TW201500072A - Medical device and process for producing medical device - Google Patents

Abstract

Provided is a medical device and production process thereof, which excels in the prevention of interfacial peeling between members abutting with each other in the radial direction, in addition to excellent flexibility. Such a medical device includes the tubular main body (210) of the catheter (200) which serves as the medical device, the inner layer (211) having the main lumen (220) therein, the coil layer (230) formed by winding the wire (231) of which traverse cross-sectional shape is non-circular, in the longitudinal direction, the outer layer (212), and the sub-lumen (280) containing the operation line (270) passing therethrough. The wire (231) of the coil layer (230), having the inner side (B) in the cross-sectional shape of the longitudinal cross-section of the catheter (200) being arc, and the maximum width direction of the cross-sectional shape inclining to the longitudinal direction, is wound so as to be fitted into both the inner layer (211) and the outer layer (212).

Description

Medical device, and method of manufacturing medical device

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

The former catheter is a thin wall structure made of resin and is used by passive bending of a guide wire or the like. Usually, the catheter lacks kink resistance. If the catheter is inserted into the body cavity and the guide wire is pulled along the guide wire, there is a problem that the lumen is crushed. Therefore, a catheter in which a wire coil is disposed around the inner tube of the resin to improve kink resistance is proposed (for example, see Patent Document 1).

The catheter described in Patent Document 1 includes a wire coil in which a strip-shaped wire (so-called flat wire) is wound around a circumference of the inner tube to be separated by a specific gap as a coil layer. The conduit with the wire layer maintains good bendability and the kink resistance is improved by the conformality of the wire coil. Moreover, by using a flat wire for the wire coil, the thickness of the coil layer can be expected to be smaller than in the case of using a round wire. Such a catheter can be preferably used, for example, for a surgery such as a blood vessel in which a renal artery is bent in a multi-directional direction.

[Previous Technical Literature] [Patent Literature]

[Patent Document 1] Japanese Patent Laid-Open Publication No. 2003-527226

However, in the catheter described in Patent Document 1, the wire coil is wound such that the flat surface of the wire abuts against the outer peripheral surface of the inner tube in parallel. Here, when the catheter inserted into the body cavity is pulled out, a large resistance acts on the catheter. The resistance is caused by the vertical resistance between the catheter and the wall surface of the body cavity which are straightly elongated in the body cavity to be bent, and the friction between the catheter and the wall surface of the body cavity. In the case of the catheter of Patent Document 1, the resistance is supported by the joint interface between the inner tube and the coil layer when the catheter is pulled out. Therefore, the bonding force between the coil layer and the inner tube is lowered to induce the peeling of the interface. As described above, in the conventional catheter, there is a problem in that it is difficult to obtain a catheter having excellent adhesion between layers and excellent kink resistance, by using a wire coil including a flat wire.

The present invention has been made in view of the above problems, and a first object thereof is to provide a wire coil (coil layer) including a flat wire, which is excellent in not only kink resistance, but also excellent in preventing interfacial peeling between members such as interlayers. Moreover, it has excellent adhesion between members and excellent bending properties, and can ensure a medical device with a sufficient inner cavity area and a manufacturing method of a medical device.

Further, in the above-described prior art catheter, when the catheter inserted into the body cavity is pulled out, the resistance acts on the catheter. This resistance is applied to the interface between the inner resin layer and the layer of the coil layer, and the interface between the outer resin layer and the outer tube layer.

As described above, the wire coil of the catheter described in Patent Document 1 is wound such that the flat surface of the wire abuts on the outer peripheral surface of the resin layer in parallel, so that the inner circumferential surface and the outer circumferential surface of the wire are opposed to each other. The axis of the catheter is parallel.

According to the study by the present inventors, in the case of such a configuration, when the catheter is pressed into the body cavity, there is a communication force before the resin layer from the wire coil to the outside, that is, a pushability is insufficient. possibility. Further, when the catheter is pulled out from the body cavity, there is a possibility that the repelling force (force in the direction of retreating) from the resin layer to the outside of the wire coil is insufficient, that is, the pull-out property is insufficient.

Thus, in a catheter having a wire coil including a flat wire, it is difficult to ensure a certain It is necessary to promote and pull out.

The present invention has been made in view of the above problems, and a second object thereof is to provide a medical device and a medical device which have a wire coil including a wire having a non-circular cross section such as a flat wire and which can ensure necessary pushability or pull-out property. The manufacturing method of the machine.

A medical device according to a first aspect of the present invention is a strip-shaped medical device; and has a coil layer that winds a wire having a non-circular cross-sectional shape into a coil shape in a longitudinal direction of the medical device; In the cross-sectional shape of the wire in the longitudinal section of the coil layer, (1) when the inner side of the wire in the radial direction is linear, the inner side is inclined with respect to the longitudinal direction, or (2) When the inner side of the wire is arcuate, the maximum width direction of the cross-sectional shape is inclined with respect to the longitudinal direction.

Further, in the medical device according to the first aspect of the present invention, the plurality of wires may be wound into a plurality of coils.

Further, the medical device according to the first aspect of the present invention may be such that a plurality of adjacent wires are wound with each other in close contact with each other.

Further, the medical device of the first aspect of the present invention may be such that one of the adjacent wires overlaps each other in the longitudinal direction.

Further, in the medical device according to the first aspect of the present invention, in the cross-sectional shape of the wire in the longitudinal section, both the side and the inner side in the radial direction are convex inward.

Further, in the medical device according to the first aspect of the present invention, the width dimension of the cross section of the wire may be longer than the thickness dimension, and the dimension of the length direction of the wire in the longitudinal section of the coil layer may be longer than the dimension of the radial direction.

Moreover, the medical device according to the first aspect of the present invention may be such that both sides of the transverse direction of the cross section of the wire are outwardly projecting arcs.

Further, in the medical device according to the first aspect of the present invention, the plurality of wires may be wound into a coil shape, and the arc-shaped sides of the adjacent wires may be in point contact with each other.

Further, in the medical device of the first aspect of the invention, the position where the adjacent wires are in point contact with each other may be located between the largest projections of the arcs on both sides.

Furthermore, the medical device of the first aspect of the present invention may also be a catheter comprising a tubular body having a strip of a main lumen therein; and the tubular body comprises: an inner layer having a main lumen therein; a coil layer, It is formed on the outer peripheral surface of the inner layer, and is formed by winding a plurality of wires in a coil shape; the outer layer is covered with at least a coil layer; and at least one sub-cavity formed on the outer circumference of the main inner cavity, and The operating line is plugged in.

Further, the medical device of the first aspect of the present invention may be partially embedded in the inner layer of the wire of the coil layer.

Moreover, the manufacturing method of the first aspect of the present invention is a method for manufacturing a long medical device, and a wire having a cross-sectional shape of a non-circular shape is wound into a coil shape in the longitudinal direction of the medical device to form a coil. The step of layering, and forming the coil layer in such a manner that, in the cross-sectional shape of the wire in the longitudinal section of the coil layer, (1) the inner side of the wire in the radial direction is linear The maximum width direction of the cross-sectional shape when the side is inclined with respect to the longitudinal direction or (2) the inner side of the wire is curved with respect to the longitudinal direction.

Moreover, the manufacturing method of the medical device according to the first aspect of the present invention may further comprise the step of winding a plurality of wires into a coil shape, and in the step of winding the plurality of windings, starting with respect to the first winding The wire is wound first, and the wire which is then wound, that is, the wire which is wound around the wire, is wound while being pressed against the inner side of the winding diameter.

A medical device according to a second aspect of the present invention is characterized in that it is a strip-shaped medical device; and has a coil layer which rolls a wire having a cross-sectional shape of a non-circular shape in the longitudinal direction of the medical machine. Wrapped in a coil shape, and the outer surface of the coil layer is flat, and in the cross-sectional shape of the wire in the longitudinal section of the coil layer, (1) when the inner side of the radial direction of the wire is linear The inner side of the wire is inclined with respect to the longitudinal direction, or (2) the inner side of the wire is curved, and the center of the cross-sectional shape of the wire is thick. The degree direction is inclined with respect to the length direction.

Furthermore, the medical device of the second aspect of the present invention may be formed by winding a plurality of wires into a coil shape.

Further, the medical device of the second aspect of the present invention may be such that a plurality of adjacent wires are closely wound with each other.

Further, the medical device according to the second aspect of the present invention may be such that one of the adjacent wires overlaps each other in the longitudinal direction and is in surface contact or point contact with each other in the cross-sectional shape.

Moreover, the medical device of the second aspect of the present invention may also be in a longitudinal section of the coil layer, the inner side edges of the adjacent wires being inclined in the same direction with respect to the length direction, and the thickness of each of the wires in the radial direction is The distal side to the proximal side gradually become larger.

Moreover, the medical device of the second aspect of the present invention may be such that the width dimension of the cross section of the wire is longer than the thickness dimension, and the inclination angle of the inner side of the wire in the longitudinal section of the coil layer is 45 with respect to the length direction. Below the degree.

Further, the medical device according to the second aspect of the present invention may be such that both sides in the width direction of the cross section of the wire are arcuately curved outward.

Further, in the medical device according to the second aspect of the present invention, the plurality of wires may be wound into a coil shape, and the arc-shaped sides of the adjacent wires may be in point contact with each other.

Further, the medical device of the second aspect of the present invention may be such that the positions where the adjacent wires are in point contact with each other are located between the largest projections of the arcs on both sides.

Moreover, the medical device of the second aspect of the present invention may also be a catheter including a tubular body having a long inner main cavity; and the tubular body comprises: an inner layer having a main inner cavity therein; a coil layer, It is formed on the outer peripheral surface of the inner layer, and is formed by winding a plurality of wires in a coil shape; an outer layer covering the coil layer; and at least one sub-cavity formed on the outer circumference of the main inner cavity and provided for The operating line is plugged in.

Moreover, the medical device of the second aspect of the present invention may also be one of the wires of the coil layer. Partially embedded into the inner layer.

Further, the first manufacturing method of the medical device according to the second aspect of the present invention is a method for manufacturing a long medical device; and the method includes the steps of: forming a cross-sectional shape of a non-circular wire in the longitudinal direction of the medical device; Winding the coil layer to form a coil layer; and grinding the outer surface of the coil layer to be flat; and forming the coil layer in a cross-sectional shape of the wire in the longitudinal section of the coil layer, (1) When the inner side of the wire in the radial direction is linear, the inner side is inclined with respect to the longitudinal direction, or (2) the inner side of the wire is curved, the wire is The center thickness direction of the cross-sectional shape is inclined with respect to the longitudinal direction.

Moreover, in the method of manufacturing a medical device according to a second aspect of the present invention, the method of winding a plurality of wires into a coil shape may be included, and in the step of winding the plurality of windings, The wire to be wound is first wound around the wire, and one of the inner sides of the wire to be wound, that is, the inner side of the wound wire, is wound while being pressed against the inner side of the winding diameter.

Further, the second manufacturing method of the medical device according to the second aspect of the present invention is a method for manufacturing a long medical device; and comprising the steps of: preparing a non-circular wire having a cross-sectional shape including a flat side; The flat side is oriented outward and the wire is wound into a coil shape in the longitudinal direction of the medical device to form a coil layer; and the coil layer is formed in such a manner that the wire is in the longitudinal section of the coil layer In the cross-sectional shape, (1) when the inner side of the wire in the radial direction is linear, the inner side is inclined with respect to the longitudinal direction, or (2) when the inner side of the wire is curved. The center thickness direction of the cross-sectional shape of the wire is inclined with respect to the longitudinal direction.

A third aspect of the present invention provides a medical apparatus characterized by having a medical machine body which is long and flexible, and which is inserted into a body cavity, the medical machine body comprising: a long resin Tube; and a wire coil which is formed by winding a wire having a non-circular cross-sectional shape into a coil shape, and is embedded coaxially with the resin pipe in the resin pipe; and in a longitudinal section of the wire, When the thickness of the wire is T, and the maximum height difference from the axis of the medical device body to the outer surface of the wire is H, the value of H/T is based on the length direction of the medical device body. The location is different.

According to the medical device, the value of H/T differs depending on the position in the longitudinal direction of the medical device body. Here, the larger the value of H/T, the larger the anchor effect of the wire per unit thickness of the wire to the resin tube. Therefore, in the longitudinal direction of the medical machine body, in order to partially increase the anchoring effect of the wire on the resin tube, by increasing the value of H/T, the wire coil and the resin tube (ie, resin) can be suppressed. Peeling of the interface of the layer).

Further, a third aspect of the present invention provides a method of manufacturing a medical device, comprising the steps of forming a body of a medical device which is long and flexible and inserted into a body cavity. The step of forming the medical device body includes the steps of: forming a long inner resin tube; forming a wire coil by winding a wire having a non-circular cross-sectional shape into a coil shape; surrounding the inner resin tube Configuring the wire coil; forming a long outer resin tube around the wire coil; and embedding the wire coil in a resin tube including the outer resin tube and the inner resin tube; and the wire In the longitudinal section, when the thickness of the wire is T, and the maximum height difference from the axis of the medical device body to the outer surface of the wire is H, in the step of forming the wire coil, The wire coil is formed in such a manner that the value of H/T differs depending on the position in the longitudinal direction of the medical device body.

A fourth aspect of the present invention provides a medical device characterized by having a medical machine body which is long and flexible and inserted into a body cavity, the medical machine body comprising: a long strip of resin And a wire coil formed by winding a wire having a non-circular cross-sectional shape into a coil shape, and being embedded coaxially with the resin tube in the resin tube; and the medical device body is The first section and the second section, which are mutually different sections in the longitudinal direction, are located at the top of the outer surface of the wire at the farthest point from the axis of the medical device body in the first section. The center position of the wire in the longitudinal direction is closer to the proximal end side, and in the second section, the top portion is located closer to the distal end side than the center position of the wire in the longitudinal direction.

According to the medical device, in the first section of the medical device body, on the outer surface of the wire, at the top of the wire farthest from the axis of the medical device body, at the center of the wire in the longitudinal direction of the body of the medical device By the base end side. As a result, in the first section, the top of the wire and the portion around it become the portion of the resin tube which is located on the outer side of the wire coil (outer resin layer) when the medical device body is pulled out from the body cavity. shape. In this way, in the first section, when the medical device body is pulled out from the body cavity, the conveyance property of the resin layer from the wire coil to the outside can be sufficiently obtained, that is, the pull-out property.

On the other hand, in the second section of the medical device body, the top of the outer surface of the wire is located at the front end side of the center position of the wire in the longitudinal direction of the medical device body. As a result, in the second section, the top of the wire and the portion around it become the shape of the outer resin layer when the medical device body is pressed into the body cavity. Thereby, in the second section, when the medical device body is pressed into the body cavity, the self-wire can be sufficiently obtained. The conveyance of the force of the coil to the outer resin layer, that is, the propulsion property.

In this manner, the advancement or extraction of the medical device having the wire coil of the wire including the non-circular cross section such as a flat wire can be secured at a necessary position in the longitudinal direction of the medical device body.

Moreover, a fourth aspect of the present invention provides a method of manufacturing a medical device, comprising: a step of forming a body of a medical device, the body of the medical device being elongated and flexible, and inserted into a body cavity, and In the longitudinal direction, there are mutually different sections, that is, the first section and the second section, The step of forming the medical device body includes the steps of: forming a long inner resin tube; forming a wire coil by winding a wire having a non-circular cross-sectional shape into a coil shape; and forming the wire coil in the inner resin tube Arranging the wire coils around; forming a long outer resin tube around the wire coil; and embedding the wire coil in a resin tube including the outer resin tube and the inner resin tube; forming the wire In the step of the coil, in the first section, the top end of the wire is located at a position farthest from the axial center of the medical device body, and is located at a center position of the wire in the longitudinal direction The wire end is formed on the base end side in such a manner that the top portion is located closer to the front end side than the center position of the wire in the longitudinal direction.

According to the first aspect of the present invention, the anchorage of the wire at the interface of the wire layer is improved, and the adhesion between the wire layer and the layer adjacent thereto is improved. As a result, it is possible to provide a medical device which is excellent in kink resistance due to the shape retention property of the coil-shaped wire, but which is excellent in adhesion between the layers of the wire layer, and a method for producing the same.

According to a second aspect of the invention, the inner side of the wire is aligned to the inner side of the coil layer The interface has a higher anchoring property, and the adhesion of the coil layer of the interface is improved. On the other hand, since the surface of the coil layer is flat, the coil layer can be made thinner. As a result, it is possible to provide a medical device which is excellent in the kneading resistance of the coil-shaped wire and excellent in the adhesion resistance of the wire layer, and a method for producing the same, which can secure a sufficient inner cavity area.

According to the third aspect of the present invention, the peeling of the interface between the wire coil of the medical device having the wire coil of the wire including the non-circular cross section such as a flat wire and the resin layer can be suppressed.

According to the fourth aspect of the present invention, the advancement or extraction of a medical device having a wire coil of a wire including a non-circular cross section such as a flat wire can be secured at a necessary position in the longitudinal direction of the medical device body.

10, 210, 310, 410‧‧‧ tubular body (thin tube)

11, 211, 311, 411‧ ‧ inner layer

12, 212, 312, 412‧‧‧ outer layers

20, 220, 320, 420‧‧‧ main lumen

30, 230, 330, 430‧‧ ‧ coil layer

31, 231, 331, 431‧‧‧ wire

32, 332, 432‧‧‧ winding gap

40, 240, 340, 440 ‧ ‧ markers

50, 250, 350, 450 ‧ ‧ coating

51‧‧‧Resin materials

70, 270, 370, 470‧‧‧ operation lines

70a, 270a, 370a, 470a‧‧‧ first line of operation

70b, 270b, 370b, 470b‧‧‧ second line of operation

71, 71a, 71b‧‧‧ front end of the operating line

80, 280, 380, 480‧ ‧ sub-cavities

80a, 280a, 380a, 480a‧‧‧ first sub-cavity

80b, 280b, 380b, 480b‧‧‧ second sub-cavity

100, 200, 300, 400‧‧‧ catheter

111, 2111, 3111, 4111‧‧‧ resin materials (inner layer)

112, 2112, 3112, 4112‧‧‧ resin materials (outer layer)

215‧‧‧ far end

216‧‧‧ proximal end

260‧‧‧Operation Department

261‧‧‧Axis

262‧‧‧Handle

263‧‧‧ grip

264‧‧‧Sliding parts

264a‧‧‧First slide

264b‧‧‧Second slider

A‧‧‧ outside side

A‧‧‧outer width dimension

B‧‧‧ inside side

b‧‧‧Inside width dimension

B10, B210‧‧‧Tube body (thin tube)

B11, B211‧‧‧ inner layer

B12, B212‧‧‧ outer layer

B15‧‧‧ far end

B16‧‧‧ proximal end

B20, B220‧‧‧ main lumen

B30, B230‧‧‧ coil layer

B31, B231‧‧‧ wire

B32, B232‧‧‧ outside side

B33, B233‧‧‧ inside side

B40, B240‧‧‧ mark

B50, B250‧‧ coating

B60‧‧‧Operation Department

B61‧‧‧Axis

B62‧‧‧Handle

B63‧‧‧ grip

B64‧‧‧Sliding parts

B64a‧‧‧First slide

B64b‧‧‧Second slider

B70, B270‧‧‧ operation line

B70a, B270a‧‧‧ first line of operation

B70b, B270b‧‧‧ second operation line

B71, B71a, B71b‧‧‧ front end (far end)

B80, B280‧‧‧ sub-cavity

B80a, B280a‧‧‧ first sub-cavity

B80b, B280b‧‧‧ second sub-cavity

B100, B200‧‧‧ catheter

B111, B2111‧‧‧ resin material (inner layer)

B112, B2112‧‧‧ resin material (outer layer)

C‧‧‧ central location

C10‧‧‧ catheter

C15‧‧‧ far end

C16‧‧‧Slim tube

C17‧‧‧ proximal end

C18‧‧‧Intermediate

C20‧‧‧Main lumen

C21‧‧‧ inner layer

C30‧‧‧ child cavity

C32‧‧‧ hollow tube

C40‧‧‧ operation line

C41‧‧‧ front end

C50‧‧‧wire coil

C50a‧‧‧ outside surface

C52‧‧‧Wire

C52a‧‧‧ outside surface

C52b‧‧‧ inside surface

C52c‧‧‧ end face of the front end

End face of C52d‧‧‧ base end

C60‧‧‧ outer layer

C64‧‧‧ coating

C66‧‧‧ mark

C70‧‧‧Operation Department

C300‧‧‧ medical machine body

C700‧‧‧ body shell

C760‧‧‧ Wheel Operation Department

C790‧‧ Wheels

CE‧‧‧ proximal end

DE‧‧‧ far end

D10‧‧‧ catheter

D15‧‧‧ far end

D16‧‧‧Slim tube

D17‧‧‧ proximal end

D18‧‧‧Intermediate

D20‧‧‧Main lumen

D21‧‧‧ inner layer

D30‧‧‧ child cavity

D32‧‧‧ hollow tube

D40‧‧‧ operation line

D41‧‧‧ front end

D50‧‧‧ wire coil

D50a‧‧‧1st wire coil

D50b‧‧‧2nd wire coil

D52‧‧‧Wire

D52a‧‧‧ outside surface

D52b‧‧‧ inside surface

D52c‧‧‧ end face of the front end

D52d‧‧‧ end face on the base end

D55‧‧‧Weld Department

D60‧‧‧ outer layer

D64‧‧‧ coating

D66‧‧‧ mark

D70‧‧‧Operation Department

D90‧‧‧Borders Department

D300‧‧‧ medical machine body

D301‧‧‧2nd intermediate part

D302‧‧‧ Main Department

D303‧‧‧Area

D350‧‧ mother catheter

D700‧‧‧ body shell

D760‧‧‧ Wheel Operation Department

D790‧‧ Wheels

H‧‧‧Maximum height difference

P‧‧‧ top

PE‧‧‧ proximal end

T‧‧‧ thickness

TP‧‧‧ wall thickness

W‧‧‧Maximum width direction

X‧‧‧ length direction

x, x'‧‧‧ the largest protrusion of the arc

Y‧‧‧ Location of contact

‧‧‧‧pitch angle

Fig. 1 is a side cross-sectional view showing a distal end portion of a catheter of a medical device according to a first embodiment.

Fig. 2 is a side cross-sectional view showing a distal end portion of a catheter of the medical device according to the second embodiment.

Fig. 3 is a side cross-sectional view showing a portion of the coil layer of Fig. 2 enlarged.

Fig. 4 is a side cross-sectional view showing a distal end portion of a catheter of the medical device according to the third embodiment.

Fig. 5 is a side cross-sectional view showing a distal end portion of a catheter of the medical device according to the fourth embodiment.

Fig. 6 is a side view showing an operation example of the catheter according to the second embodiment, wherein (a) is a side view showing the entire state before the catheter is bent, and (b) is a state in which the front end is bent over the paper surface by operating the slider. The side view, (c) is a side view showing a state in which the slider is operated so that the front end is curved toward the upper side of the paper with a larger curvature than (b), and (d) is a state in which the front end is bent toward the lower side of the paper by operating the slider. The side view, (e), is a side view showing a state in which the slider is operated so that the front end is bent toward the lower side of the paper with a larger curvature than (d).

Fig. 7 is a conceptual view showing the operation of the coils adjacent to each other in the coil layer when the catheter is bent in the second embodiment, wherein (a) is a conceptual diagram showing a straight line state, and (b) is a view above the paper surface, that is, A conceptual diagram of a state in which the warp direction of the cross-sectional shape of the wire is bent, and (c) shows a state of being bent toward the lower side of the paper surface, that is, in a direction opposite to the warping direction. Mind.

Fig. 8 is a micrograph of a cross section of a catheter according to a second embodiment, and Fig. 8 is a view showing a micrograph of a longitudinal section of a wire corresponding to the coil layer of the catheter of the second embodiment. (b) is a diagram showing a microscope photograph obtained by enlarging a portion surrounded by an ellipse in (a).

Fig. 9 is a side cross-sectional view showing a distal end portion of a catheter of the medical device according to the fifth embodiment.

Fig. 10 is a side cross-sectional view showing a portion of the vicinity of the coil layer of Fig. 9 enlarged.

Fig. 11 is a side sectional view showing the distal end portion of the catheter of the medical device according to the sixth embodiment.

Fig. 12 is a side cross-sectional view showing a portion of the vicinity of the coil layer of Fig. 11 enlarged.

Fig. 13 is a side view showing the entire catheter of the fifth embodiment and a side view showing an operation example of the distal end portion, wherein (a) is a side view showing the entire front of the catheter, and (b) is an operation slider. (c) is a side view showing a state in which the front end is bent toward the upper side of the paper, and (c) is a side view showing a state in which the front end is bent to the upper side of the paper with a larger curvature than (b), and (d) indicates that the operation is slippery. (e) is a side view showing a state in which the front end is bent toward the lower side of the paper, and (e) is a side view showing a state in which the slider is operated to bend the front end toward the lower side of the paper with a larger curvature than (d).

Fig. 14 is a conceptual view showing the operation of the coils adjacent to each other in the coil layer when the catheter is bent in the fifth embodiment, wherein (a) is a conceptual diagram showing a straight line state, and (b) is a view above the paper surface, that is, (C) is a conceptual diagram showing a state in which the cross-sectional shape of the wire is curved in the lateral direction, and (c) is a conceptual view showing a state in which the cross-sectional shape of the wire is curved, that is, the inner side of the arc of the cross-sectional shape of the wire.

Fig. 15 is a micrograph of a cross section of a catheter according to a fifth embodiment, and Fig. 15 is a view showing a micrograph of a longitudinal section of a wire corresponding to the coil layer of the catheter of the fifth embodiment. (b) is a diagram showing a microscope photograph obtained by enlarging a portion surrounded by an ellipse in (a).

Fig. 16 (a) and (b) show the mode of the medical device body of the medical device according to the seventh embodiment. Longitudinal section view.

17(a) and 17(b) are schematic views showing an example of a cross-sectional shape of a wire.

Figure 18 is a cross-sectional view taken along line A-A of Figure 16.

19(a) to 19(c) are plan views of the medical device according to the seventh embodiment.

20(a) and 20(b) are schematic longitudinal cross-sectional views showing the medical device body of the medical device according to the eighth embodiment.

21(a) and 21(b) are schematic longitudinal cross-sectional views showing the medical device body of the medical device according to the ninth embodiment.

22(a) and 22(b) are schematic longitudinal cross-sectional views showing the medical device body of the medical device according to the tenth embodiment.

23(a) and 23(b) are schematic longitudinal cross-sectional views showing the medical device body of the medical device according to the eleventh embodiment.

Fig. 24 is a schematic longitudinal sectional view showing the medical device body of the medical device according to the twelfth embodiment.

25(a) and 25(b) are schematic longitudinal cross-sectional views showing the medical device body of the medical device according to the thirteenth embodiment.

26(a) and 26(b) are schematic views showing an example of a cross-sectional shape of a wire.

Figure 27 is a cross-sectional view taken along line A-A of Figure 25.

28(a) to (c) are plan views of a medical device according to a thirteenth embodiment.

29(a) and 29(b) are schematic longitudinal cross-sectional views showing the medical device body of the medical device according to the fourteenth embodiment.

Fig. 30 is a schematic view showing the main body of the medical device of the medical device according to the fourteenth embodiment.

31(a) and 31(b) are schematic longitudinal cross-sectional views showing the medical device body of the medical device according to the fifteenth embodiment.

