WO2021049261A1 - Method for producing balloon catheter - Google Patents

Method for producing balloon catheter Download PDF

Info

Publication number
WO2021049261A1
WO2021049261A1 PCT/JP2020/031104 JP2020031104W WO2021049261A1 WO 2021049261 A1 WO2021049261 A1 WO 2021049261A1 JP 2020031104 W JP2020031104 W JP 2020031104W WO 2021049261 A1 WO2021049261 A1 WO 2021049261A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
tubular object
distance
gravity
center
Prior art date
Application number
PCT/JP2020/031104
Other languages
French (fr)
Japanese (ja)
Inventor
良紀 中野
真弘 小嶋
古賀　陽二郎
昌人 杖田
Original Assignee
株式会社カネカ
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社カネカ filed Critical 株式会社カネカ
Priority to JP2021545185A priority Critical patent/JPWO2021049261A1/ja
Publication of WO2021049261A1 publication Critical patent/WO2021049261A1/en

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow

Definitions

  • the present invention relates to a method for manufacturing a balloon catheter having a balloon.
  • stenosis of blood vessels which is a flow path for blood circulation in the body, and stenosis of blood circulation.
  • stenosis of the coronary artery that supplies blood to the heart may lead to serious diseases such as angina pectoris and myocardial infarction.
  • As a method of treating such a stenotic part of a blood vessel there is a technique of dilating the stenotic part using a balloon catheter such as angioplasty such as PTA and PTCA.
  • Angioplasty is a minimally invasive therapy that does not require thoracotomy, such as bypass surgery, and is widely practiced.
  • a balloon catheter covers the balloon with a protective tube formed of a cylindrical tube whose inner diameter is slightly larger than the outer diameter of the folded balloon in order to protect the folded balloon until use.
  • a protective tube formed of a cylindrical tube whose inner diameter is slightly larger than the outer diameter of the folded balloon in order to protect the folded balloon until use.
  • the balloon folding method as described in Patent Documents 1 to 6 has room for improvement in that it can be neatly folded so that the outer diameter becomes smaller. If the outer diameter of the folded balloon is large, it becomes difficult to insert the balloon into the protective tube, and when using a balloon catheter, the balloon expands when the balloon is taken out from the protective tube and the outer diameter is large. There is a problem that it tends to occur and the passage of the balloon catheter into the blood vessel is deteriorated.
  • 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 that can be neatly folded so that the outer diameter of the balloon becomes smaller.
  • the method for manufacturing a balloon catheter that has been able to solve the above problems is a method for manufacturing a balloon catheter having a shaft extending in the perspective direction and a balloon provided on the distal side of the shaft.
  • a tubular object preparation step that prepares a tubular object that has a space extending in the perspective direction inside, a balloon preparation step that prepares a balloon, and a balloon is placed inside the tubular object to add the inside of the balloon. It has a balloon placement step of pressing to inflate the balloon and a balloon contraction step of depressurizing the inside of the balloon and contracting the balloon to form a wing-shaped portion, and has a perspective of a tubular object in the balloon placement step.
  • the tubular object has a portion where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short and a portion where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long.
  • the distance from the center of gravity of the tubular object to the portion where the distance from the inner surface of the tubular object is short is 50, which is the distance from the center of gravity of the tubular object to the portion where the distance from the inner surface of the tubular object is long. It is characterized by being% or more and 95% or less.
  • the portion of the balloon located at a portion where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long becomes the tip of the blade-shaped portion. It is preferable that the portion of the balloon located at the portion where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short is a valley portion between a plurality of adjacent blade-shaped portions.
  • the tubular object has a groove portion extending in the perspective direction inside.
  • the groove portion is located in a portion where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short.
  • the balloon has a balloon body and a protrusion formed on the outer surface of the balloon body, and the protrusion is formed inside the groove before the balloon contraction step. It is preferable to have a projecting portion arranging step for arranging.
  • the protruding portion is made of the same material as the balloon body.
  • the number of protrusions is a plurality and the number of grooves is equal to the number of protrusions.
  • the balloon has a hydrophilic coating on the outer surface and has a coating removing step of removing the hydrophilic coating on the top of the protrusion.
  • the coating removing step is performed after the balloon placement step, and in the coating removing step, the balloon is slid in the perspective direction, and the outer surface of the protruding portion and the inner surface of the tubular object are formed. It is preferable that they are in contact with each other.
  • the method for manufacturing a balloon catheter of the present invention in a cross section perpendicular to the perspective direction of the tubular object in the balloon arrangement step of arranging the balloon in the tubular object and pressurizing the inside of the balloon to inflate the balloon.
  • the tubular object has a part where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short and a part where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long.
  • the distance from the to the portion where the distance from the inner surface of the tubular object is short is 50% or more and 95% or less of the distance from the center of gravity of the tubular object to the portion where the distance from the inner surface of the tubular object is long. It is possible to control the position where the blade-shaped portion is formed in the state where the balloon is contracted, the balloon can be neatly folded, and the outer diameter of the folded balloon can be reduced.
  • a cross-sectional view perpendicular to the perspective direction of a tubular object in the balloon arranging step of the manufacturing method according to the embodiment of the present invention is shown.
  • a cross-sectional view perpendicular to the perspective direction of a tubular object in the balloon contraction step of the manufacturing method according to the embodiment of the present invention is shown.
  • a cross-sectional view perpendicular to the perspective direction of a tubular object in the balloon arranging step of the manufacturing method according to another embodiment of the present invention is shown.
  • a cross-sectional view perpendicular to the perspective direction of a tubular object in the balloon contraction step of the manufacturing method according to another embodiment of the present invention is shown.
  • a cross-sectional view perpendicular to the perspective direction of a tubular object in the balloon arranging step of the manufacturing method according to still another embodiment of the present invention is shown.
  • a cross-sectional view perpendicular to the perspective direction of a tubular object in the balloon contraction step of the manufacturing method according to still another embodiment of the present invention is shown.
  • FIG. 1 shows a cross-sectional view in the balloon placement step of the method for manufacturing a balloon catheter according to the embodiment of the present invention
  • FIG. 2 shows a cross-sectional view in the balloon contraction step.
  • the method for manufacturing a balloon catheter is a method for manufacturing a balloon catheter having a shaft extending in the perspective direction and a balloon 1 provided on the distal side of the shaft, and is a space extending in the perspective direction.
  • the distal side refers to the direction of the treatment subject with respect to the extending direction of the balloon 1
  • the proximal side is used with respect to the opposite side of the distal side, that is, the extending direction of the balloon 1.
  • the person that is, the direction of the operator's hand.
  • the direction from the proximal side to the distal side of the balloon 1 is referred to as a perspective direction.
  • the balloon catheter is configured so that fluid is supplied to the inside of the balloon 1 through a shaft, and the expansion and contraction of the balloon 1 can be controlled by using an indeflator (balloon pressurizer).
  • the fluid may be a pressure fluid pressurized by a pump or the like.
  • the shaft extends in the perspective direction, and a fluid flow path is provided inside. Further, it is preferable that the shaft has a guide wire insertion passage inside.
  • the shaft has an outer tube and an inner tube, and the inner tube functions as a guide wire insertion passage. The space between the inner tube and the outer tube functions as a fluid flow path.
  • the inner tube extends from the distal end of the outer tube and penetrates the balloon 1 in the perspective direction, the distal side of the balloon 1 is joined to the inner tube, and the balloon It is preferable that the proximal side of 1 is joined to the outer tube.
  • the present invention is a so-called over-the-wire type balloon catheter in which a wire is inserted from the distal side to the proximal side of the shaft, and a so-called rapid exchange type in which the wire is inserted halfway from the distal side to the proximal side of the shaft. It can be applied to any of the balloon catheters of.
  • the balloon catheter may have a hub on the proximal side of the shaft to deliver fluid to the shaft.
  • the hub preferably has a fluid injection portion communicating with the fluid flow path supplied to the inside of the balloon 1 and a guide wire insertion portion communicating with the guide wire insertion passage.
  • the balloon catheter has a hub having a fluid injection part and a guide wire insertion part, the operation of supplying fluid to the inside of the balloon 1 to expand and contract the balloon 1 and the balloon catheter along the guide wire can be operated.
  • the operation of sending to the treatment target site becomes easy.
  • the joining between the shaft and the hub includes, for example, adhesion with an adhesive, welding, and the like. Above all, it is preferable that the shaft and the hub are joined by adhesion.
  • the shaft and the hub are made of a highly flexible material and the hub is made of a highly rigid material.
  • the joint strength between the shaft and the hub can be increased. As a result, it becomes possible to increase the durability of the balloon catheter.
  • the material constituting the shaft examples include polyamide-based resin, polyester-based resin, polyurethane-based resin, polyolefin-based resin, fluorine-based resin, vinyl chloride-based resin, silicone-based resin, and natural rubber. Only one of these may be used, or two or more thereof may be used in combination. Above all, the material constituting the shaft is preferably at least one of a polyamide resin, a polyolefin resin, and a fluorine resin. When the material constituting the shaft is at least one of a polyamide resin, a polyolefin resin, and a fluorine resin, the slipperiness of the surface of the shaft can be improved and the insertability of the balloon catheter into a blood vessel can be improved. ..
