Long-length medical device, method for manufacturing a long-length medical device
A long medical device with a hydrophilic coating layer varying in surface shape and irregularity addresses the need for controlled lubricity distribution, ensuring safe and efficient insertion by preventing excessive slipping at the tip and providing adequate lubrication at the proximal end.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- ASAHI INTECC CO LTD
- Filing Date
- 2024-12-12
- Publication Date
- 2026-06-24
Smart Images
Figure 2026103218000001_ABST
Abstract
Description
Technical Field
[0001] The present disclosure relates to a long medical device and a method for manufacturing a long medical device.
Background Art
[0002] A guide wire is a long medical device used by being inserted into a living body lumen such as a blood vessel. In order to improve its operability and prevent damage to blood vessels or the like that come into contact within the living body, it is necessary to have lubricity. Conventionally, in order to give the guide wire lubricity, the surface of the guide wire has been coated with a coating material. For example, Patent Document 1 discloses a medical device in which lubricity is adjusted by using different lubricating coatings for different parts.
Prior Art Documents
Patent Documents
[0003]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0004] An object of the present disclosure is to provide a novel long medical device in which the lubricity of the surface is partially changed.
Means for Solving the Problems
[0005] Firstly, this disclosure provides an elongated medical device comprising an elongated body portion including a first portion and a second portion located more proximal to the first portion, and a hydrophilic coating layer located on the outside of the body portion, wherein the surface shape of the hydrophilic coating layer located on the outside of the first portion is different from the surface shape of the hydrophilic coating layer located on the outside of the second portion. Secondly, this disclosure provides a method for manufacturing an elongated medical device, comprising forming a hydrophilic coating layer on the outside of an elongated body portion including a first portion and a second portion located more proximal to the first portion, such that the surface shape of the portion located on the outside of the first portion is different from the surface shape of the portion located on the outside of the second portion. [Brief explanation of the drawing]
[0006] [Figure 1] This is an explanatory diagram showing the overall structure of a long medical device according to the first embodiment of this disclosure. [Figure 2] Figure 1 is an explanatory diagram showing the surface condition of the first part of the elongated medical device. [Figure 3] Figure 1 is an explanatory diagram showing the surface condition of the second part of the elongated medical device. [Figure 4] This is an explanatory diagram showing the overall structure of a long medical device according to the second embodiment of this disclosure. [Modes for carrying out the invention]
[0007] The embodiments of this disclosure will be described below with reference to the drawings. This disclosure is not limited to the embodiments described below, and the embodiments described are merely examples to illustrate the technical features of this disclosure. The shapes and dimensions shown in each drawing are shown only to facilitate understanding of the contents of this disclosure and do not accurately reflect the actual shapes and dimensions.
[0008] In this specification, "tip side" means the direction along the axial direction of a long medical device such as a guide wire, and the direction in which the long medical device advances toward the target site. "Proximal end side" means the direction along the axial direction of a long medical device, and the direction opposite to the tip side. "Tip" refers to the tip end of any member or part, and "proximal end" refers to the proximal end of any member or part.
[0009] <First Embodiment> Figure 1 is an explanatory diagram showing the overall structure of a guidewire 100 according to the first embodiment of this disclosure, and is a longitudinal cross-sectional view along the axial direction of the guidewire 100. The guidewire 100 is an example of a long medical device of this disclosure and is used when inserting a combination device such as a catheter or an implantable device into blood vessels, digestive organs, etc. This disclosure is also applicable to long medical devices other than guidewires.
[0010] The guide wire 100 comprises a long main body portion 10 and a hydrophilic coating layer 6 disposed on the outside of the main body portion 10. The main body portion 10 includes a long core shaft 1 and a coil body 2 disposed on the outside of the tip of the core shaft 1. The tip of the guide wire 100 is provided with a tip 3 that connects the core shaft 1 and the coil body 2, and the base end of the coil body 2 is provided with a fixing portion 4 that fixes the core shaft 1 and the coil body 2. Inside the hydrophilic coating layer 6 is a base layer 5 that covers the coil body 2 of the main body portion 10. In this embodiment, the hydrophilic coating layer 6 and the base layer 5 are formed only on the outer surfaces of the coil body 2 and the tip tip 3 of the main body portion 2. The hydrophilic coating layer 6 and the base layer 5 may be formed to cover the entire main body portion 10, including the fixing portion 4 and the base end of the core shaft 1.
