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

Abstract

The present invention provides a method for manufacturing a balloon catheter capable of making a specific part of a resin cylindrical body hotter or colder than other parts. The balloon catheter comprises: a shaft extending in the length direction; and a resin medical balloon arranged at the distal end of the shaft, and 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) is a component for pressing an inner package (100) existing inside the heat sleeve (30), and the pressure on the inner side surface of the heat sleeve (30) from the inner package (100) varies depending on the position of the inner side surface 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 method for manufacturing a balloon, which includes a molding step of forming an expandable cylindrical portion of the balloon by blow molding a tubular parison made of a birefringent polymer material, wherein the cylindrical portion is molded in such a way that the ratio of the orientation distribution number calculated by dividing the circumferential orientation distribution number of the cylindrical portion by the axial orientation distribution number of the cylindrical portion is less than 2. Patent Document 2 describes a method for manufacturing a balloon for a catheter, which is characterized in that both sides of the tubular parison are blow molded at a predetermined ratio. The preform is stretched to form a preform with an unstretched portion of a specified width remaining in the center, and the preform is installed in a mold, heated to a first molding temperature that is higher than the secondary transformation temperature and lower than the primary transformation temperature, a pressurized fluid is flowed into the preform and stretched once, and the preform is molded into a balloon shape having a balloon portion, a tapered portion, and a small-diameter connecting portion that matches the shape of the inner surface of the mold, and then the tapered portion is formed into a balloon shape that matches the shape of the inner surface of the mold by heating the mold to a second molding temperature that is higher than the first molding temperature and lower than the primary transformation temperature and the step of stretching both sides of the preform again. and the connecting part is formed into a thin-walled secondary molding. Patent document 3 describes a balloon for a balloon catheter, characterized in that it is a balloon having a rigid part with higher rigidity and a soft part with lower rigidity in the circumferential part in the cross section perpendicular to the length direction, the rigid part and the soft part are made of the same material, and the soft part becomes a wing part and is folded when it shrinks. The molded first balloon is heated in a local area to manufacture a second balloon 12 having different rigidity parts in the non-heating part and the heating part. Patent document 4 describes a method for manufacturing a balloon, which The invention comprises: a first step of molding a first balloon; and a second step of heating a local area of ​​the first balloon along the length direction to form a heating portion which is more rigid than the non-heating portion. Patent document 5 describes a method for manufacturing a balloon catheter, which comprises: a shaft tube; a main lumen formed in the shaft tube; at least one sub-lumen arranged in the wall thickness of the shaft tube and opening at the outer peripheral portion on the top end side of the shaft tube; and a balloon which is fused to the outer peripheral portion on the top end side of the shaft tube in a manner of surrounding the outer peripheral portion on the top end side of the shaft tube and is connected to the sub-lumen.

[0004] Patent Document 1: International Publication No. 2014 / 141382

[0005] Patent Document 2: Japanese Patent Application Publication No. 2008-023270

[0006] Patent Document 3: Japanese Patent Application Publication No. 2014-057793

[0007] Patent Document 4: Japanese Patent Application Publication No. 2014-057792

[0008] Patent Document 5: Japanese Patent Application Laid-Open No. 06-335530

[0009] In the manufacturing process of a resin medical balloon, when a fluid for heating a resin tubular body and expanding the resin tubular body is sent into the interior of the resin tubular body for so-called blow molding, the expansion is usually carried out from the part of the resin tubular body with the highest temperature. The thickness of the balloon at the part that expands first in the resin tubular body is likely to be thinner than other parts. The part where the thickness of the balloon is thinner than other parts tends to become the starting point of the balloon expansion when the balloon is expanded. Therefore, when manufacturing a resin medical balloon, as long as the part that heats the resin tubular body and the heating temperature of the part can be controlled, the starting point of the balloon expansion can be controlled, thereby improving the operability of the balloon. In addition, in the cooling process after heating the resin tubular body, a specific part of the resin tubular body is also formed to a lower temperature than other parts, thereby quickly cooling the specific part to make the hardness higher than other parts, as a result, the expansion stress of a specific position of the balloon can also be increased.

[0010] However, in the balloon manufacturing methods of Patent Documents 1 to 5, it is difficult to control the temperature of a specific portion of the resin tubular body to be higher or lower than the temperature of other portions when heating and cooling the resin tubular body. Summary of the invention

[0011] 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, which can make a specific portion of a resin tubular body hotter or colder than other portions.

[0012] The first 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 sleeve, the heat sleeve is a component that presses an inner content existing on the inside of the heat sleeve, and the pressure on the inner side of the heat sleeve from the inner content varies depending on the position of the inner side of the heat sleeve.

[0013] In the method for manufacturing a balloon catheter of the present invention, it is preferred that the pressure applied to the inner side surface of the shrink fit from the content differs depending on the position in the longitudinal direction of the mold.

[0014] A second 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 inner side of a heat sleeve, wherein an inner package is configured on the inner side of the heat sleeve, the inner package has a recess on the outer side, the depth of the recess is greater than 10 μm, and the area in which the inner side surface of the heat sleeve contacts the inner package varies depending on the position of the inner side surface of the heat sleeve.

[0015] In the method for manufacturing a balloon catheter of the present invention, it is preferred that the inclusion is an outer shell member that includes at least a portion of one or more molds.

[0016] In the method for manufacturing a balloon catheter of the present invention, the outer shell member preferably has a convex portion on the outer side surface.

[0017] In the method for manufacturing a balloon catheter of the present invention, the convex portion is preferably a spacer member disposed on the outer side surface of the shell member.

[0018] In the method for manufacturing a balloon catheter of the present invention, preferably, the outer shell component includes a plurality of partial outer shell components arranged in a longitudinal direction of the mold, and the spacer component is arranged in at least any one of the partial outer shell components.

[0019] In the method for manufacturing a balloon catheter of the present invention, the convex portion preferably extends over the entire circumference of the sheath member.

[0020] In the method for manufacturing a balloon catheter of the present invention, the inner cavity of the mold preferably has a columnar portion and a tapered portion, the tapered portion exists at one end and the other end of the columnar portion, and the convex portion is provided at least partially at a portion corresponding to the columnar portion.