  • Balloon 1 is provided on the distal side of the shaft.
  • the joining between the balloon 1 and the shaft includes adhesion and welding with an adhesive, and caulking by attaching a ring-shaped member to a portion where the end of the balloon 1 and the shaft overlap.
  • it is preferable that the balloon 1 and the shaft are joined by welding. Since the balloon 1 and the shaft are welded together, it becomes difficult to release the joint between the balloon 1 and the shaft even if the balloon 1 is repeatedly expanded and contracted. Therefore, the joint strength between the balloon 1 and the shaft can be easily increased.
  • the balloon 1 preferably has a straight pipe portion, a proximal taper portion connected to the proximal side of the straight pipe portion, and a distal taper portion connected to the distal side of the straight pipe portion. It is preferable that the proximal taper portion and the distal taper portion are formed so as to reduce the diameter as the distance from the straight pipe portion increases. Since the balloon 1 has a straight tube portion, the straight tube portion is sufficiently in contact with the narrowed portion, and the narrowed portion can be easily expanded. Further, since the balloon 1 has a proximal taper portion and a distal taper portion whose outer diameter becomes smaller as the distance from the straight tube portion is increased, the balloon 1 is contracted and wound around the shaft. The outer diameters of the distal end and the proximal end of the balloon can be reduced to reduce the step between the shaft and the balloon 1. Therefore, it becomes easy to insert the balloon 1 in the perspective direction. In the present invention, the inflatable portion is regarded as the balloon 1.
  • the material constituting the balloon 1 is, for example, a polyolefin resin such as polyethylene, polypropylene or an ethylene-propylene copolymer, a polyester resin such as polyethylene terephthalate or a polyester elastomer, a polyurethane resin such as polyurethane or a polyurethane elastomer, or a polyphenylene sulfide type.
  • a polyolefin resin such as polyethylene, polypropylene or an ethylene-propylene copolymer
  • a polyester resin such as polyethylene terephthalate or a polyester elastomer
  • a polyurethane resin such as polyurethane or a polyurethane elastomer
  • a polyphenylene sulfide type examples thereof include polyamide resins such as resins, polyamide elastomers, nylon 6, nylon 6/6, nylon 6/10 and nylon 12, and natural rubbers such as fluororesins, silicone resins and latex rubbers.
  • the outer diameter of the balloon 1 is preferably 0.5 mm or more, more preferably 1 mm or more, and further preferably 1.5 mm or more.
  • the outer diameter of the balloon 1 is preferably 35 mm or less, more preferably 30 mm or less, and even more preferably 25 mm or less.
  • the length of the balloon 1 in the perspective direction is preferably 5 mm or more, more preferably 10 mm or more, and further preferably 15 mm or more.
  • the length of the balloon 1 in the perspective direction is preferably 300 mm or less, more preferably 200 mm or less, and further preferably 100 mm or less.
  • the thickness of the balloon 1 is preferably 5 ⁇ m or more, more preferably 7 ⁇ m or more, and further preferably 10 ⁇ m or more.
  • the upper limit of the thickness of the balloon 1 can be set according to the application of the balloon catheter, and can be, for example, 100 ⁇ m or less, 90 ⁇ m or less, and 80 ⁇ m or less.
  • a tubular object 10 having a space portion 11 extending in the perspective direction is prepared.
  • the balloon 1 can be arranged in the space portion 11 that the tubular object 10 has inside.
  • the material constituting the tubular object 10 examples include synthetic resins such as polycarbonate resin, polyacetal resin and fluororesin, and metals such as iron, copper and stainless steel. Above all, the material constituting the tubular object 10 is preferably metal. Since the material constituting the tubular object 10 is metal, the strength of the tubular object 10 is increased, and the pressure applied to the inside of the balloon 1 in the balloon arranging step can be increased.
  • the balloon preparation process prepare the balloon 1. After that, as shown in FIG. 1, in the balloon arranging step, the balloon 1 is arranged in the tubular object 10, and the inside of the balloon 1 is pressurized to inflate the balloon 1.
  • Examples of the method of pressurizing the inside of the balloon 1 include supplying a fluid such as a gas such as air or nitrogen gas or a liquid such as pure water or physiological saline to the inside of the balloon 1.
  • a fluid such as a gas such as air or nitrogen gas or a liquid such as pure water or physiological saline
  • a pump or the like can be used.
  • the balloon arranging step when the inside of the balloon 1 is pressurized in the tubular object 10 to inflate the balloon 1, at least a part of the outer surface of the balloon 1 is in contact with the inner surface of the space portion 11. Is preferable. In the balloon arranging step, at least a part of the outer surface of the balloon 1 is in contact with the inner surface of the space portion 11, so that the blade-shaped portion 3 can be easily formed in the balloon contraction step performed after the balloon arranging step.
  • the formation of the blade-shaped portion 3 is affected by the shape of the space portion 11 which is the internal shape of the tubular object 10, the material constituting the balloon 1, the expansion rate of the balloon 1, and the like.
  • the inner peripheral length of the space portion 11 of the tubular object 10 is preferably 1.5 times or less, preferably 1.3 times or less the outer peripheral length of the balloon 1. It is more preferably less than or equal to, more preferably 1.2 times or less, further preferably 0.2 times or more, more preferably 0.3 times or more, and 0.5 times or more. Is more preferable.
  • the balloon 1 can easily follow the space portion 11. As a result, the blade-shaped portion 3 can be easily formed.
  • the tubular object 10 is the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10.
  • the distance D1 to the portion P2 having a short distance is 50% or more and 95% or less of the distance D2 to the portion P3 having a long distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10.
  • a balloon contraction step is performed in which the inside of the balloon 1 is depressurized and the balloon 1 is contracted to form the blade-shaped portion 3.
  • the blade-shaped portion 3 refers to a portion where at least a part of the inner surface of the balloon 1 is in contact with each other in a state where the balloon 1 is contracted.
  • the tubular object 10 has a portion P2 in which the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short, and the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10.
  • the distance D1 from the center of gravity P1 of the tubular object 10 to the portion P2 having a short distance to the inner surface of the tubular object 10 is from the center of gravity P1 of the tubular object 10.
  • the tubular object 10 Since the distance to the inner surface of the tubular object 10 is 50% or more and 95% or less of the distance D2 to the portion P3, when the inside of the balloon 1 is depressurized in the balloon contraction step, the tubular object 10
  • the portion of the balloon 1 arranged in the portion P2 where the distance from the center of gravity P1 to the inner surface of the tubular object 10 is short is the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is long. It becomes easier to reach the center of gravity P1 of the tubular object 10 before the portion of the balloon 1 arranged in. At this point, the portion of the balloon 1 that has not reached the center of gravity P1 of the tubular object 10 becomes the blade-shaped portion 3.
  • the portion of the balloon 1 arranged in the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner side surface of the tubular object 10 is long forms the blade-shaped portion 3. Therefore, the position of the blade-shaped portion 3 of the balloon 1 can be controlled, and the balloon 1 can be neatly folded so that the outer diameter becomes smaller.
  • the distance D1 from the center of gravity P1 of the tubular object 10 to the portion P2 where the distance from the inner surface of the tubular object 10 is short in the balloon arrangement step is the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10. It may be 50% or more of the distance D2 to the long portion P3, but it is preferably 55% or more, more preferably 60% or more, and further preferably 65% or more.
  • the step of arranging the balloon 1 inside the tubular object 10 becomes easy. As a result, the production efficiency of the balloon catheter can be increased. Further, the distance D1 from the center of gravity P1 of the tubular object 10 to the portion P2 where the distance from the inner surface of the tubular object 10 is short in the balloon arrangement step is from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10. It may be 95% or less of the distance D2 to the portion P3 where the distance is long, but it is preferably 90% or less, more preferably 85% or less, and further preferably 80% or less.
  • the time for depressurizing the inside of the balloon 1 in the balloon contraction step is preferably shorter than the time for pressurizing the inside of the balloon 1 in the balloon placement step.
  • the number of the blade-shaped portions 3 formed in the balloon contraction step may be one, but is preferably a plurality. Since the number of the blade-shaped portions 3 formed in the balloon contraction step is a plurality, the length of the blade-shaped portions 3 is less likely to be excessively long. Therefore, the balloon 1 can be easily folded neatly.
  • the portion of the balloon 1 located at the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is long is the blade.
  • the tip portion 3a of the shape portion 3, and the portion of the balloon 1 located at the portion P2 where the distance from the center of gravity P1 of the tubular object 10 to the inner side surface of the tubular object 10 is short is adjacent to the plurality of blade-shaped portions 3. It is preferable that the valley portion 3b is between them.
  • the portion of the balloon 1 located at the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is long becomes the tip portion 3a of the blade-shaped portion 3, and the center of gravity of the tubular object 10
  • the portion of the balloon 1 located at the portion P2 where the distance from P1 to the inner surface of the tubular object 10 is short becomes the valley portion 3b of the blade-shaped portion 3, so that the tip portion 3a of the blade-shaped portion 3 of the balloon 1 is formed. And the position of the valley 3b can be controlled. Therefore, the balloon 1 can be folded more neatly, and the diameter of the balloon 1 can be further reduced.
