JP5869235B2 - Medical instruments - Google Patents

Description

  The present invention relates to a tubular medical instrument such as a catheter used by being inserted into a living body.

  Tubular medical devices such as catheters need to have high resistance to bending force applied when they are pushed forward in blood vessels. In order to meet such performance requirements, for example, as shown in Patent Document 1, a configuration in which a reinforcing layer such as a metal braid is embedded in a resin tube of a catheter is known. In this case, the kink resistance can be improved while securing a certain degree of flexibility in the catheter.

  Further, the catheter is generally provided with a contrast ring so that the position of the catheter inserted into the body can be confirmed from outside the body. In the above-mentioned Patent Document 1, in the configuration in which the inner layer and the outer layer made of resin are provided so as to sandwich the reinforcing layer inside and outside, the contrast ring is arranged on the inner layer on the distal side of the reinforcing layer and covered by the outer layer from the outside. A configuration for fixing the contrast ring is disclosed.

JP 2007-319594 A

  Here, since the catheter is used by being inserted into a living body, the contrast ring needs to be firmly fixed. However, in the configuration of Patent Document 1, an axial boundary exists between the contrast ring and the reinforcing layer, and the strength of the tube locally decreases at the boundary.

  The above-mentioned problem is a problem that occurs in the same way when a plurality of tubes having a reinforcing layer are connected in a line in the axial direction, in addition to the case where a contrast ring is provided on a tube having a reinforcing layer.

  This invention is made | formed in view of the said situation, In the structure which connects a metal member with the tube which has a reinforcement layer, the medical instrument which can implement | achieve the improvement of the connection strength suitably is provided. It is intended to provide.

  Hereinafter, means and the like effective for solving the above-described problems will be described while showing functions and effects as necessary.

  A medical instrument according to a first aspect of the present invention: a medical device comprising: a tube body having a reinforcing layer; and a metal covering body connected to the tube body, wherein the reinforcing layer penetrates inward and outward at an intermediate position in the axial direction. The covering body is disposed so as to cover the reinforcing layer from the outside, and in the covering region, the wall portion of the covering body enters the hole section. It is characterized by.

  According to this configuration, since the reinforcing layer has a hole portion penetrating inward and outward at an intermediate position in the axial direction, the tube body can be reinforced while ensuring the flexibility of the tube body. Also, since the covering is provided so as to cover the reinforcing layer from the outside, unlike the configuration in which the covering is provided while being shifted in the axial direction with respect to the reinforcing layer, the axial direction is provided between the reinforcing layer and the covering. It is possible to prevent the gaps from occurring. In this case, the wall of the covering body enters the hole of the reinforcing layer. Thereby, since the displacement of the cover body around the axis or in the axial direction is regulated by the contact between the cover body and the reinforcing layer, the fixing strength of the covering body with respect to the reinforcing layer is increased.

  In addition, as a reinforcement body which forms a reinforcement layer, linear shape, strip | belt shape, rod shape, etc. are mentioned.

  Medical device of 2nd invention: The medical device of 1st invention WHEREIN: The said reinforcement layer is formed using the reinforcement body, The said hole part is by the some reinforcement element formed of the said reinforcement body. Compartment is formed, and the outer peripheral surface of the covering body has an uneven shape corresponding to the plurality of reinforcing elements due to the wall portion of the covering body entering between the plurality of reinforcing elements. It is characterized by. As a result, the wall portion of the covering body greatly enters between the plurality of reinforcing elements, and the fixing strength can be further improved.

  Medical device of 3rd invention: In the medical device of 2nd invention, welding with the said covering body and the said reinforcement body is performed in the area | region where the said uneven | corrugated shape has arisen in the said covering body. It is characterized by. Since the configuration according to the second aspect of the present invention is provided and the position of the reinforcing body can be visually confirmed from the outer peripheral surface side of the covering body, a desired location between the covering body and the reinforcing body is set on the outer peripheral surface side of the covering body. This facilitates the work in the case of welding. Moreover, since welding is performed at a location where the covering and the reinforcing body are in close contact, the welding strength can be increased.

  Medical device of 4th invention: The medical device of 3rd invention WHEREIN: As for the welding location of the said covering body and the said reinforcement body, only a part of the width direction of the reinforcement element which has produced the said welding location is used. It is formed so that it may contain. Thereby, it becomes possible to weld a covering and a reinforcement body, without cutting a reinforcement body in the middle position. In addition, since the configuration according to the second aspect of the present invention is provided, it is possible to facilitate the work in the case where welding is performed at the location.

  Medical device of 5th invention: The medical device of 3rd or 4th invention WHEREIN: The welding location of the said cover and the said reinforcement is formed so that the location where several said reinforcement elements cross | intersect may be included. It is characterized by. Thereby, it becomes possible to ensure a wide welding area between the covering and the reinforcing body, thereby improving the welding strength. In addition, since the configuration according to the second aspect of the present invention is provided, it is possible to facilitate the work in the case where welding is performed at the location.

  A medical instrument of a sixth invention: In the medical instrument of any one of the third to fifth inventions, the tube body includes an inner layer on an inner peripheral side with respect to the reinforcing layer, In the welded portion with the reinforcing body, a hole communicating with the covering body and the reinforcing body passes through the inner layer. As a result, when welding is performed through laser irradiation, it is possible to reliably perform welding between the covering and the reinforcing body even when the irradiation intensity of the laser irradiation apparatus varies to some extent.

  The medical instrument of the seventh invention: In the medical instrument of the sixth invention, the tube body includes an outer layer so as to cover the reinforcing layer from the outside, and the hole is made of a material for forming the outer layer. Characterized by being buried. Accordingly, in the configuration in which the covering body and the reinforcing body can be reliably welded as described above, the through-hole generated in the inner layer can be filled using the outer layer forming step.

  The medical instrument of the eighth invention: In the medical instrument of any one of the second to seventh inventions, the tube body is provided with a resin layer on the outer peripheral surface side of the reinforcing layer, and the resin layer Since the thickness of the tube body changes according to the uneven shape, the outer peripheral surface corresponding to the position of the uneven shape in the tube body has no unevenness with respect to the periphery thereof. Thereby, the above-described excellent effects can be achieved while preventing the outer peripheral surface of the tube body from being uneven.

  The medical device of the ninth invention: The medical device of any one of the first to eighth inventions, wherein the reinforcing layer is in the covering region and the outer peripheral surface of the reinforcing layer is with respect to the axis of the tube body. An inclined region and a region parallel to the axis, and the covering is shaped to follow each of the inclined region and the parallel region. The wall portion of the covering body is inserted into the hole portion. Thereby, even if it is the structure where the area | region and parallel area | region which inclined for the predetermined | prescribed objective exist in the outer peripheral surface of a reinforcement layer, it becomes possible to adhere | attach a covering body with respect to these each area | region. Therefore, it is possible to firmly fix the covering.

  The medical instrument of the tenth invention: The medical instrument of any one of the first to ninth inventions, wherein the covering is a contrast ring formed of a radiopaque material. To do. Thereby, in the configuration in which the contrast ring is provided so as to cover the reinforcing layer from the outside, it is possible to achieve the excellent effects as described above.

  “Rigidity” refers to the magnitude of a moment that acts when a catheter or the like is bent in a direction perpendicular to the axial direction.

