GUIDE WIRES
20220395674 · 2022-12-15
Assignee
Inventors
Cpc classification
A61M2205/0238
HUMAN NECESSITIES
A61M2025/09133
HUMAN NECESSITIES
A61M2025/09066
HUMAN NECESSITIES
International classification
Abstract
A guide wire includes a core wire, a first resin layer that coats a part of the core wire, a coil body wound around another part of the core wire and an outer side of the first resin layer, and a second resin layer that coats the coil body, in which a part of the coil body is embedded in the first resin layer and the second resin layer.
Claims
1. A guide wire comprising: a core wire; a first resin layer that coats a part of the core wire; a coil body wound around another part of the core wire and an outer side of the first resin layer; and a second resin layer that coats the coil body, wherein: a part of the coil body is embedded in the first resin layer and the second resin layer.
2. The guide wire according to claim 1, wherein: the second resin layer is lower in hardness than the first resin layer.
3. The guide wire according to claim 1, wherein: an end portion at a proximal end side of the first resin layer is located close to a proximal end side of the core wire relative to an end portion at a proximal end side of the second resin layer.
4. The guide wire according to claim 1, wherein: the end portion at the proximal end side of the first resin layer decreases in thickness toward the proximal end side of the core wire.
5. The guide wire according to claim 1, wherein: the first resin layer includes, at its proximal end side, an inclusion portion having all of the proximal end portion of the coil body being embedded into the first resin layer, and the second resin layer is arranged only at a distal end side from a distal end of the inclusion portion.
6. The guide wire according to claim 1, wherein: the core wire includes a protrusion portion having an enlarged diameter at a position contacting the end portion at the proximal end side of the first resin layer.
7. The guide wire according to claim 6, wherein: the protrusion portion includes a reduced diameter portion having an outer diameter decreasing from a proximal end side toward a distal end side, and the end portion at the proximal end side of the first resin layer is provided in contact with the reduced diameter portion.
8. The guide wire according to claim 1, further comprising: a regulation portion arranged between the coil body and the core wire at a distal end side from the first resin layer, the regulation portion having another part of the coil body being embedded therein.
9. The guide wire according to claim 2, wherein: an end portion at a proximal end side of the first resin layer is located close to a proximal end side of the core wire relative to an end portion at a proximal end side of the second resin layer.
10. The guide wire according to claim 2, wherein: the end portion at the proximal end side of the first resin layer decreases in thickness toward the proximal end side of the core wire.
11. The guide wire according to claim 2, wherein: the first resin layer includes, at its proximal end side, an inclusion portion having all of the proximal end portion of the coil body being embedded into the first resin layer, and the second resin layer is arranged only at a distal end side from a distal end of the inclusion portion.
12. The guide wire according to claim 2, wherein: the core wire includes a protrusion portion having an enlarged diameter at a position contacting the end portion at the proximal end side of the first resin layer.
13. The guide wire according to claim 12, wherein: the protrusion portion includes a reduced diameter portion having an outer diameter decreasing from a proximal end side toward a distal end side, and the end portion at the proximal end side of the first resin layer is provided in contact with the reduced diameter portion.
14. The guide wire according to claim 2, further comprising: a regulation portion arranged between the coil body and the core wire at a distal end side from the first resin layer, the regulation portion having another part of the coil body being embedded therein.
15. The guide wire according to claim 3, wherein: the end portion at the proximal end side of the first resin layer decreases in thickness toward the proximal end side of the core wire.
16. The guide wire according to claim 3, wherein: the first resin layer includes, at its proximal end side, an inclusion portion having all of the proximal end portion of the coil body being embedded into the first resin layer, and the second resin layer is arranged only at a distal end side from a distal end of the inclusion portion.
17. The guide wire according to claim 3, wherein: the core wire includes a protrusion portion having an enlarged diameter at a position contacting the end portion at the proximal end side of the first resin layer.
18. The guide wire according to claim 17, wherein: the protrusion portion includes a reduced diameter portion having an outer diameter decreasing from a proximal end side toward a distal end side, and the end portion at the proximal end side of the first resin layer is provided in contact with the reduced diameter portion.