Hereinafter, the application of the medical device of the present invention to a catheter is based on the drawings. State is explained. In the drawings, the same components are denoted by the same reference numerals, and the description is omitted as appropriate. In the present specification, the "longitudinal section of the medical device" refers to a section obtained by cutting a medical device (a catheter in each embodiment) in parallel with the longitudinal direction through the central axis thereof. The "cross section of the medical device" refers to a section obtained by cutting a medical device in parallel with the radial direction. The same applies to the longitudinal section of the tubular body, the coil layer, the inner layer, and the like which are members of the catheter. In addition, the "cross-sectional shape of the longitudinal section" of the "coil-shaped wire" refers to the cross-sectional shape of the wire in the longitudinal section of the medical device in a state in which the wire is wound into a coil shape.

On the other hand, the term "wire" in which the cross-sectional shape is non-circular means that the long wire is placed along the width direction of the wire (relative to the direction in which the wire extends) before being formed into a coil shape. The direction of the cross section when the direction is orthogonal.

Hereinafter, in the case where it is not described in advance, the longitudinal direction refers to the longitudinal direction (long direction) of the medical device, and the radial direction refers to the thickness direction of the medical device. Further, the description of the embodiment overlapping with the preceding embodiment may be omitted in the following embodiments.

[First Embodiment]

Fig. 1 is a side cross-sectional view showing a front end portion of a tubular body 10 in a catheter 100 according to a first embodiment. The left side of Fig. 1 corresponds to the front end side of the catheter, and the right side corresponds to the side of the hand (base end side). The front end of the catheter is also referred to as the distal end DE, and the proximal end is also referred to as the proximal end CE. Here, the illustration of the proximal end CE of the catheter 100 is omitted in FIG. Further, Fig. 6 shows an overall view and an operation diagram of the catheter 100 of the present embodiment. The detailed description of Fig. 6 will be described below.

The catheter of the present embodiment includes a tubular body 10 having a strip of main lumens 20 therein as shown in FIG. Specifically, the tubular body 10 is provided with an inner layer 11, a coil layer 30, a marker 40, an outer layer 12, a coating 50, and a sub-cavity 80. The inner layer 11 corresponds to the innermost circumference of the tubular body 10 and is a tubular layer defining the main inner cavity 20. That is, the inner layer 11 has an inside Main lumen 20. The coil layer 30 is disposed on the outer circumference of the inner layer 11. The marker 40 is mounted near the distal end DE. The outer layer 12 is a layer covering the entire outer periphery of the inner layer 11 including the coil layer 30 and the marker 40. The coating 50 is formed on the outer periphery of the outer layer 12. The sub-cavity 80 (the first sub-cavity 80a and the second sub-cavity 80b) is formed on the outer circumference of the main inner chamber 20, and the operation wire 70 (the first operation wire 70a and the second operation wire 70b) is inserted.

Hereinafter, the configuration of the catheter 100 of the present embodiment will be specifically described. As shown in Fig. 1, the tubular body 10 of the catheter 100 of the present embodiment includes an inner layer 11 formed of a resin material 111, and an outer layer 12 formed of a resin material 112 different from the inner layer 11. Further, the body of the catheter 100 including the inner layer 11 and the outer layer 12, that is, the tubular body 10 is referred to as a thin tube. Further, the inner layer 11 or the outer layer 12 may be formed of one layer each, or may be formed separately as a multilayer structure formed of two or more different types or materials of the same kind.

In the present embodiment, the coil layer 30 is formed by winding (single winding) one (one) wire 31 having a non-circular cross-sectional shape in the longitudinal direction. In the present embodiment, a wire 31 having a rectangular cross-sectional shape is used. The coil layer 30 thus formed is in the cross-sectional shape of the wire 31 in the longitudinal section of the coil layer 30 as shown in FIG. 1, and the side of the outer diameter of the duct 100 is set to A, which is within the radial direction. When the side is set to B, as shown in FIG. 1, the cross-sectional shape is also a rectangular shape, and the outer side A and the inner side B are linear. Further, the linear inner side B is inclined with respect to the longitudinal direction of the duct 100. In addition, the inclination with respect to the longitudinal direction means that the longitudinal direction component and the radial direction component are contained together. In the cross-sectional shape of the wire 31, the width dimension corresponding to the long diameter dimension is longer than the thickness dimension corresponding to the short diameter dimension. The ratio of the width dimension to the thickness dimension, that is, the thickness dimension when the thickness dimension is 1 is preferably 1.1 or more and 5 or less, more preferably 1.5 or more and 4 or less, still more preferably 2 or more and 4 or less. The actual size of the width dimension of the wire 31 is 1 mm or less, preferably 0.5 mm. By using such a wire 31, the coil layer 30 is wound in such a manner that the cross-sectional shape of the wire 31 in the longitudinal section of the tubular body 10 is thinner with respect to the width as shown in FIG.

Further, the cross-sectional shape of the wire 31 is not particularly limited as long as it is non-circular. Here, as the non-circular shape, an elliptical shape, an elliptical shape, a semicircular shape, a fan shape (a fan shape having one arc, or a fan paper shape having an outer arc and an inner arc), a jade shape, and water may be exemplified. Bead or polygon. The polygon may be a concave polygon having an inner angle of more than 180 degrees in addition to a convex polygon such as a rectangle, a trapezoid, a rhombus or a parallelogram. Further, the non-circular shape may be a shape obtained by recombining the above-described shape, and specifically, may be a rounded polygon having a side protruding in an arc shape or a concave lens shape having a side recessed in an arc shape.

The length of the long side and the short side may be different when the non-circular shape is a rectangle which is assumed to be the smallest area to which it is externally attached.

The marker 40 is formed by attaching an annular member to the periphery of the distal end DE of the inner layer 11. Further, the marker 40 is formed of a material that is X-ray opaque. Therefore, by confirming the position of the marker 40 by X-ray, it is possible to confirm whether or not the catheter 100 is inserted into any position in the body of the patient.

Further, a hydrophilic coating 50 having a lubricating treatment on the outer surface is provided around the outer layer 12 near the distal end DE of the tubular body 10 as the outermost layer of the tubular body 10. The coating 50 can be arbitrarily set. For example, as long as the outer layer 12 is excellent in lubricity or hydrophilicity, the coating 50 may not be provided.

The sub-chamber 80 (the first sub-cavity 80a and the second sub-cavity 80b) through which the operation wire 70 (the first operation wire 70a and the second operation wire 70b) is inserted is formed by embedding the pipe member inside the outer layer 12. (Refer to Figure 1). Further, since the sub-chamber 80 is provided spaced apart from the main inner cavity 20 in the outer diameter direction, when the medicine or the like is supplied through the main inner chamber 20 or the optical system is inserted, the non-leakage can be prevented. Cavity 80. Further, as in the present embodiment, the sub-cavity 80 is provided on the outer side of the coil layer 30, and the inner side of the coil layer 30, that is, the main inner chamber 20 is protected with respect to the sliding operation wire 70. Further, the front end (distal end) 71 (71a, 71b) of the operation wire 70 is coupled to the marker 40. However, the present invention is not limited thereto, and the operation wire 70 may be anchored to a portion other than the marker 40, for example, the outer layer 12. Or can be processed by the caulking of the marker 40 The operation line 70 is fixed.

As a material of the inner layer 11, for example, a fluorine-based thermoplastic polymer can be used. More specifically, a resin material 111 such as polytetrafluoroethylene (PTFE) or polyvinylidene-fluoride (PVDF) or a soluble perfluoroalkoxy fluororesin (PFA) may be used. By using the fluorine-based resin in the inner layer 11, the delivery property of the contrast medium, the chemical solution, or the like is supplied to the affected part through the main lumen 20 of the catheter 100.

As the material of the outer layer 12, for example, a thermoplastic polymer can be used. As an example, in addition to polyimine (PI), polyacrylimide (PAI), polyethylene terephthalate (PET), polyethylene (PE, Polyethylene), polyamide, nylon elastomer, polyurethane, ethylene vinyl acetate, polyvinyl chloride (PVC) Or a resin material 112 such as polypropylene (PP).

As the material of the wire 31 of the coil layer 30, a flat wire made of a metal material is preferably used. However, the present invention is not limited thereto, and may be any one of the case where the inner side B of the wire 31 is linear in the cross-sectional shape of the wire 31 in the longitudinal section of the coil layer 30. The inner side B is inclined with respect to the longitudinal direction, or, as in the following embodiments of the second embodiment, when the inner side B of the wire is curved, the maximum width direction of the cross-sectional shape is relative to the longitudinal direction. It is inclined and embedded inside the inner layer 11 or the outer layer 12 to exert an anchoring effect. Any material can also be used for the wire 31. As a specific material of the wire 31, a metal material such as stainless steel (SUS), a nickel-titanium alloy, steel, titanium or a copper alloy, or a resin material can be used.

As the material of the marker 40, for example, an X-ray opaque material such as platinum can be used. Further, although the marker 40 of the present embodiment has an annular shape, the present invention is not limited thereto, and may be another coil that is disposed apart from the coil layer 30 in the longitudinal direction.

As a material of the coating layer 50, for example, a hydrophilic resin material 51 such as polyvinyl alcohol (PVA) or polyvinylpyrrolidone can be used.

The sub-cavity 80 is an aperture formed along the main lumen 20. The pore formed in the outer layer 12 may be referred to as the sub-cavity 80, or the hollow tube may be inserted into the outer layer 12 to define the inner cavity of the hollow tube as the sub-cavity 80. In the present embodiment, a hollow tube (not shown in FIG. 1 , see FIG. 3 ) containing a resin material such as PTFE or polyether ether ketone (PEEK, Polyetheretherketone) which is harder than the outer layer 12 and has a low pleatability is inserted. The outer layer 12 is passed through and the inner cavity is defined as a sub-cavity 80.

As the material of the operation wire 70, when the sub-cavity 80 through which the operation wire 70 is inserted is extruded together with the resin material 112 of the outer layer 12, the operation wire 70 is required to have heat resistance higher than the melting temperature of the resin material 112. In the case of such an operation wire 70, as a specific material, for example, PEEK, polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), PI or PTFE, etc. may be used. A polymer fiber, or a stainless steel (SUS), a corrosion-resistant coated steel wire, a metal wire such as titanium or a titanium alloy. On the other hand, when the tubular body 10 is formed, when the operation wire 70 is inserted into the sub-chamber 80, when heat resistance is not required for the operation wire 70, PVDF may be used in addition to the above materials. High density polyethylene (HDPE, high-density polyethylene) or polyester. In the above, the material for forming the catheter 100 can be appropriately selected in consideration of cost, ease of production, purpose of use, and the like.

The catheter 100 of the present embodiment is constructed by connecting an operation portion (not shown) to the proximal end of the tubular body 10 having the above configuration. The operation unit is connected to the proximal ends of the first and second operation wires 70a and 70b. By pulling the first operation wire 70a or the second operation wire 70b or both by the operation portion, the tubular body 10 of the catheter 100 can be freely bent in a desired direction from a linear shape. The operation sequence will be described in detail in the second embodiment below.

Furthermore, the bending of the catheter 100 refers to the central axis of the catheter 100 (for example, the main interior) The catheter 100 is deformed (bent) so that the central axis of the cavity 20 is linear (such as a curved line or a broken line).

Here, a representative size of the catheter 100 of the present embodiment will be described. The radius of the main inner cavity 20 can be set to about 200 μm to 300 μm. The thickness of the inner layer 11 can be set to about 10 μm to 30 μm, the thickness of the outer layer 12 can be set to about 50 μm to 150 μm, the outer diameter of the coil layer 30 can be set to a diameter of 500 μm to 860 μm, and the inner diameter of the coil layer 30 can be set to a diameter of 420 μm. ~660μm. Further, the radius from the axis of the catheter 100 (the tubular body 10) to the center of the sub-chamber 80 may be about 300 μm to 450 μm, and the inner diameter of the sub-chamber 80 may be 40 μm to 100 μm. The thickness of the operation wire 70 can be set to 30 μm to 60 μm. Further, the outermost radius including the coating layer 50 from the axis of the catheter 100 (of the tubular body 10) can be set to about 350 μm to 490 μm.

That is, the catheter 100 of the present embodiment has an outer diameter of less than 1 mm and can be inserted into a blood vessel such as a celiac artery. Further, in the catheter 100 of the present embodiment, the catheter 100 can be guided in a desired direction, for example, in a branch blood vessel.

Next, an example of a method of manufacturing the catheter 100 of the present embodiment configured as described above will be described. The method of manufacturing the catheter 100 of the present embodiment includes at least a step of winding the wire 31 having a non-circular cross-sectional shape into a coil shape in a longitudinal direction to form the coil layer 30 (hereinafter referred to as "coil layer forming step". "). More specifically, the method of manufacturing the catheter 100 includes, for example, a step of forming the inner layer 11 by the resin material 111 on the outer circumference of the core wire (hereinafter referred to as an "inner layer forming step"); and forming an outer peripheral surface of the inner layer 11 a coil layer forming step of the coil layer 30; a step of mounting the marker 40 on the outer periphery of the distal end DE of the inner layer 11 (hereinafter referred to as "marker mounting step"); and forming an outer layer 12 using the resin material 112 The step of forming the tubular body 10 (hereinafter referred to as "outer layer forming step"). In the present embodiment, the step of forming the coating layer 50 around the outer layer 12 (hereinafter referred to as "coating forming step") or the step of connecting an operation portion (not shown) (hereinafter referred to as "operation portion" Connection step"), etc. By the manufacturer that includes such steps The catheter 100 of the present embodiment is manufactured by the method. Hereinafter, each step will be described in detail.

In the inner layer forming step, as the core wire, the inner layer 11 is formed by extruding or dispersing and coating the resin material 111 as described above on a cylindrical mandrel (not shown) which has been subjected to mold release treatment. Next, in the coil layer forming step, the coil layer 30 is formed on the outer periphery of the inner layer 11 which is formed as described above. As the order, for example, the coil layer 30 is formed in advance, and in the cross-sectional shape of the wire 31 in the longitudinal section of the coil layer 30, the linear inner side B of the wire 31 is opposite to the longitudinal direction. Winding in a slanting manner. The coil layer 30 may be disposed on the outer periphery of the inner layer 11, and in the outer layer forming step described below, the coil layer 30 is slightly shrunk by the compressive force during heat shrinkage of the heat shrinkable tube, thereby embedding the wire 31 To the inner layer 11. Alternatively, the wire 31 of the wire 31 may be wound around the outer periphery of the inner layer 11 by a coil having a non-circular shape with a predetermined gap therebetween. At this time, in the cross-sectional shape of the wire 31 in the longitudinal section of the coil layer 30, the linear inner side B of the wire 31 is inclined with respect to the longitudinal direction, and the wire 31 is embedded therein. The wire 31 is wound in the manner of layer 11. Further, in the case where the inner side B of the wire is curved in the embodiment of the second embodiment, the maximum width direction of the cross-sectional shape is wound so as to be inclined with respect to the longitudinal direction.

In the marker forming step, the marker 40 made of the above material is caulked to the outer periphery of the inner layer 11 and to the side of the coil layer 30 by the distal end DE. Alternatively, only the marker 40 may be attached to the outer periphery of the distal end DE of the inner layer 11, and in the next outer layer forming step, the marker 40 is coated with the resin material 112 of the outer layer 12, thereby performing the marker 40. fixed.

In the outer layer forming step, the outer layer 12 is formed by using the resin material 112 as described above for the entire outer periphery of the inner layer 11 including the coil layer 30 and the marker 40. The outer layer 12 may also be formed by extruding the resin material 112 to the outer periphery of the inner layer 11 and forming. Alternatively, the tubular outer layer 12 having an inner diameter wider than the outer diameter of the inner layer 11 is formed in advance by the resin material 112, and the outer layer 12 is Installed on the outer circumference of the inner layer 11. Further, a heat-shrinkable tube (not shown) may be attached to the outer circumference and heated to heat-shrink the heat-shrinkable tube, whereby the inner layer 11 and the outer layer 12 may be in close contact with each other. Thereafter, the heat shrinkable tube is removed. The outer layer 12 can be easily formed by using such a method. The resin material 112 of the outer layer 12 can be melted and intruded into the winding gap 32 of the wire 31 of the coil layer 30 by any method and cured, thereby improving the adhesion between the inner layer 11 and the outer layer 12, thereby preventing interlayer The interface is peeled off. Further, the inner layer forming step and the outer layer forming step are not limited to the above methods, and any other methods may be used.

Further, at the time of the outer layer forming step, the sub-cavities 80 (the first sub-cavity 80a and the second sub-cavity 80b) including the tube member may be extruded together with the resin material 112 of the outer layer 12 to the coil layer 30. The outer circumference is formed and the sub-cavities 80 (80a, 80b) are provided in the outer layer 12. Further, the operation wires 70 (70a, 70b) may be inserted into the sub-chambers 80 (80a, 80b), and the distal ends 71 (71a, 71b) thereof may be fixed to the markers 40, respectively. Alternatively, the outer layer 12 may be extruded together with the outer layer 12 to the outer circumference of the coil layer 30 in a state in which the operation wire 70 is inserted into the sub-cavity 80.

Finally, the mandrel is pulled out from the inner layer 11. At this time, the both ends of the mandrel are pulled in mutually opposite directions as needed, thereby reducing the diameter of the mandrel. By this step, the tubular body 10 having the main lumen 20, the inner layer 11, the outer layer 12, the coil layer 30, the marker 40, the coating 50, and the sub-cavity 80 through which the operation wire 70 is inserted can be obtained. Further, the catheter 100 of the present embodiment can be manufactured by assembling the tubular body 10 and the operation portion.

As described above, in the present embodiment, in the cross-sectional shape of the wire 31 in the longitudinal section of the coil layer 30, the linear inner side B of the wire 31 is inclined with respect to the longitudinal direction. Therefore, the coil layer 30 can be embedded in the inner layer 11 and can also be embedded in the outer layer 12. Therefore, the adhesion between the inner layer 11, the coil layer 30, and the outer layer 12 can be improved by the anchoring effect of the coil layer 30. As a result, even if the load conduit 100 is strongly resistant to insertion and extraction into the body cavity, the adhesion of the layers or the peeling of the interface can be satisfactorily prevented. Further, in the cross-sectional shape of the wire 31 in the longitudinal section of the coil layer 30, the wire 31 is The inner side B of the straight line is inclined with respect to the longitudinal direction. The inclination angle with respect to the inner side B of the longitudinal direction is greater than 0 degrees and less than 45 degrees. It is preferably 5 degrees or more and 30 degrees or less. Further, the layer thickness of the coil layer 30, that is, the distance between the innermost point and the outermost point of the wire 31 is smaller than the long diameter of the cross-sectional shape of the wire 31. Thereby, the layer thickness of the coil layer 30 is suppressed, and a high bonding force of the interface between the coil layer 30 and other layers adjacent thereto (the inner layer 11 and the outer layer 12) is achieved.

Further, when the front end 71 of the duct 100 is bent following the pulling of the operation wire 70, a force for bending the axial direction of the wire 31 of the coil layer 30 is applied. However, the wire 31 is intended to resist the external force by its elastic repulsive force and bending rigidity. Therefore, the bending of the steep angle of the catheter 100 can be suppressed and bent with a large curvature. As a result, it is possible to suppress the bending of the steep angle of the main inner cavity 20, and also obtain a good restoring force, so that the kink resistance is improved and excellent bending property is obtained. Thereby, the catheter 100 having excellent flexibility in maintaining the cross-sectional area of the lumen of the main lumen 20 to a sufficient size can be obtained. The supply of the medicine or the like, the insertion of the optical system, and the like can be preferably performed via the main lumen 20. Moreover, since the specific gap 32 is interposed between the rolls of the wire 31, the adjacent rolls do not interfere with each other. Therefore, the flexibility of the catheter 100 can be improved. As described above, in the present embodiment, the catheter 100 having both excellent adhesion between layers and excellent bending resistance based on kink resistance can be obtained.

Further, in the longitudinal cross-sectional shape of the coil layer 30, the cross-sectional shape of each of the coils of the wire 31 is linear in the inner side B, and the inner side B is inclined with respect to the longitudinal direction. Thereby, the wire 31 is embedded in a wedge shape with respect to the inner layer 11, and a good anchoring effect is exerted. Further, the adhesion between the inner layer 11 and the outer layer 12 in the gap 32 of the adjacent wires 31 as described above is also maintained. Therefore, it is possible to obtain the catheter 100 which also has an effect of preventing the interfacial peeling between the coil layer 30 and the inner layer 11 and which is excellent in durability and usability. In addition, in the present specification, the "inside side B is linear" is not only a straight line but also includes an error in the formation of the wire 31 or a bending in the case of a coil shape. Even if it does not have the following arc shape, it has a substantially linear shape of warpage or deformation.

[Second Embodiment]

Next, the catheter of the second embodiment will be described with reference to Figs. 2, 3 and 6 to 8. As shown in FIG. 2, in the catheter 200 of the present embodiment, a plurality of (four in the present embodiment) winding coil layer 230, and the wire 231 has an elliptical cross section, and the first embodiment is used. The form of the catheter 100 is the same. More specifically, the outer side A and the inner side B of the cross-sectional shape of the wire 231 are curved.

As shown in FIGS. 2 and 6, the catheter 200 of the present embodiment includes a tubular body 210 and an operation portion 260. The operation portion 260 is a portion that is connected to the proximal end portion PE of the tubular body 210 and that operates the operation wire 270. The tubular body 210 includes an inner layer 211 including a resin material 2111, a coil layer 230, an outer layer 212 including a resin material 2112, a marker 240, a coating 250, and a sub-chamber 280 (the first sub-cavity 280a, the second sub-chamber) 280b). The coil layer 230 of the present embodiment is obtained by winding a plurality of wires 231 having arc-shaped ends at both ends of a cross-sectional shape. In the sub-chamber 280, an operation wire 270 (a first operation wire 270a and a second operation wire 270b) is inserted.

The longitudinal cross-sectional shape of the coil-shaped wire 231, that is, the coil layer 230, is illustrated in FIG. The cross-sectional shape (not shown) in which the wire 231 is cut perpendicularly to the extending direction is substantially the same as the longitudinal cross-sectional shape of the coil layer 230 shown in FIG. 3, and the distal side and the proximal side in the longitudinal direction. Both sides are semicircular and protrude outward, and the outer side and the inner side (upper and lower sides) are linear. That is, the cross-sectional shape of the wire 231 is an oblong shape. In the longitudinal cross-sectional shape of the coil layer 230, the inner side B of the wire 231 in the radial direction is arcuate, and its maximum width direction (a direction or b direction in FIG. 3) is inclined with respect to the longitudinal direction of the duct 200. The wire 231 is disposed at the interface between the inner layer 211 and the outer layer 212 so as to sink into the inner layer 211 and the outer layer 212.

Further, the method of manufacturing the catheter of the present embodiment is the same as the manufacturing method of the first embodiment except that a plurality of winding wires 231 are wound. Here, in the step of forming the coil layer 230, when a plurality of windings are performed, the wire 231 which starts winding first is set as the first roll. A wire wound around which the wire 231 which is started to be wound is defined as a wire which is wound later. In the step of forming the coil layer 230, a step of bringing the post-wound wire into contact with the previously wound wire and winding the previously wound wire toward the inner side of the winding diameter is performed. Therefore, as in the present embodiment, the adjacent wires 231 are in contact with each other, and the wire wound first is pressed inward by the wire wound. As a result, as shown in Figs. 2 and 3, the inner side B of the arcuate shape of the wire 231 in the longitudinal section of the catheter 200 is inclined with respect to the longitudinal direction, and the thickness of the entire coil layer 230 is obtained. (The outer diameter of the largest protruding position on the outer side A) does not need to be tapered, etc., and becomes the same diameter.

As shown in FIG. 2 and FIG. 3, in the longitudinal cross-sectional shape of the coil layer 230 of the present embodiment, the side A and the inner side B of the wire 231 in the radial direction are convex shapes that protrude toward the inner side in the radial direction. . In other words, in the longitudinal cross-sectional shape of the wire 231, the outer side A of the ridge line on the outer diameter side and the inner side B of the ridge line as the inner diameter side protrude toward the inner diameter side of the duct 200 as the width center. Conversely, the sides of the width face the warped shape on the outer diameter side. The outer side A and the inner side B are arcuate, and the longitudinal cross-sectional shape of the wire 231 is an arcuate oblong shape (hook jade shape). The shape of the orthogonal cross section (cross section) with respect to the extending direction of the wire 231 is also a warped shape of an arcuate oblong shape. Hereinafter, in the present embodiment, the cross-sectional shape of the wire 231 is not particularly distinguished from the longitudinal cross-sectional shape of the coil layer 230, and is referred to as the cross-sectional shape of the wire 231.

As shown in FIG. 3, in the cross-sectional shape of the wire 231, the outer width dimension a is shorter than the inner width dimension b (a < b). As a method of setting the wire 231 to the warped shape of such an arcuate oblong shape, the following method can be typically employed: (i) preparing the wire 231 formed into the shape in advance and winding it into a coil shape (ii) stress is applied to the flat wire 231 when the coil is wound, and deformed into an arcuate oblong shape.

The method of (ii) is described in detail. First, a flat cross-sectional shape of the wire 231 is prepared. The wire 231 is wound around the inner layer 11 or other core wires to form a coil. In the case of the layer 230, (ii-1) the center of the width of the wire 231 is pressed toward the inner diameter side to be recessed, or (ii-2) to the outer diameter of at least one of the width sides of the wire 231. The side is biased to deform the cross-sectional shape of the wire 231 into an arcuate oblong shape. Alternatively, (ii-3), after the flat wire 231 is wound to form the coil layer 230, physical treatment such as annealing is performed to deform the cross-sectional shape of the wire 231 into an arcuate elliptical shape.

As shown in FIG. 2, the coil layer 230 of this embodiment is formed by the adjacent wires 231 being in close contact with each other. Further, as shown in the enlarged cross-sectional view of Fig. 3, both sides of the arcuate shape in the width direction of the cross section of the adjacent wire 231 are in point contact with each other. Further, a position y at which the wires 231 are in point contact with each other exists between the largest projections x, x' of the arcs on both sides of the wire 231. In the coil layer 230 of the present embodiment, one of the side edges in the width direction of any of the wires 231 (the side edge of the left side of any of the wires 231 in FIG. 3) rises to the vicinity of the other strips adjacent to each other ( It is above the side edge of the right side of the other strip adjacent to the left side of the wire 231 in FIG. The strip on the upper side is a wire that is wound later, and the strip on the lower side is a wire that is first wound. Further, since FIG. 2 and FIG. 3 are cross-sectional views, the contact is performed in a point contact. However, since the point contact is continuous in the circumferential direction, the adjacent wires 231 are in line contact with each other. In the present embodiment, the cross-sectional shape of the wire 231 is deformed by the method of the above (ii-2). That is, the plurality of wires 231 are wound by overlapping the side edges of the post-wound wire over the side edges of the previously wound wire, and the side edges of the post-wound wire Stress is applied to the outer diameter side to deform the cross-sectional shape of the wire into an arcuate oblong shape.

As described above, in the present embodiment, the coil layer 230 is densely wound by using a plurality of wires 231, and the catheter 200 has excellent rigidity. Therefore, the catheter 200 excellent in kink resistance can be obtained. Further, the adjacent wires 231 of the coil layer 230 are in point contact with each other (actually in line contact). The point y at which the point contacts is present between the largest protrusions x, x' of the arcs on both sides of the wire 231. Thereby, the proximal edges are in close contact with each other in a state in which the arc-like adjacent edges of the adjacent strips overlap each other. Therefore, even if the adjacent wires 231 are rotated and displaced relative to each other, the close contact state can be maintained. the result, The catheter 200 can be freely bent in the desired direction.