(A) is a figure for demonstrating the catheter assembly in use condition, (b) is a front view of an outer catheter, (c) is a front view of an inner catheter. (A) is a front view of an outer catheter showing an outer tube portion and its periphery in an enlarged manner, and (b) is a longitudinal sectional view showing an enlarged distal end side of the outer tube portion. (A) is a longitudinal cross-sectional view of the outer tube part which expands and shows a distal end side, (b) is a longitudinal cross-sectional view of the outer tube part which expands and shows a contrast ring and its periphery in Fig.3 (a). (C) is a longitudinal sectional view of an outer pipe portion for explaining a comparative example. (A) is a front view of the outer tube part shown in the state where the outer layer is removed on the distal end side, (b) is a longitudinal sectional view of the outer tube part showing the enlarged distal end side, (c) FIG. 4B is a longitudinal cross-sectional view of the outer tube portion showing the contrast ring and its periphery in FIG. 4B in an enlarged manner, and FIG. 4D is a cross-sectional view of the outer tube portion at the position where the contrast ring is provided. (A)-(j) is a schematic diagram for demonstrating the manufacturing method of an outer pipe part. It is an outer pipe part of a modification, Comprising: It is a longitudinal cross-sectional view of the outer pipe part which expands and shows a distal end side. It is an outer pipe part of a modification, Comprising: It is a longitudinal cross-sectional view of the outer pipe part which expands and shows a distal end side. It is an outer pipe part of a modification, Comprising: It is a front view of the outer pipe part shown in the state which removed the outer layer in the distal end side. It is an outer pipe part of a modification, Comprising: It is a longitudinal cross-sectional view of the outer pipe part which expands and shows a distal end side. It is an outer pipe part of a modification, Comprising: It is a longitudinal cross-sectional view of the outer pipe part which expands and shows a distal end side. It is an outer pipe part of a modification, Comprising: It is a front view of the outer pipe part shown in the state which removed the outer layer and the contrast ring in the distal end side.

  Hereinafter, an embodiment when the present invention is applied to a catheter assembly will be described with reference to the drawings. 1A is a view for explaining the catheter assembly 10 in a use state, FIG. 1B is a front view of the outer catheter 11, and FIG. 1C is a front view of the inner catheter 12. is there.

  As shown in FIGS. 1A to 1C, the catheter assembly 10 includes an outer catheter 11 and an inner catheter 12. The outer catheter 11 is a delivery catheter that is used to introduce a balloon catheter or the like (not shown) into the peripheral stenosis lesion of the coronary artery. The inner catheter 12 is an insertion assisting tool that is inserted into the outer catheter 11 and used when the outer catheter 11 is inserted into a lesion in a living body, and assists the insertion by preceding the outer catheter 11. .

  As shown in FIG. 1 (c), the inner catheter 12 is an inner portion that is from the distal end (tip) to the middle position on the proximal end side (base end side) and constitutes the distal end side of the inner catheter 12. The pipe part 21 and the inner shaft part 22 which comprises a proximal end side rather than the said inner pipe part 21 are provided. The inner tube portion 21 has an inner tube hole 23 formed over the entire axial direction so as to be opened at both the distal end portion and the proximal end portion, and has an overall tubular shape. ing. The inner tube hole 23 is used for inserting a guide wire.

  The inner pipe portion 21 is made of a polyether block amide copolymer (PEBAX (registered trademark)), and the inner shaft portion 22 is made of stainless steel. However, the inner tube portion 21 may be formed using other synthetic resin such as polyamide, polyimide, polyimide elastomer, etc., and the inner shaft portion 22 may be other than Ni-Ti alloy. You may form with the metal of. Further, a soft tip 24 that is more flexible than the proximal side is provided at the distal end portion of the inner tube portion 21.

  The inner opening 25 of the inner tube portion 21 exists at an intermediate position in the axial direction of the inner catheter 12. That is, the inner port for pulling out the guide wire to the outside on the proximal end side is formed at an intermediate position in the axial direction of the inner catheter 12.

  As shown in FIG. 1B, the outer catheter 11 includes an outer tube portion 31 that is from the distal end to the middle position on the proximal end side and that constitutes the distal end side of the outer catheter 11, and the outer tube. And an outer shaft portion 32 that constitutes a proximal end side with respect to the portion 31. The outer tube portion 31 has an outer tube hole 33 formed over the entire axial direction so as to be opened at both the distal end portion and the proximal end portion, and has a tubular shape as a whole. ing. The outer tube hole 33 is used for inserting the inner catheter 12 and the guide wire, and in the state where the inner catheter 12 is removed, a catheter such as a balloon catheter for use with respect to a lesioned portion is inserted. . The outer pipe portion 31 corresponds to the tube body in the present embodiment.

  The outer opening 34 of the outer tube portion 31 is present at an intermediate position in the axial direction of the outer catheter 11. Here, the guide wire used when the catheter assembly 10 is inserted into the living body passes through the outer tube hole 33 on the proximal end side of the inner opening 25. Then, the guide wire G passed through the outer tube hole 33 is drawn out from the outer opening 34 of the outer tube portion 31 to the outside.

  As shown in FIG. 1A, the outer catheter 11 and the inner catheter 12 are combined to form a catheter assembly 10 in use. In the initial state of the catheter assembly 10, the soft tip 24 of the inner catheter 12 protrudes more distally than the outer tube portion 31. In the initial state, the outer opening 34 is disposed closer to the proximal end than the inner opening 25. The position of the outer opening 34 is an intermediate position in the axial direction of the catheter assembly 10, and more specifically, is a distal end side with respect to the intermediate position of the entire length of the catheter assembly 10.

  In the configuration in which the relative position between the inner opening 25 and the outer opening 34 in the initial state is the above position, the region through which the guide wire G passes when viewed from the proximal end side is the guiding formed in the guiding catheter C. Pipe hole C1 → outer pipe hole 33 → inner pipe hole 23. That is, when the guide wire G is inserted from the proximal end side, the cross-sectional area of the passing region gradually decreases. Thereby, it becomes easy to introduce the guide wire G to the distal end side.

  When performing treatment using the catheter assembly 10, first, the distal end portion of the guiding catheter C is placed at the entrance of the left coronary artery via the descending aorta, the aortic arch and the ascending aorta, and from that state, the distal end The catheter assembly 10 is protruded to the end side, and insertion into the left coronary artery is performed. In this case, since the soft tip 24 protrudes from the outer catheter 11, the passability can be improved. Furthermore, when the closed part exists, the closed part can be gradually pushed from the soft chip 24 side.

  Next, the configuration of the outer catheter 11 will be described in detail with reference to FIG.

  2A is a front view of the outer catheter 11 showing the outer tube portion 31 and its periphery in an enlarged manner, and FIG. 2B is a longitudinal sectional view showing the distal end side of the outer tube portion 31 in an enlarged manner. It is.

  As shown in FIG. 2B, the outer pipe portion 31 includes an inner layer 41 that defines the entire inner peripheral surface of the outer pipe portion 31, an outer layer 42 that defines the entire outer peripheral surface of the outer pipe portion 31, and these inner layers 41. And an intermediate layer 43 provided so as to be sandwiched between the outer layers 42.

  The inner layer 41 is a layer that serves as a base when the intermediate layer 43 and the outer layer 42 are formed. The inner layer 41 is formed using a synthetic resin. As the synthetic resin, those enumerated as materials of the outer layer 42 described later can be used. Specifically, the synthetic resin is formed using a low friction material. By forming the inner layer 41 with a low friction material in this way, the resistance when sliding the inner catheter 12 and other catheters in the outer tube hole 33 is reduced.

  Specifically, polytetrafluoroethylene is used as a material for forming the inner layer 41. However, the material forming the inner layer 41 is arbitrary as long as the sliding resistance with the inner catheter 12 and other catheters can be reduced as compared with the material forming the outer layer 42. For example, polytetrafluoroethylene Another fluorine-containing resin may be used. Examples of the fluorine-containing resin include polyvinylidene fluoride and perfluoroalkoxy resin. Moreover, other than a fluorine-containing resin, for example, polyamide, polyimide, high-density polyethylene, or the like may be used. Further, a plurality of materials listed above may be used in combination.

