Manufacturing method for long medical components

Abstract

To provide a method of manufacturing a medical long member, which can reduce contamination of a support part by a coating liquid.SOLUTION: A method of manufacturing a medical long member includes the steps of: arranging the medical long member on the support part; and coating the long member with the coating liquid in the support part, in a state in which a solvent tank with a solvent in is arranged so that a liquid level of the solvent can be positioned on the side lower than the support part.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a method for producing coated elongated medical members. [Background technology]

[0002] BACKGROUND ART Medical devices such as catheters are coated on their surfaces for the purposes of facilitating insertion into body lumens, protecting the surface of the medical device, and reinforcing it.

[0003] As an example of an apparatus used for coating, Patent Document 1 discloses a coating apparatus that includes a coating application unit that includes a fluid applicator, a first rotation mechanism, a second rotation mechanism, and a control device, and the control device causes the first rotation mechanism and the second rotation mechanism to rotate the medical device at substantially the same speed, which is greater than 500 rotations per minute.

[0004] Patent Document 2 discloses a balloon coating device that forms a coating layer on the outer surface of a balloon of a balloon catheter, the balloon coating device having a rotation mechanism that rotates the balloon around its axis, an applicator that moves relative to the balloon in the axial direction of the balloon and applies a coating liquid containing a drug to the outer surface of the balloon, and a balloon support that comes into contact with the outer surface of the balloon on the side in the direction of movement of the applicator and supports the balloon. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Special Publication No. 2016-504058 [Patent Document 2] Japanese Patent Application Laid-Open No. 2015-119801 Summary of the Invention [Problem to be solved by the invention]

[0006] The inventors' investigations revealed that when a medical elongated member such as a balloon catheter is supported by a support part of a coating device and coated, the coating liquid adhering to the support part dries, causing additives in the coating liquid to precipitate and contaminate the support part. The present invention has been made in light of the above-mentioned problems, and its object is to provide a method for manufacturing a medical elongated member that can reduce contamination of the support part by the coating liquid. [Means for solving the problem]

[0007] A method for manufacturing a medical elongated member according to an embodiment of the present invention that can solve the above problems is as follows. [1] A step of placing a medical elongated member on a support; and A method for manufacturing a medical elongated member, comprising a step of coating the elongated member at the support part with a coating liquid while positioning a solvent tank containing the solvent so that the liquid level of the solvent is located below the support part.

[0008] As described above, by arranging the solvent tank containing the solvent so that the liquid level of the solvent is located below the support part, the vapor generated from the solvent in the solvent tank can easily come into contact with the support part, thereby reducing drying of the coating liquid. As a result, contamination of the support part by the coating liquid can be reduced. The manufacturing method of the medical elongated member according to the embodiment is preferably any one of the following [2] to

[14] . [2] The method for manufacturing a medical elongated member according to [1], wherein the coating liquid is supplied from the bottom of the support part. [3] A method for manufacturing a medical elongated member according to [1] or [2], comprising the step of immersing at least a lower portion of a support member having the support portion in the solvent. [4] The method for producing a medical elongated member according to any one of [1] to [3], wherein the support portion has a recess that is recessed from the top to the bottom. [5] A method for manufacturing a medical elongated member according to any one of [1] to [4], wherein the liquid level of the solvent is controlled by raising or lowering it so that the liquid level of the solvent is located below the lowest part of the support portion and above the bottom surface of the support member having the support portion. [6] The method for producing a medical elongated member according to any one of [1] to [5], wherein the solvent is added to the solvent tank when the liquid level of the solvent is lowered. [7] The method for manufacturing a medical elongated member according to any one of [1] to [6], wherein a weight is placed in the solvent tank when the liquid level of the solvent is lowered. [8] The method for manufacturing a medical elongated member according to any one of [1] to [7], wherein the position of the solvent tank is raised when the liquid level of the solvent is lowered. [9] The method for manufacturing a medical elongated member according to any one of [1] to [8], wherein the position of the support part is lowered when the liquid level of the solvent is lowered.

[10] The method for manufacturing a medical elongated member according to any one of [1] to [9], wherein the solvent is discharged from the solvent tank while the liquid level of the solvent is rising.

[11] The method for manufacturing a medical elongated member according to any one of [1] to

[10] , wherein a weight that has been immersed in advance in the solvent tank is pulled up while the liquid level of the solvent is rising.

[12] The method for manufacturing a medical elongated member according to any one of [1] to

[11] , wherein the position of the solvent tank is lowered when the liquid level of the solvent is rising.

[13] The method for producing a medical elongated member according to any one of [1] to

[12] , wherein the position of the support part is raised when the liquid level of the solvent is rising.