  • FIG. 3 shows a cross-sectional view in the balloon placement step of the method for manufacturing a balloon catheter according to another embodiment of the present invention
  • FIG. 4 shows a cross-sectional view in the balloon contraction step.
  • the tubular object 10 preferably has a groove portion 20 extending in the perspective direction inside. Since the tubular object 10 has a groove portion 20 inside, when the balloon 1 is inflated in the balloon arranging step, the inner surface of the tubular object 10 and the outer surface of the balloon 1 are formed in the vicinity of the groove portion 20. It becomes easy to create a gap between the two.
  • the portion of the balloon 1 arranged near the groove 20 is easily pulled toward the center of gravity P1 of the tubular object 10, and the valley of the blade-shaped portion 3 is easily pulled.
  • the position of the portion 3b can be easily controlled.
  • FIG. 5 shows a cross-sectional view in the balloon placement step of the method for manufacturing a balloon catheter according to still another embodiment of the present invention
  • FIG. 6 shows a cross-sectional view in the balloon contraction step.
  • the groove portion 20 is located in the vicinity of the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner side surface of the tubular object 10 is long, and is inside the groove portion 20 in the projecting portion arranging step.
  • the protrusion 2 may be arranged on the.
  • the balloon 1 can be folded with the protruding portion 2 on the blade-shaped portion 3. It is possible. Since the protruding portion 2 is arranged in the blade-shaped portion 3, when the balloon 1 is expanded when the balloon catheter is used, the protruding portion is formed in a lesion portion such as a stenosis even in the middle of expansion of the balloon 1. 2 is easy to get caught. Therefore, it is possible to obtain a balloon catheter in which the balloon 1 can be easily fixed to the lesion and the stenosis or the like can be easily expanded.
  • the groove 20 may be near the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is long, but as shown in FIGS. 3 and 4, the center of gravity of the tubular object 10 may be located. It is preferable that the distance from P1 to the inner surface of the tubular object 10 is short in the portion P2. At this time, in determining the portion P2 in which the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short, the depth d1 of the groove portion 20 is set from the center of gravity P1 of the tubular object 10 to the tubular object 10. It shall not be added to the distance to the inner surface of. That is, as shown in FIGS.
  • the groove 20 is located in the portion P2 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short, the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short. Between the inner surface of the tubular object 10 of the portion P2 and the outer surface of the portion of the balloon 1 arranged in the portion P2 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short. It becomes easy to create a gap.
  • the portion of the balloon 1 arranged in the portion P2 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short is pulled toward the center of gravity P1 of the tubular object 10. Therefore, the valley portion 3b of the blade shape portion 3 is likely to be formed, and the folded shape of the balloon 1 can be easily controlled.
  • the balloon 1 has a balloon body 1a and a protrusion 2 formed on the outer surface of the balloon body 1a, and the groove portion is formed before the balloon contraction step. It is preferable to have a projecting portion arranging step of arranging the projecting portion 2 inside the 20.
  • the protrusion 2 is formed on the inner surface of the tubular object 10 when the inside of the balloon 1 is pressurized in the balloon placement step. It is difficult to be pressed against the surface, and the protruding portion 2 can be prevented from being crushed.
  • the protrusion 2 is inserted into the groove 20 by pressurizing the inside of the balloon 1.
  • the balloon 1 Since the balloon 1 has a protrusion 2 on the outer surface, a crack can be formed in a lesion where the protrusion 2 is calcified and hardened, and even if the lesion is a calcified lesion, the balloon 1 is sufficiently lesioned. Can be extended. Further, for example, by expanding the balloon 1 when an ISR lesion or the like occurs, the protrusion 2 is likely to be caught in the new intima which is soft and the surface is slippery, and the position of the balloon 1 is displaced when the ISR lesion or the like is expanded. Hateful.
  • the number of protrusions 2 may be one, but it is preferably plural. That is, it is preferable that a plurality of projecting portions 2 are provided on the outer surface of the balloon 1. When the number of the protrusions 2 is plurality, it becomes easy to crack the lesion portion hardened by calcification. In addition, the position of the balloon 1 can be made less likely to shift with respect to the ISR lesion.
  • the protrusion 2 extends in the perspective direction.
  • the perspective length of the protrusion 2 is preferably shorter than the perspective length of the balloon 1. Since the length of the protrusion 2 in the perspective direction is shorter than the length of the balloon 1 in the perspective direction, there is a portion where the protrusion 2 is not provided in a part of the balloon 1 in the perspective direction, and the balloon 1 is easily bent. .. Therefore, it is possible to improve the insertability of the balloon catheter in a curved blood vessel or the like.
  • the material constituting the protrusion 2 is, for example, a polyolefin resin such as polyvinyl chloride, polyethylene, polypropylene or cyclic polyolefin, a polystyrene resin, a polymethylpentene resin such as poly- (4-methylpentene-1), or a polycarbonate.
  • a polyolefin resin such as polyvinyl chloride, polyethylene, polypropylene or cyclic polyolefin
  • a polystyrene resin a polymethylpentene resin such as poly- (4-methylpentene-1
  • a polycarbonate Based resin, acrylic resin, ABS resin, polyethylene terephthalate, polyester resin such as polyethylene naphthalate, butadiene-styrene copolymer, polyamide elastomer, nylon 6, nylon 6.6, nylon 6/10, nylon 12, etc.
  • the protruding portion 2 may be provided on the outer surface of the balloon 1 by integral molding with the same material as the material constituting the balloon 1, and the material different from the material constituting the balloon 1 may be provided with the balloon 1. May be separately formed and provided on the outer surface of the balloon 1.
  • the protrusion 2 is preferably made of the same material as the balloon body 1a. Since the material constituting the protruding portion 2 and the material constituting the balloon main body 1a are the same, it is possible to increase the joint strength between the balloon main body 1a and the protruding portion 2.
  • the balloon body 1a and the protruding portion 2 are integrally molded products. Since the balloon main body 1a and the protruding portion 2 are integrally molded products, the bonding force between the balloon main body 1a and the protruding portion 2 can be further increased. Further, since the step of joining the protruding portion 2 to the balloon body 1a is not required, the time required for forming the balloon 1 can be shortened and the manufacturing efficiency can be improved.
  • the width W1 of the groove 20 is preferably larger than the width W2 of the protrusion 2. Since the width W1 of the groove 20 is larger than the width W2 of the protrusion 2, it becomes easy to arrange the protrusion 2 inside the groove 20 in the protrusion placement step, and the manufacturing efficiency of the balloon catheter is improved. It becomes possible.
  • the width W1 of the groove portion 20 is preferably 1.1 times or more, more preferably 1.2 times or more, and further preferably 1.3 times or more the width W2 of the protruding portion 2.
  • the upper limit of the ratio between the width W1 of the groove 20 and the width W2 of the protrusion 2 is not particularly limited, but can be, for example, 10 times or less, 7 times or less, 5 times or less.
  • the depth d1 of the groove portion 20 is preferably larger than the height H1 of the protruding portion 2. Since the depth d1 of the groove 20 is larger than the height H1 of the protrusion 2, the protrusion 2 is prevented from being strongly pressed against the inner surface of the tubular object 10 when the inside of the balloon 1 is pressurized, and the protrusion 2 is prevented. Part 2 is less likely to be crushed.
  • the depth d1 of the groove portion 20 is preferably 1.1 times or more, more preferably 1.2 times or more, and further preferably 1.3 times or more the height H1 of the protruding portion 2. ..
  • the upper limit of the ratio between the depth d1 of the groove 20 and the height H1 of the protrusion 2 is not particularly limited, but may be, for example, 10 times or less, 7 times or less, or 5 times or less.
  • the groove portion 20 is located in the portion P2 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short, and the protrusion portion 2 is arranged inside the groove portion 20 before the balloon contraction step. It is preferable to have.
  • the inside of the balloon 1 is depressurized in the balloon contraction step by arranging the protrusion 2 inside the groove 20 in the portion P2 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short.
  • the protrusion 2 can reach the center of gravity P1 of the tubular object 10 earlier than the other balloon 1.
  • the vicinity of the portion where the protruding portion 2 exists becomes the valley portion 3b of the blade-shaped portion 3, and the balloon 1 can be folded while controlling the position of the protruding portion 2.
  • the protruding portion 2 is arranged between the plurality of blade-shaped portions 3, it also has an effect that the protruding portion 2 is not easily crushed when the blade-shaped portion 3 is wound and folded.
  • the number of the protruding portions 2 is a plurality and the number of the groove portions 20 is equal to the number of the protruding portions 2. Since the number of protrusions 2 and the number of grooves 20 are both a plurality and the same number, it is possible to manufacture a balloon catheter having a protrusion 2 capable of sufficiently dilating a narrowed portion of a calcified lesion or an ISR lesion. it can. Further, it is possible to prevent the protruding portion 2 from being crushed by being pressed against the inner surface of the tubular object 10 during the manufacture of the balloon catheter.
