Method for manufacturing medical elongated body

Abstract

To provide a method for manufacturing a medical elongated body that easily produces a medical elongated body having surface lubricity controlled according to its intended use.SOLUTION: The method for manufacturing a medical elongated body includes an application step and an irradiation step. In the application step, a photoreactive material 12a that forms a lubricating layer 12 is applied on a surface of an elongated substrate 11. In the irradiation process, light is irradiated after the application step is completed, and the time elapsed from the end of the application step until the accumulated amount of light required for the material 12a to harden by a photocrosslinking reaction is reached is varied at different positions in a longitudinal direction of the substrate 11.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present invention relates to a method for manufacturing an elongated medical body. [Background technology]

[0002] Medical elongated objects, such as catheters and guidewires, that are inserted into living bodies are required to have excellent lubricity on their surfaces in order to reduce tissue damage, such as to blood vessels, during insertion and to improve operability for the surgeon. For this reason, methods have been developed in which the surfaces of substrates are coated with hydrophilic polymers that have lubricity.

[0003] On the other hand, depending on the intended use, improved surface lubricity may have adverse effects. For example, when a medical elongated object is inserted into a living body and its leading end strikes a bent or narrowed portion of a blood vessel, if the surface has high lubricity, the surgeon is less likely to feel any resistance to insertion. This could lead to the surgeon not realizing that the medical elongated object has struck a bent or narrowed portion of the blood vessel and continuing to push the medical elongated object forward, causing the device to advance in an unexpected direction or pass through the target site. Furthermore, if a medical elongated object is intended to be retained at the target site, a high surface lubricity could cause the device to slip and move away from the target site due to the patient's pulse or body movement. Therefore, it is necessary to control the surface lubricity of the medical elongated object depending on the intended use.

[0004] In this regard, for example, Patent Document 1 listed below describes a method for manufacturing a medical elongate body in which a substrate having a lubricating layer formed on its surface is covered with a masking member having a transparent portion and then irradiated with energy rays such as ultraviolet light. The lubricity of the region irradiated with the energy rays that have transmitted through the transparent portion is reduced. This makes it possible to manufacture a medical elongate body with surface lubricity controlled according to the intended use.

[0005] Furthermore, Patent Documents 2 and 3 listed below describe a method for manufacturing a catheter in which a tube body coated with a photoreactive lubricating layer material on its surface is covered with a mask having openings, and then irradiated with light such as ultraviolet light. The lubricating layer material polymerizes in the area irradiated with light that has passed through the openings. This allows the manufacture of catheters with surface lubricity that can be controlled depending on the intended use. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] JP 2017-79808 A [Patent Document 2] Japanese Patent Application Publication No. 2019-154827 [Patent Document 3] Japanese Patent Application Publication No. 2019-154828 Summary of the Invention [Problem to be solved by the invention]

[0007] However, the method described in Patent Document 1 requires partial irradiation of the pre-formed lubricating layer with energy rays, which makes the manufacturing procedure complicated. Furthermore, the methods described in Patent Documents 2 and 3 require irradiation with light through an opening in a mask, and the amount of the lubricating layer raw material that can be polymerized is relatively small. Therefore, the formed lubricating layer is relatively thin and has low lubricity.

[0008] Therefore, an object of the present invention is to provide a method for manufacturing a medical elongate body that can easily manufacture a medical elongate body with controlled surface lubricity depending on the intended use. [Means for solving the problem]

[0009] The present invention provides a method for manufacturing a lubricating layer using a photoreactive material, comprising: (1) applying a photoreactive material to a surface of a long substrate; This is a method for manufacturing a medical elongated body, which includes an irradiation step in which light is irradiated after the application step is completed, so that the elapsed time from the end of the application step to the time when the integrated amount of light required for the material to harden by a photocrosslinking reaction is reached varies at different positions in the longitudinal direction of the substrate.

[0010] Here, an embodiment of the present invention is (2) In the method for manufacturing a medical elongated body according to (1) above, it is preferable that the sliding resistance of the lubricating layer at the position where the elapsed time is longer is higher than the sliding resistance of the lubricating layer at the position where the elapsed time is shorter.

[0011] (3) The method for manufacturing a medical elongate body according to (1) above further comprises a step of covering the base material with a contractible light-blocking mask member to prevent exposure of the material after the coating step and before the irradiating step, It is preferable that the irradiation step is performed by shrinking the light-shielding mask member during irradiation of light, and varying the time from when the application step is completed to when the material is exposed, thereby varying the elapsed time at different positions along the longitudinal direction of the substrate.

[0012] (4) In the method for manufacturing a medical elongate body according to (3) above, it is preferable that the light-shielding mask member is made of a pipe member having a hole through which the base material coated with the material is inserted.

[0013] (5) In the method for manufacturing a medical elongate body according to (3) or (4) above, it is preferable that the light-shielding mask member is configured to be stretchable.

[0014] (6) The method for producing a medical elongate body according to (1) above further comprises a step of covering the base material with a translucent mask member having regions with different light transmittances after the coating step and before the irradiating step, Preferably, in the irradiating step, the elapsed time is made different at different positions in the longitudinal direction of the base material by irradiating the material with light that passes through the light-transmitting mask member.

