Medical wire

Abstract

The present invention comprises a bendable first flexible tube body (11) that extends in the front-rear direction, an operation wire (12) that extends in the front-rear direction and is inserted into the first flexible tube body (11), and a support body (14) that is fixed to a rear end part of the first flexible tube body (11). A front end part of the operation wire (12) is fixed to a front end part of the first flexible tube body (11) so as to be spaced from a center axis line (O1) of the first flexible tube body (11) toward one side in the radial direction. An operation part (13) to which the operation wire is fixed and that can move in the front-rear direction relative to the support body is provided to the rear of the support body. A first restriction part (16) and a second restriction part (17) that engage each other and thereby restrict relative movement of the support body and the operation part in the circumferential direction are formed on the support body and the operation part, respectively.

Description

Medical Wire

[0001] The present invention relates to a medical wire such as a guidewire. This application claims priority to Japanese Patent Application No. 2023-218948, filed on December 26, 2023, the contents of which are incorporated herein by reference.

[0002] Conventionally, as shown in Patent Document 1 below, a guidewire has been known as a medical wire, comprising a first flexible tubular body (outer flexible tubular body 4) extending in the front-rear direction and formed to be bendable, a manipulation wire (core shaft) extending in the front-rear direction and inserted inside the first flexible tubular body, and a support fixed to the rear end of the first flexible tubular body. Generally, a guidewire is inserted into a blood vessel and used to guide a balloon or a stent to a chronic total occlusion lesion or the like in a state where the guidewire penetrates a chronic total occlusion lesion or the like in the blood vessel. When penetrating a chronic total occlusion lesion or the like with the guidewire, the following procedure is taken, for example: First, the guidewire inserted into a microcatheter is advanced into the blood vessel. When the guidewire reaches a chronic total occlusion lesion or the like in the blood vessel, the previously used guidewire is removed while leaving the microcatheter in the blood vessel. Then, a new guidewire with a higher tip load or the like than the first guidewire is inserted into the microcatheter and pierced into the chronic total occlusion lesion or the like, and the chronic total occlusion lesion or the like is penetrated with the guidewire and the microcatheter. Thereafter, the microcatheter is left in the blood vessel, having penetrated the chronic total occlusion lesion, etc., and the guidewire with the high tip load, etc. is removed. The original guidewire with the low tip load, etc. is reinserted into the microcatheter, and after it has reached a position where it penetrates the chronic total occlusion lesion, etc., the microcatheter is removed, leaving the guidewire in place.

[0003] Japanese Patent Application Publication No. 2011-199

[0004] With conventional guidewires, in order to penetrate a chronic total occlusion or the like, it is necessary to use guidewires with different bending stiffnesses, such as tip loads, by inserting and removing them from blood vessels, etc., and replacing them accordingly. Furthermore, in order to select a blood vessel at a vascular bifurcation and advance into the target blood vessel before reaching a chronic total occlusion or the like, it is necessary to insert and remove the guidewire from the blood vessel and fine-tune the curvature of the front end of the guidewire (the bending tendency called preshape) outside the body. For this reason, there is a demand for shortening the surgical time.

[0005] The present invention provides a medical wire that can shorten the time required for surgery.

[0006] A medical wire according to one aspect of the present invention includes a first flexible tubular body extending in a front-to-rear direction and formed to be bendable and deformable, an operating wire extending in a front-to-rear direction and inserted inside the first flexible tubular body, and a support body fixed to the rear end of the first flexible tubular body, wherein the front end of the operating wire is fixed to the front end of the first flexible tubular body in a state spaced apart in one radial direction from the central axis of the first flexible tubular body, and an operating unit to which the operating wire is fixed and which is movable in a front-to-rear direction relative to the support body is provided behind the support body, and the support body and the operating unit are each formed with a first restricting unit and a second restricting unit which engage with each other to restrict relative circumferential movement of the support body and the operating unit.