  • the balloon 1 has a hydrophilic coating on the outer surface and has a coating removing step of removing the hydrophilic coating on the top of the protrusion 2.
  • a hydrophilic coating to the outer surface of the balloon 1 and removing the hydrophilic coating on the top of the protrusion 2
  • the top of the protrusion 2 has low slipperiness, so that the protrusion 2 can easily be caught in the lesion. Since the outer surface of the balloon 1 excluding the top of the protruding portion 2 is highly slippery due to the hydrophilic coating, it is possible to obtain a balloon catheter that is easy to perform the procedure.
  • the coating removing step is performed after the balloon arranging step, and in the coating removing step, it is preferable that the balloon 1 is slid in the perspective direction so that the outer surface of the protruding portion 2 and the inner surface of the tubular object 10 are brought into contact with each other. .. That is, it is preferable to remove the hydrophilic coating on the outer surface of the protruding portion 2 by sliding the hydrophilic coating applied to the outer surface of the protruding portion 2 while contacting the inner surface of the tubular object 10. ..
  • the coating removing step is performed by sliding the balloon 1 in the perspective direction and bringing the outer surface of the protrusion 2 into contact with the inner surface of the tubular object 10, so that the balloon 1 remains arranged in the tubular object 10. ,
  • the coating removal process can be performed with a simple operation. Therefore, it is possible to improve the manufacturing efficiency of the balloon catheter.
  • the portion in contact with the outer surface of the protruding portion 2 preferably has a higher surface average roughness Rz than the other portions.
  • the surface average roughness Rz of the portion in contact with the outer surface of the protruding portion 2 is higher than the surface average roughness Rz of the other portion, so that the outer surface of the protruding portion 2 While the hydrophilic coating can be removed efficiently, the hydrophilic coating on the outer surface of the balloon 1 excluding the protrusion 2 is difficult to remove. As a result, it is possible to facilitate the manufacture of a balloon catheter in which the slipperiness of the surface of only the protruding portion 2 is reduced.
  • the method for manufacturing a balloon catheter is a method for manufacturing a balloon catheter having a shaft extending in the perspective direction and a balloon provided on the distal side of the shaft, and is a method for manufacturing the balloon catheter in the perspective direction.
  • the tubular object has a portion in which the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short and a portion in which the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long.
  • the distance from the center of gravity of the object to the portion where the distance from the inner surface of the tubular object is short is 50% or more and 95% or less of the distance from the center of gravity of the tubular object to the portion where the distance from the inner surface of the tubular object is long. ..
  • the tubular object is tubular from the center of gravity of the tubular object in the cross section perpendicular to the perspective direction of the tubular object. There is a part where the distance to the inner surface of the object is short and a part where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long, and the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short.
  • the distance to the portion is 50% or more and 95% or less of the distance from the center of gravity of the tubular object to the inner surface of the tubular object to the long portion, so that the blade-shaped portion is formed in the state where the balloon is contracted. It becomes possible to control the position to be formed, the balloon can be neatly folded, and the outer diameter of the folded balloon can be reduced.
  • Balloon 1a Balloon body 2: Protruding part 3: Blade-shaped part 3a: Tip part of blade-shaped part 3b: Valley part of blade-shaped part 10: Cylindrical object 11: Space part 20: Groove part P1: Cylindrical object Center of gravity P2: The part where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short P3: The part where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long D1: From the center of gravity of the tubular object to the cylinder Distance of the part where the distance to the inner surface of the object is short D2: Distance of the part where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long W1: Width of the groove W2: Width of the protrusion d1: Of the groove Depth H1: Height of protrusion

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Manufacturing & Machinery (AREA)
  • Vascular Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

A method for producing a balloon catheter comprises: a cylindrical object preparation step of preparing a cylindrical object (10) having a spatial part (11) extending in a far-near direction therein; a balloon preparation step of preparing a balloon (1); a balloon arrangement step of arranging the balloon (1) in the cylindrical object (10) and pressurizing the inside of the balloon (1) to expand the balloon (1); and a balloon contraction step of depressurizing the inside of the balloon (1) and contracting the balloon (1) to form a blade shape part (3). In a cross section orthogonal to the far-near direction of the cylindrical object (10) in the balloon arrangement step, the cylindrical object (10) has a portion P2 at which a distance from a gravity point P1 of the cylindrical object (10) to an inner surface of the cylindrical object (10) is short and a portion P3 at which a distance from the gravity point P1 of the cylindrical object (10) to the inner surface of the cylindrical object (10) is long. A distance D1 from the gravity point P1 to the portion P2 is 50% or more and 95% or less of the distance D2 from the gravity point P1 to the portion P3.

Description

バルーンカテーテルの製造方法How to manufacture a balloon catheter
　本発明は、バルーンを有するバルーンカテーテルの製造方法に関する。 The present invention relates to a method for manufacturing a balloon catheter having a balloon.
　体内で血液が循環するための流路である血管に狭窄が生じ、血液の循環が滞ることにより、様々な疾患が発生することが知られている。特に、心臓へ血液を供給する冠状動脈に狭窄が生じると、狭心症、心筋梗塞等の重篤な疾病をもたらすおそれがある。このような血管の狭窄部を治療する方法として、ＰＴＡ、ＰＴＣＡといった血管形成術等の、バルーンカテーテルを用いて狭窄部を拡張させる手技がある。血管形成術は、バイパス手術のような開胸術を必要としない低侵襲療法であり、広く行われている。 It is known that various diseases occur due to stenosis of blood vessels, which is a flow path for blood circulation in the body, and stenosis of blood circulation. In particular, stenosis of the coronary artery that supplies blood to the heart may lead to serious diseases such as angina pectoris and myocardial infarction. As a method of treating such a stenotic part of a blood vessel, there is a technique of dilating the stenotic part using a balloon catheter such as angioplasty such as PTA and PTCA. Angioplasty is a minimally invasive therapy that does not require thoracotomy, such as bypass surgery, and is widely practiced.
　通常、バルーンカテーテルは、使用時まで折り畳まれた状態のバルーンを保護しておくために、折り畳まれたバルーンの外径よりも内径が少し大きい円筒形のチューブで形成された保護管をバルーンに被せるという形態が採用されている。バルーンを折り畳む方法としては、例えば、特許文献１～６に記載されているような方法がある。 Normally, a balloon catheter covers the balloon with a protective tube formed of a cylindrical tube whose inner diameter is slightly larger than the outer diameter of the folded balloon in order to protect the folded balloon until use. Is adopted. As a method of folding the balloon, for example, there is a method as described in Patent Documents 1 to 6.
特表２００９－５０５６９１号公報Special Table 2009-505691 特開２０１７－１２６７８号公報Japanese Unexamined Patent Publication No. 2017-12678 国際公開第２０１６／１６３４９５号International Publication No. 2016/163495 特表２０１５－５３２５９８号公報Special Table 2015-532598 特開２０１７－６０６１６号公報JP-A-2017-60616 特開２０１３－１６５９３０号公報Japanese Unexamined Patent Publication No. 2013-165930
　しかし、特許文献１～６に記載されているようなバルーンの折り畳み方法では、外径が小さくなるように綺麗に折り畳むという点で改善の余地があった。なお、折り畳んだ状態のバルーンの外径が大きい場合、保護管にバルーンを挿通させにくくなるといった問題や、バルーンカテーテルの使用時に、保護管からバルーンを取り出した際にバルーンが広がって外径が大きくなりやすく、バルーンカテーテルの血管内の通過性が悪くなってしまうといった問題がある。 However, the balloon folding method as described in Patent Documents 1 to 6 has room for improvement in that it can be neatly folded so that the outer diameter becomes smaller. If the outer diameter of the folded balloon is large, it becomes difficult to insert the balloon into the protective tube, and when using a balloon catheter, the balloon expands when the balloon is taken out from the protective tube and the outer diameter is large. There is a problem that it tends to occur and the passage of the balloon catheter into the blood vessel is deteriorated.
　本発明は、前記の事情に鑑みてなされたものであり、その目的は、バルーンの外径が小さくなるように綺麗に折り畳むことができるバルーンカテーテルの製造方法を提供することにある。 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 that can be neatly folded so that the outer diameter of the balloon becomes smaller.
　前記課題を解決することができたバルーンカテーテルの製造方法は、遠近方向に延在しているシャフトと、シャフトの遠位側に設けられているバルーンと、を有するバルーンカテーテルの製造方法であって、遠近方向に延在する空間部を内部に有する筒状物を準備する筒状物準備工程と、バルーンを準備するバルーン準備工程と、筒状物内にバルーンを配置し、バルーンの内部を加圧してバルーンを膨張させるバルーン配置工程と、バルーンの内部を減圧し、バルーンを収縮させて羽根形状部を形成するバルーン収縮工程と、を有しており、バルーン配置工程での筒状物の遠近方向に垂直な断面において、筒状物は筒状物の重心から筒状物の内側面までの距離が短い部分と、筒状物の重心から筒状物の内側面までの距離が長い部分とを有し、筒状物の重心から筒状物の内側面までの距離が短い部分までの距離は、筒状物の重心から筒状物の内側面までの距離が長い部分までの距離の５０％以上９５％以下であることを特徴とするものである。 The method for manufacturing a balloon catheter that has been able to solve the above problems is a method for manufacturing a balloon catheter having a shaft extending in the perspective direction and a balloon provided on the distal side of the shaft. , A tubular object preparation step that prepares a tubular object that has a space extending in the perspective direction inside, a balloon preparation step that prepares a balloon, and a balloon is placed inside the tubular object to add the inside of the balloon. It has a balloon placement step of pressing to inflate the balloon and a balloon contraction step of depressurizing the inside of the balloon and contracting the balloon to form a wing-shaped portion, and has a perspective of a tubular object in the balloon placement step. In the cross section perpendicular to the direction, the tubular object has a portion where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short and a portion where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long. The distance from the center of gravity of the tubular object to the portion where the distance from the inner surface of the tubular object is short is 50, which is the distance from the center of gravity of the tubular object to the portion where the distance from the inner surface of the tubular object is long. It is characterized by being% or more and 95% or less.