[14] The method for producing a medical elongated member according to any one of [1] to

[13] , wherein the solvent includes an organic solvent. [Effects of the Invention]

[0009] According to the present invention, with the above-mentioned configuration, it is possible to provide a method for manufacturing a medical elongated member that can reduce contamination of the support part by the coating liquid. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a cross-sectional view taken along line AA in FIG. [Figure 2] FIG. 2 is a plan view of a coating device in which a medical elongated member is placed. [Figure 3] FIG. 3 is a cross-sectional view of a modified support member. [Figure 4] FIG. 4 is a cross-sectional view taken along the line AA in FIG. 2, showing the coating device when a part of the support member is immersed in the solvent in the solvent tank. [Figure 5] FIG. 5 is a schematic diagram of a coating device and a medical elongated member. DETAILED DESCRIPTION OF THE INVENTION

[0011] The present invention will be described in more detail below based on the following embodiments. However, the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. For convenience, component reference numerals may be omitted in the drawings. In such cases, reference should be made to the specification or other drawings. The dimensions of various components in the drawings may differ from their actual dimensions, as priority is given to helping understand the features of the present invention.

[0012] A method for manufacturing a medical elongated member according to an embodiment of the present invention includes a step of placing the medical elongated member on a support part, and a step of coating the elongated member on the support part with a coating liquid while a solvent tank containing a solvent is placed so that the liquid level of the solvent is located below the support part.

[0013] As described above, by arranging the solvent tank containing the solvent so that the liquid level of the solvent is located below the support part, the vapor generated from the solvent in the solvent tank can easily come into contact with the support part, thereby reducing drying of the coating liquid and, as a result, reducing contamination of the support part by the coating liquid.

[0014] A method for manufacturing a medical elongated member according to an embodiment will be described below with reference to Figures 1 to 4. Figure 1 is a cross-sectional view taken along line AA in Figure 2. Figure 2 is a plan view of a coating device in which a medical elongated member is arranged. Figure 3 is a cross-sectional view of a modified supporting member. Figure 4 is a cross-sectional view taken along line AA in Figure 2, showing a cross-sectional view of the coating device when a part of the supporting member is immersed in the solvent in the solvent tank. Note that the coating liquid supply syringe is not shown in Figure 2.

[0015] The manufacturing method according to the embodiment includes a step of placing a medical elongated member 40 on a support part 2, and a step of coating the elongated member 40 on the support part 2 with a coating liquid 50 in a solvent tank 30 containing a solvent 30a, with the solvent tank 30 being placed so that a liquid surface 30s of the solvent 30a is located below the support part 2. Each step will be described in detail below.

[0016] As shown in FIG. 1 , in the step of placing the medical elongated member 40 on the support part 2, it is preferable to support the medical elongated member 40 at least at the bottom 2 a of the support part 2 of the coating device 1. This allows the medical elongated member 40 to be supported from below in the vertical direction n. The bottom 2 a of the support part 2 refers to a region of the support part 2 that is below a position halfway along the length of the support part 2 in the vertical direction n. Note that, at the stage of this placing step, the coating liquid 50 may or may not be present on the support part 2. Alternatively, the position of the support part 2 may be raised and / or the position of the medical elongated member 40 may be lowered to place the medical elongated member 40 on the support part 2. The coating device 1 may also have a sensor that detects that the coating liquid 50 has been supplied to the bottom 2 a of the support part 2. In this case, the sensor may be connected to the control unit 35 (described later), and the control unit 35 may generate a signal to change the height of the support part 2 and / or the medical elongated member 40 after the above detection.

[0017] The support part 2 preferably has a recess 5 recessed from the top to the bottom. Even if the medical elongated member 40 moves while the coating liquid 50 is being applied, the movement can be restricted by the recess 5. As a result, the coating film thickness is less likely to vary, and is more likely to be uniform.

[0018] The recess 5 preferably has a surface 5s that comes into contact with the medical elongated member 40 and supports the medical elongated member 40. The surface 5s of the recess 5 may be a flat surface, a curved surface, or a combination thereof. The flat surface may be parallel to the horizontal direction m or may be inclined relative to the horizontal direction m. The curved surface may be curved or bent. The surface 5s of the recess 5 may have a shape that follows the outer surface shape of the medical elongated member 40. The recess 5 may support the medical elongated member 40 at a point, a line, or a surface.

[0019] When the solvent tank 30 containing the solvent 30a is arranged so that the liquid level 30s of the solvent 30a is located below the support part 2, the solvent 30a may be placed below the support part 2 before the solvent 30a is poured into the solvent tank 30, or the solvent 30a may be poured into the solvent tank 30 before the solvent tank 30 is placed below the support part 2. By placing the solvent tank 30 so that the liquid level 30s of the solvent 30a is located below the support part 2, the vapor generated from the solvent 30a in the solvent tank 30 rises and easily comes into contact with the support part 2, making it easier to prevent the coating liquid 50 attached to the support part 2 from drying. This arrangement is preferably performed before the start of coating.

[0020] In this arrangement, it is preferable to arrange the solvent tank 30 so that the support part 2 is located inside the inner edge 30e of the solvent tank 30, as shown in Fig. 2, which is a plan view from above. This makes it easier for the vapor generated from the solvent 30a in the solvent tank 30 to come into contact with the support part 2, making it easier to prevent the coating liquid 50 attached to the support part 2 from drying. Furthermore, it is preferable that the support member 6 having the support part 2 is located inside the inner edge 30e of the solvent tank 30. This makes it easier to immerse at least a portion of the support member 6 in the solvent 30a.

[0021] In the step of coating the elongated member 40 with the coating liquid 50 in the support part 2, it is preferable to supply the coating liquid 50 from the bottom part 2a of the support part 2. This makes it possible to reduce the amount of coating liquid 50 adhering to the support part 2.