[0007] According to one aspect of the present invention, the front end of the manipulation wire is fixed to the front end of the first flexible tubular body while being spaced apart in one radial direction from the central axis of the first flexible tubular body. Therefore, when the manipulation wire is pulled rearward relative to the support portion, the first flexible tubular body undergoes compressive deformation and bends in a specific radial direction. By manipulating the manipulation wire and bending the front end of the medical wire in a specific direction, a blood vessel can be selected at a vascular bifurcation and the medical wire can be advanced into the target blood vessel. This reduces the physician's dependence on the sense of manipulation when guiding the medical wire along the blood vessel to reach a chronic total occlusion lesion or the like, and eliminates the need to insert or remove the medical wire from the blood vessel to fine-tune the curvature of the front end of the medical wire outside the body. Furthermore, when the manipulation wire is pulled rearward relative to the support portion, the front ends of the manipulation wire and the first flexible tubular body move rearward, causing the first flexible tubular body to undergo compressive deformation in the front-to-rear direction between the support portion and the first flexible tubular body, thereby increasing the bending rigidity of the first flexible tubular body. Therefore, by manipulating the manipulation wire while the medical wire is inserted into a blood vessel, the bending rigidity of the first flexible tubular body can be changed. As a result, when penetrating a chronic total occlusion or the like with the medical wire, the bending rigidity of the first flexible tubular body is kept low until the medical wire enters the blood vessel and reaches the chronic total occlusion or the like within the blood vessel. Then, when the medical wire is thrust into the chronic total occlusion or the like and penetrates the chronic total occlusion or the like with the medical wire, the manipulation wire is pulled rearward relative to the support portion to increase the bending rigidity of the first flexible tubular body. After penetrating the chronic total occlusion or the like with the medical wire, the manipulation of the manipulation wire can be released to return the bending rigidity of the first flexible tubular body to its original low state. This eliminates the need to use different medical wires with different bending rigidities by inserting and removing them from the blood vessel or the like to penetrate the chronic total occlusion or the like. As a result, the surgical time can be shortened.

[0008] Since the operation section to which the operation wire is fixed is provided behind the support, the operability of the medical wire can be improved compared to when the operation wire is directly operated.

[0009] The support body and the operating unit are each formed with a first restricting portion and a second restricting portion that engage with each other to restrict relative circumferential movement of the support body and the operating unit. This makes it possible to restrict rotational movement of the operating unit with respect to the support body when operating the operating unit, thereby reliably improving the operability of the medical wire and making it easy to assemble the operating unit to the support body.

[0010] One of the first regulating portion and the second regulating portion may be a protrusion, and the other may be a recess in which the protrusion is accommodated so as to be movable in the forward and backward directions, and the recess may be formed with an abutment portion against which the protrusion abuts in the forward and backward directions when the operating portion moves rearward relative to the support body.

[0011] The recess has a stop portion formed therein against which the protrusion hits in the forward and backward directions when the operating part moves rearward relative to the support body, so that the amount of rearward movement of the operating wire is kept within a desired range, preventing excessively large loads from being applied to the first flexible tube body.

[0012] A second flexible tube extending in the front-to-rear direction and formed to be bendable and deformable is inserted inside the first flexible tube, the operating wire is inserted inside the second flexible tube, the central axis of the second flexible tube and the front end of the operating wire are spaced apart from the central axis of the first flexible tube in one radial direction, the front end of the second flexible tube is fixed to at least one of the front ends of the first flexible tube and the operating wire, and the rear end of the second flexible tube, located rearward of the front end, is fixed to at least one of the support body and the rear end of the first flexible tube.

[0013] Because the second flexible tubular body is provided, when the manipulation wire is pulled rearward relative to the support part, the first and second flexible tubular bodies are compressed and deformed while bending in one radial direction, which makes it possible to easily adjust (design) the relationship between the manipulation force on the manipulation wire and the bending shape of the front end of the medical wire while maintaining the outer diameter of the medical wire, for example.

[0014] According to the above aspect of the present invention, the time required for surgery can be shortened.

[0015] Fig. 1 is a longitudinal cross-sectional view of a medical wire according to an embodiment; Fig. 2 is a cross-sectional view taken along the line II-II in Fig. 1; Fig. 3 is a first modified example of a medical wire according to an embodiment; Fig. 4 is a second modified example of a medical wire according to an embodiment; Fig. 5 is a third modified example of a medical wire according to an embodiment.

[0016] A first embodiment of the medical wire will be described below with reference to Figures 1 and 2A. The medical wire 1 is a guidewire including a first flexible tubular body 11, an operating wire 12, an operating section 13, a support member 14, and a second flexible tubular body 15. The first flexible tubular body 11, the operating wire 12, the operating section 13, the support member 14, and the second flexible tubular body 15 are formed of, for example, a metal material. Note that the materials forming the first flexible tubular body 11, the operating wire 12, the operating section 13, the support member 14, and the second flexible tubular body 15 may be changed as appropriate. The second flexible tubular body 15 may not be provided.