FIG. 7 is a conceptual diagram showing that the wire 231 is freely movable. Fig. 7(a) is a conceptual diagram showing a straight line state before bending. Fig. 7(b) is a conceptual view showing a state in which the coil layer 230 is bent upward on the paper surface, and shows a state in which the warp direction of the cross-sectional shape of the wire 231 is curved. Fig. 7(c) is a conceptual view showing a state in which the coil layer 230 is bent downward in the plane of the paper, and shows a state of being bent in a direction opposite to the warping direction of the cross-sectional shape of the wire 231. In any case, since the adjacent windings of the wires 231 are in point contact with each other in the cross-sectional shape, they can be freely bent like a joint or the like regardless of the warping direction or the opposite direction.

In Fig. 8(a), for reference, a micrograph of a longitudinal section of a coil layer produced by the method of the above (ii-3) is shown. Fig. 8(b) is a micrograph obtained by enlarging a portion enclosed by an ellipse in Fig. 8(a). As shown in the micrographs, the coil layer 230 is formed by winding a plurality of four wires 231 having a non-circular cross-sectional shape, and the inner side B of the wire 231 in the longitudinal section is curved. The maximum width direction of the cross-sectional shape is inclined with respect to the longitudinal direction. Further, in the longitudinal section, the adjacent wires 231 are in point contact with each other at the position y, and the position y at which the points are in contact exists between the largest projections x, x' of the arcs on both sides of the wire 231. Further, the side edges on both sides in the width direction of the longitudinal section have a warped shape toward the outside.

Here, as shown in FIG. 6, the distal end portion 215 of the catheter 200 refers to a range including a specific length of the distal end DE of the catheter 200. Furthermore, the distal end DE of the catheter 200 can also be the distal end of the tubular body 210. Further, the proximal end portion 216 of the catheter 200 is a range including a specific length of the proximal end CE of the operation portion 260 of the catheter 200. Similarly, the distal end of the tubular body 210 refers to a range including a specific length of the distal end DE, and the proximal end of the tubular body 210 refers to a specific length including the proximal end portion PE of the tubular body 10. The scope.

As shown in the respective figures of Fig. 6, the operation portion 260 connected to the proximal end portion 216 of the catheter 200 is provided with a shaft portion 261 extending along the longitudinal direction of the catheter 200, and a slider 264 (for example, the first The slider 264a and the second slider 264b) advance and retreat relative to the shaft portion 261 in the longitudinal direction of the catheter 200; the handle portion 262 rotates integrally with the shaft portion 261 about the axis of the shaft portion 261; A holder 263 is provided for the base end of the tubular body 210 to be rotatably inserted about the shaft. The proximal end portion PE of the tubular body 210 is fixed to the shaft portion 261. The distal end portion 215 of the catheter 200 can be bent by individually pulling the plurality of operation wires 270 or simultaneously pulling two or more of the sliders 264 of the operation portion 260. Further, for example, by the one hand holding the grip portion 263, the other hand pivots the handle portion 262 relative to the grip portion 263, so that the entire tubular body 210 and the shaft portion 261 can be And rotate.

The sub-chamber 280 of the present embodiment forms an opening at the proximal end portion PE of the tubular body 210 as shown in the respective figures of FIG. Furthermore, an opening may be formed at a distal side of the proximal end portion PE of the tubular body 210. An operation wire 270 is inserted into each of the sub-chambers 280, and each of the operation wires 270 is slidable relative to the sub-chamber 280.

The proximal end of the first operating wire 270a is derived from the opening of the first sub-chamber 280a and is coupled to the first slider 264a of the operating portion 260. Similarly, the proximal end of the second operating wire 270b is derived from the opening of the second sub-chamber 280b and is coupled to the second slider 264b of the operating portion 260. Further, the first slider 264a and the second slider 264b are individually slid toward the proximal side with respect to the shaft portion 261. By this operation, the respective first operation wire 270a or second operation wire 270b is pulled individually to impart a tensile force to the distal end portion 215 of the catheter 200 (i.e., the distal end DE of the tubular body 210). Thereby, the distal end portion 215 is bent toward the side of the pulled operation wire 270.

The first slider 264a of the operation portion 260 is operated in the direction in which the proximal end of the first operation wire 270a is pulled (i.e., the right direction of the sheet of Fig. 6). Then, the distal end portion 215 of the catheter 200 is given a tensile force via the operation wire 270, and the distal end portion 215 is bent toward the side of the first sub-cavity 280a through which the first operation wire 270a is inserted. However, even if the first slider 264a of the operation portion 260 is operated in a direction in which the proximal end of the first operation wire 270a is pressed relative to the catheter 200 (ie, the left direction of the sheet of FIG. 6), substantially no An operating line 270a imparts a distal end 215 Pressing force. The same applies to the second slider 264b to which the second operation wire 270b is fixed.

When the arbitrary operation line 270 of the first operation wire 270a or the second operation wire 270b is individually pulled, the curvature of the distal end portion 215 may be varied according to the distance of the traction. Furthermore, when the distal end portion 215 cannot be bent into the desired posture by merely pulling the operation wire 270 individually, the first and second operation wires 270a, 270b can be simultaneously pulled. The desired posture of the distal end 215.

Thus, the distal end portion 215 is bent into various shapes, and the rotational phase of the tubular body (thin tube) 210 is adjusted by the rotational operation of the handle portion 262. By this operation, the amount of bending and the direction of bending of the distal end portion 215 can be adjusted to allow the catheter 200 to freely enter with respect to the body cavity branched at various angles. Therefore, the catheter 200 of the present embodiment can be made to enter in a desired direction with respect to, for example, a blood vessel having a branch or a peripheral blood vessel. Further, in the catheter 200 of the present embodiment, as shown in Figs. 6(c) and (e), the bending angle of the distal end portion 215 is preferably more than 90 degrees. Thereby, even when the branch angle of the blood vessel is an acute angle such as a U-turn, the catheter 200 can be made to enter with respect to the branch branch.

Next, the operation of the catheter 200 of the second embodiment will be described with reference to Fig. 6 . First, the catheter 200 of the present embodiment is inserted into a body cavity such as a blood vessel of a patient. In the present embodiment, the first sub-cavity 280a and the second sub-chamber 280b are formed to face each other with the axis of the catheter 200 facing 180 degrees. Further, a first operation wire 270a is inserted in the first sub-chamber 280a, a second operation wire 270b is inserted in the second sub-chamber 280b, and the front end can be freely bent. Therefore, the catheter 200 can be actively inserted into the patient's body while the operation wire 270 is operated without a guide wire or the like.

Here, in the catheter 200 of the present embodiment, when the first slider 264a of the operation unit 260 is operated to pull the first operation wire 270a toward the proximal side, as shown in FIG. 6(b), the catheter 200 is far away. The end portion 215 is bent above the paper surface of FIG. Further, when the amount of pulling is increased, as shown in Fig. 6(c), the distal end portion 215 of the catheter 200 is curved with a large curvature toward the upper side of the sheet of Fig. 6.

When the second slider 264b of the operation unit 260 is operated to pull the second operation wire 270b toward the proximal side, as shown in Fig. 6(d), the distal end portion 215 of the catheter 200 is below the paper surface of Fig. 6. bending. Further, when the amount of pulling is increased, as shown in Fig. 6(e), the distal end portion 215 of the catheter 200 is curved with a large curvature toward the lower side of the paper surface of Fig. 6.

Furthermore, when the first operation wire 270a and the second operation wire 270b are pulled together, the amount of traction may be different from each other. That is, even if the desired curvature cannot be achieved even if the arbitrary operation wire 270 is individually pulled, the two operation wires 270 can be pulled to adjust the curvature. More specifically, according to the state in which the distal end portion 215 is bent by pulling one of the operation wires 270, the other operation wire 270 is pulled. By this operation, the operation of reducing the amount of bending of the distal end portion 215 or the operation of returning the posture of the distal end portion 215 from the state of being bent to the original linear posture can be performed. In this way, the amount of bending can be finely adjusted by reducing the amount of bending.

Further, in a state where the distal end portion 215 of the catheter 200 is bent, the grip portion 263 of the operation portion 260 is held by one hand, and the handle portion 262 is pivoted with respect to the grip portion 263 by the other hand. By this operation, the whole of the catheter 200 is rotated by a maximum of 90 degrees together with the shaft portion 261, so that the operator can change the bending direction of the distal end portion 215 of the catheter 200 to a desired direction, thereby making the distal position The end DE is opposite to the affected part. Further, even in the present embodiment, since the wire 231 is wound around the main inner cavity 220, the torsional rigidity of the tubular body 210 is improved. Therefore, the torque transmission efficiency at the time of the rotation operation of the catheter 200 is improved, and the rotational responsiveness to the distal end portion 215 of the rotational operation is improved. Further, since the position of the distal end can be clearly confirmed by the marker 240, the current position or direction of the distal end DE can be easily confirmed and operated.

Further, in the catheter 200 of the second embodiment, the wire 231 is wound tightly around the main lumen 220, and a coil layer 230 having a more elastic force is formed. Therefore, when the catheter 200 is bent by the operation of the operation wire 270, the coil layer 230 is subjected to a force to be bent in the axial direction. However, the coil layer 230 is intended to resist by its elastic repulsive force. Reject the external force. Therefore, the bending of the steep angle of the catheter 200 can be suppressed and bent with a large curvature. Therefore, since the bending of the steep angle of the main inner cavity 220 is also suppressed, a good restoring force is obtained, so that the kink resistance is improved and excellent bending property is obtained. Thereby, since the cross-sectional area of the lumen of the main lumen 220 can be maintained to a sufficient size, the supply of the drug or the like through the main lumen 220 or the insertion of the optical system can be preferably performed.

As described above, in the catheter 200 of the present embodiment, even if the adjacent wires 231 of the coil layer 230 are in close contact with each other and are in point contact (line contact), they do not interfere with each other, and thus can be excellent in flexibility. Coil layer 230. Further, even if the wire 231 is wound tightly, the inner side B of the wire 231 is arcuate, and the coil layer 230 which is formed obliquely with respect to the longitudinal direction in the maximum width direction of the cross-sectional shape is also wedge-shapedly embedded in the inner layer 211. Both the outer layer 212 and the outer layer 212 exert an anchoring effect. Therefore, even when the catheter 200 is inserted, even if the resistance is strongly applied in the longitudinal direction, the effect of preventing the adhesion between the layers or the peeling of the interface can be favorably prevented. Therefore, the catheter 200 having excellent adhesion between layers and excellent bending resistance based on kink resistance can be obtained. Further, the catheter 200 excellent in durability and usability can be obtained.

[Third embodiment]

Next, a catheter according to a third embodiment will be described with reference to Fig. 4 . As shown in Fig. 4, the catheter 300 of the present embodiment is a plurality of (four) wound coil layers 330, and one of the adjacent wires 331 is overlapped and brought into surface contact with each other, and is the same as the second embodiment. The catheter 200 is substantially identical in construction. As shown in FIG. 4, the catheter 300 of the present embodiment includes a tubular body 310 and an operation portion (not shown) connected to the proximal end CE of the tubular body 310. The tubular body 310 includes an inner layer 311 containing a resin material. 3111; a coil layer 330, which is formed by winding a plurality of wires 331 having arc ends at both ends of the cross section; an outer layer 312 comprising a resin material 3112; a marker 340; a coating layer 350; and a sub-cavity 380 (the first sub-cavity 380a and the second sub-chamber 380b) are inserted through the operation line 370 (the first operation line 370a and the second operation line 370b).

In the present embodiment, the outer side A and the inner side B of the wire 331 are also arcuate, and the maximum width direction of the cross-sectional shape is inclined with respect to the longitudinal direction. Moreover, since each of the wires 331 is wound so as to be fitted into the inner layer 311 and the outer layer 312, peeling of the interface between the layers can be satisfactorily prevented. Further, since one of the adjacent wires 231 of the coil layer 330 overlaps each other and comes into surface contact, the rigidity is further improved and the kink resistance is excellent. Further, at the time of bending, the adjacent wires 331 are in surface contact with each other and are relatively displaced. Further, as shown in FIG. 4, four sets of the wires 331 are wound around the gap 332. By allowing the resin material 3112 of the outer layer 312 to enter the gap 332, the adhesion between the inner layer 311 and the outer layer 312 is improved, so that the effect of preventing the interface peeling can be further improved. Further, as a modification, even if the gap 332 is not provided and wound tightly, the anchoring effect of the coil layer 330 to the inner layer 311 and the outer layer 312 is not impaired, and the resin material 3112 of the outer layer 3112 is not self-coiled. The layer 330 intrudes into the inner layer 311 side to impair the adhesion between the layers and prevent the interface peeling effect.

[Fourth embodiment]

Next, a catheter according to a fourth embodiment will be described with reference to Fig. 5 . As shown in Fig. 5, the inner side B of the wire 431 in the longitudinal section of the catheter 400-based coil layer 430 of the present embodiment is arcuate, and the maximum width direction of the cross-sectional shape is inclined with respect to the longitudinal direction, and the wire 431. The structure is substantially the same as that of the catheter 100 of the first embodiment except that it is not embedded in the inner layer 411. As shown in FIG. 5, the catheter 400 of the present embodiment includes a tubular body 410 and an operation portion (not shown) connected to the proximal end CE of the tubular body 410. The tubular body 410 includes an inner layer 411 containing a resin material. 4111; a coil layer 430, which is formed by winding a single strip of arcs 431 having arc ends at both ends; an outer layer 412 comprising a resin material 4112; a marker 440; a coating 450; and a sub-cavity 480 (the first sub-cavity 480a and the second sub-chamber 480b) are inserted through the operation line 470 (the first operation line 470a and the second operation line 470b).

In the present embodiment, the outer side A and the inner side B of the wire 431 are also arcuate, and the maximum width direction of the cross-sectional shape is inclined with respect to the longitudinal direction. Again, the outer layer 412 tree The grease material 4112 intrudes into the winding gap 432 of the wire 431 and between the coil layer 430 and the inner layer 411, so that the outer layer 412 and the inner layer 411 are in good contact with each other. Further, the wire 431 is trapped (embedded) in a wedge shape as the outer layer 412 as the base layer. By such a synergistic effect, excellent adhesion between the layers is obtained, and the interface peeling can be favorably prevented. Further, by the coil layer 430, excellent flexibility and kink resistance are obtained, and the catheter 400 excellent in flexibility can be obtained.

The present invention is not limited to the above-described embodiments, and various modifications, improvements, etc. within the scope of the object of the invention are also included.

As a variant, for example, when the wire is wound, the proximal end CE side is wound tightly so that the adjacent rolls are in close contact with each other as in the second embodiment. Further, in the distal end portion of the densely wound portion, as in the first embodiment, the wire is wound around the desired gap by a predetermined gap, and a relatively thinly wound portion is formed. In such a coil layer, the portion which is densely wound has a relatively large bending rigidity as compared with the portion which is relatively thinly wound, and therefore, when inserted into the body cavity, it is maintained in a straight line, and thus it is easy to be inserted into the affected part. Further, since the portion which is thinly wound is relatively small in bending rigidity, the bending property is good and it is easy to bend. However, the curved body can be maintained by having a moderate stiffness. Therefore, the portion which is thinly wound can easily perform the bending operation of the operation wire to the distal end portion.

Moreover, in each of the above embodiments, an example in which the catheter has two operation wires has been described. However, a sub-cavity in which three or more operation wires are inserted may be formed in the tubular body. In this case, the bending operation of the catheter can be performed by pulling one or more of the operation wires. Furthermore, in this case, the distal end portion can be bent in any direction over 360 degrees by individually controlling the traction lengths of the three or more operation wires. Thereby, the rotation of the distal end portion in a specific direction is not performed by applying a rotational force to the entire catheter, and the direction in which the catheter enters can be operated only by the operation of the operation portion to the operation line. Further, it is also possible to adopt a configuration in which the catheter has only one operation wire. In this case, the bending operation of the distal end portion of the traction by the operation wire and the rotation operation of the catheter are used in combination. borrow Thus, the distal end of the catheter can be bent in any direction of bending and in any direction. Further, the sub-cavity may be disposed on the inner side of the coil layer, or may be bent without using a sub-cavity or an operation wire. Further, although the sub-cavity is formed by the tube member, a long hole may be formed when the outer layer is formed, and the sub-cavity may be formed, and the operation wire may be inserted into the hole. Moreover, if the marker is not required, it may not be provided.

Further, in the second to fourth embodiments, the cross-sectional shape in the longitudinal section of the wire-based conduit of the coil layer is a warped shape that faces outward. However, the present invention is not limited thereto, and may be a warped shape that faces inward, or may be warped as in the first embodiment, and may be linear. In any case, due to the cross-sectional shape of the wire in the longitudinal section of the duct, (1) the inner side of the wire is linear, and the inner side is inclined with respect to the longitudinal direction, or (2) When the inner side of the wire is curved, the maximum width direction of the cross-sectional shape is inclined with respect to the longitudinal direction, and it is possible to obtain not only excellent flexibility and kink resistance but also the effect of preventing interfacial peeling between layers. Excellent product.

Further, although the above embodiments and modifications are applied to the catheter, the present invention is not limited to the catheter, and may be applied to other long medical apparatuses that are inserted into a body cavity such as an endoscope or an ultrasonic instrument.

[Fifth Embodiment]

Fig. 9 is a side cross-sectional view showing the front end portion of the tubular body B10 in the catheter B100 of the fifth embodiment. The left side of Fig. 9 corresponds to the front end side of the catheter, and the right side corresponds to the side of the hand (base end side). The front end of the catheter is also referred to as the distal end DE, and the proximal end is also referred to as the proximal end CE. However, the illustration of the proximal end CE of the catheter B100 is omitted in FIG. Further, Fig. 13 shows an overall view and an operation diagram of the catheter B100 of the present embodiment. The detailed description of Fig. 13 will be described below.

The catheter of this embodiment is shown in Fig. 9 and includes a tubular body B10 having a strip of main lumen B20 therein. Specifically, the tubular body B10 includes an inner layer B11, a coil layer B30, a marker B40, an outer layer B12, a coating layer B50, and a sub-chamber B80. Inner layer B11 is equivalent The innermost circumference of the tubular body B10 is a tubular layer defining the main lumen B20. That is, the inner layer B11 has the main inner cavity B20 inside. The coil layer B30 is disposed on the outer circumference of the inner layer B11. The marker B40 is mounted near the distal end DE. The outer layer B12 is a layer covering the entire outer periphery of the inner layer B11 including the coil layer B30 and the marker B40. The coating B50 is formed on the outer periphery of the outer layer B12. The sub-chamber B80 (the first sub-cavity B80a and the second sub-chamber B80b) is formed on the outer circumference of the main inner chamber B20, and the operation line B70 (the first operation line B70a and the second operation line B70b) is inserted.

Hereinafter, the configuration of the catheter B100 of the present embodiment will be specifically described. As shown in Fig. 9, the tubular body B10 of the catheter B100 of the present embodiment includes an inner layer B11 formed of a resin material B111, and an outer layer B12 formed of a resin material B112 different from the inner layer B11. Further, the body of the duct B100 including the inner layer B11 and the outer layer B12, that is, the tubular body B10 is referred to as a thin tube. Further, the inner layer B11 or the outer layer B12 may be formed of one layer or may be formed separately as a multilayer structure formed of two or more kinds of different kinds or materials of the same kind.

In the present embodiment, the coil layer B30 is wound by a plurality of (specifically, four) wires B31 having a cross-sectional shape that is non-circular in a plurality of directions in the longitudinal direction. Formed by winding). The coil layer B30 thus formed is a cross-sectional shape of the wire B31 in the longitudinal section of the coil layer B30 as shown in FIG. 9, and corresponds to the outer side of the outer diameter side of the pipe B100, and the side B32 is parallel with respect to the longitudinal direction. The inner side B33 on the inner diameter side has an arc shape, and the center thickness direction of the cross-sectional shape is inclined with respect to the longitudinal direction. The center thickness direction of the cross-sectional shape of the wire B31 in the longitudinal section of the coil layer B30 is a straight line in which the center of the thickness (the center of the diameter dimension) of each cross-sectional shape of the wire B31 is continuously connected in the longitudinal direction. Or the direction in which the curve extends. In the present embodiment, the direction of the arrow W shown in Fig. 10 and the following Fig. 12 corresponds to the center thickness direction of the wire B31. In addition, the center thickness direction is inclined with respect to the longitudinal direction, and means that the center thickness direction includes both the longitudinal direction component and the radial direction component. On the other hand, in the longitudinal section of the coil layer B30, the outer side B32 of the wire B31 is parallel with respect to the longitudinal direction. The outer surface of the coil layer B30 is flat and has a smooth cylindrical shape. The coil layer B30 is disposed outside the inner layer B11 And the outer layer B12 is covered, whereby the resin material B112 of the outer layer B12 is interposed between the coil layer B30 and the inner layer B11.

Here, the interface between the outer side B32 and the outer layer B12 of the wire B31 can also be peeled off, and the relative movement of both directions in the longitudinal direction is allowed. On the other hand, the inner side B33 which is inclined in the longitudinal direction is fitted with respect to the resin material B112 interposed between the inner layer B11 and the outer layer B12 between the inner layer B11 and the coil layer B30, and the inner side B33 is anchored with respect to the outer layer B12. effect. The width dimension corresponding to the long diameter dimension of the cross-sectional shape of the wire B31 of the present embodiment means the dimension of the center thickness direction of the wire B31. The width of the wire B31 is longer than the thickness of the short diameter. The ratio of the width dimension to the thickness dimension, that is, the width dimension when the thickness dimension is 1 is preferably 1.1 or more and 5 or less, more preferably 1.5 or more and 4 or less, still more preferably 2 or more and 4 or less. The actual size of the width dimension of the wire B31 is 1 mm or less, preferably 0.5 mm.

More specifically, the cross-sectional shape of the wire B31 of the present embodiment is a partial oblong shape obtained by cutting an oblong shape with the outer side B32. Both sides of the cross section of the wire B31 in the width direction are arcuate shapes that protrude outward. In addition, the cross-sectional shape of the wire B31 is not particularly limited as long as it is a non-circular shape including the flat side B32. The outer side B32 is relatively flat, and the outer side B32 has a curvature which is deliberately smaller than the other side except that the outer side B32 is substantially linear. The side shape other than the outer side edge B32 may be an arc shape, a straight line portion, and a corner portion. That is, the cross-sectional shape of the wire B31 may also be a curved shape including a partially circular, partially oblong or partially elliptical arc-shaped portion, or may be a rectangle, a trapezoid, a diamond, a parallelogram, a convex polygon, or A straight shape such as a concave polygon. More specifically, it may be a trapezoidal, triangular or pentagonal shape obtained by cutting a square or a rectangle in a line segment. The non-circular cross-sectional shape may be different in length between the long side and the short side when a rectangular shape of the smallest area is assumed to be circumscribed. Hereinafter, the cross-sectional shape of the wire B31 and the longitudinal cross-sectional shape of the coil layer B30 are not particularly distinguished, and the cross-sectional shape of the wire B31 is called.

Using such a wire B31, in the following manufacturing step, the outer side B32 of each of the wires B31, that is, the outer surface of the coil layer B30 is ground, whereby the outer surface having a flat outer surface as described above can be obtained, and The inner side B33 of the cross-sectional shape of each of the wires B31 is inclined to the coil layer B30 with respect to the longitudinal direction. Further, as shown in an enlarged view of Fig. 10, the inner side B33 of the cross-sectional shape of each adjacent wire B31 is inclined in the same direction with respect to the longitudinal direction, and the thickness of the cross-sectional shape is formed to be gradually thicker toward the oblique direction. That is, each of the wires B31 is wound in the cross-sectional shape, and the thickness a of the distal end DE side is the smallest, gradually thickens from the distal side to the proximal side, and the thickness b of the proximal end CE side is the largest. Further, it is preferable that the inclination angle of the wire B31 of the inner side B33 is 45 degrees or less with respect to the longitudinal direction. By setting the tilt angle to 45 degrees or less, the outer layer B12 between the inner layer B11 and the coil layer B30 can be well embedded, and the rigidity does not become excessively high, and the flexibility of the catheter B100 is not hindered or Flexibility. In the present embodiment, the inner side B33 of the cross-sectional shape of the wire B31 is inclined by about 20 degrees with respect to the longitudinal direction.

Here, the so-called tilt and tilt angle in the present invention will be described. In Patent Document 1, when the flat wire is wound, the inner side of the wire is wound in parallel with the longitudinal direction of the pipe. On the other hand, in the present invention, the wire B31 is wound so that the inner side B33 of the wire B31 is not parallel to the longitudinal direction and intersects at a specific angle to form the coil layer B30. Therefore, in the cross-sectional shape of the wire B31, the inner side B33 is arranged to intersect (tilt) with respect to the longitudinal direction. As in the present embodiment, the inclination angle of the wire B31 when the inner side B33 is curved is the center thickness direction of the wire B31 in the longitudinal section of the coil layer B30 (arrow W in Fig. 10). The angle at which the length of the conduit B100 intersects. Further, when the inner side B33 of the wire B31 is linear, the angle at which the inner side B33 intersects the longitudinal direction of the duct B100 is referred to as the inclination angle of the wire B31.

In the coil layer B30 of the present embodiment, as shown in Fig. 9, the adjacent wires B31 are in close contact with each other. As shown in FIG. 10, in the longitudinal section of the coil layer B30, the width of the wire B31 An arc-shaped end portion is formed on both sides of the degree direction (that is, the far side and the near side in the longitudinal direction). One of the arc-shaped end portions of the adjacent wire B31 is in surface contact with each other only by a distance c in the longitudinal direction. Further, the position y at which the two sides of the wire B31 are in contact with each other is located between the largest projections x and x' of the arcs on both sides of the wire B31. The position y of the surface contact refers to a line segment region in which the adjacent wires B31 are in contact with each other in the longitudinal section of the coil layer B30. The position y of the surface contact is located between the largest protrusions x, x', and means that the largest protrusions x, x' are located on the outer sides (including the end points of the line segment area) of the line segment region.

As described above, in the present embodiment, the coil layer B30 is wound in a relatively dense manner using a plurality of wires B31, and the arc-shaped end portions of the wire B31 overlap each other. Therefore, when the adjacent wire B31 is rotated and displaced relative to each other and the coil layer B30 is bent, the wire B31 can be kept in close contact with each other and smoothly moved relatively. Therefore, the catheter B100 can be freely bent in a desired direction with a desired curvature.

The marker B40 is formed by attaching an annular member to the periphery of the distal end DE of the inner layer B11. Further, the marker B40 is formed of a material that is X-ray opaque. Therefore, by confirming the position of the marker B40 of the distal end DE by X-ray, it can be confirmed whether or not the catheter B100 is inserted into any position in the body of the patient.

Further, around the outer layer B12 near the distal end DE of the tubular body B10, a hydrophilic coating B50 having a lubricating treatment on the outer surface is provided as the outermost layer of the tubular body B10. The coating B50 can be arbitrarily set. For example, the outer layer B12 may not be provided with the coating layer B50 as long as it is excellent in lubricity or hydrophilicity.

The sub-chamber B80 (the first sub-cavity B80a and the second sub-chamber B80b) through which the operation line B70 (the first operation line B70a and the second operation line B70b) is inserted is shown in FIG. 10 by the inside of the outer layer B12. It is formed by embedding a pipe member. Further, since it is provided to be spaced apart from the main inner chamber B20 in the outer diameter direction, when the medicine or the like is supplied through the main inner chamber B20 or the optical system is inserted, the leakage can be prevented from leaking to the sub-chamber B80. By sub-cavity B80 is disposed on the outer side of the coil layer B30, and protects the inner side of the coil layer B30, that is, the main inner chamber B20 with respect to the sliding operation line B70. Further, the front end (distal end) B71 (B71a, B71b) of the operation wire B70 is coupled to the marker B40 as shown in FIG. However, the present invention is not limited thereto, and the operation wire B70 may be anchored to a portion other than the marker B40 of the distal end DE, for example, the outer layer B12, or may be fixed by caulking of the marker B40. Operate line B70.

