Method for manufacturing balloon catheter and device for manufacturing resin medical balloon

Abstract

The present invention provides a method for manufacturing a balloon catheter that can uniformly heat and cool the entire mold and is not prone to temperature unevenness. The balloon catheter comprises: a shaft extending in the length direction; and a resin medical balloon arranged at the distal end of the shaft. The method for manufacturing the balloon catheter comprises: a step of inserting a resin cylindrical body (10) into a mold (20); and a step of arranging the mold (20) to the inside of a heat sleeve (30), wherein the heat sleeve (30) comprises a porous metal body (50), and the porous metal body (50) is arranged on the outside of the mold (20) and the inside of the heat sleeve (30).

Description

Technical Field

[0001] The present invention relates to a method for manufacturing a balloon catheter having a medical balloon made of resin, and an apparatus for manufacturing the medical balloon. Background Art

[0002] As is known to all, when the blood vessels, which are the flow paths for blood circulation in the body, become narrow, the blood circulation becomes poor, and various diseases are caused. In particular, if the coronary arteries that supply blood to the heart become narrow, there is a concern that serious diseases such as angina pectoris and myocardial infarction may occur. As a method for treating the narrowed part of such blood vessels, there are techniques such as angioplasty such as PTA and PTCA that use a balloon catheter to expand the narrowed part. Angioplasty is a minimally invasive treatment that does not require open-chest surgery such as bypass surgery, and is therefore widely practiced.

[0003] As a method for manufacturing a medical balloon made of resin used for a balloon catheter, for example, Patent Document 1 describes a rotational molding system for molding medical articles, which includes a multi-axis rotational molding machine and a molding die mounted on the molding machine, wherein a cavity of a desired shape of the medical article to be molded is divided inside the molding die. In addition, Patent Document 2 describes a resin molding mold having a mold temperature control mechanism, the mold being formed of porous sintered metal and having an impermeable surface film made of metal, synthetic resin or ceramic formed on the cavity surface, and the mold temperature control mechanism at least including a temperature control fluid supply pipe for supplying a temperature control fluid to the mold and a temperature control fluid discharge pipe for discharging the temperature control fluid supplied to the mold from the mold.

[0004] Patent Document 1: Japanese Patent Application Publication No. 2010-247538

[0005] Patent Document 2: Japanese Patent Application Laid-Open No. 7-285169

[0006] When molding a balloon, if the molding die of the balloon has uneven temperature, there is a problem that the wall thickness of the balloon is uneven or the balloon is bent in the length direction. In a balloon manufactured by a molding system such as Patent Document 1 or a balloon manufactured using a mold such as Patent Document 2, it is difficult to uniformly heat and cool the molding die of the balloon, so uneven temperature occurs. Summary of the invention

[0007] The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a method for manufacturing a balloon catheter and an apparatus for manufacturing a resin medical balloon that can uniformly heat and cool the entire mold and are less likely to cause temperature unevenness.

[0008] A method for manufacturing a balloon catheter that can solve the above-mentioned problems is a method for manufacturing a balloon catheter having a shaft extending in a length direction and a resin medical balloon arranged at a distal end of the shaft, characterized in that it comprises: a step of inserting a resin cylindrical body into a mold; and a step of configuring the mold to the inside of a heat-shrink sleeve, the heat-shrink sleeve having a porous metal body, which is configured on the outside of the mold and on the inside of the heat-shrink sleeve.

[0009] In the method for producing a balloon catheter of the present invention, it is preferred that the elastic deformation per unit thickness of the pore-containing metal body is 3 μm / mm or more, and the thermal conductivity of the pore-containing metal body is 0.325 W / m·K or more.

[0010] In the method for producing a balloon catheter of the present invention, it is preferred that the initial plastic deformation amount per unit thickness of the pore-containing metal body is 100 μm / mm or less.

[0011] In the method for producing a balloon catheter of the present invention, it is preferred that the metal content of the material constituting the pore-containing metal body is 90% or more.

[0012] In the method for producing a balloon catheter of the present invention, the number of pores in the porous metal body per inch is preferably 8 ppi or more and 8500 ppi or less.

[0013] In the method for manufacturing a balloon catheter of the present invention, the pore-containing metal body preferably includes at least one of gold, platinum, silver, copper, aluminum, stainless steel, titanium, molybdenum, tantalum, nickel and cobalt.

[0014] In the method for producing a balloon catheter of the present invention, the porous metal body is preferably disposed at a portion in the axial direction of the mold.

[0015] In the method for manufacturing a balloon catheter of the present invention, it is preferable to include a film member disposed inside the pore-containing metal body.

[0016] In the method for manufacturing a balloon catheter of the present invention, the heat-shrink jacket preferably includes a plurality of partial heat-shrink jackets.

[0017] In the method for manufacturing a balloon catheter of the present invention, the shrink sleeve preferably includes a first partial shrink sleeve located on one surface side of the mold and a second partial shrink sleeve located on the other surface side of the mold, and the first partial shrink sleeve and the second partial shrink sleeve are connected to each other.

[0018] In the method for manufacturing a balloon catheter of the present invention, it is preferred that the outer shell component is heat-coated and the outer shell component contains the mold.

[0019] A manufacturing apparatus for a resin medical balloon capable of solving the above problems is characterized by comprising: a mold in which a resin cylindrical body is inserted; a shrink sleeve that encloses the mold; and a porous metal body that is arranged outside the mold and inside the shrink sleeve.

[0020] In the apparatus for manufacturing a resin medical balloon of the present invention, the elastic deformation per unit thickness of the pore-containing metal body is preferably 3 μm / mm or more, and the thermal conductivity of the pore-containing metal body is preferably 0.325 W / m·K or more.

[0021] In the apparatus for producing a resin medical balloon of the present invention, it is preferred that the initial plastic deformation amount per unit thickness of the porous metal body is 100 μm / mm or less.

[0022] In the apparatus for manufacturing a resin medical balloon of the present invention, it is preferred that the metal content of the material constituting the porous metal body is 90% or more.

[0023] In the apparatus for manufacturing a resin medical balloon of the present invention, the number of pores in the porous metal body per inch is preferably 8 ppi or more and 8500 ppi or less.

[0024] In the apparatus for manufacturing a resin medical balloon of the present invention, the pore-containing metal body preferably includes at least one of gold, platinum, silver, copper, aluminum, stainless steel, titanium, molybdenum, tantalum, nickel and cobalt.

[0025] In the apparatus for manufacturing a resin medical balloon of the present invention, the porous metal body is preferably disposed at a portion in the axial direction of the mold.

