tends to be designed to be small. Therefore, under the bending operation of the distal end portion of the catheter, it may be difficult to seal the elastic restoring force that the outer layer may remain slightly at the distal end portion of the coil, and as a result, the peripheral surface of the distal end portion of the coil and the outer layer It has been clarified by the inventor's investigation that there is a risk of peeling.
Such peeling can result in coil loosening in the radial direction. A coil that has been loosened may not achieve its intended purpose. For example, when the reinforcing coil in the prior art 1 is loosened, there is a possibility that the reinforcement of the catheter body expected for the reinforcing coil cannot be sufficiently achieved. In addition, even when using a coil that has been heat-treated in advance and has substantially lost its elastic restoring force, the distal end of the coil behaves unexpectedly due to bending of the distal end region of the catheter, etc. There was a risk of exposure.

  In addition, although the catheter was illustrated and demonstrated here, the same subject is a problem which arises in the whole medical device with which the coil wound by the inner layer of not only a catheter but the elongate tubular main body was installed. is there.

  The present invention has been made in view of the above problems, and medical treatment in which loosening of a coil installed between an inner layer and an outer layer provided inside a tubular main body and an unexpected operation of the tip of the coil are prevented. Equipment is provided.

  The medical device of the present invention includes a long tubular body including a resin inner layer in which a main lumen is formed and a resin outer layer that encloses the inner layer. The medical device includes the inner layer enclosed in the outer layer. A coil in which the outer periphery of the tubular body is wound in the axial direction of the tubular body, and an adhesive portion that is attached to the outer peripheral surface of the inner layer and is different from the outer layer, and the tip of the coil is wrapped around the adhesive portion. It is buried.

  ADVANTAGE OF THE INVENTION According to this invention, the medical device by which the coil | winding loosening and the unexpected operation | movement of the front-end | tip part of a coil which were installed between the inner layer and outer layer which were provided in the tubular main body were prevented is provided.

Fig.1 (a) is a whole side view of the catheter concerning embodiment of this invention, FIG.1 (b) is a whole side view of the catheter which shows the state which operated the wheel operation part to one direction. It is the II-II sectional view taken on the line of FIG. It is the III-III sectional view taken on the line of FIG. It is the IV-IV sectional view taken on the line of FIG. It is explanatory drawing explaining the front-end | tip area | region of the catheter concerning 1st embodiment. It is the longitudinal cross-sectional view cut | disconnected in the position of the III-III line of FIG. 2 regarding the catheter concerning a 2nd embodiment.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same components are denoted by the same reference numerals, and redundant description will be appropriately omitted.
In the present embodiment, there are cases where a vertical direction is defined and illustrated as shown in the figure. However, this is provided for convenience in order to simply explain the relative relationship of the components, and does not limit the direction during the manufacture or use of the product implementing the present invention.
The various components of the medical device of the present invention do not have to be individually independent, but a plurality of components are formed as a single member, and a single component is formed of a plurality of members. That a certain component is a part of another component, a part of a certain component overlaps a part of another component, and the like.

<First embodiment>
Below, regarding the medical device of the present invention, the configuration of the first embodiment of the present invention will be described with reference to FIGS.

FIG. 1A is an overall side view of the catheter 100 according to the embodiment of the present invention, and FIG. 1B is an overall side view of the catheter 100 showing a state in which the wheel operation unit 92 is operated in one direction. is there.
2 is a cross-sectional view taken along the line II-II in FIG. 1, and is a cross-sectional view of the catheter 100 cut at a position where an adhesive portion 74 for embedding the distal end portion of the coil wire 70a is provided.
3 is a cross-sectional view taken along the line III-III in FIG. 2 and is a vertical cross-sectional view of the distal end region of the catheter 100 at a position where the subtube 40 is not provided.
4 is a cross-sectional view taken along line IV-IV in FIG. 2, and is a vertical cross-sectional view of the distal end region of the catheter 100 at a position having the subtube 40.
FIG. 5 is an explanatory diagram for explaining the distal end region of the catheter 100. FIG. 5 is a side view of the distal end region of the catheter 100, a part of the side surface of the outer layer 50 is omitted, and the first marker 14, the subtube 40, the wire reinforcing layer 30, the holding coil 70, and the bonding portion 74. Shows the side.
In the present specification, the longitudinal section of the medical device refers to a cross section cut in parallel to the longitudinal direction of the medical device body through the axis of the medical device body. In this specification, the cross section of the medical device refers to a cross section cut perpendicular to the axis of the medical device body.

As shown in FIG. 2, the catheter 100 according to this embodiment includes a resin inner layer (inner layer 24) in which the main lumen 20 is formed, and a resin outer layer (outer layer) enclosing the inner layer (inner layer 24). A long tubular body 10 comprising a layer 50).
The catheter 100 includes an outer layer (outer layer 50), a coil (holding coil 70) formed by winding an outer periphery of the inner layer (inner layer 24) in the axial direction of the tubular body 10, and an inner layer (inner layer 24). It adheres to the outer peripheral surface and has an adhesive portion 74 different from the outer layer (outer layer 50).
As shown in FIGS. 2, 3, and 5, the catheter 100 is characterized in that a distal end portion of a coil (holding coil 70) is embedded in an adhesive portion 74.
In the present embodiment, an adhesive portion 74 different from the outer layer (outer layer 50) is attached to the outer peripheral surface of the tip of the inner layer (inner layer 24).

  In the present specification, the term “tip portion” means a predetermined length region including the tip, and includes both the tip vicinity region including the tip and the tip vicinity region excluding the tip. The “tip region of the catheter (or tubular body)” does not mean a strictly specified region, but means a predetermined length region including the tip of the catheter (or tubular body), and It includes a region that is bent by operation. The “axis” means a central axis in the longitudinal direction of the tubular body 10.

Since the distal end portion of the holding coil 70 is embedded in the adhesive portion 74 of the catheter 100, the distal end portion is fixed at a predetermined position even when the bending operation in the distal end region of the catheter 100 is repeatedly performed. . Thereby, the holding coil 70 is satisfactorily prevented from being loosened inside the tubular main body 10, and the installation state of the holding coil 70 is maintained.
Moreover, since the front-end | tip part of the holding coil 70 is embedded in the adhesion part 74, the said front-end | tip part is prevented from performing an unexpected operation | movement. As a result, the distal end portion of the holding coil 70 is prevented from being exposed on the surface of the outer layer 50, and is further prevented from penetrating the outer layer 50 and projecting to the outer periphery of the catheter 100.