[0015] (7) In the method for manufacturing a medical elongate body according to (6) above, it is preferable that the light-transmitting mask member is made of a pipe member having a hole through which the base material coated with the material is inserted.

[0016] (8) In the method for producing a medical elongate body according to (6) or (7) above, it is preferable that the light-transmitting mask member has three or more regions with different light transmittances.

[0017] (9) In the method for producing a medical elongate body according to (1) above, it is preferable that the elapsed time is varied in the longitudinal direction of the substrate, so that the elapsed time is varied at different positions in the longitudinal direction of the substrate. [Effects of the Invention]

[0018] According to the method for manufacturing a medical elongate body of the present invention, the lubricity of the lubricating layer can be varied at different positions in the longitudinal direction of the substrate by varying the elapsed time, thereby making it possible to easily manufacture a medical elongate body with controlled surface lubricity depending on the intended use. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 10 is a diagram showing a catheter tube body having different lubricity at different positions in the longitudinal direction. [Figure 2] 10 is a flowchart showing a method for manufacturing a tube body of a catheter. [Figure 3] Figures 3(A) and 3(B) are schematic diagrams showing the irradiation device according to the first embodiment, where Figure 3(A) shows the state before the light-shielding mask member is contracted, and Figure 3(B) shows the state after the light-shielding mask member is contracted. [Figure 4] FIG. 10 is a diagram schematically illustrating an irradiation device according to a second embodiment. [Figure 5] FIG. 10 is a diagram schematically illustrating an irradiation device according to a third embodiment. [Figure 6]FIG. 6(A) is a schematic diagram showing the coating process using a dip coating device, and FIG. 6(B) is a schematic diagram showing the ultraviolet light irradiation process using a UV irradiation device. DETAILED DESCRIPTION OF THE INVENTION

[0020] Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The embodiments shown here are merely examples for embodying the technical concept of the present invention and are not intended to limit the present invention. Therefore, all other embodiments, examples, and operational techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included in the scope and spirit of the present invention, as well as in the scope of the inventions set forth in the claims and their equivalents.

[0021] In addition, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented schematically with the scale, aspect ratio, shape, etc. appropriately changed from the actual product, but these are merely examples and do not limit the interpretation of the present invention.

[0022] In the following description, the side of the catheter tube body that is operated by the hand is referred to as the "base end side," and the side that is inserted into the body lumen before other parts is referred to as the "tip side."

[0023] <Catheter tube body> An example of a tube body (corresponding to a medical elongated body) of a catheter manufactured by a manufacturing method according to an embodiment of the present invention will be described.

[0024] FIG. 1 is a diagram showing a tube body 10 of a catheter. The catheter has the tube body 10 shown in FIG. 1, a soft tip (not shown) attached to the distal end side of the tube body 10, and a hub (not shown) attached to the proximal end side of the tube body 10. The tube body 10 has a flexible, long substrate 11 and a lubricating layer 12 formed on the surface of the substrate 11. The lubricating layer 12 is formed by curing a photoreactive material 12a (see FIG. 3(A)) applied to the surface of the substrate 11 through a photocrosslinking reaction. The substrate 11 has a lumen 11a formed in the center.

[0025] The material constituting the substrate 11 is not particularly limited, and examples thereof include fluorine-based resins, nylon 66, polyether ketone, high-density polyethylene, etc. Among these, fluorine-based resins are preferable, and examples thereof that can be used include polytetrafluoroethylene (PTFE), polyvinylidene fluoride, tetrafluoroethylene-ethylene copolymer (ETFE), perfluoroalkoxy resin, etc.

[0026] The lubricating layer 12 is a photoreactive material 12a, and is not particularly limited as long as it is a hydrophilic material that exhibits lubricity upon wetting (water absorption). Examples of hydrophilic materials that form the lubricating layer include mixed materials in which an appropriate amount of crosslinking agent is added to hydrophilic polymers such as cellulose-based polymers, hyaluronic acid, polyethylene oxide-based polymers, maleic anhydride-based polymers (e.g., maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymer), acrylamide-based polymers (e.g., polyacrylamide), water-soluble nylon, polyvinyl alcohol, and polyvinylpyrrolidone, and derivatives in which an appropriate photoreactive functional group is introduced into the same hydrophilic polymers. The hydrophilic material may also be a hydrophilic copolymer containing a structural unit derived from a polymerizable monomer (A) having a sulfobetaine structure, a structural unit derived from a polymerizable monomer (B) having at least one group selected from the group consisting of a sulfonic acid group (-SO3H), a sulfate group (-OSOH), a sulfite group (-OSOH), and salts thereof, and a structural unit derived from a polymerizable monomer (C) having a photoreactive group. These hydrophilic materials are coated on the substrate 11 by conventional techniques such as coating / printing, immersion (dipping, dip coating), spraying, spin coating, and mixed solution-impregnated sponge coating.

