JP6279311B2 - 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. The coating part for applying the coating liquid containing the liquid is moved relative to the balloon in the axial direction, and the balloon is supported by at least two balloon support parts provided on the moving direction side of the application part and rotatable. while contacting with scissors to support the balloon, 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, the axis of said balloon and rotatably held about an axis parallel.

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 at least two rotatable balloon support portion for supporting across the balloon, wherein the balloon support portion, rotatable about an axis parallel to the axis of the balloon der The

In the balloon coating method configured as described above, since the balloon support portion is provided on the moving direction side of the application portion, the coating liquid does not contact the balloon support portion, and the balloon is formed by at least two rotatable balloon support portions. Since it supports while pinching, it can suppress the variation in the distance between the application part and balloon which arises in the site | part in which an application part is provided, minimizing the burden to a balloon, and can suppress the coating unevenness. 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. . In the application step, the balloon support portion is held rotatably about an axis parallel to the axis of the balloon, so that the balloon support portion rotates in the reverse direction to the balloon in response to the rotational force of the balloon. As a result, the contact resistance between the balloon support portion and the balloon can be reduced as much as possible, the balloon support portion can hardly prevent the rotation of the balloon, so that a good coating can be maintained, and the occurrence of damage to the balloon can be suppressed.

  In the application step, if the balloon support portion is rotatably held by a holding portion that can move integrally with the application portion, the balloon support portion suppresses the eccentricity of the balloon that occurs in the portion where the application portion is provided. Alternatively, even if the balloon is eccentric, the application part moves together with the balloon support part that receives force from the balloon, the distance between the application part and the balloon is maintained constant, and uneven coating is suppressed.

  In the application step, if the balloon support portion is held rotatably in all directions, the balloon support portion is rotated by receiving the rotational force of the balloon, and the contact resistance between the balloon support portion and the balloon is reduced. It can be made as small as possible. Thereby, it becomes difficult for the balloon support portion to prevent rotation of the balloon, so that a good coating can be maintained and the occurrence of damage to the balloon can be suppressed.

  In the application step, if the balloon 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 Balloon damage due to contact with the balloon can be suppressed.

In the balloon coating apparatus configured as described above, since the balloon support portion is provided on the moving direction side of the application portion, the coating liquid does not come into contact with the balloon support portion, and at least two rotatable balloon support portions are used. Since the balloon is supported while being sandwiched, 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 while minimizing the burden on the balloon, thereby suppressing uneven coating. 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. . Since the balloon support portion is rotatable around an axis parallel to the axis of the balloon, the balloon support portion rotates in the reverse direction to the balloon in response to the rotational force of the balloon. As a result, the contact resistance between the balloon support portion and the balloon can be reduced as much as possible, the balloon support portion can hardly prevent the rotation of the balloon, so that a good coating can be maintained, and the occurrence of damage to the balloon can be suppressed.

If the balloon support part is movable integrally with the application part, the eccentricity of the balloon generated at the site where the application part is provided is suppressed by the balloon support part, or even if the balloon is eccentric, the force from the balloon is reduced. 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 is maintained constant, and uneven coating is suppressed.
If the balloon support part can be rotated in any direction, the balloon support part is rotated by receiving the rotational force of the balloon, and the contact resistance between the balloon support part and the balloon can be minimized. Thereby, it becomes difficult for the balloon support portion to prevent rotation of the balloon, so that a good coating can be maintained and the occurrence of damage to the balloon can be suppressed.

It is the schematic which shows the apparatus for performing the balloon coating method which concerns on 1st Embodiment. It is sectional drawing which shows a balloon catheter. It is the top view to which the balloon coating apparatus in 1st Embodiment was expanded. 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 with the balloon coating method which concerns on 1st Embodiment. It is sectional drawing which follows the BB 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 with the balloon coating method which concerns on 2nd Embodiment. It is sectional drawing which follows the CC line of FIG. It is sectional drawing which shows the state at the time of apply | coating a coating liquid to the outer surface of a balloon with the balloon coating method which concerns on 3rd Embodiment. It is sectional drawing which shows the modification of the balloon support part in 1st Embodiment. 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.

