TW201442752A - Medical instrument and method of manufacturing medical instrument - Google Patents

Abstract

A catheter of the present invention includes a long tubular body, an operating line and an operating portion. The tubular body includes a long inner layer which draws a main lumen, a wire-reinforced layer which is formed by winding a reinforced wire around the inner layer, a plastic subtube which is assigned to extend along the longitudinal direction of the main lumen on the outside of the wire-reinforced layer and draws a sublumen which has a smaller diameter compared to the mainlumen, a plastic outer layer which includes the wire-reinforced layer and the subtube, and retaining wire. The operating line is housed inside the sublumen in a movable state and connected to the distal portion of the tubular body in its leading end. The retaining wire is included in the outer layer and binds the subtube and the wire-reinforced layer together. The retaining wire is impacted into the periphery of the outer diameter side of the subtube.

Description

Medical device and medical device manufacturing method

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

The present application claims priority based on Japanese Patent Application No. 2013-067082, filed on Jan. 27,,,,,,,,,,

There are known various medical devices such as catheters or endoscopes that introduce a medium or a machine into a body cavity. In recent years, not only endoscopes but also catheters have been provided with a direction in which the body cavity can be accessed by bending the distal end.

For example, Patent Document 1 discloses a catheter having a diameter of 180 degrees opposite to a central lumen defined by an inner layer (the main lumen). Line lumen (sub lumen: sub lumen). A direction line (hereinafter referred to as an operation line) is inserted into the sub-lumen, and the front end of the catheter is bent by operating the handle on the proximal end side to pull the operation wire.

In the catheter of Patent Document 1, two polymer tubes (hereinafter referred to as sub-lumen) are disposed along the outer surface of the thin inner layer including a fluorine-based resin material or the like (hereinafter referred to as A sub tube is inserted into the inside of the sub tube. In Patent Document 1, when the outer layer of the tubular body (outer sheath) is formed, a pressurized fluid is previously injected into the interior of the inner cavity to maintain the inner diameter against the compressive force of the inner cavity of the outer layer of the tubular body during thermoforming. .

[Previous Technical Literature] [Patent Literature]

[Patent Document 1] Japanese Patent Laid-Open Publication No. 2006-192269

However, since the compressive force which is burdened during hot forming of the outer layer of the tubular body is large, it is difficult to increase the pressure of the pressurized fluid to such an extent that the above-described compressive force is sufficiently offset. Further, if the internal pressure of the sub-tube is increased by the pressurized fluid slightly before the tubular body is compressed, the method of Patent Document 1 is accompanied by difficulty in the rupture of the sub-tube. Further, when the compressive force to be applied during hot forming of the outer layer of the tubular body is reduced, there is a possibility that the sub-tube is peeled off when the tubular body is bent when the tubular body is bent. The reason is that when the tubular body is pulled and the tubular body is bent, the secondary pipe is eccentric from the axial center and is located on the outer side or the inner side of the curved body. Therefore, the path length from the proximal end to the distal end is different from the axial center, and is outside the tubular body. The interface with the secondary pipe produces shear.

Here, although the catheter has been described as an example, the same problem is not limited to the catheter, but is a problem commonly caused by medical devices that are operated by the operation wire.

The present invention has been made in view of the above problems, and provides a medical device that can easily fix a sub-tube for inserting an operation wire to the tubular body without peeling off, and a method of manufacturing the same.

According to the present invention, there is provided a medical device comprising: a long tubular body comprising an inner layer defining a strip of a main lumen, and a reinforcing layer formed by winding a reinforcing wire around the inner layer Arranging on the outer side of the wire reinforcing layer so as to extend along the longitudinal direction of the main cavity, and defining a resin sub-tube having a diameter smaller than a sub-cavity of the main cavity, and the wire reinforcing layer and the sub-tube An outer layer made of resin; an operation wire movably inserted into the inner side of the sub-lumen and having a front end connected to a distal portion of the tubular body; and an operation portion that pulls the operation wire to cause the tubular body to Above At least a portion of the portion of the bit portion is curved; and the tubular body further includes a retaining wire encased in the outer layer, and the sub-tube is wound together with the wire reinforcing layer; the retaining wire is embedded outside the sub-tube The circumferential side of the radial side.

According to the above-mentioned medical device, the holding wire for winding the sub-tube through which the operation wire is inserted and the wire reinforcing layer are wrapped in the outer layer in a state of being fitted to the circumferential surface of the outer diameter side of the sub-tube. Therefore, the holding wire becomes an anchor with respect to both the sub-pipe and the outer layer, and therefore, peeling of the sub-tube and the outer layer can be prevented.

Further, according to the present invention, there is provided a method of manufacturing a medical device, comprising the steps of: preparing an inner structure comprising a long main core wire and winding a reinforcing wire around the main core wire; a wire reinforcing layer; a long sub-core wire covered with a resin-made sub-tube along the main core wire is disposed on the outer peripheral surface of the wire reinforcing layer, and is pressed against the surface of the sub-tube while being held by the holding surface The secondary tube is wound together with the wire reinforcing layer; the inner layer is wrapped with the wire reinforcing layer and the wire reinforcing layer and the holding wire to form an outer layer, thereby forming a tubular body; and the secondary core wire is expanded And reducing the diameter and peeling off from the sub-tube to form a sub-lumen; and removing the main core wire from the tubular body to form a main cavity.

According to the present invention, the sub-tube for inserting the operation wire can be easily fixed without being peeled off with respect to the tubular body by the holding wire in the medical machine.

10‧‧‧Tube body

14‧‧‧ first mark

16‧‧‧second mark

20‧‧‧Supervisor

22‧‧‧ main core

24‧‧‧ inner layer

26‧‧‧The inner structure

30‧‧‧Line reinforcement

32‧‧‧Strengthen line

40‧‧‧Sub-management

40a‧‧‧Sub-management

40b‧‧‧Sub-management

42‧‧‧Sub-luminal

44‧‧‧Subcore

46‧‧‧With core tube

50‧‧‧ outer layer

52‧‧‧ first outer layer

54‧‧‧ second outer layer

56‧‧‧Next material

60‧‧‧Operation line

70‧‧‧ Keep the line

70a‧‧‧coil stranded wire (holding wire)

70b‧‧‧ coil stranded wire (holding wire)

71‧‧‧Endpoint

72‧‧‧End

74‧‧‧Winding point

80‧‧‧Second reinforcement

82‧‧‧second reinforcement line

90‧‧‧Operation Department

92‧‧‧Revolving Operation Department

94‧‧‧ body shell

95‧‧‧ recess

96‧‧‧ sleeve

98‧‧‧ Slider

99‧‧‧ Protrusion

100‧‧‧ catheter

110‧‧‧Insert fixture

112‧‧‧through hole

114‧‧‧Main through hole

120‧‧‧Winding machine

122‧‧‧ spool head

126‧‧‧Scratch

D‧‧‧ embedded depth

DE‧‧‧ Remote Department

L1‧‧‧First length area

L1a‧‧‧First length area

L1b‧‧‧First length area

L2‧‧‧Second length area

L2a‧‧‧Second length area

L2b‧‧‧Second length area

W‧‧‧Mesh size in the circumferential direction

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a schematic cross-sectional view taken along line III-III of Fig. 3 in a front end portion of a catheter according to an embodiment of the present invention.

Figure 2 is a schematic enlarged cross-sectional view of the retaining wire and the secondary pipe.

Fig. 3 is a schematic longitudinal cross-sectional view showing a front end portion of a catheter according to an embodiment of the present invention.

4 is a longitudinal cross-sectional view showing a first length region and a second length region of the sub-tube.

Fig. 5(a) is a partial cross-sectional view taken along line V-V of Fig. 4 associated with the first sub-tube. Fig. 5(b) is a partial cross-sectional view taken along line V-V of Fig. 4 associated with the second sub-tube.

Fig. 6(a) is a partial cross-sectional view taken along line VI-VI of Fig. 4, which is a cross-sectional view relating to a second length region of the first sub-tube. Figure 6(b) is a partial cross-sectional view taken along line VI-VI of Figure 4, and is a cross-sectional view relating to the first length region of the second sub-tube.

Figure 7 is a side elevational view of the distal portion of the tubular body.

Fig. 8 (a) is an overall side view of a catheter according to an embodiment of the present invention. Fig. 8 (b) is a general side view showing the catheter in a state in which the rotor operating portion is operated in one direction. Fig. 8 (c) is an overall side view showing the catheter in a state in which the turning operation portion is operated in the other direction.

Fig. 9 is a schematic longitudinal cross-sectional view showing an inner structure in which an inner layer and a wire reinforcement layer are formed around a main core wire.

Fig. 10 is a schematic side view showing a core tube in which a sub-tube is formed around a sub-core wire.

Fig. 11 is a perspective view schematically showing a winding step of a holding wire.

Fig. 12 is a side view showing a state in which a second reinforcing wire is wound around the outer side of the holding wire.

Hereinafter, embodiments of the present invention will be described based on the drawings. In the drawings, the same components are denoted by the same reference numerals, and the detailed description thereof is omitted as appropriate. Further, in order to clarify the characteristic portions, the scales are not necessarily identical to the actual ones in all the drawings, and the scales are also different between the respective drawings.

The outline of the medical device of the present embodiment will be described with reference to Figs. 1 to 8 . Fig. 1 is a cross-sectional view (cross-sectional view) showing a vicinity of a front end portion of a catheter 100 perpendicularly cut with respect to a longitudinal direction. 2 is an enlarged cross-sectional view of the holding wire 70 and the sub-tube 40. 3 is a cross-sectional view (longitudinal cross-sectional view) obtained by cutting the vicinity of the front end portion of the catheter 100 in the longitudinal direction, and simplifies the first outer layer 52 and the second outer layer 54 and is collectively shown as the outer layer 50. Also, Figure 1 is a diagram of Figure 3. Section III-III line diagram. 4 is a longitudinal cross-sectional view schematically showing the first length region L1 and the second length region L2 of the sub-tube 40, and the inner layer 24, the wire reinforcement layer 30, the second reinforcement layer 80, and the second mark 16 are omitted from illustration. . Further, in FIG. 4, the first outer layer 52 and the second outer layer 54 are simplified and collectively illustrated as the outer layer 50. Fig. 5(a) is a partial cross-sectional view taken along line V-V of Fig. 4, and is a cross-sectional view relating to the first length region L1a of the first sub-tube 40a. Fig. 5 (b) is a partial cross-sectional view taken along line V-V of Fig. 4, and is a cross-sectional view relating to the second length region L2b of the second sub-tube 40b. Fig. 6(a) is a partial cross-sectional view taken along line VI-VI of Fig. 4, and is a cross-sectional view relating to the second length region L2a of the first sub-tube 40a. Figure 6(b) is a partial cross-sectional view taken along line VI-VI of Figure 4, and is a cross-sectional view relating to the first length region L1b of the second sub-tube 40b. Regarding Fig. 8, it will be described below.

