JP5659788B2 - catheter - Google Patents

Description

  The present invention relates to a catheter in which a reinforcing layer is formed on the outer periphery of a lumen, and more particularly, to a catheter formed of a coil in which a reinforcing layer is wound with a plurality of wires.

  In recent years, there has been a catheter in which a reinforcing layer is formed on the outer periphery of a lumen, and in particular, a catheter made of a coiled wire in which a reinforcing layer is a multi-winding of a plurality of wires made of the same material has been disclosed (for example, patents). Reference 1). In the catheter in which such a coil-shaped reinforcing layer is formed, flexible flexibility and kink resistance are realized.

JP 2010-88833 A

  However, in recent years, there has been a demand for the development of products having various characteristics such as a catheter that is excellent not only in flexibility but also in restorability. In the reinforcement layer formed using the wire material of the same material like patent document 1, there existed a subject that it was difficult to meet the request | requirement of giving a catheter various characteristics.

  This invention is made | formed in view of the above subjects, and it aims at providing the catheter provided with various characteristics.

  The catheter of the present invention is a catheter in which a reinforcing layer is formed on the outer periphery of a lumen, and at least a first coil and a second coil made of different materials are wound in multiple lines to form at least a reinforcing layer. Part is formed.

  Therefore, in the catheter of the present invention, the first coil and the second coil are formed of different materials. Therefore, for example, multiple windings of a first coil made of a material excellent in bendability, shape retention at the time of bending, and kink resistance, and a second coil made of a material excellent in resilience due to flexibility If the reinforcing layer is formed, a synergistic effect is exhibited without inhibiting the excellent effect of the coils of each other. As a result, it is possible to obtain a catheter that has both excellent bendability, shape retention at the time of bending, kink resistance, and the effects of contradictory restoring force due to flexibility, and excellent usability.

  In the catheter as described above, at least one of the first coil and the second coil may be made of a metal material.

  In the catheter as described above, the first coil may be made of a metal material, and the second coil may be made of a resin material.

  In the catheter as described above, each of the first coil and the second coil is formed by winding one wire, or at least one of which is formed by winding a plurality of wires. It may be.

  In the catheter as described above, at least one of the first coil and the second coil may be composed of a plurality of wires, and the plurality of wires may be made of the same material.

  In the catheter as described above, at least one of the first coil and the second coil is composed of a plurality of wires, and the plurality of wires are a plurality of different materials, and You may consist of a material different from the material of the wire which comprises the other coil different from a coil.

  Further, in the catheter as described above, an outer layer made of a resin material may be provided on the outer periphery of the reinforcing layer.

  In the catheter as described above, the second coil may be formed of the same resin material as the resin material of the outer layer.

  In the catheter as described above, the second coil made of the same resin material as the outer layer may be integrally coupled to the inner peripheral surface of the outer layer made of the resin material.

  In the catheter as described above, the number of wires constituting the second coil made of a resin material may be smaller than the number of wires constituting the first coil made of a metal material.

  Further, in the catheter as described above, at least the first coil of the reinforcing layer has a plurality of wires wound in multiple strands, and is formed of a resin material on the inner peripheral surface of the outer layer disposed on the outer periphery of the reinforcing layer. A plurality of wires of the first coil are separated from each other in the axial direction in a space separated by the second coil integrally joined to the outer layer. It may be a thing.

  In the catheter as described above, the elastic force of the second coil may be larger than the elastic force of the first coil.

  In the catheter as described above, the first coil may be made of a metal material, and the second coil may be made of a superelastic material.

  In the catheter as described above, at least one of the first coil and the second coil made of a superelastic material may be formed by winding a plurality of wires in multiple strands.

  The various components of the present invention do not necessarily have to be independent of each other. A plurality of components are formed as a single member, and a single component is formed of a plurality of members. It may be that a certain component is a part of another component, a part of a certain component overlaps with a part of another component, or the like.

  In the catheter of the present invention, at least a first coil and a second coil made of different materials are wound in multiple lines to form at least a part of the reinforcing layer. Therefore, by utilizing the characteristics of each material, for example, a catheter that can meet various requirements such as excellent flexibility as well as flexibility can be provided.

It is a typical vertical side view which shows the internal structure of the front-end | tip part of the catheter of 1st embodiment of this invention. FIG. 2 is a cross-sectional front view taken along the line II of FIG. 1, and is a schematic longitudinal front view showing an internal structure of a distal end portion of the catheter. It is a typical vertical side view which shows the internal structure of the base end part of a catheter. It is a schematic diagram which shows the reinforcement layer at the time of curving a catheter. It is a typical vertical side view which shows the internal structure of the front-end | tip part of 2nd embodiment. It is the II-II line section front view of Drawing 5, and is a typical longitudinal section front view showing the internal structure of the tip portion of a catheter. It is a typical vertical side view which shows the internal structure of the front-end | tip part of 3rd embodiment. In 3rd embodiment, it is a typical longitudinal cross-sectional enlarged side view which shows the state which couple | bonded the outer layer and the 2nd coil by heating. It is the III-III line sectional front view of Drawing 7, and is a typical longitudinal section front view showing the internal structure of the tip portion of a catheter. It is a typical vertical side view which shows the internal structure of the front-end | tip part of the catheter of 4th embodiment. It is the IV-IV sectional front view of FIG. 10, Comprising: It is a typical longitudinal front view which shows the internal structure of the front-end | tip part of a catheter.

(First embodiment)
A first embodiment of the present invention will be described below with reference to FIGS. In the present embodiment and the following embodiments, the front, rear, left and right and up and down directions are defined and illustrated as shown. However, this is provided for the sake of convenience in order to briefly explain the relative relationship between the components. Therefore, the direction at the time of manufacture and use of the product which implements the present invention is not limited.

<Configuration of catheter>
Hereinafter, the configuration of the catheter 10 of the present embodiment will be described. The good bent shape retention and kink resistance of the catheter 10 inserted into a body cavity such as a blood vessel, and the restoring force due to flexibility will be described later.