  In the present embodiment, as an example of a coil provided in the medical device of the present invention, a holding coil 70 that winds the inner layer 24 and a subtube 40 described later will be described as an example. The present embodiment also proposes a catheter 100 that can effectively utilize the coil as the holding coil 70 by exerting the effects of the present invention.

That is, in the inside of a tubular main body provided in a general long medical device, as an example of using a wire other than a coil, an example provided with a mesh-like wire layer (blade layer) braided with a wire has been proposed. Yes. For example, Patent Document 2 discloses a catheter in which two wire lumens (hereinafter referred to as secondary lumens) having a smaller diameter are provided 180 degrees opposite each other around a central lumen (hereinafter referred to as a main lumen). Have been described. A deflection wire (hereinafter referred to as an operation line) is inserted into the sub-lumen, and the distal end of the catheter is bent by pulling the operation line by operating the operation handle on the proximal end side. Yes.
More specifically, Patent Document 2 discloses a catheter in which two spaghetti tubes having sub-lumen (hereinafter referred to as sub-tubes) are laid along the outer surface of a thin inner layer made of a fluorine-based resin material or the like. An example (hereinafter also referred to as Prior Art 2) is disclosed. An operation line is inserted into the auxiliary lumen. The two sub-tubes are provided with a cylindrical wire knitted body (hereinafter referred to as a wire layer) from the outer periphery in a state where they are laid in the axial direction along the outer surface of the inner layer 180 degrees apart (for example, the same) Literature Fig. 4). The wire layer is formed by braiding a plurality of wires in a mesh shape and tightening around two subtubes laid along the inner layer. On that basis, the prior art 2 is created by impregnating the wire layer with a molten resin for forming the outer layer.

  In order to define a path for guiding the operation line from the distal end to the proximal end of the catheter in the prior art 2, it is desirable that the subtube be arranged straight along the axis of the catheter. This is because if the subtube is meandering around the inner layer, the inner wall surface of the subtube and the operation line come into contact with each other and the friction occurs when the operation line is pulled. When such friction occurs, various problems occur. First, the operation line is worn and easily broken. And the inner wall surface of a subtube wears and becomes coarse, and also friction increases. Furthermore, since the sliding resistance of the operation line increases, the pulled operation line is held by static friction with the inner wall surface of the subtube, and it becomes difficult to return the bending of the distal end of the catheter.

  However, in the prior art 2, it is extremely difficult to arrange the sub-tube straight along the axis of the catheter and maintain the arrangement. This is because it is difficult to braid the wire layer with the subtube laid on the surface of the inner layer along the axis of the catheter, and further tighten the wire layer. When the wire layer is braided with multiple wires and further tightened, it is inevitable that an external force is applied to the auxiliary lumen in the circumferential direction of the inner layer, and the auxiliary lumen is made an axis along the inner layer. It is difficult to keep it straight and parallel.

  As a result of studying the prior art 2, the present inventor employs a coil (holding coil) in which the inner layer and the subtube are wound together with a wire instead of the wire layer, thereby accurately positioning the subtube. The problem of the prior art 2 was solved. And the catheter 100 concerning this embodiment is proposed as one desirable aspect of this invention by applying the technical idea of embedding the front-end | tip part of the coil proposed in this invention to an adhesion | attachment part also to the said holding coil.

That is, in the catheter 100 according to the present embodiment, the tubular body 10 includes an inner layer 24 and a resin-made subtube 40 that is disposed outside the inner layer 24 and defines a sub-lumen 42 having a smaller diameter than the main lumen 20. An outer layer 50 containing the inner layer 24 and the sub-tube 40.
The coil provided in the catheter 100 is a holding coil 70 that is enclosed in the outer layer 50 and winds the sub-tube 40 and the inner layer 24 together, and the distal end portion of the holding coil 70 is embedded in the adhesive portion 74.

  According to the catheter 100 in which the sub-tube 40 that defines the secondary lumen 42 and the inner layer 24 that defines the main lumen 20 are wound together by the holding coil 70, the holding coil 70 causes the sub-tube 40 to be connected to the axis of the catheter 100. Can be constrained in a posture that is arranged straight along. Thereby, it is possible to avoid the occurrence of the above-described problem of the related art 2 that occurs when the holding coil 70 meanders around the inner layer 24.

  Further, as described above, since the end portion of the holding coil 70 is embedded in the adhesive portion 74 in the catheter 100, the distal end portion of the holding coil 70 is fixed in a predetermined position, and the winding of the holding coil 70 is prevented. Has been. As a result, the sub-tube 40 and the inner layer 24 that are wound together around the holding coil 70 are well maintained in the mutual arrangement relationship. The sub-tube 40 disposed straight along the axis of the catheter 100 does not meander due to the use of the catheter 100.

  Hereinafter, this embodiment will be described in detail. The catheter 100 according to the present embodiment is an intravascular catheter used by inserting the tubular main body 10 into a blood vessel.

  The tubular body 10 is a hollow tubular and long member having a main lumen (main lumen) 20 therein. For example, the tubular body 10 is formed with an outer diameter and length that allows entry into any of the eight sub-regions of the liver.

  The tubular body 10 has a laminated structure. As shown in FIGS. 2 to 4, the tubular body 10 is configured by laminating an inner layer 24 and an outer layer 50 in order from the inner diameter side with the main lumen 20 as the center. In the present embodiment, the outer layer 50 includes a first outer layer 52 and a second outer layer 54 in order from the inner diameter side. A hydrophilic layer (not shown) is formed on the outer surface of the second outer layer 54. Instead of the hydrophilic layer, the surface of the second outer layer 54 may be subjected to a hydrophilic treatment. The inner layer 24, the first outer layer 52, and the second outer layer 54 are made of a flexible resin material, and each has an annular shape and a substantially uniform thickness.

  In the present embodiment, specifically, an example is shown in which the inner layer 24 is provided as the inner layer, the outer layer 50 is provided as the outer layer, and the tip of the holding coil 70 that is a coil is embedded by the adhesive portion 74. . Although this embodiment does not limit the present invention and is not illustrated, for example, as a modified example, the first outer layer 52 and the inner layer 24 are provided as inner layers, and the second outer layer 54 is provided as an outer layer, which will be described later. An example in which the second reinforcing layer 80 is changed to a single or multiple coil is included. In such a modification, an adhesive portion is provided that embeds the tip of a coil provided in place of the second reinforcing layer 80 and adheres to the outer peripheral surface of the first outer layer 52.