In the present embodiment, the catheter 100 is exemplified as a medical device. In addition to the catheter 100, the present invention can also be applied to endoscopes and other medical devices that can pull the operation wire 60 and bend at least a portion of the distal portion DE.

In the present invention, the terminus (portion) or the distal end (portion) refers to the end (portion) of the tubular body 10 opposite to the side to which the operation portion 90 is connected, and the so-called distal portion DE (front end) Department) means a certain area containing the front end (distal end).

The catheter 100 of the present embodiment includes a long tubular body 10, an operation wire 60, and an operation portion 90. The tubular body 10 comprises: a strip inner layer 24 defining a main tube cavity 20; a wire reinforcement layer 30 wound around the main tube cavity 20 (inner layer 24) with a reinforcing wire 32; a resin strip The sub-tube 40 is disposed on the outer side of the wire reinforcement layer 30 so as to extend along the longitudinal direction of the main pipe cavity 20, and defines a sub-cavity 42 having a diameter smaller than that of the main pipe cavity 20; and an outer layer 50 made of resin. The reinforcing layer 30 and the sub-tube 40; and the holding wire 70. The operating wire 60 is movably inserted into the interior of the secondary lumen 42 and the front end is coupled to the distal portion DE of the tubular body 10. The operation portion 90 pulls the operation wire 60 to bend at least a portion of the distal portion DE of the tubular body 10. The holding wire 70 is wrapped in the outer layer 50, and the sub-tube 40 is wound together with the wire reinforcing layer 30.

The catheter 100 of the present embodiment is characterized in that the holding wire 70 is fitted to the circumferential surface of the outer diameter side of the sub-tube 40.

Hereinafter, this embodiment will be described in detail. The catheter 100 of the present embodiment is an intravascular catheter that is used to insert the tubular body 10 into a blood vessel.

The tubular body 10, also referred to as an outer sheath, is internally formed with a hollow tubular and elongated member of a main lumen 20 in the form of a through hole. More specifically, the tubular body 10 is formed to have an outer diameter and a length that can enter any of the eight sub-regions of the liver.

The tubular body 10 has a laminated construction. A main portion of the tubular body 10 is formed by sequentially laminating the inner layer 24, the first outer layer 52, and the second outer layer 54 from the inner diameter side centering on the main chamber 20. A hydrophilic layer (not shown) is formed on the outer surface of the second outer layer 54. The inner layer 24, the first outer layer 52, and the second outer layer 54 comprise flexible resin materials each having an annular shape and having a substantially uniform thickness. The first outer layer 52 and the second outer layer 54 are sometimes combined to be referred to as an outer layer 50.

The inner layer 24 is the innermost layer of the tubular body 10, and the main chamber 20 is defined by its inner wall surface. The cross-sectional shape of the main pipe 20 is not particularly limited, and is circular in the present embodiment. In the case of the main cavity 20 having a circular cross section, the diameter may be uniform throughout the length of the tubular body 10, or may be different depending on the position in the longitudinal direction. For example, the diameter (cavity) of the main lumen 20 may be continuously tapered from the front end toward the base end in a part or all of the length region of the tubular body 10.

The material of the inner layer 24 is, for example, a fluorine-based thermoplastic polymer material. Specific examples of the fluorine-based thermoplastic polymer material include polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), and perfluoroalkoxy fluororesin (PFA, perfluoroalkoxy). ). By constituting the inner layer 24 using the fluorine-based polymer material as described above, the delivery property when the chemical solution or the like is supplied through the main chamber 20 is good. Moreover, when the wire is inserted into the main chamber 20, the sliding resistance of the wire is lowered.

The outer layer 50 constitutes the main wall thickness of the tubular body 10. 50 layers of the outer layer of this embodiment The first outer layer 52 having an annular shape and having a retaining wire 70 therein; and a second outer layer 54 having an annular shape, is disposed around the first outer layer 52 and enclosing the second reinforcing layer 80.

Inside the first outer layer 52 corresponding to the inner layer of the outer layer 50, the wire reinforcing layer 30, the sub-tube 40, and the holding wire 70 are sequentially disposed from the inner diameter side. A second reinforcement layer 80 is disposed inside the second outer layer 54 corresponding to the outer layer of the outer layer 50. The second reinforcement layer 80 is in contact with the outer surface of the first outer layer 52. The wire reinforcement layer 30 and the second reinforcement layer 80 are disposed coaxially with the tubular body 10. The second reinforcement layer 80 is disposed so as to surround the line reinforcement layer 30 and the periphery of the sub-tube 40 so as to be spaced apart from each other.

As the material of the outer layer 50, a thermoplastic polymer material can be used. Examples of the thermoplastic polymer material include polyimine (PI), polyacrylimide (PAI), polyethylene terephthalate (PET), and polyethylene (PE). ,polyethylene), polyamine (PA), polyamide elastomer (PAE, Polyamide Elastomer), polyether block amide (PEBA), nylon elastomers, polyurethanes PU, polyurethane), ethylene vinyl acetate (EVA), polyvinyl chloride (PVC), or polypropylene (PP).

An inorganic filler may also be mixed in the outer layer 50. As the inorganic filler, a contrast agent such as barium sulfate or barium hypocarbonate can be exemplified. By mixing the contrast agent in the outer layer 50, the X-ray contrast of the tubular body 10 in the body cavity can be improved.

The first outer layer 52 and the second outer layer 54 comprise the same or different kinds of resin materials. In Fig. 1, the interface between the first outer layer 52 and the second outer layer 54 is clearly illustrated, but the invention is not limited thereto. When the first outer layer 52 and the second outer layer 54 are formed by the same resin material, the interface between the two layers can be integrally integrated. That is, the outer layer 50 of the present embodiment may be composed of a plurality of layers in which the first outer layer 52 and the second outer layer 54 are mutually distinguishable, or may be formed as a single layer in which the first outer layer 52 and the second outer layer 54 are integrated.

The wire reinforcing layer 30 is disposed on the inner diameter side of the operating wire 60 in the tubular body 10 and is protected. The protective layer of the inner layer 24 is protected. By the presence of the wire reinforcing layer 30 on the inner diameter side of the operation wire 60, the operation wire 60 is prevented from being broken by the first outer layer 52 and the inner layer 24 to be exposed to the main chamber 20.

The wire reinforcing layer 30 is formed by winding a reinforcing wire 32. For the material of the reinforcing wire 32, in addition to the metal materials such as tungsten (W), stainless steel (SUS), nickel-titanium alloy, steel, titanium, copper, titanium alloy or copper alloy, the shear strength may be higher than the inner layer 24 and The first outer layer 52 is a resin material such as polyimine (PI), polyamidimide (PAI) or polyethylene terephthalate (PET). In the present embodiment, a thin line of stainless steel is used as the reinforcing wire 32.

The wire reinforcing layer 30 is formed by winding or braiding the reinforcing wire 32 into a mesh shape. The number of 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 intersecting per unit length (1 inch) (the number of holes) observed in the extending direction of the reinforcing wire 32. Further, the parameter expressed by the following formula (1) is referred to as the mesh size of the wire reinforcing layer 30 observed in the extending direction of the reinforcing wire 32.

Mesh size in the direction of line extension = unit length (1 inch) / grid number line diameter... (1)

With respect to the second reinforcing layer 80 to be described later, the mesh size of the obtained second reinforcing layer 80 is also observed by the above formula (1) defined in the extending direction of the second reinforcing wire 82.

The reinforcing wire 32 is wound around the inner layer 24 obliquely. The angle formed by the direction in which the reinforcing wires 32 extend with respect to the diameter direction of the inner layer 24 is referred to as the pitch angle of the reinforcing wires 32. When the reinforcing wire 32 is wound at a close pitch, the pitch angle becomes a smaller angle. Conversely, when the reinforcing wire 32 is wound at a shallow angle along the axis of the tubular body 10, the pitch angle becomes a larger angle close to 90 degrees. The pitch angle of the reinforcing wire 32 of the present embodiment is not particularly limited, and may be 30 degrees or more, and preferably 45 degrees or more and 75 degrees or less.

Here, the parameter represented by the following formula (2) is referred to as the mesh size W in the circumferential direction of the wire reinforcing layer 30 (refer to FIG. 1).

The mesh size in the circumferential direction W = (unit length (1 inch) / grid number - the diameter of the reinforcing line 32) × √ 2... (2)

The mesh size W in the circumferential direction of the wire reinforcing layer 30 is the length of the diagonal when the mesh shape of the wire reinforcing layer 30 is regarded as a square as viewed in the extending direction of the reinforcing wire 32.

As the wire reinforcing layer 30 of the present embodiment, a braid layer in which the reinforcing wire 32 is knitted is exemplified. The mesh size W in the circumferential direction of the wire reinforcing layer 30 (woven layer) represented by the above formula (2) is larger than the outer diameter of the sub-tube 40 as shown in FIG. The first outer layer 52 is impregnated between the wire reinforcement layer 30 and the sub-tube 40. That is, regardless of the positional relationship between the intersecting position (the position of the hole) of the reinforcing wire 32 which is meshed, and the positional relationship of the sub-tube 40, any mesh of the wire reinforcing layer 30 is not completely shielded by the sub-tube 40. Thereby, in the manufacturing step described later, the first outer layer 52 is impregnated into the inside of the mesh from the periphery of the sub-tube 40, and the inner layer 24, the wire reinforcing layer 30, and the sub-tube 40 are integrally fixed.

The second reinforcement layer 80 is a protective layer disposed in the tubular body 10 on the outer diameter side of the operation wire 60 and protecting the second outer layer 54. By the presence of the second reinforcing layer 80 on the outer diameter side of the operation wire 60, the operation wire 60 is prevented from being broken by the second outer layer 54 and the hydrophilic layer (not shown) to be exposed to the outside of the tubular body 10.