[0021] In the method for manufacturing a balloon catheter of the present invention, the inner cavity of the mold preferably has a columnar portion and a tapered portion, the tapered portion exists at one end and the other end of the columnar portion, and the convex portion is provided at least partially at a portion corresponding to the tapered portion.

[0022] 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.

[0023] In the method for manufacturing a balloon catheter of the present invention, the heat shield preferably includes a first local heat shield located on one side of the mold and a second local heat shield located on the other side of the mold, and the first local heat shield and the second local heat shield are brought into proximity with each other to press the contents.

[0024] In the method for manufacturing a balloon catheter of the present invention, it is preferred that the first partial heat treatment jacket and the second partial heat treatment jacket are connected to each other.

[0025] In the method for manufacturing a balloon catheter of the present invention, it is preferred that the shrink fit includes a distal-side partial shrink fit and a proximal-side partial shrink fit that are disposed separately from each other in the longitudinal direction of the mold.

[0026] In the method for manufacturing a balloon catheter of the present invention, it is preferable to have a pore-containing metal body, and the pore-containing metal body is disposed outside the mold and inside the shrink fit.

[0027] 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.

[0028] The first device for manufacturing a resin medical balloon capable of solving the above-mentioned problems is characterized in that it comprises: a mold in which a resin cylindrical body is inserted; and a heat-shrink sleeve that surrounds the mold, the heat-shrink sleeve being a component that presses an inner content that exists on the inner side of the heat-shrink sleeve, and the pressure that the inner side surface of the heat-shrink sleeve receives from the inner content varies depending on the position of the inner side surface of the heat-shrink sleeve.

[0029] In the apparatus for manufacturing a resin medical balloon of the present invention, it is preferred that the pressure received by the inner side surface of the shrink fit from the content differs depending on the position in the longitudinal direction of the mold.

[0030] The second device for manufacturing a resin medical balloon capable of solving the above-mentioned problems is characterized in that it comprises: a mold in which a resin cylindrical body is inserted; and a heat sleeve in which the mold is contained, an inner package is arranged on the inner side of the heat sleeve, and the inner package has a recess on the outer side surface, the depth of the recess is greater than 10 μm, and the contact area between the inner side surface of the heat sleeve and the inner package varies depending on the position of the inner side surface of the heat sleeve.

[0031] In the apparatus for manufacturing a resin medical balloon of the present invention, the inclusion is preferably an outer shell member that includes at least a portion of one or more molds.

[0032] In the manufacturing apparatus for a resin medical balloon of the present invention, the outer shell member preferably has a convex portion on the outer side surface.

[0033] In the manufacturing apparatus for the resin medical balloon of the present invention, the convex portion is preferably a spacer member disposed on the outer side surface of the outer shell member.

[0034] In the resin medical balloon manufacturing apparatus of the present invention, the shell member preferably includes a plurality of partial shell members arranged in a longitudinal direction of the mold, and the spacer member is arranged in at least one of the partial shell members.

[0035] In the apparatus for manufacturing a resin medical balloon of the present invention, the convex portion preferably extends over the entire circumference of the outer shell member.

[0036] In the manufacturing device of the resin medical balloon of the present invention, the inner cavity of the mold preferably has a columnar portion and a tapered portion, the tapered portion exists on one end side and the other end side of the columnar portion, and the convex portion is arranged at least partially in the portion corresponding to the columnar portion.

[0037] In the manufacturing device of the resin medical balloon of the present invention, the inner cavity of the mold preferably has a columnar portion and a tapered portion, the tapered portion exists on one end side and the other end side of the columnar portion, and the convex portion is arranged at least partially in the portion corresponding to the tapered portion.

[0038] 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.

[0039] In the manufacturing device of the resin medical balloon of the present invention, the heat sleeve preferably has a first local heat sleeve located on one side of the mold and a second local heat sleeve located on the other side of the mold, and the first local heat sleeve and the second local heat sleeve are brought into contact with each other to press the inner content.

[0040] In the apparatus for manufacturing a resin medical balloon of the present invention, it is preferred that the first partial shrink wrap and the second partial shrink wrap are connected to each other.

[0041] In the apparatus for manufacturing a resin medical balloon of the present invention, the shrink fit preferably includes a distal-side partial shrink fit and a proximal-side partial shrink fit that are disposed separately from each other in the longitudinal direction of the mold.

[0042] In the manufacturing apparatus of the resin medical balloon of the present invention, it is preferable to have a pore-containing metal body, and the pore-containing metal body is arranged outside the mold and is shrink-fitted inside.

[0043] 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.

[0044] According to the manufacturing method of the first balloon catheter of the present invention, the pressure on the inner side of the heat sleeve from the inner contents varies depending on the position of the inner side of the heat sleeve, so that the inner contents located at the portion where the inner side of the heat sleeve receives a higher pressure from the inner contents are more likely to transfer the temperature of the heat sleeve than other portions, so that when the heat sleeve heats the inner contents, the temperature is higher than other portions, and when the heat sleeve cools the inner contents, the temperature is lower than other portions. In addition, according to the manufacturing method of the second balloon catheter of the present invention, the inner contents located at the portion with a smaller area in contact with the inner side of the heat sleeve are less likely to transfer the temperature of the heat sleeve than other portions, so that when the heat sleeve heats the inner contents, the temperature is lower than other portions, and when the heat sleeve cools the inner contents, the temperature is higher than other portions.