[0022] In a mode in which the coating liquid 50 is supplied from the bottom 2a of the support part 2, for example, as shown in Fig. 1 , the liquid tank part 4 located below the support part 2 of the support member 6 may be filled with the coating liquid 50, and the coating liquid 50 may be supplied to the bottom 2a by the surface tension of the coating liquid 50. Alternatively, the liquid level 50a of the coating liquid 50 may be raised by increasing the amount of the coating liquid 50, so that the liquid level 50a is supplied to the bottom 2a. In this case, the coating liquid 50 may spill out of the recess 5.

[0023] The liquid tank 4 preferably includes a liquid tank level adjusting unit 4c that adjusts the level of the liquid surface 50a of the coating liquid 50. The liquid tank level adjusting unit 4c preferably includes a coating liquid injector and / or a weight. The liquid level can be raised by injecting the coating liquid 50 into the liquid tank 4 using the coating liquid injector. Examples of the coating liquid injector include a syringe and a supply pipe connected to a pump. When injecting the coating liquid 50, it is preferable to inject it at a flow rate of 0.05 mL / min or more and 1 mL / min or less. On the other hand, if the liquid tank level adjusting unit 4c includes a weight, the liquid level of the liquid surface 50a of the coating liquid 50 can be raised by submerging the weight when the liquid surface 50a of the coating liquid 50 is decreasing. For details about the weight, see the description of the weight immersed in the solvent tank 30 below. The liquid tank 4 also preferably includes a groove 4g. Furthermore, the support member 6 preferably has a liquid tank level adjusting portion 4c at at least one of both end portions 4a, 4b in the extending direction 4e of the groove 4g, which improves the workability when adjusting the liquid level of the coating liquid 50.

[0024] In the coating step, a support member 6 that does not have a liquid tank portion 4 below the support portion 2 may be used, as shown in Fig. 3. The support member 6 preferably has a recess 5 and includes a discharge port 15 provided at the bottom 2a of the support portion 2, i.e., the bottom of the recess 5, an internal flow path 8 provided below the discharge port 15, and a supply pipe 23 communicating with the internal flow path 8. The coating liquid 50 may be supplied in a form that discharges it onto the bottom 2a of the support portion 2 via the supply pipe 23, the internal flow path 8, and the discharge port 15. In this case, the coating liquid 50 may spill out of the recess 5.

[0025] As shown in FIG. 4 , the manufacturing method according to the embodiment preferably includes a step of immersing at least the lower portion 61 of the support member 6 having the support portion 2 in the solvent 30a. This brings the liquid surface 30s of the solvent 30a in the solvent bath 30 closer to the support portion 2, making it easier for the vapor generated from the solvent 30a to come into contact with the support portion 2 and making it easier to prevent the coating liquid 50 adhering to the support portion 2 from drying out. The immersion is preferably performed before the start of coating, but may be performed after the start of coating. The immersion is also preferably performed before placing the medical elongated member 40 on the support portion 2, but may be performed after the placement. The immersion is also preferably performed by lowering the position of the support member 6, but may also be performed by raising the liquid surface 30s of the solvent 30a, as described below.

[0026] Preferably, at least the region of the support member 6 extending from the bottom surface 6s to a 1 / 10th position, i.e., a distance of 1 / 10 of the length in the vertical direction n, is immersed in the solvent 30a. More preferably, at least the region extending from the bottom surface 6s to a 1 / 4th position, i.e., a distance of 1 / 2 of the length in the vertical direction n, is immersed in the solvent 30a. Furthermore, during the immersion, the liquid surface 30s of the solvent 30a is preferably immersed at a distance of 1 mm or more below the lowermost portion 2m of the support portion 2 in the vertical direction n. The distance between the liquid surface 30s of the solvent 30a and the lowermost portion 2m of the support portion 2 in the vertical direction n is preferably 10 mm or less, more preferably 5 mm or less, even more preferably 2 mm or less, and preferably 1 mm or more. In Figures 1 and 4, the lowermost portion 2m of the support portion 2 corresponds to the lowermost portion of the recess 5.

[0027] In the coating process, when the coating apparatus 1 shown in Fig. 1 or the like is used, if a large amount of the coating liquid 50 spills from the recessed portion 5, the liquid level in the solvent tank 30 arranged below may rise. On the other hand, if the coating liquid 50 does not spill from the recessed portion 5 or if the amount of the coating liquid 50 that spills is small, the liquid level in the solvent tank 30 may drop due to evaporation of the solvent 30a. Control of the liquid level in the solvent tank 30 in the coating process will be described in detail below.

[0028] By raising or lowering the liquid level 30s of the solvent 30a, it is preferable to control the liquid level 30s of the solvent 30a so that it is located below the lowest part 2m of the support part 2 and above the bottom surface 6s of the support member 6 having the support part 2. By controlling the liquid level 30s of the solvent 30a so that it is located below the lowest part 2m of the support part 2, it is possible to prevent a decrease in the concentration of the coating liquid 50 caused by the solvent 30a entering the support part 2 from the recess 5 or the like. On the other hand, by controlling the liquid level 30s of the solvent 30a so that it is located above the bottom surface 6s of the support member 6 having the support part 2, it becomes easier for the vapor generated from the solvent 30a to come into contact with the support part 2, and it is possible to easily prevent the coating liquid 50 attached to the support part 2 from drying out.