　本発明のバルーンカテーテルの製造方法は、バルーン収縮工程において、筒状物の重心から筒状物の内側面までの距離が長い部分に位置しているバルーンの部分が羽根形状部の先端部となり、筒状物の重心から筒状物の内側面までの距離が短い部分に位置しているバルーンの部分が隣接する複数の羽根形状部の間の谷部となることが好ましい。 In the method for manufacturing a balloon catheter of the present invention, in the balloon contraction step, the portion of the balloon located at a portion where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long becomes the tip of the blade-shaped portion. It is preferable that the portion of the balloon located at the portion where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short is a valley portion between a plurality of adjacent blade-shaped portions.
　本発明のバルーンカテーテルの製造方法において、筒状物は遠近方向に延在する溝部を内部に有していることが好ましい。 In the method for manufacturing a balloon catheter of the present invention, it is preferable that the tubular object has a groove portion extending in the perspective direction inside.
　本発明のバルーンカテーテルの製造方法において、溝部は筒状物の重心から筒状物の内側面までの距離が短い部分にあることが好ましい。 In the method for manufacturing a balloon catheter of the present invention, it is preferable that the groove portion is located in a portion where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short.
　本発明のバルーンカテーテルの製造方法において、バルーンはバルーン本体と、該バルーン本体の外側面に形成されている突出部と、を有しており、バルーン収縮工程の前に、溝部の内部に突出部を配置する突出部配置工程を有していることが好ましい。 In the method for manufacturing a balloon catheter of the present invention, the balloon has a balloon body and a protrusion formed on the outer surface of the balloon body, and the protrusion is formed inside the groove before the balloon contraction step. It is preferable to have a projecting portion arranging step for arranging.
　本発明のバルーンカテーテルの製造方法において、突出部はバルーン本体と同一材料から構成されていることが好ましい。 In the method for manufacturing a balloon catheter of the present invention, it is preferable that the protruding portion is made of the same material as the balloon body.
　本発明のバルーンカテーテルの製造方法において、突出部の数は複数であり、溝部の数は突出部の数と等しいことが好ましい。 In the method for manufacturing a balloon catheter of the present invention, it is preferable that the number of protrusions is a plurality and the number of grooves is equal to the number of protrusions.
　本発明のバルーンカテーテルの製造方法において、バルーンは外表面に親水性コーティングが施されており、突出部の頂部の親水性コーティングを除去するコーティング除去工程を有することが好ましい。 In the method for manufacturing a balloon catheter of the present invention, it is preferable that the balloon has a hydrophilic coating on the outer surface and has a coating removing step of removing the hydrophilic coating on the top of the protrusion.
　本発明のバルーンカテーテルの製造方法において、コーティング除去工程はバルーン配置工程の後に行っており、コーティング除去工程において、バルーンを遠近方向に摺動させ、突出部の外表面と前記筒状物の内表面とを接触させていることが好ましい。 In the method for manufacturing a balloon catheter of the present invention, the coating removing step is performed after the balloon placement step, and in the coating removing step, the balloon is slid in the perspective direction, and the outer surface of the protruding portion and the inner surface of the tubular object are formed. It is preferable that they are in contact with each other.
　本発明のバルーンカテーテルの製造方法によれば、筒状物内にバルーンを配置し、バルーンの内部を加圧してバルーンを膨張させるバルーン配置工程での筒状物の遠近方向に垂直な断面において、筒状物は筒状物の重心から筒状物の内側面までの距離が短い部分と、筒状物の重心から筒状物の内側面までの距離が長い部分があり、筒状物の重心から筒状物の内側面までの距離が短い部分までの距離は筒状物の重心から筒状物の内側面までの距離が長い部分までの距離の５０％以上９５％以下であることにより、バルーンを収縮させた状態において羽根形状部が形成される位置を制御することが可能となり、バルーンを綺麗に折り畳むことができ、折り畳まれた状態のバルーンの外径を小さくすることができる。 According to the method for manufacturing a balloon catheter of the present invention, in a cross section perpendicular to the perspective direction of the tubular object in the balloon arrangement step of arranging the balloon in the tubular object and pressurizing the inside of the balloon to inflate the balloon. The tubular object has a part where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short and a part where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long. The distance from the to the portion where the distance from the inner surface of the tubular object is short is 50% or more and 95% or less of the distance from the center of gravity of the tubular object to the portion where the distance from the inner surface of the tubular object is long. It is possible to control the position where the blade-shaped portion is formed in the state where the balloon is contracted, the balloon can be neatly folded, and the outer diameter of the folded balloon can be reduced.
本発明の実施の形態における製造方法のバルーン配置工程での筒状物の遠近方向に垂直な断面図を表す。A cross-sectional view perpendicular to the perspective direction of a tubular object in the balloon arranging step of the manufacturing method according to the embodiment of the present invention is shown. 本発明の実施の形態における製造方法のバルーン収縮工程での筒状物の遠近方向に垂直な断面図を表す。A cross-sectional view perpendicular to the perspective direction of a tubular object in the balloon contraction step of the manufacturing method according to the embodiment of the present invention is shown. 本発明の他の実施の形態における製造方法のバルーン配置工程での筒状物の遠近方向に垂直な断面図を表す。A cross-sectional view perpendicular to the perspective direction of a tubular object in the balloon arranging step of the manufacturing method according to another embodiment of the present invention is shown. 本発明の他の実施の形態における製造方法のバルーン収縮工程での筒状物の遠近方向に垂直な断面図を表す。A cross-sectional view perpendicular to the perspective direction of a tubular object in the balloon contraction step of the manufacturing method according to another embodiment of the present invention is shown. 本発明のさらに他の実施の形態における製造方法のバルーン配置工程での筒状物の遠近方向に垂直な断面図を表す。A cross-sectional view perpendicular to the perspective direction of a tubular object in the balloon arranging step of the manufacturing method according to still another embodiment of the present invention is shown. 本発明のさらに他の実施の形態における製造方法のバルーン収縮工程での筒状物の遠近方向に垂直な断面図を表す。A cross-sectional view perpendicular to the perspective direction of a tubular object in the balloon contraction step of the manufacturing method according to still another embodiment of the present invention is shown.
　以下、下記実施の形態に基づき本発明をより具体的に説明するが、本発明はもとより下記実施の形態によって制限を受けるものではなく、前・後記の趣旨に適合し得る範囲で適当に変更を加えて実施することも勿論可能であり、それらはいずれも本発明の技術的範囲に包含される。なお、各図面において、便宜上、ハッチングや部材符号等を省略する場合もあるが、かかる場合、明細書や他の図面を参照するものとする。また、図面における種々部材の寸法は、本発明の特徴の理解に資することを優先しているため、実際の寸法とは異なる場合がある。 Hereinafter, the present invention will be described in more detail based on the following embodiments, but the present invention is not limited by the following embodiments as well as the present invention, and appropriate changes are made to the extent that it can be adapted to the purpose of the above and the following. In addition, it is of course possible to carry out, and all of them are included in the technical scope of the present invention. In each drawing, hatching, member reference numerals, and the like may be omitted for convenience, but in such cases, the specification and other drawings shall be referred to. Further, the dimensions of the various members in the drawings may differ from the actual dimensions because the priority is given to contributing to the understanding of the features of the present invention.
　図１は本発明の実施の形態におけるバルーンカテーテルの製造方法のバルーン配置工程での断面図を表し、図２はバルーン収縮工程での断面図を表す。バルーンカテーテルの製造方法は、遠近方向に延在しているシャフトと、シャフトの遠位側に設けられているバルーン１と、を有するバルーンカテーテルの製造方法であって、遠近方向に延在する空間部１１を内部に有する筒状物１０を準備する筒状物準備工程と、バルーン１を準備するバルーン準備工程と、筒状物１０内にバルーン１を配置し、バルーン１の内部を加圧してバルーン１を膨張させるバルーン配置工程と、バルーン１の内部を減圧し、バルーン１を収縮させて羽根形状部３を形成するバルーン収縮工程と、を有している。 FIG. 1 shows a cross-sectional view in the balloon placement step of the method for manufacturing a balloon catheter according to the embodiment of the present invention, and FIG. 2 shows a cross-sectional view in the balloon contraction step. The method for manufacturing a balloon catheter is a method for manufacturing a balloon catheter having a shaft extending in the perspective direction and a balloon 1 provided on the distal side of the shaft, and is a space extending in the perspective direction. A tubular object preparation step of preparing a tubular object 10 having a portion 11 inside, a balloon preparation step of preparing a balloon 1, and a balloon 1 being arranged in the tubular object 10 to pressurize the inside of the balloon 1. It has a balloon arranging step of inflating the balloon 1 and a balloon contraction step of depressurizing the inside of the balloon 1 and contracting the balloon 1 to form a blade-shaped portion 3.