[0011] The core shaft 1 is a long, elongated member that serves as the axis of the guide wire 100. As shown in Figure 1, the core shaft 1 has a narrow diameter section 11 at the tip end and a wide diameter section 13 at the base end, and between the narrow diameter section 11 and the wide diameter section 13, it has a tapered section 12 in which the outer diameter decreases from the base end to the tip end. The structure of the core shaft 1 shown in Figure 1 is just one example, and it can have various structures depending on the type and application of the guide wire 100.
[0012] The core shaft 1 can be formed from materials such as stainless steel alloys (SUS302, SUS304, SUS316, etc.), superelastic alloys such as Ni-Ti alloys, piano wire, nickel-chromium alloys, cobalt alloys, and tungsten, but is not limited to these. The core shaft 1 may also be formed from other known materials, as long as it prevents the core shaft 1 itself from being cut and allows the tip to rotate.
[0013] The narrow-diameter portion 11 has a flattened shape obtained, for example, by press-forming a cylindrical material. The wide-diameter portion 13 has a cylindrical shape in which the outer diameter is formed to be constant from the tip to the base. The tapered portion 12 has a frustoconical shape in which the outer diameter gradually increases from the tip to the base, so as to connect the narrow-diameter portion 11 and the wide-diameter portion 13.
[0014] The coil body 2 is wound around the core shaft 1 so as to cover the outer circumference of the small diameter section 11, the tapered section 12, and a portion of the large diameter section 13 of the core shaft 1. The coil body 2 may be a single coil formed by spirally winding a single wire with a circular cross-section into a cylindrical shape, or it may be a hollow stranded wire coil formed by twisting multiple wires together into a cylindrical shape. The coil body 2 may be composed of a combination of a single coil and a hollow stranded wire coil. Another coil body may be provided inside the coil body 2. The structure of the coil body 2 shown in Figure 1 is just one example, and it can have various structures depending on the type and application of the guide wire 100.
[0015] The coil body 2 can be formed from, for example, stainless steel alloys (SUS302, SUS304, SUS316, etc.), superelastic alloys such as Ni-Ti alloys, piano wire, nickel-chromium alloys, radiopaque alloys such as cobalt alloys, gold, platinum, tungsten, or alloys containing these elements (e.g., platinum-nickel alloys), but is not limited to these. The coil body 2 may also be formed from known materials other than those mentioned above. In this embodiment, the coil body 2 is formed as a single component from the same material throughout, and its outer diameter is configured to be constant from the tip to the base.
[0016] A tip 3 is formed at the tip of the guide wire 100 (i.e., the tip of the core shaft 1) to join the core shaft 1 and the coil body 2. The tip 3 is formed from metal solder such as silver solder, gold solder, zinc, Sn-Ag alloy, or Au-Sn alloy, and this metal solder fixes the tip of the core shaft 1 to the tip of the coil body 2. Alternatively, the tip 3 may be formed from an adhesive such as an epoxy adhesive, and the tip of the core shaft 1 and the tip of the coil body 2 may be fixed with the adhesive.
[0017] A fixing portion 4 is formed at the base end of the coil body 2 to fix the core shaft 1 and the coil body 2. The fixing portion 4 is formed of metal solder such as silver solder, gold solder, zinc, Sn-Ag alloy, or Au-Sn alloy, and the base end of the coil body 2 is fixed to the large diameter portion 13 of the core shaft 1 by this metal solder. Alternatively, the fixing portion 4 may be formed with an adhesive such as an epoxy adhesive, and the large diameter portion 13 of the core shaft 1 and the base end of the coil body 2 may be fixed with the adhesive.
[0018] The underlying layer 5 is formed of a resin material and is formed on the outer peripheral surface of the main body portion 2 in order to enhance the adhesion and integrity between the hydrophilic coating material that forms the hydrophilic coat layer 6 described later and the main body portion 2. Examples of the resin material for forming the underlying layer 5 include polyvinyl alcohol (PVA), hydrophilic urethane resins (e.g., Hydro Thane (Mitsubishi Chemical), Hydro MED (Mitsubishi Chemical), Bionate (DSM), Tecophilic (Lubrizol), HPU (Dainichi Seika)), modified polyolefin resins (e.g., polyethylene-acrylic acid (Unitika), BONDINE (Tokyo Materials)), and the like.