<First Embodiment>
The balloon coating method according to the first 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 110 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 two balloon support parts 100 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 110 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 and 4, the two balloon support portions 100 are rotatably provided on a frame body 99 extending downward from a fixed member 98 fixed to the moving table 81 while sandwiching the upper and lower sides of the balloon 30. It is located on the moving direction side of the dispensing tube 94 when the coating liquid R is applied, and is movable together with the dispensing tube 94. The two balloon support portions 100 are rotatable rollers, have a rotation axis orthogonal to the axis X of the balloon 30, and are arranged in parallel so as to sandwich the upper and lower sides of the balloon 30. Each balloon support portion 100 includes a roller portion 101 that is cylindrical and is in contact with the balloon 30, and a shaft portion 102 that is rotatably connected to the frame body 99 (holding portion).

  The separation distance L1 between the two balloon support portions 100 is preferably equal to or slightly shorter 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. is there. Although the outer diameter of the roller part 101 of the balloon support part 100 is not specifically limited, For example, it is 0.5-20 mm.

  The constituent material of the balloon support portion 100 is not particularly limited, but various resin materials such as polyamide, polyimide, phenol resin, acrylic, polyester resin, acrylic resin, polyvinyl chloride, polyacetal, and polycarbonate, and various types such as stainless steel and aluminum. Metal materials etc. can be applied. The outer peripheral surface of the roller unit 101 of the balloon support unit 100 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 constituent material of the frame 99 is not particularly limited as long as the balloon support portion 100 can be held, and general resin, metal, or the like can be applied.

  The control unit 110 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 roller portion 101 of the balloon support portion 100, and the hub 40 is connected to the rotation mechanism 60.

  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 100 will be in the state which contacted and supported the outer peripheral surface of the balloon 30 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 along the axis X in the proximal direction. 5 and 6, the coating liquid R discharged from the dispensing tube 94 draws a spiral on the outer peripheral surface of the balloon 30 by the rotation of the balloon 30 and the movement of the dispensing tube 94. It is continuously applied without a gap (application process). Further, the two balloon support portions 100 move together with the dispensing tube 94 and rotate by the force received from the balloon 30. Since the two balloon support portions 100 are positioned so as to sandwich the balloon 30, they rotate in the opposite directions.

  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 rotates, the balloon 30 tends to be eccentric due to the curvature along the axis X of the balloon 30, but since the balloon 30 is sandwiched and supported by the balloon support portion 100, the eccentricity of the balloon 30 is suppressed. The 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 100 is located at a certain distance away from the traveling direction side of the dispensing tube 94, the dispensing tube 94 is not brought into contact with the balloon support portion 100. Thus, the eccentricity of the balloon 30 at the position where the coating liquid R is applied can be minimized. Moreover, since the balloon support part 100 can rotate in contact with the balloon 30, the contact resistance between the balloon support part 100 and the balloon 30 can be reduced as much as possible, and the balloon support part 100 hardly prevents the balloon 30 from rotating. And the occurrence of damage to the balloon 30 can be suppressed. In addition, since the low friction material is provided at the portion of the roller portion 101 that contacts the outer surface of the balloon 30, the contact resistance between the balloon support portion 100 and the balloon 30 can be further reduced, and the balloon support portion 100 makes it difficult to prevent the rotation of the balloon 30 and can further prevent the balloon 30 from being damaged.

  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 appropriately 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 further increased. It can be freely adjusted.

  Then, the coating tube 32 is gradually formed on the outer surface of the balloon 30 by gradually moving the dispensing tube 94 in the direction of the axis X 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 supporting the balloon 30 with the balloon 30 sandwiched between and supported by at least two balloon support portions 100 that are rotatable. doing. Thus, since the balloon 30 is supported by the balloon support part 100 provided on the moving direction side of the dispensing tube 94, the eccentricity of the balloon 30 caused by rotation in 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 100 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 100. 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 100 can rotate in contact with the balloon 30, the contact resistance between the balloon support portion 100 and the balloon 30 can be minimized, and the balloon support portion 100 can rotate the balloon 30. As a result, it is possible to maintain a good coating and to prevent the balloon 30 from being damaged.

  Further, in the application process, the balloon support unit 100 is rotatably held by the frame body 99 (holding unit) that can move integrally with the dispensing tube 94 (application unit). The eccentricity of the balloon 30 is suppressed by the balloon support portion 100, and uneven coating is suppressed.

  Further, in the application step, the balloon support 100 is held so as to be rotatable about an axis orthogonal to the axis X of the balloon 30, so that the balloon support 100 is relatively relative to the balloon 30 in the axis X direction. When moving, the balloon support 100 rotates. Thereby, the contact resistance between the balloon support part 100 and the balloon 30 can be made as small as possible, the balloon support part 100 can hardly prevent the balloon 30 from being prevented from rotating, and a good coating can be maintained. Generation can be suppressed.

