Medical device
By coating a specific area of the outer coil of the guidewire, the problem of guidewire passability and vascular perforation risk is solved, achieving the effect of high slippage and low perforation risk in a specific area.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- ASAHI INTECC CO LTD
- Filing Date
- 2023-11-10
- Publication Date
- 2026-05-19
AI Technical Summary
Existing guidewires have surface properties that make it difficult to simultaneously improve passability and reduce the risk of vascular perforation.
A coating, such as polyurethane resin, is applied to specific areas of the outer coil of the guidewire to enhance slippage, while other areas are left uncoated to reduce slippage, thus imparting different surface properties to different areas of the guidewire.
This achieves a balance between high guidewire throughput in specific areas and reduced risk of vascular perforation, thus improving the overall performance of the guidewire.
Smart Images
Figure CN122070155A_ABST
Abstract
Description
Technical Field
[0001] The technology disclosed in this specification relates to a medical device. Background Technology
[0002] For example, the use of catheters is widely used to treat or examine narrowed or blocked sections of blood vessels (hereinafter referred to as "lesions"). A guidewire is used to guide the catheter into the lesion within the blood vessel. The guidewire has a tip and an outer coil connected to the tip.
[0003] A type of guidewire is known in which the entire outer coil is covered with a coating (see, for example, Patent Document 1).
[0004] Existing technical documents Patent documents Patent Document 1: U.S. Patent Application Publication No. 2004 / 0039304 Summary of the Invention The problem that the invention aims to solve Sometimes, it is necessary to endow guidewires with desired surface characteristics. For example, sometimes it is necessary to give guidewires surface characteristics that simultaneously improve permeability and reduce the risk of vascular perforation. Traditional guidewires have faced the challenge of achieving these desired surface characteristics. This challenge is not limited to guidewires but is a common challenge in medical devices.
[0005] This specification discloses a technique that can solve the above-mentioned problems.
[0006] Methods for solving problems (1) The medical device (100) disclosed in this specification comprises a front tip (40), an outer coil (20), and a coating (60). The outer coil (20) is connected to the front tip (40). The coating (60) covers the outer peripheral surface of the front tip (40) and the outer peripheral surface of the outer coil (20) in a region (R1) from the front end (41) of the front tip (40) to a predetermined axial position (P1). The axial position (P1) is located closer to the front end than the base end (22) of the outer coil (20).
[0007] In this medical device, the surface of the outer coil is coated with a coating in the region closer to the front end compared to a predetermined axial position, while the surface of the outer coil is not coated in the region closer to the base end compared to the predetermined axial position. Therefore, desired surface characteristics can be imparted to each region along the axial direction of the medical device. For example, the coating on the outer coil in the region closer to the front end compared to the predetermined axial position improves the slippage of the medical device, thereby enhancing its passability. Conversely, the lack of coating on the outer coil in the region closer to the base end compared to the predetermined axial position suppresses slippage, thereby reducing the risk of perforation of blood vessels, etc. As a result, the medical device can simultaneously improve passability and reduce the risk of perforation of blood vessels, etc.
[0008] (2) In the above-mentioned medical device, the coating may also be made of polyurethane resin. According to this structure, the area on the surface of the outer coil covered by the coating can effectively improve the slippage of the medical device and effectively improve the passability of the medical device.
[0009] (3) The above-mentioned medical device may also further include: a mandrel disposed inside the outer coil; and a coupling portion that engages the mandrel with the outer coil, wherein the axial direction position is located closer to the base end side than the coupling portion. According to this structure, it is possible to ensure that the area of the outer coil surface covered by the coating reaches a certain level, and the passability of the medical device can be effectively improved.
[0010] (4) In the above-mentioned medical device, an inner coil may also be included, which is connected to the front end and disposed inside the outer coil, and the axial position is located closer to the base end than the base end of the inner coil. According to this structure, it is possible to ensure that the area of the outer coil surface covered by the coating is large enough, and the passability of the medical device can be effectively improved.
[0011] (5) In the above-mentioned medical device, the coating may also be a first coating, and the medical device may further include a second coating that covers the outer periphery of the outer coil. According to this structure, the slippage of the medical device can be improved by utilizing the second coating, and the passability of the medical device can be improved.
[0012] (6) In the above-mentioned medical device, the second coating may also be hydrophilic. According to this structure, the presence of the second coating can effectively improve the slippage of the medical device and improve its passability.
[0013] (7) In the above-described medical device, the second coating may also cover the first coating in a region closer to the front end than the axial direction position. According to this structure, the presence of the first and second coatings in the region closer to the front end than the axial direction position can effectively improve the slippage of the medical device and effectively improve its passability.