The second reinforcing layer 80 is formed by coiling or knitting the second reinforcing wire 82 into a mesh shape. For the second reinforcing wire 82, the above-described materials exemplified as the reinforcing wire 32 of the wire reinforcing layer 30 can be used. The second reinforcing wire 82 and the reinforcing wire 32 may be of the same material or may be of different materials. In the present embodiment, as the second reinforcing wire 82, a woven layer obtained by knitting a thin wire of the same material (stainless steel) as the reinforcing wire 32 into a mesh shape is exemplified.

The wire diameter of the second reinforcing wire 82 and the reinforcing wire 32 may be the same or may be different. In the present embodiment, the second reinforcing wire 82 and the reinforcing wire 32 are the same wire diameter.

Further, the number of the reinforcing wires 32 constituting the wire reinforcing layer 30 and the number of the second reinforcing wires 82 constituting the second reinforcing layer 80 are not particularly limited, and are the same in the present embodiment. In FIG. 1, a braid layer including 16 lines (reinforcing line 32 and second reinforcing line 82) is illustrated for both the line reinforcing layer 30 and the second reinforcing layer 80, respectively.

The secondary tube 40 is a hollow tubular member that defines the secondary lumen 42. The sub-tube 40 is embedded inside the outer layer 50 (first outer layer 52). The sub-tube 40 can be constructed, for example, from a thermoplastic polymer material. As the above thermoplastic polymer material, polytetrafluoroethylene (PTFE), polyether ether ketone (PEEK, Polyetheretherketone) or tetrafluoroethylene can be cited. Low friction resin material such as hexafluoropropylene copolymer (FEP, Fluorinated ethylene propylene).

The secondary tube 40 includes a material having a flexural stiffness modulus and a tensile modulus of elasticity higher than the outer layer 50.

The outer surface of the sub-tube 40 is subjected to an etching treatment such as metal sodium treatment or plasma treatment. Thereby, the adhesion between the sub-tube 40 and the outer layer 50 is improved.

In the present embodiment, the plurality of sub-tubes 40 are disposed opposite to each other around the main chamber 20. More specifically, as shown in FIG. 1, four sub-tubes 40 are disposed opposite to each other at intervals of 90 degrees around the line reinforcing layer 30, and two sub-tubes 40 that are opposed by 180 degrees are respectively inserted therein. There is an operation wire 60. The four sub-tubes 40 are arranged in parallel with respect to the axial direction of the tubular body 10, respectively.

That is, in the present embodiment, the three or more sub-tubes 40 are equally disposed around the main chamber 20 and opposed to each other. As shown in FIG. 1, the four sub-tubes 40 are disposed on the same circumference so as to surround the main pipe 20. Instead of the present embodiment, three or less sub-tubes 40 or more may be disposed at equal intervals around the main chamber 20. By arranging three or more sub-tubes 40 at equal intervals around the main pipe cavity 20, the bending rigidity of the tubular body 10 is equal regardless of the bending direction of the tubular body 10. Therefore, when the tubular body 10 is rotated in a curved state by the torque, at least a part of the region of the distal portion DE can be smoothly pointed in the desired direction.

The operation wire 60 is movably inserted so as to be slidable relative to the sub-tube 40. The front end of the operation wire 60 is fixed to the distal portion DE of the tubular body 10. Specifically, the operation wire 60 of the present embodiment is fixed to the vicinity of the first mark 14 to be described later. By pulling the operation wire 60 toward the proximal end side, a tensile force is applied to a position eccentric with respect to the axial center of the tubular body 10, and therefore, the tubular body 10 is bent. Since the operation wire 60 of the present embodiment is extremely thin and has high flexibility, even if the operation wire 60 is pressed toward the distal side, the distal portion DE of the tubular body 10 is not substantially applied. Give the pressing force.

The operation wire 60 may be composed of a single wire or a twisted wire formed by twisting a plurality of thin wires. The number of the thin wires constituting one of the twist lines of the operation wire 60 is not particularly limited, but is preferably three or more. A preferred example of the number of thin lines is 7 or 3.

In the case where the operation wire 60 includes a twisted wire of a single wire, the diameter of the single wire is referred to as the wire diameter of the operation wire 60. In the case where the operation wire 60 is a twisted wire in which a plurality of twisted wires are twisted together, the diameter of the tangential circle including the plurality of twisted wires is referred to as the wire diameter of the operation wire 60.

As the operation wire 60, a metal wire such as a low carbon steel (piano wire), stainless steel (SUS), a corrosion-resistant steel wire, titanium or a titanium alloy, or tungsten can be used. In addition, as the operation wire 60, polyvinylidene fluoride (PVDF), high density polyethylene (HDPE, High Density Polyethylene), polyparaphenylene benzobis can be used. Pyroline (PBO, Poly-p-phenylenebenzobisthiazole), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), polybendyleneimine (PI), polymer fiber such as polytetrafluoroethylene (PTFE) or boron fiber.

The holding wire 70 is a member of the present embodiment in which the sub-tube 40 is wound together with the wire reinforcing layer 30. The holding wire 70 is wound around a sub-tube 40 or woven into a mesh. In addition, the holding wire 70 of this embodiment is a coil, and more specifically, a coil (a plurality of coils) in which a plurality of the holding wires 70 are wound in a plurality of pieces.

As shown by the broken line in Fig. 1, the shape of the holding layer formed by winding the holding wire 70 in the present embodiment is such that the sub-tube 40 has a substantially polygonal shape. When three or more (N) sub-pipes 40 are evenly distributed around the main pipe cavity 20, the winding shape of the holding wire layer constituted by the holding wire 70 sets each sub-tube 40 to a corner rounded corner N. Edge shape. More specifically, in the present embodiment in which the four sub-tubes 40 are uniformly disposed around the main pipe cavity 20, the winding shape of the holding wire layer is rounded square. Keeping the line layer holding line 70 is evenly arranged in the main The outer side of the plurality of sub-tubes 40 around the lumen 20 is spirally wound. By the action of the winding tension applied to the holding wire 70, the holding wire 70 is pulled in a substantially linear shape at the intermediate portion between the sub-tubes 40. However, when the flexural rigidity of the holding wire 70 is large or the winding tension is small, the retaining wire 70 may be curved in an arc shape at the intermediate portion of the sub-tubes 40. In this case, the wound shape of the wire layer may be substantially circular.

The holding wire 70 may be in contact with the surface of the wire reinforcing layer 30 in addition to the outer surface of the sub-tube 40.

The holding wire 70 is caught and fitted into the circumferential surface of the sub-tube 40, specifically, the outer surface opposite to the axial center of the main pipe cavity 20. Thereby, the relative movement of the holding wire 70 and the sub-tube 40 in the axial direction can be restricted.

When the tubular body 10 is bent, the outer side of the bend expands and the inner side is compressed. As described above, the sub-tube 40 includes a material having a flexural rigidity modulus and a tensile elastic modulus higher than that of the outer layer 50, and therefore, the outer layer 50 is softly expanded or compressed, whereas the extension or compression of the sub-tube 40 is small. Therefore, when the tubular body 10 is bent, a shearing force is generated at the interface between the sub-tube 40 and the outer layer 50, but the retaining wire 70 functions as a fixed anchor that engages with respect to both the outer layer 50 and the sub-tube 40, and holds the wire. 70 elastic deformation occurs to alleviate the above shearing force. Thereby, peeling of the interface between the sub-tube 40 and the outer layer 50 (hereinafter referred to as interface peeling) can be prevented.

Here, the holding line 70 is embedded in the circumferential surface of the sub-tube 40, referring to a cross section of at least one portion of the tubular body 10, and a part or all of the holding line 70 is located on the imaginary surface of the outer circumference of the sub-tube 40 (imaginary shape) ) more on the inside. The imaginary surface (imaginary shape) of the outer circumference of the sub-pipe 40 means the imaginary outer peripheral surface of the sub-tube 40 when the holding wire 70 is not embedded. The virtual outer shape of the sub-tube 40 can be obtained from the outer peripheral surface of the other portion of the sub-tube 40 that is close to the axial direction with respect to the fitting portion of the holding wire 70.

The holding wire 70 is fitted into the circumferential surface of the sub-tube 40 and includes at least the following two states.

The first state is as shown in FIG. 5(b) and FIG. 6(a), and the sub-tube 40 is embedded in the holding line 70. The state of this embodiment which is partially thinned. The sub-tube 40 of the present embodiment is partially thinned in thickness while maintaining a circular cross-sectional shape.

In the second state, in place of the present embodiment, the cross-sectional shape of the sub-tube 40 is uniform throughout the entire circumference and has a concave shape as a whole. In other words, the cross-sectional shape of the second state system sub-tube 40 forms a concave shape such as a concave circular shape or a concave oval shape (kidney shape or jade shape). The state in which the holding wire 70 is fitted to the recessed portion also means that the holding wire 70 is fitted to the circumferential surface of the sub-tube 40.

The distance from the imaginary surface (imaginary shape) from the outer circumference of the sub-tube 40 to the deepest portion of the holding line 70 in the cross section of the insertion portion of the holding wire 70 is set as the holding line 70 with respect to the circumferential surface of the sub-tube 40. Embed depth D (refer to Figure 2). The insertion depth D in the catheter 100 of the present embodiment is smaller than the wall thickness of the sub-tube 40. The embedding depth D may also be equal to the wall thickness of the sub-tube 40 or may be greater than the wall thickness of the sub-tube 40.

The retaining wire 70 is wound over substantially the entire length of the sub-tube 40 as viewed in the longitudinal direction of the tubular body 10. Thereby, the relative position of the wire reinforcing layer 30 and the sub-tube 40 is fixed by the holding wire 70 in a state where the pair of sub-tubes 40 are kept parallel to the axial direction of the tubular body 10 along the surface of the wire reinforcing layer 30.

As the material of the holding wire 70, any of the above-described metal materials or resin materials usable as the reinforcing wire 32 can be used. In the present embodiment, the holding wire 70 contains a material different from the reinforcing wire 32. The ductility of the retention wire 70 is preferably higher than the ductility of the reinforcement wire 32. Specifically, on the one hand, a soft stainless steel (W1 or W2) or a copper or a copper alloy of Worthite iron as an annealing material can be used for the holding wire 70, and tungsten or stainless spring steel can be used for the reinforcing wire 32 on the other hand.