  Further, since the balloon support portion 100 provided with the low friction material is used at the portion that contacts the outer surface of the balloon 30 in the application process, the balloon support portion 100 is further difficult to prevent the balloon 30 from rotating, and the balloon 30 The occurrence of damage or the like can be further suppressed.

Second Embodiment
The balloon coating method according to the second embodiment of the present invention is different from the first embodiment in the form of the balloon support and the frame. Since other configurations are the same as those of the first embodiment, the same reference numerals are given and description thereof is omitted.

  In the balloon coating apparatus according to the second embodiment, as shown in FIGS. 7 and 8, two balloon support portions 120 for suppressing the eccentricity of the balloon 30 extend downward from a fixing member 98 fixed to the moving table 81. The frame body 123 (holding unit) is rotatably held.

  The two balloon support portions 120 are provided so as to be rotatable while sandwiching the upper and lower sides of the balloon 30, are located on the moving direction side of the dispensing tube 94 when the coating liquid R is applied, and move together with the dispensing tube 94. It is possible. The two balloon support portions 120 are rotatable rollers, have a rotation axis parallel to the axis X of the balloon 30, and are arranged in parallel so as to sandwich the upper and lower sides of the balloon 30. Each balloon support portion 120 includes a roller portion 121 that is cylindrical and is in contact with the balloon 30, and a shaft portion 122 that is rotatably connected to the frame body 123. The roller part 121 may be covered with a low friction material.

  Constituent materials, dimensions, and the like of the two balloon support portions 120 can be the same as those of the balloon support portion 100 in the first embodiment.

  In the second embodiment, when the coating layer 32 containing the drug is formed on the surface of the balloon 30, the balloon catheter 10 is placed on the support base 70 so that the outer peripheral surface of the balloon 30 is in contact with the roller portion 121 of the balloon support portion 120. The hub 40 is installed so as to be rotatable, and the hub 40 is connected to the rotation mechanism 60. 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.

  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, the coating liquid R discharged from the dispensing tube 94 is continuously applied without a gap while drawing a spiral on the outer peripheral surface of the balloon 30 by the rotation of the balloon 30 and the movement of the dispensing tube 94 ( Application process). Further, the two balloon support portions 120 move together with the dispensing tube 94 and rotate by receiving the rotational force of the balloon 30. Both of the two balloon support portions 120 rotate in the reverse direction with respect to the balloon 30.

  When the balloon catheter 10 rotates, the balloon 30 tends to be eccentric due to the curvature along the axis X of the balloon 30, but since the balloon 30 is sandwiched and supported by the balloon support 120, the eccentricity of the balloon 30 is suppressed. The 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 120 is located at a certain distance away from the direction of travel of the dispensing tube 94, the dispensing tube 94 is not brought into contact with the balloon support portion 120. Thus, the eccentricity of the balloon 30 at the position where the coating liquid R is applied can be minimized. Moreover, since the balloon support part 120 can rotate in contact with the balloon 30, the contact resistance between the balloon support part 120 and the balloon 30 can be made as small as possible, and the balloon support part 120 hardly prevents the balloon 30 from rotating. And the occurrence of damage to the balloon 30 can be suppressed. In addition, since the low friction material is provided in the portion of the roller portion 121 that contacts the outer surface of the balloon 30, the contact resistance between the balloon support portion 120 and the balloon 30 can be further reduced, and the balloon support portion 120 becomes more difficult to prevent the rotation of the balloon 30, and the occurrence of damage or the like of the balloon 30 can be further suppressed.

  Further, since the adjustment of the thickness of the coating liquid R becomes easy, 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 adjusted more freely. It becomes possible.

  After the coating layer 32 is formed over the entire area to be coated by the balloon 30, the rotation mechanism 60, the moving mechanism 80 and the application mechanism 90 are stopped, and the balloon catheter 10 is removed from the balloon coating apparatus to complete the coating of the balloon 30. To do.

  As described above, in the balloon coating method according to the second embodiment, in the application step, the balloon support 120 is held so as to be rotatable about an axis parallel to the axis X of the balloon 30. In response to the force, the balloon support 120 rotates in the reverse direction to the balloon 30. Thereby, the contact resistance between the balloon support part 120 and the balloon 30 can be made as small as possible, the balloon support part 120 can hardly keep the rotation of the balloon 30 and a good coating can be maintained, and the balloon 30 can be damaged. Generation can be suppressed.