[0017] The operation unit 13 and the support body 14 are formed in a cylindrical shape and disposed coaxially with the central axis O1 of the first flexible tubular body 11. Hereinafter, the side where the first flexible tubular body 11 is located with respect to the support body 14 in the direction in which the central axis O1 extends will be referred to as the front side, the side where the operation unit 13 is located with respect to the support body 14 in the direction in which the central axis O1 extends will be referred to as the rear side, and the direction in which the central axis O1 extends will be referred to as the front-rear direction. A direction intersecting the central axis O1 as viewed from the front-rear direction will be referred to as the radial direction, and a direction going around the central axis O1 as viewed from the front-rear direction will be referred to as the circumferential direction.

[0018] The first flexible tubular body 11 extends in the front-rear direction and is formed to be bendable. The first flexible tubular body 11 is a coil spring extending in the front-rear direction. The outer diameter of the first flexible tubular body 11 is large enough to be inserted into a blood vessel (e.g., 0.2 mm to 1.0 mm). The outer shape and size of the first flexible tubular body 11 as viewed in the front-rear direction are constant over the entire length in the front-rear direction. The diameter of the wire material forming the first flexible tubular body 11 is constant over the entire length.

[0019] The diameter of the wire forming the first flexible tubular body 11 does not have to be constant along its entire length, and the outer shape and size of the first flexible tubular body 11 as viewed in the front-rear direction do not have to be constant along its entire length in the front-rear direction. For example, the outer diameter of the first flexible tubular body 11 may decrease toward the front. The first flexible tubular body 11 is not limited to a coil spring, and may be, for example, a tubular body having a peripheral wall that extends continuously along its entire length in both the front-rear direction and the circumferential direction.

[0020] The support body 14 is fixed to the rear end of the first flexible tubular body 11. The support body 14 extends in the front-rear direction and is formed to be bendable. The rear end opening edge of the first flexible tubular body 11 abuts against the front end opening edge of the support body 14 in the front-rear direction. The front end of the support body 14 and the rear end of the first flexible tubular body 11 are fixed together by, for example, soldering, brazing, adhesive, or crimping. In the illustrated example, a cylindrical intermediate fixing member 23 made of, for example, solder, brazing material, or adhesive extends forward from the front end of the support body 14. The outer peripheral surface of the intermediate fixing member 23 is seamlessly connected to the outer peripheral surfaces of the support body 14 and the first flexible tubular body 11 in the front-rear direction.

[0021] The outer diameter of the support 14 is equal to the outer diameter of the first flexible tubular body 11 and is large enough to be inserted into a blood vessel (e.g., 0.2 mm to 1.0 mm). The outer shape and size of the support 14 as viewed in the front-rear direction are constant over the entire length in the front-rear direction. Note that the outer shape and size of the support 14 as viewed in the front-rear direction do not have to be constant over the entire length in the front-rear direction. For example, the outer diameter of the support 14 may decrease toward the front. The outer shapes and sizes of the support 14 and the first flexible tubular body 11 as viewed in the front-rear direction may be different from each other. In this case, it is preferable that the support 14 does not protrude radially outward from the outer circumferential surface of the first flexible tubular body 11 as viewed in the front-rear direction.

[0022] The operation unit 13 is provided behind the support body 14. The operation unit 13 protrudes rearward from the support body 14. The operation unit 13 is provided so as to be movable in the front-rear direction relative to the support body 14. In the illustrated example, the rear end of the support body 14 is inserted into the front portion of the operation unit 13. Note that the front end opening edge of the operation unit 13 and the rear end opening edge of the support body 14 may face each other in the front-rear direction, or the front portion of the operation unit 13 may be inserted into the rear end of the support body 14. The rear end of the operation wire 12 is fixed to the operation unit 13 by, for example, soldering, brazing, adhesive, or crimping. In the illustrated example, the rear end opening of the operation unit 13 is closed by a rear fixing member 24 made of, for example, a solder material, a brazing material, or an adhesive, and the rear end of the operation wire 12 is embedded in the rear fixing member 24.