  As shown in FIGS. 1 to 3, the catheter 10 of the present embodiment is a catheter 10 in which a reinforcing layer 50 is formed on the outer periphery of the lumen 21, and includes a first coil 51 and a second coil 52. Are wound in multiple lines to form at least a part of the reinforcing layer 50. The first coil 51 and the second coil 52 are formed of different materials. Here, the first coil 51 and the second coil 52 are wound in multiple lines, and each of the first coil 51 and the second coil 52 composed of one or a plurality of coils is a unit. The first coil 51 and the second coil 52 are spirally wound in a loop shape. In other words, in the catheter 10 of the present embodiment, as a unit, there are 8 (seven) first coils 51 and one (one) second coil 52 wound spirally. The book (Hachijo) is disposed along the axis of the catheter 10.

  More specifically, in the catheter 10 of the present embodiment, the first coil 51 is formed of stainless steel (SUS), which is a metal material, and the second coil 52 is an alloy of nickel and titanium (NiTi alloy). ), For example, Nitinol (registered trademark). In the present embodiment, that the first coil 51 is made of a metal material means that the first coil 51 is usually made of a metal material (non-shape memory alloy). Here, the characteristics of SUS are excellent in rigidity, but since it is easy to yield, its restoring force is poor when it is greatly deformed. For example, when the catheter 10 is bent nearly 90 degrees, if the reinforcing layer 50 made of only SUS is used, the original shape may not be completely restored. In particular, restoration in the body cavity and changing the bending direction can be difficult. On the other hand, as a characteristic of NiTi alloy, it is a so-called superelastic shape memory alloy, which is flexible, but does not yield easily, so it is elastically restored even if it is greatly deformed. Therefore, the catheter 10 bent by the first coil 51 can be satisfactorily restored by the elastic force of the second coil 52, particularly in the body cavity.

  Further, the first coil 51 of the present embodiment is an arrangement in which seven stainless steel wire (wire) first coils 51 are arranged side by side along the axial direction (vertical direction in FIG. 1) of the catheter 10. is there. Further, the second coil 52 of the present embodiment is one in which a single wire made of NiTi alloy is arranged along the axial direction of the catheter 10. The seven first coils 51 and the second coil 52 are each wound in a strip shape. In FIG. 1, the first coil 51 is indicated by a dotted line, and the second coil 52 is indicated by a one-dot chain line. Hereinafter, the axial length of the catheter 10 is referred to as the axial length.

  Further, the catheter 10 of the present embodiment has a cylindrical inner layer 20 in which the lumen 21 is formed on the inner peripheral surface and the reinforcing layer 50 is formed on the outer peripheral surface. As shown in FIG. 3, the first coil 51 and the second coil 52 made of different materials of the reinforcing layer 50 are provided on the outer peripheral surface of the inner layer 20 on the base end side which is at least a part of the entire length. Is tightly wound around. Furthermore, the catheter 10 of the present embodiment has a cylindrical outer layer 64 in which the reinforcing layer 50 is formed on the inner peripheral surface.

  Further, in the catheter 10 of the present embodiment, as shown in FIG. 1, the first coil 51 and the second coil 52 of the reinforcing layer 50 are formed of the outer layer 64 on the distal end side which is at least a part of the entire length. It is wound on the inner peripheral surface.

  In the catheter 10 of the present embodiment, the first coil 51 and the second coil 52 of the reinforcing layer 50 are wound at a predetermined interval on the distal end side. The pitch is several times the wire diameter of the first coil 51 and the second coil 52, and such a winding operation is easy.

  In the catheter 10 of the present invention, more specifically, as shown in FIGS. 1 and 2, an inner layer 20 made of a large-diameter resin tube in which a large-diameter lumen 21 is formed, and at least the inner layer 20 is far from the inner layer 20. At least a pair of small-diameter operating line tubes 30a and 30b located outside at the distal end 15 and slidably inserted into the operation line tubes 30a and 30b, and the distal end is connected to at least the distal end 15 of the catheter 10 Slide operation lines 40a and 40b, and a reinforcing layer 50 in which the inner layer 20 and the operation line tubules 30a and 30b are integrally wound.

  Further, as shown in FIG. 1, the reinforcing layer 50 is wound around the first coil 51 and the second coil 52 at a predetermined interval in order to facilitate bending at the distal end portion 15 of the sheath 16 or the like. It has been turned. As shown in FIG. 3, the first coil 51 and the second coil 52 are tightly wound around the proximal end portion 17 of the sheath 16 in order to improve rigidity. In FIG. 3, only the second coil 52 is indicated by a one-dot chain line.

  The gap between the reinforcing layers 50 located between the inner layer 20 and the outer layer 64 is sealed with a reinforcing resin layer 60 made of resin, thereby forming the sheath 16. The sheath 16 is a flexible tubular body that is inserted into a body cavity through an endoscope or directly, and is inserted into a blood vessel such as a celiac artery and a peripheral blood vessel such as a hepatic artery branch or an internal carotid artery branch. The

  A fluorine-based thermoplastic polymer is widely used for the inner layer 20. As an example, polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), perfluoroalkoxy fluororesin (PFA), or the like can be used. As described above, by using the fluorine-based resin for the inner layer 20, the delivery property when supplying a contrast medium or a drug solution to the affected area through the lumen 21 of the catheter 10 is improved.

  A thermoplastic polymer is widely used for the reinforcing resin layer 60. Examples include polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), nylon elastomer, polyurethane (PU), ethylene-vinyl acetate resin (EVA), poly Vinyl chloride (PVC) or polypropylene (PP) can be used.

  The outer layer 64 is formed of a hydrophilic resin layer that is lubricated on the outer surface as the outermost layer of the catheter 10. For the outer layer 64, a hydrophilic material such as polyvinyl alcohol (PVA) or polyvinyl pyrrolidone can be used.

  In the catheter 10 of the present embodiment, separate operation line capillaries 30a and 30b made of polyetheretherketone (PEEK) or the like are arranged outside the inner layer 20 made of a fluorine coat layer or the like. The first coil 51 and the second coil 52 of the reinforcing layer 50 are wound around the operation wire tubules 30 a and 30 b and the inner layer 20.