[0027] In the tube body 10 of the embodiment, the lubricity of the lubricating layer 12 varies at different positions along the longitudinal direction of the substrate 11. The lubricity of the lubricating layer 12 is relatively high at the distal end side shown in the lower part of FIG. 1 (i.e., the sliding resistance value of the lubricating layer 12 is relatively low) and relatively low at the proximal end side shown in the upper part of FIG. 1 (i.e., the sliding resistance value of the lubricating layer 12 is relatively high). The lubricity of the lubricating layer 12 may vary gradually along the longitudinal direction of the substrate 11, or may vary stepwise along the longitudinal direction of the substrate 11. As used herein, "gradually varying" means that when the substrate 11 is divided into multiple regions along the longitudinal direction, the lubricity in each region is the same, but the lubricity varies differently between adjacent regions. FIG. 1 schematically illustrates a state in which the lubricity of the lubricating layer 12 varies gradually along the longitudinal direction of the substrate 11. For ease of understanding, FIG. 1 uses a gray color that becomes whiter toward the bottom, indicating that the lubricity of the lubricating layer 12 increases toward the bottom.

[0028] The lubricity of the lubricating layer 12 can be varied by varying the time elapsed from the time when the photoreactive material 12a is irradiated with light and the time when the integrated amount of light required for the material 12a to harden by a photocrosslinking reaction is reached. When the elapsed time is long, the sliding resistance of the lubricating layer 12 is higher than when the elapsed time is short.

[0029] A tube body 10 having such characteristics has high lubricity (low sliding resistance) at the distal end, which is inserted into a complex lesion, making it easier to approach the lesion. The proximal end, which is manipulated by the surgeon, has low lubricity (high sliding resistance), making it less slippery and easier to operate. The tube body 10 shown in FIG. 1 is an example of a tube body 10 manufactured using the manufacturing apparatus and manufacturing method according to the embodiment, and the position with different lubricity can be changed as appropriate depending on the intended use. For example, in contrast to the tube body 10 shown in FIG. 1, the lubricity of the lubricating layer 12 may be configured to be relatively low at the distal end (high sliding resistance) and relatively high at the proximal end (low sliding resistance).

[0030] First Embodiment (Manufacturing equipment)> Next, a manufacturing device for the tube body 10 according to the first embodiment of the present invention will be described. Figures 3(A) and 3(B) are diagrams schematically showing an irradiation device 20 according to the first embodiment.

[0031] A coating device (not shown) applies a photoreactive material 12a that forms the lubricating layer 12 to the surface of the substrate 11. For example, a dip coating device is used as the coating device.

[0032] The photoreactive material 12a is irradiated with light 31 by the irradiation device 20 and hardens through a photocrosslinking reaction. As shown in FIGS. 3(A) and 3(B), the irradiation device 20 includes a light source unit 30 and a light-shielding mask member 40. The substrate 11 has a lumen 11a through which a core 50 is inserted. The core 50 is driven to rotate by a motor (not shown), etc. This causes the substrate 11 to rotate together with the core 50. Although not shown, the irradiation device 20 further includes an adjustment unit such as a condenser lens that collimates the light 31 from the light source unit 30, a cooling unit that sprays air or the like to cool the substrate 11 irradiated with the light 31, and a controller that controls the operation of the light source unit 30 and the light-shielding mask member 40.

[0033] The light source unit 30 emits light 31, such as ultraviolet light, that causes a photocrosslinking reaction. The number of light source units 30 is arbitrary. For example, two light source units 30 can be arranged so that the light 31 is irradiated toward the light-shielding mask member 40 from different directions.

[0034] The light-shielding mask member 40 is placed over the elongated substrate 11 coated with the material 12a, and is positioned so as to prevent exposure of the material 12a. The light-shielding mask member 40 is composed of a pipe member 41 having a hole 41a through which the substrate 11 coated with the material 12a is inserted. The light-shielding mask member 40 is formed from a material that is opaque to the light 31 that causes the photocrosslinking reaction. The inner diameter of the hole 41a of the pipe member 41 is larger than the sum of the outer diameter of the substrate 11 and the thickness of the coated film. However, the inner diameter of the light-shielding mask member 40 is set to a size equal to or smaller than that which prevents the light 31 from the light source unit 30 from unnecessarily entering the light-shielding mask member 40.

[0035] The light-shielding mask member 40 is contractible. As shown in FIG. 3(A), the light-shielding mask member 40 has a shape in which a plurality of pipe members 41 are connected in the longitudinal direction. As shown in FIG. 3(B), the light-shielding mask member 40 has a plurality of pipe members 41 that are contractible in a nested manner. The exposed length of the substrate 11 increases as the light-shielding mask member 40 contracts. The light-shielding mask member 40 is not limited to a nested structure as long as it is contractible. The light-shielding mask member 40 can be contractible by, for example, a bellows structure.

[0036] The light-shielding mask member 40 may gradually shrink so that the lubricity of the lubricating layer 12 changes gradually along the longitudinal direction of the substrate 11. Alternatively, the light-shielding mask member 40 may shrink stepwise so that the lubricity of the lubricating layer 12 changes stepwise along the longitudinal direction of the substrate 11.