The inner layer 24 is included in the outer layer 50, and the main lumen 20 is formed inside. The inner layer 24 in the present embodiment is the innermost layer of the tubular body 10, and the main lumen 20 is defined by the inner wall surface thereof. Inner layer 24 defines main lumen 20 directly or indirectly. That is, the inner layer 24 is a layer positioned on the inner diameter side relative to the outer layer 50. Although the inner layer 24 may be a single layer or a multilayer, this embodiment specifically illustrates a single layer.
Here, the inclusion of the inner layer 24 in the outer layer 50 means that the inner layer 24 is not exposed on the outer peripheral surface of the outer layer 50.

  The cross-sectional shape of the main lumen 20 is not particularly limited, but is circular in this embodiment. In the case of the main lumen 20 having a circular cross section, the diameter thereof may be uniform over the axial direction of the tubular body 10 or may vary depending on the position in the axial direction.

  Examples of the material of the inner layer 24 include a fluorine-based thermoplastic polymer material. Specific examples of the fluorine-based thermoplastic polymer material include polytetrafluoroethylene resin (PTFE), polyvinylidene fluoride resin (PVDF), and perfluoroalkoxy fluorine resin (PFA). . By configuring the inner layer 24 with such a fluorine-based polymer material, the delivery property when supplying a chemical solution or the like through the main lumen 20 is improved. Further, when the guide wire is inserted into the main lumen 20, the sliding resistance of the guide wire is reduced.

  The outer layer 50 in this embodiment constitutes the main thickness of the tubular body 10. The outer layer 50 includes a first outer layer 52 having an annular cross section including the inner layer 24, the wire reinforcing layer 30, the subtube 40, and the holding coil 70, and a second reinforcing layer provided around the first outer layer 52. A second outer layer 54 having an annular cross-section that encloses the layer 80.

As the material of the outer layer 50, for example, a thermoplastic polymer material can be used. Examples of the thermoplastic polymer material include polyimide resin (PI), polyamideimide resin (PAI), polyethylene terephthalate resin (PET), polyethylene resin (PE), polyamide resin (PA), and polyamide elastomer resin. (PAE), nylon elastomers such as polyether block amide resin (PEBA), polyurethane resin (PU), ethylene-vinyl acetate resin (EVA), polyvinyl chloride resin (PVC) or polypropylene resin (PP) Can be mentioned.
The outer layer 50 may be mixed with an inorganic filler. Examples of the inorganic filler include contrast agents such as barium sulfate and bismuth subcarbonate. By mixing a contrast agent in the outer layer 50, the X-ray contrast property of the tubular body 10 in the body cavity is improved.

  The first outer layer 52 and the second outer layer 54 include the same or different resin materials. Although the interface between the first outer layer 52 and the second outer layer 54 is clearly shown in FIG. 1, the present invention is not limited to this. When the 1st outer side layer 52 and the 2nd outer side layer 54 are comprised with the same kind of resin material, the interface of both layers may be united naturally. That is, the outer layer 50 of the present embodiment may be formed of a multilayer in which the first outer layer 52 and the second outer layer 54 are distinguishable from each other, or the first outer layer 52 and the second outer layer 54 May be configured as a single layer. Of course, the outer layer 50 may be composed of three or more layers, or a different layer may be provided on the outer peripheral surface side of the outer layer 50.

  The distal end of the inner layer 24 may reach the distal end of the tubular body 10 or may terminate proximally relative to the distal end of the tubular body 10. In the present embodiment, specifically, the distal end of the inner layer 24 reaches the distal end of the tubular body 10.

Next, the holding coil 70 will be described. The holding coil 70 in the present embodiment is a coil that is included in the outer layer 50 and is wound around the outer periphery of the inner layer 24 in the axial direction of the tubular body 10.
Here, the term “encapsulation” refers to a state in which the outer periphery of the holding coil 70 is covered by the outer layer 50 and a state in which a part or all of the holding coil 70 is buried between the inner peripheral surface and the outer peripheral surface of the outer layer 50. Any of these are included. 3 and 4 show a state in which at least the tip region of the holding coil 70 is buried in the outer layer 50 between the inner peripheral surface and the outer peripheral surface. Although not shown, the holding coil 70 may be embedded in the outer layer 50 from the distal end to the proximal end.

  As shown in FIGS. 3 and 5, the distal end portion of the holding coil 70 is embedded in the bonding portion 74. Here, “embedded” means that the tip portion is embedded in the adhesive portion 74. In the present embodiment, the tip of the holding coil 70 is not exposed from the bonding portion 74 and is embedded in the bonding portion 74. However, in this specification, “the tip of the coil (holding coil 70) is embedded in the bonding portion (bonding portion 74)” means that the tip of the coil (holding coil 70) is the bonding portion (bonding portion 74). To a slightly exposed mode. Here, that the tip is slightly exposed means that the exposed length including the tip of the coil (holding coil 70) exposed from the bonding portion (bonding portion 74) is one loop or less. From the viewpoint of favorably preventing the tip from protruding from the outer layer (outer layer 50), the exposed length is preferably not more than a quarter loop, and more preferably not more than an eighth loop. Particularly preferred is zero.

The retention coil 70 terminates proximal to the distal end of the inner layer 24. The holding coil 70 is terminated on the proximal end side with respect to the first marker 14 as shown in FIGS.
Although not shown, the proximal end of the holding coil 70 may be located at a position substantially equal to the proximal end of the inner layer 24, for example, or may be located at any position in a predetermined region including the proximal end of the inner layer 24. You may do it.

The holding coil 70 is a coil configured by spirally winding an element wire around the outer periphery of the inner layer 24. Specifically, the holding coil 70 in the present embodiment co-winds the inner layer 24, the subtube 40, and the wire reinforcing layer 30 disposed between the inner layer 24 and the subtube 40. That is, the holding coil 70 is configured by combining the wire reinforcing layer 30 and the subtube 40 arranged on the outer periphery of the inner layer 24 with the inner layer 24 as the center, and winding the wire spirally around these outer periphery. Yes. By the holding coil 70, the sub-tube 40 is held in a state of being arranged straight along the axis on the outer periphery of the inner layer 24.
Here, “co-winding” means winding the outer periphery of a member on which the strands (coil strands 70a, 70b) constituting the holding coil 70 are wound substantially without slack, It means that the element wire is in contact with at least one of the surfaces. In the present embodiment, the strands of the sub-tube 40, the inner layer 24, and the outer periphery of the wire reinforcement layer 30 positioned between the sub-tube 40 and the inner layer 24 are tightly bundled, and the sub-tube 40 and the wire reinforcement layer It is in contact with part of the surface of 30.

