JP5891789B2 - Medical device and method for manufacturing medical device - Google Patents

Description

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

  A conventional catheter has a thin wall structure made of resin, and is used by being bent passively with a guide wire or the like. In general, a catheter has poor kink resistance, and if the guide wire is pulled out after being inserted into the body cavity and bent along the guide wire, the lumen (main lumen) is crushed. For this reason, a catheter has been proposed in which a wire coil is disposed on the outer periphery of a resin-made inner tube to improve kink resistance (see, for example, Patent Document 1).

  The catheter described in Patent Document 1 includes a wire coil formed by winding a ribbon-like wire (so-called flat wire) around the outer periphery of an inner tube with a predetermined gap as a coil layer. An outer tube is laminated around the inner tube, and the coil layer is embedded in the outer tube. A catheter provided with a coil layer is improved in kink resistance due to the shape retention of the wire coil while maintaining good flexibility. In addition, by using a flat wire for the wire coil, it is possible to expect a thinner coil layer as compared with the case of using a round wire, and as a result, it can be expected that a sufficient sectional area of the lumen is secured. Such a catheter can be suitably used for, for example, surgery of a blood vessel bent in multiple directions such as a renal artery.

Special table 2003-527226 gazette

  However, in the catheter described in Patent Document 1, the wire coil is wound so that the flat surface of the wire is in contact with 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. This resistance force is caused by the vertical drag between the catheter and the body cavity wall surface that tries to extend straight in the curved body cavity, and the frictional force between the catheter and the body cavity wall surface. In the case of the catheter of Patent Document 1, this resistance force is applied to the joint interface between the inner tube and the coil layer when the catheter is pulled out. For this reason, there exists a possibility that the joining force of a coil layer and an inner side tube may fall, and may induce interface peeling. As described above, the conventional catheter has a problem that it is difficult to obtain a catheter having excellent adhesion between layers and excellent kink resistance using a wire coil made of a flat wire. .

  The present invention has been made in view of the above problems, and using a wire having a non-circular cross section such as a flat wire, has excellent kink resistance, can prevent interfacial delamination well, and has a sufficient lumen. It is an object of the present invention to provide a medical device capable of securing an area and a method for manufacturing the medical device.

  The medical device of the present invention is a long medical device having a coil layer in which a wire having a non-circular cross-sectional shape is wound in a coil shape in the longitudinal direction of the medical device, and the outer surface of the coil layer In the cross-sectional shape of the wire in the longitudinal cross-section of the coil layer, (1) the inner side in the case where the inner side in the radial direction of the wire is linear is inclined obliquely with respect to the longitudinal direction. Or (2) when the inner side of the wire is arcuate, the center thickness direction of the cross-sectional shape of the wire is inclined obliquely with respect to the longitudinal direction.

Incidentally, the medical device of the present invention, a plurality of wires that are multi-start wound coiled.

The medical device of the present invention, that is multi-strip wound in close contact adjacent wires with each other to each other.

The medical device of the present invention, between a portion of the adjacent wires are not overlap each other in the longitudinal direction, that are mutually surface contact or point contact in cross-section.

  In the medical device of the present invention, in the longitudinal section of the coil layer, the inner sides of adjacent wires are inclined obliquely in the same direction with respect to the longitudinal direction, and the radial thickness of each wire is from the distal side. It may gradually increase toward the proximal side.

  In the medical device of the present invention, the width dimension of the cross section of the wire may be longer than the thickness dimension, and the inclination angle of the inner side of the wire in the longitudinal section of the coil layer may be 45 degrees or less with respect to the longitudinal direction. .

  In addition, the medical device of the present invention may have an arc shape in which both sides in the width direction of the cross section of the wire protrude outward.

  In the medical device of the present invention, a plurality of wires may be wound in a coil shape, and both arc-shaped sides of adjacent wires may be in point contact with each other.

  In the medical device of the present invention, the position of point contact between adjacent wires may be between the maximum protrusions of the arcs on both sides.

  Further, the medical device of the present invention is a catheter including a long tubular body having a main lumen therein, and the tubular body is formed on an inner layer having a main lumen inside and an outer peripheral surface of the inner layer, A coil layer formed by winding a plurality of wires in a coil shape, an outer layer covering the coil layer, and at least one sub-lumen formed on the outer periphery of the main lumen and through which an operation line is inserted. May be.

  In the medical device of the present invention, a part of the coil layer wire may be fitted in the inner layer.

A first method for manufacturing a medical device according to the present invention is a method for manufacturing a long medical device, in which a wire having a non-circular cross-sectional shape is wound in a coil shape in the longitudinal direction of the medical device. A step of forming a layer, a step of flatly grinding the outer surface of the wire of the coil layer, and a step of winding a plurality of wires in a coil shape, and a cross section of the wire in a longitudinal section of the coil layer In the 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 arcuate In the step of forming the coil layer so that the center thickness direction of the cross-sectional shape of the wire is inclined with respect to the longitudinal direction and winding it in the multiple winding step, It is a wire that begins to wind later It is intended to wind while pressing inwardly the winding diameter of the portion of the inner side of the winding wire.

A second method for manufacturing a medical device according to the present invention is a method for manufacturing an elongated medical device, the step of preparing a non-circular wire including a side having a flat cross-sectional shape, and this flat method. A step of forming a coil layer by winding the wire in the longitudinal direction of the medical device with the side facing outward, and a step of winding a plurality of wires in a coil shape, In the cross-sectional shape of the wire in the longitudinal section, (1) the inner side in the case where the inner side in 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 In the process of forming the coil layer so that the center thickness direction of the cross-sectional shape of this wire is inclined obliquely with respect to the longitudinal direction when the side is arcuate, and in the step of multi-winding, the first winding that starts winding first After that, start winding on the wire While pressing inward part winding diameter of the winding wire of the inner sides after a tire is intended to be wound.

  According to the present invention, the high anchoring property of the inner side of the wire with respect to the inner interface of the coil layer improves the adhesion of the coil layer at this interface. On the other hand, since the outer surface of the coil layer is flat, the coil layer can be thinned. As a result, it is possible to provide a medical device that can secure a sufficient lumen area, has excellent kink resistance due to shape retention of a coiled wire, and excellent adhesion of a wire layer, and a method for manufacturing the same. Can do.

It is a sectional side view of the catheter front-end | tip part of the medical device which concerns on 1st Embodiment. FIG. 2 is an enlarged side sectional view of a part near a coil layer in FIG. 1. It is a sectional side view of the catheter front-end | tip part of the medical device which concerns on 2nd Embodiment. FIG. 4 is an enlarged side sectional view of a part near the coil layer in FIG. 3. It is a side view which shows the whole catheter which concerns on 1st Embodiment, and a side view which shows the operation example of a front-end | tip part, Comprising: (a) is a side view which shows the whole before bending a catheter, (b) FIG. 5 is a side view showing a state where the slider is operated to bend the tip upward in the drawing, and (c) is a state where the slider is operated to bend the tip with a larger curvature than in FIG. It is a side view, (d) is a side view which shows the state which operated the slider and bent the front-end | tip below the paper surface, (e) operated a slider, and made the front-end | tip with a larger curvature than (d). It is a side view which shows the state bent to the paper surface lower side. It is a conceptual diagram which shows operation | movement of the coil | winding of the coil layer wire when the catheter which concerns on 1st Embodiment bends, (a) is a conceptual diagram which shows a linear state, (b) is upper surface of paper. That is, it is a conceptual diagram showing a state where the cross-sectional shape of the wire is bent in the direction of the linear outer side, and (c) shows a state where the wire is bent in the direction of the inner side of the arc of the cross-sectional shape of the wire. It is a conceptual diagram. (A) is a figure showing the microscope picture of the longitudinal cross-section of the wire corresponded to the coil layer of the catheter which concerns on 1st Embodiment. (B) is a figure showing the microscope picture which expanded the part enclosed by the ellipse in (a).