[0037] (Manufacturing method) Next, a method for manufacturing the tube body 10 according to the first embodiment will be described. Fig. 2 is a flowchart showing the method for manufacturing the tube body 10.

[0038] First, a photoreactive material 12a that forms the lubricating layer 12 is applied to the surface of a long substrate 11 (S101: application step). At this time, the material 12a may be applied to all or part of the surface of the substrate 11. The material 12a is applied to the surface of the substrate 11 by an application device such as a dip coating device, for example.

[0039] Next, after the application step is completed, light 31 is irradiated (S102: irradiation step). In this irradiation step, the time elapsed from the end of the application step until the integrated amount of light required for the material 12a to harden by a photocrosslinking reaction is reached is varied at different positions in the longitudinal direction of the substrate 11. The "elapsed time" also includes the transition time from the end of the application step to the start of irradiation with light 31. The applied material 12a dries to a certain extent during the transition time.

[0040] In the first embodiment, after the application step and before the irradiation step, there is further included a step of covering the base material 11 with a contractible light-blocking mask member 40 to prevent exposure of the material 12a (covering step).

[0041] The light-shielding mask member 40 is shrunk from a state in which the exposure of the material 12a is inhibited during irradiation with light 31. Depending on the length to which the light-shielding mask member 40 is shrunk, a portion of the substrate 11 is exposed, and the material 12a applied to the substrate 11 is also exposed. The exposed material 12a is irradiated with light 31, and a photocrosslinking reaction begins. By shrinking the light-shielding mask member 40 during irradiation with light 31, the time from when application is completed until the material 12a is exposed differs at different positions in the longitudinal direction of the substrate 11. This makes it possible to make the elapsed time differ at different positions in the longitudinal direction of the substrate 11.

[0042] In this way, in the irradiation process, the light-shielding mask member 40 is shrunk during irradiation with light 31, and the time from when the coating process is completed until the material 12a is exposed is varied, thereby making the elapsed time different at different positions along the longitudinal direction of the substrate 11.

[0043] The sliding resistance of the lubricating layer 12 at the position where the elapsed time is longer is higher than the sliding resistance of the lubricating layer 12 at the position where the elapsed time is shorter. As the elapsed time is longer, the solvent evaporates from the reaction solution containing the material 12a applied to the tube body 10 before the required cumulative light dose is reached, thereby reducing the gaps between the polymer chains of the hydrophilic polymer contained in the material 12a on the surface of the tube body 10. Therefore, the crosslink density of the hydrophilic polymer increases upon irradiation with UV light, and the degree of swelling of the lubricating layer 12 decreases. As a result, the lubricating layer 12 at the position where the elapsed time is longer has lower hydrophilicity and lubricity than the lubricating layer 12 at the position where the elapsed time is shorter. The present invention partially changes the elapsed time (the total time from the end of application to the end of UV light irradiation until the required cumulative light dose is reached) but the drying time until the end of UV light irradiation is shorter in the area where the elapsed time is shorter than in the area where the elapsed time is longer. In other words, the amount of solvent evaporates less, and crosslinking occurs with the solvent remaining. When photocrosslinking is performed with a large amount of solvent remaining, the gaps between the polymer chains of the hydrophilic polymer remain large, making it more likely to absorb water and resulting in increased swelling, i.e., increased lubricity. In contrast, in areas where a long time has passed, a large amount of solvent evaporates before crosslinking is complete. When crosslinking is performed with a small amount of solvent, the polymer chain density is high and swelling is low, i.e., lubricity is reduced.

[0044] The irradiation of ultraviolet light is terminated when the cumulative light amount required for the material 12a to harden by a photocrosslinking reaction is reached at the location where the lubricity is to be lowest (the sliding resistance value is to be highest). After the required cumulative light amount is reached, the crosslink density of the hydrophilic polymer does not change significantly unless excessive ultraviolet light is irradiated. Therefore, even after the required cumulative light amount is reached at the location where the lubricity is to be lowest (the sliding resistance value is to be highest), the irradiation of ultraviolet light may be continued for purposes such as sterilizing the surface of the lubricating layer.

[0045] According to the above manufacturing method, the manufactured tube body 10 has high lubricity (low sliding resistance) at the tip end that is inserted into a complex lesion, making it easy to approach the lesion. The base end that is manipulated by the surgeon has low lubricity (high sliding resistance), making it less slippery and easier to operate.

[0046] The light-shielding mask member 40 used in the manufacturing method is not limited to a contractible configuration, but can have a stretchable configuration. By adopting such a stretchable configuration, the length covering the material 12a can be easily adjusted. As a result, the range of different lubricity (axial length) can be easily changed, and a tube body 10 with surface lubricity controlled according to the intended use can be manufactured.

[0047] As described above, the manufacturing method of the first embodiment includes a coating step and an irradiation step. In the coating step, a photoreactive material 12a constituting the lubricating layer 12 is applied to the surface of the elongated substrate 11. In the irradiation step, light 31 is irradiated after the coating step is completed, and the elapsed time from the end of the coating step until the integrated light intensity required for the material 12a to harden by a photocrosslinking reaction is reached is varied at different positions along the longitudinal direction of the substrate 11. According to the manufacturing method configured in this manner, by varying the elapsed time, the lubricity of the lubricating layer 12 can be varied at different positions along the longitudinal direction of the substrate 11. Therefore, a tube body 10 with controlled surface lubricity can be easily manufactured depending on the intended use.