[0019] The underlying layer 5 can be formed by a known coating formation method such as applying the above hydrophilic resin material to the outer peripheral surface from the tip chip 3 to the coil body 2. The thickness of the underlying layer 5 may be, for example, 1 to 1,000 μm, but is not limited thereto.
[0020] The hydrophilic coat layer 6 is formed of a hydrophilic coating material. The hydrophilic coat layer 6 is usually formed of a material having higher swelling property (hydrophilicity) than the underlying layer 5. Examples of the hydrophilic coating material include polymers such as hyaluronic acid, polyvinyl pyrrolidone, and polyethylene glycol, and homopolymers and copolymers obtained by polymerizing monomers such as maleic acid, acrylic acid, methacrylic acid, dimethylacrylamide, carboxy betaine, phospho betaine, sulfo betaine, methoxyethyl acrylate, hydroxyethyl methacrylate, and 2-hydroxypropyl methacrylate.
[0021] The hydrophilic coat layer 6 can be formed by a known coating formation method such as applying the above hydrophilic coating material to the outer peripheral surface from the tip chip 3 coated with the underlying layer 5 to the coil body 2. The thickness of the hydrophilic coat layer 6 may be, for example, 0.1 to 20 μm, but is not limited thereto.
[0022] In the present embodiment, the main body portion 10 includes a first portion 10A and a second portion 10B disposed closer to the proximal end side than the first portion 10A. In the main body portion 10, the first portion 10A and the second portion 10B are included in a portion where the coil body 2 is disposed on the outer periphery of the core shaft 1. In the guide wire 100, the surface shape of the hydrophilic coat layer 6 located outside the first portion 10A is different from the surface shape of the hydrophilic coat layer 6 located outside the second portion 10B. In the present embodiment, the hydrophilic coat layer 6 has irregularities on at least a part of its surface, and by adjusting the degree of the irregularities, the surface shape of the hydrophilic coat layer 6 is partially changed.
[0023] In the guide wire 100, the irregularities on the surface of the hydrophilic coat layer 6 located outside the first portion 10A are formed larger than the irregularities on the surface of the hydrophilic coat layer 6 located outside the second portion 10B. Specifically, by forming the base layer 5 located outside the second portion 10B thicker than the base layer 5 located outside the first portion 10A, the irregularities on the surface of the hydrophilic coat layer 6 located outside the first portion 10A are made larger than the irregularities on the surface of the hydrophilic coat layer 6 located outside the second portion 10B.
[0024] FIG. 2 is an explanatory diagram showing the state of the surface of the first portion 10A of the guide wire 100 and is an enlarged view of the R1 portion shown in FIG. 1. FIG. 3 is an explanatory diagram showing the state of the surface of the second portion 10B of the guide wire 100 and is an enlarged view of the R2 portion shown in FIG. 1. As shown in FIGS. 2 and 3, the hydrophilic coat layer 6 disposed outside the main body portion 10 of the guide wire 100 is formed such that the size of the irregularities on the surface of the hydrophilic coat layer 6 located outside the first portion 10A is different from the size of the irregularities on the surface of the hydrophilic coat layer 6 located outside the second portion 10B. By changing the size of the irregularities formed on the surface of the hydrophilic coat layer 6, the surface shapes of the hydrophilic coat layer 6 located outside the first portion 10A of the main body portion 10 and the hydrophilic coat layer 6 located outside the second portion 10B of the main body portion 10 can be made different, and as a result, the lubricity of the surface can be partially changed.
[0025] The size of the surface irregularities of the hydrophilic coating layer 6 is the distance (height) from the bottom of a recess to the top of a convex portion in a longitudinal cross-section along the axial direction of the guide wire 100. In the first section 10A (R1 section) shown in Figure 2, the distance (height) h1 from the bottom of the recess 6b1 to the top of the convex portion 6t1 indicates the size of the irregularities in that section. In the second section 10B (R2 section) shown in Figure 3, the distance (height) h2 from the bottom of the recess 6b2 to the top of the convex portion 6t2 indicates the size of the irregularities in that section. The size of the irregularities may be, for example, 1 μm or more, but is not limited to this. In order to make the surface shapes of the hydrophilic coating layer 6 located on the outside of the first part 10A of the main body 10 and the hydrophilic coating layer 6 located on the outside of the second part 10B of the main body 10 different, the difference between the size h1 of the irregularities of the first part 10A (R1 part) and the size h2 of the irregularities of the second part 10B (R2 part) may be, for example, 100 nm or more, or 200 nm or more, but is not limited thereto.