[0023] The operation wire 12 extends in the front-rear direction and is inserted inside the first flexible tubular body 11. The operation wire 12 is formed to be elastically deformable. The front end of the operation wire 12 is fixed to the front end of the first flexible tubular body 11 by, for example, soldering, brazing, adhesive bonding, or crimping, in a state spaced apart from the central axis O1 in one radial direction. Note that a plurality of operation wires 12 may be provided at intervals in the circumferential direction.

[0024] The operation wire 12 extends straight in the front-rear direction. Note that the operation wire 12 may extend in the front-rear direction while being bent, for example. The rear portion of the operation wire 12 protrudes rearward from the support body 14. Of the front end portion of the operation wire 12, a protruding portion 12a protruding forward from the first flexible tubular body 11 is bent in one radial direction and engaged with the front-end opening edge of the first flexible tubular body 11. The protruding portion 12a of the operation wire 12 is located at the same radial position as, or radially inward from, the outer circumferential surface of the front end portion of the first flexible tubular body 11. The protruding portion 12a of the operation wire 12 is bent in one radial direction and folded back rearward, with the distal end surface of the operation wire 12 facing rearward. The distal end surface of the operation wire 12 abuts against or is close to the front-end opening edge of the first flexible tubular body 11. Note that the distal end surface of the operation wire 12 may face in one radial direction.

[0025] In the illustrated example, the front end opening of the first flexible tubular body 11 is closed by a front fixing member 25 made of, for example, solder, brazing material, or adhesive. The outer peripheral surface of the front fixing member 25 is connected to the outer peripheral surface of the first flexible tubular body 11 without any step in the front-to-rear direction. The front end of the operation wire 12, including the protruding portion 12a, is embedded in the front fixing member 25.

[0026] The bending rigidity of the intermediate section 11a of the first flexible tubular body 11, which is located between the front end (front fixing member 25) and the rear end (middle fixing member 23), decreases from the rear to the front. In the example shown, the first flexible tubular body 11 includes a first hard tubular section 22 having high bending rigidity, and a pair of first soft tubular sections 21 which have lower bending rigidity than the first hard tubular section 22 and sandwich the first hard tubular section 22 in the front-to-rear direction. Of the pair of first soft tubular sections 21, the number of turns of the first soft tubular section 21 located on the front side is greater than the number of turns of the first soft tubular section 21 located on the rear side. Note that the number of turns of the former may be equal to or less than the number of turns of the latter.

[0027] The first soft tube section 21 is formed so that the distance (inter-wire gap) between adjacent wire members in the front-to-rear direction is wider than that of the first hard tube section 22. As a result, the bending rigidity of the first soft tube section 21 is smaller than that of the first hard tube section 22, making it easier to flex flexibly to follow the bending of the blood vessel. In the illustrated example, adjacent wire members in the front-to-rear direction in the first hard tube section 22 abut against each other. In other words, the first hard tube section 22 is formed as a tightly wound coil spring. As a result, in the intermediate section 11a of the first flexible tube 11, the first hard tube section 22 is easier to flex flexibly to follow the bending deformation of the first soft tube section 21.

[0028] Of the pair of first soft tube sections 21, a front portion of the first soft tube section 21 located on the front side is joined or adhered to the front fixing member 25, and a rear portion of this first soft tube section 21 is located between the front fixing member 25 and the intermediate fixing member 23. Of the pair of first soft tube sections 21, the first soft tube section 21 located on the rear side is joined or adhered over its entire length to the intermediate fixing member 23. Therefore, of the first flexible tube 11, the intermediate section 11a located between the front fixing member 25 and the intermediate fixing member 23 is composed of the entire first hard tube section 22 and the rear portion of the first soft tube section 21 located on the front side of the pair of first soft tube sections 21. As a result, the bending rigidity of the intermediate section 11a of the first flexible tube 11 decreases stepwise from the rear to the front. Note that the bending rigidity of the intermediate section 11a of the first flexible tube 11 may also decrease linearly from the rear to the front. In the illustrated example, the length in the front-rear direction of the first hard pipe section 22 is longer than the length in the front-rear direction of the rear part of the first soft pipe section 21 that is located on the front side of the pair of first soft pipe sections 21. Note that the length of the former may be shorter than the length of the latter.