  When viewed in the axial direction of the tubular body 10, the holding coil 70 is wound over substantially the entire length of the subtube 40. As a result, the pair of subtubes 40 are accurately arranged in a state where the subtubes 40 are parallel to the axial direction on the outer periphery of the inner layer 24, and the arrangement positions are fixed.

The holding coil 70 is a single or multiple coil.
More specifically, for example, as shown in FIGS. 2 to 5, the coil (holding coil 70) in the present embodiment is a multi-strand coil including two or more strands (for example, coil strands 70 a and 70 b). . The winding directions of the coil wires 70a and 70b are common. The tips of all the strands (for example, the coil strands 70 a and 70 b) constituting the multi-strand coil are embedded in the bonding portion 74.
By selecting a multi-strip coil as the holding coil 70, the arrangement of the sub-tubes 40 can be stabilized as compared with the wire coil. However, the above description does not exclude the use of the holding coil 70 provided with a single strand of wire (not shown) instead of the multiple holding coil 70 in the present embodiment.

  In the present embodiment, the distal end portion of the holding coil 70 that is a multi-strand coil is embedded in a single adhesive portion 74. That is, the tip portions of the multi-strand coils are embedded in a common adhesive portion 74 formed in one place. As a modification of the present embodiment, a plurality of adhesive portions 74 may be provided, and the tip portions of the multi-strand coils may be embedded in different adhesive portions 74 (not shown).

The holding coil 70 is a coil formed by pitch winding two strands (coil strands 70a and 70b). Instead of the present embodiment, the holding coil 70 may be configured by three or more strands. Here, the pitch winding means that the winding is not tight winding, and at least in the partial length region of the holding coil 70, adjacent loops of strands spirally wound in a single or multi-strand are separated in the axial direction. It means doing. However, the above description does not exclude that the coil in the present invention is tightly wound.
As shown in FIG. 2 to FIG. 5, the holding coil 70 having a plurality of (specifically, two) strands wound with a pitch is wound around the outer periphery of the inner layer 24 while maintaining a constant distance between the strands. The tip portion is embedded in the adhesive portion 74 while maintaining the distance. Thus, since the front-end | tip part of the some strand embedded by the adhesion part 74 is spaced apart, since the elastic restoring force which remains in the holding coil 70 is disperse | distributed inside the adhesion part 74, it is preferable.
In the modification of the present embodiment, the tip portions of the plurality of strands forming the holding coil 70 may be bundled or brought close together and embedded in the bonding portion 74 (not shown). According to such a modification, it is possible to collect the tip end portions of the strands in the thick portion at the center of the bonding portion 74, and the tip portion is preferably prevented from protruding from the bonding portion 74. .

In addition to the metal material such as tungsten (W), stainless steel (SUS), nickel titanium alloy, steel, titanium, copper, titanium alloy or copper alloy, the material of the coil wires 70a and 70b constituting the holding coil 70 A resin material such as polyimide (PI), polyamideimide (PAI), or polyethylene terephthalate (PET), which has higher shear strength than the inner layer 24 and the first outer layer 52, can be used. The ductility of the holding coil 70 (coil strands 70a and 70b) is preferably higher than the ductility of the reinforcing wire 32 described later.
A metal wire having a Young's modulus lower than that of the reinforcing wire 32 can be used as the holding coil 70 (coil wires 70a and 70b). Specifically, copper or a copper alloy can be used for the holding coil 70, and tungsten or stainless spring steel can be used for the reinforcing wire 32.

In addition, the holding coil 70 (coil strands 70a and 70b) can be made of a dull material of the same metal as the reinforcing wire 32. Specifically, austenitic soft stainless steel (W1 or W2) that is a blunt material can be used for the holding coil 70, and stainless spring steel can be used for the reinforcing wire 32.
In this way, by using a highly ductile material for the holding coil 70, when the coil strands 70 a and 70 b are wound around the subtube 40, winding looseness is suppressed, and the distal end portion is bonded to the bonding portion 74. The holding coil 70 is stabilized in combination with the embedding. On the other hand, since the wire reinforcing layer 30 is a member that prevents the occurrence of kinks in the tubular body 10, it is preferable to use a spring material having a high elastic restoring force.

Next, the bonding part 74 will be described. The adhesive portion 74 is attached to the outer peripheral surface of the distal end portion of the inner layer 24 and embeds the distal end portion of the coil (holding coil 70) described above.
Here, “deposition” means that at least one region of the interface between the adhesive portion 74 and the inner layer 24 is in contact with no gap. Here, abutting includes any one or a combination of a chemically bonded state, a bonded state in which the bonded portion and / or the inner layer is melted.

The adhesion part 74 in this embodiment is comprised including the resin material.
Thereby, the shape of the bonding part 74 can be adjusted as desired by heating (for example, heating when the outer layer 50 is thermoformed on the outer periphery of the inner layer 24) performed in a later process than the formation process of the bonding part 74. . For example, as will be described later, the outer edge shape of the adhesive portion 74 in the longitudinal sectional view is not M-shaped or inverted U-shaped, and physically fits with the inner peripheral surface of the outer layer 50 laminated thereon. It can also be made. The adhesive portion 74 configured to include a resin material is in contact with the outer peripheral surface of the inner layer 24 and is further bonded.

The bonding portion 74 is different from the outer layer 50. This means that the outer layer 50 and the bonding portion 74 are made of different materials.
As a material for the bonding portion 74, for example, an organic adhesive or brazing can be selected.
As the organic adhesive, a room temperature curable adhesive, a thermosetting adhesive, a solution adhesive, or a hot melt adhesive can be used.
Room temperature curing adhesives include reactive adhesives such as cyanoacrylate adhesives, silicone adhesives, epoxy resin adhesives or acrylic resin adhesives, and UV curable adhesives such as urethane acrylates and epoxy acrylates. An agent can be used.
An epoxy resin adhesive can be used as the thermosetting adhesive.
Solution type adhesives include acrylic resin emulsion adhesives, α-olefin adhesives, urethane resin solvent adhesives, ethylene-vinyl acetate resin emulsion adhesives, vinyl acetate resin emulsion adhesives, or polyvinyl acetate resin solution adhesives. Agents can be exemplified.
Examples of hot melt adhesives include ethylene-vinyl acetate resin hot melt adhesives, polyurethane resin hot melt adhesives, and polyolefin resin hot melt adhesives.
As the brazing, solder or silver candy can be exemplified.