  The thickness dimension of the inner layer 41 is arbitrary, but is preferably smaller than the thickness dimension of the outer layer 42. Specifically, 0.01 mm to 0.05 mm is preferable. As a result, it is possible to reduce the diameter of the outer pipe portion 31 while realizing a good reduction in sliding resistance. Moreover, although the thickness dimension of the inner layer 41 is constant over the whole axial direction, you may change in the middle position of the axial direction.

  The intermediate layer 43 has a role of reinforcing the outer pipe portion 31. Specifically, stainless steel is used as a material for forming the intermediate layer 43. However, the material forming the intermediate layer 43 is arbitrary as long as the above-described reinforcing effect is obtained. For example, a superelastic alloy such as a Ni—Ti alloy or a Ni—Ti—Co alloy may be used. Other metals such as nickel and titanium may be used. Further, the intermediate layer 16 is not limited to metal, and may be polyester such as polyethylene terephthalate or polyolefin such as polyethylene. Rigid polyvinyl chloride, polyamide, polyimide, polystyrene, polyurethane, polycarbonate, ABS resin, Other synthetic resins such as acrylic resin, methacrylic resin, polyacetal, fluorine-containing resin, and polyether ketone may be used. Carbon fiber or glass fiber may be used. Further, a plurality of types of materials listed above may be used in combination.

  The intermediate layer 43 is formed using a linear body 43a formed of the material as described above. Specifically, the linear body 43a is knitted into a mesh shape to form a braided tube. In this way, by forming the intermediate layer 43 by the linear body 43a, flexibility of bending can be enhanced while the outer catheter 11 is reinforced. Incidentally, in the intermediate layer 43, the linear elements constituting a part of the one linear body 43a are adjacent to each other at a predetermined interval in the axial direction and around the axis.

  The linear body 43a forming the intermediate layer 43 is formed so that its cross-sectional shape is rectangular, but is not limited thereto, and may be circular or elliptical. The linear body 43 a forming the intermediate layer 43 is formed so that the thickness dimension of the intermediate layer 43 is approximately the same as that of the inner layer 41. The thickness dimension is arbitrary, but is preferably smaller than the thickness dimension of the outer layer 42. Specifically, 0.01 mm to 0.05 mm is preferable.

  Moreover, it is preferable that the pitch between the linear bodies 43a adjacent to each other in the axial direction is constant. Although the dimension of the pitch is arbitrary, it is preferably 0.1 mm to 0.5 mm in order to enhance flexibility with respect to bending while reinforcing the outer catheter 11 as described above. The pitch is not limited to be constant, and for example, the distal side may have a wider pitch, or the distal side may have a narrower pitch. Further, the pitch may continuously change along the axial direction.

  The outer layer 42 is provided so as to cover the inner layer 41 and the intermediate layer 43 from the outside. In this case, the outer layer 42 enters between a plurality of linear elements adjacent to each other in the axial direction or around the axis, and the outer layer 42 and the inner layer 41 are in contact with each other and are heat-welded in the inserted portion. Depending on the type of material that forms the outer layer 42 and the type of material that forms the inner layer 41, the outer layer 42 and the inner layer 41 may be in close contact with each other, but both may not be thermally welded.

  The outer layer 42 is formed using a synthetic resin. Examples of the synthetic resin include polyamide, polyamide elastomer, polyimide, polyimide elastomer, polypropylene, polyethylene, ethylene-vinyl acetate copolymer, polyethylene terephthalate, polybutylene terephthalate, polyester elastomer, polyurethane, polyurethane elastomer, polyvinyl chloride, polystyrene. , Polystyrene elastomer, ethylene-tetrafluoroethylene copolymer, fluorine-based elastomer, silicon rubber, latex rubber and the like. Moreover, these may be used independently and the mixture which combined 2 or more types may be used. In the outer pipe portion 31, a polyamide elastomer is used as the outer layer 42.

  The thickness dimension of the outer layer 42 is arbitrary, but is preferably larger than the thickness dimension of the inner layer 41 and the intermediate layer 43. Specifically, 0.1 mm to 1.0 mm is preferable. Thereby, it is possible to reduce a load on a tissue in a living body such as a blood vessel. The thickness dimension of the outer layer 42 is such that the proximal end portion side is thin in relation to the fact that a metal tube for connecting the outer shaft portion 32 is embedded in the proximal end portion of the outer tube portion 31. Although the distal side is constant with a predetermined dimension larger than the proximal end side, it may be constant over the entire axial direction.

  As described above, in the configuration in which the outer pipe portion 31 has a multi-layer structure having the inner layer 41, the intermediate layer 43, and the outer layer 42, specifically, a three-layer structure, the outer layer 42 extends over the entire axial direction. On the other hand, the inner layer 41 and the intermediate layer 43 extend from the proximal end portion of the outer pipe portion 31 to an intermediate position in the axial direction. Specifically, the inner layer 41 and the intermediate layer 43 do not exist over a predetermined range in the axial direction from the distal end portion of the outer tube portion 31. Therefore, the distal end flexible region 44 consisting only of the outer layer 42 exists at the distal end portion of the outer tube portion 31. By forming the tip flexible region 44 in this way, the flexibility of the distal end portion of the outer tube portion 31 is enhanced, and it is possible to reduce the load on a living tissue such as a blood vessel. In order to suitably reinforce the outer pipe portion 31 by the intermediate layer 43 while enhancing the flexibility of the distal end portion of the outer pipe portion 31, the dimension in the axial direction of the tip flexible region 44 is 0.3 mm to 2 mm. 0.0 mm is preferable, and 0.5 mm to 1.0 mm is more preferable.

  The outer layer 42 may be formed of a material having a lower hardness on the distal end side than on the proximal end side. For example, in the method of manufacturing the outer tube portion 31 described later, the cover tube 52 (see FIG. 5H) is formed of a material having a lower hardness than the outer layer of the three-layer tube 51, whereby the distal end of the outer layer 42 is formed. The side can be formed more flexibly than the proximal side.

  As shown in FIG. 2B, the outer tube portion 31 is provided with an annular contrast ring 45 so that the position of the distal end side of the outer tube portion 31 can be grasped under X-ray projection. . Examples of the material forming the contrast ring 45 include radiopaque materials such as platinum, gold, platinum, iridium, cobalt chromium alloy, and titanium. In the outer pipe portion 31, platinum is used.

  A configuration related to the installation of the contrast ring 45 will be described in detail below with reference to FIGS. 3 and 4.

  FIG. 3A is a longitudinal sectional view of the outer tube portion 31 showing the distal end side in an enlarged manner, and FIG. 3B is an outer view showing the contrast ring 45 and its periphery in FIG. It is a longitudinal cross-sectional view of the pipe part 31, FIG.3 (c) is a longitudinal cross-sectional view of the outer pipe part 81 for demonstrating a comparative example. In FIGS. 3A to 3C, for convenience of explanation, the intermediate layer 43 is shown not as a braided tube but as a tube having no holes penetrating inside and outside. 4A is a front view of the outer tube portion 31 shown with the outer layer 42 removed on the distal end side, and FIG. 4B is an enlarged view of the outer tube portion 31 showing the distal end side. 4 (c) is a longitudinal sectional view of the outer tube portion 31 showing the contrast ring 45 and its periphery in FIG. 4 (b) in an enlarged manner, and FIG. 4 (d) is a contrast ring 45. It is a cross-sectional view of the outer pipe part 31 in the place where is provided. 4B and 4C show a state where two linear bodies 43a overlap each other.

  As shown in FIGS. 3A and 4B, the contrast ring 45 is not provided in the tip flexible region 44 but is provided so as to cover the distal end portion of the intermediate layer 43 from the outside. It has been. Specifically, the contrast ring 45 is provided so as to exist on the same axis as the outer tube portion 31, and the distal end portion of the contrast ring 45 is located at the distal end portion of the intermediate layer 43. . In this case, the contrast ring 45 extends over a predetermined range from the distal end portion of the intermediate layer 43 toward the proximal side. Further, as shown in FIG. 4B, the contrast ring 45 is set so that the length dimension in the axial direction straddles a plurality of linear elements arranged in the axial direction in the intermediate layer 43.