  Hereinafter, an embodiment in which a medical device of the present invention is applied to a catheter will be described with reference to the drawings. In all the drawings, the same components are denoted by the same reference numerals, and description thereof will be omitted as appropriate. In the present specification, the “longitudinal section of a medical device” refers to a cross section of a medical device (a catheter in each embodiment) cut through the central axis in parallel with the longitudinal direction. Hereinafter, unless otherwise specified, the longitudinal direction means the longitudinal direction (longitudinal direction) of the medical device, and the radial direction means the thickness direction of the medical device. Further, the “cross section of the medical device” refers to a cross section obtained by cutting the medical device parallel to the radial direction. The same applies to longitudinal sections of a tubular body, a coil layer, an inner layer and the like which are members of the catheter. In the wire, the “cross-sectional shape in the longitudinal section” of the “coiled wire” refers to the cross-sectional shape of the wire in the longitudinal section of the medical device in a state where the wire is wound in a coil shape. On the other hand, a “wire” having a “non-circular cross-sectional shape” means that a long wire before being coiled is cut in the width direction of the wire (a direction orthogonal to the extending direction of the wire). The cross-sectional shape when it is done.

[First Embodiment]
FIG. 1 is a side sectional view of the distal end portion of the tubular main body 10 in the catheter 100 according to the first embodiment. The left side in FIG. 1 corresponds to the distal end side of the catheter, and the right side corresponds to the proximal side (proximal end side). The distal 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 proximal end CE of the catheter 100 is not shown in FIG. FIG. 5 shows an overall view and an operation diagram of the catheter 100 of the present embodiment. Details of FIG. 5 will be described later.

  As shown in FIG. 1, the catheter according to the present embodiment includes a long tubular body 10 having a main lumen 20 therein. Specifically, the tubular body 10 includes an inner layer 11, a coil layer 30, a marker 40, an outer layer 12, a coat layer 50, and a sublumen 80. The inner layer 11 is a tubular layer that defines the main lumen 20 at the innermost periphery of the tubular body 10. That is, the inner layer 11 has a main lumen 20 inside. The coil layer 30 is disposed on the outer periphery of the inner layer 11. The marker 40 is attached in the vicinity of the distal end DE. The outer layer 12 is a layer that covers the entire outer periphery of the inner layer 11 including the coil layer 30 and the marker 40. The coat layer 50 is formed on the outer periphery of the outer layer 12. The sub-lumen 80 (first sub-lumen 80a, second sub-lumen 80b) is formed on the outer periphery of the main lumen 20, and the operation line 70 (first operation line 70a, second operation line 70b) is inserted therethrough.

  Hereinafter, the structure of the catheter 100 of this embodiment is demonstrated concretely. As shown in FIG. 1, the tubular body 10 of the catheter 100 according to the present embodiment has 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. doing. The tubular body 10 that is the body of the catheter 100 including the inner layer 11 and the outer layer 12 is called a sheath. Further, the inner layer 11 or the outer layer 12 may be formed of one layer, or may be formed as a multilayer structure formed of two or more kinds of different or similar materials.

  In the present embodiment, the coil layer 30 has a plurality of (specifically, four) wires 31 each having a non-circular cross-sectional shape that are closely attached to each other in the longitudinal direction and wound in multiple strips (multi-strand winding). It is formed by doing. As shown in FIG. 1, the coil layer 30 formed in this way has an outer side 32 corresponding to the outer diameter side of the catheter 100 parallel to the longitudinal direction in the cross-sectional shape of the wire 31 in the longitudinal section of the coil layer 30. In addition, the inner side 33 corresponding to the inner diameter side has an arc shape, and the center thickness direction of the cross-sectional shape is inclined obliquely with respect to the longitudinal direction. The center thickness direction of the cross-sectional shape of the wire 31 in the longitudinal section of the coil layer 30 is a straight line or a curve drawn by continuously connecting the thickness centers (centers of radial dimensions) in the individual cross-sectional shapes of the wires 31 in the longitudinal direction. The extension direction. In the present embodiment, the direction of the arrow W shown in FIG. 2 and FIG. 4 described later corresponds to the center thickness direction of the wire 31. The fact that the central thickness direction is inclined with respect to the longitudinal direction means that the central thickness direction includes both the longitudinal component and the radial component. On the other hand, in the longitudinal section of the coil layer 30, the outer side 32 of the wire 31 is parallel to the longitudinal direction. The outer surface of the coil layer 30 is flat and has a smooth cylindrical shape. The coil layer 30 is disposed on the outer periphery of the inner layer 11 and covered with the outer layer 12, so that the resin material 112 of the outer layer 12 is interposed between the coil layer 30 and the inner layer 11.

  Here, the interface between the outer side 32 of the wire 31 and the outer layer 12 is peeled off, and relative movement in the longitudinal direction of both may be allowed. On the other hand, the inner side 33 inclined in the longitudinal direction is fitted into the resin material 112 of the outer layer 12 interposed between the inner layer 11 and the coil layer 30, so that the inner side 33 has an anchor effect on the outer layer 12. Play. In the cross-sectional shape of the wire 31 of this embodiment, the width dimension corresponding to the major axis dimension refers to the dimension of the wire 31 in the center thickness direction. The width dimension of the wire 31 is longer than the thickness dimension corresponding to the minor axis dimension. The ratio of the width dimension to the thickness dimension, ie, the width dimension when the thickness dimension is 1, is preferably 1.1 or more, 5 or less, more preferably 1.5 or more and 4 or less, and further preferably 2 or more and 4 or less. The actual width of the wire 31 is 1 mm or less, preferably 0.5 mm.

  More specifically, the cross-sectional shape of the wire 31 of this embodiment is a partial oval shape obtained by cutting an oval shape at the outer side 32. Both sides in the width direction of the cross section of the wire 31 have an arc shape protruding outward. The cross-sectional shape of the wire 31 is not particularly limited as long as it is a non-circular shape including the flat outer side 32. The fact that the outer side 32 is flat means that the curvature of the outer side 32 is significantly smaller than the other side in addition to the case where the outer side 32 is substantially linear. The side shape other than the outer side 32 may be an arc shape, may include a straight line portion, and may include a corner portion. That is, the cross-sectional shape of the wire 31 may be a curved shape including an arc portion such as a partial circle, a partial oval, or a partial ellipse, or a rectangle, trapezoid, rhombus, parallelogram, convex polygon, concave polygon, or the like. The linear shape may be used. More specifically, a trapezoid, a triangle, or a pentagon obtained by cutting a square or a rectangle with a line segment may be used. This non-circular cross-sectional shape may have a long side and a short side having different lengths assuming a rectangle having a minimum area circumscribing the non-circular cross-sectional shape. Hereinafter, the cross-sectional shape of the wire 31 may be referred to as the cross-sectional shape of the wire 31 without particularly distinguishing the cross-sectional shape of the wire 31 from the vertical cross-sectional shape of the coil layer 30.