When the holding wire 70 is made of a material having high ductility, the holding wire 70 is wound around the sub-tube 40 or woven into a mesh shape (coil winding in the present embodiment), the holding wire 70 does not The winding slack is generated and plastically elongated and deformed, thereby fixing the sub-tube 40. On the other hand, the wire reinforcing layer 30 is a member for preventing the occurrence of kinking of the tubular body 10 as will be described later. Therefore, it is preferable to use a spring-like material having a high elastic restoring force.

The state in which the holding wire 70 of the present embodiment is fitted to the sub-tube 40 will be specifically described with reference to Figs. 4 to 6 .

In the catheter 100 of the present embodiment, the first length region L1 and the second length region L2 are arranged in the axial direction of the tubular body 10. The first length region L1 is a region of at least one of the sub-tubes 40, and the embedding depth D of the holding wire 70 with respect to the circumferential surface thereof is a specific depth. The second length region L2 is a region in which the embedding depth D is deeper than the first length region L1 (refer to FIG. 4). That is, regarding the first sub-tube 40a, the first length region L1 (L1a) is a region in which the holding wire 70 is relatively shallowly embedded (refer to FIG. 5(a)), and the second length region L2 (L2a) is a holding wire 70 A region that is deeply embedded (see Figure 6(a)).

Here, the second length region L2 requires the holding wire 70 to be recessed into the sub-tube 40, whereas the first length region L1 allows the holding wire 70 to be in non-embedded contact with the surface of the sub-tube 40. That is, regarding the second length region L2, the depth D>0 is embedded, and regarding the first length region L1, the depth D≧0 is embedded.

As described above, in the first sub-pipe 40a to which the traction force is inserted through the operation wire 60, the region where the depth D of the holding wire 70 is deep is overlapped with the shallow region. Therefore, when the operation wire 60 of the first sub-tube 40a is pulled and the first sub-tube 40a receives the compressive force, the retaining wire 70 is firmly anchored to the first sub-tube 40a in the second length region L2a. When the holding wire 70 is uniformly fitted into the first sub-pipe 40a over the entire length, the interface peeling is extended in the axial direction when the interface between the outer layer 50 and the first sub-tube 40a is peeled off. On the other hand, by locally having the second length region L2a having a large insertion depth D, the stretching of the interface peeling is stopped by the second length region L2a. Therefore, the interface peeling of the first sub-tube 40a and the outer layer 50 can be satisfactorily prevented.

Regarding the first sub-tube 40a, the first length region L1a and the second length region L2a are present in the axial direction of the tubular body 10 repeatedly for a plurality of times. Therefore, even if the peeling occurs at any position in the axial direction, the stretching of the peeling is immediately stopped by the second length region L2a in the vicinity.

In the present embodiment, the operation wire 60 is inserted into the first sub-tube 40a and the second sub-tube 40b which face each other. The first sub-tube 40a and the second sub-tube 40b have first length regions L1a and L1b and second length regions L2a and L2b, respectively. Specifically, with respect to the second sub-tube 40b, the first length region L1b is a region in which the holding wire 70 is relatively shallowly embedded (refer to FIG. 6(b)), and the second length region L2b is embedded in the retaining wire 70 relatively deeply. The area (see Figure 5(b)).

By having the first length region L1 and the second length region L2 with respect to the plurality of sub-tubes 40 having the operation wires 60 inserted therein, even if any of the sub-tubes 40 are peeled off, the sub-tube 40 is not in the outer layer. 50 internal detachment.

Regarding both of the first sub-tube 40a and the second sub-tube 40b, the first length regions L1a and L1b and the second length regions L2a and L2b are repeated in the axial direction for a plurality of times. Therefore, even if any operation line 60 is pulled and the interface is peeled off at any of the first sub-tube 40a and the second sub-tube 40b, the extension is immediately stopped by the second length regions L2a, L2b.

The first length region L1a of the first sub-tube 40a and the first length region L1b of the second sub-tube 40b exist at different positions in the axial direction. That is, when the first length regions L1a and L1b are repeated in the axial direction for a plurality of times, respectively, at least one first length region L1a exists in the first length region L1b which is opposite to and in the circumferential direction of the tubular body 10 Different positions in the direction of the axis.

Further, the second length region L2a of the first sub-tube 40a and the second length region L2b of the second sub-tube 40b are located at different positions in the axial direction. That is, when the second length regions L2a and L2b are repeated in the axial direction for a plurality of times, respectively, at least one second length region L2a exists in the second length region L2b which is opposite to and in the circumferential direction of the tubular body 10 Different positions in the direction of the axis.

Here, the two length regions exist at different positions in the axial direction, and when viewed from the axial direction of the tubular body 10, one length region is completely overlapped with another length region or one length region is included in the other. The case of the length area is excluded from the purpose. That is, the first length regions L1a and L1b may be located at positions that are not completely repeated in the axial direction, or may be repeated for a portion of the length regions. The same applies to the second length regions L2a and L2b.

Thus, with respect to the first sub-tube 40a and the second sub-tube 40b facing in the circumferential direction of the tubular body 10, the first length regions L1a and L1b having a small insertion depth D are located at different positions, or the embedding depth D is large. The second length regions L2a and L2b are located at different positions. Thereby, it is possible to suppress occurrence of interfacial peeling at the same position in the axial direction of the first sub-tube 40a and the second sub-tube 40b. Therefore, it is possible to reduce the fear that the tubular body 10 generates a length region in which the press-in rigidity is weak.

The first length region L1a of the first sub-tube 40a and the second length region L2b of the second sub-tube 40b are present at the same position in the axial direction. Further, the second length region L2a of the first sub-tube 40a and the first length region L1b of the second sub-tube 40b are present at the same position in the axial direction.

Here, the two length regions exist at the same position in the axial direction, which means that when viewed from the axial direction of the tubular body 10, one length region is substantially overlapped with another length region or a length region is included in another A length area. However, it is not excluded that one of the length regions or the other of the length regions is slightly offset from each other in the axial direction.

The holding length 70 is periodically changed with respect to the winding tension of the sub-tube 40, and the holding wire 70 is spirally wound, whereby the first length region L1 and the second length region L2 can be formed as in the present embodiment. The specific method will be described below.

The length of the axial direction of the first length region L1 and the second length region L2 is equal to the winding pitch of the holding wire 70 or an integral multiple of 1/2 of the winding pitch. In the case where the holding wire layer is a coil in which the holding wire 70 is wound in a plurality of pieces, the winding pitch of the holding wire 70 refers to the circuit interval in the case where one of the holding wires 70 is focused. The holding layer of the present embodiment includes a plurality of coils of two coil strands (holding wires 70). In Figure 4, an illustration The one length region L1 and the second length region L2 are repeated every 1.5 loops. In this case, the length of the axial direction of the first length region L1 and the second length region L2 corresponds to 1.5 times the winding pitch of the coil strands constituting the holding wire 70.

The tubular body 10 is provided on the outer side of the holding wire 70 with a second reinforcing layer 80 in which the second reinforcing wire 82 is wound in a circular cross section. The second reinforcing layer 80 of the present embodiment is a woven layer obtained by weaving a fine metal wire into a mesh shape. That is, the tubular body 10 of the present embodiment includes three metal layers of the wire reinforcement layer 30, the holding wire 70, and the second reinforcement layer 80.

The second reinforcing layer 80 is a member that imparts flexural elasticity to the tubular body 10 together with the wire reinforcing layer 30. Preferably, after at least a portion of the region of the distal portion DE of the tubular body 10 is bent by the pulling operation of the operating wire 60, the tubular body 10 is elastically restored when the tensile load of the operating wire 60 is removed. Therefore, the tubular body 10 of the present embodiment preferably uses a spring-like 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 retaining wire 70 is higher than the ductility of either of the reinforcing wire 32 and the second reinforcing wire 82.

The holding wire 70 is a member for winding and fixing the sub-tube 40 around the wire reinforcing layer 30 and being fitted to the sub-tube 40 to suppress peeling from the interface with the outer layer 50. Therefore, the strength of the holding wire 70 may be lower than that of the wire reinforcing layer 30 and the second reinforcing layer 80. Therefore, in the present embodiment, as shown in FIG. 3, the winding pitch of the holding wire 70, that is, the adjacent circuit line 70 is larger than the wire reinforcing layer 30 (reinforcing wire 32) and the second reinforcing layer 80 (second Reinforce any one of the pitch intervals of line 82). The pitch interval as used herein refers to the spacing of the adjacent reinforcing wires 32 wound in the same direction in the mesh or the axial direction of the tubular body 10 of the second reinforcing wires 82 from each other. However, instead of the present embodiment, the circuit spacing of the adjacent holding wires 70 may be smaller than one of the pitch intervals of the wire reinforcing layer 30 (reinforcing wire 32) and the second reinforcing layer 80 (second reinforcing wire 82) or Both. Thereby, the sub-tube 40 and the wire reinforcement layer 30 can be preferably held by the holding wire 70. Further, the loop spacing of the adjacent holding wires 70 may be made larger than the pitch interval of the wire reinforcing layer 30 (reinforcing wire 32) and smaller than the pitch interval of the second reinforcing layer 80 (second reinforcing wire 82).

Fig. 7 is a side view showing the distal portion DE of the tubular body 10 of the present embodiment.

As described above, the distal portion DE of the tubular body 10 is provided with a marking portion (first marking 14) containing a radiopaque material. The front end (end point 71) of the holding wire 70 is then fixed to the base end side of the marking portion (first mark 14) by the bonding material 56. In other words, the first mark 14 is provided on the far side from the end portion 72 on the front end side of the holding line 70. The first mark 14 is mounted on the outer side of the wire reinforcing layer 30 (reinforcing wire 32), and the holding wire 70 and the first mark 14 are at least partially overlapped in the diameter direction of the tubular body 10.

As shown in Fig. 7, the end points 71 of the plurality of coil strands (holding wires) 70a, 70b are then fixed in a state of being pressed against the end faces of the base end side of the first mark 14. That is, the coil strands (holding wires) 70a and 70b are fixed by the first mark 14 in a state where the winding slack is suppressed.