[0026] In the apparatus for manufacturing a resin medical balloon of the present invention, the resin medical balloon preferably includes a film member, and the film member is disposed inside the pore-containing metal body.

[0027] In the apparatus for manufacturing a resin medical balloon of the present invention, the heat shrink fitting preferably includes a plurality of partial heat shrink fittings.

[0028] In the manufacturing apparatus of the resin medical balloon of the present invention, the shrink sleeve preferably includes a first partial shrink sleeve located on one surface side of the mold and a second partial shrink sleeve located on the other surface side of the mold, and the first partial shrink sleeve and the second partial shrink sleeve are connected to each other.

[0029] In the manufacturing apparatus for the resin medical balloon of the present invention, it is preferable that the outer shell member is heat-coated to contain the mold.

[0030] According to the manufacturing method of the balloon catheter of the present invention, there is a step of arranging a mold inside a heat-shrink sleeve having a porous metal body arranged outside the mold and inside the heat-shrink sleeve, so that the porous metal body can fill the gap between the heat-shrink sleeve and the mold. As a result, the mold can be uniformly heated and cooled by the heat-shrink sleeve, so that a balloon catheter with a balloon with less uneven wall thickness or less bending can be obtained.

[0031] According to the manufacturing device of the resin medical balloon of the present invention, there is a heat-shrink sleeve that contains a mold and a porous metal body arranged outside the mold and inside the heat-shrink sleeve, so that the porous metal body can fill the gap between the heat-shrink sleeve and the mold, so that the heat-shrink sleeve can be used to uniformly heat and cool the mold. Therefore, the mold is not prone to temperature unevenness, so that a balloon with uneven wall thickness or less bending can be manufactured. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 A cross-sectional view perpendicular to the longitudinal direction of a resin cylindrical body shows a manufacturing apparatus for a resin medical balloon according to an embodiment of the present invention.

[0033] Figure 2 express Figure 1 Schematic diagram of a cross section perpendicular to the longitudinal direction of a resin cylindrical body of a manufacturing apparatus for a resin medical balloon shown in FIG.

[0034] Figure 3 This is a diagram showing the amount of elastic deformation per unit thickness of a pore-containing metal body in an embodiment of the present invention.

[0035] Figure 4 This is a graph showing the amount of plastic deformation per unit thickness of a pore-containing metal body in an embodiment of the present invention. DETAILED DESCRIPTION

[0036] Hereinafter, the present invention will be described in more detail based on the following embodiments, but the present invention is not limited to the following embodiments, and can of course be implemented with appropriate changes within the scope that can be suitable for the above-mentioned and the following purports, which are all included in the technical scope of the present invention. In addition, in each of the drawings, hatching or component reference numerals are sometimes omitted for ease of explanation, but in the above case, refer to the specification and other drawings. In addition, the dimensions of various components in the drawings are prioritized to facilitate understanding of the features of the present invention, and therefore are sometimes different from the actual dimensions.

[0037] Figure 1 1 is a cross-sectional view perpendicular to the longitudinal direction of a resin cylindrical body 10 of a resin medical balloon manufacturing apparatus 1 according to an embodiment of the present invention. Figure 2 yes Figure 1 Schematic diagram of a cross section perpendicular to the length direction of the resin tubular body 10 of the manufacturing apparatus 1 for a resin medical balloon shown. The length direction of the resin tubular body 10 can be alternatively referred to as the proximal direction of the resin tubular body 10.

[0038] The resin medical balloon of the present invention can be manufactured by applying pressure to the inside of the resin cylindrical body 10, heating the resin cylindrical body 10, and extending the resin cylindrical body 10 in the length direction. Specifically, the resin medical balloon can be manufactured by blow molding the resin cylindrical body 10. In the manufacturing process of the resin medical balloon, the inside of the resin cylindrical body 10 can be pressurized before it is extended, or it can be pressurized while extending it. In addition, the inside can be pressurized during or after the extension. Among them, it is preferred to extend the resin cylindrical body 10 in the length direction while pressure is applied to the inside of the resin cylindrical body 10. By manufacturing the resin medical balloon by extending the resin cylindrical body 10 in the length direction while pressure is applied to the inside of the resin cylindrical body 10, the manufacturing efficiency of the resin medical balloon can be improved.

[0039] like Figure 1 as well as Figure 2 As shown in FIG. 1 , the manufacturing device 1 of the resin medical balloon of the present invention is characterized by comprising: a mold 20 in which a resin cylindrical body 10 is inserted; a shrink sleeve 30 in which the mold 20 is contained; and a porous metal body 50 arranged outside the mold 20 and inside the shrink sleeve 30. Hereinafter, the manufacturing device of the resin medical balloon may be simply referred to as a "manufacturing device". In addition, the manufacturing device of the present invention can also be used to manufacture products other than the resin medical balloon.

[0040] The resin cylindrical body 10 is made of synthetic resin and is a parison used in so-called blow molding.

[0041] The material constituting the resin cylindrical body 10 is preferably a thermoplastic resin. As the material constituting the resin cylindrical body 10, polyolefin resins such as polyethylene, polypropylene, and ethylene-propylene copolymers are exemplified; polyester resins such as polyethylene terephthalate and polyester elastomers; polyurethane resins such as polyurethane and polyurethane elastomers; polyphenylene sulfide resins; polyamide resins such as polyamide and polyamide elastomers; vinyl chloride resins; silicone resins; natural rubbers such as latex rubber, etc. For the above materials, only one can be used, or two or more can be used at the same time. Among them, the material constituting the resin cylindrical body 10 is suitable for use in polyamide resins, polyester resins, and polyurethane resins. In particular, from the perspective of the filmization or softness of the resin medical balloon, it is preferred to use an elastomeric resin. For example, as a material suitable for the resin cylindrical body 10 among polyamide resins, nylon 12, nylon 11, etc. are cited. From the perspective of being relatively easy to form during blow molding, nylon 12 is suitable for use. In addition, polyamide elastomers such as polyetheresteramide elastomers and polyamideether elastomers are preferably used from the viewpoint of thin film formation and flexibility of the resin medical balloon. Among them, polyetheresteramide elastomers are preferably used from the viewpoint of high yield strength and good dimensional stability of the resin medical balloon.

[0042] The wall thickness of the resin tubular body 10 can be set corresponding to the wall thickness of the resin medical balloon, but the wall thickness of the resin tubular body 10 can be formed to be, for example, less than 3 mm, less than 2 mm, less than 1 mm, more than 0.05 mm, more than 0.07 mm, or more than 0.1 mm.