[0029] The second flexible tubular body 15 extends in the front-rear direction and is formed to be bendable. The second flexible tubular body 15 is inserted inside the first flexible tubular body 11. The front end of the second flexible tubular body 15 is fixed to at least one of the front ends of the first flexible tubular body 11 and the operation wire 12, and the rear end of the second flexible tubular body 15, which is located rearward of the front end, is fixed to at least one of the support body 14 and the rear end of the first flexible tubular body 11. The second flexible tubular body 15 protrudes in both the front-rear direction from the first flexible tubular body 11. Note that the second flexible tubular body 15 does not have to protrude in the front-rear direction from the first flexible tubular body 11.

[0030] At least one of the first flexible tubular body 11 and the second flexible tubular body 15 is a coil spring extending in the front-rear direction. In the illustrated example, both the first flexible tubular body 11 and the second flexible tubular body 15 are coil springs extending in the front-rear direction. The winding directions of the first flexible tubular body 11 and the second flexible tubular body 15 are opposite to each other. However, the winding directions of the first flexible tubular body 11 and the second flexible tubular body 15 may be the same as each other. Either one of the first flexible tubular body 11 and the second flexible tubular body 15 is not limited to a coil spring and may be, for example, a tubular body having a peripheral wall that extends continuously over the entire length in both the front-rear direction and the circumferential direction.

[0031] The bending rigidity of the intermediate section 15a of the second flexible tube 15, which is located between the front end section (front fixing member 25) and the rear section (middle fixing member 23), decreases from rear to front. In the illustrated example, the second flexible tube 15 is configured by connecting a second soft tube section 31, which has low bending rigidity, and a second hard tube section 32, which has higher bending rigidity than the second soft tube section 31, in this order from front to rear. The second soft tube section 31 protrudes forward from the first flexible tube 11, and the second hard tube section 32 protrudes rearward from the first flexible tube 11. The length of the second soft tube section 31 in the front-to-rear direction is slightly shorter than the length of the second hard tube section 32 in the front-to-rear direction.

[0032] The second soft tube section 31 is formed so that the distance (inter-wire gap) between adjacent wire members in the front-to-rear direction is wider than that of the second hard tube section 32. As a result, the bending rigidity of the second soft tube section 31 is smaller than that of the second hard tube section 32, making it easier to flex flexibly to follow the bending of the blood vessel. In the illustrated example, adjacent wire members in the front-to-rear direction in the second hard tube section 32 abut against each other. In other words, the second hard tube section 32 is formed as a tightly wound coil spring. As a result, in the intermediate section 15a of the second flexible tube 15, the second hard tube section 32 is easier to flex flexibly to follow the bending deformation of the second soft tube section 31.

[0033] A front portion of the second soft tube section 31 is joined or bonded to the front fixing member 25. As a result, the front end of the second flexible tubular body 15 is fixed to the front end portions of the first flexible tubular body 11 and the operating wire 12 via the front fixing member 25. The rear portion of the second soft tube section 31 is located between the front fixing member 25 and the intermediate fixing member 23. The intermediate fixing member 23 is joined or bonded to the outer circumferential surface of a portion of the second hard tube section 32 located between the front end portion located inside the first flexible tubular body 11 and the rear end portion located inside the support body 14. As a result, the rear portion of the second flexible tubular body 15 located rearward of the front end portion is fixed to the support body 14 and the rear end portion of the first flexible tubular body 11 via the intermediate fixing member 23. In the illustrated example, the intermediate fixing member 23 does not close the inside of the second hard tube section 32, and the inside of the support body 14 is in communication with the rear portion of the second soft tube section 31 through the inside of the second hard tube section 32.

[0034] The intermediate section 15a of the second flexible tubular body 15, located between the front fixing member 25 and the middle fixing member 23, is composed of the rear section of the second soft tubular section 31 and the front end section of the second hard tubular section 32. As a result, the bending rigidity of the intermediate section 15a of the second flexible tubular body 15 decreases stepwise from the rear to the front. Alternatively, the bending rigidity of the intermediate section 15a of the second flexible tubular body 15 may decrease linearly from the rear to the front. In the illustrated example, the length in the front-rear direction of the rear section of the second soft tubular section 31 is longer than the length in the front-rear direction of the front end section of the second hard tubular section 32. Alternatively, the length of the former may be shorter than the length of the latter. Within the intermediate section 11a of the first flexible tubular body 11, the rear section of the second soft tubular section 31 straddles the boundary between the first hard tubular section 22 and the first soft tubular section 21 located at the front of the pair of first soft tubular sections 21 in the front-rear direction.