[0029] It is preferable to add the solvent 30a to the solvent tank 30 when the liquid level 30s of the solvent 30a is lowered. This makes it possible to raise the liquid level 30s of the solvent 30a and to easily prevent the coating liquid 50 adhering to the support part 2 from drying. There are no particular limitations on the method for adding the solvent 30a to the solvent tank 30, and the solvent 30a may be added using a syringe, a supply pipe connected to a pump, or the like.

[0030] It is preferable to place the weight in the solvent tank 30 when the liquid level 30s of the solvent 30a is dropping. Submerging the weight raises the liquid level 30s of the solvent 30a, making it easier to prevent the coating liquid 50 adhering to the support 2 from drying out. The entire weight does not need to be submerged in the solvent 30a; only a portion of the weight may be submerged. The weight is preferably one that can be submerged in the solvent 30a, and preferably contains a resin and / or a metal, more preferably contains a metal, and even more preferably is made of a metal. A linear body such as a wire may also be attached to the weight. The weight may also be submerged in the solvent 30a using a drive mechanism. Examples of the drive mechanism include an electric winch and a manual winch. For example, the weight can be submerged in the solvent 30a by winding it down using a winch.

[0031] It is preferable to raise the position of the solvent tank 30 when the liquid level 30s of the solvent 30a is lowered. This makes it possible to raise the liquid level 30s of the solvent 30a, and to easily prevent the coating liquid 50 adhering to the support part 2 from drying. As a means for raising the solvent tank 30, for example, a drive mechanism may be used to raise the position of the solvent tank 30. An example of the drive mechanism is an actuator having a slider that can be raised and lowered in the vertical direction n.

[0032] It is preferable to lower the position of the support part 2 when the liquid level 30s of the solvent 30a is lowered. This makes it easier to prevent drying of the coating liquid 50 attached to the support part 2. As a means for lowering the support part 2, for example, the support part 2 may be lowered by using the driving mechanism of the support member 6 as described above.

[0033] It is preferable to discharge the solvent 30a from the solvent tank 30 when the liquid level 30s of the solvent 30a is rising. This prevents the concentration of the coating liquid 50 from decreasing due to the solvent 30a entering the support part 2 through the recess 5 or the like. As a means for discharging the solvent 30a from the solvent tank 30, for example, the tip of a tube connected to a pump may be placed in the solvent 30a to discharge the solvent 30a, or a syringe may be used. Furthermore, the solvent tank 30 may have an openable / closable opening formed in the bottom and / or side. The solvent 30a can be discharged from the opening.

[0034] When the liquid level 30s of the solvent 30a is rising, it is preferable to pull up the weight that has been immersed in the solvent tank 30 in advance. This allows the liquid level 30s of the solvent 30a to be lowered, and prevents a decrease in the concentration of the coating liquid 50 caused by the solvent 30a entering the support part 2 through the recess 5 or the like. As described above, the weight may be attached with a linear body such as a wire. Alternatively, the weight may be pulled up using the driving mechanism described above.

[0035] It is preferable to lower the position of the solvent tank 30 when the liquid level 30s of the solvent 30a is rising. This makes it possible to lower the liquid level 30s of the solvent 30a and prevent a decrease in the concentration of the coating liquid 50 caused by the solvent 30a entering the support part 2 from the recess 5 or the like. As a means for lowering the solvent tank 30, for example, the above-mentioned driving mechanism may be used to lower the position of the solvent tank 30.

[0036] When the liquid level 30s of the solvent 30a is rising, it is preferable to raise the position of the support part 2. This makes it possible to lower the liquid level 30s of the solvent 30a and prevent a decrease in the concentration of the coating liquid 50 caused by the solvent 30a entering the support part 2 from the recess 5 or the like. As a means for raising the support part 2, for example, the support part 2 may be raised by using the driving mechanism of the support member 6 as described above.

[0037] When controlling the level of the liquid surface 30s of the solvent 30a, a level gauge may be used to grasp the liquid level. Examples of level gauges include non-contact level gauges that do not come into contact with the solvent 30a and contact level gauges that come into contact with the solvent 30a. Examples of non-contact level gauges include ultrasonic level gauges and radio wave level gauges. Examples of contact level gauges include float level gauges, guide rope level gauges, and pressure level gauges that are throw-in type level gauges, capacitance level gauges, and differential pressure level gauges. Alternatively, a mark may be placed on the inner edge 30e of the solvent tank 30, allowing the level of the liquid surface 30s of the solvent 30a to be visually confirmed. Furthermore, the solvent tank 30 preferably has multiple side walls, and at least one of the multiple side walls may have an inclined portion that slopes outward. Providing such an inclined portion makes it easier to check the liquid level from above.

[0038] The syringe, pump, drive mechanism, level meter, etc. described above may be connected to the control unit 35 described later. For example, when the liquid level measured by the level meter falls below or exceeds a predetermined liquid level, the control unit 35 may transmit signals for controlling the liquid level to each component, and each component may operate to raise or lower the liquid surface 30s of the solvent 30a based on the signals.