Here, as shown in FIG. 13, the distal end portion B15 of the catheter B100 is a range including a specific length of the distal end DE (front end) of the catheter B100. Furthermore, the distal end DE of the catheter B100 can also be the distal end of the tubular body B10. Further, the proximal end portion B16 of the catheter B100 is a range including a specific length of the proximal end CE of the catheter B100. Similarly, the distal end of the tubular body B10 refers to a range including a specific length of the distal end DE, and the proximal end of the tubular body B10 refers to a specific length including the proximal end PE of the tubular body B10. The scope.

The operation unit B60 is provided with a shaft portion B61 connected to the proximal end CE of the catheter B100 and extending along the longitudinal direction as shown in each of FIG. 13; the slider B64 (for example, the first slider B64a, the second slider) B64b) advancing and retracting in the longitudinal direction with respect to the shaft portion B61; the handle portion B62 is rotated integrally with the shaft portion B61 about the axis of the shaft portion B61; and the grip portion B63 is provided for the base of the tubular body B10 The end is rotatably insertable about the axis. The proximal end portion PE of the tubular body B10 is fixed to the shaft portion B61. By the operation of individually pulling the two operation wires B70 (the first operation wire B70a and the second operation wire B70b) or simultaneously pulling two or more of the sliders B64 of the operation unit B60, the catheter B100 can be used. The distal end portion B15 is curved. Further, for example, in a state in which the grip portion B63 is held by one hand, the other hand pivots the handle portion B62 with respect to the grip portion B63, so that the entire tubular body B10 and the shaft portion B61 can be And rotate.

The sub-chamber B80 of the present embodiment forms an opening at the proximal end portion PE of the tubular body B10 as shown in each of Figs. Furthermore, it can also be at the proximal end PE of the tubular body B10. An opening is formed at the distal side. In each sub-cavity B80, an operation line B70 is inserted, and each operation line B70 is slidable relative to the sub-chamber B80.

The proximal end of the first operation wire B70a is derived from the opening of the first sub-chamber B80a and is connected to the first slider B64a of the operation portion B60. Similarly, the proximal end of the second operation wire B70b is led out from the opening of the second sub-chamber B80b and is connected to the second slider B64b of the operation portion B60. Further, the first slider B64a and the second slider B64b are individually slid toward the proximal end side with respect to the shaft portion B61. By this operation, the respective first operation line B70a or second operation line B70b is pulled individually to impart a tensile force to the distal end portion B15 of the catheter B100 (i.e., the distal end DE of the tubular body B10). Thereby, the distal end portion B15 is bent toward the side of the pulled operation wire B70.

As a material of the inner layer B11, for example, a fluorine-based thermoplastic polymer can be used. More specifically, a resin material B111 such as polytetrafluoroethylene (PTFE) or polyvinylidene fluoride (PVDF) or a soluble perfluoroalkoxy fluororesin (PFA) can be used. By using the fluorine-based resin in the inner layer B11, the delivery property of the contrast medium, the chemical solution, or the like is supplied to the affected part through the main lumen B20 of the catheter B100.

As the material of the outer layer B12, for example, a thermoplastic polymer can be used. As an example, polyethylene (PE) or polyamine (PA) can be used in addition to polyimine (PI), polyamidimide (PAI), and polyethylene terephthalate (PET). A resin material B112 such as a nylon elastomer, a polyurethane (PU), an ethylene-vinyl acetate resin (EVA), a polyvinyl chloride (PVC) or a polypropylene (PP).

As the material of the wire B31 of the coil layer B30, a flat wire made of a metal material is preferably used, but the present invention is not limited thereto, and any material may be used. As a specific material of the wire B31, a metal material such as stainless steel (SUS), a nickel-titanium alloy, steel, titanium or a copper alloy, or a resin material can be used.

As the material of the marker B40, for example, an X-ray-impermeable material such as platinum can be used. Further, although the marker B40 of the present embodiment has an annular shape, the present invention is not limited thereto, and may be The other coils are disposed apart from the coil layer B30 in the longitudinal direction.

As the material of the coating layer B50, for example, a hydrophilic resin material such as polyvinyl alcohol (PVA) or polyvinylpyrrolidone can be used.

The sub-chamber B80 is an aperture formed along the main lumen B20. The pore formed in the outer layer B12 may be a sub-chamber B80, or the outer tube B12 may be inserted into the hollow tube to define the inner cavity of the hollow tube as the sub-chamber B80. In the present embodiment, a hollow tube (see FIG. 10) containing a resin material such as PTFE or polyetheretherketone (PEEK) which is harder than the outer layer B12 and has a low pleatability is inserted into the outer layer B12, and the inner cavity thereof is provided. Set to sub-chamber B80.

When the sub-cavity B80 through which the operation wire B70 is inserted and the resin material B112 of the outer layer B12 are extruded together as the material of the operation wire B70, the heat resistance of the resin material B112 at a melting temperature or higher is required for the operation wire B70. In the case of such an operation line B70, as a specific material, for example, polyetheretherketone (PEEK), polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), PI or PTFE, or the like can be used. A polymer fiber, or a stainless steel (SUS), a corrosion-resistant coated steel wire, a metal wire such as titanium or a titanium alloy. On the other hand, when the operation wire B70 is inserted into the sub-chamber B80 after the tubular body B10 is formed, when heat resistance is not required for the operation wire B70, PVDF may be used in addition to the above materials. High density polyethylene (HDPE) or polyester. As described above, the material for forming the conduit B100 can be appropriately selected in consideration of cost, ease of production, purpose of use, and the like.

The proximal end (PE) of the tubular body B10 having the above configuration is connected to an operation portion (not shown) to constitute the catheter B100 of the present embodiment. The operation unit is connected to the proximal ends of the first and second operation wires B70a and B70b. By pulling the first operation wire B70a or the second operation wire B70b or both by the operation portion, the tubular body B10 of the catheter B100 can be freely bent in a desired direction from a linear shape. The operation sequence will be described in detail in the sixth embodiment below.

In addition, the bending of the duct B100 means that the duct is formed such that the central axis of the duct B100 (for example, the central axis of the main lumen B20) is straight (curved or broken). B100 is deformed (bent).

Here, a representative size of the catheter B100 of the present embodiment will be described. The radius of the main inner chamber B20 can be set to about 200 μm to 300 μm. The thickness of the inner layer B11 can be set to about 10 μm to 30 μm, the thickness of the outer layer B12 can be set to about 50 μm to 150 μm, the outer diameter of the coil layer B30 can be set to a diameter of 500 μm to 860 μm, and the inner diameter of the coil layer B30 can be set to a diameter of 420 μm. ~660μm. Further, the radius from the axis of the catheter B100 (the tubular body B10) to the center of the sub-chamber B80 may be about 300 μm to 450 μm, and the inner diameter of the sub-chamber B80 may be 40 μm to 100 μm. The thickness of the operation wire B70 can be set to 30 μm to 60 μm. Further, the outermost radius including the coating layer B50 from the axis of the tube B100 (of the tubular body B10) may be set to about 350 μm to 490 μm.

In other words, the catheter B100 of the present embodiment has an outer diameter of less than 1 mm and can be inserted into a blood vessel such as a celiac artery. Further, the catheter B100 of the present embodiment can also enter the catheter B100 in a desired direction, for example, in a branch blood vessel.

Next, an example of a method of manufacturing the catheter B100 of the present embodiment configured as described above will be described. The method of manufacturing the catheter B100 of the present embodiment includes at least a step of winding the wire B31 having a non-circular cross-sectional shape into a coil shape in the longitudinal direction to form the coil layer B30 (hereinafter referred to as a "coil layer forming step"). ). More specifically, the method of manufacturing the catheter B100 includes, for example, a step of forming the inner layer B11 by the resin material B111 on the outer circumference of the core wire (hereinafter referred to as an "inner layer forming step"); and forming the above-mentioned outer peripheral surface of the inner layer B11 a coil layer forming step of the coil layer B30; a step of smoothing the outer surface of the coil layer B30 to smooth it (hereinafter referred to as "grinding step"); and mounting the label B40 on the outer periphery of the outer end DE of the inner layer B11 The step (hereinafter referred to as "marker mounting step"); and the step of forming the outer layer B12 by the resin material B112 to form the tubular body B10 (hereinafter referred to as "outer layer forming step"). In the present embodiment, the step of forming the coating layer B50 around the outer layer B12 (hereinafter referred to as "coating forming step") or the step of connecting the operation portion B60 (hereinafter referred to as "operation unit connecting step" is further included. )Wait. By including The catheter B100 of the present embodiment is produced by the manufacturing method of this step. Hereinafter, each step will be described in detail.

In the inner layer forming step, a cylindrical mandrel (core wire) (not shown) which has been subjected to mold release treatment as a core wire is extruded or dispersed and formed into a resin layer B111 as described above to form an inner layer. B11.

In the coil layer forming step, a method of forming the coil layer B30 by winding the wire B31 on the surface of the inner layer B11 (surface area layer method), or (ii) spirally winding the wire B31 may be used in advance. A method of forming a coil layer B30 and inserting a core wire covered by the inner layer B11 inside the coil layer B30 (individual production method). In the present embodiment, the individual production methods of (ii) are exemplified. Specifically, first, a plurality of wires B31 are wound around the surface of the coil core wire by a winding machine. This coil core wire is different from the above-described core wire (mandrel) covered by the inner layer B11. When the coil layer B30 is formed, the wire B31 may be wound around the winding machine at an angle of the inner side B33 of the cross-sectional shape of the wire B31 with respect to the longitudinal direction, and may be wound in plurality. The coil layer B30 may also include a plurality of coils formed by a single winding process of the winding machine, or a plurality of coils formed by a plurality of winding processes of the winding machine being connected to each other in the axial direction. Made of a connecting coil. Further, the coil layer B30 may be configured by juxtaposing a plurality of coils in parallel in the axial direction without connecting the plurality of coils to each other.

The above-described polishing step is performed on the coil layer B30 thus formed, so that the outer surface of the coil layer B30 is smoothly processed. The grinding step will be described in detail below. After the coil layer B30 after the washing and polishing step, the core wire covered by the inner layer B11 is inserted, and the outer layer forming step is further performed. In the outer layer forming step, the outer layer B12 is formed in the same layer as the coil layer B30 so as to include the surface of the coil layer B30 and the wire B31. In the outer layer forming step, after the resin tube having a larger inner diameter than the surface of the coil layer B30 is formed in advance, the resin tube is swim-fitted to the coil layer B30, and the compressive force is generated by heat shrinkage of the heat-shrinkable tube. These are integrally formed. At this time, the coil layer B30 can also be slightly received in the radial direction. The wire B31 is embedded in the inner layer B11. As described above, in the present embodiment, the coil layer B30 is polished in advance, and then adhered to the inner layer B11 to be integrated. Thereby, the polishing residue generated in the polishing step or the polishing liquid used in the polishing step does not come into contact with the inner layer B11. Therefore, the inner layer B11 can be cleanly maintained.

As described above, the coil layer B30 is formed by spirally winding the wire B31, and then the coil layer B30 is subjected to a polishing step. However, the method of manufacturing the catheter B100 of the present invention is not limited thereto. A wire B31 having a non-circular cross section of the flat outer side B32 and the inclined inner side B33 as illustrated in FIG. 10 may be prepared in advance, and the outer surface of the coil layer B30 may be flattened using a winding device. The wire B31 is wound to form the coil layer B30.

When the wire B31 is wound in a plurality of directions obliquely, the wire B31 which is first wound is referred to as a wire which is wound first, and when the wire B31 which is started to be wound is referred to as a wire which is wound later, The wound wire may be wound while being pressed against the previously wound wire.

Further, the wire B31 of the present embodiment has a warped shape (not shown) in which the center of the width of the cross-sectional shape protrudes in the inner diameter direction and the both sides of the width face outward after the coil layer forming step and before the polishing step. Therefore, after the polishing step, as shown in the enlarged view of FIG. 9 and FIG. 10, the width of the inner side B33 of the cross-sectional shape of the wire B31 protrudes toward the inner diameter direction, and the width of both sides of the width is inclined toward the outer side. Curved shape. Moreover, the outer side B32 is relatively flat. As a method of forming such a warped shape, (i) a method of preparing a wire B31 formed into the shape in advance and winding it into a coil shape, and (ii) when the coil is wound, can be typically used. The flat wire B31 imparts a stress to deform it into an arcuate oblong shape.

In the polishing step, the outer side B32 of each of the wires B31 of the coil layer B30 is polished using a polishing apparatus. Alternatively, after the coil core wire is removed from the coil layer B30, the outer surface of the coil layer B30 is polished by a coreless grinding disc (centerless grinding machine) to be flattened, or the coil core wire may be inserted into the coil layer B30. In the state, the coil core is rotated about the axis The outer surface of the coil layer B30 is polished by a cylindrical grinding disc to be flattened. When the outer surface of the coil layer B30 is flattened, the outer side B32 of the wire B31 is polished in parallel with the longitudinal direction, so that the appearance of the coil layer B30 is smooth and the outer diameter is substantially the same in a specific length region. Further, the outer diameter of the coil layer B30 may be polished to a tapered shape so that the diameter from the distal side to the proximal side of the longitudinal direction gradually increases. Further, in the present embodiment, as shown in FIG. 10, the outer side B32 is located on the outer side at a position y where the outer side B32 is in contact with the surface of the adjacent wire B31 in the radial direction.

In the marker mounting step, the marker B40 made of the above material is attached to the outer periphery of the inner layer B11 and to the far side DE side of the coil layer B30. The labeling step and the outer layer forming step may be performed arbitrarily. The outer layer B12 may be embedded with the label B40 attached to the distal end DE of the catheter B100, or the label B40 may be attached by caulking. On the surface of the outer layer B12.

In the outer layer forming step, the outer layer B12 is formed using the resin material B112 as described above over the entire outer periphery of the inner layer B11 including the coil layer B30 and the mark B40. The outer layer B12 can also be formed by extruding the resin material B112 to the outer periphery of the inner layer B11 and forming it. Alternatively, the tubular outer layer B12 having an inner diameter wider than the outer diameter of the inner layer B11 is formed in advance by the resin material B112, and the outer layer B12 is attached to the outer periphery of the inner layer B11. Further, a heat-shrinkable tube (not shown) may be attached to the outer circumference and heated, and the heat-shrinkable tube may be heat-shrinked, whereby the inner layer B11 and the outer layer B12 are in close contact with each other. Thereafter, the heat shrinkable tube is removed. The outer layer B12 can be easily formed by using such a method. The resin material B112 of the outer layer B12 can be melted and flowed between the coil layer B30 and the inner layer B11 and solidified by any method, whereby the inner layer B11 and the outer layer B12 are in good contact with each other, thereby preventing the interface from being peeled off well. .

On the other hand, since the inner side B33 of the wire B31 has an arc shape, and the wire which is wound later is wound by pressing the first wound wire toward the inner side in the oblique direction, the inner side B33 is held. The inclination of the center thickness direction. Therefore, the wire B31 of the coil layer B30 is well embedded in the resin material flowing between the coil layer B30 and the inner layer B11 and curing the outer layer B12. In the case of B112, since the anchoring effect is exerted, the adhesion between the coil layer B30 which is based on the strong pulling force and the layer of the resin material B112 which is disposed inside the outer layer B12 is improved. Therefore, it is possible to satisfactorily prevent the coil layer B30 from being peeled off from the interface between one portion of the inner layer B12 and the inner layer B11 which is in good contact with each other. Further, since the outer surface of the coil layer B30 has a smooth cylindrical shape, the outer surface of the coil layer B30 is not easily restrained from moving forward and backward by the outer layer B12 in the axial direction while maintaining the adhesion to the outer layer B12. Therefore, the coil layer B30 has good mobility in the longitudinal direction and can be freely bent. Further, the inner layer forming step and the outer layer forming step are not limited to the above methods, and any other methods may be used.

Further, in the outer layer forming step, the sub-chamber B80 (the first sub-cavity B80a and the second sub-chamber B80b) including the tube member may be extruded together with the resin material B112 of the outer layer B12 to the coil layer B30. The outer circumference is formed, and the sub-chamber B80 (B80a, B80b) is provided in the outer layer B12. Further, the operation wires B70 (B70a, B70b) may be inserted into the sub-chambers B80 (B80a, B80b), and the distal ends B71 (B71a, B71b) may be fixed to the markers B40, respectively. Alternatively, the outer layer B12 may be extruded together with the outer layer B12 to the outer circumference of the coil layer B30 while the operation wire B70 is inserted into the sub-chamber B80.

Finally, the mandrel is pulled out from the inner layer B11. At this time, the both ends of the mandrel are pulled in mutually opposite directions as needed, thereby reducing the diameter of the mandrel. By this step, the tubular body B10 including the main inner chamber B20, the inner layer B11, the outer layer B12, the coil layer B30, the marker B40, the coating layer B50, and the sub-chamber B80 through which the operation wire B70 is inserted can be obtained. Further, the catheter B100 of the present embodiment can be manufactured by assembling the tubular body B10 and the operation portion B60.

Fig. 14 is a conceptual diagram showing that the wire B31 can be freely operated. Fig. 14 (a) is a conceptual diagram showing a straight line state before bending. Fig. 14 (b) is a conceptual view showing a state in which the coil layer B30 is bent toward the upper side of the paper surface, that is, a state in which the outer surface is bent inward and the inner side is bent outward. Fig. 14 (c) shows a state in which the coil layer B30 is bent downward toward the paper surface, that is, the outer surface is outward. A conceptual diagram of the state in which the direction and the inner side are bent inward. In any case, the adjacent rolls of the wire B31 are in point contact with each other, so that they can be freely bent like a joint or the like regardless of the outward direction or the inner direction.

In Fig. 15 (a), for reference, a microscope photograph (schematic diagram) of a longitudinal section of a wire corresponding to the coil layer B30 is mounted. As shown in the micrograph, the coil layer B30 is wound in a plurality of four wires B31 having a non-circular cross-sectional shape. Figure 15 (b) is an enlarged view of Figure 15 (a). The outer side B32 of the wire B31 in the longitudinal section is linear, but the inner side B33 is arcuate, and the center thickness direction of the cross-sectional shape of the inner side B33 is opposite to the longitudinal direction (Fig. 15(b) Direction) Tilt. Further, in the longitudinal section, the adjacent wires B31 are in point contact with each other at the position y. The point y at which the point contacts is located between the largest protrusions x, x' of the arcs on both sides of the wire B31.

Next, the operation of the catheter B100 of the present embodiment will be described with reference to Fig. 13 . First, the catheter B100 of the present embodiment is inserted into a body cavity such as a blood vessel of a patient. In the present embodiment, the first sub-chamber B80a and the second sub-chamber B80b are formed to face each other with the axis of the catheter B100 facing 180 degrees. Further, a first operation line B70a is inserted in the first sub-chamber B80a, and a second operation line B70b is inserted in the second sub-chamber B80b, and the front end can be freely bent. Therefore, the catheter B100 can be actively inserted into the patient's body while the operation wire B70 is operated without using a guide wire or the like.

Here, in the catheter B100 of the present embodiment, when the first slider B64a of the operation unit B60 is operated and the first operation wire B70a is pulled toward the proximal side, the catheter B100 is far away as shown in FIG. 13(b). The end portion B15 is bent above the paper surface of Fig. 13. Further, when the amount of pulling is increased, the distal end portion B15 of the catheter B100 is curved with a large curvature toward the upper side of the paper surface of Fig. 13 as shown in Fig. 13(c).

When the second slider B64b of the operation unit B60 is operated and the second operation wire B70b is pulled toward the proximal side, the distal end portion B15 of the catheter B100 is bent downward toward the paper surface of Fig. 13 as shown in Fig. 13(d). . Further, if the amount of traction is increased, the far position of the catheter B100 is as shown in Fig. 13(e). The end portion B15 is curved with a large curvature toward the lower side of the paper of Fig. 13. Further, in the catheter B100 of the present embodiment, as shown in Figs. 13(c) and (e), the bending angle of the distal end portion B15 is preferably more than 90 degrees. Thereby, even when the branching angle of the blood vessel is such as to make an acute angle of U-turn, the catheter B100 can be entered with respect to the branch branch.

Furthermore, when the first operation line B70a and the second operation line B70b are pulled together, the amount of traction may be different from each other. That is, even if the desired curvature cannot be achieved even if the arbitrary operation line B70 is individually pulled, the two operation wires B70 can be pulled to adjust the curvature. More specifically, according to the state in which the distal end portion B15 is bent by pulling one of the operation wires B70, the other operation wire B70 is pulled. By this operation, the operation of reducing the amount of bending of the distal end portion B15 or the operation of returning the posture of the distal end portion B15 from the state of being bent to the original linear posture can be performed. In this way, the amount of bending can be finely adjusted by reducing the amount of bending.

Further, in a state where the distal end portion B15 of the catheter B100 is bent, the grip portion B63 of the operation portion B60 is gripped by one hand, and the handle portion B62 is pivoted with respect to the grip portion B63 by the other hand. By this operation, the whole of the catheter B100 is rotated by a maximum of 90 degrees together with the shaft portion B61, so that the operator can change the bending direction of the distal end portion B15 of the catheter B100 to a desired direction, thereby making the distal position The end DE is opposite to the affected part. Further, in the present embodiment, since the wire B31 is wound around the main inner cavity B20, the torsional rigidity of the tubular body B10 is improved. Therefore, the torque transmission efficiency at the time of the rotation operation of the duct B100 is improved, and the rotational responsiveness to the distal end portion B15 of the rotational operation is improved. Further, since the position of the distal end can be clearly confirmed by the marker B40, it is possible to easily operate while confirming the current position or direction of the distal end DE.

Further, in the catheter B100 of the present embodiment, the wire B31 is wound tightly around the main lumen B20, and a coil layer B30 having an elastic force is formed. Therefore, when the duct B100 is bent by the operation of the operation wire B70, a force to bend the axial direction is applied to the coil layer B30. However, the coil layer B30 is intended to have an elastic repulsive force. Resist the external force. Therefore, the bending of the steep angle of the catheter B100 can be suppressed and bent with a large curvature. Therefore, the bending of the steep angle of the main inner cavity B20 is also suppressed, and a good restoring force is also obtained, so that the kink resistance is improved and excellent bending property is obtained. Thereby, since the cross-sectional area of the lumen of the main lumen B20 can be maintained to a sufficient size, the supply of the drug or the like through the main lumen B20 or the insertion of the optical system can be preferably performed.

As described above, in the present embodiment, the cross-sectional shape of the wire B31 in the longitudinal section of the coil layer B30 is inclined with respect to the longitudinal direction. Therefore, the inner side B33 of the wire B31 can be fitted with respect to the base layer (outer layer B12) on the inner diameter side thereof. Therefore, the adhesion between the outer layer B12 and the coil layer B30 is improved by the anchoring effect of the coil layer B30. Therefore, even when the resistance of the catheter B100 is strongly applied to the longitudinal direction, the adhesion between the outer layer B12 and the coil layer B30 can be favorably prevented from being lowered or the interface can be peeled off. On the other hand, since the outer surface of the coil layer B30 is smooth, the coil layer B30 is not restricted by the outer layer B12 in the longitudinal direction.

That is, according to the present embodiment, since the side B32 outside the wire B31 can slide with a slight displacement amount with respect to the outer layer B12, the coil layer B30 is softly bent. Therefore, when torque is applied to the proximal end CE of the catheter B100 inserted into the curved body cavity, the distal end DE of the catheter B100 rotates well. In other words, the rotational resistance of the catheter B100 when it is bent is reduced. On the other hand, the inner side B33 of the wire B31 is well anchored with respect to the outer layer B12. Therefore, it is limited to the relatively moving amount of the wire B31 with respect to the outer layer B12 exceeding the above-described fine displacement amount when the catheter B100 is removed from the body cavity. Therefore, even in the case where the catheter B100 is removed from the curved body cavity, the outer layer B12 and the coil layer B30 are not peeled off.

[Sixth embodiment]

Next, a catheter according to a sixth embodiment will be described with reference to Figs. 11 and 12 . As shown in the enlarged views of Fig. 11 and Fig. 12, the catheter B200-based coil layer B230 of the present embodiment is fitted into the inner layer B211, and the outer surface is smoothly polished to have substantially the same plane as the surface of the inner layer B211, and is adjacent to the cross-sectional shape. The wire B231 is in point contact with each other, and the coil layer B230 The outer surface is in close contact with the outer layer B212, and is basically the same as the catheter B100 of the fifth embodiment. As shown in FIGS. 11 and 12, the catheter B200 of the present embodiment includes a tubular body B210 and an operation portion (not shown) connected to the proximal end portion PE of the tubular body B210 and operating the operation wire B270. The tubular body B210 includes An inner layer B211 comprising a resin material B2111; a coil layer B230 obtained by winding a plurality of wires B231 having arc ends at both ends; an outer layer B212 comprising a resin material B2112; a mark B240; The layer B250; and the sub-chamber B280 (the first sub-cavity B280a and the second sub-chamber B280b) are inserted through the operation line B270 (the first operation line B270a and the second operation line B270b).

Further, since the coil layer B230 is formed in the cross-sectional shape of the wire B231 in the longitudinal section and the outer side B232 is linear, the outer appearance of the coil layer B230 is a cylindrical shape having substantially the same outer diameter and a smooth outer surface. In addition, the inner side B233 of the cross-sectional shape of the wire B231 has an arc shape, and the center thickness direction (arrow W of FIG. 12) is inclined with respect to the longitudinal direction, and is wound so as to be fitted into the inner layer B211. Further, in the manufacturing method, in the polishing step, the outer surface of the coil layer B230 (the outer side B232 of the wire B231) is substantially flush with the outer peripheral surface of the inner layer B211, and is ground to the position of the point contact y. Other than the above, it is the same as that of the first embodiment, and the description thereof will not be repeated. The position y at which the two sides of the wire B231 are in point contact with each other is at least one of the largest protrusions x, x' of the arcs on both sides of the wire B231, and exists inside the winding diameter. 11 and FIG. 12 show a point contact, but in actuality, since the point contact is continuous in the circumferential direction, the adjacent wires B231 are in line contact with each other. In other words, in the coil layer B230 of the present embodiment, the wire to be wound is also wound by pressing the first wound wire toward the inside in the oblique direction, so that the inner side B233 of the coil layer B230 is kept inclined, and The embedding of the wire B231 into the inner layer B211 can be performed satisfactorily.

As described above, in the catheter B200 of the present embodiment, since the position y of the point contact (line contact) is polished, the coil layer B230 can be made thinner and the flexibility can be improved, and the coil layer B230 can be easily formed to be formed into a thinner layer. Inner layer B211. Also, in the longitudinal section of the coil layer B230 The inner side B233 of the cross-sectional shape of the wire B231 is inclined with respect to the longitudinal direction, and is embedded in the inner layer B211 in a wedge shape to exhibit an anchoring effect, thereby preventing peeling from the interface with the inner layer B211 disposed inside the coil layer B230. On the other hand, by embedding the coil layer B230 in the inner layer B211, the resin material B2112 of the outer layer B212 does not easily intrude between the wire B231 and the inner layer B211. Moreover, the smooth outer surface of the coil layer B230 is not embedded in the inner side of the outer layer B212, and the inner and outer surfaces are only in close contact. Therefore, the movability of the coil layer B230 with respect to the outer layer B212 is further improved, and the coil layer B230 which is excellent in flexibility and flexibility can be obtained. However, as shown in FIG. 11, at the distal end DE, the resin material B2111 of the inner layer B211 is in close contact with the resin material B2112 of the outer layer B212, and the coil layer B230 is embedded in the inner layer B211 with high adhesion, so even the coil layer B230 The movability of the outer layer B212 is improved, and the interface peeling of each layer (the inner layer B211, the coil layer B230, and the outer layer B212) can be favorably prevented. In this manner, even in the present embodiment, the adhesion between the holding coil layer B230 and the inner layer B211 disposed inside can be obtained, and the cross-sectional area of the main inner cavity B220 can be sufficiently ensured, and the flexibility is excellent, and durability or usability is obtained. Also excellent catheter B200.