<Third Embodiment>
The balloon coating method according to the third embodiment of the present invention differs from the first embodiment in the form of the balloon support part and the holding part that holds the balloon support part. Since other configurations are the same as those of the first embodiment, the same reference numerals are given and description thereof is omitted.

  In the balloon coating apparatus according to the third embodiment, as shown in FIG. 9, two balloon support portions 130 for suppressing the eccentricity of the balloon 30 extend downward from a fixing member 98 fixed to the moving table 81. A holding part 131 provided at 132 is rotatably held.

  The two balloon support portions 130 are provided so as to be rotatable while sandwiching the upper and lower sides of the balloon 30, are located on the moving direction side of the dispensing tube 94 when the coating liquid R is applied, and move together with the dispensing tube 94. It is possible. The two balloon support portions 130 are spheres and can be rotated in any direction. The holding part 131 slidably holds a part of the outer peripheral surface of the balloon support part 130 so that the balloon support part 130 can be rotated in any direction. The balloon support 130 is covered with a low friction material.

  As the constituent material of the two balloon support portions 130, the same constituent material as that of the balloon support portion 130 in the first embodiment can be applied.

  The separation distance L2 between the two balloon support portions 130 is preferably equal to or slightly shorter 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 during application. is there. Although the outer diameter of the balloon support part 130 is not specifically limited, For example, it is 0.5-20 mm.

  In the third embodiment, when the coating layer 32 containing a drug is formed on the surface of the balloon 30, 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 balloon support portion 130. Then, the hub 40 is connected to the rotation mechanism 60. 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.

  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, the coating liquid R discharged from the dispensing tube 94 is continuously applied without a gap while drawing a spiral on the outer peripheral surface of the balloon 30 by the rotation of the balloon 30 and the movement of the dispensing tube 94 ( Application process). Further, the two balloon support portions 130 move together with the dispensing tube 94 and rotate by receiving the rotational force of the balloon 30.

  When the balloon catheter 10 rotates, the balloon 30 tends to be eccentric due to the curvature along the axis X of the balloon 30, but since the balloon 30 is sandwiched and supported by the balloon support 130, the eccentricity of the balloon 30 is suppressed. The 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 130 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 130. Thus, the eccentricity of the balloon 30 at the position where the coating liquid R is applied can be minimized. Further, since the balloon support portion 130 can rotate in any direction in contact with the balloon 30, the contact resistance between the balloon support portion 130 and the balloon 30 can be minimized, and the balloon support portion 130 rotates the balloon 30. And the occurrence of damage to the balloon 30 can be suppressed. In addition, since the low friction material is provided at the portion of the balloon support 130 that contacts the outer surface of the balloon 30, the contact resistance between the balloon support 130 and the balloon 30 can be further reduced, and the balloon support The portion 130 can further prevent the rotation of the balloon 30 and can further prevent the balloon 30 from being damaged.

  Further, since the adjustment of the thickness of the coating liquid R becomes easy, 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 adjusted more freely. It becomes possible.

  After the coating layer 32 is formed over the entire area to be coated by the balloon 30, the rotation mechanism 60, the moving mechanism 80 and the application mechanism 90 are stopped, and the balloon catheter 10 is removed from the balloon coating apparatus to complete the coating of the balloon 30. To do.

  As described above, in the balloon coating method according to the third embodiment, in the application process, the balloon support 130 is rotated by receiving the rotational force of the balloon 30 in order to hold the balloon support 130 in any direction. In addition, the contact resistance between the balloon support 130 and the balloon 30 can be minimized. Thereby, since it becomes difficult for the balloon support part 130 to prevent rotation of the balloon 30, a better coating can be maintained, and the occurrence of damage to the balloon 30 can be suppressed.

  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 portions 100, 120, and 130 may move integrally due to the eccentricity of the balloon 30. That is, when the balloon 30 is decentered, the balloon support 100 can be moved along with the eccentricity of the balloon 30, instead of forcibly suppressing the decentering of the balloon 30 by the balloon support 100. In this case, even when the balloon 30 is decentered, the dispensing tube 94 moves together with the balloon support portions 100, 120, and 130 when the balloon support portions 100, 120, and 130 move. The distance to the balloon 30 does not change, uneven coating is suppressed, and variations in the thickness of the coating liquid R applied to the balloon 30 are suppressed.