[0045] According to the manufacturing device of the first resin medical balloon of the present invention, the heat sleeve is a component that presses the inner inclusion existing on the inner side of the heat sleeve, and the pressure on the inner side of the heat sleeve from the inner inclusion is different due to the position of the inner side of the heat sleeve, so the inner inclusion located at the part where the inner side of the heat sleeve bears a higher pressure from the inner inclusion is easier to transfer the temperature of the heat sleeve than other parts. Therefore, it is possible to heat the inner inclusion at a higher temperature than other parts when the heat sleeve heats the inner inclusion, and it is possible to cool the inner inclusion at a lower temperature than other parts when the heat sleeve cools the inner inclusion. In addition, according to the manufacturing device of the second resin medical balloon of the present invention, the inner inclusion arranged on the inner side of the heat sleeve has a recessed portion on the outer side, and the area of ​​contact between the inner side of the heat sleeve and the inner inclusion is different due to the position of the inner side of the heat sleeve, so the inner inclusion located at the part with a smaller area in contact with the inner side of the heat sleeve is less likely to transfer the temperature of the heat sleeve than other parts. Therefore, it is possible to heat the inner inclusion at a lower temperature than other parts when the heat sleeve heats the inner inclusion, and it is possible to cool the inner inclusion at a higher temperature than other parts when the heat sleeve cools the inner inclusion. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] Figure 1 A front view showing an apparatus for manufacturing a resin medical balloon according to an embodiment of the present invention.

[0047] Figure 2 express Figure 1 A II-II cross-sectional view of an apparatus for manufacturing a resin medical balloon is shown.

[0048] Figure 3 express Figure 1 A cross-sectional view taken along line III-III of a device for manufacturing a resin medical balloon is shown.

[0049] Figure 4 A plan view showing an inner content of the apparatus for producing a resin medical balloon according to an embodiment of the present invention.

[0050] Figure 5 express Figure 4 VV cross-sectional view of the inner package shown. DETAILED DESCRIPTION

[0051] 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.

[0052] First, refer to Figure 1 to Figure 5The first resin medical balloon manufacturing apparatus of the present invention will be described.

[0053] Figure 1 1 is a front view of a manufacturing apparatus 1 for a resin medical balloon according to an embodiment of the present invention. Figure 2 yes Figure 1 A cross-sectional view of a cross section perpendicular to the longitudinal direction of a resin tubular body 10 in a resin medical balloon manufacturing apparatus 1 shown in FIG. Figure 3 yes Figure 1 A cross-sectional view of a cross section perpendicular to the longitudinal direction of a resin tubular body 10 in the manufacturing apparatus 1 for a resin medical balloon shown in FIG. Figure 4 This is a plan view of the content 100 in the resin medical balloon manufacturing apparatus 1 as viewed from above. The length direction of the resin tubular body 10 can be alternatively referred to as the far-near direction of the resin tubular body 10 .

[0054] 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, it 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. The resin medical balloon is manufactured by extending the resin cylindrical body 10 in the length direction while pressure is applied to the inside of the resin cylindrical body 10, thereby improving the manufacturing efficiency of the resin medical balloon.

[0055] like Figure 1 to Figure 3 As shown, the manufacturing device 1 of the first resin medical balloon of the present invention is characterized in that it has: a mold 20 in which a resin cylindrical body 10 is inserted; and a shrink sleeve 30 in which the mold 20 is contained, and the shrink sleeve 30 is a component that presses the inner inclusion 100 existing inside the shrink sleeve 30, and the pressure received by the inner side surface of the shrink sleeve 30 from the inner inclusion 100 varies depending on the position of the inner side surface of the shrink sleeve 30. Hereinafter, the manufacturing device of the resin medical balloon is sometimes 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 resin medical balloons.

[0056] The resin cylindrical body 10 is made of synthetic resin and is a parison used in so-called blow molding.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] like Figure 2 as well as Figure 3 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.

[0067] The heat sleeve 30 is a component that presses the inner contents 100 existing inside the heat sleeve 30, and the pressure on the inner side of the heat sleeve 30 from the inner contents 100 varies depending on the position of the inner side of the heat sleeve 30. The portion of the inner side of the heat sleeve 30 that receives a higher pressure from the inner contents 100 is in close contact with the inner contents 100 compared to other portions, so that the temperature of the heat sleeve 30 is easily transferred to the inner contents 100. Therefore, the inner side of the heat sleeve 30 receives a different pressure from the inner contents 100 depending on the position of the inner side of the heat sleeve 30, thereby allowing the inner contents 100 located at the portion of the inner side of the heat sleeve 30 that receives a higher pressure from the inner contents 100 to be heated by the heat sleeve 30 at a higher temperature than other portions during heating, and to be cooled by the heat sleeve 30 at a lower temperature than other portions during cooling.

[0068] 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 .

[0069] 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.

[0070] 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.

[0071] 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.

[0072] The pressure on the inner side of the heat sleeve 30 from the inner inclusion 100 may be different depending on the position of the inner side of the heat sleeve 30, for example, it may be different depending on the position in the longitudinal direction of the mold 20, or it may be different depending on the position in the circumferential direction of the mold 20. The pressure on the inner side of the heat sleeve 30 from the inner inclusion 100 is preferably different depending on the position in the longitudinal direction of the mold 20. The pressure on the inner side of the heat sleeve 30 from the inner inclusion 100 is different depending on the position in the longitudinal direction of the mold 20, so that a part of the inner inclusion 100 that is easy to transfer the temperature of the heat sleeve 30 can be set in the longitudinal direction of the mold 20, for example, the central part of the resin cylindrical body 10 in the longitudinal direction can be made hotter than other parts.

[0073] Next, the manufacturing apparatus of the second resin medical balloon of the present invention will be described. In the following description, the description of the parts overlapping with the above description will be omitted.

[0074] like Figure 4 as well as Figure 5 As shown, the manufacturing device 1 of the second resin medical balloon of the present invention is characterized in that it comprises: a mold 20, in which a resin cylindrical body 10 is inserted; and a heat-shrink sleeve 30, which contains the mold 20, and an inner package 100 is arranged on the inner side of the heat-shrink sleeve 30, and the inner package 100 has a recess 110 on the outer side surface, and the depth of the recess 110 is greater than 10μm, and the contact area between the inner side surface of the heat-shrink sleeve 30 and the inner package 100 varies depending on the position of the inner side surface of the heat-shrink sleeve 30.

