JP6276582B2 - Balloon coating method and balloon coating apparatus - Google Patents

Description

  The present invention relates to a balloon coating method and a balloon coating apparatus for forming a coating layer on the surface of a balloon.

  In recent years, a balloon catheter has been used to improve a lesion (stenosis) occurring in a living body lumen. A balloon catheter is usually provided with a long shaft portion and a balloon that is provided on the distal end side of the shaft portion and is radially expandable, and the deflated balloon is passed through a thin living body lumen. The lesion can be expanded by expanding after reaching the target location in the body.

  However, if the lesion is forcibly expanded, the endothelial cells proliferate excessively and new stenosis (restenosis) may develop in the lesion. For this reason, recently, a drug-eluting balloon in which a drug for suppressing stenosis is coated on the outer surface of the balloon has been used. By expanding the drug-eluting balloon, the drug coated on the outer surface can be instantaneously released to the lesioned part, and the drug can be transferred to the living tissue, thereby suppressing restenosis.

  Examples of a method for forming a coating layer containing a drug on a balloon include a spray method, a drop method, and a stringing method. The spray method is a method in which a coating liquid containing a drug is sprayed from a dispensing tube that does not come into contact with the balloon in the form of a mist, and then the coating liquid is dried to form a coating layer on the outer surface of the balloon. The drop method is a method in which a coating liquid is dropped from a dispensing tube that does not contact the balloon, and then the coating liquid is dried to form a coating layer on the outer surface of the balloon. The thread drawing method is a method of forming a coating layer on the outer surface of the balloon by supplying the coating solution onto the outer surface of the balloon via a thread or the like that contacts the balloon and then drying the coating solution.

  When applying the coating liquid to the balloon by the various methods described above, the dispensing tube or the thread supply device for supplying the coating liquid is moved in the axial direction of the balloon while rotating the balloon. The coating liquid can be continuously applied to the surface (see, for example, Patent Document 1).

Japanese Patent No. 4906926

  When the balloon is curved along the axis, when the balloon is rotated, the balloon is eccentric as the balloon rotates, and the distance between the device to be applied and the balloon changes. Since the balloon has a different curvature along the axial center depending on the individual, the change in the distance between the device to be applied and the balloon differs depending on the individual. When the distance between the device to be applied and the balloon changes, uneven coating occurs, the thickness of the drug coated on the balloon becomes non-uniform, and it becomes difficult to obtain a desired thickness.

  By the way, the drug coated on the outer surface of the balloon can be in different morphological types such as a crystalline type, an amorphous type, and a mixed type thereof depending on the length of time when the solvent is volatilized. Either crystal or amorphous is not necessarily desirable, and it is desirable that it can be selected according to the purpose. When the distance between the device to be applied and the balloon changes and the coating liquid is non-uniformly applied, the time for which the solvent evaporates also becomes non-uniform, and the morphological type of the drug coated on the balloon can be set appropriately. It becomes difficult.

  The present invention has been made to solve the above-described problems, and an object of the present invention is to provide a balloon coating method and a balloon coating apparatus capable of appropriately setting the thickness, morphological type, and the like of a drug coated on a balloon. To do.

A balloon coating method according to the present invention that achieves the above object is a balloon coating method for forming a coating layer on the outer surface of a balloon of a balloon catheter, wherein the drug is rotated while the balloon is rotated about the axis of the balloon. An application part for applying a coating solution containing a liquid is moved relative to the balloon in the axial direction, and a balloon support part provided on the movement direction side of the application part is brought into contact with the balloon to support the balloon. and while, have a coating step of applying the coating liquid on the outer surface of the balloon by the application unit, in the coating step, the balloon support portion is deformable in response to the outer diameter of the balloon, the balloon Contact with the outer surface in a continuous range in the circumferential direction .

The balloon coating apparatus according to the present invention that achieves the above object is a balloon coating apparatus that forms a coating layer on the outer surface of a balloon of a balloon catheter, and rotates the balloon about the axis of the balloon. A mechanism, an application part 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; in contact with the outer surface possess a balloon support portion for supporting the balloon, wherein the balloon support portion is a circular arc shape that contacts with a continuous range in the circumferential direction with respect to the outer surface of said balloon, said balloon It can be deformed according to the outer diameter . The balloon support part for supporting the balloon is configured separately from the application part for applying the coating liquid, and the balloon support part does not touch the coating liquid.