19. The guide wire according to claim 3, further comprising: a regulation portion arranged between the coil body and the core wire at a distal end side from the first resin layer, the regulation portion having another part of the coil body being embedded therein.
20. The guide wire according to claim 4, wherein: the first resin layer includes, at its proximal end side, an inclusion portion having all of the proximal end portion of the coil body being embedded into the first resin layer, and the second resin layer is arranged only at a distal end side from a distal end of the inclusion portion.
Description
BRIEF DESCRIPTION OF DRAWINGS
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DETAILED DESCRIPTION OF EMBODIMENTS
First Embodiment
[0041]
[0042] In
[0043] The core wire 10 is a tapered long member having a large diameter at the proximal end side and a small diameter at the distal end side. The core wire 10 includes a small diameter portion 11, a first reduced diameter portion 12, a first increased diameter portion 13, a second reduced diameter portion 14, and a second increased diameter portion 15, in this order from the distal end side to the proximal end side. An outer diameter and a length at each portion of the core wire 10 may be freely determined.
[0044] The small diameter portion 11 is formed at the distal end portion of the core wire 10. The small diameter portion 11 is a portion where an outer diameter of the core wire 10 is smallest, and has a substantially columnar shape having a substantially constant outer diameter. The distal end of the small diameter portion 11 is formed with a distal end joint portion 40. The first reduced diameter portion 12 is formed between the small diameter portion 11 and the first increased diameter portion 13. The first reduced diameter portion 12 has a tapered shape in which the outer diameter decreases from the proximal end side toward the distal end side. The first increased diameter portion 13 is formed between the first reduced diameter portion 12 and the second reduced diameter portion 14. The first increased diameter portion 13 has a substantially columnar shape having a substantially constant outer diameter larger than the outer diameter of the small diameter portion 11. A part of the first increased diameter portion 13 at the proximal end side is coated with the first resin layer 50. The outer peripheral surfaces of the small diameter portion 11, the first reduced diameter portion 12, and the first increased diameter portion 13 are covered by the coil body 20.
[0045] The second reduced diameter portion 14 is formed between the first increased diameter portion 13 and the second increased diameter portion 15. The second reduced diameter portion 14 has a tapered shape in which the outer diameter decreases from the proximal end side toward the distal end side. The second increased diameter portion 15 is formed at the proximal end portion of the core wire 10. The second increased diameter portion 15 is a portion where an outer diameter of the core wire 10 is largest, and has a substantially columnar shape having a substantially constant outer diameter. The second reduced diameter portion 14 and the second increased diameter portion 15 are not covered by the coil body 20, and are used when an operator grasps the guide wire 1. An outer diameter and a length of each portion (the small diameter portion 11 to the second increased diameter portion 15) of the core wire 10 may be freely determined.
[0046] The coil body 20 is formed by spirally winding a wire 21 around the core wire 10 and the first resin layer 50. The coil body 20 has a substantially cylindrical shape having a substantially constant outer diameter from the proximal end side to the distal end side. The coil body 20 is arranged, at the distal end side, to cover the small diameter portion 11, the first reduced diameter portion 12, and the first increased diameter portion 13 of the core wire 10 with a space therebetween. The coil body 20 is arranged, at the proximal end side, to cover an outer side of the first resin layer 50 in a state of invading into the outer side (outer peripheral surface) of the first resin layer 50. It is noted that the coil body 20 is not arranged in the second reduced diameter portion 14 and the second increased diameter portion 15 of the core wire 10.
[0047] The coil body 20 of the first embodiment is a loosely wound single-thread coil formed by winding one wire 21 into a single thread with a gap formed between adjacent strands of the wire 21. It is noted that the coil body 20 may be a multi-thread coil formed by winding a plurality of wires 21 into a multi-thread, or may be a single-thread twisted-wire coil formed by winding a twisted wire obtained by twisting a plurality of wires 21 into a single thread, or may be a multi-thread twisted-wire coil formed by winding each twisted wire into multiple threads using a plurality of twisted wires obtained by twisting a plurality of wires 21. It is possible to freely determine an outer diameter and an inner diameter of the coil body 20.