  By using such a wire 31 and grinding the outer side 32 of each wire 31, that is, the outer surface of the coil layer 30, in the manufacturing process described later, as described above, the outer surface has a flat cylindrical shape. In addition, the coil layer 30 in which the inner side 33 in the cross-sectional shape of each wire 31 is inclined with respect to the longitudinal direction can be obtained. Further, as shown in the enlarged view of FIG. 2, the inner side 33 of the cross-sectional shape of each adjacent wire 31 is inclined in the same direction with respect to the longitudinal direction, and the thickness of the cross-sectional shape is inclined. It is gradually formed thicker in the direction. That is, each winding of the wire 31 has a minimum thickness a on the distal end DE side in the cross-sectional shape, and gradually becomes thicker from the distal side to the proximal side, and the thickness b on the proximal end CE side is the maximum. It becomes. Moreover, it is preferable that the inclination angle of the said wire 31 of the inner side 33 is 45 degrees or less with respect to a longitudinal direction. By setting the inclination angle to 45 degrees or less, good insertion into the outer layer 12 interposed between the inner layer 11 and the coil layer 30 is possible, and the rigidity of the catheter 100 is not increased excessively. Does not hinder flexibility and flexibility. In the present embodiment, the inner side 33 in the cross-sectional shape of the wire 31 is inclined about 20 degrees with respect to the longitudinal direction.

  Here, the inclination and the inclination angle referred to in the present invention will be described. In patent document 1, when winding a flat wire, it winds so that the inner side of a wire may become parallel with respect to the longitudinal direction of a catheter. On the other hand, in the present invention, the coil layer 30 is formed by winding the wire 31 so that the inner side 33 of the wire 31 intersects at a predetermined angle without being parallel to the longitudinal direction. Therefore, in the cross-sectional shape of the wire 31, the inner side 33 is disposed so as to intersect (tilt) with respect to the longitudinal direction. The inclination angle of the wire 31 when the inner side 33 is arcuate as in this embodiment refers to the central thickness direction (arrow W in FIG. 2) of the wire 31 in the longitudinal section of the coil layer 30 and the longitudinal direction of the catheter 100. The angle at which When the inner side 33 of the wire 31 is linear, the angle at which the inner side 33 intersects the longitudinal direction of the catheter 100 is referred to as the inclination angle of the wire 31.

  In the coil layer 30 of the present embodiment, adjacent wires 31 are in close contact with each other, as shown in FIG. As shown in FIG. 2, in the longitudinal section of the coil layer 30, arc-shaped ends are formed on both sides of the wire 31 in the width direction (that is, the distal side and the proximal side in the longitudinal direction). Between adjacent wires 31, part of the arc-shaped end portions overlap each other in the longitudinal direction by a distance c and are in surface contact. Moreover, the position y of the mutual surface contact on both sides of the wire 31 is located between the maximum projecting portions x and x ′ of the arcs on both sides of the wire 31. The surface contact position y is a line segment region where adjacent wires 31 are in contact with each other in the longitudinal section of the coil layer 30. The position y of the surface contact is located between the maximum protrusions x and x ′ means that the maximum protrusions x and x ′ are located on both outer sides (on the end points of this line segment area). Is included).

  As described above, in the present embodiment, the coil layer 30 is closely wound using the multiple wires 31 and the arc-shaped ends of the wires 31 overlap each other. For this reason, when the adjacent wires 31 are relatively rotated and displaced and the coil layer 30 is bent, the wires 31 can be smoothly moved relative to each other while maintaining a close contact state. Therefore, the catheter 100 can be freely bent in a desired direction with a desired curvature.

  The marker 40 is formed by attaching a ring member to the outer periphery of the inner layer 11 near the distal end DE. The marker 40 is made of a radiopaque material. Therefore, by confirming the position of the marker 40 at the distal end DE by X-ray, it is possible to confirm to which position in the patient's body the catheter 100 has been inserted.

  Further, around the outer layer 12 in the vicinity of the distal end DE of the tubular body 10, a hydrophilic coat layer 50 having a lubrication treatment applied to the outer surface is provided as the outermost layer of the tubular body 10. The coat layer 50 may be provided arbitrarily. For example, if the outer layer 12 is excellent in lubricity and hydrophilicity, the coat layer 50 may not be provided.

  The sub-lumen 80 (first sub-lumen 80a, second sub-lumen 80b) through which the operation line 70 (first operation line 70a, second operation line 70b) is inserted is piped inside the outer layer 12, as shown in FIG. It is formed by embedding a member. Also. By providing the main lumen 20 away from the outer diameter direction, it is possible to prevent these from leaking into the sub-lumen 80 when a medicine or the like is supplied through the main lumen 20 or an optical system is inserted. it can. Then, by providing the sub-lumen 80 on the outer side of the coil layer 30 as in the present embodiment, the inner side of the coil layer 30, that is, the main lumen 20 is protected against the sliding operation line 70. Further, the tip (distal end) 71 (71a, 71b) of the operation line 70 is connected to the marker 40 as shown in FIG. However, the present invention is not limited to this, and the operation line 70 may be fixed to a portion other than the marker 40 at the distal end DE, for example, the outer layer 12, or the operation line 70 may be formed by caulking the marker 40. It may be fixed.

  Here, as shown in FIG. 5, the distal end 15 of the catheter 100 refers to a range of a predetermined length including the distal end DE (tip) of the catheter 100. The distal end DE of the catheter 100 is also the distal end of the tubular body 10. Further, the proximal end portion 16 of the catheter 100 refers to a range of a predetermined length including the proximal end CE of the catheter 100. Similarly, the distal end of the tubular body 10 refers to a range of a predetermined length including the distal end DE, and the proximal end of the tubular body 10 includes the proximal end PE of the tubular body 10. A range of a predetermined length.

  As shown in each drawing of FIG. 5, the operation unit 60 is connected to the proximal end CE of the catheter 100 and has a shaft portion 61 extending in the longitudinal direction and a slider that advances and retreats in the longitudinal direction with respect to the shaft portion 61. 64 (for example, the first slider 64a and the second slider 64b), the handle portion 62 that rotates around the shaft portion 61 integrally with the shaft portion 61, and the proximal end portion of the tubular body 10 can rotate around the shaft. And a gripping portion 63 inserted into the. A proximal end portion PE of the tubular body 10 is fixed to the shaft portion 61. By performing an operation of pulling two operation lines 70 (first operation line 70 a and second operation line 70 b) individually or simultaneously on the slider 64 of the operation unit 60, The distal end portion 15 can be bent. Further, for example, the entire tubular body 10 is rotated together with the shaft portion 61 by rotating the handle portion 62 with respect to the grip portion 63 with the other hand while holding the grip portion 63 with one hand. Can be done.

  The sub-lumen 80 of the present embodiment is open at the proximal end PE of the tubular body 10 as shown in each drawing of FIG. In addition, you may open in the distal side rather than the proximal end PE of the tubular main body 10. The operation lines 70 are inserted into the sub-lumens 80, and the operation lines 70 are slidable with respect to the sub-lumens 80.

  The proximal end of the first operation line 70 a is led out from the opening of the first sub-lumen 80 a and is connected to the first slider 64 a of the operation unit 60. Similarly, the proximal end of the second operation line 70 b is led out from the opening of the second sub-lumen 80 b and is connected to the second slider 64 b of the operation unit 60. Then, the first slider 64a and the second slider 64b are individually slid toward the base end side with respect to the shaft portion 61. By this operation, the first operation line 70a or the second operation line 70b connected to each is pulled individually, and a tensile force is applied to the distal end portion 15 of the catheter 100 (that is, the distal end DE of the tubular body 10). It is done. Thereby, the distal end portion 15 is bent toward the pulled operation line 70.