The present invention is not limited to the above-described embodiments, and various modifications, improvements, etc. within the scope of the object of the invention are also included.

Further, in each of the above embodiments, the coil layer is formed by a plurality of windings. However, as another variation, the coil layer may be formed by winding (one winding) one wire. In this case, the section in the longitudinal direction may be wound in contact with each other, or one of the adjacent wires may be wound in close contact with each other. Even in the case of the catheter having such a coil layer, the adhesion between the inner layer and the coil layer can be maintained, and the cross-sectional area of the main inner cavity can be sufficiently ensured, and the flexibility is excellent.

Moreover, in each of the above embodiments, an example in which the catheter has two operation wires has been described. However, a sub-cavity in which three or more operation wires are respectively inserted may be formed in the tubular body. In this case, the bending operation of the catheter can be performed by pulling one or more of the operation wires. Furthermore, in this case, by controlling three or more individually The traction length of the wire is manipulated so that the distal end can be bent in any direction over 360 degrees. Thereby, the rotation of the distal end portion in the specific direction is not performed by applying the rotational force to the entire catheter, and the direction of entry of the catheter can be operated only by the operation of the operation portion to the operation line. Further, it is also possible to adopt a configuration in which the catheter has only one operation wire. In this case, the bending operation of the distal end portion of the traction by the operation wire and the rotation operation of the catheter are used in combination. Thereby, the distal end of the catheter can be bent in any bending direction and in any direction. Further, the sub-cavity may be disposed on the inner side of the coil layer, or may be bent without using a sub-cavity or an operation wire. Further, although the sub-cavity is formed by the tube member, a long hole may be formed when the outer layer is formed, and the sub-cavity may be formed, and the operation wire may be inserted into the hole. Also, if the marker is not needed, it may not be set.

Moreover, in each of the above embodiments, the wire of the coil layer before polishing has a warped shape in which both sides in the width direction of the cross-sectional shape in the longitudinal direction face outward. Therefore, after the polishing, the inner side is curved inward in the radial direction. However, the present invention is not limited thereto, and may be a curved shape that faces the inner side of both sides, and may have an arc shape in which the inner side after polishing is convex toward the outer side in the radial direction, or may be linear without being warped. In any case, it is possible to obtain a catheter which maintains excellent adhesion between the inner layer and the coil layer, sufficiently secures the sectional area of the main inner cavity, and is excellent in flexibility.

Further, in each of the above embodiments, the outer surface of the coil layer is polished in parallel with the longitudinal direction of the duct, and the outer appearance is cylindrical. However, the present invention is not limited thereto, and the coil layer may be polished obliquely in the longitudinal direction as long as the coil layer can be freely moved in the longitudinal direction, and the outer shape is tapered. In the case of a cone shape, the diameter of the distal end DE side may be larger, and the diameter gradually decreases toward the proximal end CE direction, or the diameter of the distal end DE side may be smaller and closer to the side. A cone whose diameter gradually increases in the direction of the CE at the end. Further, the tapered shape and the cylindrical shape may be combined. Further, the curved portion of the catheter, that is, the coil layer portion near the distal end may be polished to smooth the outer surface, and the non-bending portion, that is, the vicinity of the proximal end may be formed so as not to grind the outer surface of the coil layer and the cross section of the wire Outer side of shape The state of the side tilt. In this case, in the catheter, the distal end action is not restricted by the outer layer and has excellent flexibility, and the outer surface near the proximal end is embedded in the outer layer, thereby improving the adhesion. Further, since both the distal end and the proximal end are excellent in rigidity, it is possible to prevent kinking due to an intrusion force or the like, and the catheter can smoothly travel to the affected part.

Further, although the above embodiments and modifications are applied to the catheter, the present invention is not limited to the catheter, and may be applied to other long medical apparatuses that are inserted into a body cavity such as an endoscope or an ultrasonic instrument.

[Seventh embodiment]

Fig. 16 is a schematic longitudinal sectional view showing a medical device body C300 of a catheter C10 which is a preferred example of the medical device according to the seventh embodiment. Here, Fig. 16(a) shows the distal end portion (distal end portion C15), and Fig. 16(b) shows the intermediate portion C18 adjacent to the proximal end side of the distal end portion C15. The left side of Fig. 16 corresponds to the front end side of the catheter, and the right side corresponds to the side of the hand (base end side).

17 is a schematic view showing an example of a cross-sectional shape and a posture (inclination or non-tilt) of the wire C52, wherein FIG. 17(a) and FIG. 17(b) show the cross-sectional shape of the distal end portion C15, respectively. The posture, the cross-sectional shape and posture of the intermediate portion C18.

Figure 18 is a cross-sectional view taken along line A-A of Figure 16. In addition, in FIG. 18, illustration of the wire coil C50 is abbreviate|omitted.

Figure 19 is a schematic top plan view of a catheter. 19(a) shows a state in which the bending operation of the front end portion of the medical device main body C300 is not performed, and FIG. 19(b) shows a state in which the operation of bending the front end portion of the medical device main body C300 in one direction is performed. Fig. 19 (c) shows a state in which the operation of bending the front end portion of the medical device main body C300 in the opposite direction is performed.

The medical device (for example, the catheter C10) of the present embodiment has a medical device body C300 that is long and flexible and inserted into a body cavity. The medical machine body C300 comprises: a long resin tube (thin tube C16); and a wire coil C50, which is formed by a cross-sectional shape The non-circular wire C52 is wound in a coil shape and is embedded in the resin tube coaxially with the resin tube. In the longitudinal section of the wire C52, the thickness of the wire C52 is set to T, and the maximum height difference from the axis of the medical device body C300 to the outer surface C52a of the wire is set to H, then H/T The value varies depending on the position in the longitudinal direction of the medical device body C300.

Hereinafter, it demonstrates in detail.

As shown in Fig. 19, the catheter C10 includes a medical device body C300 and an operating mechanism for performing a bending operation of the front end portion of the medical device body C300.

The operating mechanism includes an operation wire C40 (Fig. 16, Fig. 18), and an operation portion C70 for performing an operation of pulling the operation wire C40. The operation wire C40 is embedded in the medical device body C300 along the longitudinal direction of the medical device body C300. The operation unit C70 is provided at a base end portion of the medical device body C300. In the operation unit C70, the proximal end portion of the operation wire C40 is coupled, and by operating the operation portion C70, the front end portion of the medical device body C300 can be bent.

The medical machine body C300, which is the body of the catheter C10, is long and flexible, and is inserted into a body cavity for use.

A preferred example of the catheter C10 is an intravascular catheter that is inserted into a blood vessel. More specifically, a preferred example of the medical device body C300 of the catheter C10 is formed to allow the medical device body C300 to enter the size of any of the eight sub-regions of the liver.

Further, in the present specification, a specific length region including the distal end (front end) DE of the catheter C10 (and the medical device body C300) is referred to as a distal end portion C15 of the catheter C10 (and the medical device body C300). Similarly, a specific length region including the proximal end (base end) (not shown) of the catheter C10 (and the medical device body C300) is referred to as a proximal end of the catheter C10 (and the medical device body C300) (base end) Department) C17 (Figure 19). Further, a specific length region adjacent to the proximal end side of the distal end portion C15 in the longitudinal direction of the catheter C10 (and the medical device body C300) is referred to as an intermediate portion C18. The intermediate portion C18 is located at the front end side of the closer end portion C17.

As shown in FIG. 16 and FIG. 18, inside the medical device body C300, a main body is formed. The cavity C20 and the sub-chamber C30. The main lumen C20 and the sub-chamber C30 extend along the longitudinal direction of the medical device body C300 (the conduit C10) (the left-right direction in Fig. 16). The main lumen C20 is disposed, for example, at a center of a cross section (a cross section orthogonal to the longitudinal direction) of the medical device body C300, and the sub-chamber C30 is disposed around the main lumen C20. More specifically, for example, in the cross section, the sub-cavities C30 are disposed at rotationally symmetrical positions with respect to each other with respect to the center of the main lumen C20.

The catheter C10 has, for example, a plurality of sub-chambers C30. The diameter of each sub-chamber C30 is smaller than that of the main lumen C20.

The sub-cavities C30 and the main inner chamber C20 and the sub-cavity C30 are spaced apart from each other and are individually arranged. The plurality of sub-cavities C30 are, for example, dispersedly disposed around the main inner chamber C20. In the example of FIGS. 16 and 18, the number of sub-chambers C30 is two, and the sub-chambers C30 are disposed around the main inner chamber C20 at intervals of 180 degrees.

Inside the sub-chambers C30, operation lines C40 are respectively inserted. That is, the duct C10 has, for example, two operation wires C40.

The operation wire C40 is relatively movable toward the longitudinal direction of the sub-chamber C30 with respect to the sub-chamber C30 by sliding relative to the peripheral wall of the sub-chamber C30. That is, the operation wire C40 can slide in the longitudinal direction of the sub-chamber C30.

The operation wire C40 may also include a single wire, but may be a stranded wire formed by twisting a plurality of thin wires.

The number of the thin wires constituting one strand is not particularly limited, and is preferably three or more. A preferred example of the number of thin lines is three or seven.

When the number of the thin lines constituting the operation line C40 is three, the three thin lines are arranged in point symmetry in the cross section. When the number of the thin wires constituting the operation wire C40 is seven, the seven thin wires are arranged in a honeycomb shape in a point symmetry in the cross section.

The outer dimension of the operation wire C40 (the diameter of the circle outside the strand) can be set, for example, to 25 to 55 μm.

As a material constituting the wire of the operation wire C40 (or a thin wire constituting the strand), in addition to a flexible metal wire such as a low carbon steel (piano wire), stainless steel (SUS), titanium or a titanium alloy, a poly (PBO, Poly(ρ-phenylene benzobisoxazole), Polyetheretherketone (PEEK), Polyphenylene Sulfide (PPS), Polybutylene Terephthalate (PBT) Polymer fibers such as polyimine (PI) or polytetrafluoroethylene (PTFE) and boron fibers.

Here, as the structure of the sub-chamber C30, for example, the following two structures can be exemplified.

In the first structure, as shown in FIGS. 16 and 18, the hollow tube C32 formed in advance is embedded in the outer layer C60 (described below) along the longitudinal direction of the medical device body C300, and the hollow tube C32 is placed. The inner cavity is set as the sub-cavity C30. That is, in these examples, the sub-chamber C30 includes a lumen embedded in the hollow tube C32 in the medical device body C300.

The hollow tube C32 may contain, for example, a thermoplastic resin. Examples of the thermoplastic resin include low friction resins such as polytetrafluoroethylene (PTFE) or polyether ether ketone (PEEK).

In the second structure, a hollow of a strip along the longitudinal direction of the medical device body C300 is formed in the outer layer C60 (described below), thereby forming the sub-chamber C30.

The medical device main body C300 has, for example, a thin tube C16 including an inner layer C21, an outer layer C60 laminated on the inner layer C21, and a coating layer C64 formed around the outer layer C60.

The thin tube C16 contains, for example, a resin material. In other words, the thin tubes C16 each include a resin layer C60 and an inner layer C21. In other words, the thin tube C16 is a hollow resin layer including the outer layer C60 and the inner layer C21, that is, a resin tube.

The resin tube is disposed coaxially with the wire coil C50 (described below) and covered with the wire coil C50. The resin tube is adhered to the wire coil C50.

The inner layer C21 contains a tubular resin material. At the center of the inner layer C21, a main inner cavity C20 is formed.

The outer layer C60 contains a resin material of the same or different kind as the inner layer C21. Sub-cavity C30 formation Inside the outer layer C60.

The material of the inner layer C21 is, for example, a fluorine-based thermoplastic polymer material. Specifically, the fluorine-based thermoplastic polymer material is, for example, polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), or soluble perfluoroalkoxy fluororesin (PFA).

When the inner layer C21 contains such a fluorine-based resin, the delivery property when the contrast medium, the chemical solution, or the like is supplied to the affected part through the main lumen C20 is improved.

For example, the material of the outer layer C60 is, for example, a thermoplastic polymer. Examples of the thermoplastic polymer include polyimine (PI), polyamidimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), and polyamine (PA). , nylon elastomer, polyurethane (PU), ethylene vinyl acetate resin (EVA), polyvinyl chloride (PVC) or polypropylene (PP).

The resin material constituting the thin tube C16 may also contain an inorganic filler. For example, as the resin material constituting the outer layer C60 which is the majority of the wall thickness of the thin tube C16, those containing an inorganic filler can be used.

The inorganic filler is, for example, barium sulfate or barium hypocarbonate. By mixing such an inorganic filler into the outer layer C60, the X-ray contrast property is improved.

The coating C64 constitutes the outermost layer of the medical device body C300 and contains a hydrophilic material. Further, the coating layer C64 may be formed only in a region of a portion of the length of the distal end portion C15 of the medical device body C300, or may be formed over the entire length of the medical device body C300.

The coating layer C64 is formed of, for example, a hydrophilic resin material such as polyvinyl alcohol (PVA) or polyvinylpyrrolidone, thereby being hydrophilic. Further, the coating layer C64 may be formed by at least subjecting the outer surface of the outer layer C60 to a hydrophilic state by subjecting the outer surface of the outer layer C60 to a lubricating treatment.

The conduit C10 further has a wire coil C50 wound around the inner layer C21. The wire coil C50 is configured, for example, by winding one of the elastic bodies or a plurality of wires (wire) C52 into a coil shape. As a material of the wire C52 constituting the wire coil C50, an example As a preferred example, a metal is used, but it is not limited to this example, and other materials (for example, a resin) may be used as long as it is a material having higher rigidity and elasticity than the inner layer C21 and the outer layer C60. Specifically, as the metal material of the wire C52, for example, stainless steel (SUS), nickel-titanium alloy, steel, titanium or a copper alloy can be used. An example of the cross-sectional shape of the wire C52 will be described below.

The wire coil C50 is enclosed in the outer layer C60.

In the present embodiment, the sub-cavity C30 is formed inside the outer layer C60 on the outer side of the wire coil C50.

Here, a representative size of each component of the catheter C10 of the present embodiment will be described.

The radius of the main inner cavity C20 can be set to about 200 to 300 μm, the thickness of the inner layer C21 can be set to about 10 to 30 μm, the thickness of the outer layer C60 can be set to about 50 to 150 μm, and the outer diameter of the wire coil C50 can be set to diameter. 500~860μm, the inner diameter of the wire coil C50 can be set to a diameter of 420~660μm.

The radius (distance) from the axis of the medical device body C300 to the center of the sub-chamber C30 is about 300 to 450 μm, and the inner diameter (diameter) of the sub-chamber C30 is 40 to 100 μm. Further, the thickness of the operation wire C40 is set to be about 30 to 60 μm.

The outer diameter (radius) of the medical device body C300 is about 350 to 490 μm, that is, the outer diameter is less than 1 mm in diameter. Thereby, the medical device main body C300 of the present embodiment can be inserted into a blood vessel such as a celiac artery.

A circular marker C66 including a material that does not transmit radiation such as X-rays is provided at the distal end portion C15 of the medical device main body C300. Specifically, the marker C66 contains a metal material such as platinum. The marker C66 is disposed, for example, around the main lumen C20 and inside the outer layer C60.

The front end portion C41 of the operation wire C40 is fixed to the distal end portion C15 of the medical machine body C300. The aspect in which the front end portion C41 of the operation wire C40 is fixed to the distal end portion C15 is not particularly limited. For example, the front end portion C41 of the operation wire C40 may be welded or fastened to the marker C66, or may be welded to the distal end portion C15 of the medical device body C300, or may be fixed to the marker C66 by an adhesive. The distal end C15 of the medical machine body C300.

The sub-chamber C30 forms an opening at least on the proximal end C17 side of the catheter C10. The base end portion of each operation wire C40 protrudes from the opening of the sub-chamber C30 toward the proximal end side. The proximal end portion of each operation wire C40 is connected to the operation portion C70 provided at the proximal end portion C17 of the medical device main body C300.

As shown in FIG. 19, the operation portion C70 includes, for example, a main body casing C700, and a wheel operating portion C760 that is rotatably provided with respect to the main body casing C700.

The base end portion of the medical machine body C300 is introduced into the body casing C700. At the rear end of the body casing C700, a hub C790 is mounted. The base end of the thin tube C16 is fixed to the front end of the hub C790.

The hub C790 is internally formed with a hollow cylindrical body that penetrates the hub C790 forward and backward. The hollow of the hub C790 is in communication with the main lumen C20 of the medical machine body C300.

In the hub C790, an injector (syringe) (not shown) can be inserted from the rear. By injecting a liquid such as a chemical liquid into the hub C790 by the injector, the liquid can be supplied to the front end of the medical device body C300 via the main lumen C20, and the liquid is supplied from the front end of the medical machine body C300 to the patient. Inside the body cavity.

For example, the operation wire C40 and the hollow pipe C32 are branched from the thin tube C16 at the front end of the body casing C700.

The hollow tube C32 is opened at the proximal end portion, and the proximal end portion of the operation wire C40 protrudes from the opening of the proximal end portion of the hollow tube C32 toward the proximal end side.

The base end portion of each operation wire C40 is directly or indirectly connected to the wheel operating portion C760. By rotating the wheel operating portion C760 in an arbitrary direction, the operation wire C40 can be individually pulled toward the proximal end side, and the distal end portion C15 of the medical device body C300 can be bent.

As shown in FIG. 19(b), if the wheel operating portion C760 is rotated in the direction of its rotation axis When the rotation is performed, an operation wire C40 is pulled toward the proximal end side. Thus, for the distal end portion C15 of the medical machine body C300, the tensile force is imparted by the one operation line C40. Thereby, the distal end portion C15 of the medical device body C300 is bent toward the side of the sub-chamber C30 through which the operation line C40 is inserted, with reference to the axis of the medical device body C300. That is, the distal end portion C15 of the medical device body C300 is bent in one direction.

Further, as shown in FIG. 19(c), when the operation of rotating the wheel operating portion C760 in the other direction around the rotation axis is performed, the other operation wire C40 is pulled toward the proximal end side. Thus, for the distal end portion C15 of the medical machine body C300, the tensile force is imparted by the other operation line C40. Thereby, the distal end portion C15 of the medical device body C300 is bent toward the side of the sub-chamber C30 through which the other operation wire C40 is inserted, with reference to the axis of the medical device body C300. That is, the distal end portion C15 of the medical device body C300 is curved in the other direction.

Here, the bending of the medical device main body C300 includes a state in which the medical device main body C300 is bent into a "ㄑ" shape and a curved shape.

In this way, by operating the wheel operating portion C760 of the operating portion C70, the two operating lines C40 are selectively pulled, whereby the distal end portion C15 of the medical device body C300 can be oriented in the first direction, and vice versa. The direction is curved in the second direction. The first direction and the second direction are included in the same plane.

By combining the torque operation for the shaft rotation of the entire catheter C10 and the pulling operation, the direction of the distal end DE of the medical device body C300 can be freely controlled.

Further, by adjusting the amount of pulling of the operation wire C40, the amount of bending of the distal end DE of the medical device body C300 can be adjusted.

Therefore, the medical device body C300 of the catheter C10 of the present embodiment can enter in a desired direction with respect to a body cavity such as a branched blood vessel.

That is, by performing the operation of bending the distal end portion C15, the direction of entry into the body cavity can be changed.

Next, the medical device body C300 will be described in more detail with reference to FIGS. 16 and 17 .

The wire C52 constituting the wire coil C50 has a non-circular cross-sectional shape. In the case of the present embodiment, the wire C52 is, for example, a so-called flat wire having a flat rectangular shape in a horizontal cross section. In the cross-sectional shape of the wire C52, the width dimension corresponding to the long diameter dimension is longer than the thickness dimension corresponding to the short diameter dimension. The ratio of the width dimension to the thickness dimension, that is, the width dimension when the thickness dimension is 1 is preferably 1.1 or more and 5 or less, more preferably 1.5 or more and 4 or less, still more preferably 2 or more and 4 or less. The actual size of the width dimension of the wire C52 is 1 mm or less, preferably 0.5 mm. The wire C52 is wound so that the thickness of the wire C52 in the longitudinal section of the medical device main body C300 becomes thinner with respect to the width.

Further, when the wire C52 is wound into a coil shape, the wire C52 is wound at an appropriate angle and at an appropriate angle, and the cross-sectional shape and the longitudinal cross-sectional shape of the wire C52 are bent, for example, as shown in the figure. The concave shape shown in 16.

Here, as will be described in more detail, for example, as shown in FIG. 17, the outer surface C52a has a concave curved surface, and the inner surface C52b has a convex curved surface. In addition, the end faces C52c and C52d on the distal end side and the proximal end side are convex curved surfaces that protrude toward the distal end side and the proximal end side, respectively.

As shown in Fig. 16 (a), for example, in the distal end portion C15 of the medical device body C300, the wire C52 is inclined with respect to the longitudinal direction of the medical device body C300. That is, as shown in Fig. 17 (a), in the longitudinal section of the wire C52, the maximum width direction W of the cross-sectional shape of the wire C52 is inclined with respect to the longitudinal direction X of the medical device body C300. The inclination angle with respect to the maximum width direction W of the longitudinal direction X is greater than 0 degrees and less than 45 degrees. It is preferably 5 degrees or more and 30 degrees or less.

Further, the outer surface C52a and the inner surface C52b of the wire C52 are also inclined with respect to the longitudinal direction X.

As a method of winding the wire C52 so that the maximum width direction W is inclined with respect to the longitudinal direction X, the following method is mentioned, for example.

(1) A method of winding the wire C52 while twisting the wire C52 by twisting the wire C52 in an oblique direction with respect to the longitudinal direction X around the axis of the wire C52

As an example of the method, a method of applying twist to the wire C52 so as to plastically deform the wire C52 is exemplified. In addition, as another example of the method, the wire C52 is wound while applying a twist to the wire C52, and the shape of the wire C52 is elastically deformed by heat treatment. The method.

(2) A method in which the mutually adjacent winding portions of the wire coil C50 are partially overlapped with each other in the longitudinal direction of the medical device body C300

Further, the shape of the original wire C52 before winding may have a shape having an inclined surface with respect to the longitudinal direction X, and particularly a shape in which the outer surface C52a is inclined with respect to the longitudinal direction X.

On the other hand, as shown in Fig. 16 (b), for example, in the longitudinal direction of the medical device body C300, in the intermediate portion C18 adjacent to the proximal end side of the distal end portion C15, the wire C52 is opposed to the medical device. The length direction of the body C300 is parallel. That is, as shown in Fig. 17 (b), in the longitudinal section of the wire C52, the maximum width direction W of the cross-sectional shape of the wire C52 is parallel to the longitudinal direction X of the medical device body C300.

As shown in Fig. 17, the thickness of the wire C52 is T, and the maximum height difference from the axis of the medical device body C300 to the outer surface C52a of the wire C52 is H. The maximum height difference H is the difference between the longest and the shortest from the axis of the medical device body C300 to the outer surface C52a. In the case of the present embodiment, the value of H/T differs depending on the position in the longitudinal direction of the medical device body C300. That is, in the case of the present embodiment, the value of H/T in the distal end portion C15 of the medical device body C300 is higher. The value of H/T in the intermediate portion C18 of the medical machine body C300 is large.

As a result, the anchoring effect of the wire C52 of the shape factor of the wire C52 on the thin tube C16 and the anchoring effect per unit thickness of the wire C52 (hereinafter referred to as the shape factor unit anchoring effect) are based on the length direction of the medical device body C300. The location is different. That is, in the case of the present embodiment, the shape factor unit anchoring effect in the distal end portion C15 of the medical device body C300 is larger than the shape factor unit anchoring effect in the intermediate portion C18 of the medical machine body C300.

Here, the shape factor refers to a factor including the shape and posture of the wire C52 (relative to the inclination of the thin tube C16). The shape factor unit anchoring effect is different from the wire C52 which is increased in shape or posture due to the shape of the wire C52 as compared with the case where the wire C52 has a shape such as a rectangular cross section and is not inclined with respect to the longitudinal direction of the medical device body C300. The anchoring effect of the unit thickness on the relative movement of the wire C52 and the thin tube C16 in the longitudinal direction of the medical machine body C300. The higher the anchoring effect, the better the peeling of the wire coil C50 and the thin tube C16 (especially the outer layer C60) can be satisfactorily prevented when the medical device body C300 of the body cavity is removed.

Here, for example, when the thickness of the wire C52 in the distal end portion C15 and the thickness of the wire C52 in the intermediate portion C18 are equal to each other, the value of the above H is based on the position in the longitudinal direction of the medical device body C300. And different. That is, in this case, the value of H in the distal end portion C15 of the medical device body C300 is larger than the value of H in the intermediate portion C18 of the medical device body C300.

As a result, the anchoring effect of the wire C52 of the shape factor of the wire C52 on the thin tube C16 (hereinafter referred to as the shape factor anchoring effect) differs depending on the position in the longitudinal direction of the medical device body C300. That is, in the case of the present embodiment, the shape factor anchoring effect in the distal end portion C15 of the medical device body C300 is larger than the shape factor anchoring effect in the intermediate portion C18 of the medical machine body C300.

The shape factor anchoring effect and the wire C52 are in the shape of a cross-sectional rectangle and are not opposite to The anchoring effect of the relative movement of the wire C52 and the thin tube C16 in the longitudinal direction of the medical device body C300, which is increased by the shape or posture of the wire C52, compared to the case where the length direction of the medical device body C300 is increased. .

Further, in the case of the present embodiment, in any of Figs. 17(a) and 17(b), as shown in Fig. 17(a), in the outer surface C52a of the wire C52, The top portion P located farthest from the axis of the medical machine body C300 is offset from the center position C of the wire C52 in the longitudinal direction of the medical machine body C300.

However, in the distal end portion C15, the wire C52 is inclined, and as shown in Fig. 17 (a), the top portion P exists only in the longitudinal direction of the medical device body C300, and the center position C of the wire C52 is One side of the benchmark.

As shown in Fig. 16 (a), in the distal end portion C15, the mutually adjacent winding portions of the wire coil C50 partially overlap each other in the longitudinal direction of the medical device body C300.

On the other hand, as shown in Fig. 16 (b), in the intermediate portion C18, the mutually adjacent winding portions of the wire coil C50 do not overlap each other.

Thereby, the value of the H/T and the value of H in the distal end portion C15 are larger than the values of the H/T and H in the intermediate portion C18.

In other words, in a portion of the longitudinal direction of the medical device body C300 (for example, the distal end portion C15), the mutually adjacent winding portions of the wire coil C50 partially overlap each other in the longitudinal direction. Further, the value of H/T and the value of H in the partial section (for example, the distal end portion C15) are larger than the values of H/T and H in the section adjacent to a part of the section (for example, the intermediate portion C18). Big.

Specifically, in the example of Fig. 16 (a), the winding portion of the wire coil C50 adjacent to each other, the front end side of the winding portion rear portion (base end portion), the outer peripheral side, the base end side The front portion (front end portion) of the winding portion rises. Thereby, in the distal end portion C15, the wire C52 is inclined in the longitudinal section thereof, and the front end side of the wire C52 is inclined away from the axis of the medical device body C300.

However, the oblique direction of the wire C52 may be opposite to that of Fig. 16(a). That is, in the longitudinal section of the wire C52, the base end side of the wire C52 may be inclined in a direction away from the axis of the medical device body C300.