In the balloon coating method configured as described above, since the balloon is supported by the balloon support portion provided on the moving direction side of the application portion, the application portion is provided without bringing the coating liquid into contact with the balloon support portion. It is possible to suppress uneven coating by suppressing a change in the distance between the application portion and the balloon that occurs at the site. Thereby, variation in the thickness of the coating liquid applied to the balloon is suppressed, and the thickness of the coating liquid (coating layer) can be easily adjusted. Furthermore, by adjusting the thickness of the coating liquid, it becomes easy to adjust the time for volatilizing the solvent, and the morphological type and size of the drug contained in the coating layer can be set more freely. . Moreover, in the said application | coating process, since the said balloon support part is made to contact in the circumferentially continuous range with respect to the outer surface of the said balloon, the influence by eccentricity of a balloon can be suppressed more effectively. Further, in the application step, since a balloon support portion that can be deformed according to the outer diameter of the balloon is used, the balloon support portion is deformed to an optimum size for supporting the balloon according to the outer diameter of the balloon. it can. For this reason, even when there are individual differences in balloons or when different types of balloons are coated, the balloons can be supported by one balloon support part.

  By using a balloon support portion that can move integrally with the application portion, the balloon support portion can suppress the eccentricity of the balloon that occurs at the site where the application portion is provided, or even if the balloon is eccentric, it receives force from the balloon. The application part moves together with the balloon support part so that the distance between the application part and the balloon can be kept constant, and coating unevenness can be suppressed.

  In the application step, if the axis of the balloon is positioned inside a polygon having at least three points included in a region of the balloon support that is in contact with the balloon, all orthogonal to the axis The influence of the eccentricity of the balloon in the direction can be suppressed.

  In the application step, if the support portion provided with a low friction material is used at a portion that contacts the outer surface of the balloon, the balloon support portion does not hinder the rotation of the balloon, and the balloon support portion and the balloon It is possible to suppress the damage of the balloon due to the contact of.

In addition, the balloon coating apparatus configured as described above includes a balloon support unit that contacts the outer surface of the balloon and supports the balloon on the moving direction side of the application unit, so that the coating solution contacts the balloon support unit. Without making it, the variation in the distance between the application portion and the balloon that occurs in the portion where the application portion is provided can be suppressed, and uneven coating can be suppressed. Thereby, variation in the thickness of the coating liquid applied to the balloon is suppressed, and the thickness of the coating liquid (coating layer) can be easily adjusted. Furthermore, by adjusting the thickness of the coating liquid, it becomes easy to adjust the time for volatilizing the solvent, and the morphological type and size of the drug contained in the coating layer can be set more freely. . Moreover, since the said balloon support part is circular arc shape which contacts in the range continuous in the circumferential direction with respect to the outer surface of the said balloon, the influence by eccentricity of a balloon can be suppressed more effectively. Further, since the balloon support portion can be deformed according to the outer diameter of the balloon, the balloon support portion can be deformed to an optimum size for supporting the balloon according to the outer diameter of the balloon. For this reason, even when there are individual differences in balloons or when different types of balloons are coated, the balloons can be supported by one balloon support part.

  If the balloon support part is movable integrally with the application part, the balloon support part can suppress the eccentricity of the balloon that occurs at the part where the application part is provided, or even if the balloon is eccentric, the balloon support part can The application part moves together with the balloon support part that receives the light, so that the distance between the application part and the balloon can be maintained constant, and uneven coating can be suppressed.

It is the schematic which shows the apparatus for performing the balloon coating method which concerns on embodiment. It is sectional drawing which shows a balloon catheter. It is a front view which shows a balloon support part. It is a side view which shows a balloon support part. It is sectional drawing which follows the AA line of FIG. It is a top view which shows the state at the time of apply | coating a coating liquid to the outer surface of a balloon. It is a front view which shows the modification of a balloon support part. It is a top view which shows the other example of a balloon catheter.

  Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

  The balloon coating method according to the embodiment of the present invention forms a coating layer containing a drug on the surface of the balloon, and is performed by the balloon coating apparatus 50 shown in FIG. In this specification, the side of the balloon catheter 10 to be inserted into the living body lumen is referred to as “tip” or “tip side”, and the proximal side for operation is referred to as “base end” or “base end side”.