  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), polyvinylidene fluoride (PVDF), or perfluoroalkoxy fluororesin (PFA) can be used. As described above, by using the fluorine-based resin for the inner layer 11, the delivery property when supplying a contrast medium or a drug solution to the affected area through the main lumen 20 of the catheter 100 is improved.

  As a material of the outer layer 12, for example, a thermoplastic polymer can be used. Examples include polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), nylon elastomer, polyurethane (PU), ethylene-vinyl acetate resin (EVA), poly A resin material 112 such as vinyl chloride (PVC) or polypropylene (PP) can be used.

  As a material of the wire 31 of the coil layer 30, it is preferable to use a flat wire made of a metal material, but the present invention is not limited to this, and any material may be used. 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 a material of the marker 40, for example, an X-ray opaque material such as platinum can be used. Moreover, although the marker 40 of this embodiment is ring shape, it is not restricted to this, The other coil arrange | positioned spaced apart from the coil layer 30 in the longitudinal direction may be sufficient.

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

  The sub-lumen 80 is a hole formed along the main lumen 20. The holes formed through the outer layer 12 may be the sublumen 80, or a hollow tube may be inserted into the outer layer 12 and the lumen of the hollow tube may be the sublumen 80. In this embodiment, a hollow tube (see FIG. 2) made of a resin material that is harder and less tacky than the outer layer 12, such as PTFE and polyetheretherketone (PEEK), is inserted into the outer layer 12, and the lumen is Sub-Bremen 80.

  As the material of the operation line 70, when the sub-lumen 80 inserted through the operation line 70 together with the resin material 112 of the outer layer 12 is extruded, the operation line 70 is required to have heat resistance equal to or higher than the melting temperature of the resin material 112. In the case of such an operation line 70, as specific materials, for example, polyether ether ketone (PEEK), polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), polymer fiber such as PI or PTFE, or Metal wires such as stainless steel (SUS), steel wire coated with corrosion resistance, titanium or titanium alloy can be used. On the other hand, when the operation line 70 is not required to have heat resistance, such as when the operation line 70 is inserted into the sub-lumen 80 after the tubular body 10 is molded, in addition to the above materials, PVDF, high-density polyethylene (HDPE) ) Or polyester can also be used. As described above, the material for forming the catheter 100 can be appropriately selected in consideration of cost, ease of manufacture, purpose of use, and the like.

  The catheter 100 of this embodiment is configured by connecting an operation unit (not shown) to the proximal end (PE) of the tubular body 10 having the above-described configuration. The operation unit is connected to the proximal ends of the first and second operation lines 70a and 70b. By pulling the first operation line 70a or the second operation line 70b or both by the operation unit, the tubular body 10 of the catheter 100 can be freely bent in a desired direction from a linear shape. The operation procedure will be described in detail in a second embodiment described later.

  The bending of the catheter 100 means that the catheter 100 is deformed (bent) so that the central axis of the catheter 100 (for example, the central axis of the main lumen 20) is not a straight line (such as a curved line or a polygonal line). .

  Here, typical dimensions of the catheter 100 of the present embodiment will be described. The radius of the main lumen 20 can be about 200 μm to 300 μm. The inner layer 11 can have a thickness of about 10 μm to 30 μm, the outer layer 12 can have a thickness of about 50 μm to 150 μm, the outer diameter of the coil layer 30 can be 500 μm to 860 μm, and the inner diameter of the coil layer 30 can be 420 μm to 660 μm. The radius from the axial center (of the tubular body 10) of the catheter 100 to the center of the sublumen 80 can be about 300 μm to 450 μm, and the inner diameter of the sublumen 80 can be 40 μm to 100 μm. The thickness of the operation line 70 can be set to 30 μm to 60 μm. The outermost radius including the coat layer 50 from the axis of the catheter 100 (of the tubular body 10) can be about 350 μm to 490 μm.

  That is, the outer diameter of the catheter 100 of this embodiment is less than 1 mm in diameter, and can be inserted into blood vessels such as the celiac artery. In addition, the catheter 100 of the present embodiment can enter the catheter 100 in a desired direction even in a branching blood vessel, for example.

  Next, an example of a method for manufacturing the catheter 100 of the present embodiment having the above-described configuration will be described. In the method of manufacturing the catheter 100 of the present embodiment, the step of forming the coil layer 30 by winding the wire 31 having a non-circular cross-sectional shape in a coil shape in the longitudinal direction (hereinafter referred to as “coil layer forming step”). At least. More specifically, the method of manufacturing the catheter 100 includes, for example, a step of forming the inner layer 11 with the resin material 111 on the outer periphery of the core wire (hereinafter referred to as an “inner layer forming step”), and an outer peripheral surface of the inner layer 11 as described above. A coil layer forming step of forming the coil layer 30, a step of grinding and smoothing the outer surface of the coil layer 30 (hereinafter referred to as “grinding step”), and an outer periphery of the inner layer 11 in the vicinity of the distal end DE. A step of mounting the marker 40 (hereinafter referred to as “marker mounting step”), a step of forming the outer layer 12 from the resin material 112 and forming the tubular body 10 (hereinafter referred to as “outer layer forming step”), Have In the present embodiment, a step of forming the coat layer 50 around the outer layer 12 (hereinafter referred to as “coat layer forming step”), a step of connecting the operation unit 60 (hereinafter referred to as “operation unit connection step”) And so on). The catheter 100 of this embodiment is manufactured by a manufacturing method including such steps. Hereinafter, each step will be described in detail.

  In the inner layer forming step, the inner layer 11 is formed by extruding the resin material 111 as described above or forming a dispersion coating on a cylindrical mandrel (core wire) (not shown) that is optionally mold-released on the surface as a core wire. To do.

  In the coil layer forming step, (i) a method of forming the coil layer 30 by winding the wire 31 around the surface of the inner layer 11 (surface lamination method) or (ii) spirally winding the wire 31 to form the coil layer 30 in advance. A method (individual creation method) in which a core wire covered with the inner layer 11 is inserted into the coil layer 30 in advance can be employed. In this embodiment, the individual creation method of (ii) is illustrated. Specifically, first, a plurality of wires 31 are wound around the surface of the coil core wire by using a winding machine. This coil core wire is separate from the core wire (mandrel) covered with the inner layer 11. In forming the coil layer 30, the wire 31 may be set in a winding machine at an angle at which the inner side 33 inclines obliquely with respect to the longitudinal direction in the cross-sectional shape of the wire 31, and multiple windings may be performed. The coil layer 30 may be composed of a single multi-strand coil formed by a single winding process of the winding machine, or a plurality of multiple coils formed by a multiple winding process of the winding machine. You may comprise a strip coil by connecting with each other in the axial direction. Furthermore, the coil layer 30 may be configured by arranging a plurality of multi-strip coils side by side in the axial direction without being connected to each other.