[0043] For example, the resin cylindrical body 10 can be manufactured by extrusion molding, injection molding, etc. Among them, it is preferable to manufacture the resin cylindrical body 10 by extrusion molding. Manufacturing the resin cylindrical body 10 by extrusion molding can produce a large number of resin cylindrical bodies 10 in a short time, thereby improving the production efficiency of the resin medical balloon.

[0044] The mold 20 inserts the resin cylindrical body 10 therein and manufactures the resin medical balloon by blow molding the resin cylindrical body 10. The mold 20 has a space having the same shape as the outer shape of the resin medical balloon therein, and the resin cylindrical body 10 is arranged in the internal space.

[0045] The mold 20 preferably has a plurality of partial molds. Specifically, a structure including a central mold that forms a straight tube portion in the central part of the resin medical balloon and end molds that exist on both sides of the central mold and form tapered portions located at both ends of the straight tube portion of the resin medical balloon is exemplified. The mold 20 has a structure including a central mold and end molds disposed on both sides of the central mold, and thus, resin medical balloons of various shapes can be manufactured by replacing the central mold or the end molds.

[0046] The material constituting the mold 20 is preferably metal, more preferably iron, copper, aluminum or an alloy thereof. For example, stainless steel is cited as an alloy of iron, brass is cited as an alloy of copper, and duralumin is cited as an alloy of aluminum. Since the material constituting the mold 20 is iron, copper, aluminum or an alloy thereof, the heat capacity of the mold 20 is large, and the thermal conductivity is high, so the temperature of the entire mold 20 is easy to become constant. As a result, the resin cylindrical body 10 disposed inside the mold 20 is not easy to have temperature unevenness, so that the manufacture of the resin medical balloon is easy.

[0047] The length of the resin tubular body 10 in the longitudinal direction is preferably greater than the length of the inner space of the mold 20 in the longitudinal direction. That is, it is preferred that both ends of the resin tubular body 10 are exposed from the mold 20 when the resin tubular body 10 is arranged inside the mold 20. The length of the resin tubular body 10 in the longitudinal direction is greater than the length of the inner space of the mold 20 in the longitudinal direction, thereby making it easy to perform blow molding of the resin tubular body 10, thereby improving the manufacturing efficiency of the resin medical balloon.

[0048] The length of the resin tubular body 10 in the longitudinal direction is preferably 1.05 times or more of the length of the internal space of the mold 20, more preferably 1.10 times or more, and further preferably 1.15 times or more. By setting the lower limit of the ratio of the length of the resin tubular body 10 in the longitudinal direction to the length of the internal space of the mold 20 in the above range, it is possible to fully hold the two ends of the resin tubular body 10 during blow molding of the resin tubular body 10, and to stretch the resin tubular body 10 to both sides in the longitudinal direction, thereby facilitating the elongation start process. In addition, the upper limit of the ratio of the length of the resin tubular body 10 in the longitudinal direction to the length of the internal space of the mold 20 can be formed, for example, to be less than 100 times, or less than 90 times, or less than 80 times, or less than 70 times the length of the internal space of the mold 20.

[0049] The shrink fit 30 wraps the mold 20 and adjusts the temperature of the mold 20. That is, the shrink fit 30 can heat or cool the mold 20, or both.

[0050] like Figure 1 as well as Figure 2 As shown, the shrink jacket 30 preferably has a temperature regulator 40. When the shrink jacket 30 is used to heat the mold 20, a cartridge heater or the like is exemplified as the temperature regulator 40, and when the shrink jacket 30 is used to cool the mold 20, a cooling water flow path or the like is exemplified as the temperature regulator 40. The shrink jacket 30 has the temperature regulator 40, thereby making it easy to change the temperature of the shrink jacket 30.

[0051] The pore-containing metal body 50 is disposed outside the mold 20 and inside the shrink fit 30 . That is, the pore-containing metal body 50 is provided between the mold 20 and the shrink fit 30 .

[0052] The pore-containing metal body 50 is a metal body having a plurality of pores. The pore-containing metal body 50 is arranged outside the mold 20 and inside the shrink sleeve 30, so that the pores of the pore-containing metal body 50 sandwiched by the mold 20 and the shrink sleeve 30 are partially flattened and the pore-containing metal body 50 is deformed, thereby the pore-containing metal body 50 can fill the gap between the mold 20 and the shrink sleeve 30. As a result, the shrink sleeve 30 can uniformly heat or cool the mold 20 to easily transfer the temperature of the shrink sleeve 30 to the mold 20, thereby manufacturing a resin medical balloon with less uneven wall thickness or less bending.

[0053] It is preferred that the elastic deformation per unit thickness of the pore-containing metal body 50 is 3 μm / mm or more, and the thermal conductivity of the pore-containing metal body 50 is 0.325 W / m·K or more. Since the elastic deformation per unit thickness of the pore-containing metal body 50 is 3 μm / mm or more, and the thermal conductivity of the pore-containing metal body 50 is 0.325 W / m·K or more, the pore-containing metal body 50 has both elastic deformability and thermal conductivity. Therefore, the pore-containing metal body 50 can fully fill the gap between the mold 20 and the shrink sleeve 30, and can fully transfer the temperature of the shrink sleeve 30 to the mold 20, so that it is easy to evenly heat or cool the mold 20.

[0054] In addition, the porous metal body 50 was subjected to 100 N / cm 2 The pore-containing metal body 50 was compressed five times with a pressure of , and then the elastic deformation per unit thickness and thermal conductivity of the pore-containing metal body 50 were measured. This simulates the following situation: the pore-containing metal body 50 is repeatedly pressed by the mold 20 or the shrink fit 30 using the manufacturing apparatus 1.

[0055] The elastic deformation amount per unit thickness of the pore-containing metal body 50 is preferably 3 μm / mm or more, more preferably 3.5 μm / mm or more, and further preferably 4 μm / mm or more. By setting the lower limit of the elastic deformation amount per unit thickness of the pore-containing metal body 50 to the above range, the pore-containing metal body 50 is easily elastically deformed, so that the pore-containing metal body 50 is easy to follow the shape of the gap between the mold 20 and the shrink sleeve 30. In addition, the upper limit of the elastic deformation amount per unit thickness of the pore-containing metal body 50 can be formed, for example, to be 30 μm / mm or less, or 25 μm / mm or less, or 20 μm / mm or less.

[0056] The thermal conductivity of the pore-containing metal body 50 is preferably 0.325 W / m·K or more, more preferably 0.412 W / m·K or more, and further preferably 0.5 W / m·K or more. By setting the lower limit of the thermal conductivity of the pore-containing metal body 50 to the above range, the pore-containing metal body 50 becomes a structure having pores and having sufficient thermal conductivity, so that the temperature of the shrink sleeve 30 is easily transferred to the mold 20, thereby enabling the mold 20 to be efficiently heated or cooled by the shrink sleeve 30. In addition, the upper limit of the thermal conductivity of the pore-containing metal body 50 can be formed, for example, to be 400 W / m·K or less, or 300 W / m·K or less, or 200 W / m·K or less.