[0039] The solvent 30a in the solvent tank 30 preferably contains an organic solvent. This facilitates vapor generation. The solvent 30a before coating begins is preferably an organic solvent. Examples of organic solvents include methanol, ethanol, dioxane, tetrahydrofuran, dimethylformamide, acetonitrile, dimethyl sulfoxide, acetone, and mixtures thereof. Among these, methanol, ethanol, dioxane, tetrahydrofuran, acetonitrile, acetone, and mixtures thereof are more preferred, with ethanol, tetrahydrofuran, and mixtures thereof being even more preferred, and ethanol being particularly preferred. The boiling point of the organic solvent is preferably 170°C or lower, more preferably 120°C or lower, and even more preferably 80°C or lower. This improves the evaporation rate. Meanwhile, the boiling point of the organic solvent is preferably 50°C or higher, more preferably 55°C or higher, and even more preferably 60°C or higher. This reduces air pollution caused by excessive evaporation.

[0040] The mass of the solvent 30a in the solvent tank 30 at the start of coating is preferably larger than the mass of the coating liquid 50 in the liquid tank section 4. Furthermore, the volume of the solvent 30a in the solvent tank 30 at the start of coating is preferably larger than the volume of the coating liquid 50 in the liquid tank section 4. This allows the amount of vapor generated from the solvent 30a in the solvent tank 30 to be increased.

[0041] The coating liquid 50 preferably contains an additive and a solvent. Examples of additives include silicone resin, urethane resin, (meth)acrylic resin, fluororesin, polyolefin resin, epoxy resin, polyester resin, cellulose compound, glycol compound, or a mixture thereof. Examples of cellulose compounds include cellulose, cellulose acetate, cellulose butyrate, cellophane, cellulose nitrate, propionyl cellulose, cellulose ether, carboxymethyl cellulose, or a mixture thereof. Examples of glycol compounds include polyethylene glycol, polypropylene glycol, or a mixture thereof. The coating liquid 50 may also contain additives such as monomers, reactive compounds such as photoreactive compounds, crosslinking agents, etc. These additives can be selected based on factors such as improving the operability of the medical elongated member 40, such as its slidability, protecting and reinforcing the medical elongated member 40, and ease of handling during coating.

[0042] The solvent of the coating liquid 50 preferably contains an organic solvent. Examples of the organic solvent include methanol, ethanol, dioxane, tetrahydrofuran, dimethylformamide, acetonitrile, dimethyl sulfoxide, acetone, and mixtures thereof. Among these, methanol, ethanol, dioxane, tetrahydrofuran, acetonitrile, acetone, and mixtures thereof are more preferred, with tetrahydrofuran being even more preferred. The boiling point of the organic solvent in the coating liquid 50 is preferably lower than the boiling point of the organic solvent in the solvent 30a in the solvent bath 30. This facilitates drying of the medical elongated member 40 after coating. The difference in boiling points is preferably 1°C or more, more preferably 5°C or more, and even more preferably 10°C or more. Meanwhile, the difference in boiling points is preferably 30°C or less, more preferably 25°C or less, and even more preferably 20°C or less. This facilitates evaporation of the solvent 30a from the solvent bath 30.

[0043] The coating liquid 50 may further contain a drug, such as an immunosuppressant, an immunostimulant, an anticancer agent, an antiviral agent, an antibacterial agent, an antineoplastic agent, an analgesic, an anti-inflammatory agent, an antibiotic, an antiepileptic agent, an anxiolytic agent, an antianesthetic agent, an antagonist, a neuron blocking agent, an anticholinergic agent, an antiarrhythmic agent, an antihypertensive agent, a hormone, a nutritional agent, or a mixture thereof.

[0044] The support part 2 has a plurality of recesses 5, and the recesses 5 are preferably arranged side by side in the horizontal direction m. This makes it easier to support the plurality of medical elongated members 40 at approximately the same height. The recesses 5 are preferably arranged side by side in a straight line.

[0045] The number of recesses 5 is preferably 1 or more, more preferably 2 or more, and even more preferably 4 or more, and is preferably 15 or less, more preferably 10 or less, and even more preferably 8 or less. As will be described later, when the support member 6 has a first recess 5a and a second recess 5b facing each other, the pair of recesses can be counted as one recess.

[0046] Furthermore, the coating apparatus 1 preferably has a support member 6 , and the support member 6 preferably has a support section 2 and a liquid tank section 4 .

[0047] When starting coating using the coating device 1, it is preferable to allow the liquid level 50a of the coating liquid 50 in the liquid tank 4 to reach the bottom 5c of the recess 5. By immersing each bottom 5c of a plurality of recesses 5 in the coating liquid 50 in the liquid tank 4 in this manner, a plurality of medical elongated members 40 can be coated all at once. Furthermore, this makes it easier to make the amount of coating liquid 50 at each bottom 5c uniform, thereby reducing variation in the amount of coating among a plurality of medical elongated members 40. In this embodiment, the bottom 5c of the recess 5 corresponds to the bottom 2a of the support part 2.