Specifically, coil stranded wires (holding wires) 70a, 70b are spirally wound on the surface of the wire reinforcing layer 30. Next, the bonding material 56 is applied from the spirally wound coil strands (holding wires) 70a, 70b. Thereby, the material 56 is in a state of being filled into the mesh of the reinforcing wire 32 and embedding the length of one of the coil strands (holding wires) 70a, 70b. After the material 56 is dried, the remaining lengths of the coil strands 70a, 70b are cut, whereby the end points 71 of the coil strands 70a, 70b (holding lines) are not loosely fixed to the base of the first mark 14. End face on the end side. Thereby, the end points 71 of the coil strands 70a, 70b do not damage the outer layer 50 or the sub-tube 40.

As shown in FIG. 7, the wire reinforcing layer 30 is formed by weaving a plurality of reinforcing wires 32. A plurality of reinforcing wires 32 crossing each other constitute a rectangular mesh. Next, the material 56 is filled to the inner side of the plurality of meshes adjacent to the base end side of the mark portion (first mark 14) in the wire reinforcing layer 30. The front end (end point 71) of the holding wire 70 (coil strands 70a, 70b) is then fixed by the bonding material 56.

Further, the wire reinforcing layer 30 may be pressed and fixed to the outer peripheral surface of the inner layer 24 by the annular first mark 14 without using the bonding material 56.

Material 56 is then filled into a plurality of adjacent meshes. Material 56 can then follow the first The base end side of the mark 14 is disposed on the entire circumference, or may be provided only in a partial area including the end point 71. In the present embodiment, a plurality of meshes filled with the wire reinforcing layer 30 of the bonding material 56 are adjacent to each other to constitute a non-surrounding region in the wire reinforcing layer 30. By providing the adhesive material 56 not in a wraparound manner rather than in a wraparound manner, the end point 71 is easier to handle and prevents the softness of the tubular body 10 on the proximal end side of the first indicia 14 from being damaged.

Subsequent material 56 may use an organic based adhesive or flux.

As the organic binder, a room temperature curing type adhesive, a thermosetting type adhesive, a solution type adhesive, or a hot melt type adhesive can be used.

As the room temperature curing type adhesive, an amine acrylate group can be used in addition to a reaction-based adhesive such as a cyanoacrylate-based adhesive, a polyoxynylene-based adhesive, an epoxy-based adhesive, or an acrylic-based adhesive. An ultraviolet curing adhesive such as an acid ester or an epoxy acrylate.

As the thermosetting adhesive, an epoxy resin-based adhesive can be used.

Examples of the solution-based adhesive include an acrylic resin emulsion adhesive, an α-olefin based adhesive, a urethane resin solvent-based adhesive, an ethylene-vinyl acetate resin emulsion adhesive, and a vinyl acetate resin emulsion adhesive. Or a polyvinyl acetate resin solution is an adhesive.

As the hot-melt type adhesive, an ethylene-vinyl acetate resin hot melt adhesive, a polyurethane resin hot melt adhesive, and a polyolefin resin hot melt adhesive can be exemplified.

As the flux, solder or solder silver can be exemplified.

The material 56 then preferably has a higher melting point than the outer layer 50, and in particular the second outer layer 54. Thereby, the end points 71 of the coil strands (holding lines) 70a, 70b are also fixed when the outer layer 50 is thermoformed around the holding wire 70 (holding layer), so that the end portion 72 does not cause winding slack. . From the above viewpoints and the rapidity of the curing speed, a cyanoacrylate-based room temperature curing type adhesive which is an instant adhesive can be preferably used.

The wire layer is wound by winding a plurality of coil strands (holding wires) 70a and 70b. Multiple lines The front ends (end points 71) of the loop strands (holding wires) 70a, 70b are fixed by the following material 56 at substantially the same position in the circumferential direction of the tubular body 10.

As shown in Fig. 7, the coil strands (holding wires) 70a and 70b of the present embodiment are bundled at the leading end (end point 71) and then fixed. However, instead of this, the coil strands (holding wires) 70a and 70b are not converged, and the end points 71 are disengaged from each other in the axial direction of the tubular body 10. Further, the end points 71 of the coil twisted wires (holding wires) 70a, 70b are located at substantially the same position in the circumferential direction of the tubular body 10, and the end points 71 are separated from each other by the main cavity 20. The purpose of the present invention is to include the state in which the end points 71 are located on the same side with respect to the main pipe cavity 20 and are slightly shifted in the circumferential direction, except for the state in which the positions of the end points 71 are strictly coincident with each other.

The wall thickness of the sub-tube 40 is smaller than any of the wire diameters of the holding wire 70 and the operation wire 60. Further, the wire diameter of the holding wire 70 is smaller than the wire diameter of the operation wire 60. By keeping the wire 70 as a small diameter and having a small radius of curvature and allowing the retaining wire 70 to be inserted into the sub-tube 40 at a specific depth, the central angle of the embedding in the retaining wire 70 can be increased. Therefore, the stretching of the interface peeling can be favorably prevented.

The distal portion DE of the tubular body 10 is provided with a first mark 14 and a second mark 16 located closer to the side than the first mark 14. The first mark 14 and the second mark 16 are annular members including a material such as X-rays such as platinum that is not transparent to radiation. By setting the positions of the two marks of the first mark 14 and the second mark 16 as marks, the position of the front end of the tubular body 10 in the body cavity (blood vessel) can be visually observed under the observation of radiation (X-ray). Thereby, the timing at which the bending operation of the catheter 100 is most suitable can be easily judged.

The front end of the operation wire 60 is fixed to a portion of the tubular body 10 which is further on the far side than the second mark 16. By pulling the operation wire 60, the portion of the distal portion DE that is closer to the distal side than the second marker 16 is bent. In the catheter 100 of the present embodiment, the front end portion of the operation wire 60 is fixed to the first mark 14. The aspect in which the operation wire 60 is fixed to the first mark 14 is not particularly limited, and examples thereof include welding, hot-melt bonding, adhesion by an organic adhesive, mechanical locking of the operation wire 60 and the first mark 14, and the like.

The inner diameter of the second mark 16 is larger than the inner diameter of the first mark 14. The first mark 14 is disposed in contact with or substantially in contact with the outer surface of the wire reinforcing layer 30. The inner diameter of the first mark 14 is larger than the outer diameter of the wire reinforcing layer 30 and smaller than the inner diameter of the second reinforcing layer 80.

The positional relationship between the inner wall surface and the outer circumferential surface of the first mark 14 and the diameter direction of the sub-tube 40 is not particularly limited. In the case where the operation wire 60 is fixed to the outer circumferential surface of the first mark 14, the outer circumferential surface of the first mark 14 may be located inside (the inner diameter side) of the arrangement position of the front end of the sub-tube 40 as shown in FIG. The outer diameter of the first mark 14 is set. In addition, when the operation wire 60 is fixed to the end surface on the proximal end side of the first mark 14, the end surface may be overlapped with the front end of the sub-tube 40 in the diameter direction. In this case, the outer circumferential surface of the first mark 14 may be located closer to the outer diameter side than the arrangement position of the front end of the sub-tube 40.

The second mark 16 is disposed in contact with or substantially in contact with the outer surface of the second reinforcement layer 80. The inner diameter of the second mark 16 is larger than the outer diameter of the second reinforcing layer 80.

As shown in FIG. 3, the distal end of the wire reinforcing layer 30 reaches the disposed area of the first mark 14. The arrangement area of the first mark 14 means a length region in which the first mark 14 is formed when viewed from the axial direction of the tubular body 10. The same applies to the second mark 16. The distal end of the wire reinforcement layer 30 is located closer to the distal side of the tubular body 10 than the proximal end of the first indicia 14. Further, the distal end of the wire reinforcing layer 30 is located in the vicinity of the distal end of the first mark 14. By the line reinforcing layer 30 reaching the arrangement area of the first mark 14, the discontinuity of the flexural rigidity of the tubular body 10 at the proximal end of the first mark 14 is alleviated to prevent the occurrence of kinking.

The distal end of the second reinforcing layer 80 is closer to the bit side than the proximal end of the first mark 14 and closer to the far side than the proximal end of the disposed area of the second mark 16. The distal end of the second reinforcing layer 80 is located adjacent the distal end of the second indicia 16. Thereby, the flexural rigidity of the tubular body 10 is discontinuous at the distal end of the second mark 16. Therefore, when the operation line 60 is pulled, the tubular body 10 can be significantly bent on the slightly distal side of the second mark 16. Further, even if the tubular body 10 is significantly bent as described above, since the wire reinforcing layer 30 is continuously formed to the arrangement area of the first mark 14 as described above, no kinking occurs in the tubular body 10. change In other words, one of the wire reinforcing layer 30 or the second reinforcing layer 80 is continuously formed to the vicinity of the distal end of the tubular body 10 to prevent kinking, and the other is terminated in the middle of the distal portion DE, whereby The tubular body 10 is caused to have a discontinuity in flexural rigidity to clearly define the bending position.

The proximal ends of the wire reinforcing layer 30 and the second reinforcing layer 80 are located at the proximal end of the tubular body 10, that is, inside the operating portion 90.

The distal end of the inner layer 24 can reach the distal end of the tubular body 10 or, alternatively, terminate at the proximal end side at the more distal end. The position at which the inner layer 24 terminates may also be the inside of the arrangement area of the first mark 14.

Further, the present invention is not limited to the above-described embodiments, and variations, improvements, and the like within the scope of the object of the invention are included in the present invention.

In the above embodiment, the wire reinforcement layer 30 is a braided layer, and the first outer layer 52 is impregnated from the periphery of the wire reinforcement layer 30 from the periphery of the auxiliary pipe 40, and the inner layer 24 and the wire are formed. The reinforcing layer 30 and the sub-tube 40 are integrally fixed. Alternatively, the first outer layer 52 of the outer layer 50 on the inner layer may be substantially impregnated between the wire reinforcement layer 30 and the secondary tube 40. That is, the outer diameter of the sub-tube 40 may be larger than the mesh size W in the circumferential direction of the wire reinforcing layer 30 represented by the above formula (2). Moreover, the mesh directly below the sub-tube 40 may be closed by the sub-tube 40, and the first outer layer 52 is a mesh containing a cavity portion that is not completely filled.

Further, in the above-described embodiment, the reinforcing wire 32, the holding wire 70, and the second reinforcing wire 82 are all lines having a circular cross section. However, these are not limited to a circular cross section, and may be an elliptical cross section or a cross section. The line of polygons, etc.