[0048] The coil body 20 is fixed to the core wire 10 by the distal end joint portion 40 and the intermediate fixing portion 60. The distal end joint portion 40 is a member that joins the distal end portion of the coil body 20 and the distal end portion of the small diameter portion 11 of the core wire 10. The intermediate fixing portion 60 is a member that fixes a part of the coil body 20 and a part of the first increased diameter portion 13 of the core wire 10, in the vicinity of an intermediate portion in the direction of the axial line O of the coil body 20. It is noted that the guide wire 1 may be formed with a plurality of intermediate fixing portions used for fixing the coil body 20 and the core wire 10.
[0049] The first resin layer 50 is a layer of resin that coats a part of an outer side (outer peripheral surface) of the core wire 10. Specifically, the first resin layer 50 coats a part of the proximal end side of the first increased diameter portion 13 of the core wire 10. The first resin layer 50 may be formed of a resin material having a hardness higher than that of the second resin layer 30, such as, for example, hard urethane. Here, “hardness” refers to the micro Vickers hardness measured by a micro Vickers hardness tester.
[0050] The first resin layer 50 includes an invading portion 51 and a reduced thickness portion 52. The invading portion 51 is a portion embedded with the wire 21 of the coil body 20 on the outside (outer peripheral surface), and has a substantially constant outer diameter except for a recess portion embedded with the wire 21. In a cross section illustrated in the drawings, about half of the wire 21 is embedded in the invading portion 51. However, the ratio of the wire 21 to be embedded in the invading portion 51 may be freely changed. The reduced thickness portion 52 is an end portion at the proximal end side of the first resin layer 50, in other words, a portion provided at the proximal end side of the invading portion 51, and has a thickness of the resin layer that gradually decreases from the distal end side toward the proximal end. In the present embodiment, a length L1 of the invading portion 51 in the direction of the axial line O is longer than a length L2 of the reduced thickness portion 52 in the direction of the axial line O. The lengths L1 and L2 may be freely determined.
[0051] The second resin layer 30 is a layer of resin that coats an outer side (outer peripheral surface) of the coil body 20. Specifically, the second resin layer 30 coats outer sides of each of a whole of the coil body 20 from the distal end to the proximal end, the distal end joint portion 40, and the invading portion 51 of the first resin layer 50, and does not coat an outer side of the reduced thickness portion 52 of the first resin layer 50. The second resin layer 30 may be formed of a resin material having a hardness lower than that of the first resin layer 50, such as, for example, soft urethane.
[0052] A depressed portion 31 is formed in a part of the second resin layer 30 that coats the coil body 20 and does not coat the first resin layer 50. The depressed portion 31 is a portion in which the resin layer enters into the gap between adjacent strands of the wire 21. When the depressed portion 31 is provided, it is possible to increase a contact surface between the second resin layer 30 and the coil body 20 (specifically, the wire 21), and it is possible to improve the joint strength between the second resin layer 30 and the coil body 20. It is not required that the second resin layer 30 includes the depressed portion 31. In the second resin layer 30, in a portion coating both the coil body 20 and the first resin layer 50, the second resin layer 30 and the first resin layer 50 contact each other in a gap between adjacent strands of the wire 21.
[0053] When such a configuration is provided, in the guide wire 1 according to the first embodiment, a part of the coil body 20 (specifically, a portion at the proximal end side of the coil body 20) is configured to be embedded into the second resin layer 30 and the first resin layer 50. In the guide wire 1, an end portion 50p at the proximal end side of the first resin layer 50 is located closer to the proximal end side relative to an end portion 30p at the proximal end side of the second resin layer 30.