[0075] The inner package 100 disposed inside the heat sleeve 30 has a recess 110 on the outer side surface. The area where the inner side surface of the heat sleeve 30 contacts the inner package 100 varies depending on the position of the inner side surface of the heat sleeve 30. Therefore, the portion of the inner package 100 located in the recess 110 is farther away from the heat sleeve 30 than other portions of the inner package 100, and is not easy to contact the heat sleeve 30, so the area in contact with the inner side surface of the heat sleeve 30 is small. Therefore, the portion of the inner package 100 located in the recess 110 is not easy to transfer the temperature of the heat sleeve 30 compared to other portions of the inner package 100, so that when the heat sleeve 30 heats the inner package 100, the temperature is lower than other portions, and when the heat sleeve 30 cools the inner package 100, the temperature is higher than other portions.

[0076] The depth of the recess 110 may be 10 μm or more, but is preferably 15 μm or more, more preferably 20 μm or more, and further preferably 30 μm or more. By setting the lower limit of the depth of the recess 110 within the above range, the temperature of the heat sleeve 30 is not easily transferred to the portion of the inner package 100 located in the recess 110, thereby making the temperature of the portion of the inner package 100 located in the recess 110 lower when the inner package 100 is heated and higher when the inner package 100 is cooled than the temperature of other portions of the inner package 100. In addition, the depth of the recess 110 is preferably 90% or less of the wall thickness of the inner package 100, more preferably 85% or less, and further preferably 80% or less. By setting the upper limit of the depth of the recess 110 within the above range, the temperature of the heat sleeve 30 is also transferred to the portion of the inner package 100 located in the recess 110, so that the entire resin tubular body 10 can be fully heated and cooled. As a result, the resin medical balloon can be manufactured efficiently.

[0077] The recess 110 is preferably provided on the outer side of the outer shell member 70. By providing the recess 110 on the outer side of the outer shell member 70, the temperature of the portion of the outer shell member 70 located at the recess 110 is easily lowered when the inner shell member 100 is heated, and is easily higher when the inner shell member 100 is cooled, compared with other portions of the outer shell member 70. Therefore, it is easy to generate a temperature difference in the inner shell member 100 when manufacturing a resin medical balloon.

[0078] The recess 110 may be a structure integral with the outer shell member 70, or may be a component different from the outer shell member 70 and mounted on the outer shell member 70. The recess 110 is preferably an isolation component 121 disposed on the outer shell member 70. Since the recess 110 is an isolation component 121 disposed on the outer shell member 70, the position of the isolation component 121 can be changed to change the position of the temperature higher or lower than other parts of the inner package 100.

[0079] The inclusion 100 is preferably an outer shell member 70 that includes at least a portion of one or more molds 20. That is, the outer shell member 70 that includes at least a portion of one or more molds 20 in which the resin tubular body 10 is inserted is preferably the inclusion 100. When the inclusion 100 is the outer shell member 70, the mold 20 can be easily handled when the mold 20 is small or when the mold 20 has a plurality of partial molds, and the manufacturing efficiency of the resin medical balloon can be improved.

[0080] like Figure 4As shown, the outer shell member 70 preferably has a convex portion 120 on the outer side surface. Since the outer shell member 70 has the convex portion 120 on the outer side surface, the portion of the convex portion 120 is easily in close contact with the heat sleeve 30. As a result, the temperature of the heat sleeve 30 is easily transferred to the portion of the inner package 100 arranged at the portion where the convex portion 120 exists, so that it is easy to identify a portion of the inner package 100 with a higher temperature or a lower temperature than other portions, thereby making it easy to control the temperature when manufacturing the resin medical balloon.

[0081] The height of the convex portion 120 is preferably 10 μm or more, more preferably 20 μm or more, and further preferably 30 μm or more. By setting the lower limit of the height of the convex portion 120 within the above range, the convex portion 120 is fully pressed against the inner side of the heat sleeve 30, so that the temperature of the heat sleeve 30 is easily transferred to the inner package 100 located at the portion of the convex portion 120. In addition, the height of the convex portion 120 is preferably less than 90% of the wall thickness of the outer shell member 70, more preferably less than 85%, and further preferably less than 80%. By setting the upper limit of the height of the convex portion 120 within the above range, the temperature of the heat sleeve 30 can also be fully transferred to the portion of the outer shell member 70 other than the convex portion 120. Therefore, the time required for heating and cooling the resin cylindrical body 10 can be shortened, thereby improving the manufacturing efficiency of the resin medical balloon. In addition, when the housing member 70 has both the convex portion 120 and the concave portion 110, and the convex portion 120 is adjacent to the concave portion 110, the height of the convex portion 120 does not include the depth of the concave portion 110. That is, when measuring the height of the convex portion 120, the value obtained by subtracting the depth of the concave portion 110 from the height of the convex portion of the housing member 70 is used as the height of the convex portion 120.

[0082] The convex part 120 may be an integral structure of the outer shell member 70, or may be a component different from the outer shell member 70 and mounted on the outer shell member 70. The convex part 120 is preferably an isolation component 121 disposed on the outer side of the outer shell member 70. The convex part 120 is an isolation component 121 disposed on the outer side of the outer shell member 70, so that the position of the isolation component 121 can be changed to change the position of the temperature higher or lower than other parts of the inner package 100.

[0083] like Figure 4As shown, the shell member 70 has a plurality of partial shell members 71, 72, 73 arranged in a row in the length direction of the mold 20, and the isolation member 121 is preferably disposed on at least one of the partial shell members 71, 72, 73. By disposing the isolation member 121 on at least one of the partial shell members 71, 72, 73, it is easy to change the position of the protrusion 120 in the shell member 70, thereby making it easy to control the portion to be higher in temperature than other portions when the thermal jacket 30 heats the inner inclusions 100 and the portion to be lower in temperature than other portions when the thermal jacket 30 cools the inner inclusions 100.

[0084] like Figure 2 as well as Figure 3 As shown, the convex portion 120 preferably extends over the entire circumference of the outer shell member 70. Since the convex portion 120 extends over the entire circumference of the outer shell member 70, the entire circumference of the outer shell member 70 is easily in close contact with the inner circumference of the heat sleeve 30 at the portion where the convex portion 120 is arranged. Therefore, the temperature of the heat sleeve 30 is easily transferred to the entire circumference of the inner package 100 at the portion where the convex portion 120 is arranged, so that the inner package 100 can be efficiently heated and cooled.