  Here, typical dimensions of the sheath 16 of the present embodiment will be exemplified. The outermost diameter of the sheath 16 is less than 1 mm in diameter, specifically about 700 to 900 μm. The inner layer 20 has an inner diameter of about 400 to 600 μm, the reinforcing resin layer 60 has a thickness of about 100 to 150 μm, and the first coil 51 and the second coil 52 have a diameter of 20 to 100 μm. Further, the inner diameters of the operation line thin tubes 30a and 30b are 40 to 100 μm, and the thicknesses of the slide operation lines 40a and 40b are 30 to 60 μm.

  Moreover, in the said embodiment, SUS and NiTi alloy are used as the 1st coil 51 and the 2nd coil 52 of the reinforcement layer 50, respectively. However, the present invention is not limited to this. At least one is preferably a metal material. More preferably, one is a metal material and the other is a resin material. Specifically, as the first coil 51, a corrosion-resistant coated steel wire, a metal wire such as titanium or a titanium alloy may be used. Moreover, in the said embodiment, although the superelastic NiTi alloy is used as the 2nd coil 52, what is necessary is just to have an elastic force, and this invention is not limited to this. For example, as the second coil 52, a nylon resin material, a polyethylene material, or the like may be used. Further, the same kind of resin material as that of the outer layer 64 and the inner layer 20 may be used. Note that the cross-sectional shapes of the first coil 51 and the second coil 52 of the reinforcing layer 50 are not particularly limited, and may be a regular circle, an ellipse, a square, a rectangle, a polygon, or the like. It is a regular round shape.

  The first coil 51 and the second coil 52 may be flat wires or square wires, and the line width of the second coil 52 may be wider than the line width of the first coil 51 (both Not shown). In the present embodiment, the first coil 51 and the second coil 52 are round and have the same width.

  The operation wire thin tubes 30 a and 30 b are held by the reinforcing layer 50 along the outer peripheral surface of the inner layer 20. That is, the operation wire tubules 30a and 30b extend in the longitudinal direction and are embedded inside the reinforcing resin layer 60 and the reinforcement layer 50, and the slide operation wires 40a and 40b are slidably inserted therethrough. .

  Further, a part or all of the operation wire tubules 30a and 30b may be provided spirally with respect to the sheath 16, and may include a circumferential component together with a longitudinal component. Hereinafter, the slide operation line 40a may be referred to as a first slide operation line, and the slide operation line 40b may be referred to as a second slide operation line.

  In the catheter 10 of the present embodiment, as shown in FIG. 2, the pair of operation line capillaries 30 a and 30 b through which the slide operation lines 40 a and 40 b are inserted are arranged to face the periphery of the inner layer 20. . In other words, in the present embodiment, the operation line tubule 30a and the operation line tubule 30b are formed to be opposed to each other by 180 degrees across the axis of the catheter 10. The slide operation line 40a is inserted through the operation line capillary 30a, and the slide operation line 40b is inserted through the operation line capillary 30b.

  The operation wire capillaries 30 a and 30 b can be integrally formed on the outer peripheral surface of the inner layer 20 by being extruded together with a resin material constituting the inner layer 20. As the material of the operation wire tubules 30a and 30b, for example, polyether ether ketone, polysulfone (from the viewpoint of slidability with the slide operation wires 40a and 40b) is superior in heat resistance to the resin material of the reinforcing resin layer 60. Fluoropolymer materials such as PSF), polytetrafluoroethylene (PTFE), and polyvinylidene fluoride (PVDF) can be suitably used.

  The method of inserting the slide operation lines 40a and 40b into the operation line thin tubes 30a and 30b is not particularly limited, and various methods can be employed. For example, the slide operation lines 40a and 40b may be inserted from one end side of the sheath 16 in which the operation line thin tubes 30a and 30b are embedded in advance. Alternatively, the sheath 16 may be formed by extruding the operation line capillaries 30a and 30b into which the slide operation lines 40a and 40b have been inserted in advance together with the resin material of the inner layer 20.

  Specific materials for the slide operation lines 40a and 40b include, for example, polyether ether ketone, polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), polymer fibers such as PI or PTFE, SUS, and corrosion resistance. A coated steel wire, a metal wire such as titanium or a titanium alloy can be used.

  When the slide operation lines 40a and 40b are not required to have heat resistance, such as when the slide operation lines 40a and 40b are inserted into the sheath 16 in which the operation line thin tubes 30a and 30b are embedded in advance, the slide operation lines 40a and 40b In addition to the above materials, polyvinylidene fluoride, high density polyethylene (HDPE), polyester, or the like can be used as the material for the wires 40a and 40b.

  As shown in FIG. 1, the distal end 15 of the sheath 16 is provided with a ring-shaped marker 66 made of a material that does not transmit detection waves such as X-rays. Specifically, a metal material such as platinum or tungsten can be used for the marker 66. The marker 66 of the present embodiment is provided outside the inner layer 20 and inside the outer layer 64.

  Tip portions (distal end portion 15 portions) 41 of the slide operation lines 40 a and 40 b are fixed to the distal end portion 15 of the catheter 10. The aspect which fixes the front-end | tip part 41 of the slide operation lines 40a and 40b to the distal end part 15 is not specifically limited.

  For example, the tip portions 41 of the slide operation lines 40 a and 40 b may be fastened to the marker 66 or welded to the distal end portion 15 of the sheath 16. Alternatively, the marker 66 or the distal end portion 15 of the sheath 16 may be adhered and fixed with an adhesive. In the present embodiment, the tip portions 41 of the slide operation lines 40 a and 40 b are embedded in the resin of the reinforcing resin layer 60.

  The distal end portion 15 of the sheath 16 refers to a predetermined region on the distal end side that is inserted into the body of the subject of the sheath 16. Further, the proximal end portion 17 of the sheath 16 refers to a predetermined region on the end side operated by the operator.