  First, the structure of the balloon catheter 10 will be described. As shown in FIG. 2, the balloon catheter 10 includes a long catheter body 20, a balloon 30 provided at the distal end of the catheter body 20, and a hub 40 fixed to the proximal end of the catheter body 20. Have.

  The catheter body 20 includes an outer tube 21 that is a tubular body having an open front end and a proximal end, and an inner tube 22 disposed inside the outer tube 21. An expansion lumen 23 through which an expansion fluid for expanding the balloon 30 circulates is formed between the outer tube 21 and the inner tube 22, and a guide wire through which a guide wire is inserted inside the inner tube 22. A lumen 24 is formed.

  The balloon 30 has a distal end bonded to the inner tube 22 and a proximal end bonded to the outer tube 21, and the balloon 30 communicates with the expansion lumen 23. A cylindrical straight portion 31 having the same outer diameter when expanded is formed in the central portion of the balloon 30 in the axial center X direction, and the outer diameter gradually changes on both sides of the straight portion 31 in the axial center X direction. A tapered portion 33 is formed. And the coating layer 32 containing a chemical | medical agent is formed in the whole outer surface of the straight part 31. FIG. In addition, the range in which the coating layer 32 is formed in the balloon 30 is not limited to the straight portion 31, and may include at least a part of the tapered portion 33 in addition to the straight portion 31, or one of the straight portions 31. It may be only part.

  The hub 40 includes a first opening 41 that functions as a port that communicates with the expansion lumen 23 of the outer tube 21 and allows the expansion fluid to flow in and out, and a second opening 42 through which the guide wire lumen 24 is inserted. . The second opening 42 is provided with a hemostasis valve 43 that suppresses blood outflow.

  The balloon 30 is preferably formed of a material having a certain degree of flexibility. Examples of such a material include polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, Polyolefins such as ionomers or mixtures of two or more thereof, soft polyvinyl chloride resins, polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, fluororesins and other thermoplastic resins, silicone rubbers, latex rubbers and the like can be used.

  Next, the balloon coating apparatus 50 will be described. As shown in FIG. 1, the balloon coating apparatus 50 includes a rotation mechanism 60 that holds the balloon catheter 10 and rotates it around the axis X of the balloon 30, a support base 70 that supports the balloon catheter 10, and the balloon catheter 10. A moving mechanism 80 including a moving table 81 that can move in the direction of the axis X, an application mechanism 90 that applies the coating liquid R to the outer surface of the balloon 30, and a control unit 100 that controls the balloon coating apparatus 50. Have.

  The rotation mechanism 60 holds the hub 40 of the balloon catheter 10 and rotates the balloon catheter 10 by a driving source such as a built-in motor. In the balloon catheter 10, the core material 61 is inserted and held in the guide wire lumen 24, and the core material 61 prevents the coating liquid R from flowing into the guide wire lumen 24. Further, the balloon catheter 10 has a cap 63 placed on the first opening 41 of the hub 40 so as to cover the expansion lumen 23, and can seal the expansion fluid when the balloon 30 is expanded. A three-way cock may be used instead of the cap 63.

  The support base 70 includes a tubular proximal end support portion 71 that accommodates and rotatably supports the catheter body 20 and a distal end support portion 72 that rotatably supports the core member 61. Note that the distal end side support portion 72 may rotatably support the distal end portion of the catheter main body 20 instead of the core member 61 if possible. In the present embodiment, the core member 61 is rotated together with the balloon catheter 10. However, the balloon member 10 may be rotated outside the core member 61 by fixing the core member 61 to the distal end side support portion 72. .

  The moving mechanism 80 includes a moving table 81 that can move linearly in a direction parallel to the axis X of the balloon 30. The moving table 81 can move linearly by a driving source such as a built-in motor. An application mechanism 90 is placed on the moving table 81, and the application mechanism 90 is linearly moved in both directions along the axis X of the balloon catheter 10.

  The application mechanism 90 includes a container 92 for storing the coating liquid R, a liquid supply pump 93 for supplying the coating liquid R in an arbitrary amount, and a dispensing tube 94 (application unit) for applying the coating liquid R to the balloon 30. ) And a balloon support portion 97 for suppressing the eccentricity of the balloon 30.