[0048] The liquid tank section 4 preferably has grooves 4g extending in the direction in which the plurality of recesses 5 are arranged. The presence of grooves in the liquid tank section 4 can reduce the amount of evaporation of the coating liquid 50 from the liquid tank section 4. Furthermore, the extension of the grooves 4g in the direction in which the plurality of recesses 5 are arranged can efficiently supply the coating liquid 50 to each bottom 5c.

[0049] The recesses 5 are preferably spaced apart from one another in the extending direction 4e of the grooves 4g, which makes it easier to avoid contact between the elongated medical members 40 during coating.

[0050] 2, it is preferable that each of the recesses 5 is capable of supporting the elongated medical member 40 such that the axial direction u of the elongated medical member 40 is perpendicular to the extending direction 4e of the grooves 4g. This makes it easier to coat the elongated medical member 40 while moving the support member 6 in the axial direction u of the elongated medical member 40.

[0051] 1 and 2, the coating apparatus 1 preferably includes a support member 6 having a bottom plate 6a having a length and a width, a first side plate 6b formed on one end of the bottom plate 6a in the width direction, and a second side plate 6c formed on the other end of the bottom plate 6a in the width direction and facing the first side plate 6b. Furthermore, it is preferable that the first side plate 6b has a plurality of first recesses 5a on an upper portion thereof, and the second side plate 6c has a plurality of second recesses 5b on an upper portion thereof facing the plurality of first recesses 5a, and each of the plurality of recesses 5 has a first recess 5a and a second recess 5b.

[0052] It is preferable that the support member 6 further has a third side plate 6d formed on one longitudinal end of the bottom plate 6a, and a fourth side plate 6e formed on the other longitudinal end of the bottom plate 6a and facing the third side plate 6d.

[0053] Although not shown, the support member 6 may have at least one top plate above the first side plate 6b and the second side plate 6c, in a portion other than the recesses 5. This can reduce evaporation of liquid from the liquid tank portion 4.

[0054] Each of these plates may be flat, curved or bent, and may be integrally formed.

[0055] The liquid tank section 4 is preferably located between the first side plate 6b and the second side plate 6c and below the plurality of recesses 5. This makes it easier to immerse the bottoms 5c of the plurality of recesses 5 in the coating liquid 50 in the liquid tank section 4 all at once. Furthermore, the liquid tank section 4 is preferably located between the third side plate 6d and the fourth side plate 6e. Furthermore, it is preferable that the plates constituting the liquid tank section 4 do not have through-holes.

[0056] The support member 6 preferably contains a resin and / or a metal, more preferably contains a metal, and even more preferably is made of a metal, while the solvent tank 30 preferably contains a resin and / or a metal, more preferably contains a metal, and even more preferably is made of a metal.

[0057] The medical elongated member 40 is a long member for forming a medical device. The medical elongated member 40 may be tubular with one or more lumens. Alternatively, the medical elongated member 40 may have a solid shape. The medical elongated member 40 may be flexible and / or elastic. The medical elongated member 40 preferably contains a resin and / or a metal. Examples of the resin include polyamide resin, polyester resin, polyurethane resin, polyolefin resin, fluorine resin, vinyl chloride resin, silicone resin, natural rubber, or a mixture thereof. Examples of the metal include stainless steel such as SUS304 or SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or a combination thereof.

[0058] Examples of the medical elongated member 40 include a catheter, a guide wire, a tube, a stent, a pipe, a rod, and the like. Examples of the catheter include a balloon catheter, a cannula, a stent delivery catheter, and a microcatheter.

[0059] Hereinafter, a medical elongated member 40 and each part that the coating device 1 may have will be described with reference to FIG. 5, which is a schematic diagram of the coating device and medical elongated member according to the embodiment.

[0060] As shown in Figure 5, the elongated member 40 preferably has a first end 41 and a second end 42 in the longitudinal axis direction u. The outer diameter of the elongated member 40 may be constant throughout the entire longitudinal axis direction u, or the outer diameter may vary depending on the position in the longitudinal axis direction u. As shown in Figure 5, the elongated member 40 may have a large diameter portion 43 and a small diameter portion 44. Because Figure 5 shows the elongated member 40 for forming a balloon catheter, the large diameter portion 43 has a straight tube portion 431 and tapered portions 432 on both sides of the straight tube portion 431.

[0061] 5, the coating apparatus 1 may further include a first holding part 25 that holds a first end 41 side of the long member 40 in the longitudinal axis direction u, and a second holding part 26 that holds a second end 42 side of the long member 40 in the longitudinal axis direction u. With this configuration, the long member 40 is stably held during coating, thereby preventing the long member 40 from shifting position.

[0062] The first holding portion 25 and the second holding portion 26 may have any mechanism capable of holding and releasing the elongated member 40 and / or the core material 28 (described later). For example, the elongated member 40 and / or the core material 28 may be held by pinching, clamping, grasping, sucking, fitting, or the like. The first holding portion 25 or the second holding portion 26 may be composed of one or more members. The first holding portion 25 and the second holding portion 26 may each have chuck pieces facing each other in the horizontal direction m or the vertical direction n. In FIG. 5, the first holding portion 25 has chuck pieces 251 and 252, and the second holding portion 26 has chuck pieces 261 and 262.