In addition, as shown in FIG. 16 , the wire coil C50 is wound into a coil by a plurality of wires C52 (a plurality of wires C52) in a state of being aligned in the winding axis direction, for example. A plurality of coils formed in a shape. 16 shows an example in which the number (number) of the wires C52 constituting the wire coil C50 is four (four), but the number of the wires C52 constituting the wire coil C50 may be four. Multiple roots other than roots.

In the case of the present embodiment, the value of the H/T is larger as the closer to the front end side of the medical device body C300, for example. Further, for example, the value of H described above is, for example, larger as it approaches the front end side of the medical device body C300.

Next, a method of manufacturing the medical device of the present embodiment will be described.

The manufacturing method has the step of forming a medical machine body C300 which is long and flexible and inserted into a body cavity.

This step has the following steps.

1) Step of forming a long inner resin tube (inner layer C21)

2) a step of forming the wire coil C50 by winding a wire C52 having a non-circular cross-sectional shape into a coil shape

3) Step of arranging the wire coil C50 around the inner resin tube (inner layer C21)

4) a step of forming a long outer resin tube (outer layer C60) around the wire coil C50, and embedding the wire coil C50 with the resin tube (thin tube C16) including the outer resin tube and the inner resin tube

Here, in the longitudinal section of the wire C52, the thickness of the wire C52 is set to T, and the maximum height difference from the axis of the medical device body C300 to the outer surface of the wire C52 is set to H.

In the step of forming the wire coil C50, according to the value of H/T according to the body of the medical machine The wire coil C50 is formed in a different manner from the position of the C300 in the longitudinal direction.

Hereinafter, it demonstrates in detail.

For example, as described below, the catheter C10 is manufactured by separately forming the respective portions of the catheter C10 and combining them.

The outer layer C60 is produced, for example, by extrusion molding a resin material as a molding material by an extrusion molding apparatus (not shown). At the time of the extrusion molding, the core material (mandrel) is extruded together with the resin material, whereby the resin material serving as the outer layer C60 is adhered to the periphery of the core wire.

The material of the core wire is not particularly limited, and examples thereof include alloy steel such as copper or copper alloy, carbon steel or SUS, and nickel or a nickel alloy.

The mold release treatment can also be arbitrarily performed on the surface of the core wire. As the mold release treatment, an optical or chemical surface treatment may be applied in addition to the application of a release agent such as a fluorine-based or a lanthanum-based compound.

Here, each of the positions at which the sub-chamber C30 is formed by embedding the hollow tube C32 in the outer layer C60 forms a hollow in the longitudinal direction, for example, supplying gas to the position. The fluid is extruded on one side. The inner diameter of the hollow is larger than the outer diameter of the hollow tube C32. This is because the step of inserting the hollow tube C32 into the hollow is easy.

The hollow outer layer C60 can be formed by pulling out the core wire after extrusion molding. Further, the wire diameter of the core wire for forming the outer layer C60 is larger than the outer diameter of the wire coil C50. This is to facilitate the step of wrapping the outer layer C60 around the wire coil C50 (and the inner layer C21).

The inner layer C21 is produced by extrusion molding a resin material by an extrusion molding apparatus (not shown) different from the extrusion molding apparatus for forming the outer layer C60. At the time of the extrusion molding, the core material (which is made of a different core wire than the outer layer C60) is extruded together with the resin material, whereby the resin material serving as the inner layer C21 is adhered to the periphery of the core wire. The wire diameter of the core wire is equivalent to the diameter of the main inner cavity C20. Furthermore, the inner layer C21 can also be formed by a dispersion forming device. Forming.

The material of the core wire is not particularly limited as long as it has sufficient tensile strength, and examples thereof include copper or a copper alloy, carbon steel or alloy steel such as SUS, and nickel or a nickel alloy (such as a nickel-titanium alloy).

The mold release treatment can also be arbitrarily performed on the surface of the core wire. As the mold release treatment, an optical or chemical surface treatment may be applied in addition to the application of a release agent such as a fluorine-based or a lanthanum-based compound.

Further, a hollow tube C32 was separately prepared. The hollow tube C32 extrudes the resin material by using an extrusion molding apparatus for forming the inner layer C21 and an extrusion molding apparatus (not shown) different from the extrusion molding apparatus for forming the outer layer C60. Made by forming. Here, extrusion molding is performed by ejecting a fluid such as a gas from a discharge pipe disposed at the center of an extrusion port (nozzle) of the extrusion molding apparatus, and is formed hollow at the center of the hollow pipe C32.

Further, a dummy core wire inserted into the hollow tube C32 is prepared, and the dummy core wire is inserted into the hollow tube C32.

Further, a wire coil C50 is additionally formed.

The wire coil C50 is configured by, for example, connecting a plurality of wire coils having different bending rigidity and torsional rigidity in the longitudinal direction.

The plurality of wire coils are respectively wound around the core wire (the core wire for forming the inner layer C21 and the core wire of the outer layer C60), and the wire C52 is wound into a coil shape by a winding machine. Made separately. Thereafter, the core wires in each of the wire coils are pulled out. Further, after the wire coils are externally inserted into the same core wire, the wire coils are joined by laser welding or the like and joined in the longitudinal direction to form a wire coil C50. . Thereafter, the core wire in the wire coil C50 is pulled out.

Here, as described above, the inclination of the wire C52 differs depending on the position in the longitudinal direction of the medical device body C300. Specifically, for example, in the distal end portion C15, the maximum width direction W of the wire C52 is inclined with respect to the longitudinal direction of the medical device body C300, whereas in the intermediate portion C18, the maximum width direction of the wire C52 is obtained. W relative to doctor The length direction of the treatment machine body C300 is parallel.

Therefore, the wire C52 is wound around the wire coil disposed at the distal end portion C15 so as to be inclined with respect to the longitudinal direction of the medical device body C300 in the maximum width direction W of the wire C52. Moreover, the wire C52 is wound around the wire coil disposed in the intermediate portion C18 so that the maximum width direction W of the wire C52 is parallel to the longitudinal direction of the medical device body C300.

Here, if the thickness of the wire C52 is T, and the maximum height difference from the axis of the medical device body C300 to the outer surface C52a of the wire C52 is H, the value of H/T is made according to medical treatment. The position of the machine body C300 in the longitudinal direction is different. Specifically, the value of H/T in the wire coil disposed at the distal end portion C15 is made larger than the value of H/T in the wire coil disposed in the intermediate portion C18.

Further, as an example, the value of H described above differs depending on the position in the longitudinal direction of the medical device main body C300. Specifically, the value of H in the wire coil disposed at the distal end portion C15 is made larger than the value of H in the wire coil disposed in the intermediate portion C18.

For example, in the wire coil disposed at the distal end portion C15, the wire C52 is wound so that the mutually adjacent winding portions of the wire coil partially overlap each other in the longitudinal direction of the medical device body C300.

On the other hand, in the wire coil disposed in the intermediate portion C18, the wire C52 is wound so that the mutually adjacent winding portions of the wire coil do not overlap each other.

After the inner layer C21 to which the core wire is attached is formed and the wire coil C50 is formed, the wire coil C50 is extrapolated to the inner layer C21 to which the core wire is attached.

Further, the outer layer C60 is externally inserted into the wire coil C50.

Thereby, the core wire, the inner layer C21, the wire coil C50, and the outer layer C60 are arranged concentrically from the center side.

Next, for each of the hollows of the outer layer C60, the hollow tube C32 (with a dummy core) is inserted.

Next, a heat shrinkable tube is wrapped around the outer layer C60. Next, the heat shrinkable tube is shrunk by heating, and the outer layer C60 is fastened from the periphery, and the outer layer C60 is heated. Further, the heating temperature is higher than the melting temperature of the outer layer C60 and lower than the melting temperature of the inner layer C21. By this heating, the outer layer C60 is melted, and the outer layer C60 is adhered to the wire coil C50 and the inner layer C21 (joined by welding). At this time, the resin material constituting the outer layer C60 contains the wire coil C50, and the resin material is impregnated into the wire coil C50.

Thus, the outer layer C60 can be adhered to a tubular shape coaxial with the wire coil C50 with respect to the wire coil C50.

Thereafter, the outer layer C60 is cooled and solidified. Thereafter, the heat shrinkable tube is removed from the outer layer C60 by cutting the slit into the heat shrinkable tube and tearing the heat shrinkable tube.

Next, the dummy core wire is pulled out from the hollow pipe C32, and the operation wire C40 is inserted into the hollow pipe C32.

Further, the marker C66 is additionally prepared, and each of the operation wires C40 is fixed with respect to the marker C66.

Next, the marker C66 is fixed to the front end of the medical device body C300. To this end, for example, the outer layer C60 of the front end of the medical machine body C300 is cut off, and the inner layer C21 is exposed at the front end of the medical machine body C300. At this time, the hollow tube C32 is also cut together with the outer layer C60. Next, a state in which the front end portion of the operation wire C40 protrudes toward the front end side from the front end of the hollow tube C32 is set.

Next, the marker C66 is inserted around the front end of the medical device body C300 around the inner layer C21, and the marker C66 is caulked with respect to the periphery of the inner layer C21.

Next, the coating resin (not shown) formed in advance in a cylindrical shape covers the periphery of the front end portion of the medical device main body C300, and the heat-shrinkable tube different from the heat-shrinkable tube is used to weld the resin to the outer layer by welding. C60 and inner layer C21 are joined. Further, the outer layer C60 and the coating resin are, for example, melted and integrated with each other. Further, the surface on the front end side of the marker C66 is also covered by the molten outer layer C60 or the coating resin.

Next, the hub C790 is connected to the base end of the medical machine body C300.

Next, the core wire in the inner layer C21 is pulled out. The extraction of the core wire is performed by stretching the both ends in the longitudinal direction of the core wire to reduce the diameter of the core wire until the core wire is plastically deformed. Thereby, in the center of the inner layer C21, a hollow which becomes the main inner cavity C20 is formed.

Next, the base end portion of the operation wire C40 is directly or indirectly connected to the wheel operating portion C760 of the separately formed operation portion C70. Further, the main body casing C700 of the operation portion C70 is assembled with the wheel operating portion C760, and the hub C790 is attached to the body casing C700.

In this manner, the medical device body C300 is bent by the pulling operation of the operation wire C40.

Next, the coating layer C64 is formed thinly.

In this way, the conduit C10 can be manufactured.

According to the seventh embodiment described above, the value of H/T differs depending on the position in the longitudinal direction of the medical device main body C300. Here, the larger the value of H/T, the greater the anchoring effect of the wire C52 on the thin tube C16 (especially the outer layer C60) per unit thickness of the wire C52. Therefore, in the longitudinal direction of the medical device body C300, in order to partially increase the anchoring effect of the wire C52 on the thin tube C16, by increasing the value of H/T, the wire coil C50 and the outer layer C60 can be suppressed. The peeling of the interface.

Specifically, as described above, in the distal end portion C15, the value of H/T can be increased. Thereby, when the catheter C10 is removed from the body cavity, the peeling of the wire coil C50 and the outer layer C60 of the thin tube C16 in the distal end portion C15 can be suppressed.

Further, in the intermediate portion C18, since the thickness of the arrangement region of the wire coil C50 can be suppressed, the intermediate portion C18 can suppress the increase in the diameter of the medical device body C300 and the sufficient cavity of the main lumen C20. The area is guaranteed.

As an example, the value of H may be different depending on the position in the longitudinal direction of the medical device main body C300. For example, by setting the value of H in the distal end portion C15 to be larger than the value of H in the intermediate portion C18, the wire can be further suppressed in the distal end portion C15. Peeling of the interface between the coil C50 and the thin tube C16. Further, the thickness of the arrangement region of the wire coil C50 in the intermediate portion C18 can be further suppressed, and in the intermediate portion C18, it is possible to further suppress the diameter of the medical device body C300 and ensure the fullerness of the main cavity C20. Inner cavity area.

[Eighth Embodiment]

Fig. 20 is a schematic longitudinal sectional view showing the medical device main body C300 of the catheter C10 of the eighth embodiment. 20(a) shows the distal end portion C15, and FIG. 20(b) shows the intermediate portion C18. The left side of Fig. 20 corresponds to the front end side of the catheter, and the right side corresponds to the side of the hand (base end side).

The duct C10 of the present embodiment is different from the above-described seventh embodiment only in the aspects described below, and is configured in the same manner as the seventh embodiment described above.

In the case of the present embodiment, the inclination of the wire C52 in the distal end portion C15 and the inclination of the wire C52 in the intermediate portion C18 are opposite to those in the seventh embodiment. That is, as shown in FIG. 20(a), for example, in the distal end portion C15, the wire C52 is parallel to the longitudinal direction of the medical device body C300. On the other hand, as shown in FIG. 20(b), in the intermediate portion C18, the wire C52 is inclined with respect to the longitudinal direction of the medical device body C300.

In the case of the present embodiment, the value of H/T of the distal end portion C15 of the medical device body C300 is smaller than the value of H/T in the intermediate portion C18 of the medical device body C300.

Further, as an example, the value of H of the distal end portion C15 of the medical device body C300 is smaller than the value of H in the intermediate portion C18 of the medical device body C300.

As shown in Fig. 20 (a), in the distal end portion C15, the mutually adjacent winding portions of the wire coil C50 do not overlap each other.

On the other hand, as shown in FIG. 20(b), in the intermediate portion C18, the mutually adjacent winding portions of the wire coil C50 partially overlap each other in the longitudinal direction of the medical device body C300.

Thereby, the value of the H/T and the value of H in the distal end portion C15 are smaller than the values of the H/T and the value of H in the intermediate portion C18.

In other words, in the one-part section (intermediate portion C18) in the longitudinal direction of the medical device main body C300, the mutually adjacent winding portions of the wire coil C50 partially overlap each other in the longitudinal direction. Further, the value of H/T and the value of H in the partial section (middle portion C18) are larger than the values of H/T and H in the section (distal end portion C15) adjacent to a part of the section.

In the case of the present embodiment, the value of H/T is, for example, smaller as it approaches the front end side of the medical device body C300. Further, for example, the value of H is, for example, smaller as it is closer to the front end side of the medical device body C300.

According to the eighth embodiment described above, the anchoring effect of the wire coil C50 on the thin tube C16 can be relatively large in the intermediate portion C18 and relatively small in the distal end portion C15. Thereby, in the distal end portion C15, the outer layer C60 and the wire coil C50 can relatively move relatively, and the mobility of the wire coil C50 and the flexibility of the distal end portion C15 become good.

[Ninth Embodiment]

Fig. 21 is a schematic longitudinal sectional view showing a medical device main body C300 of a catheter C10 according to a ninth embodiment. Here, Fig. 21(a) shows the distal end portion C15, and Fig. 21(b) shows the intermediate portion C18. The left side of Fig. 21 corresponds to the front end side of the catheter, and the right side corresponds to the side of the hand (base end side).

The duct C10 of the present embodiment is different from the above-described seventh embodiment only in the aspects described below, and is configured in the same manner as the seventh embodiment described above.

In the case of the present embodiment, the thickness (thickness) of the wire C52 in the distal end portion C15 is thinner (thinner) than the thickness (thickness) of the wire C52 in the intermediate portion C18.

In other words, in the one-part section (distal end portion C15) in the longitudinal direction of the medical device main body C300, the mutually adjacent winding portions of the wire coil C50 partially overlap each other in the longitudinal direction of the medical device body C300. Further, the value of H/T in the partial section (distal end portion C15) is larger than the value of H/T in the section (intermediate portion C18) adjacent to the partial section. Moreover, the closer the wire C52 is to the front end side of the medical device body C300, the thinner the thickness.

Further, regarding the number (number of strips) of the wires C52 constituting the wire coil C50, the intermediate portion C18 is smaller than the distal end portion C15. For example, in the example of FIG. 21(b), in the intermediate portion C18, one (one) wire C52 is wound by a pitch to form a wire coil C50.

According to the ninth embodiment, since the thickness of the wire C52 in the distal end portion C15 is thin, the bending rigidity of the wire coil C50 in the distal end portion C15 and the medical device body C300 can be suppressed. Further, in the distal end portion C15, the mutually adjacent winding portions of the wire coil C50 partially overlap each other in the longitudinal direction of the medical device body C300, whereby the value of the above H/T can be secured.

[10th embodiment]

Fig. 22 is a schematic longitudinal sectional view showing the medical device main body C300 of the catheter C10 of the tenth embodiment. 22(a) shows the distal end portion C15, and FIG. 22(b) shows the intermediate portion C18. The left side of Fig. 22 corresponds to the front end side of the catheter, and the right side corresponds to the side of the hand (base end side).

The catheter C10 of the present embodiment is different from the above-described eighth embodiment only in the aspects described below, and is configured in the same manner as the eighth embodiment described above.

In the case of the present embodiment, the number of the wires C52 constituting the wire coil C50 in the intermediate portion C18 (the number of the wires) is larger than the number of the wires C52 constituting the wire coil C50 in the distal end portion C15 ( The number of articles is too large.

In other words, in one of the sections (intermediate portion C18) in the longitudinal direction of the medical device main body C300, the number of the wires C52 constituting the wire coil C50 is larger than the interval between the adjacent portions (the distal end portion C15). The number of wires C52 of the wire coil C50 is large. For example, the number of bars in the intermediate portion C18 is twelve.

In the intermediate portion C18, by increasing the number of the wires C52, it is easy to incline the maximum width direction W of the cross-sectional shape of the wire C52 with respect to the longitudinal direction of the medical device body C300. That is, the pitch angle α of the wire C52 (the angle formed by the longitudinal direction of the medical device body C300 and the axial direction of the wire C52) differs depending on the position in the longitudinal direction of the medical device body C300, specifically, the intermediate portion The pitch angle α in C18 is farther than the far end The pitch angle α in the portion C15 is large. Thereby, in the intermediate portion C18, it is easy to incline the maximum width direction W of the cross-sectional shape of the wire C52 with respect to the longitudinal direction of the medical device body C300.

[11th embodiment]

Fig. 23 is a schematic longitudinal sectional view showing the medical device main body C300 of the catheter C10 of the eleventh embodiment. Here, Fig. 23(a) shows the distal end portion C15, and Fig. 23(b) shows the proximal end portion C17. The left side of Fig. 23 corresponds to the front end side of the catheter, and the right side corresponds to the side of the hand (base end side).

The duct C10 of the present embodiment is different from the above-described seventh embodiment only in the aspects described below, and is configured in the same manner as the seventh embodiment described above.

In the case of the present embodiment, in the thin tube C16, if the thickness of the portion outside the wire coil C50 is TP, the value of TP becomes thinner as it approaches the front end side of the medical device body C300. . That is, the wall thickness TP of the outer layer C60 in the distal end portion C15 is thinner than the wall thickness TP in the proximal end portion C17.

More specifically, for example, the closer to the front end side of the medical machine body C300, the larger the value of H/TP becomes.

For example, as shown in Fig. 23, the value of H/T in the distal end portion C15 is larger than the value of H/T in the near end portion C17. In this case, in the distal end portion C15, the anchoring effect of the wire coil C50 can be sufficiently obtained with respect to the thin outer layer C60.

Further, although not shown, the value of H/T in the distal end portion C15 may be made smaller than the value of H/T in the proximal end portion C17. In this case, in the distal end portion C15, the thickness of the outer layer C60 can be reduced by making the value of H/T smaller corresponding to the thinner outer layer C60.

[12th embodiment]

Fig. 24 is a schematic longitudinal sectional view showing the proximal end portion C17 of the medical device main body C300 of the catheter C10 of the twelfth embodiment. The left side of Fig. 24 corresponds to the front end side of the catheter, and the right side corresponds to the side of the hand (base end side).

The duct C10 of the present embodiment is different from the above-described seventh embodiment only in the aspects described below, and is configured in the same manner as the seventh embodiment described above.

In the case of the present embodiment, in the proximal end portion C17, the outer surface C50a of the wire coil C50 is relatively flat. For example, the outer surface C50a is planarized by grinding the outer surface C50a (the outer surface C52a of the wire C52).

Thereby, the layer thickness of the wire coil C50 in the proximal end portion C17 can be suppressed.

In each of the above embodiments, the example in which the cross-sectional shape of the wire C52 is rectangular is described. However, the cross-sectional shape of the wire C52 is not particularly limited as long as it is non-circular. Here, as the non-circular shape, an elliptical shape, an elliptical shape, a semicircular shape, a fan shape (a fan shape having one arc, or a fan shape having an outer arc and an inner arc (fan paper shape)), and a jade jade can be exemplified. Shape, spindle, waterdrop or polygon. The polygon may be a concave polygon having an inner angle of more than 180 degrees in addition to a convex polygon such as a rectangle, a trapezoid, a rhombus or a parallelogram. Further, the non-circular shape may be a shape obtained by recombining the above-described shape, and specifically, may be a rounded polygon having a side protruding in an arc shape or a concave lens shape having a side recessed in an arc shape. The length of the long side and the short side may be different when the non-circular shape is a rectangle which is assumed to be the smallest area to which it is externally attached. Further, the wire C52 having a different H/T value in the wire C52 of the shape may be selected according to the position in the longitudinal direction of the medical device body C300.

Further, the above-described active type catheter C10 having an operating mechanism has been exemplified, but the present invention is not limited to this example, and can be applied to a non-active type catheter having no operating mechanism.

[13th embodiment]

Fig. 25 is a schematic view showing a medical device body D300 of a catheter D10 which is a preferred example of the medical device according to the thirteenth embodiment. Here, Fig. 25(a) shows the distal end portion (distal end portion D15), and Fig. 25(b) shows the proximal end portion D17. The left side of Fig. 25 corresponds to the front end side of the catheter, and the right side corresponds to the side of the hand (base end side).

Fig. 26 is a view showing an example of a cross-sectional shape and a posture (inclination direction) of the wire D52. 26(a) and 26(b) show the cross-sectional shape and posture of the distal end portion D15 and the cross-sectional shape and posture of the proximal end portion D17, respectively.

Figure 27 is a cross-sectional view taken along line A-A of Figure 25.

Figure 28 is a schematic top plan view of a catheter. In addition, FIG. 28(a) shows a state in which the bending operation of the front end portion of the medical device main body D300 is not performed, and FIG. 28(b) shows a state in which the operation of bending the front end portion of the medical device main body D300 in one direction is performed. Fig. 28(c) shows a state in which the operation of bending the front end portion of the medical device main body D300 in the opposite direction is performed.

The medical device (for example, the catheter D10) of the present embodiment has a long and flexible medical device body D300 that is inserted into a body cavity. The medical device body D300 includes: a long resin tube (thin tube D16); and a wire coil D50 formed by winding a wire D52 having a non-circular cross-sectional shape into a coil shape, and a resin tube Coaxially embedded in the resin tube.

The medical device body D300 has a first section (for example, a distal end portion D15) and a second section (for example, a proximal end portion D17) which are mutually different sections in the longitudinal direction thereof.

In the first section, in the outer surface D52a of the wire D52, the top portion P located farthest from the axis of the medical machine body D300 is located at the center position C of the wire D52 which is longer than the longitudinal direction of the medical machine body D300. At the base end side.

In the second section, the top portion P is located at the front end side of the center position C of the wire D52 in the longitudinal direction of the medical device body D300.

Hereinafter, it demonstrates in detail.

As shown in Fig. 28, the catheter D10 includes a medical device body D300 and an operating mechanism for performing a bending operation of the front end portion of the medical device body D300.

The operating mechanism includes an operation wire D40 (FIG. 25, FIG. 27) and an operation portion D70 for performing an operation of pulling the operation wire D40. The operation wire D40 is embedded in the medical device body D300 along the longitudinal direction of the medical device body D300. The operation unit D70 is installed in the medical machine book The base end of the body D300. The base end portion of the operation wire D40 is connected to the operation unit D70. By operating the operation portion D70, the operation wire D40 is pulled toward the proximal end side of the medical device body D300, whereby the front end portion of the medical device body D300 can be bent.

The medical machine body D300, which is the body of the catheter D10, is long and flexible, and is inserted into a body cavity for use.

A preferred example of the catheter D10 is an intravascular catheter that is inserted into a blood vessel. More specifically, a preferred example of the medical device body D300 of the catheter D10 is formed to allow the medical device body D300 to enter the size of any of the eight sub-regions of the liver.

Further, in the present specification, a specific length region including the distal end (front end) DE of the catheter D10 (and the medical device body D300) is referred to as a distal end portion D15 of the catheter D10 (and the medical device body D300). Similarly, a specific length region including the proximal end (base end) (not shown) of the catheter D10 (and the medical device body D300) is referred to as the proximal end of the catheter D10 (and the medical machine body D300) (base end) Department) D17 (Figure 28). Further, a specific length region adjacent to the proximal end side of the distal end portion D15 in the longitudinal direction of the catheter D10 (and the medical device body D300) is referred to as an intermediate portion D18. The intermediate portion D18 is located at the front end side of the more proximal end portion D17.

As shown in FIGS. 25 and 27, a main inner chamber D20 and a sub-cavity D30 are formed inside the medical device main body D300. The main lumen D20 and the sub-chamber D30 extend along the longitudinal direction of the medical device body D300 (the conduit D10) (the left-right direction in Fig. 25). The main lumen D20 is disposed, for example, at a center of a cross section (a cross section orthogonal to the longitudinal direction) of the medical device body D300, and the sub-chamber D30 is disposed around the main lumen D20. More specifically, for example, in the cross section, the sub-cavities D30 are disposed at rotationally symmetrical positions with respect to each other with respect to the center of the main lumen D20.

The catheter D10 includes, for example, a plurality of sub-chambers D30. Each sub-chamber D30 has a smaller diameter than the main lumen D20.

The sub-chambers D30 and the main lumen D20 and the sub-chamber D30 are spaced apart from each other and are individually arranged. The plurality of sub-cavities D30 are, for example, dispersedly disposed around the main inner cavity D20. In the example of FIGS. 25 and 27, the number of sub-chambers D30 is two, and the sub-chambers D30 are arranged around the main inner cavity D20 at intervals of 180 degrees.

Inside the sub-chamber D30, an operation line D40 is inserted through each of them. That is, the duct D10 has, for example, two operation wires D40.

The operation wire D40 is relatively movable toward the longitudinal direction of the sub-chamber D30 with respect to the sub-chamber D30 by sliding relative to the peripheral wall of the sub-chamber D30. That is, the operation wire D40 can slide in the longitudinal direction of the sub-chamber D30.

The operation wire D40 may also include a single wire, but may be a stranded wire formed by twisting a plurality of thin wires to each other.

The number of the thin wires constituting one strand is not particularly limited, but is preferably three or more. A preferred example of the number of thin lines is three or seven.

When the number of the thin wires constituting the operation wire D40 is three, the three thin wires are arranged in point symmetry in the cross section. When the number of the thin wires constituting the operation wire D40 is seven, the seven thin wires in the cross section are arranged in a honeycomb shape in a point symmetry.

The outer dimension of the operation wire D40 (the diameter of the circle outside the strand) can be set, for example, to 25 to 55 μm.

As a material constituting the wire of the operation wire D40 (or a thin wire constituting the strand), in addition to a flexible metal wire such as a low carbon steel (piano wire), stainless steel (SUS), titanium or a titanium alloy, a poly (p-phenylene benzobisoxazole) (PBO), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), polyimine (PI) Or polymer fibers such as polytetrafluoroethylene (PTFE) or boron fiber.

Here, as the structure of the sub-chamber D30, for example, the following two structures can be exemplified.

In the first structure, as shown in FIGS. 25 and 27, the hollow tube D32 formed in advance is embedded in the outer layer D60 (described below) along the longitudinal direction of the medical device body D300, and the hollow tube D32 is embedded. The inner cavity is set to the sub-cavity D30. That is, in these examples, the sub-chamber D30 includes a lumen embedded in the hollow tube D32 in the medical device body D300.

The hollow tube D32 may contain, for example, a thermoplastic resin. Examples of the thermoplastic resin include low friction resins such as polytetrafluoroethylene (PTFE) or polyether ether ketone (PEEK).