  The liquid feed pump 93 is a syringe pump, for example, and is controlled by the control unit 100 to suck the coating liquid R from the container 92 through the suction tube 95 and to the dispensing tube 94 through the supply tube 96. Can be supplied in an arbitrary amount. The liquid feed pump 93 is installed on the moving table 81 and can move linearly by the movement of the moving table 81. The liquid feed pump 93 is not limited to a syringe pump as long as the coating liquid R can be fed, and may be a tube pump, for example.

  The dispensing tube 94 is a tubular member that discharges the coating liquid R from an opening that opens toward the outer surface of the balloon 30. The opening of the dispensing tube 94 is formed so as to open in a plane orthogonal to the axis of the dispensing tube 94, but is not limited thereto. The dispensing tube 94 is fixed to a fixing member 98 fixed to the moving table 81, and moves linearly in both directions along the axis X of the balloon catheter 10 together with the liquid feeding pump 93 installed on the moving table 81. Is possible. The dispensing tube 94 may not be circular as long as the coating liquid R can be supplied. Note that the method of applying the coating liquid R to the balloon 30 is not limited to the method using the dispensing tube 94. For example, a porous material such as a fiber material, a woven fabric, a nonwoven fabric, or a sponge containing the coating liquid R, You may apply | coat using a spatula-shaped member, a brush, etc.

  The inner diameter of the dispensing tube 94 is not particularly limited, but is, for example, 0.1 to 2.0 mm, and is preferably set as appropriate depending on the size of the balloon 30 and the viscosity of the coating liquid R.

  The constituent material of the dispensing tube 94 is not particularly limited as long as the coating liquid R can be applied, and general resins and metals can be applied.

  As shown in FIGS. 3 to 5, the balloon support 97 is fixed to a fixed beam 99 extending downward from a fixed member 98 fixed to the moving table 81, and a dispensing tube 94 when applying the coating liquid R is used. It is possible to move together with the dispensing tube 94. The balloon support portion 97 is formed in an arc shape exceeding 180 degrees, and the inner peripheral surface can continuously contact the outer peripheral surface of the balloon 30. Therefore, a portion where the axis X of the balloon 30 is located inside the polygon T having at least three points included in the region of the balloon support 97 that contacts the balloon 30 and the contact position is 180 degrees or more is located. not exist. The balloon support 97 has a circular cross section perpendicular to the direction in which the arc extends, but is not necessarily limited to a circular shape. Corners 97A are smoothly formed on the inner peripheral surfaces at both ends of the arc of the balloon support 97. Thus, since the balloon support portion 97 has a circular cross section and the corner portions 97A are smoothly formed, the balloon support portion 97 can contact the balloon 30 without applying a load as much as possible. In addition, the balloon support portion 97 can expand so that the ends of the arc are separated from each other. Therefore, the inner diameter of the inner peripheral surface that contacts the balloon 30 can be adjusted according to the outer diameter of the balloon 30. . Further, it is preferable that the balloon support portion 97 can be selected and replaced as appropriate depending on the type of the balloon 30 and the like.

  The inner diameter of the balloon support portion 97 is preferably equal to or less than the outer diameter of the outer peripheral surface of the balloon 30 so as to come into contact with the outer peripheral surface of the balloon 30 at the time of application.

  The constituent material of the balloon support 97 is preferably a deformable material. For example, polyamide, polyphenol resin, acrylic, polyester resin, acrylic resin, polyvinyl chloride, polyacetal, polycarbonate, or the like can be applied. The inner peripheral surface that contacts the balloon 30 of the balloon support 97 may be coated with a low friction material. The low friction material is, for example, a fluorine resin such as polytetrafluoroethylene (PTFE), a silicon resin, or the like.

  The control unit 100 is configured by a computer, for example, and comprehensively controls the rotation mechanism 60, the movement mechanism 80, and the coating mechanism 90.

  The coating liquid R contains a drug, an additive, and a volatile solvent. The drug is a substance that acts on the living body, and may be either a water-soluble drug or a water-insoluble drug, but a water-insoluble drug is preferable from the viewpoint of suppressing elution of the drug into the blood.

  The water-insoluble drug means a drug that is insoluble or hardly soluble in water, and specifically has a solubility in water of less than 5 mg / mL at pH 5-8. Its solubility may be less than 1 mg / mL and even less than 0.1 mg / mL. Water-insoluble drugs include fat-soluble drugs.