  The contrast ring 45 is provided such that its inner peripheral surface is in contact with the outer peripheral surface of the intermediate layer 43. Here, when the contrast ring 45 is mounted, the inner ring 41 and the intermediate layer 43 that are not covered by the outer layer 42 are covered with the contrast ring 45 from the distal end portion, and external force is applied from the outer peripheral surface side and crimped. Thus, the contrast ring 45 is attached. In this case, in order to suitably perform the fixing by caulking, it is preferable that the inner diameter of the contrast ring 45 is brought close to the outer diameter of the intermediate layer 43 in advance. The sliding resistance of the contrast ring 45 with respect to the layer 43 becomes large, and the work of arranging the contrast ring 45 becomes difficult.

  On the other hand, in this outer pipe part 31, the area | region where the contrast ring 45 is arrange | positioned in the intermediate | middle layer 43 is formed so that it may taper. Specifically, as shown in FIG. 3A, the tapered region 43b is formed by gradually decreasing the outer diameter toward the distal end while keeping the inner diameter constant. . Moreover, the said taper area | region 43b is formed by making the thickness gradually small toward a distal end part, making constant the thickness around an axis | shaft in each position of an axial direction.

  The angle A (see FIG. 3B) at which the tapered surface of the tapered region 43b is inclined with respect to the axis is preferably 30 ° or less, more preferably 20 ° or less from the viewpoint of extending the tapered region 43b to some extent in the axial direction. 10 ° or less is particularly preferable. On the other hand, in view of facilitating the mounting operation of the contrast ring 45, the angle A is preferably 1 ° or more, more preferably 2 ° or more, and particularly preferably 3 ° or more.

  The tapered region 43 b has a length dimension in the axial direction shorter than a length dimension in the axial direction of the contrast ring 45. On the other hand, the distal end portion of the contrast ring 45 exists at the distal end portion of the intermediate layer 43 as described above. Therefore, the contrast ring 45 has a region 45a that covers the entire tapered region 43b from the outside, and an intermediate layer 43 that is continuous on the proximal side with respect to the tapered region 43b and has a constant outer diameter and inner diameter. And a region 45b that covers the parallel region 43c extending in parallel to the outside from the outside.

  Since the tapered region 43b is formed in the intermediate layer 43, when the contrast ring 45 is mounted, the contact area between the contrast ring 45 and the intermediate layer 43 gradually increases as the contrast ring 45 is pushed proximally. It is possible to make the attachment work easier. Further, the contrast ring 45 includes not only a region 45a that covers the tapered region 43b from the outside, but also a region 45b that covers the parallel region 43c from the outside, so that the deformation amount of the contrast ring 45 during caulking is suppressed. There will be a region where the contrast ring 45 can be fixed in the state. As a result, in the configuration that facilitates the mounting operation as described above, there is a region where the deformation amount of the contrast ring 45 after crimping is suppressed, and the contrast ring 45 is in a stable state in the intermediate layer 43. It becomes possible to support it.

  Here, in order to taper the distal end side of the intermediate layer 43, the outer diameter extends from the distal end portion in the middle of the axial direction as described above and continuously toward the distal end portion. In addition to the configuration in which the taper is reduced, a configuration of a comparative example as shown in FIG. Specifically, the intermediate layer 82 provided in the outer pipe portion 81 of the comparative example has a step portion 83 at an intermediate position in the axial direction, and the distal side of the step portion 83 is closer to the proximal side. And the outer diameter of the distal region is constant. A contrast ring 84 is provided so as to cover the distal region from the outside. However, the contrast ring 84 does not cover the entire region on the distal side, and the contrast ring 84 and the stepped portion 83 are separated in the axial direction.

  Since the intermediate layer 82 formed as a braided tube is formed by winding the linear body 82a, the linear body 82a has a force to spread outward. On the other hand, when the diameter is reduced by bringing the intermediate layer 82 into contact with a polishing tool and physically polishing, the intermediate layer 82 is heated to spread outside the linear body 82a. The power to try increases. In the configuration in which the intermediate layer 82 is reduced in diameter using the stepped portion 83, the strength of the intermediate layer 82 greatly changes across the stepped portion 83, and the distal region, which is the weaker side, is located. However, as shown in FIG.3 (c), we are anxious about floating up outside. Further, since the force to spread outward is larger on the proximal side than the stepped portion 83, the region including the regions continuous on the proximal side and the distal side with respect to the stepped portion 83, to the outside is included. I am concerned that it will rise. This lifting can also occur when a part of the linear body 82a is cut during polishing. Moreover, in the manufacturing method of the outer pipe part 31 to be described later, when the cover tube 52 is heated to be welded (see FIG. 5 (i)), the linear body 82a may be caused to spread outward. When such lifting occurs before the outer layer 85 is formed or during the outer layer 85 forming step, a part of the linear body 82 a is exposed from the surface of the outer layer 85.

  On the other hand, in the outer pipe portion 31, the tapered region 43b is formed over a predetermined range in the axial direction from the distal end portion toward the proximal side, and gradually toward the distal end portion. The outer diameter is reduced. Therefore, since a large change in strength is unlikely to occur as described above, it is difficult to lift. Further, in the case of tapering in this way, even if the linear body 43a is cut, it is generated on the distal end side, and the above-described lifting is less likely to occur from this point.

  Furthermore, since the tapered region 43b is entirely covered with the contrast ring 45, it is expected that the linear body 43a is restrained by the contrast ring 45 even if the linear body 43a is lifted. In particular, the contrast ring 45 has an annular shape and is provided so as to straddle the boundary between the tapered region 43b and the parallel region 43c. Therefore, a gap for the linear body 43a to float in the tapered region 43b is hardly generated. It has become.

  Next, a configuration for caulking the contrast ring 45 to the intermediate layer 43 will be described.

  As already described, the contrast ring 45 is provided so as to cover the distal end portion of the intermediate layer 43 and is provided so as to be in contact with the outer peripheral surface of the intermediate layer 43. In this case, as shown in FIGS. 4A and 4B, the contrast ring 45 is provided such that the wall of the contrast ring 45 enters between a plurality of linear elements arranged in the axial direction or around the axis. It has been. This amount of penetration is set so that irregularities corresponding to the linear bodies 43a are generated not only on the inner peripheral surface side of the contrast ring 45 but also on the outer peripheral surface side. Therefore, as shown in FIG. 4A, the contrast ring 45 is in close contact with the linear body 43a of the intermediate layer 43, and the outer peripheral surface of the contrast ring 45 has an uneven shape along the outline of the linear body 43a. 45c occurs. The uneven shape 45c is formed on the outer peripheral surface of the contrast ring 45 so that the presence of the unevenness can be visually observed.

  Since the contrast ring 45 is crimped to the intermediate layer 43 formed as a braided tube so that the uneven shape 45c is generated as described above, the wall portion of the contrast ring 45 is a linear body from a plurality of directions. It faces 43a. Specifically, as shown in FIGS. 4C and 4D, the contrast ring 45 has a surface facing the linear body 43a from the proximal side and a distance from the linear body 43a. It has a surface facing from the rear side, a surface facing the linear body 43a from a predetermined direction around the axis, and a surface facing from the opposite direction to the predetermined direction. Thereby, even if an external force is applied to the contrast ring 45 through the outer layer 42 when the outer catheter 11 is used, the displacement of the contrast ring 45 is restricted by the linear body 43a.