[0054] The core wire 10 preferably provides an antithrombotic property, flexibility, and biocompatibility, and may be formed of a material such as a stainless alloy (SUS304, SUS316, and the like), a superelastic alloy such as a nickel-titanium alloy, a piano wire, a nickel-chromium based alloy, a cobalt alloy, and tungsten. The wire 21 of the coil body 20 may be formed of, for example, a stainless alloy such as SUS304 and SUS316, a superelastic alloy such as a nickel-titanium alloy, a piano wire, a radiolucent alloy such as a nickel-chromium based alloy and a cobalt alloy, gold, platinum, tungsten, and a radiopaque alloy such as an alloy containing these elements (for example, a platinum-nickel alloy). The distal end joint portion 40 is preferably flexible and may be formed of, for example, a resin material such as polyurethane and polyurethane elastomer. The intermediate fixing portion 60 may be formed of any joining agent, such as, for example, a metal solder such as silver solder, gold solder, zinc, Sn-Ag alloy, and Au-Sn alloy, or an adhesive such as an epoxy adhesive. It is noted that the materials of each of the above-mentioned members are merely examples, and each member may be formed of a well-known material other than the materials mentioned above.
[0055] The guide wire 1 may be produced, for example, as follows. Firstly, the first resin layer 50 is formed in a part of the first increased diameter portion 13 of the core wire 10. Next, a freely chosen joining agent such as an epoxy adhesive is applied to an outer side (outer peripheral surface) of the invading portion 51 of the first resin layer 50. Subsequently, the wire 21 is wound around the outer sides of the small diameter portion 11 to the first increased diameter portion 13 of the core wire 10 and the invading portion 51 of the first resin layer 50 to form the coil body 20. Next, the distal end joint portion 40 and the intermediate fixing portion 60 are formed. Subsequently, a freely chosen joining agent such as an epoxy adhesive is applied to outer sides (outer peripheral surfaces) of the coil body 20, the distal end joint portion 40, and the invading portion 51 of the first resin layer 50. Next, the second resin layer 30 is formed on outer sides (outer peripheral surfaces) of the coil body 20, the distal end joint portion 40, and the invading portion 51 of the first resin layer 50. Finally, caulking is applied to the second resin layer 30 from an outer side to bring the second resin layer 30 into close contact with the coil body 20, the distal end joint portion 40, and the first resin layer 50. It is noted that the caulking may be omitted.
[0056]
[0057] As described above, the guide wire 1 of the first embodiment includes the indirectly connected portion P1 and the directly connected portion P2, and thus, as compared to a configuration including only the directly connected portion, it is possible to increase an area of the connected portion (in other words, a contact surface between members contributing to the connection of the first resin layer 50 and the second resin layer 30) and it is possible to improve a connection strength between the first resin layer 50 and the second resin layer 30. When the indirectly connected portion P1 in which the first resin layer 50 and the second resin layer 30 are connected via the coil body 20 is provided, even if shear stress SS is applied along a longitudinal direction (
[0058] In the guide wire 1 according to the first embodiment, the second resin layer 30 has a lower hardness than the first resin layer 50, and thus, it is possible to flexibly configure the second resin layer 30 and the coil body 20 coated with the second resin layer 30, and it is possible to further improve the flexibility of the guide wire 1. The hardness of the first resin layer 50 is equal to or higher than the hardness of the second resin layer 30, and thus, it is possible to cause the first resin layer 50 to function as a protective member that protects a part of the coil body 20 and a part of the core wire 10.
[0059] In the guide wire 1 of the first embodiment, the end portion 50p at the proximal end side of the first resin layer 50 is located closer to the proximal end side of the core wire 10 relative to the end portion 30p at the proximal end side of the second resin layer 30 (
Second Embodiment
[0060]
[0061] As described above, the configuration of the guide wire 1A can be changed in various ways, and the regulation portion 70 may be provided. In the illustrated example, a surface at the proximal end side of the regulation portion 70 contacts a surface at the distal end side of the first resin layer 50, but the regulation portion 70 may be provided with a distance from the first resin layer 50. It is possible to freely determine the length L3 in which the regulation portion 70 is provided, and it is also possible to freely change a magnitude relationship between the lengths L1 and L2. Such a guide wire 1A according to the second embodiment exhibits an effect similar to that of the first embodiment.