  Examples of some preferred water-insoluble drugs include immunosuppressants, such as cyclosporines including cyclosporine, immunoactive agents such as rapamycin, anticancer agents such as paclitaxel, antiviral or antibacterial agents, anti-neoplastic agents, Includes analgesics and anti-inflammatory agents, antibiotics, antiepileptic agents, anxiolytic agents, anti-anesthetic agents, antagonists, neuron blocking agents, anticholinergic agents, antiarrhythmic agents, antihypertensive agents, hormonal agents and nutritional agents.

  The water-insoluble drug is preferably at least one selected from the group consisting of rapamycin, paclitaxel, docetaxel and everolimus. Rapamycin, paclitaxel, docetaxel and everolimus each include analogs and / or derivatives thereof as long as they have similar medicinal properties. For example, paclitaxel and docetaxel are in an analog relationship, and rapamycin and everolimus are in a derivative relationship. Of these, paclitaxel is more preferred.

  The coating liquid R in this embodiment is preferably a concentration of 5 to 60 mg / mL, more preferably a concentration of 20 to 50 mg / mL, and even more preferably a concentration of 30 to 40 mg / mL. contains.

  The additive is not particularly limited, and a polymer (polymer) and / or a polymer or low molecular weight compound that forms a solid dispersion with the drug can be applied. For example, polyolefin, polyisobutylene, ethylene-α-olefin copolymer Polymers, acrylic polymers and copolymers, polyvinyl chloride, polyvinyl methyl ether, polyvinylidene fluoride, polyvinylidene chloride, polyacrylonitrile, polyvinyl ketone, polystyrene, polyvinyl acetate, ethylene-methyl methacrylate copolymer, Acrylonitrile-styrene copolymer, ABS resin, nylon 12 and its block copolymer, polycaprolactone, polyoxymethylene, polyester, polyether, polyamide, epoxy resin, polyurethane, rayon triacetate, cellulose, vinegar Cellulose, cellulose butyrate, cellophane, cellulose nitrate, propionyl cellulose, cellulose ether, carboxymethyl cellulose, chitin, polylactic acid, polyglycolic acid, polyethylene oxide, polylactic acid-polyethylene oxide copolymer, polyethylene glycol, polypropylene glycol, glycerol, At least one selected from the group consisting of polyvinyl alcohol, polyvinyl pyrrolidone, organic acids, and organic acid esters is preferred. In addition, an additive does not necessarily need to be provided.

  The additive is preferably in a small amount relative to the drug, and preferably does not form a matrix. The additive preferably does not contain micelles, liposomes, contrast agents, emulsifiers, and surfactants, but may contain them. Moreover, it is preferable that an additive does not contain a polymer but contains only a low molecular weight compound.

  The volatile solvent is not particularly limited, but preferably contains at least one volatile organic solvent such as methanol, ethanol, dioxane, tetrahydrofuran, dimethylformamide, acetonitrile, dimethyl sulfoxide, and acetone. Moreover, water etc. may be mixed with the volatile organic solvent.

  Next, a balloon coating method for forming a coating layer 32 containing a drug on the surface of the balloon 30 using the balloon coating apparatus 50 described above will be described.

  First, an expansion fluid is supplied into the balloon 30 from the first opening 41 of the balloon catheter 10, the cap 30 is put on the first opening 41 in a state where the balloon 30 is expanded, and the balloon 30 is sealed. Keep expanded. Note that the coating layer 32 can be formed on the surface of the balloon 30 without expanding the balloon 30, and in this case, it is not necessary to supply the expansion fluid into the balloon 30.

  Next, the balloon catheter 10 is rotatably installed on the support base 70 so that the outer peripheral surface of the balloon 30 is in contact with the inner peripheral surface of the balloon support portion 97, and the hub 40 is connected to the rotation mechanism 60. At this time, the balloon support portion 97 expands according to the outer diameter of the balloon 30 and has an optimum size for supporting the balloon 30.

  Next, the moving table 81 is moved so that the dispensing tube 94 is positioned at the most distal end position where the coating layer 32 is formed in the balloon 30. Thereby, the balloon support part 97 will be in the state which contacted and supported the outer peripheral surface of the balloon 30 continuously in the circumferential direction by the advancing direction side of the dispensing tube 94. FIG.