[0057] The initial plastic deformation per unit thickness of the pore-containing metal body 50 is preferably 100 μm / mm or less. When the pore-containing metal body 50 is disposed between the mold 20 and the shrink sleeve 30, the pore-containing metal body 50 is not prone to large plastic deformation, so that the pore-containing metal body 50 can fully fill the gap between the mold 20 and the shrink sleeve 30.

[0058] The initial plastic deformation per unit thickness of the pore-containing metal body 50 is preferably 100 μm / mm or less, more preferably 90 μm / mm or less, and further preferably 85 μm / mm or less. By setting the upper limit of the initial plastic deformation per unit thickness of the pore-containing metal body 50 to the above range, the pore-containing metal body 50 is not easily plastically deformed, so that when the pore-containing metal body 50 is arranged on the outside of the mold 20 and the inside of the shrink sleeve 30, the pore-containing metal body 50 easily fills the gap between the mold 20 and the shrink sleeve 30. In addition, the lower limit of the initial plastic deformation per unit thickness of the pore-containing metal body 50 can be formed, for example, to be 1 μm / mm or more, or 3 μm / mm or more, or 5 μm / mm or more.

[0059] The metal content of the material constituting the pore-containing metal body 50 is preferably 90% or more. By setting the metal content of the material constituting the pore-containing metal body 50 to be 90% or more, the strength of the pore-containing metal body 50 is increased, and thus the pore-containing metal body 50 can be repeatedly arranged on the outside of the mold 20 and on the inside of the heat-shrink jacket 30. In addition, since the thermal conductivity of the pore-containing metal body 50 can be increased, the temperature of the heat-shrink jacket 30 can be efficiently transferred to the mold 20, thereby improving the manufacturing efficiency of the resin medical balloon.

[0060] The metal content of the material constituting the pore-containing metal body 50 is preferably 90% or more, more preferably 93% or more, and further preferably 95% or more. By setting the lower limit of the metal content of the material constituting the pore-containing metal body 50 to the above range, the strength and thermal conductivity of the pore-containing metal body 50 can be improved. In addition, the metal content of the material constituting the pore-containing metal body 50 is preferably high, and the upper limit of the metal content can be formed to, for example, 100% or less, or 99.5% or less, or 99% or less.

[0061] The number of pores per inch of the porous metal body 50 is preferably 8 ppi or more and 8500 ppi or less. Since the number of pores per inch of the porous metal body 50 is 8 ppi or more and 8500 ppi or less, the porous metal body 50 is easily elastically deformed, thereby easily filling the gap between the mold 20 and the shrink sleeve 30.

[0062] The number of pores per inch of the porous metal body 50 is preferably 8 ppi or more, more preferably 50 ppi or more, and further preferably 100 ppi or more. By setting the lower limit of the number of pores per inch of the porous metal body 50 to the above range, the elasticity of the porous metal body 50 can be improved. In addition, the number of pores per inch of the porous metal body 50 is preferably 8500 ppi or less, more preferably 8000 ppi or less, and further preferably 7500 ppi. By setting the upper limit of the number of pores per inch of the porous metal body 50 to the above range, the porous metal body 50 has sufficient elasticity and the temperature of the heat sleeve 30 is easily transferred to the mold 20 through the porous metal body 50, thereby improving the manufacturing efficiency of the resin medical balloon.

[0063] The pore-containing metal body 50 preferably includes at least one of gold, platinum, silver, copper, aluminum, stainless steel, titanium, molybdenum, tantalum, nickel, and cobalt. The pore-containing metal body 50 includes at least one of gold, platinum, silver, copper, aluminum, stainless steel, titanium, molybdenum, tantalum, nickel, and cobalt, so that the pore-containing metal body 50 can have sufficient elasticity and thermal conductivity.

[0064] Among them, the pore-containing metal body 50 more preferably contains at least one of silver, copper and nickel, and further preferably contains silver. Since the pore-containing metal body 50 contains at least one of silver, copper and nickel, it is easy to manufacture and handle the pore-containing metal body 50, and the pore-containing metal body 50 can obtain a balance between elasticity and thermal conductivity.

[0065] The pore-containing metal body 50 may be disposed in the entire axial direction of the mold 20, but is preferably disposed in a local axial direction of the mold 20. By disposing the pore-containing metal body 50 in a local axial direction of the mold 20, it is possible to set the portion in the axial direction of the mold 20 where there is no gap between the mold 20 and the shrink sleeve 30 and the mold 20 and the shrink sleeve 30 are in contact via the pore-containing metal body 50. The temperature of the shrink sleeve 30 is transferred to the mold 20 by utilizing the portion where the mold 20 and the shrink sleeve 30 are in contact via the pore-containing metal body 50, so that the mold 20 can be uniformly heated or cooled.

[0066] Although not shown, the pore-containing metal body 50 is preferably also disposed between the heat sleeve 30 and the temperature regulator 40. By disposing the pore-containing metal body 50 between the heat sleeve 30 and the temperature regulator 40, the pore-containing metal body 50 can fill the gap between the heat sleeve 30 and the temperature regulator 40. Therefore, the temperature of the temperature regulator 40 is easily transferred to the heat sleeve 30, and the pore-containing metal body 50 has a high heat diffusion capacity toward the surface, so that the temperature of the heat sleeve 30 can be quickly constant.

[0067] like Figure 1 As shown, the manufacturing apparatus 1 preferably has a film member 60 disposed on the inner side of the pore-containing metal body 50. That is, the film member 60 is preferably disposed on the inner side of the pore-containing metal body 50 and on the outer side of the mold 20. Since the manufacturing apparatus 1 has the film member 60, the film member 60 can protect the surface of the pore-containing metal body 50. Therefore, even if the manufacturing apparatus 1 is repeatedly used and the mold 20 is attached and detached relative to the shrink sleeve 30 and the pore-containing metal body 50, the film member 60 can protect the surface of the pore-containing metal body 50, thereby preventing the pore-containing metal body 50 from being damaged.

[0068] Examples of the material constituting the film member 60 include metals such as silver, copper, iron, nickel, or alloys thereof; aromatic polyetherketone resins such as polyetheretherketone (PEEK); polyimide resins; synthetic resins such as fluororesins such as ethylene-tetrafluoroethylene copolymer (ETFE), etc. Among them, the material constituting the film member 60 is preferably metal, and more preferably the same as the material constituting the porous metal body 50. Since the material constituting the film member 60 is metal, the thermal conductivity of the film member 60 is good, and thus when the temperature of the shrink sleeve 30 is transmitted to the mold 20 through the porous metal body 50 and the film member 60, it is not easy to become an obstacle to heat conduction.