[0035] The operation wire 12 is inserted inside the second flexible tubular body 15. The central axis O2 of the second flexible tubular body 15 and the front end of the operation wire 12 are spaced apart in one radial direction from the central axis O1 of the first flexible tubular body 11. The front end of the operation wire 12 is fixed to the front end of the second flexible tubular body 15 by, for example, soldering, brazing, adhesive bonding, or crimping, while being spaced apart in one radial direction from the central axis O2 of the second flexible tubular body 15. The operation wire 12 is disposed on the inner circumferential surface of the second flexible tubular body 15.

[0036] The protruding portion 12a of the operation wire 12 also protrudes forward from the second flexible tubular body 15, is bent in one radial direction, and is engaged with the edge of the front end opening of the second flexible tubular body 15. The protruding portion 12a of the operation wire 12 is bent back, and a circumferential portion of the front end portion of the second flexible tubular body 15 is pinched in the radial direction by the front end portion of the operation wire 12, including the protruding portion 12a. The entire front end portion of the operation wire 12, including the protruding portion 12a, is embedded in the front fixing member 25.

[0037] The outer peripheral surface of the front portion of the support 14 and the outer peripheral surface of a portion of the medical wire 1 located forward of the front portion of the support 14 are coated with a hydrophilic material. This allows the medical wire 1 to be moved smoothly through blood vessels with less snagging. The outer peripheral surface of the portion of the medical wire 1 located rearward of the front portion of the support 14 is coated with a hydrophobic material. This makes it less likely for the hand operating the medical wire 1 to slip. The outer peripheral surface of the operating portion 13 does not need to be coated with a hydrophobic material. Examples of hydrophilic materials include polyvinylpyrrolidone, maleic acid-based resins, and hyaluronic acid-based resins. Examples of hydrophobic materials include fluorine-based resins (PTFE, PFA, etc.), silicone-based resins, etc.

[0038] In this embodiment, the support body 14 and the operating unit 13 are each formed with a first restricting portion 16 and a second restricting portion 17 that engage with each other to restrict relative circumferential movement of the support body 14 and the operating unit 13. One of the first restricting portion 16 and the second restricting portion 17 is a protrusion, and the other is a recess that accommodates the protrusion so that it can move in the front-to-rear direction. In the illustrated example, the first restricting portion 16 of the support body 14 is a protrusion that protrudes radially outward from the outer circumferential surface of the support body 14, and the second restricting portion 17 of the operating unit 13 is a recess that recesses radially outward from the inner circumferential surface of the operating unit 13. One first restricting portion 16 and one second restricting portion 17 are provided.

[0039] The first restricting portion 16 is formed in a rectangular parallelepiped shape extending in the front-rear direction. The first restricting portion 16 may also be formed in a rod shape extending in the radial direction. As shown in FIG. 2A , the first restricting portion 16 has a rectangular shape in a cross section along the radial direction and perpendicular to the front-rear direction. Of the two pairs of sides defining the rectangular shape, one pair rises from the outer peripheral surface of the support body 14, and the other pair extends in the circumferential direction. The circumferential size (width) of the first restricting portion 16 is constant throughout the entire radial range. The rear end edge of the first restricting portion 16 is seamlessly connected to the rear end opening edge of the support body 14 in the radial direction.

[0040] The second restricting portion 17 is a groove that does not penetrate radially and extends in the front-rear direction. The second restricting portion 17 opens at the rear-end opening edge of the operating unit 13 and is located rearward of the front-end opening edge of the operating unit 13. The circumferential size (groove width) of the second restricting portion 17 is constant throughout the radial direction. A pair of circumferentially opposing side surfaces of the inner surface defining the second restricting portion 17 abuts or is close to the first restricting portion 16 in the circumferential direction. The front end surface of the inner surface of the second restricting portion 17, which is located at the front end and faces rearward, is separated forward from the first restricting portion 16 in a standby state in which no load is applied from the operation wire 12 to the first flexible tubular body 11 and the second flexible tubular body 15. The front end surface of the second restricting portion 17 forms an abutment portion 17a against which the first restricting portion 16 abuts in the front-rear direction when the operating unit 13 moves rearward relative to the support body 14.