  Similarly, the distal end portion 41 of the slide operation lines 40a and 40b refers to a predetermined area including the distal ends of the slide operation lines 40a and 40b, and the proximal end portions of the slide operation lines 40a and 40b are the slide operation lines 40a and 40b. A predetermined region including the base end of

  The catheter 10 of the present embodiment has a slide operation mechanism (not shown) that manually operates a pair of slide operation lines 40a and 40b drawn from the pair of operation line tubules 30a and 30b in the vicinity of the proximal end portion 17 of the sheath 16. Z).

  In the catheter 10 of the present embodiment, when the first slide operation line 40a or the second slide operation line 40b is pulled, tension is applied to the distal end portion 15 of the sheath 16, and the slide operation line The distal end 15 bends to the side through which 40a and 40b are inserted. Here, the bending of the sheath 16 means that a part or all of the sheath 16 is bent or bent. Kink resistance refers to preventing the sheath 16 from being crushed and the lumen from being blocked when the sheath 16 is bent.

<Performance of catheter>
As described above, the first coil 51 is formed of seven SUSs having excellent rigidity, and the second coil 52 is formed of a single superelastic NiTi alloy having excellent elasticity. The advantages of both can be exhibited. Therefore, the flexible flexibility of the first coil 51 provides shape retention and kink resistance at the time of bending, and the excellent elasticity of the second coil 52 allows for excellent restoring force and usability. A good catheter 10 can be provided. In particular, even when the catheter 10 is largely bent in the body cavity, the original shape can be restored satisfactorily and the bending direction can be changed flexibly and freely.

  Furthermore, in the catheter 10 of the present embodiment, seven first coils 51 and one second coil 52 are wound in multiple lines. Therefore, by forming the first coil 51 and the second coil 52 from materials having different X-ray transmittances, an inter-loop distance P between the second coils 52 separated by the first coil 51 of the seven articles. (See FIG. 1) is non-zero. Further, by observing the inter-loop distance P along the axial direction of the catheter 10, more information on the shape of the catheter 10 can be obtained.

  FIG. 4 is a schematic diagram showing a state in which X-rays are detected at a plurality of detection positions (a) to (c). The catheter 10 is curved upward. Here, even when the detection direction of a detection wave such as an X-ray coincides with the bending direction of the catheter 10 (upward in the drawing), the bending direction of the catheter 10 can be obtained according to the present embodiment. Can do.

  Furthermore, even when the loop of the second coil 52 cannot be observed due to interference with the silhouette of the first coil 51, the catheter 10 can be observed by paying attention to the change in the inter-loop distance P of the second coil 52. The curved shape can be obtained.

  Furthermore, the catheter 10 of the present embodiment has a cylindrical inner layer 20 in which the lumen 21 is formed on the inner peripheral surface and the reinforcing layer 50 is formed on the outer peripheral surface. A plurality of types of the first coil 51 and the second coil 52 of the reinforcing layer 50 are tightly wound on the outer peripheral surface of the inner layer 20 on the base end side which is at least a part of the entire length. For this reason, the proximal end side of the catheter 10 can be firmly reinforced, and insertion into the human body can be facilitated.

  Furthermore, the detection wave may consist of magnetic resonance or may consist of ultrasonic waves. In these cases, of course, the first coil 51 and the second coil 52 are different in the reflectivity and transmittance of magnetism and ultrasonic waves.

  The present invention is not limited to the above-described embodiment, and includes various modifications and improvements as long as the object of the present invention is achieved. For example, in the said form, it illustrated that the operation wire thin tubes 30a and 30b were formed with resin. However, the operation wire thin tube may be formed of a thin tube coil wound with an extremely fine metal wire or resin wire (not shown).

  Moreover, in the said embodiment, it illustrates that the 1st coil 51 comprised from seven (seven strips) wire and the 2nd coil 52 comprised from one (one strip) wire are wound in multiple strips. did. However, the number and cross-sectional shape of such multi-strand windings can be combined in various ways, and the second coil 52 may have a plurality of wires. Further, the wire of the first coil 51 may be one and the wire of the second coil 52 may be plural. Or both the 1st coil 51 and the 2nd coil 52 may be comprised with only one wire, and the number of both wires may be comprised with the same number.

  Moreover, in the said embodiment, it illustrated that the material of the 1st coil 51 and the 2nd coil 52 was different. However, the first coil 51 and the second coil 52 may be formed of the same material. In this case, the surface treatment is different, so the rigidity and elastic force are different, the flexibility is excellent, the flexibility is excellent, the shape retention and the kink resistance during bending are excellent, and further, the elasticity is good. In addition, the catheter 10 having excellent usability and excellent restoring force can be obtained. In addition, the X-ray transmittance and reflectance can be made different so that both can be easily distinguished.

  Furthermore, in the above-described embodiment, the plurality of types of the first coil 51 and the second coil 52 of the reinforcing layer 50 are tightly wound on the outer peripheral surface of the inner layer 20 on the base end side that is at least a part of the entire length. ing. And it illustrated that the 1st coil 51 and the 2nd coil 52 of the reinforcement layer 50 were pitch-wound on the internal peripheral surface of the outer layer 64 by the front end side which is at least one part of full length. However, the first coil 51 and the second coil 52 of the reinforcing layer 50 may be tightly wound on the outer peripheral surface of the inner layer 20 over the entire length, and the first coil 51 and the second coil 52 of the reinforcing layer 50 may be wound over the entire length. The second coil 52 may be pitch-wound on the inner peripheral surface of the outer layer 64. Further, the types of the first coil 51 and the second coil 52 may be different between the proximal end side and the distal end side (not shown).

  In the above embodiment, the slide operation lines 40a and 40b protruding forward from the operation line tubules 30a and 30b are embedded in the resin of the reinforcing resin layer 60 and connected to the distal end portion of the inner layer 20. did. However, at least a part of the distal end side of the operation wire thin tubes 30a and 30b may be formed of a thin tube coil (not shown).

  Such a thin tube coil has a structure in which an extremely fine metal wire or resin wire is wound to have the same diameter as the resin portion of the operation wire thin tubes 30a and 30b, and is formed to have a total length of 20 to 200 mm, for example. In such a catheter (not shown), since the sheath 16 is easily bent at the portion of the thin tube coil, the shape retaining property at the time of bending due to the bending property of the distal end portion 15 of the sheath 16 can be improved. In addition, the sheath 16 can be satisfactorily restored to the original shape such as a linear shape by the restoring force of the NiTi alloy having super elasticity, regardless of the shape of the bending.