[0069] The film member 60 is preferably larger than the pore-containing metal body 50. Since the film member 60 is larger than the pore-containing metal body 50, the film member 60 can sufficiently protect the surface of the pore-containing metal body 50, thereby making the pore-containing metal body 50 less likely to be damaged.

[0070] The thickness of the film member 60 is preferably smaller than the thickness of the porous metal body 50. Since the thickness of the film member 60 is smaller than the thickness of the porous metal body 50, the film member 60 can be easily deformed along the shape of the mold 20 and other parts in contact with the film member 60, thereby making the film member 60 closely attached to the mold 20 and other parts. As a result, the temperature of the shrink sleeve 30 can be easily transmitted to the mold 20 and other parts via the film member 60.

[0071] Preferably, the temperature of the shrink sleeve 30 when heating the mold 20 is the same as or higher than the heating target temperature of the mold 20 , and the temperature of the shrink sleeve 30 when cooling the mold 20 is the same as or lower than the cooling target temperature of the mold 20 .

[0072] The lower limit of the temperature of the shrink sleeve 30 when heating the mold 20 is preferably a temperature 1°C higher than the heating target temperature of the mold 20, more preferably a temperature 5°C higher, further preferably a temperature 10°C higher, further preferably a temperature 15°C higher, and particularly preferably a temperature 20°C higher. By setting the lower limit of the temperature of the shrink sleeve 30 in the above range, the temperature of the mold 20 can be raised to the heating target temperature in a short time. In addition, the upper limit of the temperature of the shrink sleeve 30 when heating the mold 20 is preferably a temperature 250°C higher than the heating target temperature of the mold 20, more preferably a temperature 225°C higher, and further preferably a temperature 200°C higher. By setting the upper limit of the temperature of the shrink sleeve 30 in the above range, the temperature of the mold 20 can be easily adjusted.

[0073] The upper limit of the temperature of the shrink sleeve 30 when cooling the mold 20 is preferably a temperature 1°C lower than the cooling target temperature of the mold 20, more preferably a temperature 3°C lower, further preferably a temperature 5°C lower, further preferably a temperature 7°C lower, and particularly preferably a temperature 10°C lower. By setting the upper limit of the temperature of the shrink sleeve 30 in the above range, the temperature of the mold 20 can be quickly reduced to the cooling target temperature. In addition, the lower limit of the temperature of the shrink sleeve 30 when cooling the mold 20 is preferably a temperature 100°C lower than the cooling target temperature of the mold 20, more preferably a temperature 90°C lower, and further preferably a temperature 80°C lower. By setting the lower limit of the temperature of the shrink sleeve 30 in the above range, the temperature of the mold 20 can be easily adjusted.

[0074] The heat jacket 30 preferably includes a heating jacket for heating the mold 20 and a cooling jacket for cooling the mold 20. The heat jacket 30 includes both the heating jacket and the cooling jacket, thereby eliminating the need to significantly change the temperature of the heat jacket 30 during the manufacturing process of the resin medical balloon in order to change the temperature of the heat jacket 30 from, for example, a temperature suitable for heating the mold 20 to a temperature suitable for cooling the mold 20, thereby shortening the time required for temperature adjustment of the heat jacket 30. As a result, the manufacturing efficiency of the resin medical balloon can be improved.

[0075] The heat sleeve 30 preferably has a plurality of partial heat sleeves. That is, the heat sleeve 30 preferably consists of a plurality of partial heat sleeves. The heat sleeve 30 has a plurality of partial heat sleeves, so that the heat sleeve 30 can be divided, thereby making it easy to arrange the mold 20 or the porous metal body 50 inside the heat sleeve 30.

[0076] A plurality of partial shrink sleeves may be arranged along the circumferential direction of the mold 20, or a plurality of partial shrink sleeves may be arranged along the axial direction of the mold 20. When a plurality of partial shrink sleeves are arranged along the circumferential direction of the mold 20, for example, the shrink sleeve 30 may be formed into a half-split structure, so that the mold 20 or the porous metal body 50 may be easily arranged inside the shrink sleeve 30. When a plurality of partial shrink sleeves are arranged along the axial direction of the mold 20, the temperature of each partial shrink sleeve may be set separately, so that the heating temperature or cooling temperature of the mold 20 may be different in the axial direction of the mold 20.

[0077] like Figure 1 as well as Figure 2 As shown, the shrink sleeve 30 preferably includes a first partial shrink sleeve 31 located on one surface side of the mold 20 and a second partial shrink sleeve 32 located on the other surface side of the mold 20, and the first partial shrink sleeve 31 and the second partial shrink sleeve 32 are connected to each other. Since the first partial shrink sleeve 31 and the second partial shrink sleeve 32 are connected to each other, the shrink sleeve 30 has a structure that can be opened and closed on one surface side and the other surface side of the mold 20. As a result, it is easy to arrange or remove the mold 20 inside the shrink sleeve 30, so that the manufacturing efficiency of the resin medical balloon can be improved.

[0078] As a method of connecting the first partial heat sleeve 31 and the second partial heat sleeve 32 to each other, there are exemplified methods such as connecting the first partial heat sleeve 31 and the second partial heat sleeve 32 by means of a cylinder, or connecting the first partial heat sleeve 31 and the second partial heat sleeve 32 by means of a hinge. Among them, the first partial heat sleeve 31 and the second partial heat sleeve 32 are preferably connected to each other by means of a cylinder. Since the first partial heat sleeve 31 and the second partial heat sleeve 32 are connected to each other by means of a cylinder, the heat sleeve 30 can be opened and closed by means of the cylinder, so that the opening and closing operation of the heat sleeve 30 can be easily and reliably performed. In addition, since the first partial heat sleeve 31 and the second partial heat sleeve 32 are connected to each other by means of a cylinder, the force of pressing the first partial heat sleeve 31 and the second partial heat sleeve 32 to the inner contents such as the mold 20 can be controlled. In addition, as the types of cylinders, there are exemplified air cylinders, hydraulic cylinders, electric cylinders, etc.

[0079] The shrink sleeve 30 preferably includes an outer shell member 70, and the outer shell member 70 includes the mold 20. That is, the outer shell member 70 is preferably disposed outside the mold 20, and the shrink sleeve 30 is disposed outside the outer shell member 70. The shrink sleeve 30 includes the outer shell member 70, so that when the mold 20 is small or has a plurality of partial molds, the mold 20 can be easily handled, thereby improving the manufacturing efficiency of the resin medical balloon.