  In the configuration in which the concavo-convex shape 45c is generated in the contrast ring 45, the concave portion viewed from the outer peripheral surface side is in contact with the outer peripheral surface of the inner layer 41 at a portion covering the tapered region 43b, but is not limited thereto. It is good also as a structure which touches the outer peripheral surface of the inner layer 41 also in the location which covers the parallel area | region 43c. Further, the concave portion may not be in contact with the outer peripheral surface of the inner layer 41, and a material different from the inner layer 41, for example, a material for forming the outer layer 42 may be interposed between the inner layer 41 and the outer peripheral surface. .

  As described above, the contrast ring 45 covers the entire tapered region 43b in the intermediate layer 43 and enters the parallel region 43c side from the tapered region 43b side. However, the contrast ring 45 is in close contact with the linear body 43a. The contrast ring 45 has a shape following the tapered region 43b and the parallel region 43c. That is, as shown in FIG. 4B, the contrast ring 45 follows the tapered region 43b, whereby the outer peripheral surface tends to become an intermittently tapered shape toward the distal end portion. And a parallel follow-up region 45b showing a tendency that the outer peripheral surface is parallel to the axis by following the parallel region 43c. Thereby, the contrast ring 45 can be brought into close contact with both the tapered region 43b and the parallel region 43c of the intermediate layer 43, and the displacement restriction effect of the contrast ring 45 using the linear body 43a is enhanced.

  Next, a configuration for laser welding of the contrast ring 45 will be described.

  The contrast ring 45 is welded to the linear body 43a of the intermediate layer 43 as shown in FIGS. 4 (c) and 4 (d). This welding is performed by performing laser irradiation. As shown in FIG. 4A, the welded portion 46 is formed not to include the entire width direction of the predetermined linear body 43 a but to weld a part of the width direction and the contrast ring 45. Has been. Thereby, it can prevent that the linear body 43a is not cut | disconnected in the welding location 46. FIG.

  In more detail about the welding location 46, the said welding location 46 is formed in the location where the predetermined linear body 43a and the other linear body 43a cross | intersect. In this case, the welding location 46 is formed so that a part of the predetermined linear body 43 a in the width direction and a part of the other linear body 43 a in the width direction are welded to the contrast ring 45. Thereby, in the configuration in which the linear body 43a is not cut during welding, a wide contact area between the contrast ring 45 and the linear body 43a can be secured, and the welding strength can be improved.

  In addition, although the through-hole has arisen in the contrast ring 45 in the welding location 46, the width dimension of the said through-hole is 0.1 mm-1 .. 0 mm is preferable, and 0.3 mm to 0.6 mm is more preferable.

  Here, as already described, the contrast ring 45 is crimped so that the wall portion enters between the plurality of linear elements, so that the outer peripheral surface of the contrast ring 45 corresponds to the arrangement of the linear bodies 43a. The uneven shape 45c is generated. Therefore, even when the intermediate layer 43 is covered with the contrast ring 45, the position of the linear body 43a can be grasped visually. Therefore, the laser irradiation operation for generating the welded portion 46 at the position as described above can be facilitated. Furthermore, since welding is performed at a position where the contrast ring 45 is in close contact with the linear body 43a, the welding strength can be improved.

  As shown in FIG. 4A, the welded portion 46 is formed in the parallel follow-up region 45b among the tapered follow-up region 45a and the parallel follow-up region 45b in the contrast ring 45. Since the parallel follow-up region 45b is less deformed when caulking the contrast ring 45 than the tapered follow-up region 45a, the degree of contact with the linear body 43a can be made higher than that of the tapered follow-up region 45a. Then, since the accuracy of the position of the linear body 43a grasped from the concavo-convex shape 45c of the contrast ring 45 is improved, laser welding while not cutting the linear body 43a, and the intersection of the plurality of linear bodies 43a This makes it easier to perform laser welding. Further, due to the high degree of adhesion, the welding strength can be further improved. Further, if the welded portion 46 exists in the taper follow-up region 45a, the contrast ring 45 is welded to the taper region 43b of the intermediate layer 43. In this case, since the linear body 43a of the tapered region 43b is thin, the linear body 43a may be broken when a load is applied to the contrast ring 45. On the other hand, since the welded portion 46 exists in the parallel follow-up region 45b as described above, the contrast ring 45 is welded to the linear body 43a that is not thinned. Occurrence can be suppressed.

  A plurality of welding locations 46 are formed. Specifically, as shown in FIG. 4 (d), a plurality of welding locations 46 are formed around the axis at predetermined positions in the axial direction. More specifically, the welding locations 46 are formed at three locations around the axis so as to be equally spaced. Assuming a configuration in which two welds 46 are formed around the axis so that the welds 46 are equidistant, the contrast ring 45 may be misaligned around a virtual line connecting the welds 46. Concerned. On the other hand, by forming three or more welding locations 46, it is difficult for such a positional shift of the contrast ring 45 to occur. However, it is not limited to this, and the welding location 46 may be one location or two locations.

  As shown in FIG. 4C, at the welded portion 46, a through hole 46 a is formed at least in the contrast ring 45. Further, the through hole 46a penetrates the linear body 43a and also penetrates the inner layer 41. By performing laser irradiation so as to penetrate the inner layer 41 in this way, even when the irradiation intensity of the laser irradiation apparatus varies to some extent, it is possible to reliably weld the contrast ring 45 and the linear body 43a. It becomes possible.

  In the configuration in which the laser irradiation is performed so as to penetrate the inner layer 41 in this way, the through hole 46a is filled with a material for forming the outer layer 42 as shown in FIGS. 4 (c) and 4 (d). Has been buried. The displacement of the intermediate layer 43 and the contrast ring 45 in the axial direction is regulated by the filling portion of the outer layer 42, so that the bonding strength of the intermediate layer 43 and the contrast ring 45 can be increased. The bonding strength between the contrast ring 45 and the outer layer 42 can be increased.

  In this case, the filling region 46b of the material is formed so as to form the same curved surface with respect to the periphery thereof, in other words, on the inner peripheral surface of the outer pipe portion 31, the convex portion directed inward and directed outward. The filling region 46b is formed so that both of the recesses do not occur. Thus, not only the through hole 46a is blocked using the material forming the outer layer 42, but also the passage of the inner catheter 12 and other catheters inserted into the outer tube hole 33 is not reduced. It becomes possible to do.

  The covering with the outer layer 42 will be further described. As described above, the contrast ring 45 has an uneven shape 45c on its outer peripheral surface, and also has a tapered follow-up region 45a and a parallel follow-up region 45b. On the other hand, the outer layer 42 absorbs these irregularities by changing the thickness of the outer layer 42 so that the influence of these irregularities does not occur on the outer peripheral surface of the outer pipe portion 31. Therefore, there is no unevenness on the outer peripheral surface of the outer tube portion 31 at the position where the contrast ring 45 is provided, and the outer peripheral surface is parallel to the axis. As a result, it is possible to achieve the excellent effects as described above while not reducing the passage of the outer tube portion 31 in the living body.

  Next, a method for manufacturing the outer pipe portion 31 will be described with reference to FIG. 5A to 5J are schematic views for explaining a method for manufacturing the outer pipe portion 31. FIG.

  As shown in FIG. 5A, first, a three-layer tube 51 having an inner layer 41, an intermediate layer 43, and an outer layer 42 is formed by performing a preparation process. The three-layer tube 51 has a constant outer diameter except for the proximal end portion, and a constant inner diameter over the entire axial direction. Note that the outer shaft portion 32 is already fixed to the three-layer tube 51.

  After that, as shown in FIG. 5B, the outer layer 42 is removed from one end of the three-layer tube 51 over a predetermined range, and the exposed inner layer 41 and intermediate layer 43 are removed from the end of the outer layer 42 by a predetermined length ( For example, an exposure step of cutting to 5 mm) is performed. In this case, in the region where the outer layer 42 is peeled off, the outer peripheral surface of the intermediate layer 43 is exposed, but the forming material of the outer layer 42 enters between a plurality of linear elements formed by the linear bodies 43a. Yes.