[0026] In this embodiment, by making the thickness of the base layer 5 located outside the first portion 10A different from the thickness of the base layer 5 located outside the second portion 10B, it is achieved that the size of the surface irregularities of the hydrophilic coating layer 6 located outside the first portion 10A is different from the size of the surface irregularities of the hydrophilic coating layer 6 located outside the second portion 10B. By forming the base layer 5 covering the coil body 2 with different thicknesses in the portion located outside the first portion 10A and the portion located outside the second portion 10B, it is possible to change the size of the irregularities formed on the surface of the hydrophilic coating layer 6 formed on the base layer 5.
[0027] When the base layer 5 is formed on the outer surface of the coil body 2, the base layer 5 is formed in a shape that follows the shape of the coil body 2. In other words, the base layer 5 has irregularities corresponding to the outer shape of the coil body 2. If the base layer 5 is made thicker, the irregularities caused by the shape of the coil body 2 that are exposed on the surface of the base layer 5 become smaller, and if the base layer 5 is made thinner, the irregularities caused by the shape of the coil body 2 that are exposed on the surface of the base layer 5 become larger. When the irregularities on the surface of the base layer 5 become smaller, the irregularities on the surface of the hydrophilic coating layer 6 formed on top of the base layer 5 also become smaller. The closer the surface of the hydrophilic coating layer 6 is to being flat and smooth, the lower the resistance and the higher the lubricity. When the irregularities on the surface of the base layer 5 become larger, the irregularities on the surface of the hydrophilic coating layer 6 formed on top of the base layer 5 also become larger. The more uneven the surface of the hydrophilic coating layer 6 becomes, the greater the resistance and the lower the lubricity.
[0028] In the guide wire 100 of this embodiment, the thickness of the base layer 5 is partially different by making the base layer 5 located outside the first portion 10A a single layer structure and the base layer 5 located outside the second portion 10B a double layer structure. As shown in Figure 2, the base layer 5 located outside the first portion 10A has a single layer structure consisting only of the first base layer 51, and a hydrophilic coating layer 6 is formed on top of the first base layer 51. As shown in Figure 3, the base layer 5 located outside the second portion 10B has a double layer structure consisting of the first base layer 51 and the second base layer 52, with the second base layer 52 formed on top of the first base layer 51, and a hydrophilic coating layer 6 formed on top of the second base layer 52. Due to the difference in the thickness of the base layer 5, the size h1 of the irregularities in the first portion 10A (R1 portion) shown in Figure 2 is larger than the size h2 of the irregularities in the second portion 10B (R2 portion).
[0029] The thickness of the first base layer 51 may be, for example, 0.5 to 500 μm, but is not limited thereto. The thickness of the second base layer 52 may be, for example, 0.5 to 500 μm, but is not limited thereto. The first base layer 51 and the second base layer 52 may be formed from the same hydrophilic resin material, or they may be formed from different hydrophilic resin materials.
[0030] In such a guidewire 100, the lubricity of the hydrophilic coating layer 6 located on the outside of the second portion 10B at the proximal end of the main body 10 can be made superior to the lubricity of the hydrophilic coating layer 6 located on the outside of the first portion 10A at the tip of the main body 10. The guidewire 100 realized in this way has the characteristic that the tip end does not slip too much and the proximal end has sufficient lubrication. For example, it is suitable for guidewires used in PTCA (percutaneous transluminal coronary angioplasty) treatment, where lubrication is required at the proximal end of the coil body 2 for safety, while lubrication at the tip end needs to be suppressed to prevent vascular perforation while also allowing the operator to feel the procedure.
[0031] As described above, with the guide wire 100, even when the hydrophilic coating layer 6 is formed from a single material, the surface lubricity can be partially changed by a simple method of forming different surface shapes for the hydrophilic coating layer 6 located on the outside of the first part 10A of the main body 10 and the hydrophilic coating layer 6 located on the outside of the second part 10B of the main body 10.