[0048] The sliding resistance of the lubricating layer 12 at the position where the elapsed time is longer is higher than the sliding resistance of the lubricating layer 12 at the position where the elapsed time is shorter. This makes it possible to manufacture a tube body 10 in which the lubricity at the position where the elapsed time is longer is controlled to be lower than that at the position where the elapsed time is shorter.

[0049] The manufacturing method further includes a step of covering the substrate 11 with a shrinkable light-shielding mask member 40 after the coating step and before the irradiation step to prevent exposure of the material 12a. The irradiation step involves shrinking the light-shielding mask member 40 during irradiation with light 31, thereby varying the time from the end of the coating step to the exposure of the material 12a, thereby varying the elapsed time at different positions along the length of the substrate 11. According to this manufacturing method, by shrinking the light-shielding mask member 40, the lubricity of the lubricating layer 12 can be varied at different positions along the length of the substrate 11, making it possible to easily manufacture a tube body 10 with controlled surface lubricity depending on the intended use.

[0050] The light-shielding mask member 40 is composed of a pipe member 41 having a hole 41a through which the substrate 11 coated with the material 12a is inserted. By using the light-shielding mask member 40 having such a configuration, the substrate 11 can be easily covered with the light-shielding mask member 40, and exposure of the material 12a can be easily prevented.

[0051] The light-shielding mask member 40 can be configured to be stretchable. By configuring it in this way, the length that covers the material 12a can be easily adjusted. As a result, the range (axial length) over which lubricity differs can be easily changed.

[0052] Second Embodiment (manufacturing equipment) A manufacturing device for the tube body 10 according to the second embodiment of the invention will be described below. Fig. 4 is a diagram schematically showing an irradiation device 20 according to the second embodiment.

[0053] The irradiation device 20 of the second embodiment differs from the irradiation device 20 of the first embodiment, which uses a light-blocking mask member 40, in that it uses a light-transmitting mask member 60 having portions with different light transmittances. The other configurations are the same as those of the first embodiment, and some overlapping configurations will not be described.

[0054] As shown in FIG. 4, the irradiation device 20 includes a light source unit 30 and a light-transmitting mask member 60.

[0055] The light source unit 30 emits light 31, such as ultraviolet light, that causes a photocrosslinking reaction.

[0056] The light-transmitting mask member 60 is placed over the elongated substrate 11 coated with the material 12a. Light 31 from the light source unit 30 passes through the light-transmitting mask member 60 and is irradiated onto the material 12a. The light-transmitting mask member 60 is composed of a pipe member 61 having a hole 61a through which the substrate 11 coated with the material 12a is inserted. The light-transmitting mask member 60 is formed from the material 12a through which the light 31 that causes a photocrosslinking reaction passes. The inner diameter of the hole 61a of the pipe member 61 is larger than the sum of the outer diameter of the substrate 11 and the coated film thickness. However, the inner diameter of the light-transmitting mask member 60 is set to a size equal to or smaller than that which prevents the light 31 from the light source unit 30 from unnecessarily entering the light-transmitting mask member 60.

[0057] As shown in FIG. 4, the light-transmitting mask member 60 has a shape in which a plurality of pipe members 61 are connected in the longitudinal direction. Each pipe member 61 has a different light transmittance. For example, each pipe member 61 is made of the same pipe material, with films of different light transmittances attached to the outer surface thereof. The light-transmitting mask member 60 has a relatively high light transmittance at the tip end side shown in the lower part of FIG. 4 and a relatively low light transmittance at the base end side shown in the upper part of FIG. 4. For ease of understanding, in FIG. 4, the light-transmitting pipes are colored gray, becoming whiter as they go downward, indicating that the light transmittance increases as they go downward.

[0058] 4 has a light transmittance that changes stepwise so that the lubricity of the lubricating layer 12 changes stepwise along the longitudinal direction of the substrate 11. However, the light transmittance of the light-transmitting mask member 60 may also change gradually so that the lubricity of the lubricating layer 12 changes gradually along the longitudinal direction of the substrate 11.

[0059] The light-transmitting mask member 60 has three or more regions with different light transmittances. If there are two regions with different light transmittances, this is equivalent to covering the substrate 11 with a light-blocking masking material. If there are three or more regions with different light transmittances, the lubricity of the lubricating layer 12 can be suitably made different at different positions in the longitudinal direction of the substrate 11.

[0060] (Manufacturing method) The method for manufacturing the tube body 10 according to the second embodiment also includes a coating step and an irradiation step, similar to the first embodiment. The "elapsed time" includes the transition time from the end of the coating step to the start of irradiation with light 31. The coated material 12a dries to a certain extent during the transition time.