  Moreover, in the catheter 10 mentioned above, it assumed that the front-end | tip part of the operation wire thin tubes 30a and 30b was embed | buried under the reinforcement resin layer 60 behind the position where the marker 66 is arrange | positioned. However, the present invention is not limited to this, and the distal end portions of the operation wire tubules 30a and 30b may be embedded in the reinforcing resin layer 60 ahead of the position where the marker 66 is disposed (FIG. Not shown).

  Furthermore, in the said embodiment, it illustrated that the inside of the inner layer 20 opened directly. However, a layer film such as a fluorine coat (PTFE) may be formed on the inner peripheral surface of the inner layer 20 with a layer thickness of 15 μm or the like.

  Moreover, in the said embodiment, it has illustrated that the distal end part 15 of the sheath 16 can be deflected to two directions by having a pair of slide operation line 40a, 40b. However, by disposing the two pairs of slide operation lines 40a and 40b at positions orthogonal to the axis of the catheter 10, the distal end portion 15 of the sheath 16 can be deflected in four directions, up, down, left and right (not shown). ) Also. In the above-described embodiment, two sets of the slide operation line 40a and the operation line capillary 30a and the slide operation line 40b and the operation line capillary 30b are formed to face each other by 180 degrees with the axis of the catheter 10 interposed therebetween. However, the present invention is not limited to this, and three sets of operation lines and operation line tubules may be formed at intervals of 120 degrees, or four or more sets may be formed.

  In the above embodiment, a material having excellent rigidity such as SUS is used as the first coil 51, and a superelastic material such as a NiTi alloy is used as the second coil 52, or a resin having a lower elastic force than the superelastic material is used. An elastic material having a normal elastic force is used. However, the present invention is not limited to this. For example, when the elastic force is important, a superelastic material such as a NiTi alloy or an elastic material such as a resin is used as the first coil 51, and a material having excellent rigidity such as SUS is used as the second coil 52. Good. Even in such a configuration, due to the good rigidity and flexibility of the second coil 52, the flexibility, the shape retention and the kink resistance during bending, and the good elasticity of the first coil 51. Thus, the catheter 10 having excellent resilience and good usability can be obtained. Also, for example, when a super elastic material is used for the coil layer wound inside, and a resin material having a normal elastic force is used for the coil layer wound outside, the resilience of the super elastic material and the flexibility of the resin material Good bending durability can be obtained by a synergistic effect with the property.

  Here, the superelastic material refers to a material that is excellent in ability to restore to its original state when unloaded even if it is deformed under a strong load. As the superelastic material, there are a metal material and a resin material. The superelastic metal material is generally called a shape memory alloy. Shape memory alloys are rich in elastic force and have the property of being restored to a predetermined state set (stored) in advance by elastic restoring force even when various deformations are applied. Specifically, among shape memory alloys, a material having a Young's modulus lower than that of a hard steel wire specified in JIS G3602 and a large yield point strain is preferably used.

  More specifically, Ni—Ti-based shape memory alloys, Cu-based shape memory alloys, Fe-based shape memory alloys, and the like can be used as the shape memory alloy that is a superelastic metal material. Among them, it is more preferable to use a Ni—Ti shape memory alloy that is most easy to handle and excellent in corrosion resistance and biocompatibility. In addition, since Ni-Ti type | mold shape memory alloy and Cu type | mold shape memory alloy belong to the alloy type | system | group which shows a thermoelastic martensitic transformation, compared with Fe type | mold shape memory alloy which does not belong to this alloy type | system | group, The hysteresis width is narrow and suitable for use in the reinforcing layer 50 of the catheter 10.

  The Ni-Ti-based shape memory alloy is most preferably Nitinol (registered trademark) described above, but Ni-Ti-X (X = Fe, Cu, V, Co, etc.) can also be suitably used. As the Cu-based shape memory alloy, a Cu—Zn—X (X = Al, Fe, etc.) alloy or the like can be suitably used.

  Examples of superelastic resin materials include sulfone resins such as polysulfone resin (PSU), polyethersulfone resin (PESU), polyphenylsulfone resin (PPSU), and nylon superelasticity such as grillamide resin. Resins and the like can be suitably used.

(Second embodiment)
A second embodiment of the present invention will be described below with reference to FIGS. 5 and 6. The catheter 10 of the present embodiment is a catheter 10 in which a reinforcing layer 50 is formed on the outer periphery of the lumen 21 as in the first embodiment, and includes a first coil 51 and a second coil 52. Are wound in multiple lines to form at least a part of the reinforcing layer 50. The first coil 51 and the second coil 52 are formed of different materials. In the present embodiment, a third coil 53 formed of a material different from that of the first coil 51 and the second coil 52 is further used. That is, different materials are sandwiched between five first coils 51 (shown by dotted lines in FIG. 5) and one second coil 52 (shown by two-dot chain lines in FIG. 5) made of the same kind of material. The total number of eight wire rods consisting of the two third coils 53 (shown by a one-dot chain line in FIG. 5) as a unit is spirally wound around the outer circumference of the inner layer 20, and the axis of the catheter 10 is A reinforcing layer 50 is disposed along the line. Further, the cross-sectional shapes of the first coil 51, the second coil 52, and the third coil 53 of the reinforcing layer 50 are not particularly limited as in the first embodiment, and may be a regular circle, an ellipse, a square, The shape may be a rectangle, a polygon, or the like, but in the present embodiment, it is a general regular circle.

  Here, the wire made of the same kind of material in this specification is, for example, the wire used for the second coil, which is the wire made of the same SUS, all of the wire used for the first coil 51 is the same. It means that they are made of the same material, such as a wire made of a NiTi alloy. The different material means, for example, that the first coil 51 is configured using a SUS wire and a copper wire. Therefore, it does not mean that one line is formed by joining SUS and copper.