In the second configuration, a hollow of a strip along the longitudinal direction of the medical device body D300 is formed in the outer layer D60 (described below), thereby forming the sub-chamber D30.

The medical device body D300 has, for example, a thin tube D16 including an inner layer D21, an outer layer D60 laminated around the inner layer D21, and a coating layer D64 formed around the outer layer D60.

The thin tube D16 contains, for example, a resin material. That is, the thin tubes D16 are each composed of a resin layer outer layer D60 and an inner layer D21. In other words, the thin tube D16 is a resin tube which is a hollow resin layer including the outer layer D60 and the inner layer D21.

This resin pipe is disposed coaxially with the wire coil D50 (described below) and covered with the wire coil D50. The resin tube is adhered to the wire coil D50.

The inner layer D21 contains a tubular resin material. At the center of the inner layer D21, a main inner cavity D20 is formed.

The outer layer D60 contains a resin material of the same or different kind as the inner layer D21. The sub-cavity D30 is formed inside the outer layer D60.

The material of the inner layer D21 is, for example, a fluorine-based thermoplastic polymer material. Specifically, the fluorine-based thermoplastic polymer material is, for example, polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), or soluble perfluoroalkoxy fluororesin (PFA).

When the inner layer D21 contains such a fluorine-based resin, the delivery property when the contrast medium, the chemical solution, or the like is supplied to the affected part through the main lumen D20 is improved.

For example, the material of the outer layer D60 is, for example, a thermoplastic polymer. Examples of the thermoplastic polymer include polyimine (PI), polyamidimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), and polyamine (PA). , nylon elastomer, polyurethane (PU), ethylene vinyl acetate resin (EVA), polyvinyl chloride (PVC) or polypropylene (PP).

The resin material constituting the thin tube D16 may also contain an inorganic filler. For example, as a composition Most of the wall thickness of the thin tube D16 is a resin material of the outer layer D60, and those containing an inorganic filler can be used.

The inorganic filler is, for example, barium sulfate or barium hypocarbonate. By mixing such an inorganic filler into the outer layer D60, the X-ray contrast property is improved.

The coating D64 constitutes the outermost layer of the medical machine body D300 and contains a hydrophilic material. Further, the coating layer D64 may be formed only in a region extending over a portion of the distal end portion D15 of the medical device body D300, or may be formed over the entire length of the medical device body D300.

The coating layer D64 is formed of, for example, a hydrophilic resin material such as polyvinyl alcohol (PVA) or polyvinylpyrrolidone, thereby being hydrophilic. Further, the coating layer D64 may be formed by subjecting the outer surface of the outer layer D60 to a lubricating treatment to at least make the outer surface of the outer layer D60 hydrophilic.

The conduit D10 further has a wire coil D50 wound around the inner layer D21. The wire coil D50 is configured, for example, by winding one of the elastic bodies or a plurality of wires (wire) D52 into a coil shape. As a material of the wire D52 constituting the wire coil D50, for example, a metal is preferably used, but it is not limited to this example, and may be used as long as it has a higher rigidity and elasticity than the inner layer D21 and the outer layer D60. Other materials (such as resin). Specifically, as the metal material of the wire D52, for example, stainless steel (SUS), nickel-titanium alloy, steel, titanium or a copper alloy can be used. An example of the cross-sectional shape of the wire D52 will be described below.

The wire coil D50 is wrapped in the outer layer D60.

In the present embodiment, the sub-cavity D30 is formed inside the outer layer D60 on the outer side of the wire coil D50.

Here, a representative size of each component of the catheter D10 of the present embodiment will be described.

The radius of the main inner cavity D20 can be set to about 200~300μm, and the thickness of the inner layer D21 can be set. The thickness of the outer layer D60 can be set to about 50 to 150 μm, the outer diameter of the wire coil D50 can be set to 500 to 860 μm, and the inner diameter of the wire coil D50 can be set to be 420 to 660 μm.

The radius (distance) from the axis of the medical device body D300 to the center of the sub-chamber D30 is about 300 to 450 μm, and the inner diameter (diameter) of the sub-chamber D30 is 40 to 100 μm. Further, the thickness of the operation wire D40 is set to be about 30 to 60 μm.

The outer diameter (radius) of the medical machine body D300 is about 350 to 490 μm, that is, the outer diameter is less than 1 mm in diameter. Thereby, the medical device main body D300 of the present embodiment can be inserted into a blood vessel such as a celiac artery.

At the distal end portion D15 of the medical device body D300, a circular marker D66 containing a material such as X-rays that does not transmit radiation is provided. Specifically, the marker D66 contains a metal material such as platinum. The marker D66 is disposed, for example, around the main lumen D20 and inside the outer layer D60.

The front end portion D41 of the operation wire D40 is fixed to the distal end portion D15 of the medical machine body D300. The aspect in which the front end portion D41 of the operation wire D40 is fixed to the distal end portion D15 is not particularly limited. For example, the front end portion D41 of the operation wire D40 may be welded or fastened to the marker D66, or may be welded to the distal end portion D15 of the medical device body D300, or may be fixed to the marker D66 by an adhesive. The distal end portion D15 of the medical machine body D300.

The sub-chamber D30 forms an opening at least on the proximal end portion D17 side of the catheter D10. The base end portion of each operation wire D40 protrudes from the opening of the sub-chamber D30 toward the proximal end side. The proximal end portion of each operation wire D40 is coupled to the operation portion D70 provided at the proximal end portion D17 of the medical device body D300.

As shown in FIG. 28, the operation portion D70 includes, for example, a main body casing D700, and a wheel operating portion D760 that is rotatably provided with respect to the main body casing D700.

The base end portion of the medical machine body D300 is introduced into the body casing D700. In vitro At the rear end of the casing D700, a hub D790 is mounted. The base end of the thin tube D16 is fixed to the front end of the hub D790.

The hub D790 is formed with a hollow cylindrical body that penetrates the hub D790 forward and backward. The hollow of the hub D790 is in communication with the main lumen D20 of the medical machine body D300.

In the hub D790, an injector (syringe) (not shown) can be inserted from the rear. By injecting a liquid such as a chemical solution into the hub D790 by the injector, the liquid can be supplied to the front end of the medical device body D300 via the main lumen D20, and the liquid is supplied from the front end of the medical machine body D300 to the body cavity of the patient. Internal supply.

For example, the operation wire D40 and the hollow tube D32 are branched from the thin tube D16 at the front end of the body casing D700.

The hollow tube D32 has its base end portion open, and the base end portion of the operation wire D40 protrudes from the opening of the base end portion of the hollow tube D32 toward the proximal end side.

The base end portions of the operation wires D40 are directly or indirectly connected to the wheel operating portion D760. By rotating the wheel operating portion D760 in an arbitrary direction, the operation wire D40 can be individually pulled toward the proximal end side, whereby the distal end portion D15 of the medical device body D300 can be bent.

As shown in Fig. 28 (b), when the operation of rotating the wheel operating portion D760 in one direction about the rotation axis is performed, an operation wire D40 is pulled toward the proximal end side. Thus, for the distal end portion D15 of the medical machine body D300, the tensile force is imparted by the one operation line D40. Thereby, the distal end portion D15 of the medical device body D300 is bent toward the side of the sub-chamber D30 through which the operation line D40 is inserted, with reference to the axis of the medical device body D300. That is, the distal end portion D15 of the medical device body D300 is curved in one direction.

Further, as shown in FIG. 28(c), when the operation of rotating the wheel operating portion D760 in the other direction around the rotation axis is performed, the other operation wire D40 is pulled toward the proximal end side. Thus, for the distal end portion D15 of the medical machine body D300, the tensile force is imparted by the other operation wire D40. Thereby, the distal end portion D15 of the medical machine body D300 is a medical machine body The axis of the D300 is bent toward the side of the sub-chamber D30 through which the other operation line D40 is inserted. That is, the distal end portion D15 of the medical machine body D300 is curved in the other direction.

Here, the bending of the medical device main body D300 includes a state in which the medical device main body D300 is bent into a "ㄑ" shape and a curved shape.

In this manner, by operating the wheel operating portion D760 of the operating portion D70, the two operating wires D40 are selectively pulled, whereby the distal end portion D15 of the medical device body D300 can be oriented in the first direction, and vice versa. The direction is curved in the second direction. The first direction and the second direction are included in the same plane as each other.

By combining the torque operation for the shaft rotation of the entire catheter D10 and the pulling operation, the direction of the distal end DE of the medical device body D300 can be freely controlled.

Further, by adjusting the amount of pulling of the operation wire D40, the amount of bending of the distal end DE of the medical machine body D300 can be adjusted.

Therefore, the medical device main body D300 of the catheter D10 of the present embodiment can enter a desired direction with respect to a body cavity such as a branching blood vessel.

That is, by performing an operation of bending the distal end portion D15, the direction of entry into the body cavity can be changed.

Next, the medical device body D300 will be described in more detail with reference to FIGS. 25 and 26.

The wire D52 constituting the wire coil D50 has a non-circular cross-sectional shape. In the case of the present embodiment, the wire D52 is, for example, a so-called flat wire having a rectangular shape in a flat cross section. In the cross-sectional shape of the wire D52, the width dimension corresponding to the long diameter dimension is longer than the thickness dimension corresponding to the short diameter dimension. The ratio of the width dimension to the thickness dimension, that is, the width dimension when the thickness dimension is 1 is preferably 1.1 or more and 5 or less, more preferably 1.5 or more and 4 or less, still more preferably 2 or more and 4 or less. The actual size of the width dimension of the wire D52 is 1 mm or less, preferably 0.5 mm. Wire D52 The thickness of the wire D52 in the longitudinal section of the medical machine body D300 is wound in such a manner that the thickness becomes thinner with respect to the width.

Further, when the wire D52 is wound into a coil shape, the wire D52 is wound at an appropriate angle and at an appropriate angle, whereby the cross-sectional shape and the longitudinal cross-sectional shape of the wire D52 are curved, for example, as shown in FIG. The concave shape is shown.

When the shape is described in more detail, for example, as shown in FIG. 26, the outer surface D52a has a concave curved surface, and the inner surface D52b has a convex curved surface. Further, the end faces D52c and D52d on the distal end side and the proximal end side are convex curved surfaces that protrude toward the distal end side and the proximal end side, respectively.

As shown in Fig. 25 (a) and Fig. 26 (a), for example, in the distal end portion D15 of the medical device body D300, the outer surface D52a of the wire D52 is located at the axial center of the medical device body D300. The distal top P (Fig. 26(a)) is located at the proximal end side of the center position C (Fig. 26(a)) of the wire D52 on the longitudinal direction X (Fig. 26(a)) of the medical machine body D300. . That is, in the case of the present embodiment, the first section is the distal end portion D15 (front end portion) of the medical device main body D300.

Further, for example, in the distal end portion D15, the outer surface D52a of the wire D52 is inclined toward the axial center of the medical device body D300 toward the front end side of the medical device body D300. That is, for example, in the distal end portion D15, the outer side surface D52a is inclined toward the front end side of the medical device body D300.

Further, for example, in the longitudinal end portion D15, in the longitudinal section of the wire D52, the maximum width direction W (Fig. 26 (a)) of the cross-sectional shape of the wire D52 is approached toward the front end of the medical device body D300. The direction of the axis of the machine body D300 is inclined.

On the other hand, as shown in Fig. 25 (b) and Fig. 26 (b), for example, in the proximal end portion D17 of the medical device body D300, the top portion D of the outer surface D52a of the wire D52 (Fig. 26(b) The center position C (Fig. 26 (b)) of the wire D52 located in the longer length direction X (Fig. 26 (b)) is at the front end side. That is, in the case of the present embodiment, the second section is a medical device The first section (the distal end portion D15) of the main body D300 is a portion on the proximal end side. Further, in the case of the present embodiment, the second section is the proximal end portion (proximal end portion D17) of the medical device main body D300, and the first interval is a portion closer to the distal end side than the second section of the medical device main body D300.

Further, for example, in the proximal end portion D17, the outer surface D52a of the wire D52 is inclined toward the axial center of the medical device body D300 toward the proximal end side of the medical device body D300. That is, for example, in the proximal end portion D17, the outer side surface D52a is inclined toward the proximal end side of the medical device body D300.

That is, the direction in which the outer surface D52a is inclined is opposite to the distal end portion D15 and the proximal end portion D17.

The inclination angle of the outer side surface D52a with respect to the longitudinal direction X (for example, the average inclination angle in the entire surface of the outer side surface D52a) is, for example, greater than 0 degrees and not reached in the distal end portion D15 and the proximal end portion D17, respectively. 45 degrees, preferably 5 degrees or more and 30 degrees or less.

Further, the inner surface D52b of the wire D52 is also inclined with respect to the longitudinal direction X in the same manner as the outer surface D52a in each of the distal end portion D15 and the proximal end portion D17.

Further, for example, in the proximal end portion D17, in the longitudinal section of the wire D52, the maximum width direction W (Fig. 26(b)) of the cross-sectional shape of the wire D52 faces the proximal end side of the medical device body D300. Tilt to the direction of the axis of the medical machine body.

That is, the direction of the inclination in the maximum width direction W with respect to the longitudinal direction X is opposite to the distal end portion D15 and the proximal end portion D17.

The inclination angle with respect to the maximum width direction W in the longitudinal direction X is, for example, greater than 0 degrees and less than 45 degrees, and preferably 5 degrees or more and 30 degrees or less, in the distal end portion D15 and the proximal end portion D17, respectively.

As a method of winding the wire D52 at the base end side or the front end side of the center position C of the wire D52 in which the top portion P is located in the longitudinal direction X, for example, the following may be mentioned law.

(1) A method of winding the wire D52 while facing the wire D52 by twisting the wire D52 in a direction inclined with respect to the longitudinal direction X around the axis of the wire D52.

As an example of the method, a method of applying a twist so as to plastically deform the wire D52 and winding the wire D52 is exemplified. Further, as another example of the method, the wire D52 is wound while the wire D52 is elastically deformed, and the shape of the wire D52 is elastically deformed by heat treatment. The method.

(2) A method in which the mutually adjacent winding portions of the wire coil D50 are partially overlapped with each other in the longitudinal direction of the medical device body D300.

Further, the shape of the original wire D52 before winding may have a shape having an inclined surface with respect to the longitudinal direction X, and particularly a shape in which the outer surface D52a is inclined with respect to the longitudinal direction X.

By the same method, the outer surface D52a of the wire D52 can be inclined toward the front end side or the proximal end side of the medical machine body D300 toward the axis of the medical machine body D300.

By the same method, the maximum width direction W can be inclined toward the front end side or the base end side of the medical device body D300 toward the axis of the medical device body D300.

In the present embodiment, for example, as shown in FIGS. 25(a) and 25(b), in the distal end portion D15 and the proximal end portion D17, the mutually adjacent winding portions of the wire coil D50 are mutually The medical machine body D300 partially overlaps each other in the longitudinal direction.

Specifically, in the distal end portion D15, on the outer peripheral side of the winding portion front end portion (front end portion) on the proximal end side of the winding portion adjacent to each other of the wire coil D50, the winding portion on the front end side is The part (base end) rises. Thereby, in the distal end portion D15, the top portion P is located at the center position C of the center line C of the wire D52 in the longer length direction X, and the outer side surface D52a faces The front end side of the medical device body D300 is inclined toward the axis of the medical device body D300, and the maximum width direction W is inclined toward the axis of the medical device body D300 toward the front end side of the medical device body D300.

On the other hand, in the proximal end portion D17, in the winding portion adjacent to each other in the winding portion of the wire coil D50, the winding portion of the rear end portion (base end portion) on the front end side, and the winding portion on the base end side The front part (front end part) rises. Thereby, in the proximal end portion D17, the top portion P is located at the front end side of the center position C of the wire D52 in the longer length direction X, and the outer side surface D52a is closer to the medical machine body toward the base end of the medical machine body D300. The direction of the axis of the D300 is inclined, and the maximum width direction W is inclined toward the direction of the axis of the medical device body D300 toward the proximal end side of the medical device body D300.

In addition, as shown in FIG. 25, the wire coil D50 is wound by, for example, a plurality of wires D52 (a plurality of wires D52) in a state of being aligned in the winding axis direction. A plurality of coils formed in a coil shape. 25 shows an example in which the number (number) of the wires D52 constituting the wire coil D50 is four (four), but the number of the wires D52 constituting the wire coil D50 may be four. Multiple roots other than roots.

Next, a method of manufacturing the medical device of the present embodiment will be described.

The manufacturing method has the steps of forming a medical device body D300 which is long and flexible, and is inserted into the body cavity, and has different degrees in the longitudinal direction of the medical machine body D300. The first interval (for example, the distal end portion D15) and the second interval (for example, the proximal end portion D17) of the interval.

This step has the following steps.

1) Step of forming a long inner resin tube (inner layer D21)

2) a step of forming the wire coil D50 by winding a wire D52 having a non-circular cross-sectional shape into a coil shape

3) Step of arranging the wire coil D50 around the inner resin tube (inner layer D21)

4) forming a long outer resin tube (outer layer D60) around the wire coil D50, and Step of embedding the wire coil D50 on the resin tube (thin tube D16) including the outer resin tube and the inner resin tube

In the step of forming the wire coil D50, the wire D52 located in the longer length direction X at the top P of the wire D52 on the outer surface D52a of the wire D52 at the farthest point from the axis of the medical machine body D300. The center position C is located at the proximal end side, and the wire coil D50 is formed so that the top portion P is located at the front end side of the center position C of the wire D52 in the longitudinal direction X.

Hereinafter, it demonstrates in detail.

For example, as described below, the catheter D10 is manufactured by individually forming the respective portions of the catheter D10 and combining them.

The outer layer D60 is produced by, for example, extrusion molding a resin material as a molding material by an extrusion molding apparatus (not shown). At the time of the extrusion molding, the core material (mandrel) is extruded together with the resin material, whereby the resin material serving as the outer layer D60 is adhered to the periphery of the core wire.

The material of the core wire is not particularly limited, and examples thereof include alloy steel such as copper or copper alloy, carbon steel or SUS, and nickel or a nickel alloy.

The mold release treatment can also be arbitrarily performed on the surface of the core wire. As the mold release treatment, an optical or chemical surface treatment may be applied in addition to the application of a release agent such as a fluorine-based or a lanthanum-based compound.

Here, the space in which the sub-cavity D30 is formed by embedding the hollow tube D32 in the outer layer D60 is formed in a hollow manner along the longitudinal direction, for example, gas is supplied to the position. The fluid is extruded on one side. The inner diameter of the hollow is larger than the outer diameter of the hollow tube D32. This is to facilitate the step of inserting the hollow tube D32 into the hollow later.

The hollow outer layer D60 can be formed by pulling out the core wire after extrusion molding. Further, the wire diameter for forming the outer layer D60 is larger than the outer diameter of the wire coil D50. This is to make the outer layer D60 around the wire coil D50 (and the inner layer D21). The steps are easy.

The inner layer D21 is produced by extrusion molding a resin material by an extrusion molding apparatus (not shown) different from the extrusion molding apparatus for forming the outer layer D60. At the time of the extrusion molding, the core material (which is made of a different core wire than the outer layer D60) is extruded together with the resin material, whereby the resin material serving as the inner layer D21 is adhered to the periphery of the core wire. The wire diameter of the core wire is equivalent to the diameter of the main inner cavity D20. Further, the inner layer D21 can also be formed by a dispersion forming device.

The material of the core wire is not particularly limited as long as it has sufficient tensile strength, but examples thereof include copper or copper alloy, carbon steel or alloy steel such as SUS, nickel or nickel alloy (nickel-titanium alloy, etc.). .

The mold release treatment can also be arbitrarily performed on the surface of the core wire. As the mold release treatment, an optical or chemical surface treatment may be applied in addition to the application of a release agent such as a fluorine-based or a lanthanum-based compound.

Further, a hollow tube D32 was separately prepared. The hollow tube D32 extrudes the resin material by using an extrusion molding apparatus for forming the inner layer D21 and an extrusion molding apparatus (not shown) different from the extrusion molding apparatus for forming the outer layer D60. Made by forming. Here, extrusion molding is performed by ejecting a fluid such as a gas from a discharge pipe disposed at the center of an extrusion port (nozzle) of the extrusion molding apparatus, and a hollow is formed at the center of the hollow pipe D32.

Further, a dummy core wire inserted into the hollow tube D32 is prepared, and the dummy core wire is inserted into the hollow tube D32.

Further, a wire coil D50 is separately prepared.

The wire coil D50 is configured by, for example, connecting a plurality of wire coils having different bending rigidity and torsional rigidity in the longitudinal direction.

The plurality of wire coils are respectively wound around the core wire (the core wire of the inner layer D21 and the outer core D60 are used), and the wire D52 is wound into a coil shape by a winding machine. And made separately. Thereafter, the core wires in each of the wire coils are pulled out. Further, after the wires are externally inserted into the same core wire, The wire coils D50 are formed by joining the wire coils by laser welding or the like and joining them in the longitudinal direction. Thereafter, the core wire in the wire coil D50 is pulled out.

Here, for the wire coil disposed at the distal end portion D15, the center position C of the wire D52 whose top portion P is located in the longer length direction X is at the proximal end side, and the outer side surface D52a faces the front end of the medical machine body D300 The wire is inclined laterally close to the axis of the medical device body D300, and the wire WD is wound in such a manner that the maximum width direction W is inclined toward the axis of the medical device body D300 toward the front end side of the medical device body D300.

The wire coil disposed at the distal end portion D15 is, for example, wound on the outer peripheral side of the front portion (front end portion) of the winding portion on the proximal end side of the winding portion adjacent to each other of the wire coil, and the winding of the front end side The wire D52 is wound so that the rear portion (base end portion) of the portion rises.

Further, with respect to the wire coil disposed at the proximal end portion D17, the center position C of the wire D52 whose top portion P is located in the longer length direction X is at the front end side, and the outer side surface D52a faces the base end side of the medical device body D300. The wire D52 is wound so as to be inclined toward the axis of the medical device body D300, and the maximum width direction W is inclined toward the proximal end side of the medical device body D300 toward the axis of the medical device body D300.

For the wire coil disposed at the proximal end portion D17, for example, the outer peripheral side of the winding portion (base end portion) on the front end side of the winding portion adjacent to each other of the wire coil, the base end side roll The wire D52 is wound so that the front portion (front end portion) of the winding portion rises.

After the inner layer D21 to which the core wire is attached is formed and the wire coil D50 is formed, the wire coil D50 is extrapolated to the inner layer D21 to which the core wire is attached.

Further, the outer layer D60 is externally inserted into the wire coil D50.

Thereby, the core wire, the inner layer D21, the wire coil D50, and the outer layer D60 are arranged in a concentric manner from the center side.

Next, for each of the hollows of the outer layer D60, the hollow tube D32 (with a dummy core) is inserted.

Next, a heat shrinkable tube is wrapped around the outer layer D60. Then, heat shrinking by heating The tube contracts and the outer layer D60 is fastened from the periphery and the outer layer D60 is heated. Further, the heating temperature is higher than the melting temperature of the outer layer D60 and lower than the melting temperature of the inner layer D21. The outer layer D60 is melted by the heating, and the outer layer D60 is adhered to the wire coil D50 and the inner layer D21 (joined by welding). At this time, the resin material constituting the outer layer D60 is wrapped with the wire coil D50, and the resin material is impregnated into the wire coil D50.

Thus, the outer layer D60 can be adhered to a tubular shape coaxial with the wire coil D50 with respect to the wire coil D50.

Thereafter, the outer layer D60 is cooled and solidified. Thereafter, the heat shrinkable tube is removed from the outer layer D60 by cutting the slit into the heat shrinkable tube and tearing the heat shrinkable tube.

Next, the dummy core wire is pulled out from the hollow tube D32, and the operation wire D40 is inserted into the hollow tube D32.

Further, the marker D66 is additionally prepared, and each operation line D40 is fixed with respect to the marker D66.

Next, the marker D66 is fixed to the front end of the medical device body D300. To this end, for example, the front outer layer D60 of the medical machine body D300 is cut off, and the inner layer D21 is exposed at the front end of the medical machine body D300. At this time, the hollow tube D32 is also cut together with the outer layer D60. Next, a state in which the front end portion of the operation wire D40 protrudes toward the front end side from the front end of the hollow tube D32 is assumed.

Next, the marker D66 is inserted around the front end of the medical device body D300 around the inner layer D21, and the marker D66 is caulked with respect to the periphery of the inner layer D21.

Next, the coating resin (not shown) which has been previously formed into a cylindrical shape covers the periphery of the front end portion of the medical device main body D300, and the heat-shrinkable tube different from the heat-shrinkable tube is used to weld the coating resin to the outer layer D60 by fusion welding. The inner layer D21 is joined. Further, the outer layer D60 and the coating resin are, for example, melted and integrated with each other. Further, the surface on the front end side of the marker D66 is also covered by the molten outer layer D60 or the coated resin.

Next, the hub D790 is connected to the base end of the medical machine body D300.

Next, the core wire in the inner layer D21 is pulled out. The extraction of the core wire is performed by stretching the both ends in the longitudinal direction of the core wire to reduce the diameter of the core wire until the core wire is plastically deformed. Thereby, a hollow which becomes the main internal cavity D20 is formed in the center of the inner layer D21.

Next, the base end portion of the operation wire D40 is directly or indirectly connected to the wheel operation portion D760 of the separately manufactured operation portion D70. Further, the main body casing D700 of the operation portion D70 is assembled with the wheel operating portion D760, and the hub D790 is attached to the body casing D700.

In this manner, the state in which the medical device body D300 is bent by the pulling operation on the operation wire D40 is set.

Next, the coating layer D64 is formed thinly.

In this way, the catheter D10 can be manufactured.

According to the thirteenth embodiment of the above, in the distal end portion D15 of the medical device body D300, the outer surface D52a of the wire D52 is located at the top of the medical device body D300 at the top P of the medical device body D300. The center position C of the wire D52 in the longitudinal direction X of the body D300 is at the base end side. As a result, in the distal end portion D15, the top portion P of the wire D52 and the portion around it are caught on the outer side of the wire coil D50 located in the thin tube D16 when the medical device body D300 is pulled out from the body cavity. The shape of the portion (including the majority of the outer layer D60: the outer resin layer). Therefore, when the medical machine body D300 is pulled out from the body cavity, the anchoring effect of the wire D52 on the outer resin layer is sufficiently obtained. Thereby, in the distal end portion D15, when the medical device main body D300 is pulled out from the body cavity, the conveyance property, that is, the pull-out property of the retracting force from the wire coil D50 to the outer resin layer can be sufficiently obtained. Moreover, when the medical device main body D300 is pulled out from the body cavity, the peeling of the wire coil D50 and the thin tube D16 (especially the outer layer D60) can be satisfactorily suppressed.

On the other hand, in the proximal end portion D17 of the medical device body D300, the top portion P of the outer surface D52a of the wire D52 is located at the center position C of the wire D52 in the longitudinal direction of the medical machine body D300 from the front end side. . As a result, in the proximal end portion D17, the top portion P of the wire D52 and the portion around it press the medical machine body D300 into the body cavity. In the inside, it is in the shape of a portion (including a large portion of the outer layer D60: hereinafter referred to as an outer resin layer) which is located on the outer side of the wire coil D50 in the thin tube D16. Therefore, when the medical device body D300 is pressed into the body cavity, the anchoring effect of the wire D52 on the outer resin layer is sufficiently obtained. Thereby, in the distal end portion D15, when the medical device main body D300 is press-fitted into the body cavity, the conveyance of the force from the wire coil D50 to the outer resin layer, that is, the propulsion property can be sufficiently obtained.

In this manner, the ductility or the pull-out property of the duct D10 having the wire coil D50 of the wire D52 having a non-circular cross section such as a flat wire can be secured at a position necessary for the longitudinal direction of the medical device body D300.