[0080] When the shrink sleeve 30 includes the outer shell member 70, the pore-containing metal body 50 is preferably arranged inside the shrink sleeve 30 and outside the outer shell member 70. That is, the pore-containing metal body 50 is preferably arranged between the shrink sleeve 30 and the outer shell member 70. Since the pore-containing metal body 50 is arranged inside the shrink sleeve 30 and outside the outer shell member 70, the pore-containing metal body 50 can fill the gap between the shrink sleeve 30 and the outer shell member 70, thereby uniformly transferring the temperature of the shrink sleeve 30 to the outer shell member 70. As a result, the mold 20 can be uniformly heated or cooled via the outer shell member 70.

[0081] Examples of the material constituting the outer shell member 70 include metals such as iron, copper, aluminum, or alloys thereof; aromatic polyetherketone resins such as polyetheretherketone (PEEK); polyimide resins; synthetic resins such as fluororesins such as ethylene-tetrafluoroethylene copolymer (ETFE), etc. Among them, the material constituting the outer shell member 70 is preferably metal, and more preferably the same metal as the metal constituting the mold 20. Since the material constituting the outer shell member 70 is metal, the temperature of the shrink sleeve 30 is easily transferred to the outer shell member 70, thereby easily transferring the temperature of the shrink sleeve 30 to the mold 20 uniformly via the outer shell member 70.

[0082] The method for manufacturing the balloon catheter of the present invention will be described. In the following description, the description of the parts overlapping with the above description will be omitted.

[0083] The manufacturing method of the balloon catheter of the present invention is a manufacturing method of the balloon catheter having a shaft extending in the length direction and a resin medical balloon arranged at the distal end of the shaft, characterized by comprising: a step of inserting a resin cylindrical body into a mold; and a step of arranging the mold to the inside of a heat-shrink sleeve, the heat-shrink sleeve having a porous metal body, the porous metal body being arranged outside the mold and inside the heat-shrink sleeve. Hereinafter, the resin medical balloon is sometimes referred to as a "balloon".

[0084] In the present invention, the distal side refers to the direction closer to the treatment object (affected part) relative to the extension direction of the balloon, and the proximal side refers to the opposite side of the distal side, that is, the direction closer to the hand of the user, i.e., the operator, relative to the extension direction of the balloon. In addition, the direction from the proximal side of the balloon toward the distal side is called the length direction.

[0085] The balloon catheter is configured to supply fluid to the inside of the balloon through a shaft, and to control the expansion and contraction of the balloon using a pressurizing device (balloon pressurizer). The fluid may be a pressure fluid pressurized by a pump or the like.

[0086] The shaft extends in the proximal and distal directions, and a flow path for a fluid is provided inside. In addition, the shaft preferably has an insertion path for a guide wire inside. As a structure in which the shaft has a flow path for a fluid and an insertion path for a guide wire inside, a structure in which the shaft has an outer tube and an inner tube is exemplified. By having such a structure of the shaft, the inner tube can function as an insertion path for a guide wire, and the space between the inner tube and the outer tube can function as a flow path for a fluid. When the shaft has an outer tube and an inner tube, it is preferred that the inner tube extends and protrudes from the distal end of the outer tube and penetrates the balloon in the proximal and distal directions, the distal side of the balloon is engaged with the inner tube, and the proximal side of the balloon is engaged with the outer tube.

[0087] The present invention can be applied to any of the so-called over the wire type balloon catheters that insert a wire from the distal side of the shaft to the proximal side, and the so-called rapid exchange type balloon catheters that insert a wire midway from the distal side of the shaft to the proximal side. Although not shown in the figure, in the case where the balloon catheter is over the wire type, in order to feed the fluid into the shaft, a hub portion may also be provided on the proximal side of the shaft. The hub portion preferably has a fluid injection portion that is connected to the flow path of the fluid supplied to the inside of the balloon. The balloon catheter has a hub portion, and the hub portion has a fluid injection portion, thereby supplying fluid to the inside of the balloon to make the balloon expansion and contraction operations easy. In addition, in the case where the balloon catheter is over the wire type, it is preferably provided with a guide wire insertion portion that is connected to the insertion path of the guide wire. The over the wire type balloon catheter has a hub portion, and the hub portion is provided with a guide wire insertion portion, thereby facilitating the operation of feeding the balloon catheter to the treatment object site along the guide wire.

[0088] As examples of the joining between the shaft and the hub, there are bonding with adhesives, welding, etc. Among them, the shaft and the hub are preferably joined by bonding. The shaft and the hub are bonded, so that even if the shaft is made of a relatively flexible material and the hub is made of a relatively rigid material, for example, the material constituting the shaft and the hub are different, the joining strength between the shaft and the hub can be improved, thereby improving the durability of the balloon catheter.

[0089] As the material constituting the shaft, polyamide resin, polyester resin, polyurethane resin, polyolefin resin, fluorine resin, vinyl chloride resin, silicon resin, natural rubber, etc. are exemplified. Only one of these substances can be used, or two or more can be used simultaneously. Among them, the material constituting the shaft is preferably at least one of polyamide resin, polyolefin resin and fluorine resin. By constituting the material of the shaft as at least one of polyamide resin, polyolefin resin and fluorine resin, the slipperiness of the surface of the shaft can be improved, thereby improving the insertability of the balloon catheter to the blood vessel.

[0090] The balloon is arranged at the distal end of the shaft. As examples of the connection between the balloon and the shaft, there are bonding based on an adhesive, welding, installing an annular component at the position where the balloon and the shaft overlap and caulking, etc. Among them, the balloon and the shaft are preferably connected by welding. The balloon and the shaft are welded, thereby improving the connection strength between the balloon and the shaft, so that even if the balloon is repeatedly expanded and contracted, the connection between the balloon and the shaft is not easy to be separated.

[0091] The balloon preferably has a straight tube portion, a proximal tapered portion connected to the proximal side of the straight tube portion, and a distal tapered portion connected to the distal side of the straight tube portion. The proximal tapered portion and the distal tapered portion are preferably formed to reduce in diameter as they move away from the straight tube portion. Since the balloon has a straight tube portion, the straight tube portion is in full contact with the stenosis portion, making it easy to expand the stenosis portion. Furthermore, since the balloon has a proximal tapered portion and a distal tapered portion whose outer diameters decrease as they move away from the straight tube portion, when the balloon is contracted and wound around the shaft, the outer diameters of the distal end and the proximal end of the balloon can be reduced, thereby reducing the step difference between the shaft and the balloon, making it easy to insert the balloon in the length direction. In addition, in the present invention, the expandable portion is regarded as a balloon.