A hydrophilic layer (not shown) formed on the outer surface of the second outer layer 54 constitutes the outermost layer of the catheter 100. The hydrophilic layer may be formed over the entire length of the tubular body 10, or may be formed only in a portion of the length of the end side including the distal portion DE. The hydrophilic layer contains, for example, a maleic anhydride-based polymer such as polyvinyl alcohol (PVA) or a copolymer thereof, or a hydrophilic resin material such as polyvinylpyrrolidone.

The representative dimensions of the components of the catheter 100 of the present embodiment will be described.

The diameter of the main pipe 20 can be set to 400 μm to 600 μm (including the upper limit and the lower limit, the same applies hereinafter), the thickness of the inner layer 24 can be set to 5 μm to 30 μm, and the thickness of the outer layer 50 can be set to 10 μm to 200 μm. The wall thickness of the sub-tube 40 is thinner than the inner layer 24, and can be set to 1 μm to 10 μm. The inner diameter of the wire reinforcing layer 30 can be set to 410 μm to 660 μm, the outer diameter of the wire reinforcing layer 30 can be set to 450 μm to 740 μm, and the inner diameter of the second reinforcing layer 80 can be set to 560 μm to 920 μm, outside the second reinforcing layer 80. The diameter can be set to 600 μm to 940 μm.

The inner diameter of the first mark 14 can be set to 450 μm to 740 μm, the outer diameter of the first mark 14 can be set to 490 μm to 820 μm, the inner diameter of the second mark 16 can be set to 600 μm to 940 μm, and the outer diameter of the second mark 16 can be set. Set to 640 μm to 960 μm. The width dimension of the first mark 14 (the dimension of the tubular body 10 in the longitudinal direction) may be set to 0.3 mm to 2.0 mm, and the width of the second mark 16 may be set to 0.3 mm to 2.0 mm.

The radius (distance) of the center of the conduit 100 to the center of the sub-tube 40 can be set to 300 μm to 450 μm, the inner diameter (diameter) of the sub-tube 40 can be set to 40 μm to 100 μm, and the thickness of the operation wire 60 can be set to 25 μm. 60 μm.

The tubular body 10 has a diameter of 700 μm to 980 μm, that is, an outer diameter of less than 1 mm in diameter, and can be inserted into a blood vessel such as a celiac artery.

Fig. 8 (a) is an overall side view of the catheter 100 of the present embodiment. Fig. 8(b) is a general side view showing the catheter 100 in a state in which the rotor operating portion 92 is operated in one direction (clockwise direction in the drawing). Fig. 8(c) is a general side view showing the catheter 100 in a state in which the turning operation portion 92 is operated in the other direction (counterclockwise direction in the drawing).

The catheter 100 includes an operation portion 90 that is provided at a base end portion of the tubular body 10 and that individually pulls a plurality of operation wires 60 (refer to FIGS. 1 to 3). The operation portion 90 includes a body casing 94 for the user to grasp by hand, and a wheel operating portion 92 that is provided to be rotatable relative to the body casing 94. The base end of the tubular body 10 is introduced into the interior of the body casing 94. The two sub-tubes 40 (see FIGS. 1 to 3) through which the operation wires 60 are inserted are branched from the tubular body 10 inside the front end of the body casing 94. The base end portion of the operation wire 60 extracted from the sub-pipes 40 is coupled to the runner Operation unit 92. By rotating the operation wheel operating portion 92 in either direction, one operation wire 60 can be pulled to the proximal end side to impart tension and the other can be relaxed. Thereby, the pulled operation wire 60 bends at least a part of the distal portion DE of the catheter 100 (see FIGS. 8(b) and 8(c)). Here, the tubular body 10 is bent in such a manner that the tubular body 10 is bent in a "ㄑ" shape and curved in an arc shape.

The two operation wires 60 are selectively pulled by the operation of the rotary operation portion 92 of the operation portion 90, whereby at least a part of the distal portion DE of the catheter 100 can be selectively included in the same The first or second direction of the plane is curved.

A concave-convex engaging portion is formed on the circumferential surface of the runner operating portion 92. In the present embodiment, the longitudinal roll pattern of the waveform is exemplified. A recess 95 is formed in the body casing 94 at a position in contact with the runner operating portion 92. A slider 98 that slides toward the reel operating portion 92 in a retractable manner is provided in the recessed portion 95. A protrusion 99 is formed in the slider 98 toward the front end portion of the runner operating portion 92. The projection 99 is smaller than the opening width of the concave-convex engaging portion (longitudinal roll) of the circumferential surface of the turning operation portion 92. When the slider 98 is slid toward the turning operation portion 92, the projection 99 is locked to the circumferential surface of the turning operation portion 92 to restrict the rotation of the turning operation portion 92. Thereby, the rotation of the turning operation portion 92 is restricted in a state where one portion of the distal portion DE of the catheter 100 is curved, so that the curved state of the catheter 100 can be maintained. Fig. 8(a) shows a state in which the projection 99 of the slider 98 is not engaged with the turning operation portion 92, and the turning operation portion 92 is rotatable. 8(b) and 8(c) show a state in which the projection 99 of the slider 98 is engaged with the turning operation portion 92, and the rotation of the turning operation portion 92 is restricted to maintain the bent state of the distal portion DE.

By rotating the operating portion 90 about the axis of the tubular body 10, the distal portion DE of the tubular body 10 can be rotated at a specific angle by the action of torque. By the combination of the operation of the turning operation portion 92 and the overall shaft rotation of the operating portion 90, the orientation of the distal portion DE of the catheter 100 can be freely controlled.

The catheter 100 is provided with a sleeve 96 that is disposed in communication with the main lumen 20 of the tubular body 10. A syringe (not shown) is mounted on the sleeve 96. The sleeve 96 is disposed at a rear end of the body casing 94. A syringe is attached from the rear of the sleeve 96 (to the right of Fig. 8(a)). By injecting a chemical solution or the like into the sleeve 96 by means of a syringe, a chemical solution or the like can be supplied into the body cavity of the patient via the main lumen 20. Examples of the chemical solution and the like include a contrast agent, a liquid anticancer agent, physiological saline, and NBCA (n-butyl-2-cianoacrylate, isobutyl cyanoacrylate) used as a transient adhesive. Other than that, it is not limited to a liquid, and a medical device such as a plug coil or a pellet (a plug-like substance) can be exemplified as a chemical solution or the like.

〔Production method〕

Next, a method of manufacturing the catheter 100 of the present embodiment will be described with reference to Figs. 9 to 12 . FIG. 9 is a longitudinal cross-sectional view of the inner structure 26 in which the inner layer 24 and the wire reinforcement layer 30 are formed around the main core wire 22. FIG. 10 is a side view of the cored tube 46 in which the sub-tube 40 is formed around the sub-core wire 44. Fig. 11 is a perspective view schematically showing a winding step of the holding wire 70. FIG. 12 is a side view showing a state in which the second reinforcing wire 82 is wound around the sub-tube 40.

First, the outline of the manufacturing method of the catheter 100 (hereinafter may be referred to as the present manufacturing method) of the medical device of the present embodiment will be described.

The manufacturing method includes an inner structure preparation step, a sub-tube holding step, a body forming step, a sub-core wire removal step, and a main core wire removal step.

In the inner structure preparation step, a step of including the main core wire 22 and the inner structure 26 of the wire reinforcement layer 30 in which the reinforcing wire 32 is wound around the main core wire 22 is prepared.

The sub-tube holding step is a step of disposing the sub-core wire 44 covered by the resin sub-tube 40 on the outer peripheral surface of the wire reinforcing layer 30 along the main core wire 22, and pressing the holding wire 70 to the surface of the sub-tube 40. The sub-tube 40 is wound together with the wire reinforcing layer 30 by the holding wire 70.

The body forming step is a step of forming the tubular body 10 in such a manner that the sub-tube 40 and the wire reinforcing layer 30 and the holding wire 70 are wound together.

The secondary core wire pulling step is such that the secondary core wire 44 is expanded and reduced in diameter to be stripped from the secondary pipe 40 The step of forming the sub-lumen 42 is performed.

The main core removal step is a step of unwinding the main core 22 from the tubular body 10 to form the main chamber 20.

Hereinafter, this manufacturing method will be described in detail.

In the inner structure preparation step, first, the inner layer 24 is formed around the main core wire 22. The main core wire 22 is a mandrel (core material), and is a wire having a circular cross section of the main pipe 20. The material of the main core wire 22 is not particularly limited, and a wire made of silver-plated copper or a copper alloy can be used. In addition to this, stainless steel may be used as the material of the main core wire 22. The inner layer 24 can be formed by immersing the main core wire 22 in a coating liquid obtained by dispersing a fluorine-based polymer such as polytetrafluoroethylene (PTFE) in a solvent, followed by drying.

Then, a plurality of reinforcing wires 32 are woven into a mesh shape on the outer surface of the inner layer 24 to form the wire reinforcing layer 30.

As shown in FIG. 9, after the annular first mark 14 is press-fitted around the front end portion of the reinforcing wire 32, the reinforcing wire 32 is cut away from the distal side of the first mark 14.

The inner structure 26 is produced by the above steps.

The cored tube 46 shown in Fig. 10 is produced simultaneously with the inner structure preparation step or in tandem with the inner structure preparation step. In the inner structure preparation step, the sub-tube 40 is formed on the circumferential surface of the sub-core wire 44. The secondary core wire 44 defines a wire having a circular cross section of the secondary lumen 42. The material of the secondary core wire 44 is not particularly limited, and a metal material having a strength higher than that of the main core wire 22 such as stainless steel can be used. The diameter of the secondary core wire 44 is thinner than the main core wire 22. By using the metal material having a higher strength than the main core wire 22 as the sub-core wire 44, the sub-core wire 44 can be expanded and reduced in diameter without being broken in the sub-core wire pulling step to be preferably peeled off from the sub-tube 40. The wall thickness of the sub-tube 40 is preferably thinner than the inner layer 24. When the sub-tube 40 is produced using a fluorine-based polymer such as polytetrafluoroethylene (PTFE), the sub-core wire 44 can be formed by immersing the coating liquid obtained by dispersing the polymer in a solvent, followed by drying.

In addition, the inner diameter of the sub-tube 40 may be larger than the outer diameter of the sub-core 44. After the sub-tube 40 is drawn into a tubular shape, it is coated around the sub-core wire 44 to form a core tube 46.