  It is preferable that the Shore hardness of the member constituting the bonding portion 74 is equal to or greater than the Shore hardness of the member constituting the outer layer 50 disposed in the vicinity of the bonding portion 74. This is because it is possible to satisfactorily prevent the tip of the holding coil 70 from protruding outside the catheter 100 by embedding the tip of the holding coil 70 in a member harder than the outer layer 50.

The melting point of the bonding portion 74 is preferably higher than the melting point of the outer layer 50. Examples of the melting point index include Vicat softening point.
That is, in this embodiment, it is preferable that the Vicat softening point of the member constituting the adhesive portion 74 is higher than the Vicat softening point of the member constituting the outer layer 50. Thereby, after the formation process of the adhesion part 74, in the heating process at the time of thermoforming the outer layer 50, the adhesion part 74 is melted before the outer layer 50, and the tip part of the embedded holding coil 70 is The holding coil 70 is not loosened by being exposed from the bonding portion 74 or the like.

  Here, the member constituting the bonding portion 74 means the material when the bonding portion 74 is made of a single material, and the case where the bonding portion 74 is made of a mixed material including a plurality of materials. Means the mixed material. The mixed material is, for example, a material in which two or more resin materials described above are mixed, or a material in which one or two or more resin materials and any additive are mixed. About the member which comprises the outer side layer 50, it is the meaning similar to the above-mentioned.

  From the viewpoint of the Shore hardness and the Vicat softening point described above, a cyanoacrylate-based room-temperature curable adhesive is suitably selected as the material of the bonding portion 74. In addition, a polyamide-based elastomer (nylon-based elastomer) is suitably selected as the material for the outer layer 50. From the viewpoint of realizing the desired arrangement of the sub-tube 40 with high accuracy, an instantaneous adhesive may be selected as the cyanoacrylate-based room temperature curable adhesive.

As described above, the coil (holding coil 70) in the present embodiment is a multi-strand coil including two or more strands (coil strands 70a and 70b). As shown in FIG. 3, the outer peripheral surface of the bonding portion 74 is embedded between the adjacent wires in the axial direction and embedded in the bonding portion 74 (specifically, between the coil wire 70a and the coil wire 70b). It has a recess 76 formed. The recess 76 is recessed toward the inner layer 24 side. The inner peripheral surface of the outer layer 50 has a convex portion 78 that fits into the concave portion 76.
Here, the outer peripheral surface of the bonding portion 74 refers to the surface of the bonding portion 74 opposite to the surface facing the axis, and the inner peripheral surface of the outer layer 50 refers to the surface of the outer layer 50 facing the axis. .

  When the concave portion 76 and the convex portion 78 are fitted, the contact area between the adhesive portion 74 and the outer layer 50 increases, and the boundary surface is difficult to peel off, and the arrangement position of the adhesive portion 74 is difficult to change. Therefore, the tip end portion of the holding coil 70 embedded in the adhesive portion 74 is maintained at a predetermined position.

As shown in FIG. 3, the recess 76 observed in the longitudinal section of the tubular body 10 forms an M shape.
The M-shape is formed by bending the outer peripheral surface of the bonding portion 74 into a corrugated shape along the cross section of the coil wires 70 a and 70 b constituting the holding coil 70. The M-shape has a mountain-shaped outer edge that protrudes in the direction of the outer layer 50 on both sides with the recess 76 interposed therebetween, and the fitting state with the inner peripheral surface of the outer layer 50 is good.

As shown in FIG. 5, the recess 76 extends along the extending direction of the strands (coil strands 70 a and 70 b) embedded in the bonding portion 74.
In other words, the fitting region between the adhesive portion 74 and the outer layer 50 extends in a direction different from the axial direction. This prevents the adhesive portion 74 from shifting in the axial direction and maintains a predetermined position.

The bonding portion 74 in the present embodiment is locally provided in a partial region of the inner layer 24 in the circumferential direction.
In other words, the adhesive portion 74 is provided not in a circular shape but in a non-circular shape with respect to the inner layer 24.
Since the adhesive portion 74 is locally provided at the distal end portion of the inner layer 24, the catheter 100 is prevented from being damaged in the flexibility of the distal end region.

Further, as shown in FIG. 5, the bonding portion 74 in the present embodiment is locally provided not only in the circumferential direction but also in the axial direction.
That is, the bonding portion 74 includes a single portion of one strand (for example, the coil strand 70a) that constitutes the coil (holding coil 70) and is embedded in the bonding portion 74, and the one portion in the axial direction. It terminates between the adjacent one strand (for example, coil strand 70a). In other words, the bonding portion 74 embeds the tip portion of the coil (holding coil 70) and does not reach other loops adjacent to the tip portion in the axial direction, and is in a limited region in the axial direction. Is provided.

Next, the wire layer (wire reinforcing layer 30) will be described.
As shown in FIGS. 2 to 5, the catheter 100 according to the present embodiment has a wire (reinforcing wire 32) braided covering the outer periphery of the inner layer 24 between the inner layer 24 and the coil (holding coil 70). A wire layer (wire reinforcing layer 30). As shown in FIGS. 2 and 3, a partial region of the wire layer (wire reinforcing layer 30) is embedded in the adhesive portion 74.

  As described above, since a part of the reinforcing wire 32 constituting the wire reinforcing layer 30 that goes around the outer periphery of the inner layer 24 is embedded in the adhesive portion 74, the adhesive portion 74 is separated from the outer periphery of the inner layer 24. Hard to peel. Since the adhesive portion 74 can satisfactorily maintain the predetermined position, loosening of the holding coil 70 embedded therein is prevented.

  The wire reinforcement layer 30 is a protective layer that is provided on the inner diameter side of the operation line 60 in the tubular body 10 and protects the inner layer 24. The presence of the wire reinforcing layer 30 on the inner diameter side of the operation line 60 prevents the operation line 60 from being exposed to the main lumen 20 by breaking the first outer layer 52 and the inner layer 24.