  Next, the coating liquid R is supplied to the dispensing tube 94 while adjusting the amount of liquid fed by the liquid feeding pump 93, the balloon catheter 10 is rotated by the rotating mechanism 60, and the moving table 81 is moved to move the dispensing tube. 94 is gradually moved in the proximal direction. Thereby, as shown in FIG. 6, the coating liquid R discharged from the dispensing tube 94 spirals on the outer peripheral surface of the balloon 30 by the rotation of the balloon 30 and the movement of the dispensing tube 94 in the axial direction. It is applied without any gaps while drawing (application process).

  The moving speed of the dispensing tube 94 is, for example, 0.05 to 5 mm / second, but is not limited thereto. The discharge speed of the coating liquid R from the dispensing tube 94 is, for example, 0.05 to 5 μL / second, but is not limited thereto. The rotation speed of the balloon 30 is, for example, 10 to 300 rpm, but is not limited thereto.

  When the balloon catheter 10 is rotated, the balloon 30 tends to be eccentric due to the curvature, but since the balloon 30 is supported by the balloon support portion 97, the eccentricity of the balloon 30 is suppressed. Thereby, the variation in the thickness of the coating liquid R applied to the balloon 30 is suppressed, and the thickness of the coating liquid R (coating layer 32) can be easily adjusted. In particular, since the balloon support portion 97 is located at a certain distance from the traveling direction side of the dispensing tube 94, the dispensing tube 94 is not brought into contact with the balloon support portion 97. Thus, the eccentricity of the balloon 30 at the position where the coating liquid R is applied can be minimized. In addition, a portion where the axis X of the balloon 30 is located inside the polygon T having at least three points included in the region of the balloon support 97 that contacts the balloon 30 and the contact position is 180 degrees or more is located. Since it does not exist, the eccentricity of the balloon 30 in all directions orthogonal to the axis X is reliably suppressed. In particular, since the balloon support portion 97 is in contact with the outer surface of the balloon 30 in a range continuous in the circumferential direction, the eccentricity of the balloon 30 can be more effectively suppressed. In addition, since a low friction material is provided at a portion of the balloon support 97 that contacts the outer surface of the balloon 30, the balloon support 97 does not hinder the rotation of the balloon 30, and the balloon support 97 and the balloon 30 Damage to the balloon 30 due to contact can be suppressed.

  Thereafter, the volatile solvent contained in the coating liquid R applied to the surface of the balloon 30 is volatilized, and the coating layer 32 containing the drug and additive is gradually formed on the surface of the balloon 30. The volatilization time is appropriately set depending on the solvent, and is, for example, about several seconds to several tens of seconds.

  The drug coated on the outer surface of the balloon 30 can be in different morphological types such as crystalline, amorphous, and mixed. Even when the drug is in a crystalline form, there are various morphological types having different crystal structures. Further, the crystal and the amorphous may be arranged to have regularity in the coating layer 32, but may be arranged irregularly. And the morphological type | mold of such a chemical | medical agent is influenced by the length of time to volatilize a volatile solvent, and atmospheric temperature. Therefore, as described above, by adjusting the thickness of the coating liquid R, it becomes easy to adjust the time for volatilizing the solvent, and the morphological type and size of the drug contained in the coating layer 32 can be more freely controlled. It becomes possible to adjust.

  Then, the coating layer 32 is gradually formed on the outer surface of the balloon 30 by gradually moving the dispensing tube 94 along the axis X from the distal end side toward the proximal end side while rotating the balloon 30. . After the coating layer 32 is formed over the entire area to be coated by the balloon 30, the rotation mechanism 60, the movement mechanism 80, and the application mechanism 90 are stopped.

  Although the thickness of the coating layer 32 is 1-50 micrometers, for example, it is not limited to this, According to the dimension of the balloon 30, the kind of chemical | medical agent, etc., it can set suitably.

  Thereafter, the balloon catheter 10 is removed from the balloon coating apparatus 50, and the coating of the balloon 30 is completed.