[0014] (8) In the above-described medical device, the slippage of the region from the tip of the tip to the axial position may be higher than the slippage of the region from the axial position to the base of the outer coil. According to this structure, the slippage of the region from the tip of the tip of the medical device to the aforementioned axial position can be improved, thereby improving the permeability of the medical device, while suppressing the slippage of the region closer to the base compared to this region, thereby reducing the risk of perforation of blood vessels, etc., caused by the medical device.
[0015] It should be noted that the technology disclosed in this specification can be implemented in various ways, such as by means of medical devices and manufacturing methods thereof. Attached Figure Description
[0016] Figure 1 This is an explanatory diagram that schematically illustrates the structure of the guidewire in the embodiment. Detailed Implementation
[0017] A. Implementation method: (Structure of guidewire 100) Figure 1 This is an explanatory diagram that schematically shows the structure of the guidewire 100 in the embodiment. Figure 1 The mutually orthogonal XYZ axes used to specify the direction are shown, and a longitudinal section (YZ section) of guidewire 100 is shown. Along a direction parallel to the central axis AX of guidewire 100 (hereinafter referred to as the "axial direction"), the positive Z-axis side is the distal side (distal side) inserted into the body, and the negative Z-axis side is the proximal side (proximal side) operated by a physician or other personnel. Figure 1 The diagram shows the guidewire 100 as a straight line generally parallel to the Z-axis. The guidewire 100 has the flexibility to bend to a certain extent. In this specification, for the guidewire 100 and its constituent components, the end on the front end side is referred to as the "front end", the front end and its vicinity are referred to as the "front end", the end on the base end side is referred to as the "base end", and the base end and its vicinity are referred to as the "base end".
[0018] Guidewire 100 is a medical device. Guidewire 100 is inserted into a blood vessel to guide other medical devices (not shown), such as catheters, to lesions within the blood vessel. Guidewire 100 includes a spindle 10, an outer coil 20, an inner coil 30, a tip 40, a first intermediate joint 51, a second intermediate joint 52, a first base-side joint 53, a second base-side joint 54, a first coating 60, a second coating 70, and a third coating 80.
[0019] The mandrel 10 is an elongated component. The central axis of the mandrel 10 is approximately aligned with the central axis AX of the guide wire 100. The mandrel 10 includes a first part 11, a second part 12, a third part 13, a fourth part 14, a fifth part 15, a sixth part 16, a seventh part 17, and an eighth part 18. The first part 11, the second part 12, the third part 13, the fourth part 14, the fifth part 15, the sixth part 16, the seventh part 17, and the eighth part 18 are arranged sequentially from the front end towards the base end.
[0020] In this embodiment, the cross-sectional (XY section) shapes of the first portion 11, third portion 13, fifth portion 15, and eighth portion 18 of the mandrel 10 at various positions along the axial direction are constant. The cross-sectional area of the third portion 13 is larger than that of the first portion 11. The cross-sectional area of the fifth portion 15 is larger than that of the third portion 13. The cross-sectional area of the eighth portion 18 is larger than that of the fifth portion 15. The cross-sectional shapes of the second portion 12, fourth portion 14, sixth portion 16, and seventh portion 17 of the mandrel 10 are smoothly connected to the cross-sectional shapes of adjacent portions along the axial direction. The second portion 12, fourth portion 14, sixth portion 16, and seventh portion 17 are tapered portions, and their cross-sectional areas gradually increase from the front end side to the base end side.
[0021] The mandrel 10 of this shape can be manufactured, for example, by stamping a precursor having a constant cross-section along the axial direction at a pressing rate corresponding to the shape of each part of the mandrel 10.
[0022] Materials used to form the mandrel 10 include, for example, metallic materials, and more specifically, stainless steel (SUS302, SUS304, SUS316, etc.), nickel-titanium alloys, piano wire, nickel-chromium alloys, cobalt alloys, tungsten, etc.
[0023] The outer coil 20 is a hollow cylindrical component formed by spirally winding wire. The outer coil 20 is, for example, a tightly wound coil. The outer coil 20 is arranged around the outer periphery of the front end of the core 10. In the axial direction, the position of the front end 21 of the outer coil 20 is approximately the same as the position of the front end of the core 10.
[0024] The inner coil 30 is a hollow cylindrical component formed by spirally winding wire. The inner coil 30 is, for example, a tightly wound coil. The inner coil 30 is positioned within the space inside the outer coil 20, surrounding the outer periphery of the front end of the mandrel 10. In the axial direction, the position of the front end 31 of the inner coil 30 is approximately the same as the position of the front end of the mandrel 10, while the position of the base end 32 of the inner coil 30 is closer to the front end than the position of the base end 22 of the outer coil 20.
[0025] The outer and inner diameters of the outer coil 20 and the inner coil 30 can remain constant along the axial direction or change along the axial direction.