  The wire reinforcing layer 30 is formed by winding a reinforcing wire 32 in a coiled or mesh shape. More specifically, as the wire reinforcing layer 30 of this embodiment, a blade layer in which reinforcing wires 32 are braided in a mesh shape is illustrated. The first outer layer 52 is impregnated between the wire reinforcing layer 30 and the subtube 40. The number of the reinforcing wires 32, the coil pitch, and the number of meshes are not particularly limited. Here, the number of meshes of the wire reinforcing layer 30 refers to the number of intersections (number of eyes) per unit length (1 inch) viewed in the extending direction of the reinforcing wires 32.

  As shown in FIGS. 3 and 4, the distal end of the wire reinforcing layer 30 reaches the region where the first marker 14 is disposed. The distal end of the wire reinforcing layer 30 is located distal to the proximal end of the first marker 14, specifically, in the vicinity of the distal end of the first marker 14. Since the wire reinforcing layer 30 reaches the region where the first marker 14 is disposed, the discontinuity of the bending rigidity of the tubular body 10 at the proximal end of the first marker 14 is alleviated to prevent the occurrence of kinks. ing.

  Since the material of the reinforcing wire 32 can be the same material as that of the above-described coil wires 70a and 70b, detailed description thereof will be omitted here. In this embodiment, the reinforcing wire 32 is a fine stainless steel wire.

The catheter 100 in the present embodiment can further include a second reinforcing layer 80.
The second reinforcing layer 80 is a protective layer that is provided on the outer diameter side of the operation line 60 in the tubular body 10 and protects the second outer layer 54. The presence of the second reinforcing layer 80 on the outer diameter side of the operation line 60 causes the operation line 60 to be exposed to the outside of the tubular body 10 by breaking the second outer layer 54 and the hydrophilic layer (not shown). To prevent.

  The tubular body 10 of this embodiment includes three metal layers, that is, a wire reinforcing layer 30, a holding coil 70, and a second reinforcing layer 80. The holding coil 70 is located closer to the axial line than the second reinforcing layer 80. As described above, the holding coil 70 has its tip portion embedded in the bonding portion 74 to prevent loose winding. Therefore, it is avoided that the second reinforcing layer 80 receives a pressing force in the outward direction from the holding coil 70 due to the loosening of the holding coil 70.

  The distal end of the second reinforcing layer 80 is more proximal than the proximal end of the first marker 14 and more distal than the proximal end of the region where the second marker 16 is disposed. More specifically, the distal end of the second reinforcing layer 80 is located in the vicinity of the distal end of the second marker 16.

  The second reinforcing layer 80 is formed by winding the second reinforcing wire 82 into a coil or mesh shape. A material similar to that of the reinforcing wire 32 of the wire reinforcing layer 30 can be used for the second reinforcing wire 82. The second reinforcing wire 82 and the reinforcing wire 32 may be made of the same material or different materials. In this embodiment, the blade layer which braided the thin wire provided with the same kind of material (stainless steel) as the reinforcement wire 32 as the 2nd reinforcement wire 82 is illustrated.

  The second reinforcing layer 80 is a member that imparts bending elasticity to the tubular main body 10 together with the wire reinforcing layer 30. It is preferable that the tubular body 10 is elastically restored when the tensile load of the operation line 60 is removed after the distal end region of the tubular body 10 is bent by the pulling operation of the operation line 60. For this reason, it is preferable that the tubular main body 10 of this embodiment uses a spring metal material for the wire reinforcing layer 30 (reinforcing wire 32) and the second reinforcing layer 80 (second reinforcing wire 82). Therefore, the ductility of the holding coil 70 is higher than any of the ductility of the reinforcing wire 32 and the second reinforcing wire 82.

The subtube 40 is a hollow tubular member that defines a secondary lumen 42. The subtube 40 is embedded in the outer layer 50 (first outer layer 52). The subtube 40 can be made of, for example, a thermoplastic polymer material. Examples of the thermoplastic polymer material include low friction resin materials such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), or tetrafluoroethylene / hexafluoropropylene copolymer (FEP).
The subtube 40 is made of a material having a higher bending rigidity and tensile elastic modulus than the outer layer 50.

  The outer surface of the sub-tube 40 may be subjected to an etching process such as a metal sodium process or a plasma process. This improves the adhesion between the subtube 40 and the outer layer 50 and contributes to maintaining the predetermined position of the subtube 40.

  As shown in FIG. 2, a plurality of sub-tubes 40 are arranged facing the periphery of the main lumen 20. In the catheter 100 of the present embodiment, the two sub tubes 40 (40a, 40b) are arranged around the main lumen 20 so as to face each other by 180 degrees. The operation lines 60 are inserted into the sub tubes 40, respectively. The two sub tubes 40 are disposed in parallel to the axial direction of the tubular body 10. Since the inner layer 24 and the subtube 40 are wound together around the holding coil 70, the arrangement position of the subtube 40 with respect to the inner layer 24 is maintained well.

  As shown in FIG. 2, the plurality of sub-tubes 40 are arranged on the same circumference so as to surround the main lumen 20. Instead of this embodiment, three or four subtubes 40 may be arranged around the main lumen 20 so as to face each other at intervals of 120 degrees or 90 degrees, respectively. Five or more sub-tubes 40 may be arranged. The operation lines 60 may be disposed on all the sub tubes 40, or the operation lines 60 may be disposed on some of the sub tubes 40.

  The operation line 60 is loosely inserted in the sub tube 40 so as to be slidable. The distal end portion of the operation line 60 is fixed to the distal end region of the tubular main body 10. The tip of the operation line 60 may be fixed to the first marker 14 or may be embedded and fixed in the outer layer 50. By pulling the operation line 60 to the proximal end side, a tensile force is applied to a position eccentric with respect to the axis of the tubular body 10, so that the tubular body 10 bends. In the present embodiment, specifically, the distal end portion of the operation line 60 is fixed to a portion of the tubular body 10 that is more distal than the second marker 16. More specifically, the tip of the operation line 60 is fixed to the first marker 14. The mode of fixing the operation line 60 to the first marker 14 is not particularly limited, and examples thereof include solder bonding, heat fusion, adhesion with an adhesive, and mechanical engagement between the operation line 60 and the first marker 14. .