[0085] When the housing member 70 has a plurality of partial housing members 71, 72, 73, the projection 120 preferably extends over the entire circumference of at least one of the partial housing members 71, 72, 73. Since the projection 120 extends over the entire circumference of at least one of the molds 20 of the partial housing members 71, 72, 73, the portion having the projection 120 in the partial housing members 71, 72, 73 is more likely to become hotter when heated and to become colder when cooled than other portions.

[0086] Figure 5 yes Figure 4 The VV cross-sectional view of the inner package 100 is shown. Figure 5As shown, the inner cavity of the mold 20 has a columnar portion 21 and a tapered portion 22, the tapered portion 22 exists at one end side and the other end side of the columnar portion 21, and the convex portion 120 is preferably arranged at least partially in the portion corresponding to the columnar portion 21. The columnar portion 21 of the mold 20 helps to form the straight tube portion of the resin medical balloon, and the tapered portion 22 of the mold 20 helps to form the tapered portion of the resin medical balloon arranged at the distal side and the proximal side of the straight tube portion of the resin medical balloon. By arranging the convex portion 120 at least partially in the portion corresponding to the columnar portion 21, the portion that becomes the straight tube portion of the resin medical balloon after molding can be heated at a higher temperature than other portions when the inner package 100 is heated, and can be cooled at a lower temperature than other portions when the inner package 100 is cooled. Therefore, for example, a resin medical balloon can be manufactured in which the thickness of the straight tube portion is easily reduced to expand the straight tube portion, or a resin medical balloon can be manufactured in which the hardness of the straight tube portion is high and the expansion stress of the narrowed portion of the blood vessel is high.

[0087] Although not shown in the figure, it is also preferred that the inner cavity of the mold 20 has a columnar portion 21 and a tapered portion 22, the tapered portion 22 exists at one end side and the other end side of the columnar portion 21, and the convex portion 120 is disposed at least partially in the portion corresponding to the tapered portion 22. By disposing the convex portion 120 at least partially in the portion corresponding to the tapered portion 22, the portion that becomes the tapered portion of the resin medical balloon after molding can be heated at a higher temperature than other portions when the inner package 100 is heated, and can be cooled at a lower temperature than other portions when cooled.

[0088] The shrink sleeve 30 preferably has a plurality of partial shrink sleeves. That is, the shrink sleeve 30 preferably consists of a plurality of partial shrink sleeves. Since the shrink sleeve 30 has a plurality of partial shrink sleeves, the shrink sleeve 30 can be divided, thereby facilitating the arrangement of the mold 20 inside the shrink sleeve 30.

[0089] 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 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.

[0090] like Figure 1 to Figure 3As shown, the heat sleeve 30 preferably includes a first partial heat sleeve 31 located on one side of the mold 20 and a second partial heat sleeve 32 located on the other side of the mold 20, and the first partial heat sleeve 31 and the second partial heat sleeve 32 are brought close to each other to press the inner inclusion 100. The first partial heat sleeve 31 and the second partial heat sleeve 32 are brought close to each other to press the inner inclusion 100, thereby adjusting the distance between the first partial heat sleeve 31 and the second partial heat sleeve 32 to adjust the pressure on the inner side surface of the heat sleeve 30 from the inner inclusion 100. Therefore, the heat sleeve 30 can easily press the inner inclusion 100.

[0091] like Figure 1 as well as Figure 2 As shown, it is preferred that the first partial shrink sleeve 31 and the second partial shrink sleeve 32 are connected to each other. By connecting the first partial shrink sleeve 31 and the second partial shrink sleeve 32 to each other, the shrink sleeve 30 has a structure that can be opened and closed on one side and the other side of the mold 20. As a result, it is easy to arrange or remove the mold 20 inside the shrink sleeve 30, thereby improving the manufacturing efficiency of the resin medical balloon.

[0092] 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.

[0093] like Figure 1 As shown, the heat sleeve 30 preferably includes a distal heat sleeve 33 and a proximal heat sleeve 34 that are separated from each other in the longitudinal direction of the mold 20. Since the heat sleeve 30 includes the distal heat sleeve 33 and the proximal heat sleeve 34 that are separated from each other in the longitudinal direction of the mold 20, it is easy to set different temperatures using the distal heat sleeve 33 and the proximal heat sleeve 34. Therefore, the heating temperature or cooling temperature of the resin cylindrical body 10 can be set to different temperatures according to different parts.

[0094] When the heat-shrink sleeve 30 has a distal local heat-shrink sleeve 33 and a proximal local heat-shrink sleeve 34 that are separated from each other in the longitudinal direction of the mold 20, the distance between the distal local heat-shrink sleeve 33 and the proximal local heat-shrink sleeve 34 is preferably 1 mm or more, more preferably 3 mm or more, and further preferably 5 mm or more. By setting the lower limit of the distance between the distal local heat-shrink sleeve 33 and the proximal local heat-shrink sleeve 34 to the above range, a suitable distance can be set between the distal local heat-shrink sleeve 33 and the proximal local heat-shrink sleeve 34, so that the distal local heat-shrink sleeve 33 and the proximal local heat-shrink sleeve 34 are less likely to be affected by temperature. In addition, the distance between the distal local heat-shrink sleeve 33 and the proximal local heat-shrink sleeve 34 is preferably 20 mm or less, more preferably 18 mm or less, and further preferably 15 mm or less. By setting the upper limit of the distance between the distal local heat sleeve 33 and the proximal local heat sleeve 34 within the above range, it is possible to prevent a large amount of external air from entering between the mold 20 and the heat sleeve 30 due to the gap between the distal local heat sleeve 33 and the proximal local heat sleeve 34 becoming too large, thereby improving the efficiency of the heat sleeve 30 in heating and cooling the mold 20. In addition, the heat sleeve 30 may further have a local heat sleeve at the distal side of the distal local heat sleeve 33, and may further have a local heat sleeve at the proximal side of the proximal local heat sleeve 34. In addition, the number of local heat sleeves located on one surface side of the mold 20 may be the same as or different from the number of local heat sleeves located on the other surface side of the mold 20.