[0026] Materials used to form the outer coil 30 and the inner coil 30 include, for example, metallic materials, and more specifically, radiation-transmitting alloys such as stainless steel (SUS302, SUS304, SUS316, etc.), nickel-titanium alloys, piano wire, nickel-chromium alloys, or cobalt alloys; and radiation-impermeable alloys such as gold, platinum, tungsten, or alloys containing these elements (e.g., platinum-nickel alloys).
[0027] The front tip 40 engages the front end of the mandrel 10 with the front ends of the outer coil 20 and the inner coil 30. That is, the outer coil 20 and the inner coil 30 are connected to the front tip 40. The outer peripheral surface of the front end side of the front tip 40 is a smooth surface (e.g., approximately hemispherical). The first base end side engagement 53 engages the mandrel 10 with the base end of the outer coil 20. The second base end side engagement 54 engages the mandrel 10 with the base end of the inner coil 30. The first intermediate engagement 51 engages the mandrel 10 with the middle portion of the outer coil 20. The middle portion of the outer coil 20 refers to the portion of the outer coil 20 excluding the front and base ends (the same applies below). The first intermediate engagement 51 engages the mandrel 10 with the middle portion of the inner coil 30. The first intermediate engagement 51 is an example of an engagement. The second intermediate engagement 52 is located closer to the base end side than the first intermediate engagement 51, engaging the mandrel 10 with the middle portion of the outer coil 20. Materials used to form the tip 40 and the joints 51, 52, 53, and 54 include, for example, silver solder, gold solder, zinc, Sn-Ag alloy, Au-Sn alloy, and other metal solders; or epoxy resin adhesives and other adhesives.
[0028] The first coating 60 covers the outer peripheral surface of the tip 40 and the outer peripheral surface of the outer coil 20 in a first region R1 at a predetermined position in the axial direction from the tip 41 of the tip 40 of the guide wire 100 to the axial direction (hereinafter referred to as "first axial direction position P1"). Polyurethane resin is, for example, a material forming the first coating 60.
[0029] The second coating 70 covers the outer periphery of the outer coil 20 in a second region R2 at a predetermined position in the axial direction from the tip 41 of the guide wire 100 tip 40 to the axial direction (hereinafter referred to as "second axial direction position P2"). More specifically, in the second region R2 (excluding the first region R1), the second coating 70 covers the outer periphery of the outer coil 20, and in the first region R1, the second coating 70 covers the first coating 60. This structure can be achieved, for example, by forming the second coating 70 in the second region R2, which includes the first region R1, after the first coating 60 is formed in the first region R1. For example, the second coating 70 is a hydrophilic coating. Examples of materials forming the second coating 70 include polyvinylpyrrolidone, polyacrylic acid, polyacrylamide, polyvinyl alcohol, maleic anhydride copolymer, and hyaluronic acid.
[0030] The third coating 80 covers the outer periphery of the mandrel 10 in the region of the guide wire 100 closer to the base end than the outer coil 20. PTFE is, for example, an example material for forming the third coating 80.
[0031] (Effects of this implementation method) As described above, the guide wire 100 of this embodiment includes a tip 40, an outer coil 20, and a first coating 60. The outer coil 20 is connected to the tip 40. The first coating 60 covers the outer peripheral surface of the tip 40 and the outer peripheral surface of the outer coil 20 in a region R1 from the tip 41 of the tip 40 to a position P1 in the first axial direction. The first axial direction position P1 is located closer to the tip side than the base end 22 of the outer coil 20. Thus, in the guide wire 100 of this embodiment, the surface of the outer coil 20 is covered by the first coating 60 in the first region R1 closer to the tip side than the first axial direction position P1, and the surface of the outer coil 20 is not covered by the first coating 60 in the region closer to the base end side than the first axial direction position P1. Therefore, according to the guide wire 100 of this embodiment, desired surface characteristics can be imparted to each region along the axial direction. For example, in the first region R1, closer to the front end than the position P1 along the first axial direction, the surface of the outer coil 20 is covered by the first coating 60, thus improving the slippage of the guidewire 100 and thereby enhancing its throughput. In the region closer to the base end than the position P1 along the first axial direction, the surface of the outer coil 20 is not covered by the first coating 60, thus inhibiting the slippage of the guidewire 100 and reducing the risk of perforation of blood vessels, etc. As a result, the guidewire 100 can simultaneously achieve both improved throughput and reduced risk of vascular perforation.
[0032] The first coating 60 may be made of polyurethane resin. Thus, the first region R1 covered by the first coating 60 on the surface of the outer coil 20 can effectively improve the slippage of the guide wire 100 and effectively improve the passage of the guide wire 100.
[0033] The guide wire 100 may also include a mandrel 10 and a first intermediate joint 51. The mandrel 10 is disposed inside the outer coil 20, and the first intermediate joint 51 joins the mandrel 10 to the outer coil 20. The first axial position P1 is located closer to the base end than the first intermediate joint 51. This ensures that the size of the first region R1 covered by the first coating 60 on the surface of the outer coil 20 reaches a certain level, effectively improving the passability of the guide wire 100.