　本発明において、遠位側とはバルーン１の延在方向に対して処置対象者側の方向を指し、近位側とは遠位側の反対側、すなわちバルーン１の延在方向に対して使用者、つまり術者の手元側の方向を指す。また、バルーン１の近位側から遠位側への方向を遠近方向と称する。 In the present invention, the distal side refers to the direction of the treatment subject with respect to the extending direction of the balloon 1, and the proximal side is used with respect to the opposite side of the distal side, that is, the extending direction of the balloon 1. The person, that is, the direction of the operator's hand. Further, the direction from the proximal side to the distal side of the balloon 1 is referred to as a perspective direction.
　バルーンカテーテルは、シャフトを通じてバルーン１の内部に流体が供給されるように構成され、インデフレーター（バルーン用加圧器）を用いてバルーン１の拡張および収縮を制御することができる。流体は、ポンプ等によって加圧した圧力流体であってもよい。 The balloon catheter is configured so that fluid is supplied to the inside of the balloon 1 through a shaft, and the expansion and contraction of the balloon 1 can be controlled by using an indeflator (balloon pressurizer). The fluid may be a pressure fluid pressurized by a pump or the like.
　シャフトは、遠近方向に延在しており、内部に流体の流路が設けられている。また、シャフトは、内部にガイドワイヤの挿通路を有していることが好ましい。シャフトが内部に流体の流路およびガイドワイヤの挿通路を有する構成とするには、例えば、シャフトが外側チューブと内側チューブとを有しており、内側チューブがガイドワイヤの挿通路として機能し、内側チューブと外側チューブの間の空間が流体の流路として機能することが挙げられる。シャフトが外側チューブと内側チューブとを有している場合、内側チューブが外側チューブの遠位端から延出してバルーン１を遠近方向に貫通し、バルーン１の遠位側が内側チューブに接合され、バルーン１の近位側が外側チューブと接合されることが好ましい。 The shaft extends in the perspective direction, and a fluid flow path is provided inside. Further, it is preferable that the shaft has a guide wire insertion passage inside. To configure the shaft to have a fluid flow path and a guide wire insertion passage inside, for example, the shaft has an outer tube and an inner tube, and the inner tube functions as a guide wire insertion passage. The space between the inner tube and the outer tube functions as a fluid flow path. When the shaft has an outer tube and an inner tube, the inner tube extends from the distal end of the outer tube and penetrates the balloon 1 in the perspective direction, the distal side of the balloon 1 is joined to the inner tube, and the balloon It is preferable that the proximal side of 1 is joined to the outer tube.
　本発明は、シャフトの遠位側から近位側にわたってワイヤを挿通する、所謂オーバーザワイヤ型のバルーンカテーテルと、シャフトの遠位側から近位側に至る途中までワイヤを挿通する、所謂ラピッドエクスチェンジ型のバルーンカテーテルのいずれにも適用することができる。図示していないが、バルーンカテーテルがオーバーザワイヤ型である場合、シャフトに流体を送り込むために、シャフトの近位側にハブを有していてもよい。ハブは、バルーン１の内部に供給される流体の流路と連通した流体注入部と、ガイドワイヤの挿通路と連通したガイドワイヤ挿入部を有することが好ましい。バルーンカテーテルが流体注入部とガイドワイヤ挿入部を備えるハブを有していることにより、バルーン１の内部に流体を供給してバルーン１を拡張および収縮させる操作や、ガイドワイヤに沿ってバルーンカテーテルを処置対象部位へ送り込む操作を容易に行いやすくなる。 The present invention is a so-called over-the-wire type balloon catheter in which a wire is inserted from the distal side to the proximal side of the shaft, and a so-called rapid exchange type in which the wire is inserted halfway from the distal side to the proximal side of the shaft. It can be applied to any of the balloon catheters of. Although not shown, if the balloon catheter is of the over-the-wire type, it may have a hub on the proximal side of the shaft to deliver fluid to the shaft. The hub preferably has a fluid injection portion communicating with the fluid flow path supplied to the inside of the balloon 1 and a guide wire insertion portion communicating with the guide wire insertion passage. Since the balloon catheter has a hub having a fluid injection part and a guide wire insertion part, the operation of supplying fluid to the inside of the balloon 1 to expand and contract the balloon 1 and the balloon catheter along the guide wire can be operated. The operation of sending to the treatment target site becomes easy.
　シャフトとハブとの接合は、例えば、接着剤による接着、溶着等が挙げられる。中でも、シャフトとハブは、接着によって接合されていることが好ましい。シャフトとハブとが接着されていることにより、例えば、シャフトは柔軟性の高い材料から構成され、ハブは剛性の高い材料から構成されている等、シャフトを構成する材料とハブを構成する材料とが異なっている場合に、シャフトとハブとの接合強度を高めることができる。その結果、バルーンカテーテルの耐久性を高めることが可能となる。 The joining between the shaft and the hub includes, for example, adhesion with an adhesive, welding, and the like. Above all, it is preferable that the shaft and the hub are joined by adhesion. By adhering the shaft and the hub, for example, the shaft is made of a highly flexible material and the hub is made of a highly rigid material. When they are different, the joint strength between the shaft and the hub can be increased. As a result, it becomes possible to increase the durability of the balloon catheter.
　シャフトを構成する材料は、例えば、ポリアミド系樹脂、ポリエステル系樹脂、ポリウレタン系樹脂、ポリオレフィン系樹脂、フッ素系樹脂、塩化ビニル系樹脂、シリコーン系樹脂、天然ゴム等が挙げられる。これらは１種のみを用いてもよく、２種以上を併用してもよい。中でも、シャフトを構成する材料は、ポリアミド系樹脂、ポリオレフィン系樹脂、およびフッ素系樹脂の少なくとも１つであることが好ましい。シャフトを構成する材料がポリアミド系樹脂、ポリオレフィン系樹脂、およびフッ素系樹脂の少なくとも１つであることにより、シャフトの表面の滑り性を高め、バルーンカテーテルの血管への挿通性を向上させることができる。 Examples of the material constituting the shaft include polyamide-based resin, polyester-based resin, polyurethane-based resin, polyolefin-based resin, fluorine-based resin, vinyl chloride-based resin, silicone-based resin, and natural rubber. Only one of these may be used, or two or more thereof may be used in combination. Above all, the material constituting the shaft is preferably at least one of a polyamide resin, a polyolefin resin, and a fluorine resin. When the material constituting the shaft is at least one of a polyamide resin, a polyolefin resin, and a fluorine resin, the slipperiness of the surface of the shaft can be improved and the insertability of the balloon catheter into a blood vessel can be improved. ..
　バルーン１は、シャフトの遠位側に設けられている。バルーン１とシャフトとの接合は、接着剤による接着、溶着、バルーン１の端部とシャフトとが重なっている箇所にリング状の部材を取り付けてかしめること等が挙げられる。中でも、バルーン１とシャフトは、溶着によって接合されていることが好ましい。バルーン１とシャフトとが溶着されていることにより、バルーン１を繰り返し拡張および収縮させてもバルーン１とシャフトとの接合が解除されにくくなる。そのため、バルーン１とシャフトの接合強度を容易に高めることができる。 Balloon 1 is provided on the distal side of the shaft. The joining between the balloon 1 and the shaft includes adhesion and welding with an adhesive, and caulking by attaching a ring-shaped member to a portion where the end of the balloon 1 and the shaft overlap. Above all, it is preferable that the balloon 1 and the shaft are joined by welding. Since the balloon 1 and the shaft are welded together, it becomes difficult to release the joint between the balloon 1 and the shaft even if the balloon 1 is repeatedly expanded and contracted. Therefore, the joint strength between the balloon 1 and the shaft can be easily increased.