In the sub-tube holding step, the sub-core wires 44 are placed on the outer peripheral surface of the wire reinforcing layer 30 along the main core wire 22, and are wound together by the holding wires 70. In the present manufacturing method, the timing at which the sub-core wires 44 are disposed along the main core wire 22 and the timing at which the sub-core wires 44 are wound together with the main core wires 22 by the holding wires 70 are substantially simultaneously. As shown in Fig. 11, a plurality of (four in the present manufacturing method) cored tubes 46 are fed along the inner structure 26 by the through holes 112 of the insertion jig 110, and the winder device 120 is provided around the core structure 46. The plurality of spool heads 122 rotate in the same direction. A retaining wire 70 is wound around the spool head 122. A main through hole 114 through which the inner structure 26 is inserted is formed in the insertion jig 110. Four through holes 112 are formed at equal intervals around the main through hole 114.

The main core wire 22 exposed to the front end of the inner structure 26 and the sub-core wire 44 exposed to the front end of the plurality of core tubes (four in the present manufacturing method) are integrally formed by a jig (not shown). fixed. In this state, the first mark 14 is directed toward the distal end side (upper side in FIG. 11), and the inner shaft structure 26 and the cored tube 46 are extruded at a specific conveying speed to rotate the bobbin head 122. Thereby, the holding wire 70 is wound around the wire reinforcing layer 30 and the sub-tube 40 in a coil shape. By adjusting the conveying speed of the inner structure 26 and the cored tube 46 and the rotational speed of the bobbin head 122, the winding pitch of the holding wire 70 can be increased or decreased.

In the present manufacturing method, the holding wire 70 is spirally wound around the holding wire 70 while periodically changing the winding tension of the holding wire 70 with respect to the sub-tube 40. The method of periodically changing the winding tension of the holding wire 70 is not limited to one. Here, a first method in which the plurality of bobbin heads 122 are uniformly disposed around the inner structure 26, and the inner structure 26 is periodically eccentrically biased by an external force, and a plurality of bobbin heads 122 are eccentrically disposed on the inner structure The second method around 26.

In the first method of holding the holding wire 70 together, the inner structure 26 is relatively diametrically opposed to the secondary core wire 44 in the diametrical direction, and is wound together by the holding wire 70.

As shown in FIG. 11, in the present manufacturing method, four sub-core wires 44 are disposed opposite each other at a 90-degree interval around the wire reinforcement layer 30. Further, when three sub-core wires 44 are disposed, the three sub-core wires 44 may be oriented at 120 degrees. In the present manufacturing method, the positions of the plurality of (two) bobbin heads 122 are selected such that the winding points 74 of the plurality of (two) holding wires 70 are rotationally symmetrical with respect to the circumference of the wire reinforcing layer 30. Thereby, the individual winding tensions of the plurality of holding wires 70 are offset.

In this state, the inner structure 26 is forcibly eccentric, and the insertion depths D of the plurality of holding wires 70 are different from each other.

As shown in FIG. 11, a grip 126 is attached around the inner structure 26. The gripping member 126 slidably grips the inner structural body 26 that is extruded through the main through hole 114 at a specific conveying speed. The gripper 126 and one of the insertion jigs 110 or both are driven by a drive unit (not shown) so as to relatively move in the radial direction of the inner structure body 26. Furthermore, in FIG. 11, the gripping member 126 is exemplarily disposed in a direction in which the insertion jig 110 is disposed in the conveying direction of the inner structure 26, but the gripping member 126 may be integrally formed with the insertion jig 110. Settings.

More specifically, in the first method, the driving unit (not shown) causes the gripping member 126 to swing back and forth in a direction in which one of the 180 degrees of the opposing pair of the sub tubes 40 is coupled. The pulsation period is different from the rotation period of the bobbin head 122 or is set to an integral multiple of the rotation period. The turbulence period can also be variable.

The inner structure 26 is forcibly decentered by the gripping member 126, and the winding tension imparted to the sub-tube 40 by the holding wire 70 is periodically changed in the turbulent cycle. Thereby, the first length region L1 and the second length region L2 are formed in the sub-tube 40 (see FIG. 4). Specifically, when the grip member 126 eccentrically biases the inner structure body 26 toward the direction in which the sub-tube 40 (the first sub-tube 40a) is pressed, the bobbin head 122 rolls the holding line 70 in the first sub-tube 40a. The winding tension imparted by the wrap 74 is increased. Thereby, the second length region L2a having a large insertion depth D is formed in the first sub-tube 40a. At this time, at the same position in the axial direction, the other bobbin head 122 is given to the winding point 74 of the holding wire 70 in the second sub-pipe 40b disposed opposite to the first sub-pipe 40a by 180°. The winding tension becomes small. Thereby, the first length region L1b having a small insertion depth D is formed in the second sub-tube 40b.

When the gripper 126 periodically pulsates and the inner structure 26 is eccentric toward the second sub-tube 40b, the second sub-tube 40b forms a second length region L2b having a large insertion depth D. Further, at the same position in the axial direction, the first sub-tube 40a is formed with the first length region L1a having a small insertion depth D.

Further, in the first method described above, the case where the inner structure 26 is swayed is exemplified, but the present invention is not limited thereto. The inner structure 26 can also be rotated and swayed along the circumference of the main through hole 114. In other words, the eccentric inner structure 26 may be rotated such that the axial center of the inner structure 26 (the main core 22) is smaller than the circle of the main through hole 114. Thereby, the first length region L1 and the second length region L2 can be formed equally for all (four in the present manufacturing method) sub-tubes 40.

In the second method, the plurality of bobbin heads 122 wound around the plurality of holding wires 70 are rotated in a state of being disposed asymmetrically around the inner structure 26 (not shown). When the two bobbin heads 122 are used to wind the two holding wires 70, the positional relationship of the two bobbin heads 122 can be set to 120 degrees or more and less than 180 degrees with respect to the central angle centering on the inner structure body 26. . When the bobbin head 122 is too close, the resultant of the winding tension causes the inner structure 26 to be excessively eccentric. However, if the angle range is the above, the inner structure 26 can be made to have a period equal to the rotation period of the bobbin head 122 or a rotation period. An integer multiple of the period is periodically eccentric.

Furthermore, in the first method and the second method, the turbulent period of the inner structure 26 can also be changed in one tubular body 10. Thereby, the lengths of the repeated first length region L1 and second length region L2 can be changed according to the distance from the front end of the tubular body 10. As an example, the lengths of the first length region L1 and the second length region L2 are shorter in the distal portion DE, and the lengths of the first length region L1 and the second length region L2 are longer in the intermediate portion or the proximal portion. . Thereby, the adhesion between the sub-tube 40 and the outer layer 50 at the distal portion DE which is significantly curved when the operation wire 60 is pulled can be satisfactorily improved.

Further, in the present manufacturing method, the case where the secondary core wire 44 is fed out while being wound together with respect to the main core wire 22 has been described, but the present invention is not limited to the above. The main length of the sub-core wire 44 may be temporarily fixed to the main core wire 22 by a jig or the like in advance, and then the auxiliary core wire 44 may be wound together with the main core wire 22 by the holding wire 70.

In the body forming step, the outer layer is formed by the inner inner structure 26, the cored tube 46, and the holding wire 70 (hereinafter, the structure) to form the tubular body 10. First, a first outer layer 52 is formed around the structure. The first outer layer 52 can also be formed by coating and extruding a molten resin material onto the surface of the structure. Alternatively, a resin ring or a resin tube which is formed in a ring shape or a tubular shape in advance may be attached to the periphery of the structure, and then heat-shrinked using a heat-shrinkable tube or the like. The first outer layer 52 encloses the sub-tube 40 and the retaining wire 70 embedded in the sub-tube 40. Thereby, the retaining wire 70 is anchored to both the first outer layer 52 and the secondary tube 40.

Then, the second reinforcing wire 82 is woven around the sub-tube 40 embedded in the first outer layer 52 to form the second reinforcing layer 80 (see FIG. 12). After the second mark 16 is press-fitted around the front end of the second reinforcing layer 80, the second reinforcing wire 82 is cut off on the distal side of the second mark 16.

Further, the second outer layer 54 is formed so as to cover the second reinforcement layer 80 and the second mark 16 (see FIG. 1). The second outer layer 54 may be formed by coating and coating the molten resin material on the surface of the second reinforcement layer 80, or may be formed into a ring or a tubular resin ring or a resin tube. The heat forming is performed after being installed around the structure.

In the sub-core wire removal step, the secondary core wire 44 is expanded to be reduced in diameter, thereby being peeled off from the auxiliary pipe 40. After the diameter-reduced sub-core wire 44 is removed from the sub-tube 40, the operation wire 60 is inserted into a part or all of the sub-tubes 40 of the plurality of roots. In the present embodiment, the operation wire 60 is inserted into the first sub-tube 40a and the second sub-tube 40b only in one of 180 degrees, and the operation wire 60 is not inserted into the other two sub-tubes 40. Furthermore, the reduced-diameter secondary core wire 44 may not be removed from the secondary pipe 40 to be used as the operation wire 60, and when the operation wire 60 having a diameter much smaller than the inner diameter of the secondary pipe 40 is used, the secondary wire may be removed. After the core wire 44, a different operating line 60 will be used It is sufficient to insert into the sub-tube 40.

The main core wire unplugging step removes the main core wire 22 from the tubular body 10 to form the main pipe cavity 20. The sub-core wire unplugging step and the main core wire unplugging step may be performed at the same time, or the main core wire unplugging step may be performed after the sub-core wire unplugging step. In the latter case, since the main core wire 22 is inserted into the main pipe cavity 20, the expansion deformation of the tubular body 10 can be suppressed. Therefore, when the sub-core wire 44 is expanded in the sub-core wire pulling-out step, the sub-tube 40 does not follow the sub-core. The core wire 44 is elongated. Therefore, the sub-core wire 44 having a diameter smaller than that of the main core wire 22 and easily broken can be favorably removed from the sub-tube 40.

In the present manufacturing method, after a hydrophilic layer (not shown) is formed on the surface of the second outer layer 54, the operation portion 90 is attached to the proximal end portion of the tubular body 10. With the above steps, the catheter 100 can be obtained.

Further, the various constituent elements of the present invention are not necessarily required to exist independently, and a plurality of constituent elements are formed as one member, and one constituent element is formed of a plurality of members, and one constituent element is another constituent element. In part, one part of a component is partially overlapped with one of the other components.