  The coil layer 30 thus molded is subjected to the above grinding step to smoothly process the outer surface of the coil layer 30. The grinding process will be described in detail later. After washing the coil layer 30 after the grinding step, the core wire covered with the inner layer 11 is loosely inserted, and the outer layer forming step is further performed. In the outer layer forming step, the outer layer 12 is formed in the same layer as the coil layer 30 so as to include the surface of the coil layer 30 and the wire 31. In the outer layer forming step, a resin tube having an inner diameter larger than the surface of the coil layer 30 is preliminarily molded, and then the resin tube is mounted on the coil layer 30 and is compressed by the compressive force resulting from the heat shrinkage of the heat shrinkable tube. Molded in one piece. At this time, the wire 31 may be fitted into the inner layer 11 by slightly contracting the coil layer 30 in the radial direction. As described above, in the present embodiment, the coil layer 30 is ground in advance and is then applied to the inner layer 11 to be integrated. Thereby, the shavings generated in the grinding process and the grinding liquid used in the grinding process do not come into contact with the inner layer 11. For this reason, the inner layer 11 can be kept clean.

  In the above description, the coil layer 30 is formed by spirally winding the wire 31 and then the grinding process is performed on the coil layer 30. However, the method for manufacturing the catheter 100 of the present invention is not limited to this. A non-circular cross-section wire 31 having a flat outer side 32 and an inclined inner side 33 as illustrated in FIG. 2 is prepared in advance, and the outer surface of the coil layer 30 is flattened using a winding device. The coil layer 30 may be formed by winding the wire 31 as described above.

  When the wire 31 is inclined and wound in multiple lines, the wire 31 that starts winding first is referred to as a first winding wire, and the wire 31 that starts winding thereafter is referred to as a subsequent winding wire. It is good to wind while pressing against the wire.

  Further, the wire 31 of the present embodiment has a warped shape in which the center of the width in the cross-sectional shape protrudes in the inner diameter direction and the both sides of the width are directed outward after the coil layer forming step and before the grinding step ( Not shown). Therefore, after the grinding process, as shown in the enlarged views of FIGS. 1 and 2, the width center of the inner side 33 in the cross-sectional shape of the wire 31 protrudes in the inner diameter direction, and both sides of the width incline toward the outer side. It has a warped shape. The outer side 32 is flat. As a method for forming such a warped shape, (i) a method in which a wire 31 previously formed in the shape is prepared and wound into a coil shape, and (ii) coil winding around a flat wire 31 A method of applying stress sometimes and deforming it into a bow or oval can be typically employed.

  In the grinding process, the outer side 32 of each wire 31 of the coil layer 30 is ground using a grinding device. After removing the coil core wire from the coil layer 30, the outer surface of the coil layer 30 may be ground and flattened using a coreless grinder (centerless grinder), or the coil core wire is inserted into the coil layer 30. In this state, the outer surface of the coil layer 30 may be ground and flattened by a cylindrical grinder while rotating the coil core wire. When the outer surface of the coil layer 30 is flattened, the outer side 32 of the wire 31 is ground parallel to the longitudinal direction so that the outer appearance of the coil layer 30 is smooth and the outer diameter is within a predetermined length region. It is good to make it substantially the same. Alternatively, the coil layer 30 may be ground in a tapered shape so that the outer diameter gradually increases from the distal side to the proximal side in the longitudinal direction. Furthermore, in this embodiment, as shown in FIG. 2, it grinds so that the outer side 32 may be located outside in radial direction rather than the position y of mutual surface contact of the adjacent wire 31.

  In the marker mounting process, the marker 40 made of the above-described material is mounted on the outer periphery of the inner layer 11 and on the distal end DE side with respect to the coil layer 30. The time sequence between the marker attaching step and the outer layer forming step is arbitrary, and the marker 40 attached to the distal end DE of the catheter 100 may be embedded in the outer layer 12, or the marker 40 may be placed on the surface of the outer layer 12. It may be attached by caulking.

  In the outer layer forming step, the outer layer 12 is formed using the resin material 112 as described above on the entire outer periphery of the inner layer 11 including the coil layer 30 and the marker 40. The outer layer 12 may be formed by extruding the resin material 112 on the outer periphery of the inner layer 11. Alternatively, a tubular outer layer 12 having an inner diameter larger than the outer diameter of the inner layer 11 is formed in advance with the resin material 112, and the outer layer 12 is attached to the outer periphery of the inner layer 11. Further, the inner layer 11 and the outer layer 12 may be brought into close contact with each other by attaching a heat shrinkable tube (not shown) to the outer periphery of the tube and heating the heat shrinkable tube to cause heat shrinkage. Thereafter, the heat shrink tube is removed. By using such a method, the outer layer 12 can be easily formed. In any method, the resin material 112 of the outer layer 12 melts and flows between the coil layer 30 and the inner layer 11 and solidifies so that the inner layer 11 and the outer layer 12 are in good contact with each other, and the interfacial separation is good. Can be prevented.

  On the other hand, the inner side 33 of the wire 31 is arcuate, and the rear winding wire is wound by pressing the first winding wire inward in the inclination direction, so that the oblique inclination in the center thickness direction of the inner side 33 is maintained. Is done. Therefore, since the wire 31 of the coil layer 30 is satisfactorily fitted into the resin material 112 of the outer layer 12 that has flowed between the coil layer 30 and the inner layer 11 and solidified, and exerts an anchor effect, the action of a strong pulling force The adhesion between the coil layer 30 and the layer made of the resin material 112 of the outer layer 12 is improved. Therefore, it is possible to satisfactorily prevent interface peeling between the coil layer 30 and a part of the outer layer 12 disposed on the inner side and the inner layer 11 that is in close contact with the outer layer 12. Further, since the outer surface of the coil layer 30 has a smooth cylindrical shape, the outer surface of the coil layer 30 is restrained from moving forward and backward in the axial direction while maintaining the adhesion to the outer layer 12. It becomes difficult. Therefore, the coil layer 30 has good mobility in the longitudinal direction and can be bent freely. The inner layer forming step and the outer layer forming step are not limited to the above methods, and any other method may be used.

  Further, in the outer layer forming step, the sub-lumen 80 (first sub-lumen 80a, second sub-lumen 80b) made of a pipe member is extruded on the outer periphery of the coil layer 30 together with the resin material 112 of the outer layer 12 to form the outer layer. The sub-lumen 80 (80a, 80b) may be provided in 12. Then, the operation line 70 (70a, 70b) may be inserted into the sub-lumen 80 (80a, 80b), and the tip 71 (71a, 71b) may be fixed to the marker 40, respectively. Alternatively, it may be extruded to the outer periphery of the coil layer 30 together with the outer layer 12 in a state where the operation line 70 is inserted into the sub-lumen 80.

  Finally, the mandrel is pulled out from the inner layer 11. At this time, if necessary, the mandrel is reduced in diameter by pulling both ends of the mandrel in opposite directions. By such a process, the tubular body 10 including the main lumen 20, the inner layer 11, the outer layer 12, the coil layer 30, the marker 40, the coat layer 50, and the sublumen 80 through which the operation line 70 is inserted is obtained. be able to. And the catheter 100 of this embodiment can be manufactured by assembling this tubular main body 10 and the operation part 60.

  FIG. 6 shows a conceptual diagram in which the wire 31 operates freely. FIG. 6A is a conceptual diagram showing a linear state before bending. FIG. 6B is a conceptual diagram showing a state where the coil layer 30 is bent upward in the drawing, that is, a state where the outer surface is bent inward and the inner side is bent outward. FIG. 6C is a concept showing a state where the coil layer 30 is bent downward in the drawing, that is, a state where the outer surface is bent outward and the inner side is bent inward. In any case, since the cross-sectional shape of the adjacent windings of the wire 31 is in point contact, it can be freely bent like a joint in the outer direction or in the inner direction.