[Fourteenth embodiment]

Fig. 29 is a schematic view showing the medical device main body D300 of the catheter D10 of the fourteenth embodiment. Here, Fig. 29(a) shows the distal end portion D15, and Fig. 29(b) shows the intermediate portion D18. The left side of Fig. 29 corresponds to the front end side of the catheter, and the right side corresponds to the side of the hand (base end side).

The duct D10 of the present embodiment is different from the above-described thirteenth embodiment only in the aspects described below, and is configured in the same manner as the thirteenth embodiment.

In the present embodiment, the catheter D10 also has an operation wire D40 which is embedded in the medical device body D300 and which is used to perform the operation of pulling the operation wire D40 toward the proximal end side of the medical device body D300. The machine body D300 is bent.

In the thirteenth embodiment, an example in which the proximal end portion D17 is the second interval has been described. On the other hand, in the case of the present embodiment, the second section is the intermediate portion D18 which is a section adjacent to the proximal end side of the distal end portion D15 of the first section.

The bending rigidity of the medical device body D300 which is the distal end portion D15 of the first section is smaller than the bending rigidity of the medical device body D300 which is the intermediate portion D18 of the second section.

For example, the wire coil D50 includes a first wire coil D50a disposed at the distal end portion D15 and a second wire coil D50b disposed at the intermediate portion D18. The first wire coil D50a and the second wire coil D50b are connected to each other in the longitudinal direction. For example, the first gold The end portions of the filament coil D50a and the second wire coil D50b are coupled to each other via the welded portion D55.

Here, the thickness (thickness) of the wire D52 constituting the first wire coil D50a is thinner (thinner) than the thickness (thickness) of the wire D52 constituting the second wire coil D50b. Thereby, the bending rigidity in the intersecting direction with respect to the axial direction of the first wire coil D50a is smaller than the bending rigidity in the intersecting direction with respect to the axial direction of the second wire coil D50b. Thereby, the bending rigidity in the direction of the direction of the axial direction with respect to the distal end portion D15 of the medical device body D300 including the first wire coil D50a is relatively higher than that of the medical device body D300 including the second wire coil D50b. The bending rigidity of the intermediate portion D18 in the direction of the axial direction is small.

More specifically, at the boundary portion D90 between the distal end portion D15 and the intermediate portion D18, the bending rigidity of the medical machine body D300 does not continuously change.

Further, when the operation wire D40 is pulled toward the proximal end side, when the medical device body D300 is bent, the distal end portion D15 is mainly bent, and the intermediate portion D18 is not curved.

As described above, in the case of the present embodiment, the intermediate portion D18 adjacent to the proximal end side of the distal end portion D15 is the second interval. That is, in the intermediate portion D18, the top portion P of the wire D52 and the portion around it become the shape of the outer resin layer when the medical device body D300 is pressed into the body cavity.

Therefore, when the medical device body D300 is pressed into the inside of the body cavity in a state where the distal end portion D15 is bent, the intermediate portion D18 adjacent to the proximal end side of the distal end portion D15 can be sufficiently advanced. Sex.

Further, in the distal end portion D15, as in the thirteenth embodiment, sufficient pull-out property is obtained.

Fig. 30 is a schematic view showing the medical device body D300 of the catheter D10 of the fourteenth embodiment. In Fig. 30, the distal end portion D15 of the medical device body D300 is shown at the proximal end portion D17. Part of it. Further, Fig. 30 shows a mother duct D350 which is used in combination with the duct D10 at the time of implementation. Furthermore, the mutual counterparts of the female catheter D350 and the catheter D10 are prepared as a set (catheter set).

As shown in FIG. 30, the medical device body D300 is inserted into the female catheter D350 for use. The front end of the female catheter D350 is introduced to the vicinity of the affected part (for example, about 20 cm from the affected part), and the portion of the medical device body D300 including the distal end portion D15 and the front end portion of the intermediate portion D18 protrudes from the front end of the female catheter D350 to the affected part. Import.

As shown in FIG. 30, the medical device main body D300 has a second intermediate portion (third interval) D301 which is a portion of a specific length region extending toward the distal end side and the proximal end side of the distal end of the female catheter D350 when inserted into the female catheter D350. The second intermediate portion D301 is a section adjacent to the proximal end side of the intermediate portion D18 in the medical device main body D300.

Although not shown in the drawings, in the second intermediate portion D301, similarly to the distal end portion D15, the top portion P of the wire D52 and the portion around it are used when the medical device body D300 is pulled out from the body cavity. The shape of the outer resin layer is caught.

In other words, in the second intermediate portion D301, the top portion P (see FIG. 26(a)) is located at the center position C of the wire D52 in the longitudinal direction X (see FIG. 26(a)) (see FIG. 26(a)). At the proximal end side, the outer side surface D52a is inclined toward the axis of the medical device body D300 toward the front end side of the medical device body D300, and the maximum width direction W (refer to FIG. 26(a)) faces the medical machine body D300. The front end side is inclined toward the direction of the axis of the medical machine body D300.

Thereby, when the medical device main body D300 is pulled out from the body cavity and pulled out from the mother duct D350, sufficient pull-out property is obtained in the second intermediate portion D301. Therefore, the front end of the female catheter D350 resists the frictional resistance experienced by the medical machine body D300, so that the medical machine body D300 can be easily pulled out from the female catheter D350.

Further, the medical device main body D300 has a main portion (fourth section) D302 adjacent to the proximal end side of the second intermediate portion D301. Furthermore, the main portion D302 has a proximal end at its base end. D17.

In the entirety of the main portion D302 including the proximal end portion D17, similarly to the proximal end portion D17 in the thirteenth embodiment, the top portion P of the wire D52 and the portion around it are directed to the body cavity of the medical device body D300. When the inner press is pressed, the shape of the outer resin layer is caught.

That is, in the main portion D302, the top portion P (see FIG. 26(b)) is located at the center position C (see FIG. 26(a)) of the wire D52 in the longer direction X (see FIG. 26(b)). The side surface, and the outer side surface D52a is inclined toward the axial center of the medical device body D300 toward the proximal end side of the medical device body D300, and the maximum width direction W approaches the medical device body D300 toward the proximal end side of the medical device body D300. The direction of the axis is inclined.

Thereby, when the medical device body D300 is press-fitted into the body cavity and pressed into the mother pipe D350, sufficient propulsion is obtained in the main portion D302.

For example, in the second intermediate portion D301 and the main portion D302, the mutually adjacent winding portions of the wire coil D50 partially overlap each other in the longitudinal direction of the medical device body D300.

In the second intermediate portion D301, on the outer peripheral side of the winding portion front end portion (front end portion) on the proximal end side of the winding portion adjacent to each other in the wire coil D50, the front end side of the winding portion rear portion (base end) Department) rose.

In the main portion D302, the winding portion of the winding end portion adjacent to each other in the winding portion of the wire coil D50 is on the outer peripheral side of the winding portion (base end portion) on the front end side, and the front portion (front end portion) of the winding portion on the proximal end side. rise.

Further, in the fourteenth embodiment, the distal end of the medical device main body D300 which is located on the distal end side of the boundary portion D90 of the welded portion D55 corresponding to the first wire coil D50a and the second wire coil D50b. In the entirety of the portion D15, the top portion P (see Fig. 26 (a)) is located at the center end position of the center line C (see Fig. 26 (a)) of the wire D52 in the longer length direction X (see Fig. 26 (a)). An example is given.

However, the fourteenth embodiment is not limited to this example, and in the medical device body D300, In the specific length region D303 (FIG. 29) adjacent to the front end side of the boundary portion D90, that is, the base end portion of the distal end portion D15, the top portion P (see FIG. 26(b)) may be located in the longer length direction X (refer to the figure). The center position C (see Fig. 26(b)) of the wire D52 on 26(b)) is on the front end side.

In this case, for example, a portion of the wire coil D50 disposed at the distal end portion D15 is a case where two wire coils (not shown) are connected to each other.

[Fifteenth Embodiment]

Fig. 31 is a schematic view showing the medical device main body D300 of the catheter D10 of the fifteenth embodiment. Here, Fig. 31(a) shows the distal end portion D15, and Fig. 31(b) shows the proximal end portion D17. The left side of Fig. 31 corresponds to the front end side of the catheter, and the right side corresponds to the side of the hand (base end side).

The duct D10 of the present embodiment is different from the above-described thirteenth embodiment only in the aspects described below, and is configured in the same manner as the thirteenth embodiment.

In the thirteenth embodiment, the distal end portion D15 which is the distal end portion of the medical device main body D300 is the first interval, and the proximal end portion D17 which is the proximal end portion of the medical device main body D300 is the second interval. It was explained. On the other hand, in the case of the present embodiment, the distal end portion D15 is the second section, and the proximal end portion D17 is the first section.

That is, as shown in Fig. 31 (a), in the distal end portion D15, the top portion P (see Fig. 26 (b)) is located at the center of the wire D52 in the longer length direction X (see Fig. 26 (b)). C (see FIG. 26(b)) is located on the distal end side, and the outer surface D52a is inclined toward the axis of the medical device body D300 toward the proximal end side of the medical device body D300, and the maximum width direction W (refer to FIG. 26 ( b)) tilting toward the axis of the medical machine body D300 toward the proximal end side of the medical machine body D300.

On the other hand, as shown in Fig. 31 (b), in the proximal end portion D17, the top portion P (see Fig. 26 (a)) is located in the wire length D52 in the longer length direction X (see Fig. 26 (a)). The center position C (refer to FIG. 26(a)) is at the proximal end side, and the outer side surface D52a is inclined toward the axis of the medical device body D300 toward the front end side of the medical device body D300, and the maximum width direction W is toward the medical machine. The front end of the body D300 is laterally close to the axis of the medical machine body D300 Tilt in direction.

As described above, in the case of the present embodiment, the second section is the front end of the medical device main body D300, and the first section is the portion closer to the proximal end side than the second section of the medical device main body D300. Further, the first section is the base end portion of the medical device main body D300, and the second section is the portion closer to the distal end side than the first section of the medical device main body D300.

In the present embodiment, in the distal end portion D15 and the proximal end portion D17, the mutually adjacent winding portions of the wire coil D50 partially overlap each other in the longitudinal direction of the medical device body D300.

In the distal end portion D15, in the winding portion where the wire coils D50 are adjacent to each other, the outer peripheral side of the winding portion rear end portion (base end portion) on the front end side, and the front portion of the winding portion on the base end side (front end portion) Department) rose.

In the proximal end portion D17, on the outer peripheral side of the front portion (front end portion) of the winding portion on the proximal end side of the winding portion adjacent to each other of the wire coil D50, the rear end portion of the winding portion (base end) Department) rose.

According to the fifteenth embodiment, as in the thirteenth embodiment, the wire coil having the wire D52 having a non-circular cross section such as a flat wire can be secured at a position necessary for the longitudinal direction of the medical device main body D300. Advance or pullout of the D50 catheter D10.

However, in the distal end portion D15, when the medical device body D300 is press-fitted into the body cavity, the conveyance of the force from the wire coil D50 to the outer resin layer, that is, the propulsion property can be sufficiently obtained.

Further, in the proximal end portion D17, when the medical device main body D300 is pulled out from the body cavity, the conveyance of the retracting force from the wire coil D50 to the outer resin layer, that is, the pull-out property can be sufficiently obtained.

In each of the above embodiments, the example in which the cross-sectional shape of the wire D52 is rectangular is described. However, the cross-sectional shape of the wire D52 is not particularly limited as long as it is non-circular. set. Here, as the non-circular shape, an elliptical shape, an elliptical shape, a semicircular shape, a fan shape (a fan shape having one arc, or a fan shape having an outer arc and an inner arc (fan paper shape)), and a jade jade can be exemplified. Shape, spindle, waterdrop or polygon. The polygon may be a concave polygon having an inner angle of more than 180 degrees in addition to a convex polygon such as a rectangle, a trapezoid, a rhombus or a parallelogram. Further, the non-circular shape may be a shape obtained by recombining the above-described shape, and specifically, may be a rounded polygon having a side protruding in an arc shape or a concave lens shape having a side recessed in an arc shape. The length of the long side and the short side may be different when the non-circular shape is a rectangle which is assumed to be the smallest area to which it is externally attached. Further, the wire D52 having different H/T values in the wire D52 of the shape may be selected according to the position in the longitudinal direction of the medical device body D300.

Further, although the above-described active type conduit D10 having an operating mechanism has been exemplified, the present invention is not limited to this example, and can be applied to a non-active type catheter having no operating mechanism.

[Industrial availability]

The first aspect of the present invention can be applied to an excellent resistance to kinkability by having a wire coil (coil layer) including a flat wire, and can well prevent interfacial peeling between members such as interlayers, and has excellent inter-component properties. A medical device having excellent adhesion and excellent bending properties, and a method for manufacturing a medical device.

The second aspect of the present invention can be applied to a medical device which uses a wire having a non-circular cross section such as a flat wire, is excellent in kink resistance, and can prevent interfacial peeling between layers and can secure a sufficient inner cavity area, and The manufacturing method of medical equipment.

The third aspect of the present invention can be applied to a medical device and a medical device manufacturing method which have a wire coil including a wire having a non-circular cross section such as a flat wire and which can suppress peeling of the interface between the wire coil and the resin layer.

The fourth aspect of the present invention can be applied to a medical device and a medical device manufacturing method having a wire coil including a wire having a non-circular cross section such as a flat wire and ensuring necessary propulsion or extraction.

10‧‧‧Tube body (thin tube)

11, 311‧‧‧ inner layer

12. 312‧‧‧ outer layer

20‧‧‧Main cavity

30‧‧‧Coil layer

31‧‧‧Wire

32‧‧‧ winding gap

40‧‧‧Marks

50‧‧‧ Coating

51‧‧‧Resin materials

70‧‧‧Operation line

70a‧‧‧First line of operation

70b‧‧‧Second operation line

71, 71a, 71b‧‧‧ front end of the operating line

80‧‧‧ child cavity

80a‧‧‧The first sub-cavity

80b‧‧‧Second sub-cavity

100‧‧‧ catheter

111‧‧‧Resin material (inner layer)

112‧‧‧Resin material (outer layer)

A‧‧‧ outside side

B‧‧‧ inside side

CE‧‧‧ proximal end

DE‧‧‧ far end

Claims (54)

A medical device characterized in that it is a long strip-shaped medical device and has a coil layer that winds a wire having a non-circular cross-sectional shape into a coil shape in a longitudinal direction of the medical device. In the cross-sectional shape of the wire in the longitudinal section of the coil layer, (1) when the inner side of the wire in the radial direction is linear, the inner side is inclined with respect to the longitudinal direction, Or (2) when the inner side of the wire is arcuate, the maximum width direction of the cross-sectional shape is inclined with respect to the longitudinal direction. The medical device of claim 1, wherein the plurality of wires are wound in a coil shape. The medical device of claim 2, wherein the adjacent wires are wound in a plurality of layers with each other in close contact with each other. The medical device of claim 3, wherein one of the adjacent wires is overlapped with each other in the longitudinal direction. The medical device according to any one of claims 1 to 3, wherein in the cross-sectional shape of the wire in the longitudinal section, the outer side and the inner side in the radial direction are convex inward. The medical device according to any one of claims 1 to 3, wherein a width dimension of the cross section of the wire is greater than a thickness dimension, and a dimension of the length direction of the wire in the longitudinal section of the coil layer is larger than a dimension of a radial direction . The medical device according to any one of claims 1 to 3, wherein both sides of the transverse direction of the cross section of the wire are outwardly projecting arcs. A medical device characterized in that it is a medical device as claimed in claim 7 in which a plurality of the above-mentioned wires are wound into a plurality of coils, and The two sides of the arc shape adjacent to the above-mentioned metal wire are in point contact with each other. The medical device of claim 8, wherein the position at which the adjacent wires are in contact with each other is located between the largest projections of the arcs on the both sides. The medical device according to any one of claims 1 to 3, wherein the medical device is a catheter comprising a tubular body having a strip of a main lumen therein; and the tubular body comprises: an inner layer having the above-mentioned main body a cavity layer formed on an outer peripheral surface of the inner layer, and formed by winding a plurality of the plurality of wires in a coil shape; an outer layer covering at least the coil layer; and at least one sub-cavity The outer circumference of the main inner cavity is formed, and the operation wire is inserted. A medical device according to claim 10, wherein one of said wires of said coil layer is partially embedded in said inner layer. A method of manufacturing a medical device, characterized in that it is a method for manufacturing a medical device having a long strip shape, and has a wire having a non-circular cross-sectional shape wound in a coil shape in a longitudinal direction of the medical device. In the step of forming the coil layer, the coil layer is formed in such a manner that, in the cross-sectional shape of the wire in the longitudinal section of the coil layer, (1) the inner side of the wire in the radial direction is linear In the case where the inner side is inclined with respect to the longitudinal direction or (2) the inner side of the wire is curved, the maximum width direction of the cross-sectional shape is inclined with respect to the longitudinal direction. The method of manufacturing a medical device according to claim 12, comprising the step of winding a plurality of the plurality of wires into a coil shape, and in the step of winding the plurality of windings, the wire to be wound first That is, the wire is wound first, and one of the portions of the wire to be wound, which is to be wound thereafter, is wound while being pressed against the inner side of the winding diameter. A medical device characterized in that it is a long strip-shaped medical device and has a coil layer that winds a wire having a non-circular cross-sectional shape into a coil shape in a longitudinal direction of the medical device. And the outer surface of the coil layer is flat, and in the cross-sectional shape of the wire in the longitudinal section of the coil layer, (1) when the inner side of the wire in the radial direction is linear When the inner side is inclined with respect to the longitudinal direction or (2) the inner side of the wire is curved, the center thickness direction of the cross-sectional shape is inclined with respect to the longitudinal direction. The medical device of claim 14, wherein the plurality of the plurality of wires are wound into a coil shape. The medical device of claim 15, wherein the adjacent wires are wound in a plurality of layers in close contact with each other. The medical device of claim 16, wherein one of the adjacent wires is overlapped with each other in the longitudinal direction. The medical device of claim 16 or 17, wherein in the longitudinal section of the coil layer, the inner side of the adjacent wire is inclined in the same direction with respect to the length direction, and the thickness of each wire is radial It gradually becomes larger from the distal side to the proximal side. The medical device according to any one of claims 14 to 17, wherein a width dimension of the cross section of the wire is longer than a thickness dimension, and an inclination angle of the inner side of the wire in a longitudinal section of the coil layer is relatively It is 45 degrees or less in the above longitudinal direction. The medical device of any one of claims 14 to 17, wherein the above-mentioned wire is Both sides of the transverse direction in the width direction are arcs that protrude outward. A medical device characterized in that the plurality of wires are wound into a coil-like medical device according to claim 20, and the two sides of the arc of the adjacent wire are in point contact with each other. . The medical device of claim 21, wherein the position at which the adjacent wires are in contact with each other is located between the largest projections of the arcs on the both sides. The medical device of any one of claims 14 to 17, wherein the medical machine is a catheter comprising a tubular body having a strip of a main lumen therein; and the tubular body comprises: an inner layer having the inner main body therein a coil layer formed on an outer peripheral surface of the inner layer, and formed by winding a plurality of the plurality of wires in a coil shape; an outer layer covering the coil layer; and at least one sub-cavity forming It is outside the main inner cavity and the operation wire is inserted. A medical device according to claim 23, wherein one of said wires of said coil layer is partially embedded in said inner layer. A method of manufacturing a medical device, characterized in that it is a method for manufacturing a long medical device, and comprising the steps of winding a wire having a non-circular cross-sectional shape into a coil in a longitudinal direction of the medical device. Forming the coil layer; and polishing the outer surface of the wire of the coil layer to be flat; and forming the coil layer in a cross-sectional shape of the wire in a longitudinal section of the coil layer, (1) When the inner side of the radial direction of the wire is linear, the inner side is inclined with respect to the longitudinal direction, or (2) the inner side of the wire is curved. The above sectional shape The center thickness direction is inclined with respect to the above length direction. The method of manufacturing a medical device according to claim 25, comprising the step of winding a plurality of the plurality of wires into a coil shape, wherein in the step of winding the plurality of wires, the wire is wound first. The wire is wound first, and one of the inner sides of the wire which is wound after the wire is wound, and the inner side of the wire is wound while being pressed in the inner side of the winding diameter. A method of manufacturing a medical device, characterized in that it is a method for manufacturing a long strip medical device, and comprising the steps of: preparing a non-circular wire having a flat cross-sectional shape including a flat side; and flattening the flat side The coil layer is formed by winding the wire in a coil shape in a longitudinal direction of the medical device, and forming the coil layer in such a manner that the wire layer is in a longitudinal section of the coil layer In the shape, (1) when the inner side of the radial direction of the wire is linear, the inner side is inclined with respect to the longitudinal direction, or (2) the inner side of the wire is curved. In the case, the center thickness direction of the cross-sectional shape is inclined with respect to the longitudinal direction. A medical machine characterized by having a medical machine body which is long and flexible and inserted into a body cavity; and the medical machine body comprises: a long resin tube; and a wire coil, The wire is formed by winding a wire having a non-circular cross-sectional shape into a coil shape, and is embedded in the resin tube coaxially with the resin tube; and the metal is formed in a longitudinal section of the wire The thickness of the wire is set to T, which is the maximum height from the axis of the medical machine body to the outer surface of the wire. When the low difference is H, the value of H/T differs depending on the position in the longitudinal direction of the medical device body. The medical device of claim 28, wherein the outer surface of the wire is located at a position farthest from the axis of the medical device body in the longitudinal direction from the center position of the wire. The medical device of claim 28 or 29, wherein in the longitudinal section of the wire, a maximum width direction of the cross-sectional shape of the wire is inclined with respect to the longitudinal direction. The medical device of claim 28 or 29, wherein the value of H is different depending on the position in the longitudinal direction. The medical device of claim 28 or 29, wherein the closer to the front end side of the medical machine body, the greater the value of H/T. The medical device of claim 28 or 29, wherein the closer to the base end side of the medical machine body, the greater the value of the H/T. The medical device of claim 32, wherein the mutually adjacent winding portions of the wire coils partially overlap each other in the longitudinal direction in a portion of the longitudinal direction of the medical device body, wherein The value of the above H/T is larger than the value of the above H/T in the section adjacent to the partial section. The medical device of claim 32, wherein the mutually adjacent winding portions of the wire coils partially overlap each other in the longitudinal direction in a portion of the longitudinal direction of the medical device body, wherein The value of H/T is larger than the value of H/T in the section adjacent to the partial section, and the thickness of the wire is thinner as it approaches the front end side of the medical device body. The medical device according to claim 34, wherein the number of the wires constituting the wire coil in the partial portion is more than the number of the wires constituting the wire coil in a portion adjacent to the portion of the interval many. The medical device of claim 32, wherein in the resin tube, if the wall thickness of the portion outside the wire coil is TP, the value of TP is closer to the front end side of the medical device body. thin. The medical device of claim 37, wherein the closer to the front end side of the medical machine body, the greater the value of H/TP. A medical device according to claim 28 or 29, wherein the pitch angle of said wire differs depending on the position in the longitudinal direction of said medical machine body. The medical device of claim 28 or 29, wherein the outer side surface of the wire coil is flat at the base end of the medical machine body. A method of manufacturing a medical device, comprising: a step of forming a body of a medical device, the body of the medical device being long and flexible, and being inserted into a body cavity, and the step of forming the body of the medical device comprises the following a step of forming a long inner resin tube; forming a wire coil by winding a wire having a non-circular cross-sectional shape into a coil shape; arranging the wire coil around the inner resin tube; a long outer resin tube is formed around the wire coil, and the wire coil is embedded in a resin tube including the outer resin tube and the inner resin tube; and the wire is formed in a longitudinal section of the wire The thickness is set to T, which is the maximum height from the axis of the medical machine body to the outer surface of the wire. When the low difference is H, the wire coil is formed in a step of forming the wire coil so that the value of H/T differs depending on the position in the longitudinal direction of the medical device body. A medical machine characterized by having a medical machine body which is long and flexible and inserted into a body cavity, the medical machine body comprising: a long resin tube; and a wire coil The wire is formed by winding a wire having a non-circular cross-sectional shape into a coil shape, and is embedded coaxially with the resin tube in the resin tube; and the medical device body has different lengths in the longitudinal direction thereof. The first section and the second section, which are the first section and the second section, are located on the outer surface of the wire at a position farther from the axial center of the medical device body than the wire. The center position is further on the proximal end side, and in the second section, the top portion is located closer to the distal end side than the center position of the wire in the longitudinal direction. The medical device according to claim 42, wherein the outer surface of the wire is inclined toward a front end side of the medical device main body in a direction close to an axis of the medical device main body in the first interval, and is in the second interval The outer surface of the wire is inclined toward the proximal end side of the medical device body in a direction close to the axis of the medical device body. The medical device according to claim 42 or 43, wherein in the longitudinal section of the wire, the maximum width direction of the cross-sectional shape of the wire is directed toward the front end side of the medical device body in the first section, so as to be close to the medical treatment Axis of the machine body The direction is inclined. In the second section, in the longitudinal section of the wire, the maximum width direction is inclined toward a proximal end side of the medical device body in a direction close to an axis of the medical device body. The medical device according to claim 42 or 43, wherein the first section is a front end of the medical device body, and the second section is a portion closer to a proximal end side than the first section of the medical device body. The medical device according to claim 42 or 43, wherein the second section is a proximal end portion of the medical device body, and the first section is a portion closer to a distal end side than the second section of the medical device body. The medical device of claim 45, which has an operation wire embedded in the medical device body, and when the operation wire is pulled toward the proximal end side of the medical device body, the medical device body is The second section is a section adjacent to the proximal end side of the first section, and the bending stiffness of the first section is smaller than the bending stiffness of the second section. The medical device according to claim 47, wherein the bending rigidity of the medical device body is discontinuously changed at a boundary portion between the first section and the second section. The medical device according to claim 47 or 48, wherein the medical device is a catheter used for inserting the medical device body into a female catheter, the medical device body having a third interval, the third interval and the second interval Adjacent to the end side, and extending to the front end side and the base end side of the front end of the mother duct when inserted into the female duct, wherein the top portion is located at a center position of the wire in the longitudinal direction in the third section More on the base side. The medical device according to claim 49, wherein the medical device body has a fourth section adjacent to a proximal end side of the third section, and in the fourth section, the top portion is located at a center of the wire in the longitudinal direction The position is closer to the front side. The medical device according to claim 42 or 43, wherein the second section is a front end of the medical device main body, and the first section is a portion closer to a proximal end side than the second section of the medical device main body. The medical device according to claim 42 or 43, wherein the first section is a proximal end portion of the medical device body, and the second section is a portion closer to a distal end side than the first section of the medical device body. The medical device according to claim 42 or 43, wherein in the at least one of the first section and the second section, the mutually adjacent winding portions of the wire coils partially overlap each other in the longitudinal direction. A method of manufacturing a medical device, comprising: a step of forming a body of a medical device, the body of the medical device being long and flexible, and inserted into a body cavity and having different lengths in a longitudinal direction thereof The section is the first section and the second section, and the step of forming the medical device body includes the steps of: forming a long inner resin tube; and winding the wire having a non-circular cross-sectional shape into a coil shape Forming a wire coil; arranging the wire coil around the inner resin tube; and forming a long outer resin tube around the wire coil, and in the resin tube including the outer resin tube and the inner resin tube Embedding the above wire a coil in the step of forming the wire coil, wherein the first portion of the wire is located on the outer surface of the wire at a position farthest from a center of the medical device body The center position of the wire is further on the base end side, and the wire coil is formed so that the top portion is located closer to the front end side than the center position of the wire in the longitudinal direction in the second section.