[0062]
Third Embodiment
[0063]
[0064] The first resin layer 50B includes an inclusion portion 53 at the proximal end side from the invading portion 51 and at the distal end side from the reduced thickness portion 52 (in other words, between the invading portion 51 and the reduced thickness portion 52). In the inclusion portion 53, all of the proximal end portion of the coil body 20, in other words, all of the wire 21 forming the coil body 20 at the proximal end portion of the coil body 20, is embedded. The inclusion portion 53 has a substantially constant outer diameter, and the outer diameter of the inclusion portion 53 is substantially the same as a portion having the largest outer diameter of the second resin layer 30B. In the illustrated example, a length L13 of the inclusion portion 53 in the direction of the axial line O is substantially the same as a length L11 of the invading portion 51. The second resin layer 30B is not provided in an outer side (outer peripheral surface) of the inclusion portion 53, and the outer area of the inclusion portion 53 is exposed to the outside. That is, the second resin layer 30B is arranged only at the distal end side from the distal end of the inclusion portion 53.
[0065] As described above, the configuration of the guide wire 1B can be changed in various ways, and the first resin layer 50B may include the inclusion portion 53 in which all of the proximal end portion of the coil body 20 is embedded. In the illustrated example, the reduced thickness portion 52 in which the resin layer gradually decreases in thickness, is provided at the proximal end side of the inclusion portion 53 having a substantially constant outer diameter, but the inclusion portion 53 and the reduced thickness portion 52 may be integrally configured. That is, a configuration may be such that the thickness of the resin layer gradually decreases in the inclusion portion 53. An outer side (outer peripheral surface) of the inclusion portion 53 may be covered with the second resin layer 30B. Such a guide wire 1B according to the third embodiment exhibits an effect similar to those of the above-described first and second embodiments.
[0066] According to the guide wire 1B of the third embodiment, the first resin layer 50B includes, at the proximal end side, the inclusion portion 53 having all of the proximal end portion of the coil body 20 being embedded into the first resin layer 50B. Therefore, when the hardness of the first resin layer 50B is configured to be equal to or higher than the hardness of the second resin layer 30B, it is possible to improve a protection capability of protecting the end portion at the proximal end side of the coil body 20 and a part of the core wire 10 corresponding to the end portion at the proximal end side of the coil body 20. Processing for gradually decreasing the thickness of the resin layer of the end portion at the proximal end side of the first resin layer 50B toward the proximal end side is easier.
Fourth Embodiment
[0067]
[0068] The core wire 10C further includes the protrusion portion 16 in addition to the small diameter portion 11 to the second increased diameter portion 15 described in the first embodiment. The protrusion portion 16 is provided in the vicinity of the end portion at the proximal end side of the first increased diameter portion 13 and at a position contacting the end portion 50p at the proximal end side of the first resin layer 50C. As illustrated in
[0069] As described above, the configuration of the guide wire 1C can be changed in various ways, and it is possible to adopt a configuration in which the core wire 10C including the protrusion portion 16 is provided and the end portion 50p at the proximal end side of the first resin layer 50C is protected by the protrusion portion 16. The outer diameter Φ2 of the protrusion portion 16 can be freely changed as long as such a diameter Φ2 is larger than the outer diameter Φ1 of the first increased diameter portion 13 and smaller than the outer diameter Φ3 of the inclusion portion 53. Such a guide wire 1C according to the fourth embodiment exhibits an effect similar to those of the above-described first to third embodiments.
[0070] According to the guide wire 1C of the fourth embodiment, the core wire 10C includes the protrusion portion 16 having an enlarged diameter at a position contacting the end portion 50p at the proximal end side of the first resin layer 50C. Therefore, it is possible to protect the end portion 50p at the proximal end side of the first resin layer 50C with the protrusion portion 16 of the core wire 10C, and it is possible to suppress peeling of the proximal end portion 50p of the first resin layer 50C. It is further possible to regulate a movement of the wire 21 (the wire 21 configuring the coil body 20) when the shear stress along the longitudinal direction (X-axial direction) is applied to the guide wire 1C, by the protrusion portion 16 of the core wire 10C. As a result, it is possible to provide a guide wire 1C having enhanced resistance to breakage and improved safety.