  FIG. 7A shows a micrograph (image diagram) of a longitudinal section of a wire corresponding to the coil layer 30 as a reference. As shown in the micrograph, the coil layer 30 has four wires 31 having a non-circular cross-sectional shape wound in a dense manner. FIG. 7B is an enlarged view of FIG. The outer side 32 of the wire 31 in the longitudinal section is linear, but the inner side 33 is arcuate, and the central thickness direction of the cross-sectional shape of the inner side 33 is oblique to the longitudinal direction (the horizontal direction in the figure). Inclined. In this longitudinal section, adjacent wires 31 are in point contact with each other at position y. The point contact position y is located between the maximum protrusions x and x ′ of the arcs on both sides of the wire 31.

  Next, operation | movement of the catheter 100 which concerns on this embodiment is demonstrated using FIG. First, the catheter 100 of this embodiment is inserted into a body cavity such as a blood vessel of a patient. In the present embodiment, the first sub-lumen 80a and the second sub-lumen 80b are formed to face each other by 180 degrees with the axis of the catheter 100 interposed therebetween. The first operation line 70a is inserted into the first sub-lumen 80a, and the second operation line 70b is inserted into the second sub-lumen 80b so that the tip can be bent freely. Therefore, the catheter 100 can be actively inserted into the patient's body while operating the operation line 70 without requiring a guide wire or the like.

  Here, in the catheter 100 of the present embodiment, when the first slider 64a of the operation unit 60 is operated and the first operation line 70a is pulled proximally, as shown in FIG. The end 15 is bent upward in the drawing of FIG. Further, when this pulling amount is increased, the distal end portion 15 of the catheter 100 bends with a large curvature upward in the plane of FIG. 5 as shown in FIG.

  When the second slider 64b of the operation unit 60 is operated and the second operation line 70b is pulled proximally, the distal end portion 15 of the catheter 100 is moved as shown in FIG. Bends downward on the page. Further, when this pulling amount is increased, the distal end portion 15 of the catheter 100 bends with a large curvature downward in the drawing of FIG. 5 as shown in FIG. In addition, in the catheter 100 of this embodiment, as shown to FIG.5 (c), (e), it is preferable that the bending angle of the distal end part 15 exceeds 90 degree | times. Thereby, even if it is a case where the branch angle of a blood vessel is an acute angle which makes a U-turn, the catheter 100 can be advanced with respect to this branch branch.

  Note that when the first operation line 70a and the second operation line 70b are pulled together, the pulling amounts may be different from each other. That is, when a desired curvature is not achieved even if any of the operation lines 70 is pulled individually, the curvature may be adjusted by pulling both the operation lines 70. More specifically, either one of the operation lines 70 is pulled from a state where the distal end portion 15 is bent by pulling any one of the operation lines 70. By this operation, an operation for reducing the amount of bending of the distal end portion 15 and an operation for returning the posture of the distal end portion 15 from the bent state to the original linear posture can be performed. In this way, the bending amount can be finely adjusted by the operation of reducing the bending amount.

  Further, in a state where the distal end portion 15 of the catheter 100 is bent, the grasping portion 63 of the operation unit 60 is grasped with one hand, and the handle portion 62 is rotated with respect to the grasping portion 63 with the other hand. . By this operation, the entire catheter 100 is rotated together with the shaft portion 61 by a maximum of 90 degrees, and the operator changes the bending direction of the distal end portion 15 of the catheter 100 to a desired direction and opposes the distal end DE to the affected portion. Can be made. In this embodiment, since the wire 31 is wound around the main lumen 20, the torsional rigidity of the tubular body 10 is increased. Therefore, the torque transmission efficiency during the rotation operation of the catheter 100 is increased, and the rotational response of the distal end portion 15 to the rotation operation is improved. Furthermore, since the tip position can be clearly confirmed with the marker 40, the operation can be performed while easily confirming the current position and orientation of the distal end DE.

  In the catheter 100 according to the present embodiment, the wire 31 is tightly wound around the main lumen 20 to form the coil layer 30 having elasticity. Therefore, when the catheter 100 is bent by an operation on the operation line 70, an external force is applied to the coil layer 30 to bend its axial direction. However, the coil layer 30 tries to resist the external force by its elastic repulsive force. Therefore, the catheter 100 can be bent with a large curvature while suppressing the sharp bending of the catheter 100. Therefore, since the sharp bending of the main lumen 20 can be suppressed and a good restoring force can be obtained, the kink resistance is improved and excellent flexibility is obtained. Thereby, since the cross-sectional area of the lumen of the main lumen 20 can be maintained at a sufficient size, it is possible to suitably carry out supply of medicines and the like through the main lumen 20 and insertion of the optical system.

  As described above, in the present embodiment, in the coil layer 30, the cross-sectional shape of the wire 31 in the longitudinal section is inclined obliquely with respect to the longitudinal direction. Therefore, the inner side 33 of the wire 31 can be fitted into the base layer (outer layer 12) located on the inner diameter side. Therefore, the adhesion between the outer layer 12 and the coil layer 30 is improved by the anchor effect of the coil layer 30. For this reason, even if a strong resistance acts in the longitudinal direction when the catheter 100 is inserted and removed, it is possible to satisfactorily prevent a decrease in adhesion between the outer layer 12 and the coil layer 30 and interface peeling. On the other hand, since the outer surface of the coil layer 30 is smooth, the operation of the coil layer 30 in the longitudinal direction is not restricted by the outer layer 12.

  That is, according to the present embodiment, the outer side 32 of the wire 31 can slide with respect to the outer layer 12 with a minute displacement, so that the coil layer 30 is flexibly bent. Therefore, when torque is applied to the proximal end CE of the catheter 100 inserted into the bent body cavity, the distal end DE of the catheter 100 rotates well. In other words, the rotational resistance when the catheter 100 is bent is reduced. On the other hand, the inner side 33 of the wire 31 is well anchored to the outer layer 12. Therefore, when the catheter 100 is removed from the body cavity, the wire 31 is restricted from moving relative to the outer layer 12 beyond the fine displacement. For this reason, even when the catheter 100 is removed from the bent body cavity, the outer layer 12 and the coil layer 30 do not peel off.

[Second Embodiment]
Next, the catheter according to the second embodiment will be described with reference to FIGS. 3 and 4. As shown in the enlarged views of FIGS. 3 and 4, the catheter 200 of the present embodiment has a coil layer 230 fitted into the inner layer 211, and the outer surface is smoothly ground substantially flush with the surface of the inner layer 211. The configuration is almost the same as that of the catheter 100 according to the first embodiment except that the adjacent wires 231 are in point contact with each other and the outer surface of the coil layer 230 is in close contact with the outer layer 212. As shown in FIGS. 3 and 4, the catheter 200 of the present embodiment includes an inner layer 211 made of a resin material 2111, a coil layer 230 formed by winding a wire 231 having both ends of an arc shape, and a resin material 2112. Sublayer 280 (first sublumen 280a, second sublumen 280b) through which the outer layer 212, the marker 240, the coat layer 250, and the operation lines 270 (first operation line 270a, second operation line 270b) are inserted. ), And an operation portion (not shown) that is connected to the proximal end portion PE of the tubular body 210 and operates the operation line 270.