  Thereafter, as shown in FIG. 5C, a polishing step is performed to form a tapered region 43b in a predetermined range from the distal end portion toward the proximal side in the intermediate layer 43. In the polishing step, the axial direction of the three-layer tube 51 is inclined with respect to the polishing surface of the polishing tool D1, and the distal end side of the three-layer tube 51 is physically contacted with the polishing surface. Perform proper polishing. The inclination angle at this time is, for example, 5 °. Further, the polishing tool D1 is rotated and the three-layer tube 51 is also rotated. As a result, a tapered region 43b is formed in the intermediate layer 43 as shown in FIG. The tapered region 43b has a symmetrical shape with respect to the axis, and the material for forming the outer layer 42 that has entered between the plurality of linear elements is also removed in the tapered region 43b. In addition, although the said grinding | polishing is performed in the range in which the inner layer 41 is not grind | polished, a part of inner layer 41 may be grind | polished.

  Thereafter, as shown in FIG. 5E, an arrangement step of arranging the contrast ring 45 is performed so as to cover the entire tapered region 43b in the intermediate layer 43 and the distal end portion of the parallel region 43c from the outside. In this case, the contrast ring 45 is mounted from the end of the three-layer tube 51 on the side where the intermediate layer 43 is exposed, and the mounting operation is performed because the tapered region 43b is formed as described above. Is facilitated. In addition, since one end side of the contrast ring 45 overlaps the parallel region 43c from the outside, and the inner diameter of the contrast ring 45 is set to be close to the outer diameter of the parallel region 43c, the contrast ring 45 on the intermediate layer 43 is set. Can be performed in a stable state.

  Thereafter, as shown in FIG. 5 (f), a caulking step of applying an external force to the contrast ring 45 from the outer peripheral surface side is performed using the caulking device D2. At this time, caulking is performed so that the wall portion of the contrast ring 45 enters between a plurality of linear elements formed by the linear bodies 43 a of the intermediate layer 43. Further, in order to suitably perform such caulking, a resin sheet or the like is provided between the caulking device D2 and the contrast ring 45 so that the shape of the contrast ring 45 follows the shape of the intermediate layer 43. It is good to interpose the buffer material by. Further, crimping is performed in a state where the inner diameter fixing mandrel D3 is inserted inside the three-layer tube 51 so that the inner diameter does not change. By performing the caulking step, as shown in FIG. 5G, an uneven shape 45 c is formed in the contrast ring 45, and the contrast ring 45 follows the tapered region 43 b and the parallel region 43 c of the intermediate layer 43. It becomes a shape. However, the inner diameter of the three-layer tube 51 is the same throughout the axial direction.

  Then, as shown in FIG.5 (g), the welding process for welding the contrast ring 45 to the intermediate | middle layer 43 is performed using laser irradiation apparatus D4. At this time, by confirming the concave / convex shape 45c of the contrast ring 45, laser irradiation is performed so as to include a part of the intersecting portions of the plurality of linear bodies 43a. Further, in order to reduce the influence of the change in the laser irradiation intensity on the welding intensity, the laser irradiation is performed so as to penetrate not only the contrast ring 45 and the linear body 43a but also the inner layer 41. Laser irradiation is performed at three locations on the parallel follow-up region 45b of the contrast ring 45. As a result, the contrast ring 45 is welded to the intermediate layer 43.

  After that, as shown in FIG. 5 (h), a covering process is performed in which the cover tube 52 formed of the material for forming the outer layer 42 is placed on the exposed contrast ring 45, intermediate layer 43, and inner layer 41. Then, as shown in FIG. 5 (i), a thermal welding process is performed in which the cover tube 52 is thermally welded to the outer layer 42 and the inner layer 41 already existing in the three-layer tube 51. At this time, in a state where the mandrel D5 for fixing the inner diameter is inserted into the inner side of the three-layer tube 51, using the welding device D6, a portion continuous with the cover tube 52 in the three-layer tube 51 and the cover tube 52 Is heated while applying external force. Thereby, as shown in FIG.5 (j), manufacture of the outer pipe part 31 is completed. When the cover tube 52 is heat-welded, the cover tube 52 may be heat-welded by covering the outer peripheral surface of the cover tube 52 with a heat-shrinkable tube and heating the outer peripheral surface of the heat-shrinkable tube. .

  According to the embodiment described in detail above, the following excellent effects are obtained.

  A structure in which the contrast ring 45 is provided so as to cover the intermediate layer 43 formed using the linear body 43a from the outside, so that the contrast ring 45 is shifted in the axial direction with respect to the intermediate layer 43. In contrast, it is possible to prevent a gap in the axial direction from occurring between the intermediate layer 43 and the contrast ring 45. In this case, the contrast ring 45 is crimped so that the wall portion enters between a plurality of linear elements formed by the linear bodies 43a. Thereby, since the displacement around the axis of the contrast ring 45 or in the axial direction is restricted by the contact between the contrast ring 45 and the linear body 43a, the fixing strength of the contrast ring 45 with respect to the intermediate layer 43 is increased.

  The caulking is performed in such a manner that uneven shapes 45 c corresponding to the plurality of linear bodies 43 a are generated on the outer peripheral surface of the contrast ring 45. As a result, the wall portion of the contrast ring 45 greatly enters between the plurality of linear elements, and the fixing strength can be further improved. Furthermore, since the position of the linear body 43a can be visually confirmed from the outer peripheral surface side of the contrast ring 45, a desired portion of the contrast ring 45 and the linear body 43a is welded from the outer peripheral surface side of the contrast ring 45. In this case, the work can be facilitated.

  By performing welding at the location where the uneven shape 45c is generated as described above, the welding can be performed at the location where the contrast ring 45 and the linear body 43a are in close contact. Therefore, the welding strength can be improved.

  In the configuration in which the contrast ring 45 is provided so as to cover the intermediate layer 43 from the outside as described above, the predetermined range from the distal end portion to the proximal side of the intermediate layer 43 is directed toward the distal end portion. A tapered region 43b is formed so as to be tapered. Thereby, the workability when the contrast ring 45 is arranged outside the intermediate layer 43 is improved.

  In this case, the tapered region 43b is not formed by a stepped portion extending in the thickness direction, but is formed as a tapered shape that gradually narrows toward the distal end portion. As a result, the tapered region 43b can be formed without causing a boundary where the strength greatly changes, and therefore, the occurrence of the lifting of the linear body 43a can be suppressed.

  The entire tapered region 43 b is covered from the outside by the contrast ring 45. This makes it possible to prevent the linear body 43a from floating from the outside by the contrast ring 45. Therefore, it becomes possible to suppress the occurrence of lifting of the linear body 43a.

  In particular, the contrast ring 45 is provided so as to extend from the tapered region 43b side of the intermediate layer 43 to the parallel region 43c side. Thereby, even if the linear body 43a tries to float at the boundary portion between the tapered region 43b and the parallel region 43c, it can be suppressed by the contrast ring 45.

  In the configuration in which the contrast ring 45 is provided so as to enter the parallel region 43c side from the tapered region 43b side of the intermediate layer 43, the contrast ring 45 and the intermediate layer 43 on the parallel region 43c side where deformation amount during caulking is suppressed. And welding. As a result, welding can be performed at a more closely attached portion, and the welding strength can be improved.

  The welded portion 46 between the contrast ring 45 and the linear body 43a is formed not to include the entire width direction of the linear body 43a but to weld a part of the width direction to the contrast ring 45. . Thereby, it can prevent that the linear body 43a is not cut | disconnected in the welding location 46. FIG. Moreover, the said welding location 46 is formed in the location where the predetermined linear body 43a and the other linear body 43a cross | intersect. Thereby, in the configuration in which the linear body 43a is not cut during welding, a wide contact area between the contrast ring 45 and the linear body 43a can be secured, and the welding strength can be improved.

  The present invention is not limited to the description of the above embodiment, and may be implemented as follows, for example.