  In the first to third embodiments described above, the balloon support portions 100, 120, and 130 are disposed above and below the balloon 30. However, the positions where the balloon support portions 100, 120, and 130 are disposed are not limited. It may be arranged on the horizontal direction side of the center X. Further, two balloon support portions 100, 120, and 130 are provided as a pair, but three or more balloon support portions 100, 120, and 130 may be provided as a pair. In this case, the balloon support portions are preferably arranged at equal angles in the circumferential direction of the balloon 30, but may not be arranged at equal angles. When three or more balloon support parts are used, the balloons 30 in all directions orthogonal to the axis X are arranged by arranging them around the balloon 30 so that the balloon support parts do not leave at an interval of 180 degrees or more. Can be effectively suppressed.

  Further, as a modification of the balloon support portion 100 in the first embodiment, as shown in FIG. 10, a concave portion 142 that is recessed in an arc shape may be provided at the center of the roller portion 141 of the balloon support portion 140. The radius of curvature of the recess 142 is preferably greater than or equal to the radius of curvature of the balloon 30. With such a configuration, the eccentricity of the balloon 30 in the direction along the rotation axis of the balloon support 140 can be effectively suppressed.

  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 250 of the rapid exchange type balloon catheter 200 may be coated. The balloon catheter 200 includes a hub 210, a base shaft 220, an intermediate portion 230, a distal shaft 240, a balloon 250, and an inner tube shaft 260 from the proximal end side.

  A base shaft 220 made of a material having a relatively high rigidity such as a metal or a part of resin is joined to the hub 210 so as to allow fluid to flow therethrough.

  An intermediate portion 230 is provided on the distal end side of the base shaft 220 so as to allow fluid to flow therethrough. A distal end shaft 240 made of a material such as resin is provided on the distal end side of the intermediate portion 230 so as to allow fluid to flow therethrough. A proximal end portion of the balloon 250 is provided on the distal end side of the distal shaft 240 so as to allow fluid to flow therethrough.

  The inner tube shaft 260 passes through the tip shaft 240 and the balloon 250 coaxially. The distal end portion of the inner tube shaft 260 is a distal end tip 261, and the distal end tip 261 extends from the distal end portion of the balloon 250 to the distal end side. The distal tip 261 is joined to the distal end portion of the balloon 250 in a liquid-tight state. The proximal end of the inner tube shaft 260 is extended to a guide wire opening 262 provided in a part from the intermediate portion 230 to the distal shaft 240, and is joined in a liquid-tight state. The guide wire can be inserted into the inner tube shaft 260 with the distal end opening 263 of the distal tip 261 as an inlet and the guide wire opening 202 as an outlet.

  Even in the rapid exchange type balloon catheter 200 described above, the balloon 250 is expanded and sealed, the hub 210 is attached to the rotation mechanism 60, and at least one of the base shaft 220, the intermediate portion 230, and the distal shaft 240 is supported by the support base 70. The core member 61 can be inserted into the inner tube shaft 260 from the guide wire opening 262 and attached to the balloon coating apparatus 50. And a coating layer can be formed in the outer surface of the balloon 250 by the method similar to the method demonstrated in the above-mentioned embodiment.

10,200 balloon catheter,
30,250 balloons,
32 coating layer,
50 balloon coating equipment,
60 rotation mechanism,
80 moving mechanism,
90 coating mechanism,
94 Dispensing tube (application part),
99,113 frame (holding part),
100, 120, 130, 140 balloon support,
121 holding part,
R coating solution.

Claims (7)

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. at least two balloon support portion rotatably provided in contact across the balloon while supporting the balloon, have a coating step of applying the coating liquid on the outer surface of said balloon by said coating unit,
Wherein in the coating step, the balloon support portion rotatably held to that balloon coating process around the axis parallel to the axis of the balloon.   The balloon coating method according to claim 1, wherein in the application step, the balloon support portion is rotatably held by a holding portion that can move integrally with the application portion. In the coating step, the balloon coating method according to claim 1 or 2, the balloon support portion rotatably held in all directions. The balloon coating method according to any one of claims 1 to 3 , wherein in the application step, the balloon support portion provided with a low friction material at a portion that contacts 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 at at least two balloons supporting portion rotatably supports across the balloon in contact with the outer surface of the balloon in the moving direction side of the coating unit,
The balloon support portion is rotatably der Ru balloon coating device about the axis parallel to the axis of the balloon. The balloon coating apparatus according to claim 5 , wherein the balloon support part is movable integrally with the application part.   The balloon coating apparatus according to claim 5 or 6, wherein the balloon support portion is rotatable in any direction.

Images