  In addition, since the outer side 232 of the coil layer 230 is linear in the cross-sectional shape of the wire 231 in the longitudinal section, the outer appearance of the coil layer 230 is a cylindrical shape having substantially the same outer diameter and a smooth outer surface. Further, the inner side 233 in the cross-sectional shape of the wire 231 has an arc shape, and is wound so that the center thickness direction (arrow W in FIG. 4) is inclined with respect to the longitudinal direction and is fitted into the inner layer 211. . As for the manufacturing method, the outer surface of the coil layer 230 (outer side 232 of the wire 231) is substantially flush with the outer peripheral surface of the inner layer 211 and is ground to the point contact position y in the grinding step. Except for this, since it is the same as that of the first embodiment, a duplicate description is omitted. The position y of point contact with each other on both sides of the wire 231 exists inside the winding diameter with respect to at least one of the maximum protrusions x and x ′ of the arcs on both sides of the wire 231. 3 and 4 are cross-sectional views and are expressed as being in point contact, but actually, since point contact is continuous in the circumferential direction, adjacent wires 231 are mutually connected. Line contact. Also in the coil layer 230 of the present embodiment, since the post-winding wire is wound by pressing the pre-winding wire inward in the inclination direction, the inclination of the inner side 233 of the coil layer 230 is maintained, and the wire to the inner layer 211 is retained. 231 can be inserted well.

  As described above, in the catheter 200 of this embodiment, since the grinding is performed up to the point contact (line contact) position y, the coil layer 230 can be made thinner and the flexibility can be improved. The coil layer 230 can be easily inserted into the formed inner layer 211. Further, the inner side 233 of the cross-sectional shape of the wire 231 in the longitudinal section of the coil layer 230 is inclined obliquely with respect to the longitudinal direction, and is fitted into the inner layer 211 in a wedge shape to exert an anchor effect. Interfacial peeling with the inner layer 211 disposed on the substrate can be prevented. On the other hand, by inserting the coil layer 230 into the inner layer 211, the resin material 2112 of the outer layer 212 is less likely to enter between the wire 231 and the inner layer 211. The smooth outer surface of the coil layer 230 does not fit into the inner side of the outer layer 212, and the inner and outer surfaces are in close contact. Therefore, the mobility of the coil layer 230 with respect to the outer layer 212 is further improved, and the coil layer 230 that is softer and more flexible can be obtained. However, as shown in FIG. 3, the resin material 2111 of the inner layer 211 and the resin material 2112 of the outer layer 212 are in close contact with each other at the distal end DE, and the coil layer 230 is fitted into the inner layer 211 and has high adhesion. For this reason, even if the mobility of the coil layer 230 with respect to the outer layer 212 is improved, it is possible to satisfactorily prevent interfacial separation of each layer (the inner layer 211, the coil layer 230, and the outer layer 212). Thus, also in this embodiment, the adhesiveness between the coil layer 230 and the inner layer 211 disposed on the inside thereof is maintained, and the cross-sectional area of the main lumen 220 is sufficiently secured, while having excellent flexibility and durability. The catheter 200 excellent in usability can be obtained.

  The present invention is not limited to the above-described embodiment, and includes various modifications and improvements as long as the object of the present invention is achieved.

  Further, in each of the above embodiments, the coil layer is formed by multiple winding, but as another different modification, even if the coil layer is formed by winding one wire (single winding). Good. Also in this case, it may be wound so that the cross section in the longitudinal direction is in point contact, or may be wound so that adjacent wires are in close contact with each other. Even a catheter having such a coil layer can maintain the adhesiveness between the inner layer and the coil layer, ensure a sufficient cross-sectional area of the main lumen, and have excellent flexibility.

  In each of the above embodiments, an example in which the catheter has two operation lines has been described. However, three or more sublumens through which the operation lines are inserted may be formed on the tubular body. In this case, the bending operation of the catheter can be performed by pulling one or more of these operation lines. In this case, the distal end can be bent in any direction over 360 degrees by individually controlling the pulling lengths of three or more operation lines. As a result, the approach direction of the catheter can be operated only by pulling the operation line by the operation unit without applying a rotation operation to apply a rotational force to the entire catheter and direct the distal end portion in a predetermined direction. Is possible. It is also possible to adopt a configuration in which the catheter has only one operation line. In this case, the distal end bending operation by pulling the operation line and the catheter rotation operation are used in combination. As a result, the distal end portion of the catheter can be bent in an arbitrary bending amount direction and an arbitrary direction. Further, the sublumen may be disposed on the inner side of the coil layer, or may be bent using a guide wire or the like without providing the sublumen or the operation line. Further, although sublumen is formed of a pipe member, a long hole may be formed at the time of forming the outer layer to form sublumen, and an operation line may be inserted into the hole. In addition, a marker may be omitted if it is not necessary.

  Moreover, in each said embodiment, the wire of the coil layer before grinding is the curvature shape in which the both sides of the width direction in the cross-sectional shape of a longitudinal direction turned outward. Therefore, after grinding, the inner side has an arc shape bulging inward in the radial direction. However, the present invention is not limited to this, and may have a warped shape that faces inward on both sides, and may have an arc shape in which the inner side after grinding bulges outward in the radial direction. It may be linear without being. In any case, it is possible to obtain a catheter that is excellent in flexibility while maintaining excellent adhesion between the inner layer and the coil layer and sufficiently securing the cross-sectional area of the main lumen.

  Moreover, in each said embodiment, the outer surface of a coil layer is ground in parallel with the longitudinal direction of a catheter, and the external appearance is a cylindrical shape. However, the present invention is not limited to this, and as long as the coil layer can be freely moved in the longitudinal direction, the coil layer may be slanted in the longitudinal direction and ground to have a tapered shape. In the case of a taper shape, the taper may be a taper having a large diameter on the distal end DE side and gradually decreasing in the proximal end CE direction, or a small diameter on the distal end DE side and gradually increasing in the proximal end CE direction. It may be a taper. Moreover, you may combine a taper shape and a cylindrical shape. In addition, the outer surface of the catheter bend portion, that is, the coil layer portion near the distal end is ground to smooth the outer surface, and the non-bent portion, that is, the vicinity of the proximal end, does not grind the outer surface of the coil layer. You may form in the state in which the outer side in cross-sectional shape inclined diagonally. In this case, in the catheter, the distal end has excellent flexibility without being restricted by the outer layer, and the outer surface near the proximal end can be fitted into the outer layer to improve adhesion. . Furthermore, since both the distal end and the proximal end are excellent in rigidity, unexpected kinking due to a pushing force or the like is prevented, and the catheter can be smoothly advanced to the affected area.