[0061] In the second embodiment, after the application step and before the irradiation step, a step of covering the base material 11 with a light-transmitting mask member 60 having areas with different light transmittances (covering step) is further included.

[0062] Light 31 from the light source unit 30 passes through the light-transmitting mask member 60 and is irradiated onto the material 12a. The irradiated light 31 causes the material 12a to start a photocrosslinking reaction. The light-transmitting mask member 60 has areas with different light transmittances. Therefore, in the irradiation step, the elapsed time from the end of the application step until the accumulated amount of light required for the material 12a to harden through the photocrosslinking reaction is reached differs depending on the areas with different light transmittances. The elapsed time is shorter in areas with relatively high light transmittance, and longer in areas with relatively low light transmittance.

[0063] In this way, in the irradiation step, the light 31 is transmitted through the light-transmitting mask member 60 and irradiated onto the material 12a, so that the elapsed time is made different at different positions in the longitudinal direction of the base material 11.

[0064] Due to the above-mentioned mechanism, the sliding resistance of the lubricating layer 12 at the position where the elapsed time is longer is higher than the sliding resistance of the lubricating layer 12 at the position where the elapsed time is shorter.

[0065] According to the above manufacturing method, the manufactured tube body 10 has a high lubricity (low sliding resistance) at the tip end, which is inserted into a complex lesion before the other parts, making it easier to approach the lesion. The base end, which is manipulated by the surgeon, has a low lubricity (high sliding resistance), making it less slippery and easier to operate.

[0066] As described above, the manufacturing method of the second embodiment, like the first embodiment, includes a coating step and an irradiation step. In the coating step, a photoreactive material 12a constituting the lubricating layer 12 is coated on the surface of the elongated substrate 11. In the irradiation step, light 31 is irradiated after the coating step is completed, and the elapsed time from the end of the coating step to the time when the integrated light intensity required for the material 12a to harden by a photocrosslinking reaction is reached is varied at different positions along the longitudinal direction of the substrate 11. According to the manufacturing method configured in this manner, by varying the elapsed time, the lubricity of the lubricating layer 12 can be varied at different positions along the longitudinal direction of the substrate 11. Therefore, a tube body 10 with controlled surface lubricity can be easily manufactured depending on the intended use.

[0067] The manufacturing method further includes, after the coating step and before the irradiating step, a step of covering the substrate 11 with a light-transmitting mask member 60 having regions with different light transmittances. In the irradiating step, light 31 is transmitted through the light-transmitting mask member 60 and irradiated onto the material 12a, thereby varying the elapsed time at different positions in the longitudinal direction of the substrate 11. According to the manufacturing method configured in this manner, the lubricity of the lubricating layer 12 can be varied at different positions in the longitudinal direction of the substrate 11, and a tube body 10 with controlled surface lubricity can be easily manufactured depending on the intended use.

[0068] The light-transmitting mask member 60 is composed of a pipe member 61 having a hole 61a through which the base material 11 coated with the material 12a is inserted. By using the light-transmitting mask member 60 having such a configuration, the base material 11 can be easily covered with the light-transmitting mask member 60.

[0069] The light-transmitting mask member 60 has three or more portions with different light transmittances. By configuring it in this way, the lubricity of the lubricating layer 12 can be made to suitably differ at different positions in the longitudinal direction of the substrate 11.

[0070] <Third embodiment> (manufacturing equipment) A manufacturing device for the tube body 10 according to the third embodiment of the invention will be described below. Fig. 5 is a diagram schematically showing an irradiation device 20 according to the third embodiment.

[0071] The irradiation device 20 of the second embodiment differs from the irradiation device 20 of the first embodiment using the light-blocking mask member 40 and the irradiation device 20 of the second embodiment using the light-transmitting mask member 60 in that the illuminance of the light 71 irradiated onto the material 12a is varied in the longitudinal direction of the substrate 11. The other configurations are the same as those of the first and second embodiments. A description of the overlapping configurations will be omitted.

[0072] As shown in Fig. 5, the irradiation device 20 has a light source unit 70. The light source unit 70 emits light 71, for example, ultraviolet light, that causes a photocrosslinking reaction. The light source unit 70 can vary the illuminance of the light 71 irradiated onto the material 12a in the longitudinal direction of the substrate 11. The light source unit 70 emits light 71 with a relatively high illuminance at the distal end side shown in the lower side of Fig. 5, and light with a relatively low illuminance at the proximal end side shown in the upper side of Fig. 5.

[0073] 5 changes the illuminance of light 71 in stages (three stages in the illustrated example) so that the lubricity of the lubricating layer 12 changes stepwise along the longitudinal direction of the substrate 11. However, the light source unit 70 may also gradually change the illuminance of light 71 so that the lubricity of the lubricating layer 12 changes gradually along the longitudinal direction of the substrate 11.

[0074] (Manufacturing method) The manufacturing method of the tube body 10 according to the third embodiment also includes a coating step and an irradiation step, similar to the first and second embodiments. The "elapsed time" includes the transition time from the end of the coating step to the start of irradiation with the light 71. The coated material 12a dries to a certain extent during the transition time.