[0032] The guide wire 100 of this embodiment can be manufactured, for example, by the following method. (1) A long main body portion 10 is provided, which includes a core shaft 1 and a coil body 2 positioned outside the tip of the core shaft 1. The main body portion 10 includes a first portion 10A and a second portion 10B positioned closer to the base end than the first portion 10A, in the portion where the coil body 2 is positioned. (2) A first base layer 51 is formed so as to cover the coil body 2 of the main body 10. The first base layer 51 is formed on the outer circumferential surfaces of both the first portion 10A and the second portion 10B of the coil body 2 of the main body 10. (3) After the first sub-layer 51 is formed, the second sub-layer 52 is formed only in the portion located outside the second portion 10B of the coil body 2 of the main body 10. As a result, a single-layer sub-layer 5 is formed outside the first portion 10A of the coil body 2 of the main body 10, and a double-layer sub-layer 5 is formed outside the second portion 10B of the coil body 2 of the main body 1. (4) After the base layer 5 is formed to cover the coil body 2 of the main body 10, a hydrophilic coating layer 6 is formed to cover the base layer 5. The thickness of the base layer 5 located outside the first part 10A is different from the thickness of the base layer 5 located outside the second part 10B, so that the surface shape of the part of the hydrophilic coating layer 6 located outside the first part 10A is different from the surface shape of the part located outside the second part 10B. Specifically, the hydrophilic coating layer 6 is formed so that the size of the surface irregularities of the hydrophilic coating layer 6 located outside the first part 10A is different from the size of the surface irregularities of the hydrophilic coating layer 6 located outside the second part 10B.
[0033] <Second Embodiment> Figure 4 is an explanatory diagram showing the overall structure of a guide wire 200 according to a second embodiment of the present disclosure. The guide wire 200 comprises a long main body portion 210 and a hydrophilic coating layer 206 disposed on the outside of the main body portion 210. The main body portion 210 includes a long core shaft 201 and a coil body 202 disposed on the outside of the tip of the core shaft 201. The tip of the guide wire 200 is provided with a tip 203 that joins the core shaft 201 and the coil body 202, and the base end of the coil body 202 is provided with a fixing portion 204 that fixes the core shaft 201 and the coil body 202. Inside the hydrophilic coating layer 206, a base layer 205 is disposed that covers the coil body 202 of the main body portion 210.
[0034] The structure of the main body 210 including the core shaft 201 and coil body 202, the tip 203, and the fixing part 204 is the same as the structure of each component of the guide wire 100 in the first embodiment (main body 10 including the core shaft 1 and coil body 2, tip 3, and fixing part 4), so a detailed explanation is omitted. The base layer 205 and the hydrophilic coating layer 206 are formed in the same way as the base layer 5 and hydrophilic coating layer 6 of the guide wire 100 in the first embodiment, so a detailed explanation is omitted.
[0035] Unlike the guide wire 100 of the first embodiment, the guide wire 200 has a surface irregularity of the hydrophilic coating layer 206 located outside the first portion 210A that is smaller than the surface irregularity of the hydrophilic coating layer 206 located outside the second portion 210B. Specifically, the base layer 205 located outside the first portion 210A is made thicker than the base layer 205 located outside the second portion 210B, thereby making the surface irregularity of the hydrophilic coating layer 206 located outside the first portion 210A smaller than the surface irregularity of the hydrophilic coating layer 206 located outside the second portion 210B. In the first embodiment, the base layer 5 located outside the first portion 10A was a single-layer structure consisting only of the first base layer 51, and the base layer 5 located outside the second portion 10B was a two-layer structure consisting of the first base layer 51 and the second base layer 52. However, in the guide wire 200 of the second embodiment, the base layer 205 located outside the first portion 210A is a two-layer structure, and the base layer 205 located outside the second portion 210B is a single-layer structure, thereby partially differentiating the thickness of the base layer 5. The specific configuration of the base layer 205 is simply the same as the configuration of the base layer 5 described in the first embodiment, but with the first portion 10A and the second portion 10B swapped, so a detailed explanation is omitted.
[0036] In such a guide wire 200, the lubricity of the hydrophilic coating layer 206 located on the outside of the first portion 210A, which is located at the tip end of the main body 210, can be made superior to the lubricity of the hydrophilic coating layer 206 located on the outside of the second portion 210B, which is located at the base end of the main body 210. The guide wire 200 realized in this way has the characteristic that the tip end slides well and the base end does not slide too much, making it suitable for use as a guide wire, for example, for passing through a stent strut.
[0037] This disclosure provides, firstly, an elongated medical device comprising a main body portion including a first portion and a second portion located more proximal to the first portion, and a hydrophilic coating layer located on the outside of the main body portion, wherein the surface shape of the hydrophilic coating layer located on the outside of the first portion is different from the surface shape of the hydrophilic coating layer located on the outside of the second portion (Disclosure 1).