  As described above, the balloon coating method according to the present embodiment is a balloon coating method in which the coating layer 32 is formed on the outer surface of the balloon 30 of the balloon catheter 10, and the balloon 30 is centered on the axis X of the balloon 30. The dispensing tube 94 (application portion) for applying the coating liquid R containing the drug is moved relative to the balloon 30 in the direction of the axis X while being rotated, and provided on the moving direction side of the dispensing tube 94. The coating liquid R is applied to the outer surface of the balloon 30 by the dispensing tube 94 while the balloon support part 97 is brought into contact with the balloon 30 to support the balloon 30. In this way, since the balloon 30 is supported by the balloon support portion 97 provided on the moving direction side of the dispensing tube 94, the eccentricity of the balloon 30 caused by rotation at the portion where the dispensing tube 94 is provided is suppressed, Uneven coating is suppressed. Thereby, the variation in the thickness of the coating liquid R applied to the balloon 30 is suppressed, and the thickness of the coating liquid R (coating layer 32) can be easily adjusted. And since the balloon support part 97 is located in the advancing direction side of the dispensing tube 94, the coating liquid R is applied from the dispensing tube 94 without bringing the coating liquid R into contact with the balloon support part 97. The eccentricity of the balloon 30 at the position can be minimized. Furthermore, by adjusting the thickness of the coating liquid R, it becomes easy to adjust the time for which the solvent is volatilized, and the form type and size of the drug contained in the coating layer 32 can be set more freely. It becomes. A desired therapeutic effect can be expected by forming an appropriate coating layer 32 on the balloon 30.

  In addition, since the balloon support portion 97 that can move integrally with the dispensing tube 94 (application portion) is used, the eccentricity of the balloon 30 in the portion where the dispensing tube 94 is provided is suppressed by the balloon support portion 97, and coating unevenness is caused. It is suppressed.

  Further, in the coating process, the axis X of the balloon 30 is positioned inside the polygon T formed with at least three soot points included in the region in contact with the balloon 30 of the balloon support 97 as a vertex. Eccentricity of the balloon 30 in all directions orthogonal to can be suppressed.

  Further, in the application step, the balloon support 97 is brought into contact with the outer surface of the balloon 30 in a range that is continuous in the circumferential direction, so that eccentricity of the balloon 30 can be more effectively suppressed.

  Further, since the balloon support portion 97 provided with a low friction material is used in a portion that contacts the outer surface of the balloon 30 in the coating process, the balloon support portion 97 does not hinder the rotation of the balloon 30 and the balloon support portion 97 is used. Damage to the balloon 30 due to contact between the balloon 30 and the balloon 30 can be suppressed.

  In addition, in the coating process, since the balloon support portion 97 that can be deformed according to the outer diameter of the balloon 30 is used, the balloon support portion 97 has an optimum size for supporting the balloon 30 according to the outer diameter of the balloon 30. It can be transformed. For this reason, even when there are individual differences in the balloon 30 or when different types of balloons 30 are coated, the balloon 30 can be supported by one balloon support portion 97.

  Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, in the embodiment described above, the coating liquid R is applied from the distal end side to the proximal end side of the balloon 30, but may be applied from the proximal end side toward the distal end side.

  In addition, the dispensing tube 94 and the balloon support 97 may move integrally due to the eccentricity of the balloon 30. That is, when the balloon 30 is decentered, the balloon support 97 is not forcedly suppressed by the balloon support 97, but the balloon support 97 can be moved along with the decentering of the balloon 30. In this case, even if the balloon 30 is eccentric, the dispensing tube 94 moves together with the balloon support 97 when the balloon support 97 moves, so that the distance between the dispensing tube 94 and the balloon 30 is increased. It does not change, the coating unevenness is suppressed, and the variation in the thickness of the coating liquid R applied to the balloon 30 is suppressed.

  In the present embodiment, the balloon support portion 97 is formed in an arc shape, but as shown in FIG. 7, the balloon support portion 100 may be formed in an annular shape. When the balloon support part 100 is formed in an annular shape, the deformable range becomes smaller (or becomes undeformable) depending on the outer diameter of the balloon 30, but the balloon 30 is more reliably formed than the arcuate shape. Eccentricity can be suppressed.

  Further, in this embodiment, the balloon support portion 97 is in contact with the outer surface of the balloon 30 in a range that is continuous in the circumferential direction. Good. Therefore, the balloon support portion does not have to be arcuate or annular, and may be formed of, for example, a polygon or an ellipse, or a plurality of members arranged in the circumferential direction. In addition, a plurality of balloon support portions may be provided in the axial center X direction of the balloon 30.

  Further, in the balloon coating method according to the above-described embodiment, the balloon catheter 10 coats the balloon 30 of the over-the-wire type balloon catheter 10 as shown in FIG. The balloon 190 of the rapid exchange type balloon catheter 140 may be coated. The balloon catheter 140 includes a hub 150, a base shaft 160, an intermediate portion 170, a distal shaft 180, a balloon 190, and an inner tube shaft 200 from the proximal end side.