　バルーン１は、直管部、直管部の近位側に接続される近位側テーパー部、および直管部の遠位側に接続される遠位側テーパー部を有することが好ましい。近位側テーパー部および遠位側テーパー部は、直管部から離れるにつれて縮径するように形成されていることが好ましい。バルーン１が直管部を有していることにより、直管部が狭窄部と十分に接触して狭窄部の拡張が行いやすくなる。さらに、バルーン１が直管部から離れるにつれて外径が小さくなる近位側テーパー部および遠位側テーパー部を有していることにより、バルーン１を収縮させてシャフトに巻き付けた際に、バルーン１の遠位端部および近位端部の外径を小さくして、シャフトとバルーン１との段差を小さくすることができる。そのため、バルーン１を遠近方向に挿通させやすくなる。なお、本発明においては、膨張可能な部分をバルーン１と見なす。 The balloon 1 preferably has a straight pipe portion, a proximal taper portion connected to the proximal side of the straight pipe portion, and a distal taper portion connected to the distal side of the straight pipe portion. It is preferable that the proximal taper portion and the distal taper portion are formed so as to reduce the diameter as the distance from the straight pipe portion increases. Since the balloon 1 has a straight tube portion, the straight tube portion is sufficiently in contact with the narrowed portion, and the narrowed portion can be easily expanded. Further, since the balloon 1 has a proximal taper portion and a distal taper portion whose outer diameter becomes smaller as the distance from the straight tube portion is increased, the balloon 1 is contracted and wound around the shaft. The outer diameters of the distal end and the proximal end of the balloon can be reduced to reduce the step between the shaft and the balloon 1. Therefore, it becomes easy to insert the balloon 1 in the perspective direction. In the present invention, the inflatable portion is regarded as the balloon 1.
　バルーン１を構成する材料は、例えば、ポリエチレン、ポリプロピレン、エチレン－プロピレン共重合体等のポリオレフィン系樹脂、ポリエチレンテレフタレート、ポリエステルエラストマー等のポリエステル系樹脂、ポリウレタン、ポリウレタンエラストマー等のポリウレタン系樹脂、ポリフェニレンサルファイド系樹脂、ポリアミドエラストマー、ナイロン６、ナイロン６・６、ナイロン６・１０、ナイロン１２等のポリアミド系樹脂、フッ素系樹脂、シリコーン系樹脂、ラテックスゴム等の天然ゴム等が挙げられる。これらは１種のみを用いてもよく、２種以上を併用してもよい。バルーン１を構成する材料は、中でも、ポリアミド系樹脂であることが好ましく、ナイロン１２であることがより好ましい。バルーン１を構成する材料がポリアミド系樹脂であることにより、バルーン１の柔軟性を高めることが可能となる。 The material constituting the balloon 1 is, for example, a polyolefin resin such as polyethylene, polypropylene or an ethylene-propylene copolymer, a polyester resin such as polyethylene terephthalate or a polyester elastomer, a polyurethane resin such as polyurethane or a polyurethane elastomer, or a polyphenylene sulfide type. Examples thereof include polyamide resins such as resins, polyamide elastomers, nylon 6, nylon 6/6, nylon 6/10 and nylon 12, and natural rubbers such as fluororesins, silicone resins and latex rubbers. Only one of these may be used, or two or more thereof may be used in combination. The material constituting the balloon 1 is preferably a polyamide resin, and more preferably nylon 12. Since the material constituting the balloon 1 is a polyamide resin, the flexibility of the balloon 1 can be increased.
　バルーン１の外径は、０．５ｍｍ以上であることが好ましく、１ｍｍ以上であることがより好ましく、１．５ｍｍ以上であることがさらに好ましい。バルーン１の外径の下限値を上記の範囲に設定することにより、血管内の狭窄部を十分に拡張することができる。また、バルーン１の外径は、３５ｍｍ以下であることが好ましく、３０ｍｍ以下であることがより好ましく、２５ｍｍ以下であることがさらに好ましい。バルーン１の外径の上限値を上記の範囲に設定することにより、バルーン１の外径が過度に大きくなることを防止することができる。 The outer diameter of the balloon 1 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 1 to the above range, the narrowed portion in the blood vessel can be sufficiently expanded. The outer diameter of the balloon 1 is preferably 35 mm or less, more preferably 30 mm or less, and even more preferably 25 mm or less. By setting the upper limit value of the outer diameter of the balloon 1 in the above range, it is possible to prevent the outer diameter of the balloon 1 from becoming excessively large.
　バルーン１の遠近方向の長さは、５ｍｍ以上であることが好ましく、１０ｍｍ以上であることがより好ましく、１５ｍｍ以上であることがさらに好ましい。バルーン１の遠近方向の長さの下限値を上記の範囲に設定することにより、一度に拡張できる狭窄部の面積を大きくして手技にかかる時間を短縮することが可能となる。また、バルーン１の遠近方向の長さは、３００ｍｍ以下であることが好ましく、２００ｍｍ以下であることがより好ましく、１００ｍｍ以下であることがさらに好ましい。バルーン１の遠近方向の長さの上限値を上記の範囲に設定することにより、狭窄部の拡張のためにバルーン１の内部に送り込む流体の量を減らし、バルーン１を十分に拡張させるために必要な時間を短くすることができる。 The length of the balloon 1 in the perspective direction is preferably 5 mm or more, more preferably 10 mm or more, and further preferably 15 mm or more. By setting the lower limit of the length of the balloon 1 in the perspective direction within the above range, it is possible to increase the area of the constricted portion that can be expanded at one time and shorten the time required for the procedure. The length of the balloon 1 in the perspective direction is preferably 300 mm or less, more preferably 200 mm or less, and further preferably 100 mm or less. By setting the upper limit of the perspective length of the balloon 1 in the above range, it is necessary to reduce the amount of fluid sent into the balloon 1 for the expansion of the stenosis and to sufficiently expand the balloon 1. Time can be shortened.
　バルーン１の厚みは、５μｍ以上であることが好ましく、７μｍ以上であることがより好ましく、１０μｍ以上であることがさらに好ましい。バルーン１の厚みの下限値を上記の範囲に設定することにより、バルーン１の強度を高めて狭窄部を十分に拡張することができる。また、バルーン１の厚みの上限値は、バルーンカテーテルの用途に応じて設定することができ、例えば、１００μｍ以下、９０μｍ以下、８０μｍ以下とすることができる。 The thickness of the balloon 1 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 1 in the above range, the strength of the balloon 1 can be increased and the narrowed portion can be sufficiently expanded. The upper limit of the thickness of the balloon 1 can be set according to the application of the balloon catheter, and can be, for example, 100 μm or less, 90 μm or less, and 80 μm or less.
　筒状物準備工程において、遠近方向に延在する空間部１１を内部に有する筒状物１０を準備する。筒状物１０が内部に有している空間部１１には、バルーン１を配置することができる。 In the tubular object preparation step, a tubular object 10 having a space portion 11 extending in the perspective direction is prepared. The balloon 1 can be arranged in the space portion 11 that the tubular object 10 has inside.
　筒状物１０を構成する材料は、例えば、ポリカーボネート系樹脂、ポリアセタール系樹脂、フッ素系樹脂等の合成樹脂、鉄、銅、ステンレス等の金属等が挙げられる。中でも、筒状物１０を構成する材料は、金属であることが好ましい。筒状物１０を構成する材料が金属であることによって筒状物１０の強度が高まり、バルーン配置工程においてバルーン１の内部に加える圧力を高くすることが可能となる。 Examples of the material constituting the tubular object 10 include synthetic resins such as polycarbonate resin, polyacetal resin and fluororesin, and metals such as iron, copper and stainless steel. Above all, the material constituting the tubular object 10 is preferably metal. Since the material constituting the tubular object 10 is metal, the strength of the tubular object 10 is increased, and the pressure applied to the inside of the balloon 1 in the balloon arranging step can be increased.
　バルーン準備工程において、バルーン１を準備する。その後、図１に示すように、バルーン配置工程において、筒状物１０内にバルーン１を配置し、バルーン１の内部を加圧してバルーン１を膨張させる。 In the balloon preparation process, prepare the balloon 1. After that, as shown in FIG. 1, in the balloon arranging step, the balloon 1 is arranged in the tubular object 10, and the inside of the balloon 1 is pressurized to inflate the balloon 1.
　バルーン１の内部を加圧する方法としては、例えば、空気、窒素ガス等の気体や、純水、生理食塩水等の液体といった流体をバルーン１の内部に供給すること等が挙げられる。流体を加圧するには、例えば、ポンプ等を用いることができる。 Examples of the method of pressurizing the inside of the balloon 1 include supplying a fluid such as a gas such as air or nitrogen gas or a liquid such as pure water or physiological saline to the inside of the balloon 1. To pressurize the fluid, for example, a pump or the like can be used.