  The first coil 51 and the second coil 52 may be flat wires or square wires, and the line width of the second coil 52 may be wider than the line width of the first coil 51 (both Not shown). In the present embodiment, as in the first embodiment, the first coil 51 and the second coil 52 have a regular circular shape and the same width.

  Further, the catheter 10 of the present embodiment has a cylindrical inner layer 20 in which the lumen 21 is formed on the inner peripheral surface and the reinforcing layer 50 is formed on the outer peripheral surface. Furthermore, the catheter 10 of the present embodiment has a cylindrical outer layer 64 in which the reinforcing layer 50 is formed on the inner peripheral surface. Since the material and operation of each member are the same as those in the first embodiment, detailed description thereof is omitted.

  Further, as shown in FIGS. 5 and 6, the inner layer 20 made of a large-diameter resin tube in which the large-diameter lumen 21 is formed, and at least a pair of small diameters located outside at least the distal end portion 15 of the inner layer 20. Operating line tubules 30a and 30b, and slide operating lines 40a and 40b that are slidably inserted into the operating line tubules 30a and 30b and whose distal ends are connected to at least the distal end portion 15 of the catheter 10. Since these materials, forming methods, and operations are the same as those in the first embodiment, detailed description thereof is omitted.

  Further, as shown in FIG. 5, the reinforcing layer 50 includes a first coil 51, a second coil 52, and a third coil 53 in order to facilitate bending at the distal end portion 15 of the sheath 16. It is wound at a predetermined interval (pitch). Further, although not shown in the proximal end portion 17 of the sheath 16 or the like, even if the first coil 51, the second coil 52, and the third coil 53 are tightly wound in order to improve rigidity. Good.

  The gap between the reinforcing layers 50 located between the inner layer 20 and the outer layer 64 is sealed with a reinforcing resin layer 60 made of resin, thereby forming the sheath 16. Since the action, dimensions, and the like of the sheath 16 are the same as those in the first embodiment, detailed description thereof is omitted.

  As the material of the first coil 51, as in the first embodiment, by using SUS having excellent rigidity, the catheter 10 has good rigidity and flexibility, and is flexible and bent. Retainability and kink resistance are improved. The material of the first coil 51 is not limited to SUS, and other materials may be used as long as they are excellent in rigidity and excellent in flexibility when coiled. Specifically, the same materials as those described in the first embodiment can be used.

  Moreover, as the second coil 52, the elasticity of the catheter 10 is improved and an excellent restoring force is given by using a NiTi alloy having superelasticity as in the first embodiment. . The second coil 52 is not limited to the NiTi alloy, and other materials may be used as long as the second coil 52 has a superelastic force or a normal elastic force and has excellent resilience. Specifically, the same materials as those described in the first embodiment can be used.

  On the other hand, as the third coil 53 disposed with the second coil 52 interposed therebetween, it is preferable to use a resin material or the like having normal elasticity. Specifically, for example, a nylon resin or a polyethylene resin can be used. In particular, it is more preferable to use a material having a lower elastic force than the second coil 52.

  Thus, by interposing the third coil 53 having a lower elastic force than the second coil 52 between the rigid first coil 51 and the second coil 52, the rigid material is gradually removed. It becomes a material with strong elasticity. In addition, the elastic force is gradually weakened from the superelastic material to become a rigid material. Therefore, the third coil 53 serves as a buffer for the contradictory characteristics of flexibility, shape retention and resilience at the time of bending, flexible flexibility due to good flexibility, shape when bending due to rigidity It becomes easy to balance the holding force, the kink resistance, and the restoring force due to good elasticity. And, in use, it is easy to bend, the bent state can be maintained well, and when the bend is released, a catheter 10 with excellent usability that can be restored to its original linear shape is obtained. Can do.

  In the present embodiment, the first coil 51 is formed of a rigid material, the second coil 52 is formed of a superelastic material, and the third coil 53 is formed of a normal elastic material. The present invention is not limited to this. For example, the first coil 51 is formed of a superelastic material, the second coil 52 is formed of a rigid material, and the third coil 53 sandwiching the first coil 51 is less elastic than the first coil 51, The coil 52 may be formed of an intermediate material having a lower rigidity than the coil 52 and may have a cushioning material element. With this configuration, it is possible to obtain the catheter 10 with more excellent elasticity.

(Third embodiment)
A third embodiment of the present invention will be described below with reference to FIGS. Since the basic configuration and operation of the catheter 10 of the present embodiment are the same as those of the first and second embodiments, detailed description thereof is omitted. Hereinafter, differences from the first and second embodiments will be mainly described. In addition, three SUSs as the first coil 51 and one resinous material (details will be described later) as the second coil 52 are wound around the outer periphery of the inner layer 20 in a total of four lines to form the reinforcing layer 50. doing. In FIG. 7, only the second coil 52 made of a resin material is indicated by a dotted line.

  In the first and second embodiments, the first coil 51 and the second coil 52 are exemplified to have the same diameter. However, in the present embodiment, the wire diameter of the second coil 52 is larger than the wire diameter of the first coil 51. The second coil 52 is formed of the same resin material as the resin material forming the outer layer 64, and the inner layer 20 and the second coil 52 are coupled to each other. In the present embodiment, the tip portions 41 of the slide operation lines 40 a and 40 b and the marker 66 are embedded in the resin of the reinforcing resin layer 60.

  Here, the same kind of resin material is not only the same resin material but also different resin materials, the main components are the same, the glass transition temperature and the melting point are the same or almost the same, and they are bonded to each other. It is meant to include things that are easy to do. For example, if both are polyethylene resins, such as one being low-density polyethylene and the other being high-density polyethylene, it is assumed that they are the same kind of resin material. Also, even if both are low density, medium density, or high density polyethylene, they are the same type of resin material even if the additives are different, such as different fillers and catalysts, and the blending ratio of the components is different. And In addition, the same kind of resin, both of which are polyethylene resins, nylon resins, polyvinyl resins, polypropylene resins, polystyrene resins, polyvinyl chloride resins, etc. Material. Moreover, it is set as the resin material of the same kind, whether it is a monomer or a polymer.