[0063] The elongated member 40 preferably has a lumen extending in the longitudinal direction, and the coating apparatus 1 preferably has an elongated core 28 disposed in the lumen of the elongated member 40. The core 28 has a first end 281 and a second end 282 in the longitudinal direction. The core 28 is threaded through the lumen of the elongated member 40 shown in FIG. 5 , with the first end 281 of the core 28 extending from the first end 41 of the elongated member 40 and the second end 282 of the core 28 extending from the second end 42 of the elongated member 40. The first holding unit 25 holds the end of the core 28 on the first end 281 side, and the second holding unit 26 holds the end of the core 28 on the second end 282 side. Holding the elongated member 40 via the core 28 in this manner enables coating of the entire elongated member 40 in the longitudinal direction u. Furthermore, because the elongated member 40 is not directly held, scratches on the surface of the elongated member 40 can be reduced. The coating liquid 50 may be applied to only a portion of the elongated member 40 in the longitudinal axis direction u, or may be applied to the entire elongated member 40 in the longitudinal axis direction u.

[0064] The core material 28 is a long, rod-shaped member. The core material 28 may be solid or hollow. For the material that constitutes the core material 28, the description of the material that constitutes the long member 40 can be referred to.

[0065] It is preferable that at least one of the first holding unit 25 and the second holding unit 26 has a rotation mechanism 27 that rotates the elongated member 40. With this configuration, the coating can be performed while the elongated member 40 is being rotated, which makes it easier to apply the coating liquid 50 uniformly in the circumferential direction of the elongated member 40. Note that while FIG. 5 shows an example in which the second holding unit 26 has the rotation mechanism 27, the first holding unit 25 may have the rotation mechanism 27, or the first holding unit 25 and the second holding unit 26 may each have a rotation mechanism 27.

[0066] The rotation mechanism 27 may revolve the elongated member 40 around the axis x of the coating apparatus 1, or may rotate the elongated member 40 about the center of its longitudinal axis. The direction of the axis x of the coating apparatus 1 may be parallel to the horizontal direction m. The direction of the axis x may be parallel to the longitudinal axis direction u of the elongated member 40. The direction of the axis x may be the longitudinal axis direction of the core material 28 before the elongated member 40 is revolved. The rotation mechanism 27 includes an actuator such as a motor that drives the first holding unit 25 or the second holding unit 26. For the configuration of the actuator, refer to the description of the drive mechanism 10 described below.

[0067] The support part 2 only needs to be configured to support at least a portion of the elongated member 40 in the longitudinal axis direction u, and does not need to support the entire elongated member 40 in the longitudinal axis direction u. For example, it is preferable that the support part 2 supports the elongated member 40 between the first end 41 and the second end 42. The support part 2 may support the elongated member 40 at one point in the longitudinal axis direction u, or at multiple points.

[0068] The support unit 2 is preferably movable in the longitudinal direction u of the elongated member 40. For example, a rail may be arranged on the support member 6, and the support unit 2 may move along the rail. Furthermore, as indicated by arrow A in FIG. 5 , the support unit 2 may move from the first end 41 toward the second end 42 of the elongated member 40, or from the second end 42 toward the first end 41. The support unit 2 may also be movable in the radial direction of the elongated member 40. This facilitates movement along the shape of the elongated member 40, making it easier to achieve a uniform coating film thickness. The support unit 2 may be movable in the horizontal direction m or the vertical direction n. When the coating apparatus 1 has multiple support members 6, it is preferable that the multiple support members 6 be movable together.

[0069] The support member 6 may have a drive mechanism 10 to move the support part 2. The drive mechanism 10 is preferably connected to a control unit 35, and the movement of the support part 2 can be controlled by the control unit 35. The drive mechanism 10 preferably includes an actuator with one or more axes that drives the support part 2. The actuator may include mechanical elements such as a motor, a linear guide, a ball screw, a timing belt pulley, a slider, a rack and pinion, etc.

[0070] The coating apparatus 1 preferably has a liquid tank level adjusting unit 4c at one end 4a of the liquid tank unit 4 in the extending direction of the groove. The liquid tank level adjusting unit 4c preferably has a coating liquid supply unit 21. The coating liquid supply unit 21 may have a storage unit 22 that stores the coating liquid 50 and a supply pipe 23 connected to the storage unit 22. The storage unit 22 and the supply pipe 23 may be connected to a pump 24. The pump 24 may be connected to a control unit 35 and supply a predetermined amount of the coating liquid 50 to the supply pipe 23 side. Examples of the pump 24 include a syringe pump and a tube pump.

[0071] 5, the coating liquid 50 is preferably poured into one end 4a of the groove from above the liquid tank section 4. However, the coating liquid 50 may also be poured from the side or bottom of the liquid tank section 4. For example, an internal flow path such as a through-hole communicating with the liquid tank section 4 may be provided in the support member 6, the supply pipe 23 may be connected to the internal flow path, and the coating liquid 50 may be poured from the internal flow path. The inner diameter of the internal flow path, the supply pipe 23, is preferably 0.1 mm or more and 3.0 mm or less.