[0095] like Figure 1 as well as Figure 2 As shown, the manufacturing apparatus 1 preferably includes a pore-containing metal body 50 disposed outside the mold 20 and inside the shrink fit 30 . That is, the pore-containing metal body 50 is preferably provided between the mold 20 and the shrink fit 30 .

[0096] 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.

[0097] 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.

[0098] In addition, the porous metal body 50 was subjected to 100 N / cm 2 The pore-containing metal body 50 was compressed five times at a pressure of , and then the elastic deformation amount per unit thickness and the thermal conductivity of the pore-containing metal body 50 were measured.

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] 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.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] 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.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] The manufacturing method of the first balloon catheter and the second 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.

[0114] The first method for manufacturing a balloon catheter of the present invention 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, and is 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 inner side of a heat sleeve, the heat sleeve being a component that presses an inner content existing on the inner side of the heat sleeve, and the pressure on the inner side surface of the heat sleeve from the inner content varies depending on the position of the inner side surface of the heat sleeve.

[0115] The second method for manufacturing a balloon catheter of the present invention 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 inner side of a heat sleeve, wherein an inner package is configured on the inner side of the heat sleeve, the inner package has a recess on the outer side, the depth of the recess is greater than 10 μm, and the area in which the inner side surface of the heat sleeve contacts the inner package varies depending on the position of the inner side surface of the heat sleeve.

[0116] Hereinafter, the resin medical balloon is sometimes referred to as a "balloon". In the present invention, the distal side refers to the direction of the treatment object (affected part) side 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 of the user, i.e., the operator's hand side relative to the extension direction of the balloon. In addition, the direction from the proximal side of the balloon toward the distal side is referred to as the length direction.

[0117] 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.

[0118] 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.

[0119] 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.

[0120] 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.

[0121] 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.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] 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.

[0126] 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.

[0127] The method for manufacturing the first balloon catheter and the second balloon catheter of the present invention includes a step of inserting a resin cylindrical body into a mold and a step of arranging the mold inside a shrink fit.

[0128] 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.

[0129] 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.

[0130] 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.

[0131] In the manufacturing method of the first balloon catheter of the present invention, the heat sleeve is a component that presses the inner contents present on the inner side of the heat sleeve, and the pressure on the inner side of the heat sleeve from the inner contents varies depending on the position of the inner side of the heat sleeve. The portion of the inner side of the heat sleeve that receives a higher pressure from the inner contents than other portions is in close contact with the inner contents compared to other portions, so that the temperature of the heat sleeve is easily transferred to the inner contents. Therefore, the pressure on the inner side of the heat sleeve from the inner contents varies depending on the position of the inner side of the heat sleeve, so that the inner contents of the portion of the inner side of the heat sleeve that receives a higher pressure from the inner contents can be heated at a higher temperature than other portions when heated, and cooled at a lower temperature than other portions when cooled.

[0132] In the manufacturing method of the second balloon catheter of the present invention, an inner inclusion having a recess with a depth of 10 μm or more is arranged on the outer side surface, and the area where the inner side surface of the heat sleeve contacts the inner inclusion varies depending on the position of the inner side surface of the heat sleeve, so that the portion of the inner inclusion located in the recess is farther away from the heat sleeve than other portions, and is not easy to contact the heat sleeve, thereby reducing the area in contact with the inner side surface of the heat sleeve. Therefore, the portion of the inner inclusion located in the recess is not easy to transfer the temperature of the heat sleeve compared to other portions. As a result, the heat sleeve can heat the inner inclusion at a lower temperature than other portions, and can cool the inner inclusion at a higher temperature than other portions.

[0133] As described above, the manufacturing device of the first resin medical balloon of the present invention is characterized in that it has: a mold in which a resin cylindrical body is inserted; and a heat sleeve in which the mold is contained, the heat sleeve is a component that presses the inner contents existing on the inner side of the heat sleeve, and the pressure received by the inner side of the heat sleeve from the inner contents varies depending on the position of the inner side of the heat sleeve. In addition, the manufacturing method of the first balloon catheter of the present invention is characterized in that it has: a step of inserting a resin cylindrical body into the mold; and a step of arranging the mold to the inner side of the heat sleeve, the heat sleeve is a component that presses the inner contents existing on the inner side of the heat sleeve, and the pressure received by the inner side of the heat sleeve from the inner contents varies depending on the position of the inner side of the heat sleeve. According to the manufacturing device of the first resin medical balloon and the manufacturing method of the first balloon catheter of the present invention, the heat sleeve is a component that presses the inner contents present on the inner side of the heat sleeve, and the pressure on the inner side surface of the heat sleeve from the inner contents varies depending on the position of the inner side surface of the heat sleeve. As a result, the inner contents located at a portion of the inner side surface of the heat sleeve where the pressure on the inner contents is higher can easily transfer the temperature of the heat sleeve compared to other portions. Therefore, when the heat sleeve heats the inner contents, the temperature can be higher than other portions, and when the heat sleeve cools the inner contents, the temperature can be lower than other portions.

[0134] The second resin medical balloon manufacturing device of the present invention is characterized in that it has: a mold in which a resin cylindrical body is inserted; and a heat-shrink sleeve, which contains the mold, and an inner package is arranged on the inner side of the heat-shrink sleeve, and the inner package has a recess extending along the circumferential direction of the inner package on the outer side. In addition, the second balloon catheter manufacturing method of the present invention is characterized in that it has: a step of inserting the resin cylindrical body into the mold; and a step of arranging the mold to the inner side of the heat-shrink sleeve, and the inner package is arranged on the inner side of the heat-shrink sleeve, and the inner package has a recess on the outer side, and the depth of the recess is 10μm or more, and the area of ​​contact between the inner side of the heat-shrink sleeve and the inner package varies depending on the position of the inner side of the heat-shrink sleeve. According to the manufacturing device of the second resin medical balloon and the manufacturing method of the second balloon catheter of the present invention, the inner material arranged on the inner side of the heat sleeve has a recessed portion on the outer side surface, and the contact area between the inner side surface of the heat sleeve and the inner material varies depending on the position of the inner side surface of the heat sleeve. As a result, the portion of the inner material located in the recessed portion is less likely to transfer the temperature of the heat sleeve than other portions. Therefore, when the heat sleeve heats the inner material, the temperature can be lower than other portions, and when the heat sleeve cools the inner material, the temperature can be higher than other portions.