[0041] As described above, with the medical wire 1 according to this embodiment, the front end of the manipulation wire 12 is fixed to the front end of the first flexible tubular body 11 in a state spaced apart in one radial direction from the central axis O1 of the first flexible tubular body 11. Therefore, when the manipulation wire 12 is pulled rearward relative to the support portion 14, the first flexible tubular body 11 is compressed and deformed while bending in one radial direction. This allows the front end of the medical wire 1 to be bent in a desired direction by manipulating the manipulation wire 12, thereby selecting a blood vessel at a vascular bifurcation and advancing the medical wire 1 into the target blood vessel. This reduces the physician's dependency on the sense of manipulation when guiding the medical wire 1 along the blood vessel to reach a chronic total occlusion lesion or the like, and also eliminates the need to insert and remove the medical wire from the blood vessel to fine-tune the curvature of the front end of the medical wire outside the body.

[0042] Furthermore, when the manipulation wire 12 is pulled rearward relative to the support portion 14, the front ends of the manipulation wire 12 and the first flexible tubular body 11 move rearward, and the first flexible tubular body 11 is compressed and deformed in the front-to-rear direction between the support portion 14, thereby increasing the bending rigidity of the first flexible tubular body 11. Therefore, by manipulating the manipulation wire 12 while the medical wire 1 is inserted into a blood vessel, the bending rigidity of the first flexible tubular body 11 can be changed.

[0043] As a result, when the medical wire 1 is to penetrate a chronic total occlusion lesion or the like, the bending rigidity of the first flexible tubular body 11 is kept low until the medical wire 1 is advanced into a blood vessel and reaches the chronic total occlusion lesion or the like within the blood vessel, and when the medical wire 1 is thrust into the chronic total occlusion lesion or the like and penetrates the chronic total occlusion lesion or the like with the medical wire 1, the manipulation wire 12 is pulled rearward relative to the support part 14 to increase the bending rigidity of the first flexible tubular body 11, and after penetrating the chronic total occlusion lesion or the like, the manipulation of the manipulation wire 12 can be released to return the bending rigidity of the first flexible tubular body 11 to its original low state. This eliminates the need to use different medical wires with different bending rigidities by inserting and removing them from the blood vessel or the like to penetrate a chronic total occlusion lesion or the like.

[0044] As a result, the operation time can be reduced.

[0045] Since the operation section 13 to which the operation wire 12 is fixed is provided behind the support 14, the operability of the medical wire 1 can be improved compared to when the operation wire 12 is directly operated.

[0046] The support body 14 and the operating unit 13 are each formed with a first restricting portion 16 and a second restricting portion 17 that engage with each other to restrict relative circumferential movement of the support body 14 and the operating unit 13. This makes it possible to restrict rotational movement of the operating unit 13 relative to the support body 14 when operating the operating unit 13, thereby reliably improving the operability of the medical wire 1 and making it easy to assemble the operating unit 13 to the support body 14.

[0047] One of the first restricting portion 16 and the second restricting portion 17 is a protrusion, and the other is a recess that accommodates the protrusion so that it can move in the front-rear direction, and the recess is formed with an abutment portion 17a that the protrusion abuts in the front-rear direction when the operating portion 13 moves rearward relative to the support body 14. Therefore, the amount of rearward movement of the operating wire 12 is kept within a desired range, and it is possible to prevent an excessively large load from being applied to the first flexible tubular body 11.

[0048] Since the second flexible tube 15 is provided, when the operating wire 12 is pulled rearward relative to the support portion 14, the first flexible tube 11 and the second flexible tube 15 are compressed and deformed while bending in one radial direction.As a result, it is possible to easily adjust (design) the relationship between the operating force on the operating wire 12 and the bending shape of the front end of the medical wire 1, for example, while maintaining the outer diameter of the medical wire 1.

[0049] The technical scope of the present invention is not limited to the above-described embodiment, and various modifications can be made without departing from the spirit of the present invention.

[0050] For example, the bending rigidity of the intermediate portions 11a, 15a may be the same over the entire length in the front-rear direction. The protruding portion 12a of the operation wire 12 may be bent in one radial direction so that the distal end surface of the operation wire 12 faces in one radial direction, and may be opposed to the front-rear direction while being spaced forward from the front-end opening edge of the first flexible tubular body 11. In this case, the front fixing member 25 may also be filled between the protruding portion 12a of the operation wire 12 and the front-end opening edge of the first flexible tubular body 11, and the front end of the operation wire 12, including the protruding portion 12a, may be embedded in the front fixing member 25. The second flexible tubular body 15 may not be provided, and the protruding portion 12a of the operation wire 12 may be bent in one radial direction and engaged with the front-end opening edge of the first flexible tubular body 11.