Further, the present manufacturing method describes a plurality of steps in order, but the order of description does not limit the order or timing at which a plurality of steps are performed. Therefore, when the manufacturing method is implemented, the order of the plurality of steps can be changed within a range in which the content does not have an obstacle, and part or all of the execution timing of the plurality of steps can also be repeated.

This embodiment and the present manufacturing method include the following technical ideas.

(1) A medical machine comprising: a long tubular body comprising: a long inner layer defining a main lumen; and a wire reinforcing layer wound around the inner layer a resin-made strip-shaped sub-pipe disposed on the outer side of the wire reinforcing layer so as to extend along the longitudinal direction of the main cavity, and defining a sub-cavity having a smaller diameter than the main cavity; and a resin An outer layer enclosing the wire reinforcement layer and the auxiliary pipe; an operation wire movably inserted into the inside of the sub-lumen and having a front end connected to the tubular body a distal portion of the body; and an operating portion that pulls the operation wire to bend the distal portion of the tubular body; and the tubular body further includes a retaining wire, the retaining wire is wrapped in the outer layer, and the pair is The tube is wound together with the wire reinforcing layer; the holding wire is fitted to the circumferential surface of the outer diameter side of the sub-tube.

(2) The medical device according to the above (1), wherein the first length region in which the depth of insertion of the retaining line with respect to the circumferential surface of the sub-tube is a specific depth is deeper than the embedding depth is deeper than the first length region The two length regions are arranged in the axial direction of the tubular body.

(3) The medical device according to (2) above, wherein the plurality of the sub-tubes are disposed opposite to each other around the main cavity.

(4) The medical device according to (3) above, wherein the three or more of the sub-tubes are disposed uniformly around the main chamber and opposed to each other.

(5) The medical device according to the above (3) or (4), wherein the operation line is inserted into the first sub-tube and the second sub-tube opposite to each other, the first sub-tube and the second Each of the sub tubes has the first length region and the second length region.

(6) The medical device according to the above (5), wherein the first length region of the first sub-tube and the first length region of the second sub-tube are different in the axial direction position.

(7) The medical device according to the above (5) or (6), wherein the second length region of the first sub-tube and the second length region of the second sub-tube are present in the axial center Different positions in the direction.

(8) The medical device according to the above (6) or (7), wherein the first length region of the first sub-tube and the second length region of the second sub-tube are present in the axial center In the same position in the direction, the second length region of the first sub-tube and the first length region of the second sub-tube are located at the same position in the axial direction.

(9) The medical device according to any one of (2) to (8), wherein the first length region and the second length region are repeatedly repeated in the axial direction.

(10) The medical device according to any one of (2) to (9), wherein the holding wire is a plurality of coils obtained by winding a plurality of coil strands.

(11) The medical device according to (10), wherein a length of the axial direction of the first length region and the second length region is equal to a winding pitch of the coil strand, or is the winding An integer multiple of the pitch.

(12) The medical device according to any one of (1) to (11), further comprising a second reinforcing layer obtained by winding the second reinforcing wire in a circular cross section on the outer side of the holding wire.

(13) The medical device according to (12) above, wherein the retention line has a ductility higher than a ductility of any of the reinforcing wire and the second reinforcing wire.

(14) The medical device according to any one of (1) to (13), wherein the distal portion of the tubular body is provided with a marking portion including a radiation-impermeable material, and the front end of the holding wire is provided by a bonding material Then, it is fixed to the proximal end side of the above-mentioned marker portion.

(15) The medical device according to (14), wherein the wire reinforcing layer is formed by knitting a plurality of the reinforcing wires, and the inner side of the plurality of meshes adjacent to a proximal end side of the marking portion is formed in the wire reinforcing layer The above-mentioned adhesive material is filled, and the front end of the above-mentioned holding wire is then fixed by the above-mentioned adhesive material.

(16) The medical device according to the above (15), wherein the holding wire is formed by winding a plurality of coil twisted wires, and a plurality of the front ends of the coil twisted wires are substantially at the same position in a circumferential direction of the tubular body. The subsequent material is then fixed.

(17) The medical device according to the above (15) or (16), wherein the plurality of meshes are adjacent to each other to constitute a non-surrounding region in the wire reinforcing layer.

(18) The medical device according to any one of the above (1) to (13), further comprising a catheter provided in communication with the main cavity and provided with a sleeve of the syringe.

(19) A method of manufacturing a medical device, comprising the steps of: preparing a medial structure The inner structure includes a long main core wire and a wire reinforcing layer obtained by winding a reinforcing wire around the main core wire; and a long secondary core wire covered with a resin sub pipe is disposed along the main core wire And pressing the holding wire on the outer peripheral surface of the wire reinforcing layer to sink the holding wire onto the surface of the sub-tube, and winding the sub-tube together with the wire reinforcing layer by the holding wire; Forming an outer layer by forming the outer layer by the auxiliary tube and the wire reinforcing layer and the holding wire; forming the tubular body by expanding and reducing the diameter of the secondary core wire to form a sub-tube; and forming the main core wire from the above The tubular body is removed to form a main lumen.

(20) The method of manufacturing a medical device according to the above (19), characterized in that, in the step of winding together, the inner structure is eccentrically opposed to the sub-core wire in the radial direction Keep the wires wound together.

10‧‧‧Tube body

20‧‧‧Supervisor

24‧‧‧ inner layer

30‧‧‧Line reinforcement

32‧‧‧Strengthen line

40‧‧‧Sub-management

42‧‧‧Sub-luminal

50‧‧‧ outer layer

52‧‧‧ first outer layer

54‧‧‧ second outer layer

60‧‧‧Operation line

70‧‧‧ Keep the line

80‧‧‧Second reinforcement

82‧‧‧second reinforcement line

100‧‧‧ catheter

W‧‧‧Mesh size in the circumferential direction

Claims (20)

A medical machine characterized by comprising: a long tubular body comprising: an inner layer of a strip defining a main cavity; and a wire reinforcing layer wound around the inner layer to form a reinforcing wire; a resin-made long tube, which is disposed on the outer side of the wire reinforcement layer so as to extend along the longitudinal direction of the main cavity, and defines a sub-cavity having a smaller diameter than the main cavity; and an outer layer made of resin. Enclosing the wire reinforcing layer and the auxiliary pipe; the operating wire is movably inserted into the inner side of the auxiliary pipe and the front end is connected to the distal portion of the tubular body; and the operating portion is configured to pull the operation wire The distal portion of the tubular body is bent; the tubular body further includes a retaining wire wrapped in the outer layer, and the secondary pipe is wound together with the wire reinforcing layer, and the retaining wire is embedded in the secondary pipe The outer surface of the outer diameter side. The medical device of claim 1, wherein the first length region of the retention line with respect to the circumferential surface of the sub-tube is a specific depth, and the second length region having a depth deeper than the first length region The arrangement is present in the axial direction of the tubular body. The medical device of claim 2, wherein the plurality of the sub-tubes are disposed opposite to each other around the main chamber. In the medical device of claim 3, three or more of the sub-tubes are disposed uniformly around the main chamber and opposed to each other. The medical device of claim 3 or 4, wherein the operation line is inserted into the first sub-pipe and the second sub-tube opposite to each other, and the first sub-pipe and the second sub-tube respectively have the above a first length region and the second length region. The medical device of claim 5, wherein the first length region of the first sub-tube and the first length region of the second sub-tube are located at different positions in the axial direction. The medical device according to claim 5 or 6, wherein the second length region of the first sub-tube and the second length region of the second sub-tube are located at different positions in the axial direction. The medical device of claim 6 or 7, wherein the first length region of the first sub-tube and the second length region of the second sub-tube have the same position in the axial direction The first length region of the first sub-tube and the first length region of the second sub-tube are located at the same position in the axial direction. The medical device according to any one of claims 2 to 8, wherein the first length region and the second length region are repeatedly repeated in the axial direction. The medical device according to any one of claims 2 to 9, wherein the holding wire is a plurality of coils obtained by winding a plurality of coil strands. The medical device of claim 10, wherein a length of the axial direction of the first length region and the second length region is equal to a winding pitch of the coil strand, or an integer of the winding pitch Times. The medical device according to any one of claims 1 to 11, further comprising a second reinforcing layer formed by winding the second reinforcing wire in a circular cross section on the outer side of the holding wire. The medical device of claim 12, wherein the retention line has a ductility higher than that of the reinforcing wire and the second reinforcing wire. The medical device according to any one of claims 1 to 13, wherein a distal portion of the tubular body is provided with a marking portion including a radiopaque material, and a front end of the holding wire is subsequently fixed to the marking by a bonding material. The base side of the part. The medical device according to claim 14, wherein the wire reinforcing layer is formed by weaving a plurality of the reinforcing wires, and the inner side of the plurality of meshes adjacent to the base end side of the marking portion in the wire reinforcing layer is filled with the above-mentioned The material, the front end of the above-mentioned holding wire is then fixed by the above-mentioned adhesive material. The medical device according to claim 15, wherein the holding wire is wound by a plurality of coil strands, and the plurality of coil twisted wires are substantially at the same position in the circumferential direction of the tubular body from the above-mentioned material. Then fixed. A medical device according to claim 15 or 16, wherein said plurality of meshes are adjacent to each other to constitute a non-surrounding region in said wire reinforcing layer. The medical device according to any one of claims 1 to 13, further comprising a catheter provided in communication with the main chamber and provided with a sleeve for the syringe. A method for manufacturing a medical device, comprising the steps of: preparing an inner structure comprising a long main core wire and a wire reinforcing layer obtained by winding a reinforcing wire around the main core wire; The sub-core wire of the long strip covered by the sub-tube is disposed on the outer peripheral surface of the wire reinforcing layer along the main core wire, and presses the holding wire to sink onto the surface of the sub-tube, and the sub-pipe and the The wire reinforcing layer is wound together; the outer layer is formed by the inner tube and the wire reinforcing layer and the holding wire wound together to form a tubular body; and the secondary core wire is expanded and reduced in diameter from the auxiliary pipe Stripping to form a secondary lumen; and removing the main core wire from the tubular body to form a main lumen. The manufacturing method of the medical device according to claim 19, wherein in the step of winding together, the inner structure is eccentrically opposed to the sub-core wire in the radial direction, and is wound together by the holding wire.