  A base shaft 160 made of a relatively rigid material such as a metal or a part of resin is joined to the hub 150 so as to allow fluid to flow therethrough.

  An intermediate portion 170 is provided on the distal end side of the base shaft 160 so as to allow fluid to flow therethrough. A distal end shaft 180 made of a material such as resin is provided at the distal end side of the intermediate portion 170 so as to allow fluid to flow therethrough. A proximal end portion of the balloon 190 is provided on the distal end side of the distal shaft 180 so as to allow fluid to flow therethrough.

  The inner tube shaft 200 passes through the tip shaft 180 and the balloon 190 coaxially. The distal end portion of the inner tube shaft 200 is a distal tip 201, and the distal tip 201 extends from the distal end portion of the balloon 190 to the distal end side. The tip 201 is joined to the tip of the balloon 190 in a liquid-tight state. The proximal end of the inner tube shaft 200 extends to a guide wire opening 202 provided in a part from the intermediate portion 170 to the distal shaft 180, and is joined in a liquid-tight state. The guide wire can be inserted into the inner tube shaft 200 with the distal end opening 203 of the distal tip 201 as an inlet and the guide wire opening 202 as an outlet.

  Even in the rapid exchange type balloon catheter 140 described above, the balloon 190 is expanded and sealed, the hub 150 is attached to the rotation mechanism 60, and at least one of the base shaft 160, the intermediate portion 170, and the distal shaft 180 is supported by the support base 70. The core member 61 can be inserted into the inner tube shaft 200 from the guide wire opening 202 and attached to the balloon coating apparatus 50. Then, a coating layer can be formed on the outer surface of the balloon 190 by a method similar to the method described in the above embodiment.

10,140 balloon catheter,
30,190 balloons,
32 coating layer,
50 balloon coating equipment,
60 rotation mechanism,
80 moving mechanism,
90 coating mechanism,
94 Dispensing tube (application part),
97,100 balloon support,
R coating solution.

Claims (8)

A balloon coating method for forming a coating layer on an outer surface of a balloon of a balloon catheter,
While rotating the balloon about the axis of the balloon, the application unit for applying the coating liquid containing the drug is moved relative to the balloon in the axial direction, and on the moving direction side of the application unit. while the balloon supporting portion provided in contact with the balloon supporting the balloon, have a coating step of applying the coating liquid on the outer surface of said balloon by said coating unit,
A balloon coating method in which, in the coating step, a balloon support portion that is deformable according to the outer diameter of the balloon is brought into contact with the outer surface of the balloon in a continuous range in the circumferential direction .   In the coating step, the outer surface of the balloon has an arc shape that contacts in a continuous range of more than 180 degrees and less than 360 degrees in the circumferential direction, and ends of the arcs according to the outer diameter of the balloon The balloon coating method according to claim 1, wherein a balloon support portion that is deformable so as to be separated from the balloon is brought into contact with the outer surface of the balloon. Balloon coating process according to claim 1 or 2 using the coating portion integrally with movable balloon support. In the said application | coating process, The axial center of the said balloon is located inside the polygon which makes at least 3 points | pieces the vertex contained in the area | region which contacts the said balloon of the said balloon support part in any one of Claims 1-3 . The balloon coating method as described.   The balloon coating method according to any one of claims 1 to 4, wherein, in the application step, the support portion in which a low friction material is provided at a portion in contact with the outer surface of the balloon is used. A balloon coating apparatus for forming a coating layer on an outer surface of a balloon of a balloon catheter,
A rotation mechanism for rotating the balloon around the axis of the balloon;
An application unit 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;
Have a, a balloon support member for supporting the balloon in contact with the outer surface of the balloon in the moving direction side of the coating unit,
The balloon support device has a circular arc shape that contacts an outer surface of the balloon in a continuous range in the circumferential direction, and is deformable according to the outer diameter of the balloon.   The balloon support portion has an arc shape that contacts the outer surface of the balloon in a continuous range of more than 180 degrees and less than 360 degrees in the circumferential direction, and the end of the arc according to the outer diameter of the balloon The balloon coating apparatus according to claim 6, wherein the balloon coating apparatus is deformable so as to be separated from each other. The balloon coating apparatus according to claim 6 or 7, wherein the balloon support part is movable integrally with the application part.

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