  The materials of the outer layer 64 and the second coil 52 are not particularly limited as long as they are of the same type and can be coupled to each other as described above. The outer layer 64 is a lubrication treatment as the outermost layer of the catheter 10. Is preferably a hydrophilic resin layer provided on the outer surface. Therefore, as described in the first embodiment, it is preferable to use a hydrophilic material such as polyvinyl alcohol (PVA) or polyvinyl pyrrolidone as the material of the outer layer 64 and the second coil 52.

  Then, as shown in FIG. 7, the reinforcing layer 50 includes, on the distal end portion 15 side, three first coils 51 and one second coil 52 at predetermined intervals, with multiple intervals through the predetermined intervals. It is wound. Further, at the proximal end portion 17 of the sheath 16 or the like, although not shown, the first coil 51 and the second coil 52 may be tightly wound in order to improve rigidity.

  Further, after the outer layer 64 is disposed or when the outer layer 64 is formed, the second coil 52 is melted and bonded to the outer layer 64 by heating as shown in FIGS. Although the second coil 52 is coupled to the outer layer 64, it is not necessarily coupled to the inner layer 20. However, by combining with the inner layer 20, excessive movement of the first coil 51 in the axial direction can be satisfactorily suppressed as will be described later.

  In this way, by connecting the outer layer 64 and the second coil 52, the movement of the second coil 52 in the axial direction is suppressed. Further, as shown in FIGS. 7, 8, and 9, a gap in which the reinforcing layer 50 formed between the operation line thin tubes 30 a and 30 b and the outer layer 64 is disposed is separated by a second coil 52. A space 70 is formed. In the space 70, the first coil 51 made of two SUSs can move in the axial direction of the lumen 21.

  The catheter 10 of the third embodiment configured as described above has good flexibility when coiled due to the rigidity of the metal first coil 51, and is flexible and bent. Excellent retention and kink resistance. Further, the uniformity of the elastic force of the resinous second coil 52 bonded to the outer layer 64 is maintained, and the restoring force is also excellent. Furthermore, since the first coil 51 can freely move in the axial direction of the lumen 21 in the space 70 separated by the second coil 52, the catheter 10 can be bent more flexibly and finely. In addition, since the second coil 52 is coupled to the outer layer 64 and the space 70 is separated, the first coil 51 is not excessively moved in the axial direction, and can be bent with good balance. Restorability is not impaired. Therefore, the catheter 10 excellent in usability can be provided.

(Fourth embodiment)
A fourth embodiment of the present invention will be described below with reference to FIGS. 10 and 11. Since the basic configuration and operation of the catheter 10 of the present embodiment are the same as those of the first to third embodiments, detailed description thereof is omitted. Hereinafter, differences from the first and second embodiments will be mainly described. In FIG. 10, the first coil 51 is indicated by a dotted line, and the second coil 52 is indicated by a one-dot chain line.

  In each said embodiment, it illustrated that the number of the wire which comprises the 1st coil 51 was larger than the number of the wire which comprises the 2nd coil 52. However, in the present embodiment, the same number of first coils 51 and second coils 52 are used, four (four). The reinforcing layer 50 is disposed along the axial center of the catheter 10 by winding them in a spiral manner on the outer periphery of the inner layer 20 as a unit. Also in the present embodiment, the cross-sectional shapes of the first coil 51 and the second coil 52 of the reinforcing layer 50 are not particularly limited, and may be a regular circle, an ellipse, a square, a rectangle, a polygon, or the like. In this embodiment, it is a general regular circle.

  The first coil 51 and the second coil 52 may be flat wires or square wires, and the line width of the second coil 52 may be wider than the line width of the first coil 51 (both Not shown). In the present embodiment, similarly to the above-described embodiments, the first coil 51 and the second coil 52 have a regular circular shape and the same width.

  Further, the catheter 10 of the present embodiment has a cylindrical inner layer 20 in which the lumen 21 is formed on the inner peripheral surface and the reinforcing layer 50 is formed on the outer peripheral surface. Then, as shown in FIG. 10, the first coil 51 and the second coil 52 made of different materials of the reinforcing layer 50 are on the outer peripheral surface of the inner layer 20 on the base end side which is at least a part of the entire length. Is tightly wound around. Furthermore, the catheter 10 of the present embodiment has a cylindrical outer layer 64 in which the reinforcing layer 50 is formed on the inner peripheral surface. The gap between the reinforcing layers 50 located between the inner layer 20 and the outer layer 64 is sealed with a reinforcing resin layer 60 made of resin. Since the material and action of each member are the same as those in the first and second embodiments, detailed description thereof is omitted.

  In the catheter 10 according to the fourth embodiment configured as described above, the metal first coil 51 has excellent rigidity, flexibility, shape retention, and kink resistance due to the rigidity and flexibility. The resilience of the resin-made second coil 52 is excellent in restoring force. Furthermore, since the first coil 51 and the second coil 52 are formed of the same number of wires and the same diameter, the surface areas of the first coil 51 and the second coil 52 in the reinforcing layer 50 are also the same. With a large area. Therefore, the flexibility, the shape retention during bending, the kink resistance, and the restoring force due to flexibility can be improved in a more balanced manner. Therefore, the catheter 10 excellent in usability can be obtained.

  As described above, in each of the embodiments, the reinforcing layer 50 in which the first coil 51 and the second coil made of different materials are wound in multiple lines, and the first coil 51 and the second coil made of different materials. The reinforcing layer 50 in which 52 and the third coil 53 are wound in multiple lines is described. However, the present invention is not limited to this as long as the catheter 10 having both flexible flexibility and restoring force can be obtained, and there are many wires each constituting four or more coils made of different materials. The wound reinforcing layer 50 may be used. Each coil may be composed of a single wire, or may be composed of a plurality of wires. Moreover, even if it belongs to the same coil in each coil, you may use a different wire different from the wire material of another coil, and also in a coil.

  In each of the above-described embodiments, the operation line capillary tubes 30a and 30b and the slide operation lines 40a and 40b that are slidably inserted into the operation line tubes 30a and 30b and are actively operated. However, the present invention is not limited to this. For example, at least a first coil 51 and a second coil made of different materials are inserted into a catheter 10 that is inserted into a blood vessel so as to follow the guide wire and passively reaches the affected area. You may use the reinforcement layer 50 by which the coil 52 was wound by many strips.