[0075] In the third embodiment, the light 71 from the light source unit 70 is irradiated onto the material 12a with illuminance varying in the longitudinal direction of the substrate 11. The integrated amount of light required for the material 12a to harden through a photocrosslinking reaction is determined by the following formula (1).

[0076] Equation (1) is Accumulated light intensity (mJ / cm 2 ) = light illuminance (mW / cm 2 ) × time (s) is.

[0077] Therefore, in the irradiation step, the time elapsed from the end of the application step until the accumulated amount of light required for the material 12a to harden by the photocrosslinking reaction is reached varies depending on the area where the illuminance of the light 71 is different. The elapsed time is short in areas where the illuminance of the light 71 is relatively strong, and long in areas where the illuminance of the light 71 is relatively weak.

[0078] In this way, in the irradiation step, the illuminance of the light 71 irradiating the material 12a is varied in the longitudinal direction of the substrate 11, so that the elapsed time is varied at different positions in the longitudinal direction of the substrate 11.

[0079] Due to the above-mentioned mechanism, the sliding resistance of the lubricating layer 12 at the position where the elapsed time is longer is higher than the sliding resistance of the lubricating layer 12 at the position where the elapsed time is shorter.

[0080] According to the above manufacturing method, the manufactured tube body 10 has a high lubricity (low sliding resistance) at the tip end, which is inserted into a complex lesion before the other parts, making it easier to approach the lesion. The base end, which is manipulated by the surgeon, has a low lubricity (high sliding resistance), making it less slippery and easier to operate.

[0081] As described above, the manufacturing method of the third embodiment, like the first and second embodiments, includes a coating step and an irradiation step. In the coating step, a photoreactive material 12a constituting the lubricating layer 12 is applied to the surface of the elongated substrate 11. In the irradiation step, light 71 is irradiated after the coating step is completed, and the elapsed time from the end of the coating step to the time when the integrated light intensity required for the material 12a to harden by a photocrosslinking reaction is reached is varied at different positions along the longitudinal direction of the substrate 11. According to the manufacturing method configured in this manner, by varying the elapsed time, the lubricity of the lubricating layer 12 can be varied at different positions along the longitudinal direction of the substrate 11. Therefore, a tube body 10 with surface lubricity controlled according to the intended use can be easily manufactured.

[0082] In the irradiation step, the illuminance of the light 71 irradiated onto the material 12a is varied along the longitudinal direction of the substrate 11, thereby varying the elapsed time at different positions along the longitudinal direction of the substrate 11. According to the manufacturing method configured in this manner, the lubricity of the lubricating layer 12 can be varied at different positions along the longitudinal direction of the substrate 11, and a tube body 10 with controlled surface lubricity can be easily manufactured depending on the intended use.

[0083] <Other variations> The present invention has been described above through the first, second, and third embodiments, but the present invention is not limited to the described contents and can be modified as appropriate based on the description of the claims.

[0084] For example, the light-blocking mask member 40 shown in the first embodiment can be used in combination with the change in illuminance of the light 71 shown in the third embodiment. Also, the light-transmitting mask member 60 shown in the second embodiment can be used in combination with the change in illuminance of the light 71 shown in the third embodiment.

[0085] <Test> A test was conducted to confirm the difference in lubricity of the lubricating layer caused by differences in "elapsed time." "Elapsed time" is the time from the end of application of the material to the time when the accumulated light intensity required for the material to harden through a photocrosslinking reaction is reached. Lubricity was evaluated by the sliding resistance value of the lubricating layer.

[0086] 6A is a schematic diagram showing the coating process by the dip coating device 110, and FIG. 6B is a schematic diagram showing the ultraviolet light irradiation process by the UV irradiation device 120. As shown in FIG.

[0087] The test tube used in the test was the base material (5 Fr inner diameter) of the Terumo Guiding Sheath GS-1 (manufactured by Terumo Corporation). The test tube had a total length of 15 cm. The photoreactive materials constituting the lubricating layer were as follows: First, 1.95 g (7.0 mmol) of [2-(methacryloyloxy)ethyl]dimethyl-(3-sulfopropyl)ammonium hydroxide (MSPB) manufactured by Sigma-Aldrich, 0.410 g (2.0 mmol) of 2-acrylamido-2-methyl-1-propanesulfonic acid (AMPS) manufactured by Tokyo Chemical Industry Co., Ltd., and 0.266 g (1.0 mmol) of 4-methacryloyloxybenzophenone (MBP) manufactured by MRC Unitec Co., Ltd. were dissolved in 10 mL of a methanol / water (9 / 1 v / v) mixed solvent to prepare a reaction solution. Next, this reaction solution was placed in a 30 mL eggplant-shaped flask, and oxygen was removed by sufficient nitrogen bubbling. 31 mg (0.10 mmol) of the polymerization initiator 2,2'-azobis(4-methoxy-2,4-dimethylvaleronitrile) was added. The flask was then quickly sealed and polymerized in a 50 °C water bath for 2 hours. As the polymerization proceeded, insoluble matter precipitated. The solvent was then removed by decantation, and the resulting insoluble matter was dissolved in 1 mL of a methanol / water (7 / 3 v / v) mixed solvent. The solution was reprecipitated in acetone, the supernatant was removed by decantation, and the solution was washed twice with methanol to obtain a copolymer. The resulting copolymer was then dissolved in methanol / water (7 / 3 v / v) to a concentration of 10 wt % to prepare coating solution 112a containing the photoreactive material 112.