[0092] The outer diameter of the balloon is preferably 0.5 mm or more, more preferably 1 mm or more, and further preferably 1.5 mm or more. By setting the lower limit of the outer diameter of the balloon to the above range, the stenosis in the blood vessel can be fully expanded. In addition, the outer diameter of the balloon is preferably 35 mm or less, more preferably 30 mm or less, and further preferably 25 mm or less. By setting the upper limit of the outer diameter of the balloon to the above range, the outer diameter of the balloon can be prevented from becoming larger.

[0093] The length of the length direction of the balloon is preferably more than 5mm, more preferably more than 10mm, and more preferably more than 15mm. By setting the lower limit of the length of the balloon in the length direction to the above range, the area of ​​the stenosis that can be expanded once can be increased and the time required for the process can be shortened. In addition, the length of the balloon in the length direction is preferably less than 300mm, more preferably less than 200mm, and more preferably less than 100mm. By setting the upper limit of the length of the balloon in the length direction to the above range, the amount of fluid sent to the inside of the balloon in order to expand the stenosis can be reduced, thereby shortening the time required for fully expanding the balloon.

[0094] The thickness of the balloon is preferably 5 μm or more, more preferably 7 μm or more, and further preferably 10 μm or more. By setting the lower limit of the thickness of the balloon to the above range, the strength of the balloon can be increased, so that the stenosis can be fully expanded. In addition, the upper limit of the thickness of the balloon can be set corresponding to the purpose of the balloon catheter, for example, it can be formed to be less than 100 μm, or less than 90 μm, or less than 80 μm.

[0095] The method for manufacturing a balloon catheter of the present invention comprises a step of inserting a resin cylindrical body into a mold and a step of arranging the mold inside a shrink fit.

[0096] The mold has a space in the same shape as the outer shape of the resin medical balloon. In the process of inserting the resin cylindrical body into the mold, the resin cylindrical body is arranged in the internal space of the mold. After the process of inserting the resin cylindrical body into the mold, the resin cylindrical body is blow-molded to manufacture the balloon.

[0097] The shrink sleeve is a structure that can place a mold inside and adjust the temperature of the mold inside. In the process of placing the mold inside the shrink sleeve, the shrink sleeve is used to at least one of heat and cool the mold.

[0098] As a specific example, when the mold is heated by heat-shrinking, the blow molding of the resin cylindrical body is performed. In addition, when the mold is cooled by heat-shrinking, the mold is cooled by heat-shrinking after blow molding the resin cylindrical body to cool the molded balloon.

[0099] The pore-containing metal body is arranged on the outside of the mold and the inside of the shrink sleeve. That is, the pore-containing metal body is provided between the mold and the shrink sleeve. By arranging the pore-containing metal body on the outside of the mold and the inside of the shrink sleeve, the pores of the pore-containing metal body sandwiched between the mold and the shrink sleeve are partially flattened and the pore-containing metal body is deformed, so that the pore-containing metal body can fill the gap between the mold and the shrink sleeve. Therefore, the temperature of the shrink sleeve is easily transferred to the mold evenly, so that the shrink sleeve can be used to evenly heat or cool the mold. As a result, the balloon is not prone to uneven wall thickness or bending.

[0100] As described above, the manufacturing device of the resin medical balloon of the present invention is characterized by comprising: a mold in which a resin cylindrical body is inserted; a heat-shrink sleeve in which the mold is contained; and a pore-containing metal body arranged outside the mold and inside the heat-shrink sleeve. In addition, the manufacturing method of the balloon catheter of the present invention is a manufacturing method of a balloon catheter having a shaft extending in the length direction and a resin medical balloon provided at the distal end of the shaft, characterized by comprising: a step of inserting the resin cylindrical body into the mold; and a step of arranging the mold to the inside of the heat-shrink sleeve, the heat-shrink sleeve having a pore-containing metal body arranged outside the mold and inside the heat-shrink sleeve. According to the manufacturing device of the resin medical balloon and the manufacturing method of the balloon catheter of the present invention, there are a heat-shrink sleeve that encloses the mold and a porous metal body arranged on the outside of the mold and on the inside of the heat-shrink sleeve, so that the porous metal body can fill the gap between the heat-shrink sleeve and the mold, thereby enabling the heat-shrink sleeve to be used to uniformly heat and cool the mold, so that temperature unevenness is not easy to occur, thereby being able to manufacture balloons with uneven wall thickness or less bending.

[0101] Example

[0102] The present invention will be described in more detail below with reference to the following embodiments, but the present invention is not limited to the following embodiments on this basis, and can of course be implemented with appropriate changes within the scope applicable to the foregoing and following purposes, all of which are included in the technical scope of the present invention.

[0103] (Density and expansion ratio of porous metal body before compression)

[0104] As a pore-containing metal body, a silver sample (5 mm × 25 mm rectangle) containing pores was prepared, and the mass was measured to obtain the density. In addition, the foaming rate of the pore-containing metal body was calculated based on the ratio of the calculated density of the pore-containing metal body to the density of the material constituting the pore-containing metal body. The results are shown in Table 1. In addition, the density and foaming rate of the pore-containing metal body were measured without performing the compression operation described later.

[0105] Foaming rate = density of the material constituting the sample / density of the sample

[0106] The calculation of the expansion ratio of the porous metal body is described by taking Sample 1 (silver, thickness before compression: 0.4 mm) shown in Table 1 as a specific example. The density of Sample 1 is 3.75 g / cm 3 The density of silver, the metal constituting sample 1, is 10.5 g / cm 3 Density of the material constituting the sample / density of the sample = 10.5 (g / cm 3 ) / 3.75(g / cm 3 ), whereby the foaming ratio of sample 1 becomes 2.8 times.

[0107] (Elastic deformation per unit thickness of porous metal body)

[0108] First, as a pore-containing metal body, a silver sample (5 mm×25 mm rectangle) containing pores was prepared and its thickness was measured. The measured value of the thickness was taken as the thickness of the sample before compression.

[0109] Next, 100 N / cm was applied to the sample 5 times. 2 The thickness of the sample during the application of 0.5 MPa is measured. This operation simulates the situation in which a porous metal body is repeatedly pressed against a mold or a shrink fit using a manufacturing device for a resin medical balloon. The measured value of the thickness is taken as the thickness of the sample during compression.

[0110] Furthermore, after the operation of applying 0.5 MPa of pressure to compress the sample was repeated 5 times, the thickness of the sample was measured while applying 0.1 MPa of pressure to the sample. This operation is used to eliminate the influence of the measurement error caused by the uneven surface of the porous metal body when measuring the thickness of the sample. That is, in order to eliminate the influence of the surface properties of the sample, the thickness of the sample under the state of applying 0.1 MPa of pressure is used as a reference. The measured value of this thickness is used as the thickness of the compressed sample.