[0071] According to the guide wire 1C of the fourth embodiment, the end portion 50p at the proximal end side of the first resin layer 50C is provided in contact with the reduced diameter portion 161 of the protrusion portion 16. Therefore, it is possible to surely protect the end portion 50p at the proximal end side of the first resin layer 50C, and it is possible to reduce a possibility that kinking occurs in the core wire 10C, by suppressing concentration of stress applied to the protrusion portion 16 when a shear stress along the longitudinal direction (X-axial direction) is applied to the guide wire 1C. It is possible to suppress generation of a step as a result of exposure of the core wire 10C at the distal end side from the protrusion portion 16, and thus, it is possible to suppress catching on the additional device and improve the slidability with respect to the additional device.
Comparative Examples
[0072]
[0073]
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[0075]
Fifth Embodiment
[0076]
Sixth Embodiment
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Seventh Embodiment
[0078]
Eighth Embodiment
[0079]
Modifications of Present Embodiments
[0080] The disclosed embodiments are not limited to the above-described embodiments, and may be implemented in various modes without departing from the spirit of the disclosed embodiments. The following modifications can be applied, for example.
First Example Modification
[0081] In the above-described first to eighth embodiments, examples of the configurations of the guide wires 1 and 1A to 1G are described. However, the configuration of the guide wire 1 can be variously modified. For example, it is not required that the guide wire 1 includes the small diameter portion 11 and the first reduced diameter portion 12. For example, the core wire 10 of the guide wire 1 may be formed by a plurality of core wires formed by using different materials. For example, it is not required that the second resin layer 30 covers the distal end joint portion 40, or covers the entire coil body 20. For example, the first resin layer 50 may be integrally configured with the second resin layer 30. For example, the end portion 50p at the proximal end side of the first resin layer 50 may be provided in contact with the second reduced diameter portion 14 of the core wire 10.
Second Example Modification
[0082] The configurations of the guide wires 1 and 1A to 1G of the first to eighth embodiments described above, and the configurations of the guide wires 1 and 1A to 1G of the modification described above may be appropriately combined. For example, in the configuration of the first embodiment, the inclusion portion 53 (third embodiment) may be provided, or the protrusion portion 16 (fourth and eighth embodiments) may be provided. For example, in the configurations described in the second, third, and fourth embodiments, the first resin layer 50D of the fifth embodiment may be used, the second resin layer 30E of the sixth embodiment may be used, and the first resin layer 50F of the seventh embodiment may be used.
[0083] Although the aspects have been described based on the embodiments and the modifications, the embodiments of the above-described aspects are for facilitating understanding of the aspects, and do not limit the aspects. The aspects can be modified and improved without departing from the spirit of the aspects and the scope of the claims, and equivalent aspects are included in the aspects. Further, unless a technical feature is described as essential in the present specification, the technical feature may be omitted as appropriate.
DESCRIPTION OF REFERENCE NUMERALS
[0084] 1, 1A to 1G, 1w to 1z Guide wire
[0085] 10, 10C, 10G Core wire
[0086] 11 Small diameter portion
[0087] 12 First reduced diameter portion
[0088] 13 First increased diameter portion
[0089] 14 Second reduced diameter portion
[0090] 15 Second increased diameter portion
[0091] 16, 16G, 16w, 16z Protrusion portion
[0092] 20 Coil body
[0093] 21 Wire
[0094] 30, 30B, 30E Second resin layer
[0095] 31 Depressed portion
[0096] 40 Distal end joint portion
[0097] 50, 50B to 50D, 50F, 50x, 50y First resin layer
[0098] 51 Invading portion
[0099] 52, 52C, 52w Reduced thickness portion
[0100] 53 Inclusion portion
[0101] 60 Intermediate fixing portion
[0102] 70 Regulation portion
[0103] 161 Reduced diameter portion
[0104] 162 Increased diameter portion