  (1) In the modification shown in FIG. 6, the contrast ring 45 is not provided so as to cover the entire tapered region 43b but covers only a part of the tapered region 43b in the axial direction. In this case, the distal end portion and the proximal end portion of the tapered region 43b are not covered by the contrast ring 45. However, the tapered region 43b is far from the intermediate layer 43 as in the above embodiment. It is formed over a predetermined range from the distal end portion toward the proximal side, and is formed so as to gradually become thinner toward the distal end portion. Therefore, since the tapered region 43b is formed without the presence of a boundary where the strength changes greatly, the linear body is less likely to be lifted compared to the modification shown in FIG.

  (2) In the modification shown in FIG. 7, the tapered region 61 is formed such that the distal side is thinner than the proximal side with respect to the stepped portion 62, and the distal side is The outer diameter is constant. In this configuration, the contrast ring 45 is provided so as to cover the entire tapered region 61, and is provided so as to extend from the tapered region 61 side to the parallel region 63 side in the intermediate layer 43. Thereby, it is possible to suppress the floating of the linear body forming the intermediate layer 43 by the contrast ring 45.

  (3) In the modification shown in FIG. 8, the position of the welded portion between the linear body 43a of the intermediate layer 43 and the contrast ring 45 is different from that in the above embodiment, and at least the first welded portion 71 and the second welded portion. Part 72.

  The 1st welding location 71 is formed so that the whole location where the predetermined linear body 43a and the other linear body 43a cross may be included. In this case, the area of the welding location 71 is increased, and the welding strength is improved. Further, since the area where the linear body 43a intersects in this way is larger than the area where the linear body 43a does not intersect, the area of the portion that floats on the surface of the contrast ring 45 is increased. It is easy to become a landmark.

  The 2nd welding location 72 is formed in the location different from the location which cross | intersects. Thereby, the welding location 72 can be formed, without restricting the relative displacement between the some linear bodies 43a. Moreover, the said 2nd welding location 72 is formed so that only a part of the width direction in the predetermined linear body 43a may be included. In addition, it is good also as a structure which has only any one of the 1st welding location 71 and the 2nd welding location 72, and the 1st welding location 71 is not the parallel tracking area | region 45b of the contrast ring 45 but the taper tracking area | region 45a. It is good also as a structure currently formed, and the 2nd welding location 72 is good also as a structure currently formed in the parallel follow-up area | region 45b instead of the taper follow-up area | region 45a of the contrast ring 45.

  (4) In the modification shown in FIG. 9, the welded portion 46 is formed so as to penetrate the contrast ring 45 and the linear body 43a, while the inner layer 41 is formed so as not to penetrate. Thereby, it becomes possible to prevent the low friction layer from disappearing at the place where the welded portion 46 is formed.

  (5) In the modification shown in FIG. 10, the welded portion 46 is formed so as to penetrate the contrast ring 45, while not penetrating the linear body 43 a and the inner layer 41. Thereby, it becomes possible to form the welding location 46, suppressing the strength reduction of the linear body 43a.

  (6) FIG. 11 shows a modification in a state (the state of FIG. 5D) after the distal end side of the intermediate layer 43 is polished and before the contrast ring 45 is attached. In this case, the linear body 43a existing at the distal end is cut and lost. Even in this case, since the polishing is performed obliquely, the occurrence of lifting of the linear body 43a is suppressed. Further, since the polishing is performed obliquely, the amount of the linear body 43a that is lost is suppressed. That is, the malfunction that the linear body 43a is cut | disconnected in the location more proximal side is suppressed. Since the defect of the linear body 43a is suppressed to a narrow range only on the distal side, the reinforcing effect by the intermediate layer 43 is preferably maintained.

  (7) In the configuration in which the contrast ring 45 is provided to extend from the tapered region 43b side to the parallel region 43c side in the intermediate layer 43, the parallel region 43c does not include the tapered region 43b in the object whose shape is to be followed by caulking. It is good also as a structure made to follow only. In this case, when the contrast ring 45 is caulked, the contrast ring 45 can be prevented from being greatly deformed. Moreover, in the said structure, in order to support the contrast ring 45 in the stable state, the structure with which the formation material of the outer layer 42 is filled between the contrast ring 45 and the taper area | region 43b is preferable.

  (8) The method of forming the tapered region 43b in the intermediate layer 43 is not limited to a method by physical polishing, and may be another method such as electrolytic polishing. Even in this case, since there is a concern that the linear body 43a may be lifted as the intermediate layer 43 is reduced in diameter, the tapered region 43b is directed from the distal end of the intermediate layer 43 to the proximal side. At least one of a configuration in which the tapered region 43b is formed so as to gradually narrow toward the distal end portion and a contrast ring 45 is provided so as to cover the entire tapered region 43b while being formed over a predetermined range. It is preferable to apply one.

  (9) The intermediate layer 43 is not limited to a configuration in which the intermediate layer 43 is a braided tube formed by using a plurality of linear bodies 43a, and the intermediate layer 43 is formed by using a single linear body. It is good also as a structure which is a shape. The intermediate layer 43 is not limited to the braided tube or coil using the linear body 43a as described above, and may be a braided tube or coil using a rod-shaped body or a strip-shaped body. Further, one or more of a linear body, a rod-shaped body, and a belt-shaped body are extended in the axial direction of the outer pipe section 31, are made to circulate around the axis of the outer pipe section 31, and are provided in a spiral shape. The intermediate layer 43 having a hole penetrating inward and outward at an intermediate position in the axial direction may be formed by providing at least one method. In this configuration, the holes penetrating inward and outward in the intermediate layer 43 include a slit shape extending in the axial direction, a slit shape extending around the axis, and a slit shape extending spirally, in addition to the lattice shape.

  Even in this case, in the intermediate layer 43, a plurality of reinforcing elements (linear elements, rod-shaped elements, strip-shaped elements) are arranged in the axial direction by a predetermined reinforcing body (linear bodies, rod-shaped bodies, strip-shaped bodies). Therefore, it is possible to provide the contrast ring 45 so that the wall portion enters between the reinforcing elements. In addition, the taper region 43b is formed over a predetermined range from the distal end of the intermediate layer 43 toward the proximal side, and the taper region 43b is gradually narrowed toward the distal end. By applying at least one of the configurations in which the contrast ring 45 is provided so as to cover the entire region 43b, the mounting work of the contrast ring 45 can be facilitated while suppressing the lifting of the reinforcing body.

  Further, as another structure for forming a hole portion penetrating inward and outward in the intermediate layer 43, the intermediate layer 43 is formed by one wall portion, and a slit extending in the axial direction on the wall portion, extending around the axis. A structure that forms a slit or a slit extending in a spiral shape is conceivable. Even in this case, in the intermediate layer 43, a plurality of reinforcing elements (linear elements, rod-shaped elements, strip-shaped elements, slits) are formed by a predetermined reinforcing body (linear bodies, rod-shaped bodies, strip-shaped bodies, one wall portion). Therefore, the contrast ring 45 can be provided so that the wall portion enters between the reinforcing elements.

  (10) The configuration related to the caulking of the contrast ring 45 as already described, or the taper of the intermediate layer 43, in the configuration in which the contrast ring 45 is provided not at the distal end portion of the intermediate layer 43 but at the proximal end portion. The following configuration may be applied.

  (11) The configuration for attaching the contrast ring 45 to the intermediate layer 43 as described above may be applied to a configuration in which a metal tube is connected to a tube having a reinforcing layer such as a braided tube or a coil. .