[0088] The test tube was wiped with acetone. Then, as shown in Fig. 6(A), the above-mentioned photoreactive material 112 was applied to the test tube 100 using a dip coating device 110. Specifically, the test tube 100 was immersed in the above-mentioned coating liquid 112a while the upper end of the test tube 100 was held by a slider 111 of the dip coating device 110. The slider 111 was pulled up at a predetermined speed, and the test tube 100 coated with the photoreactive material 112 was obtained.

[0089] Next, as shown in Fig. 6(B), the test tube 100 was rotated and irradiated with ultraviolet light 113 for 180 seconds using a UV irradiation device 120. The dot pattern on the test tube 100 indicates the areas where the photoreactive material 112 was applied.

[0090] The sliding resistance of the lubricating layer was measured by measuring the sliding resistance of a portion of the area where the material was applied. The sliding resistance was measured using a pinch tester (Oak River DL1000). The test tube coated with the material was immersed in water and sandwiched between silicone sheets, and the resistance was measured when the test tube was slid up and down.

[0091] Tests were conducted in two cases: when the elapsed time until the UV cumulative light intensity required for UV curing was reached was 180 seconds, and when it was 300 seconds. Table 1 below shows the measurement results when the elapsed time was 180 seconds, and Table 2 shows the measurement results when the elapsed time was 300 seconds.

[0092] [Table 1]

[0093] [Table 2]

[0094] As shown in Tables 1 and 2, the coating weight after UV irradiation averaged 6.7 when the elapsed time was 180 seconds, and 6.5 when the elapsed time was 300 seconds, with no significant difference between the two. However, differences were apparent in the sliding resistance values. Regarding the sliding resistance value at the 10th cycle, the sliding resistance value at 300 seconds (average 10.1) was about three times higher than the sliding resistance value at 180 seconds (average 3.5). Regarding the sliding resistance value at the 50th cycle, the sliding resistance value at 300 seconds (average 10.1) was about two times higher than the sliding resistance value at 180 seconds (average 5.5).

[0095] From the above test results, it was confirmed that when the same cumulative amount of ultraviolet light is applied, the sliding resistance of the lubricating layer when the "elapsed time" is long is higher than the sliding resistance of the lubricating layer when the elapsed time is short. [Explanation of symbols]

[0096] 10 Tube body (long medical body) 11 Base material 11a lumens 12 Lubricating layer 12a Photoreactive material constituting the lubricating layer 20 Irradiation device 30 Light source section 31 light 40 Light-shielding masking material 41 Pipe members 41a hole 50 core wire 60 Translucent mask member 61 Pipe members 61a hole 70 Light source section 71 light

Claims

1. a coating step of coating a photoreactive material constituting a lubricating layer on a surface of a long substrate; a radiation step of irradiating light after the application step is completed, so that the elapsed time from the end of the application step to the time when the accumulated light amount required for the material to harden by a photocrosslinking reaction is reached varies at different positions along the longitudinal direction of the substrate.

2. The method for manufacturing a medical elongated body according to claim 1 , wherein the sliding resistance of the lubricating layer at the position where the elapsed time is longer is higher than the sliding resistance of the lubricating layer at the position where the elapsed time is shorter.

3. The method further includes a step of covering the base material with a contractible light-blocking mask member to prevent exposure of the material after the coating step and before the irradiating step, The method for manufacturing a medical elongated body according to claim 1, wherein the irradiation process comprises shrinking the light-shielding mask member during irradiation of light, and varying the time from when the application process is completed until the material is exposed, thereby varying the elapsed time at different positions along the longitudinal direction of the substrate.

4. The method for manufacturing a medical elongate member according to claim 3 , wherein the light-shielding mask member is made of a pipe member having a hole through which the base material coated with the material is inserted.

5. 5. The method for manufacturing a medical elongated member according to claim 3, wherein the light-shielding mask member is configured to be stretchable.

6. The method further includes a step of covering the base material with a translucent mask member having regions with different light transmittances after the coating step and before the irradiating step, The method for manufacturing a medical elongated body according to claim 1 , wherein the irradiation step causes the elapsed time to be different at different positions in the longitudinal direction of the base material by irradiating the material with light that passes through the translucent mask member.

7. The method for manufacturing a medical elongate member according to claim 6 , wherein the light-transmitting mask member is made of a pipe member having a hole through which the base material coated with the material is inserted.

8. The method for manufacturing a medical elongate body according to claim 6 or 7, wherein the light-transmitting mask member has three or more portions with different light transmittances.

9. The method for manufacturing a medical elongated body according to claim 1 , wherein the irradiation step varies the illuminance of the light irradiated onto the material in the longitudinal direction of the substrate, thereby varying the elapsed time at different positions in the longitudinal direction of the substrate.

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