[0051] A plurality of first and second restricting portions 16 and 17 may be provided. For example, as shown in FIG. 2B , one each may be provided on either side of the central axis O1 in the radial direction. The first and second restricting portions 16 and 17 may have a circumferential size that increases radially outward. For example, as shown in FIG. 2C , a pair of circumferentially opposing side surfaces of the inner surface of the second restricting portion 17 may extend in a direction away from each other radially outward. The surfaces of the first restricting portion 16 that abut or are adjacent to these side surfaces may also extend in a direction away from each other radially outward. As shown in FIG. 2D , the second restricting portion 17 may be configured to penetrate the operating portion 13 in the radial direction, and the first restricting portion 16 may be configured to penetrate the second restricting portion 17 and protrude radially outward from the outer circumferential surface of the operating portion 13.

[0052] The radially outer end surface of the first restricting portion 16 may be formed as a curved surface that protrudes radially outward, or may be recessed radially inward, or the first restricting portion 16 may be pointed radially outward. The first restricting portion 16 and the second restricting portion 17 may extend in a direction that is inclined with respect to the front-to-rear direction. The first restricting portion 16 and the second restricting portion 17 may be the outer peripheral surface of the support body 14 and the inner peripheral surface of the operating portion 13 that have a non-circular shape in a cross section that is aligned radially and perpendicular to the front-to-rear direction. In other words, the outer peripheral surface of the support body 14 and the inner peripheral surface of the operating portion 13 may have similar non-circular shapes in the cross section, with the outer peripheral surface of the support body 14 forming the first restricting portion 16 and the inner peripheral surface of the operating portion 13 forming the second restricting portion 17. The first restricting portion 16 and the second restricting portion 17 may be formed by plastic processing the support body 14 and the operating portion 13. The first restricting portion 16 of the support body 14 may be a recess recessed radially inward from the outer circumferential surface of the support body 14, and the second restricting portion 17 of the operating unit 13 may be a protrusion protruding radially inward from the inner circumferential surface of the operating unit 13. Furthermore, this protrusion may be formed by pressing the outer circumferential surface of the operating unit 13 radially inward to plastically deform the operating unit 13.

[0053] In addition, it is possible to replace the components in the above-described embodiments with well-known components as appropriate, without departing from the spirit of the present invention, and the above-described embodiments and variations may be combined as appropriate.

[0054] REFERENCE SIGNS LIST 1 medical wire 11 first flexible tubular body 12 operating wire 13 operating section 14 support body 15 second flexible tubular body 16 first restricting section 17 second restricting section 17a abutting section O1 central axis of first flexible tubular body O2 central axis of second flexible tubular body

Claims

1. A medical wire comprising a first flexible tube body extending in the front-rear direction and formed to be bendable, an operating wire extending in the front-rear direction and inserted inside the first flexible tube body, and a support fixed to the rear end portion of the first flexible tube body, wherein the front end portion of the operating wire is fixed to the front end portion of the first flexible tube body in a state of being separated from the central axis of the first flexible tube body in one direction in the radial direction, and an operating portion that is fixed to the operating wire and is movable in the front-rear direction with respect to the support is provided behind the support, and a first restricting portion and a second restricting portion that restrict relative movement in the circumferential direction of the support and the operating portion by engaging with each other are respectively formed on the support and the operating portion.

2. Among the first restricting portion and the second restricting portion, one of them is a protrusion, and the other is a recess in which the protrusion is accommodated so as to be movable in the front-rear direction, and the recess is formed with an abutting portion against which the protrusion abuts in the front-rear direction when the operating portion moves rearward with respect to the support. The medical wire according to claim 1.

3. A second flexible tube body extending in the front-rear direction and formed to be bendable is inserted inside the first flexible tube body, the operating wire is inserted inside the second flexible tube body, the central axis of the second flexible tube body and the front end portion of the operating wire are separated from the central axis of the first flexible tube body in one direction in the radial direction, the front end portion of the second flexible tube body is fixed to at least one of the front end portions of the first flexible tube body and the operating wire, and the rear portion of the second flexible tube body located behind the front end portion is fixed to at least one of the support and the rear end portion of the first flexible tube body. The medical wire according to claim 1 or 2.

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