[0111] The value obtained by subtracting the thickness of the sample during compression from the thickness of the sample after compression is calculated as the amount of elastic deformation. The value obtained by dividing the amount of elastic deformation by the thickness of the sample before compression is calculated as the "elastic deformation per unit thickness". The results are shown in Table 1 and the elastic deformation per unit thickness of the porous metal body. Figure 3 shown.

[0112] Elastic deformation per unit thickness = (thickness of sample after compression - thickness of sample during compression) / thickness of sample before compression

[0113] (Plastic deformation per unit thickness of porous metal body)

[0114] The value obtained by subtracting the thickness after compression from the thickness of the sample before compression is calculated as the amount of plastic deformation. The value obtained by dividing the amount of plastic deformation by the thickness of the sample before compression is calculated as the "amount of plastic deformation per unit thickness". The results are shown in Table 1 and the amount of plastic deformation per unit thickness of the porous metal body. Figure 4 shown.

[0115] Plastic deformation per unit thickness = (thickness of sample before compression - thickness of sample after compression) / thickness of sample before compression [Table 1]

[0116]

[0117] The elastic deformation per unit thickness of the porous metal body is more than 3 μm / mm, so that it can be fully deformed along the concave and convex of the mold or the heat sleeve. Therefore, the heat of the heat sleeve can be evenly transferred to the mold, which is preferred. In addition, the plastic deformation per unit thickness of the porous metal body is less than 100 μm / mm, so that even if the mold or the heat sleeve is removed after deformation along the mold or the heat sleeve, it is not easy to leave a mark, so it is easy to restore the original shape. Therefore, even if the porous metal body is used repeatedly, it is not easy to generate a gap between the porous metal body and the mold or the heat sleeve, so that the mold can be evenly heated and cooled, which is preferred.

[0118] Description of Reference Numerals

[0119] 1… a manufacturing device for a resin medical balloon; 10… a resin cylindrical body; 20… a mold; 30… a heat-shrink sleeve; 31… a first partial heat-shrink sleeve; 32… a second partial heat-shrink sleeve; 40… a temperature regulator; 50… a porous metal body; 60… a film component; 70… a shell component.

Claims

1. A method for manufacturing a balloon catheter, the balloon catheter comprising: a shaft extending in a longitudinal direction; and a resin medical balloon disposed at a distal end of the shaft, the method for manufacturing the balloon catheter being characterized by: a step of inserting a resin cylindrical body into a mold; and The step of placing the mold toward the inside of the shrink fit, The shrink sleeve has a porous metal body, which is arranged on the outer side of the mold and the inner side of the shrink sleeve. The number of pores in the porous metal body per inch is 8 ppi or more and 8500 ppi or less.

2. The method for manufacturing a balloon catheter according to claim 1, wherein: The elastic deformation per unit thickness of the porous metal body is 3 μm / mm or more. The thermal conductivity of the porous metal body is greater than 0.325 W / m·K.

3. The method for manufacturing a balloon catheter according to claim 1 or 2, wherein: The initial plastic deformation amount per unit thickness of the pore-containing metal body is 100 μm / mm or less.

4. The method for manufacturing a balloon catheter according to claim 1 or 2, wherein: The metal content of the material constituting the pore-containing metal body is 90% or more.

5. The method for manufacturing a balloon catheter according to claim 1 or 2, wherein: The porous metal body includes at least one of gold, platinum, silver, copper, aluminum, stainless steel, titanium, molybdenum, tantalum, nickel and cobalt.

6. The method for manufacturing a balloon catheter according to claim 1 or 2, wherein: The porous metal body is disposed at a local portion of the axial direction of the mold.

7. The method for manufacturing a balloon catheter according to claim 1 or 2, wherein: A thin film member is provided, and the thin film member is arranged inside the pore-containing metal body.

8. The method for manufacturing a balloon catheter according to claim 1 or 2, wherein: The thermal sleeve has a plurality of local thermal sleeves.

9. The method for manufacturing a balloon catheter according to claim 8, wherein: The shrink sleeve includes a first partial shrink sleeve located on one surface side of the mold and a second partial shrink sleeve located on the other surface side of the mold. The first local heat sleeve and the second local heat sleeve are connected to each other.

10. The method for manufacturing a balloon catheter according to claim 1 or 2, wherein: The heat-shrink sleeve contains a shell component, and the shell component contains the mold.

11. A device for manufacturing a resin medical balloon, characterized in that: have: a mold in which a resin cylindrical body is inserted; a shrink sleeve containing the mold; and A porous metal body is disposed outside the mold and inside the shrink sleeve so that the porous metal body fills the gap between the shrink sleeve and the mold. The number of pores in the porous metal body per inch is 8 ppi or more and 8500 ppi or less.

12. The manufacturing device for a resin medical balloon according to claim 11, wherein: The elastic deformation per unit thickness of the porous metal body is 3 μm / mm or more. The thermal conductivity of the porous metal body is greater than 0.325 W / m·K.

13. The manufacturing device for a resin medical balloon according to claim 11 or 12, wherein: The initial plastic deformation amount per unit thickness of the pore-containing metal body is 100 μm / mm or less.

14. The manufacturing device for a resin medical balloon according to claim 11 or 12, wherein: The metal content of the material constituting the pore-containing metal body is 90% or more.

15. The manufacturing device for a resin medical balloon according to claim 11 or 12, wherein: The porous metal body includes at least one of gold, platinum, silver, copper, aluminum, stainless steel, titanium, molybdenum, tantalum, nickel and cobalt.

16. The manufacturing device for a resin medical balloon according to claim 11 or 12, wherein: The porous metal body is disposed at a local portion of the axial direction of the mold.

17. The manufacturing device for a resin medical balloon according to claim 11 or 12, wherein: A thin film member is provided, and the thin film member is arranged inside the pore-containing metal body.

18. The manufacturing device for a resin medical balloon according to claim 11 or 12, wherein: The thermal sleeve has a plurality of local thermal sleeves.

19. The manufacturing device for a resin medical balloon according to claim 18, wherein: The shrink sleeve includes a first partial shrink sleeve located on one surface side of the mold and a second partial shrink sleeve located on the other surface side of the mold. The first local heat sleeve and the second local heat sleeve are connected to each other.

20. The manufacturing device for a resin medical balloon according to claim 11 or 12, wherein: The heat-shrink sleeve contains a shell component, and the shell component contains the mold.

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