[0135] CROSS-REFERENCE TO RELATED APPLICATIONS

[0136] This application claims the benefit of priority based on Japanese Patent Application No. 2019-237207 filed on December 26, 2019. The entire contents of the specification of Japanese Patent Application No. 2019-237207 filed on December 26, 2019 are incorporated herein by reference.

[0137] Description of reference numerals:

[0138] 1… a manufacturing device for a resin medical balloon; 10… a resin tubular body; 20… a mold; 21… a columnar portion; 22… a conical portion; 30… a heat-shrink sleeve; 31… a first partial heat-shrink sleeve; 32… a second partial heat-shrink sleeve; 33… a distal partial heat-shrink sleeve; 34… a proximal partial heat-shrink sleeve; 40… a temperature regulator; 50… a porous metal body; 70… a shell component; 71… a partial shell component; 72… a partial shell component; 73… a partial shell component; 100… an inner part; 110… a recessed portion; 120… a convex portion; 121… an isolation 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: The process of inserting the parison into the mold; and The step of placing the mold toward the inside of the shrink fit, The heat shield is a component that presses the inner contents present inside the heat shield. The pressure on the inner side of the heat shield from the inner contents varies depending on the position of the inner side of the heat shield. The inner package is an outer shell component that encloses at least part of one or more molds.

2. The method for manufacturing a balloon catheter according to claim 1, wherein: The pressure on the inner side surface of the shrink sleeve from the inner contents varies depending on the position in the longitudinal direction of the mold.

3. The method for manufacturing a balloon catheter according to claim 1, wherein: The housing member has a convex portion on an outer side surface.

4. The method for manufacturing a balloon catheter according to claim 3, wherein: The protrusion is a spacer member disposed on the outer side surface of the housing member.

5. The method for manufacturing a balloon catheter according to claim 4, wherein: The shell member includes a plurality of partial shell members arranged side by side in the longitudinal direction of the mold, and the spacer member is arranged in at least one of the partial shell members.

6. The method for manufacturing a balloon catheter according to any one of claims 3 to 5, wherein: The projection extends over the entire circumference of the housing member.

7. The method for manufacturing a balloon catheter according to any one of claims 3 to 5, wherein: The inner cavity of the mold has a columnar portion and a tapered portion, the tapered portion exists on one end side and the other end side of the columnar portion, and the convex portion is disposed at least partially in a portion corresponding to the columnar portion.

8. The method for manufacturing a balloon catheter according to any one of claims 3 to 5, wherein: The inner cavity of the mold has a columnar portion and a tapered portion, the tapered portion exists on one end side and the other end side of the columnar portion, and the convex portion is disposed at least partially in a portion corresponding to the tapered portion.

9. The method for manufacturing a balloon catheter according to any one of claims 1 to 5, wherein: The thermal sleeve has a plurality of local thermal sleeves.

10. The method for manufacturing a balloon catheter according to any one of claims 1 to 5, wherein: The shrink sleeve includes a first partial shrink sleeve located on one side of the mold and a second partial shrink sleeve located on the other side of the mold, and the first partial shrink sleeve and the second partial shrink sleeve are brought into proximity with each other to press the inner contents.

11. The method for manufacturing a balloon catheter according to claim 10, wherein: The first local heat sleeve and the second local heat sleeve are connected to each other.

12. The method for manufacturing a balloon catheter according to claim 9, wherein: The shrink fit includes a distal side partial shrink fit and a proximal side partial shrink fit that are disposed apart from each other in the longitudinal direction of the mold.

13. The method for manufacturing a balloon catheter according to any one of claims 1 to 5, wherein: A porous metal body is provided, and the porous metal body is arranged outside the mold and inside the shrink sleeve.

14. The method for manufacturing a balloon catheter according to claim 13, 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.

15. 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 comprising: The process of inserting the parison into the mold; and The step of placing the mold toward the inside of the shrink fit, An inner package is arranged inside the heat sleeve. The inner package has a concave portion on the outer side surface, The depth of the concave portion is greater than 10 μm. The contact area between the inner side of the heat sleeve and the inner contents varies depending on the position of the inner side of the heat sleeve. The inner package is an outer shell component that encloses at least part of one or more molds.

16. The method for manufacturing a balloon catheter according to claim 15, wherein: The housing member has a convex portion on an outer side surface.

17. The method for manufacturing a balloon catheter according to claim 16, wherein: The protrusion is a spacer member disposed on the outer side surface of the housing member.

18. The method for manufacturing a balloon catheter according to claim 17, wherein: The shell member includes a plurality of partial shell members arranged side by side in the longitudinal direction of the mold, and the spacer member is arranged in at least one of the partial shell members.

19. The method for manufacturing a balloon catheter according to any one of claims 16 to 18, wherein: The projection extends over the entire circumference of the housing member.

20. The method for manufacturing a balloon catheter according to any one of claims 16 to 18, wherein: The inner cavity of the mold has a columnar portion and a tapered portion, the tapered portion exists on one end side and the other end side of the columnar portion, and the convex portion is disposed at least partially in a portion corresponding to the columnar portion.

21. The method for manufacturing a balloon catheter according to any one of claims 16 to 18, wherein: The inner cavity of the mold has a columnar portion and a tapered portion, the tapered portion exists on one end side and the other end side of the columnar portion, and the convex portion is disposed at least partially in a portion corresponding to the tapered portion.

22. The method for manufacturing a balloon catheter according to any one of claims 15 to 18, wherein: The thermal sleeve has a plurality of local thermal sleeves.

23. The method for manufacturing a balloon catheter according to any one of claims 15 to 18, wherein: The shrink sleeve includes a first partial shrink sleeve located on one side of the mold and a second partial shrink sleeve located on the other side of the mold, and the first partial shrink sleeve and the second partial shrink sleeve are brought into proximity with each other to press the inner contents.

24. The method for manufacturing a balloon catheter according to claim 23, wherein: The first local heat sleeve and the second local heat sleeve are connected to each other.