[0038] According to the disclosure (Disclosure 1), even when the hydrophilic coating layer is formed from a single material, it is possible to easily manufacture long medical devices with partially altered surface lubricity simply by forming the surface shapes of the hydrophilic coating layer located on the outside of the first part of the main body and the hydrophilic coating layer located on the outside of the second part of the main body to be different.
[0039] In the above disclosure (Disclosure 1), the hydrophilic coating layer has irregularities on at least a portion of its surface, and the size of the irregularities on the surface of the hydrophilic coating layer located outside the first portion may be different from the size of the irregularities on the surface of the hydrophilic coating layer located outside the second portion (Disclosure 2).
[0040] According to the disclosure (Disclosure 2), by changing the size of the irregularities formed on the surface of the hydrophilic coating layer, the surface shape of the hydrophilic coating layer located on the outside of the first part of the main body and the surface shape of the hydrophilic coating layer located on the outside of the second part of the main body can be made different, and as a result, the lubricity of the surface can be partially changed.
[0041] In the above disclosure (Disclosure 2), the main body portion may include a core shaft and a coil body disposed on the outside of the tip of the core shaft, and the portion in which the coil body is disposed may include the first portion and the second portion (Disclosure 3). In the above disclosure (Disclosure 3), at least a base layer covering the coil body of the main body portion is disposed inside the hydrophilic coating layer, and the thickness of the base layer located outside the first portion may be different from the thickness of the base layer located outside the second portion (Disclosure 4).
[0042] According to such disclosures (Disclosures 3 and 4), by forming the underlying layer covering the coil body with different thicknesses in the portion located outside the first portion and the portion located outside the second portion, the size of the irregularities formed on the surface of the hydrophilic coating layer formed on the underlying layer can be changed.
[0043] In the above disclosure (Disclosure 2-4), the surface irregularities of the hydrophilic coating layer located outside the first portion may be larger than those of the surface irregularities of the hydrophilic coating layer located outside the second portion (Disclosure 5).
[0044] According to the disclosure (Disclosure 5), the lubricity of the hydrophilic coating layer located on the outside of the second portion located at the base end of the main body is superior to that of the hydrophilic coating layer located on the outside of the first portion located at the tip end of the main body, thus enabling the realization of a long medical device with the characteristics of not being too slippery at the tip end and having sufficient lubricity at the base end.
[0045] In the above disclosure (Disclosure 2-4), the surface irregularities of the hydrophilic coating layer located outside the first portion may be smaller than the surface irregularities of the hydrophilic coating layer located outside the second portion (Disclosure 6).
[0046] According to the disclosure (Disclosure 6), the lubricity of the hydrophilic coating layer located on the outside of the first part at the tip of the main body is superior to that of the hydrophilic coating layer located on the outside of the second part at the base of the main body, thus enabling the creation of a long medical device with the characteristic that the tip slides well and the base does not slide too much.
[0047] Secondly, this disclosure provides a method for manufacturing an elongated medical device, comprising forming a hydrophilic coating layer on the outside of an elongated main body portion, which includes a first portion and a second portion located more proximal to the first portion, such that the surface shape of the portion located outside the first portion differs from the surface shape of the portion located outside the second portion (Disclosure 7).
[0048] According to the disclosure (Disclosure 7), even when the hydrophilic coating layer is formed from a single material, a long medical device with partially altered surface lubricity can be manufactured in a simple manner by making the surface shape of the hydrophilic coating layer located on the outside of the first part of the main body and the hydrophilic coating layer located on the outside of the second part of the main body different.
[0049] In the above disclosure (Disclosure 7), the hydrophilic coating layer is formed to have irregularities on at least a portion of its surface, and the hydrophilic coating layer may be formed such that the size of the irregularities on the surface of the hydrophilic coating layer located outside the first portion is different from the size of the irregularities on the surface of the hydrophilic coating layer located outside the second portion (Disclosure 8).
[0050] According to such disclosure (Disclosure 8), by changing the size of the irregularities formed on the surface of the hydrophilic coating layer, the surface shape of the hydrophilic coating layer located on the outside of the first part of the main body and the surface shape of the hydrophilic coating layer located on the outside of the second part of the main body can be made different, and as a result, the lubricity of the surface can be partially changed.
[0051] In the above disclosure (Disclosure 8), the main body includes a core shaft and a coil body disposed on the outside of the tip of the core shaft, and the portion in which the coil body is disposed includes the first portion and the second portion, and a base layer may be formed to cover the coil body of the main body before forming the hydrophilic coating layer (Disclosure 9).