The operation wire 60 may be formed of a single wire, but may be a stranded wire formed by twisting a plurality of thin wires.
As the operation wire 60, low carbon steel (piano wire), stainless steel (SUS), steel wire coated with corrosion resistance, titanium or a titanium alloy, or metal wire such as tungsten can be used. In addition, the operation line 60 includes polyvinylidene fluoride (PVDF), high density polyethylene (HDPE), poly (paraphenylenebenzobisoxazole) (PBO), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), Polymer fibers such as polybutylene terephthalate (PBT), polyimide (PI), polytetrafluoroethylene (PTFE), or boron fiber can be used.

  A first marker 14 and a second marker 16 located on the proximal side of the first marker 14 are provided at the distal end region of the tubular body 10. The first marker 14 and the second marker 16 are ring-shaped members including a material that does not transmit radiation such as X-rays such as platinum. By using the positions of the two markers of the first marker 14 and the second marker 16 as an index, the position of the distal end of the tubular body 10 in the body cavity (blood vessel) can be visually confirmed under radiation (X-ray) observation. Thereby, the optimal timing for performing the bending operation of the catheter 100 can be easily determined.

As shown in FIGS. 1A and 1B, the catheter 100 has an operation unit 90.
The operation unit 90 illustrated in FIG. 1A includes a main body case 94 that is gripped by a user's hand, and a wheel operation unit 92 that is provided so as to be rotatable with respect to the main body case 94. The proximal end portion of the tubular main body 10 is introduced into the main body case 94.

  The catheter 100 includes a hub 96 provided in communication with the main lumen 20 of the tubular body 10. A syringe (not shown) is attached to the hub 96. The hub 96 is provided at the rear end portion of the main body case 94, and a syringe is mounted from the rear of the hub 96 (right side in FIG. 1A). By injecting the drug solution or the like into the hub 96 by the syringe, the drug solution or the like can be supplied into the body cavity of the subject through the main lumen 20.

  The tubular main body 10 has a side hole that communicates with the sub-tube 40 from the outer peripheral surface inside the front end portion of the main body case 94. The operation line 60 (see FIGS. 2 and 4) is drawn out of the tubular body 10 through this side hole. The proximal end portion of the drawn operation line 60 is directly or indirectly connected to the wheel operation unit 92. By rotating the wheel operation unit 92 in either direction, one of the two operation lines 60 can be pulled to the base end side to apply tension, and the other can be loosened. Thereby, the pulled operation line 60 bends the distal end region of the catheter 100. Specifically, as shown in FIG. 1B, when the wheel operation unit 92 is rotated in one direction (clockwise), one operation line 60 is pulled to the proximal end side, and the distal end region of the tubular body 10 is Bend. Although not shown, when the wheel operation unit 92 is rotated in the other direction (counterclockwise), the other operation line 60 is pulled to the proximal end side, and the distal end region of the tubular body 10 is bent in the opposite direction.

  A frame portion 95 is formed in the main body case 94 at a position in contact with the wheel operation portion 92. The frame portion 95 is provided with a slider 98 that slides forward and backward toward the wheel operation portion 92. A protrusion 99 is formed on an end portion of the slider 98 facing the wheel operation portion 92. When the slider 98 is slid toward the wheel operation unit 92, the protrusion 99 is hooked on the peripheral surface of the wheel operation unit 92 to restrict the rotation of the wheel operation unit 92. Thereby, the bent state of the catheter 100 can be maintained. FIG. 1A shows a state in which the protrusion 99 of the slider 98 and the wheel operation unit 92 are not engaged and the wheel operation unit 92 can rotate. FIG. 1B shows a state in which the protrusion 99 of the slider 98 and the wheel operation part 92 are engaged to restrict the rotation of the wheel operation part 92 and the bent state of the distal end region of the tubular main body 10 is maintained.

<Second embodiment>
A second embodiment of the present invention will be described below with reference to FIG. 6 by taking the catheter 200 as an example. FIG. 6 is a longitudinal sectional view of the catheter 200 according to the second embodiment, cut along the line III-III in FIG. The catheter 200 is different from the catheter 100 in matters described below, and other configurations are appropriately configured in the same manner as the catheter 100.

In the catheter 200, the adhesive portion 74 </ b> A forms one raised portion 75 that substantially protrudes toward the outer layer 50.
Here, “substantially” means that the outer edge adjacent to the outer layer 50 of the bonding portion 74 </ b> A does not have at least a recess that is recessed toward the inner layer 24. The outer edge includes a case where the entire outer edge protrudes toward the outer layer 50 and a case where a part of the outer edge is substantially parallel to the axis.
In other words, in the longitudinal cross section of the catheter 200, the outer edge adjacent to the outer layer 50 in the cross section of the bonding portion 74 observed on the upper side with the axis as the lower side has a gentle inverted U shape. The entire outer edge protrudes substantially on the outer layer 50 side.

  In the catheter 200, the distal end portion of the holding coil 70 is embedded in the adhesive portion 74 </ b> A that is the raised portion 75. Thereby, it is possible to ensure a sufficient distance from the outer periphery of the tip portion to the outer edge of the bonding portion 74A, and the embedded state of the tip portion can be stabilized. The distal end portion of the holding coil 70 in the catheter 200 is unlikely to be released from the fixed state caused by protruding the raised portion 75.

The embodiment of the present invention has been described above. The present invention is not limited to the above-described embodiment, and includes various modifications and improvements as long as the object of the present invention is achieved.
For example, in the first embodiment and the second embodiment, the holding coil 70 has been described as an example of the coil in the present invention. However, the coil is not limited to this.
For example, the wire reinforcing layer 30 described in the first embodiment is configured by a coil in which a wire is wound around the inner layer 24, and an adhesive portion that adheres the tip of the coil to the outer periphery of the inner layer 24. The present invention encompasses embodiments embedded in
Further, the first outer layer 52 and the inner layer 24 described in the first embodiment are used as inner layers, the second outer layer 54 is used as an outer layer, and the second reinforcing layer 80 is formed of a coil formed by winding wire. The present invention encompasses an embodiment in which the tip of the coil is embedded in an adhesive portion that adheres to the outer peripheral surface of the first outer layer 52.