[0072] The coating apparatus 1 includes a solvent tank 30 containing a solvent 30a, and is disposed so that a liquid surface 30s of the solvent 30a is located below the support member 2. This allows vapor generated from the solvent 30a in the solvent tank 30 to rise and contact the support member 2, making it easier to prevent the coating liquid 50 adhering to the support member 2 from drying. Furthermore, the solvent tank 30 may also function as a tray for the coating liquid 50 spilled from the recess 5. The solvent tank 30 preferably moves in conjunction with the movement of the support member 6 in the longitudinal axis direction u. The solvent tank 30 may also be movable in the radial direction of the elongated member 40, in the horizontal direction m, or in the vertical direction n. The solvent tank 30 may be connected to the support member 6. In these cases, the solvent tank 30 is also preferably connected to the drive mechanism 10.

[0073] The coating apparatus 1 preferably has a control unit 35 that controls the operation of each unit constituting the coating apparatus 1. The control unit 35 may be connected to the coating liquid supply unit 21, the first holding unit 25, the second holding unit 26, the rotation mechanism 27, the drive mechanism 10, the solvent tank 30, or two or more of these units.

[0074] The functions of the control unit 35 may be realized by hardware or software, such as a logic circuit formed in an integrated circuit.

[0075] The control unit 35 may include a computer that executes instructions of a program, which is software for realizing the functions of the control unit 35. The computer preferably includes a processor and a computer-readable recording medium that stores the program. The processor executes the program stored in the computer-readable recording medium, thereby realizing the functions. A CPU (Central Processing Unit) can be used as the processor. A ROM (Read Only Memory) or the like can be used as the recording medium. The recording medium can also include a RAM (Random Access Memory). The program can be supplied to the computer via any transmission medium that can transmit the program. Examples of the transmission medium include a communication network and a communication line. [Explanation of symbols]

[0076] 1 Coating equipment 2 Support part 2a Bottom of support 2m Bottom of support m horizontal direction n Vertical direction x-axis 4 Liquid tank section 4a, 4b both ends 4c Liquid tank liquid level adjustment part 4e Extending direction 4g groove 5 recess 5a First recess 5b Second recess 5c Bottom of the recess 5s Recessed surface 6 Support member 6a Bottom plate 6b First side panel 6c Second side panel 6d Third side panel 6e Fourth side panel 6s Bottom surface of support member 6l lower 8 Internal flow path 10 Drive mechanism 15 Outlet 21 Coating liquid supply section 22 Storage section 23 Supply pipe 24 Pump 25 1st holding part 251, 252 chuck pieces 26 Second holding part 261, 262 chuck pieces 27 Rotation mechanism 28 Core material 281 1st end 282 2nd end 30 Solvent tank 30a Solvent 30e Inner edge of solvent reservoir 30s Solvent level 35 Control Unit 40 Long medical components u Axial direction of long members 41 1st end 42 2nd end 43 Large diameter section 44 Small diameter section 431 Straight pipe section 432 Tapered section 50 Coating liquid 50a Coating liquid level

Claims

1. A step of placing a medical elongated member on a support member having a support portion and a liquid tank portion located below the support portion and containing a coating liquid; A method for manufacturing a medical elongated member, comprising a step of coating the elongated member at the support part with the coating liquid while positioning a solvent tank containing the solvent so that the liquid level of the solvent is located below the support part.

2. The method for manufacturing a medical elongated member according to claim 1 , wherein the coating liquid is supplied from the bottom of the support portion.

3. The method for manufacturing a medical elongated member according to claim 1 or 2, further comprising the step of immersing at least a lower portion of the support member in the solvent.

4. The method for manufacturing a medical elongated member according to any one of claims 1 to 3, wherein the support portion has a recess that is recessed from the top to the bottom.

5. A method for manufacturing a medical elongated member described in any one of claims 1 to 4, wherein the liquid level of the solvent is controlled by raising or lowering it so that the liquid level of the solvent is located below the lowest part of the support portion and above the bottom surface of the support member.

6. The method for manufacturing a medical elongated member according to any one of claims 1 to 5, wherein the solvent is added to the solvent tank when the liquid level of the solvent is lowered.

7. The method for manufacturing a medical elongated member according to any one of claims 1 to 6, wherein a weight is placed in the solvent tank when the liquid level of the solvent is lowered.

8. The method for manufacturing a medical elongated member according to any one of claims 1 to 7, wherein the position of the solvent tank is raised when the liquid level of the solvent is lowered.

9. The method for manufacturing a medical elongated member according to any one of claims 1 to 8, wherein the position of the support part is lowered when the liquid level of the solvent is lowered.

10. The method for manufacturing a medical elongated member according to any one of claims 1 to 9, wherein the solvent is discharged from the solvent tank while the liquid level of the solvent is rising.

11. The method for manufacturing a medical elongated member according to any one of claims 1 to 10, wherein a weight that has been immersed in advance in the solvent tank is pulled up when the liquid level of the solvent is rising.

12. The method for manufacturing a medical elongated member according to any one of claims 1 to 11, wherein the position of the solvent tank is lowered when the liquid level of the solvent is rising.

13. The method for manufacturing a medical elongated member according to any one of claims 1 to 12, wherein the position of the support part is raised when the liquid level of the solvent is rising.

14. The method for producing a medical elongated member according to any one of claims 1 to 13, wherein the solvent includes an organic solvent.

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