In addition, each of the above-described embodiments and modifications is performed on a catheter, but the present invention is not limited to the catheter, and is used by being inserted into a body cavity such as an endoscope or an ultrasonic instrument. It can also be applied to long medical devices.
Hereinafter, examples of the reference form will be added.
1. A long medical device,
A coil layer in which a wire having a non-circular cross-sectional shape is wound in a coil shape in the longitudinal direction of the medical device,
The outer surface of the coil layer is flat, and
In the cross-sectional shape of the wire in the longitudinal cross-section of the coil layer, (1) the inner side in the case where the inner side in the radial direction of the wire is linear, is inclined obliquely with respect to the longitudinal direction, or (2) A medical device, wherein a central thickness direction of the cross-sectional shape when the inner side of the wire is arcuate is inclined with respect to the longitudinal direction.
2. A plurality of the wires are wound in a coil shape. Medical device as described in.
3. The adjacent wires are closely wound and wound in multiple strips. Medical device as described in.
4). 2. Some of the adjacent wires overlap each other in the longitudinal direction. Medical device as described in.
5. In the longitudinal section of the coil layer, the inner sides of the adjacent wires are inclined obliquely in the same direction with respect to the longitudinal direction, and the radial thickness of each wire gradually increases from the distal side to the proximal side. 2. It is getting bigger. Or 4. Medical device as described in.
6). 1. 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 degrees or less with respect to the longitudinal direction. To 5. The medical device according to any one of the above.
7). 1. Both sides in the width direction of the cross section of the wire have an arc shape protruding outward. To 6. The medical device according to any one of the above.
8). 6. A plurality of the wires are wound in a coil shape. A medical device according to claim 1,
A medical device characterized in that the arc-shaped both sides of the adjacent wires are in point contact with each other.
9. 7. The position of the point contact between adjacent wires is between the maximum protrusions of the arcs on both sides. Medical device as described in.
10. A medical device is a catheter comprising an elongated tubular body having a main lumen therein,
The tubular body is
An inner layer having the main lumen inside;
The coil layer is formed on the outer peripheral surface of the inner layer, and a plurality of the wires are wound in a coil shape,
An outer layer covering the coil layer;
At least one sub-lumen formed on the outer periphery of the main lumen and through which an operation line is inserted;
Having 1. To 9. The medical device according to any one of the above.
11. 9. A part of the wire of the coil layer is fitted in the inner layer. Medical device as described in.
12 A method of manufacturing a long medical device,
A step of forming a coil layer by winding a wire having a non-circular cross-sectional shape in a coil shape in the longitudinal direction of the medical device;
Grinding the outer surface of the wire of the coil layer flatly,
In the cross-sectional shape of the wire in the longitudinal cross-section of the coil layer, (1) the inner side in the case where the inner side in the radial direction of the wire is linear, is inclined obliquely with respect to the longitudinal direction, or (2) The coil layer is formed so that the central thickness direction of the cross-sectional shape when the inner side of the wire is arcuate is inclined with respect to the longitudinal direction. Production method.
13. Having a step of winding a plurality of wires in a coil shape;
In the multi-winding step, a part of the inner side of the trailing wire, which is the wire that starts to be wound later, is pressed against the leading wire, which is the wire that starts to be wound, in the inner direction of the winding diameter. 11. Winding while A method for producing a medical device according to claim 1.
14 A method of manufacturing a long medical device,
A step of preparing a non-circular wire including a side having a flat cross-sectional shape, and a step of forming a coil layer by winding the wire in a coil shape in the longitudinal direction of the medical device with the flat side facing outward Have
In the cross-sectional shape of the wire in the longitudinal cross-section of the coil layer, (1) the inner side in the case where the inner side in the radial direction of the wire is linear, is inclined obliquely with respect to the longitudinal direction, or (2) The coil layer is formed so that the central thickness direction of the cross-sectional shape when the inner side of the wire is arcuate is inclined with respect to the longitudinal direction. Production method.

10, 210 Tubular body (sheath)
11, 211 Inner layer 111, 2111 Resin material (inner layer)
12, 212 Outer layer 112, 2112 Resin material (outer layer)
15 distal end 16 proximal end 20, 220 main lumen 30, 230 coil layers 31, 231 wire 32, 232 outer side 33, 233 inner side 40, 240 marker 50, 250 coat layer 60 operation unit 61 shaft unit 62 Handle part 63 Grasping part 64 Slider 70, 270 Operation line 70a, 270a First operation line 70b, 270b Second operation line 71 Tip (distal end)
80, 280 Sub-lumen 80a, 280a First sub-lumen 80b, 280b Second sub-lumen 100, 200 Catheter CE Proximal end DE Distal end PE Proximal end x, x 'Maximum protrusion y of arc (surface contact or Position of point contact)

Claims (10)

A long medical device,
A coil layer in which a wire having a non-circular cross-sectional shape is wound in a coil shape in the longitudinal direction of the medical device,
The outer surface of the coil layer is flat, and
In the cross-sectional shape of the wire in the longitudinal cross-section of the coil layer, (1) the inner side in the case where the inner side in the radial direction of the wire is linear, is inclined obliquely with respect to the longitudinal direction, or (2) The central thickness direction of the cross-sectional shape when the inner side of the wire is arcuate is inclined obliquely with respect to the longitudinal direction ,
A plurality of wires are wound in a coil shape,
The adjacent wires are in close contact with each other and wound multiple times,
A medical device characterized in that a part of the adjacent wires overlaps each other in the longitudinal direction . In the longitudinal section of the coil layer, the inner sides of the adjacent wires are inclined obliquely in the same direction with respect to the longitudinal direction, and the radial thickness of each wire gradually increases from the distal side to the proximal side. The medical device according to claim 1 , wherein the medical device is large. The longer than the width the thickness dimension of the cross section of the wire, to claim 1 or 2 inclination angle of the inner side of the wire in the longitudinal section of the coil layer is not more than 45 degrees to the longitudinal The medical device described. The medical device according to any one of claims 1 to 3 , wherein both sides in the width direction of the cross section of the wire have an arc shape protruding outward. The medical device according to claim 4 , wherein a plurality of the wires are wound in a coil shape.
A medical device characterized in that the arc-shaped both sides of the adjacent wires are in point contact with each other. The medical device according to claim 5 , wherein the position of the point contact between the adjacent wires is between the maximum protrusions of the arcs on both sides. A medical device is a catheter comprising an elongated tubular body having a main lumen therein,
The tubular body is
An inner layer having the main lumen inside;
The coil layer is formed on the outer peripheral surface of the inner layer, and a plurality of the wires are wound in a coil shape,
An outer layer covering the coil layer;
At least one sub-lumen formed on the outer periphery of the main lumen and through which an operation line is inserted;
The medical device according to any one of claims 1 to 6 , comprising: The medical device according to claim 7 , wherein a part of the wire of the coil layer is fitted into the inner layer. A method of manufacturing a long medical device,
A step of forming a coil layer by winding a wire having a non-circular cross-sectional shape in a coil shape in the longitudinal direction of the medical device;
Grinding the outer surface of the wire of the coil layer flatly;
Winding a plurality of wires in a coil shape ,
In the cross-sectional shape of the wire in the longitudinal cross-section of the coil layer, (1) the inner side in the case where the inner side in the radial direction of the wire is linear, is inclined obliquely with respect to the longitudinal direction, or (2) forming the coil layer so that a central thickness direction of the cross-sectional shape when the inner side of the wire is arcuate is inclined with respect to the longitudinal direction ;
In the multi-winding step, a part of the inner side of the trailing wire, which is the wire that starts to be wound later, is pressed against the leading wire, which is the wire that starts to be wound, in the inner direction of the winding diameter. A method of manufacturing a medical device, wherein the medical device is wound while being wound . A method of manufacturing a long medical device,
A step of preparing a non-circular wire including a side having a flat cross-sectional shape, and a step of forming a coil layer by winding the wire in a coil shape in the longitudinal direction of the medical device with the flat side facing outward When,
A step of winding a plurality of the wires in a coil shape ,
In the cross-sectional shape of the wire in the longitudinal cross-section of the coil layer, (1) the inner side in the case where the inner side in the radial direction of the wire is linear, is inclined obliquely with respect to the longitudinal direction, or (2) forming the coil layer so that a central thickness direction of the cross-sectional shape when the inner side of the wire is arcuate is inclined with respect to the longitudinal direction ;
In the multi-winding step, a part of the inner side of the trailing wire, which is the wire that starts to be wound later, is pressed against the leading wire, which is the wire that starts to be wound, in the inner direction of the winding diameter. A method of manufacturing a medical device, wherein the medical device is wound while being wound .