The above embodiment includes the following technical idea.
(1) A long tubular body including a resin inner layer having a main lumen formed therein and a resin outer layer containing the inner layer,
A coil that is enclosed in the outer layer and is wound around the outer periphery of the inner layer in the axial direction of the tubular body, and has an adhesive portion that adheres to the outer peripheral surface of the inner layer and is different from the outer layer;
A medical device, wherein a tip end portion of the coil is embedded in the adhesive portion.
(2) a wire layer formed by braiding a wire covering the outer periphery of the inner layer between the inner layer and the coil;
The medical device according to (1), wherein a part of the wire layer is embedded in the adhesive portion.
(3) The medical device according to (1) or (2), wherein the bonding portion includes a resin material.
(4) The medical device according to (3), wherein a Shore hardness of a member constituting the adhesion portion is equal to or greater than a Shore hardness of a member constituting the outer layer disposed in the vicinity of the adhesion portion.
(5) The medical device according to (3) or (4), wherein a Vicat softening point of a member constituting the adhesive portion is higher than a Vicat softening point of a member constituting the outer layer.
(6) The coil is a multi-strand coil including two or more strands,
The medical device according to any one of (1) to (5), wherein tip ends of all the strands constituting the multi-strand coil are embedded in the adhesive portion.
(7) The coil is a multi-strand coil including two or more strands,
The outer peripheral surface of the bonding portion has a recess formed between the strands embedded in the bonding portion and adjacent in the axial direction.
The recess is recessed toward the inner layer side,
The medical device according to (6), wherein the inner peripheral surface of the outer layer has a convex portion that fits into the concave portion.
(8) The medical device according to (7), wherein the concave portion observed in the longitudinal section of the tubular main body forms an M shape.
(9) The medical device according to (7) or (8), wherein the concave portion extends along an extending direction of the strand embedded in the adhesive portion.
(10) The medical device according to any one of (1) to (6), wherein the bonding portion forms one raised portion that protrudes toward the outer layer.
(11) The medical device according to any one of (1) to (10), wherein the adhesive portion is locally provided in a partial region in the circumferential direction of the inner layer.
(12) One portion of one strand of the bonding portion that constitutes the coil and is embedded in the bonding portion, and one portion of the one strand adjacent to the one portion in the axial direction The medical device according to any one of (1) to (11), wherein the medical device is terminated with another portion.
(13) The tubular body includes the inner layer, a resin-made subtube disposed outside the inner layer and defining a sub-lumen having a smaller diameter than the main lumen, and the inner layer and the outer layer containing the subtube. And including
The coil is a holding coil that is included in the outer layer and winds the subtube and the inner layer together,
The medical device according to any one of (1) to (12), wherein a tip end portion of the holding coil is embedded in the adhesive portion.
(14) The medical device according to any one of (1) to (13), wherein the medical device is a catheter.
(15)
A resin-made inner layer having a main lumen formed therein, a resin-made subtube that is disposed outside the inner layer and defines a sub-lumen having a smaller diameter than the main lumen, and encloses the inner layer and the subtube A long tubular body including a resin outer layer;
An operation line that is movably inserted into the sub-lumen and has a tip connected to a distal portion of the tubular body;
An operation portion for pulling the operation line to bend the distal portion of the tubular body;
A holding coil included in the outer layer and wound together with the subtube and the inner layer,
A medical device having an adhesive portion formed on the outer peripheral surface of the inner layer, and a distal end portion of the holding coil embedded in the adhesive portion.

DESCRIPTION OF SYMBOLS 10 ... Tubular main body 14 ... 1st marker 16 ... 2nd marker 20 ... Main lumen 24 ... Inner layer 30 ... Wire reinforcement layer 32 ... Reinforcement wire 40 ... Sub Tube 42 ... Sub lumen 50 ... Outer layer 52 ... First outer layer 54 ... Second outer layer 60 ... Operation line 70 ... Holding coils 70a, 70b ... Coil element Wires 74, 74A ... Adhesive part 75 ... Raised part 76 ... Concave part 78 ... Convex part 80 ... Second reinforcing layer 82 ... Second reinforcing wire 90 ... Operation part 92- ..Wheel operation part 94... Body case 95... Frame part 96... Hub 98... Slider 99.

Claims (14)

A long tubular body including a resin inner layer having a main lumen formed therein, and a resin outer layer containing the inner layer,
A coil that is enclosed in the outer layer and is wound around the outer periphery of the inner layer in the axial direction of the tubular body, and has an adhesive portion that adheres to the outer peripheral surface of the inner layer and is different from the outer layer;
A medical device, wherein a tip end portion of the coil is embedded in the adhesive portion. A wire layer formed by braiding a wire covering the outer periphery of the inner layer between the inner layer and the coil;
The medical device according to claim 1, wherein a partial region of the wire layer is embedded in the adhesive portion.   The medical device according to claim 1, wherein the adhesive portion includes a resin material.   The medical device according to claim 3, wherein a Shore hardness of a member constituting the adhesion portion is equal to or greater than a Shore hardness of a member constituting the outer layer disposed in the vicinity of the adhesion portion.   The medical device according to claim 3 or 4, wherein a Vicat softening point of a member constituting the adhesive portion is higher than a Vicat softening point of a member constituting the outer layer. The coil is a multi-strand coil comprising two or more strands;
The medical device according to any one of claims 1 to 5, wherein tip portions of all the strands constituting the multi-strand coil are embedded in the adhesive portion. The coil is a multi-strand coil comprising two or more strands;
The outer peripheral surface of the bonding portion has a recess formed between the strands embedded in the bonding portion and adjacent in the axial direction.
The recess is recessed toward the inner layer side,
The medical device according to claim 6, wherein an inner peripheral surface of the outer layer has a convex portion that fits into the concave portion.   The medical device according to claim 7, wherein the concave portion observed in the longitudinal section of the tubular main body forms an M shape.   The medical device according to claim 7 or 8, wherein the recess extends along an extending direction of the strand embedded in the adhesive portion.   The medical device according to any one of claims 1 to 6, wherein the adhesive portion forms one raised portion that protrudes toward the outer layer side.   The medical device according to any one of claims 1 to 10, wherein the adhesive portion is locally provided in a partial region of the inner layer in a circumferential direction.   The bonded portion constitutes the coil and is embedded in the bonded portion, and one portion of the single strand is adjacent to the one portion in the axial direction. The medical device according to any one of claims 1 to 11, which terminates between The tubular body includes the inner layer, a resin-made subtube that is disposed outside the inner layer and defines a sub-lumen having a smaller diameter than the main lumen, and the inner layer and the outer layer containing the subtube. Including
The coil is a holding coil that is included in the outer layer and winds the subtube and the inner layer together,
The medical device according to any one of claims 1 to 12, wherein a distal end portion of the holding coil is embedded in the adhesive portion.   The medical device according to any one of claims 1 to 13, wherein the medical device is a catheter.

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