25. The method for manufacturing a balloon catheter according to claim 22, wherein: The shrink fit includes a distal side partial shrink fit and a proximal side partial shrink fit that are disposed apart from each other in the longitudinal direction of the mold.

26. The method for manufacturing a balloon catheter according to any one of claims 15 to 18, wherein: A porous metal body is provided, and the porous metal body is arranged outside the mold and inside the shrink sleeve.

27. The method for manufacturing a balloon catheter according to claim 26, 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.

28. A device for manufacturing a resin medical balloon, characterized in that: have: a mold in which the parison is inserted; and A heat-shrink sleeve, which contains the mold, The heat shield is a component that presses the inner contents present inside the heat shield. The pressure on the inner side of the heat shield from the inner contents varies depending on the position of the inner side of the heat shield. The inner package is an outer shell component that encloses at least part of one or more molds.

29. The manufacturing device for a resin medical balloon according to claim 28, wherein: The pressure on the inner side surface of the shrink sleeve from the inner contents varies depending on the position in the longitudinal direction of the mold.

30. The manufacturing device for a resin medical balloon according to claim 28, wherein: The housing member has a convex portion on an outer side surface.

31. The manufacturing device for a resin medical balloon according to claim 30, wherein: The protrusion is a spacer member disposed on the outer side surface of the housing member.

32. The manufacturing device for a resin medical balloon according to claim 31, wherein: The shell member includes a plurality of partial shell members arranged side by side in the longitudinal direction of the mold, and the spacer member is arranged in at least one of the partial shell members.

33. The manufacturing device for a resin medical balloon according to any one of claims 30 to 32, wherein: The projection extends over the entire circumference of the housing member.

34. The manufacturing device for a resin medical balloon according to any one of claims 30 to 32, wherein: The inner cavity of the mold has a columnar portion and a tapered portion, the tapered portion exists on one end side and the other end side of the columnar portion, and the convex portion is disposed at least partially in a portion corresponding to the columnar portion.

35. The manufacturing device for a resin medical balloon according to any one of claims 30 to 32, wherein: The inner cavity of the mold has a columnar portion and a tapered portion, the tapered portion exists on one end side and the other end side of the columnar portion, and the convex portion is disposed at least partially in a portion corresponding to the tapered portion.

36. The manufacturing device for a resin medical balloon according to any one of claims 28 to 32, wherein: The thermal sleeve has a plurality of local thermal sleeves.

37. The manufacturing device for a resin medical balloon according to any one of claims 28 to 32, wherein: The shrink sleeve includes a first partial shrink sleeve located on one side of the mold and a second partial shrink sleeve located on the other side of the mold, and the first partial shrink sleeve and the second partial shrink sleeve are brought into proximity with each other to press the inner contents.

38. The manufacturing device for a resin medical balloon according to claim 37, wherein: The first local heat sleeve and the second local heat sleeve are connected to each other.

39. The manufacturing device for a resin medical balloon according to claim 36, wherein: The shrink fit includes a distal side partial shrink fit and a proximal side partial shrink fit that are disposed apart from each other in the longitudinal direction of the mold.

40. The manufacturing device for a resin medical balloon according to any one of claims 28 to 32, wherein: A porous metal body is provided, and the porous metal body is arranged outside the mold and inside the shrink sleeve.

41. The resin medical balloon manufacturing device according to claim 40, 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.

42. A device for manufacturing a resin medical balloon, characterized in that: have: a mold in which the parison is inserted; and A heat-shrink sleeve, which contains the mold, An inner package is arranged inside the heat sleeve. The inner package has a concave portion on the outer side surface, The depth of the concave portion is greater than 10 μm. The contact area between the inner side of the heat sleeve and the inner contents varies depending on the position of the inner side of the heat sleeve. The inner package is an outer shell component that encloses at least part of one or more molds.

43. The manufacturing device for a resin medical balloon according to claim 42, wherein: The housing member has a convex portion on an outer side surface.

44. The manufacturing device for a resin medical balloon according to claim 43, wherein: The protrusion is a spacer member disposed on the outer side surface of the housing member.

45. The manufacturing device for a resin medical balloon according to claim 44, wherein: The shell member includes a plurality of partial shell members arranged side by side in the longitudinal direction of the mold, and the spacer member is arranged in at least one of the partial shell members.

46. ​​The manufacturing device for a resin medical balloon according to any one of claims 43 to 45, wherein: The projection extends over the entire circumference of the housing member.

47. The manufacturing device for a resin medical balloon according to any one of claims 43 to 45, wherein: The inner cavity of the mold has a columnar portion and a tapered portion, the tapered portion exists on one end side and the other end side of the columnar portion, and the convex portion is disposed at least partially in a portion corresponding to the columnar portion.

48. The manufacturing device for a resin medical balloon according to any one of claims 43 to 45, wherein: The inner cavity of the mold has a columnar portion and a tapered portion, the tapered portion exists on one end side and the other end side of the columnar portion, and the convex portion is disposed at least partially in a portion corresponding to the tapered portion.

49. The manufacturing device for a resin medical balloon according to any one of claims 42 to 45, wherein: The thermal sleeve has a plurality of local thermal sleeves.

50. The manufacturing device for a resin medical balloon according to any one of claims 42 to 45, wherein: The shrink sleeve includes a first partial shrink sleeve located on one side of the mold and a second partial shrink sleeve located on the other side of the mold, and the first partial shrink sleeve and the second partial shrink sleeve are brought into proximity with each other to press the inner contents.

51. The manufacturing device for a resin medical balloon according to claim 50, wherein: The first local heat sleeve and the second local heat sleeve are connected to each other.

52. The manufacturing device for a resin medical balloon according to claim 51, wherein: The shrink fit includes a distal side partial shrink fit and a proximal side partial shrink fit that are disposed apart from each other in the longitudinal direction of the mold.

53. The manufacturing device for a resin medical balloon according to any one of claims 42 to 45, wherein: A porous metal body is provided, and the porous metal body is arranged outside the mold and inside the shrink sleeve.

54. The resin medical balloon manufacturing device according to claim 53, 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.

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