Needless to say, the above-described embodiment and a plurality of modifications can be combined within a range in which the contents do not conflict with each other. Further, in the above-described embodiments and modifications, the structure of each part has been specifically described, but the structure and the like can be changed in various ways within the scope of the present invention.
Hereinafter, examples of the reference form will be added.
1.
A catheter having a reinforcement layer formed on the outer periphery of the lumen;
A catheter in which at least a part of the reinforcing layer is formed by winding at least a first coil and a second coil made of different materials in multiple lines.
2.
At least one of the first coil and the second coil is made of a metal material. The catheter according to 1.
3.
The first coil is made of a metal material,
The second coil is made of a resin material. Or 2. The catheter according to 1.
4).
Each of the first coil and the second coil is formed by winding a single wire, or at least one of which is formed by winding a plurality of wires in multiple lines. Or 3. The catheter according to 1.
5.
3. In the first coil or the second coil, at least one of the coils is composed of a plurality of wires, and the plurality of wires are made of the same material. The catheter according to 1.
6).
In the first coil or the second coil, at least one of the coils is composed of a plurality of wires, and the plurality of wires are a plurality of different materials, and are different from the coils. 3. It is made of a material different from the material of the wire constituting the coil. The catheter according to 1.
7).
1. An outer layer made of a resin material is provided on the outer periphery of the reinforcing layer. To 6. The catheter according to any one of the above.
8).
6. The second coil is formed of the same resin material as the resin material of the outer layer. The catheter according to 1.
9.
6. The second coil made of the same resin material as the outer layer is integrally coupled to the inner peripheral surface of the outer layer made of the resin material. Or 8. The catheter according to 1.
10.
7. The number of wires constituting the second coil made of a resin material is smaller than the number of wires constituting the first coil made of a metal material. Or 9. The catheter according to 1.
11.
At least the first coil has a plurality of wires wound in multiple lines,
The second coil made of the resin material is integrally coupled to the inner circumferential surface of the outer layer disposed on the outer periphery of the reinforcing layer, and is separated by the second coil integrally coupled to the outer layer. 8. The plurality of wire rods of the first coil are separated from each other in the axial direction within the space. Or 10. The catheter according to 1.
12
1. The elastic force of the second coil is larger than the elastic force of the first coil. To 11. The catheter according to any one of the above.
13.
The first coil is made of a metal material;
11. The second coil is made of a superelastic material. The catheter according to 1.
14
12. At least one of the first coil and the second coil made of a superelastic material is formed by winding a plurality of wires in multiple strands. The catheter according to 1.

10 Catheter 20 Inner layer 21 Lumen 50 Reinforcing layer 51 First coil 52 Second coil 53 Third coil 64 Outer layer 70 Space

Claims (12)

A catheter having a reinforcement layer formed on the outer periphery of the lumen;
At least a part of the reinforcing layer is formed by winding at least a first coil and a second coil made of different materials in multiple lines ,
At least one of the first coil or the second coil is made of a metal material,
Each of the first coil and the second coil is wound with one wire, or at least one of the plurality of wires is wound in multiple lines,
In the first coil or the second coil, at least one of the coils is composed of a plurality of wires, and the plurality of wires are made of the same material . A catheter having a reinforcement layer formed on the outer periphery of the lumen;
At least a part of the reinforcing layer is formed by winding at least a first coil and a second coil made of different materials in multiple lines,
At least one of the first coil or the second coil is made of a metal material,
Each of the first coil and the second coil is wound with one wire, or at least one of the plurality of wires is wound in multiple lines,
In the first coil or the second coil, at least one of the coils is composed of a plurality of wires, and the plurality of wires are a plurality of different materials, and are different from the coils. The catheter which consists of a material different from the material of the wire which comprises the said coil . The first coil is made of a metal material,
The catheter according to claim 1, wherein the second coil is made of a resin material. The catheter according to any one of claims 1 to 3 , further comprising an outer layer made of a resin material on an outer periphery of the reinforcing layer. The catheter according to claim 4 , wherein the second coil is formed of a resin material of the same type as the resin material of the outer layer. A catheter having a reinforcement layer formed on the outer periphery of the lumen;
At least a part of the reinforcing layer is formed by winding at least a first coil and a second coil made of different materials in multiple lines,
An outer layer made of a resin material on the outer periphery of the reinforcing layer;
The catheter in which the second coil made of the same resin material as that of the outer layer is integrally coupled to the inner peripheral surface of the outer layer made of the resin material . The catheter according to claim 6 , wherein the second coil is formed of a resin material of the same type as the resin material of the outer layer. A catheter having a reinforcement layer formed on the outer periphery of the lumen;
At least a part of the reinforcing layer is formed by winding at least a first coil and a second coil made of different materials in multiple lines,
An outer layer made of a resin material on the outer periphery of the reinforcing layer;
The second coil is formed of the same resin material as the resin material of the outer layer,
A catheter in which the number of wires constituting the second coil made of a resin material is smaller than the number of wires constituting the first coil made of a metal material . At least the first coil has a plurality of wires wound in multiple lines,
The second coil made of the resin material is integrally coupled to the inner circumferential surface of the outer layer disposed on the outer periphery of the reinforcing layer, and is separated by the second coil integrally coupled to the outer layer. The catheter according to any one of claims 6 to 8, wherein a plurality of the wire rods of the first coil are separated from each other in the axial direction within the open space. A catheter having a reinforcement layer formed on the outer periphery of the lumen;
At least a part of the reinforcing layer is formed by winding at least a first coil and a second coil made of different materials in multiple lines,
A catheter in which the elastic force of the second coil is larger than the elastic force of the first coil . The first coil is made of a metal material;
The catheter according to claim 10 , wherein the second coil is made of a superelastic material. The catheter according to claim 11 , wherein at least one of the first coil and the second coil made of a superelastic material is formed by winding a plurality of wires in multiple strands.

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