  (12) When attention is paid to the fact that the wall of the contrast ring 45 enters between a plurality of linear elements so that the displacement of the contrast ring 45 can be regulated by the linear body 43a that forms the intermediate layer 43. In addition, a configuration in which a concavo-convex shape 45c is formed on the outer peripheral surface of the contrast ring 45, and a tapered region 43b is formed in the intermediate layer 43 over a predetermined range from the distal end portion toward the proximal side, and the tapered region The structure formed so that 43b may become thin gradually toward a distal end part is arbitrary. However, by providing these configurations, it is possible to achieve the effects as described in the above embodiment.

  (13) The present invention may be applied to a balloon catheter. For example, the present invention may be applied to a catheter body that generates a guide wire lumen in a balloon catheter, and the present invention is applied to a catheter body that generates a fluid lumen through which a compressed fluid passes when the balloon is inflated or deflated. May be. The balloon catheter may be any of PTCA, PTA, IABP, and the like. In addition, the present invention may be applied to various suction catheters, blood flow blocking catheters, catheters for penetrating the distal end portion by being pressed against a blockage site due to a thrombus, a guiding catheter, and the like. . In addition, the present invention may be applied to a catheter used when treating or examining a “tube” or “body cavity” in a living body such as a ureter other than blood vessels or a digestive tract.

(About other inventions extracted from the disclosure scope of this specification)
Hereinafter, the invention that can be extracted within the disclosure scope of the present specification will be described while showing effects and the like as necessary.

  (A1) A tube body having a reinforcing layer formed using a linear body, a strip-shaped body, or a rod-shaped body, and a covering body connected to one end side of the reinforcing layer, wherein the reinforcing layer has the one end A predetermined range toward the center in the axial direction is formed thinner than the center in the axial direction, and the covering is provided so as to cover the entire predetermined range. A medical instrument characterized. According to this configuration, it is possible to facilitate the work when the covering body is attached to the reinforcing layer while suppressing the occurrence of the lifting of the linear body.

  (B1) a tube body having a reinforcing layer formed using a linear body, a strip-shaped body, or a rod-shaped body, and a covering body connected to one end side of the reinforcing layer, and the reinforcing layer includes the one end A predetermined range from the central side in the axial direction to the central side in the axial direction is formed narrower than the central side in the axial direction. A medical instrument characterized by being provided so as to extend to an area. According to this configuration, it is possible to stably support the covering body in the reinforcing layer while facilitating the work when the covering body is attached to the reinforcing layer.

  (B2) The welded portion between the covering body and the reinforcing layer is an area covered by the covering body in the reinforcing layer and is formed in a central area in the axial direction with respect to the predetermined range. The medical instrument according to (B1) above, characterized by According to this configuration, since welding is performed at a location where the contact area between the covering and the reinforcing layer is wide, the welding strength can be improved.

  (C1) In a medical instrument comprising a tube body having a reinforcing layer and an inner layer on the inner peripheral side of the reinforcing layer, and a metal covering body connected to the tube body, the covering body is The reinforcing layer is disposed so as to cover from the outside, and a welded portion between the covering and the reinforcing layer is formed in the covering region, and the welded portion includes the covering and the reinforcing layer. A medical instrument characterized in that a communicating hole penetrates the inner layer. According to this configuration, when welding is performed through laser irradiation, it is possible to reliably perform welding between the covering and the reinforcing layer even when the irradiation intensity of the laser irradiation apparatus varies to some extent.

  (C2) The tube body includes an outer layer so as to cover the reinforcing layer from the outside, and the hole is filled with a material for forming the outer layer, as described in (C1) above Medical instrument. According to this configuration, in the configuration in which the welding of the covering and the reinforcing layer can be reliably performed as described above, the through hole generated in the inner layer can be filled using the outer layer forming step.

  (D1) In a medical instrument comprising a tube body having a reinforcing layer formed using a linear body, a band-shaped body, or a rod-shaped body, and a metal covering body connected to the tube body, the covering The body is disposed so as to cover the reinforcing layer from the outside, and a welded portion between the covering body and the reinforcing layer is formed in the covering region, and the welded portion causes the welded portion to be generated. A medical device characterized by being formed so as to include only a part of the reinforcing element in the width direction. According to this structure, it becomes possible to weld a covering body and a reinforcement layer, without cutting a linear body, a strip | belt-shaped body, or a rod-shaped body in the middle position.

  (D2) The welding location is formed so as to include a location where a plurality of reinforcing elements formed by the linear body, strip-shaped body, or rod-shaped body intersect, as described in (D1) above Medical instrument. According to this configuration, it is possible to secure a wide welding area between the covering and the reinforcing layer, and the welding strength can be improved.

  (E1) A tube body having a reinforcing layer is provided, and the reinforcing layer is formed by using the reinforcing body and is partitioned by a plurality of reinforcing elements formed by the reinforcing body in the axial direction. A hole portion penetrating inward and outward is formed at an intermediate position, and a predetermined range from one end in the axial direction toward the central side is further provided with an end side region formed narrower than the central side in the axial direction. The medical device is characterized in that the end side region is formed by gradually narrowing the reinforcing layer toward the one end. According to this structure, it becomes possible to make the edge part of a reinforcement layer thin, suppressing generation | occurrence | production of the lift of a linear body, a strip | belt-shaped body, or a rod-shaped body.

  DESCRIPTION OF SYMBOLS 10 ... Catheter assembly, 11 ... Outer catheter, 31 ... Outer tube part, 33 ... Outer tube hole, 41 ... Inner layer, 42 ... Outer layer, 43 ... Intermediate layer, 43a ... Linear body, 43b ... Tapered area, 43c ... Parallel Area 44 ... Flexible tip area 45 ... Contrast ring 45a ... Tapered follow area 45b ... Parallel follow area 45c ... Concave and convex shape 46 ... Welded part.

Claims (8)

A tube body having a reinforcing layer formed in a mesh shape using a plurality of reinforcing bodies;
A metal covering connected to the tube body;
With
The tube body includes an inner layer on the inner peripheral side than the reinforcing layer,
In the reinforcing layer, a hole that penetrates inward and outward at an intermediate position in the axial direction is formed,
The hole is defined by a plurality of reinforcing elements formed by the reinforcing body,
The covering is arranged so as to cover the reinforcing layer from the outside,
In the covering region, the wall portion of the covering body enters between the plurality of reinforcing elements, and thereby the outer peripheral surface of the covering body has an uneven shape corresponding to the plurality of reinforcing elements ,
In the region where the uneven shape is generated in the covering, welding of the covering and the reinforcing body is performed,
A medical instrument characterized in that, at the welded portion between the covering and the reinforcing body, a hole communicating with the covering and the reinforcing body passes through the inner layer . The welding portion of the covering body and the reinforcing body, medical claim 1, characterized in that it is formed to include only a portion of the width direction of the reinforcing elements that cause the welding point Appliances. The welding portion of the covering body and the reinforcing body, medical instrument according to claim 1 or 2, wherein a plurality of said reinforcing elements is formed to include at the intersection. The tube body includes an outer layer so as to cover the reinforcing layer from the outside,
The hole is medical instrument according to claim 1 to 3, characterized by being filled with the material for forming the outer layer. The tube body includes a resin layer on the outer peripheral surface side of the reinforcing layer,
Since the thickness of the resin layer changes in accordance with the uneven shape, the outer peripheral surface corresponding to the position of the uneven shape in the tube body has no unevenness with respect to its periphery. The medical instrument according to any one of claims 1 to 4 . The reinforcing layer has, in the covering region, a region where the outer peripheral surface of the reinforcing layer is inclined with respect to the axis of the tube body, and a region parallel to the axis.
The covering body is shaped so as to follow each of the inclined region and the parallel region, and a wall portion of the covering body enters the hole portion in both the regions. Item 6. The medical instrument according to any one of Items 1 to 5 . The medical device according to any one of claims 1 to 6 , wherein the covering is a contrast ring formed of a radiopaque material. The medical device according to any one of claims 1 to 7 , wherein the reinforcing body forming the reinforcing layer is one of a linear shape, a strip shape, and a rod shape.

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