[0034] The guidewire 100 may also include an inner coil 30, which is connected to the front tip 40 and positioned inside the outer coil 20. The position P1 in the first axial direction is located closer to the base end 32 of the inner coil 30. This ensures that the size of the first region R1 covered by the first coating 60 on the surface of the outer coil 20 reaches a certain level, effectively improving the passability of the guidewire 100.
[0035] The guide wire 100 may also have a second coating 70 that covers the outer periphery of the outer coil 20. Thus, the presence of the second coating 70 can improve the slippage of the guide wire 100 and improve the passage of the guide wire 100.
[0036] The second coating 70 can also be hydrophilic. Thus, due to the presence of the second coating 70, the slippage of the guidewire 100 can be effectively improved, and the passage of the guidewire 100 can be effectively improved.
[0037] Alternatively, in the region closer to the front end than the position P1 along the first axis, the second coating 70 may cover the first coating 60. Thus, in the aforementioned region closer to the front end than the position P1 along the first axis, the presence of the first coating 60 and the second coating 70 can effectively improve the slippage of the guidewire 100 and effectively improve the passage of the guidewire 100.
[0038] Alternatively, the slippage of the first region R1 from the tip 41 of the guidewire 100 to the position P1 in the first axial direction can be higher than the slippage of the region from the position P1 in the first axial direction to the base 22 of the outer coil 20. This increases the slippage of the first region R1 of the guidewire 100, thereby improving the permeability of the guidewire 100, while suppressing the slippage of the region closer to the base compared to the first region R1, thus reducing the risk of vascular perforation caused by the guidewire 100.
[0039] B. Variation example: The technology disclosed in this specification is not limited to the above-described embodiments, and can be modified in various ways without departing from its spirit, for example, the following modifications are also possible.
[0040] The structure of the guide wire 100 in the above embodiment is merely an example and can be deformed in various ways. For example, it can be deformed arbitrarily as long as the base end (first axial direction position P1) of the area on the surface of the outer coil 20 covered by the first coating 60 is located closer to the front end side than the base end 22 of the outer coil 20.
[0041] As long as the base end of the area on the surface of the outer coil 20 covered by the second coating 70 is located closer to the base end side than the position P1 in the first axial direction, it can be deformed arbitrarily.
[0042] The guide wire 100 may not have an inner coil 30, or the guide wire 100 may have coils other than the outer coil 20 and the inner coil 30.
[0043] The guidewire 100 may not have the second coating 70 and / or the third coating 80, or the guidewire 100 may have coatings other than the first coating 60, the second coating 70 and the third coating 80.
[0044] The positions of the various joints 51, 52, 53, and 54 on the guidewire 100 are just examples and can be varied. At least one of the joints 51, 52, 53, and 54 may be omitted.
[0045] The technology disclosed in this specification is not limited to guidewire 100, but can also be applied to general medical devices.
Claims
1. A medical device (100), wherein, The medical device (100) comprises: Tip (40); Outer coil (20), the outer coil being connected to the front end pin (40); and A coating (60) covers the outer peripheral surface of the front end tip (40) and the outer peripheral surface of the outer coil (20) in a region (R1) from the front end (41) of the front end tip (40) to a predetermined axial position (P1), the axial position (P1) being located closer to the front end side than the base end (22) of the outer coil (20).
2. The medical device (100) according to claim 1, wherein, The coating (60) is made of polyurethane resin.
3. The medical device (100) according to claim 1 or 2, wherein, The medical device (100) also has: A mandrel (10) disposed inside the outer coil (20); and A coupling (51) joins the mandrel (10) to the outer coil (20). The axial position (P1) is located closer to the base end side than the joint (51).
4. The medical device (100) according to any one of claims 1 to 3, wherein, The medical device (100) also includes an inner coil (30), which is connected to the front end pin (40) and disposed inside the outer coil (20). The axial position (P1) is located closer to the base end side compared to the base end (32) of the inner coil (30).
5. The medical device (100) according to any one of claims 1 to 4, wherein, The coating (60) is the first coating (60). The medical device (100) also has a second coating (70) that covers the outer periphery of the outer coil (20).
6. The medical device (100) according to claim 5, wherein, The second coating (70) is hydrophilic.
7. The medical device (100) according to claim 5 or 6, wherein, In the region closer to the front end than the axial direction position (P1), the second coating (70) covers the first coating (60).
8. The medical device (100) according to claim 7, wherein, The slippage of the region (R1) from the front end (41) of the tip (40) to the axial position (P1) is greater than the slippage of the region from the axial position (P1) to the base end (22) of the outer coil (20).