[0052] According to such disclosure (Disclosure 9), by forming the underlying layer covering the coil body so that the thickness differs between the portion located outside the first portion and the portion located outside the second portion, the size of the irregularities formed on the surface of the hydrophilic coating layer formed on the underlying layer can be changed.
[0053] In the above disclosure (Disclosure 9), the substrate may include a first substrate and a second substrate, with the first substrate formed in both the first and second portions, and the second substrate formed outside the first substrate in either the first or second portion (Disclosure 10).
[0054] According to such disclosure (Disclosure 10), by partially making the substrate a two-layer structure, the thickness of the substrate covering the coil body can be partially changed, so that the size of the irregularities formed on the surface of the hydrophilic coating layer formed on the substrate can be changed in a simple manner.
[0055] The elongated medical device relating to this disclosure has been described above based on the drawings. This disclosure is not limited to the above embodiments, and various modifications are possible. For example, depending on the application of the elongated medical device, the lubricity may be varied at three or more locations on the surface of the hydrophilic coating layer.
Claims
1. A long main body portion (10) includes a first portion (10A) and a second portion (10B) positioned closer to the base end than the first portion (10A), The main body (10) is provided with a hydrophilic coating layer (6) located on the outside, A long medical device (100) in which the surface shape of the hydrophilic coating layer (6) located on the outside of the first portion (10A) is different from the surface shape of the hydrophilic coating layer (6) located on the outside of the second portion (10B).
2. The hydrophilic coating layer (6) has irregularities on at least a portion of its surface, The elongated medical device (100) according to claim 1, wherein the size of the surface irregularities of the hydrophilic coating layer (6) located outside the first portion (10A) is different from the size of the surface irregularities of the hydrophilic coating layer (6) located outside the second portion (10B).
3. The main body (10) includes a core shaft (1) and a coil body (2) disposed on the outside of the tip of the core shaft (1), The elongated medical device (100) according to claim 2, wherein the portion in which the coil body (2) is arranged includes the first portion (10A) and the second portion (10B).
4. Inside the hydrophilic coating layer (6), a base layer (5) is provided that covers at least the coil body (2) of the main body (10). The elongated medical device (100) according to claim 3, wherein the thickness of the underlayment (5) located outside the first portion (10A) is different from the thickness of the underlayment (5) located outside the second portion (10B).
5. The elongated medical device (100) according to any one of claims 2-4, wherein the surface irregularities of the hydrophilic coating layer (6) located outside the first portion (10A) are formed to be greater than the surface irregularities of the hydrophilic coating layer (6) located outside the second portion (10B).
6. The elongated medical device (100) according to any one of claims 2-4, wherein the surface irregularities of the hydrophilic coating layer (6) located outside the first portion (10A) are smaller than the surface irregularities of the hydrophilic coating layer (6) located outside the second portion (10B).
7. A method for manufacturing a long medical device (100), comprising forming a hydrophilic coating layer (6) on the outside of a long main body (10) which includes a first part (10A) and a second part (10B) positioned closer to the proximal end than the first part (10A), such that the surface shape of the part located outside the first part (10A) and the surface shape of the part located outside the second part (10B) are different.
8. The hydrophilic coating layer (6) is formed to have irregularities on at least a portion of its surface, A method for manufacturing a long medical device (100) according to claim 7, wherein the hydrophilic coating layer (6) is formed such that the size of the surface irregularities of the hydrophilic coating layer (6) located outside the first portion (10A) is different from the size of the surface irregularities of the hydrophilic coating layer (6) located outside the second portion (10B).
9. The main body (10) includes a core shaft (1) and a coil body (2) disposed on the outside of the tip of the core shaft (1), The portion in which the coil body (2) is arranged includes the first portion (10A) and the second portion (10B), A method for manufacturing a long medical device (100) according to claim 8, wherein a base layer (5) is formed to cover the coil body (2) of the main body (10) before forming the hydrophilic coating layer (6).
10. The aforementioned subsoil layer (5) includes a first subsoil layer (51) and a second subsoil layer (52), The first sublayer (51) is formed in both the first portion (10A) and the second portion (10B). A method for manufacturing a long medical device (100) according to claim 9, wherein the second base layer (52) is formed on the outside of the first base layer (51) in either the first portion (10A) or the second portion (10B).