　バルーン配置工程において、筒状物１０内にてバルーン１の内部を加圧してバルーン１を膨張させた際に、バルーン１の外表面の少なくとも一部が空間部１１の内表面に接していることが好ましい。バルーン配置工程において、バルーン１の外表面の少なくとも一部が空間部１１の内表面に接していることにより、バルーン配置工程の後に行うバルーン収縮工程において、羽根形状部３を形成しやすくなる。羽根形状部３の形成は、筒状物１０の内部形状である空間部１１の形状や、バルーン１を構成する材料やバルーン１の膨張率等に影響される。例えば、筒状物１０の遠近方向に垂直な断面において、筒状物１０の空間部１１の内周長は、バルーン１の外周長の１．５倍以下であることが好ましく、１．３倍以下であることがより好ましく、１．２倍以下であることがさらに好ましく、また、０．２倍以上であることが好ましく、０．３倍以上であることがより好ましく、０．５倍以上であることがさらに好ましい。筒状物１０の空間部１１の内周長とバルーン１の外周長との比率の上限値および下限値を上記の範囲に設定することにより、バルーン１が空間部１１に沿いやすくなる。その結果、羽根形状部３の形成が容易となる。 In the balloon arranging step, when the inside of the balloon 1 is pressurized in the tubular object 10 to inflate the balloon 1, at least a part of the outer surface of the balloon 1 is in contact with the inner surface of the space portion 11. Is preferable. In the balloon arranging step, at least a part of the outer surface of the balloon 1 is in contact with the inner surface of the space portion 11, so that the blade-shaped portion 3 can be easily formed in the balloon contraction step performed after the balloon arranging step. The formation of the blade-shaped portion 3 is affected by the shape of the space portion 11 which is the internal shape of the tubular object 10, the material constituting the balloon 1, the expansion rate of the balloon 1, and the like. For example, in a cross section perpendicular to the perspective direction of the tubular object 10, the inner peripheral length of the space portion 11 of the tubular object 10 is preferably 1.5 times or less, preferably 1.3 times or less the outer peripheral length of the balloon 1. It is more preferably less than or equal to, more preferably 1.2 times or less, further preferably 0.2 times or more, more preferably 0.3 times or more, and 0.5 times or more. Is more preferable. By setting the upper limit value and the lower limit value of the ratio of the inner peripheral length of the space portion 11 of the tubular object 10 to the outer peripheral length of the balloon 1 within the above range, the balloon 1 can easily follow the space portion 11. As a result, the blade-shaped portion 3 can be easily formed.
　図１に示すように、バルーン配置工程での、筒状物１０の遠近方向に垂直な断面において、筒状物１０は、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２と、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３とを有しており、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２までの距離Ｄ１は、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３までの距離Ｄ２の５０％以上９５％以下である。 As shown in FIG. 1, in the cross section perpendicular to the perspective direction of the tubular object 10 in the balloon arrangement step, the tubular object 10 is the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10. Has a short portion P2 and a portion P3 having a long distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10, and the inner surface of the tubular object 10 from the center of gravity P1 of the tubular object 10 The distance D1 to the portion P2 having a short distance is 50% or more and 95% or less of the distance D2 to the portion P3 having a long distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10.
　図２に示すように、バルーン配置工程の後に、バルーン１の内部を減圧し、バルーン１を収縮させて羽根形状部３を形成するバルーン収縮工程を行う。羽根形状部３は、バルーン１が収縮している状態において、バルーン１の内表面の少なくとも一部同士が接している部分を指す。 As shown in FIG. 2, after the balloon placement step, a balloon contraction step is performed in which the inside of the balloon 1 is depressurized and the balloon 1 is contracted to form the blade-shaped portion 3. The blade-shaped portion 3 refers to a portion where at least a part of the inner surface of the balloon 1 is in contact with each other in a state where the balloon 1 is contracted.
　バルーン配置工程において、筒状物１０が、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２と、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３とを有し、かつ、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２までの距離Ｄ１は、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３までの距離Ｄ２の５０％以上９５％以下であることにより、バルーン収縮工程にてバルーン１の内部を減圧した際に、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２に配置されているバルーン１の部分が、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３に配置されているバルーン１の部分よりも先に筒状物１０の重心Ｐ１に到達しやすくなる。この時点で筒状物１０の重心Ｐ１に到達していないバルーン１の部分が羽根形状部３となる。つまり、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３に配置されているバルーン１の部分が羽根形状部３を形成することとなる。そのため、バルーン１の羽根形状部３の位置を制御することができ、バルーン１の外径が小さくなるように綺麗に折り畳むことが可能となる。 In the balloon arranging step, the tubular object 10 has a portion P2 in which the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short, and the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10. The distance D1 from the center of gravity P1 of the tubular object 10 to the portion P2 having a short distance to the inner surface of the tubular object 10 is from the center of gravity P1 of the tubular object 10. Since the distance to the inner surface of the tubular object 10 is 50% or more and 95% or less of the distance D2 to the portion P3, when the inside of the balloon 1 is depressurized in the balloon contraction step, the tubular object 10 The portion of the balloon 1 arranged in the portion P2 where the distance from the center of gravity P1 to the inner surface of the tubular object 10 is short is the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is long. It becomes easier to reach the center of gravity P1 of the tubular object 10 before the portion of the balloon 1 arranged in. At this point, the portion of the balloon 1 that has not reached the center of gravity P1 of the tubular object 10 becomes the blade-shaped portion 3. That is, the portion of the balloon 1 arranged in the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner side surface of the tubular object 10 is long forms the blade-shaped portion 3. Therefore, the position of the blade-shaped portion 3 of the balloon 1 can be controlled, and the balloon 1 can be neatly folded so that the outer diameter becomes smaller.
　バルーン配置工程における筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２までの距離Ｄ１は、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３までの距離Ｄ２の５０％以上であればよいが、５５％以上であることが好ましく、６０％以上であることがより好ましく、６５％以上であることがさらに好ましい。筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２までの距離Ｄ１と、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３までの距離Ｄ２との比率の下限値を上記の範囲に設定することにより、筒状物１０の内部にバルーン１を配置する工程が行いやすくなる。その結果、バルーンカテーテルの生産効率を高めることができる。また、バルーン配置工程における筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２までの距離Ｄ１は、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３までの距離Ｄ２の９５％以下であればよいが、９０％以下であることが好ましく、８５％以下であることがより好ましく、８０％以下であることがさらに好ましい。筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２までの距離Ｄ１と、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３までの距離Ｄ２との比率の上限値を上記の範囲に設定することにより、バルーン収縮工程において羽根形状部３が安定して形成されやすくなる。そのため、バルーン１を綺麗に折り畳みやすくなる。 The distance D1 from the center of gravity P1 of the tubular object 10 to the portion P2 where the distance from the inner surface of the tubular object 10 is short in the balloon arrangement step is the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10. It may be 50% or more of the distance D2 to the long portion P3, but it is preferably 55% or more, more preferably 60% or more, and further preferably 65% or more. The distance D1 from the center of gravity P1 of the tubular object 10 to the portion P2 where the distance from the inner surface of the tubular object 10 is short, and the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is long. By setting the lower limit of the ratio to the distance D2 to the above range, the step of arranging the balloon 1 inside the tubular object 10 becomes easy. As a result, the production efficiency of the balloon catheter can be increased. Further, the distance D1 from the center of gravity P1 of the tubular object 10 to the portion P2 where the distance from the inner surface of the tubular object 10 is short in the balloon arrangement step is from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10. It may be 95% or less of the distance D2 to the portion P3 where the distance is long, but it is preferably 90% or less, more preferably 85% or less, and further preferably 80% or less. The distance D1 from the center of gravity P1 of the tubular object 10 to the portion P2 where the distance from the inner surface of the tubular object 10 is short, and the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is long. By setting the upper limit of the ratio to the distance D2 to the above range, the blade-shaped portion 3 can be easily formed stably in the balloon contraction step. Therefore, the balloon 1 can be easily folded neatly.
　バルーン収縮工程におけるバルーン１の内部を減圧する時間は、バルーン配置工程におけるバルーン１の内部を加圧する時間よりも短いことが好ましい。バルーン収縮工程においてバルーン１の内部を減圧して収縮させる時間を、バルーン１の内部を加圧して膨張させる時間よりも短くすることにより、羽根形状部３や羽根形状部３以外のバルーン１の外表面にシワや弛みが発生しにくく、綺麗にバルーン１を折り畳むことが可能となる。 The time for depressurizing the inside of the balloon 1 in the balloon contraction step is preferably shorter than the time for pressurizing the inside of the balloon 1 in the balloon placement step. By making the time for depressurizing and contracting the inside of the balloon 1 shorter than the time for pressurizing and expanding the inside of the balloon 1 in the balloon contraction step, the outside of the balloon 1 other than the blade-shaped portion 3 and the blade-shaped portion 3 Wrinkles and slack are less likely to occur on the surface, and the balloon 1 can be folded neatly.
　図２に示すように、バルーン収縮工程において形成する羽根形状部３の数は、１つであってもよいが複数であることが好ましい。バルーン収縮工程にて形成する羽根形状部３の数が複数であることにより、羽根形状部３の長さが過度に長くなりにくくなる。そのため、バルーン１を綺麗に折り畳みやすくなる。 As shown in FIG. 2, the number of the blade-shaped portions 3 formed in the balloon contraction step may be one, but is preferably a plurality. Since the number of the blade-shaped portions 3 formed in the balloon contraction step is a plurality, the length of the blade-shaped portions 3 is less likely to be excessively long. Therefore, the balloon 1 can be easily folded neatly.
　図１および図２に示すように、バルーン１の配置工程において、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３に位置しているバルーン１の部分が羽根形状部３の先端部３ａとなり、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２に位置しているバルーン１の部分が隣接する複数の羽根形状部３の間の谷部３ｂとなることが好ましい。筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３に位置しているバルーン１の部分が羽根形状部３の先端部３ａとなって、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２に位置しているバルーン１の部分が羽根形状部３の谷部３ｂとなることにより、バルーン１の羽根形状部３の先端部３ａおよび谷部３ｂの位置を制御することが可能となる。そのため、バルーン１をより綺麗に折り畳むことができ、バルーン１のさらなる小径化を図ることができる。 As shown in FIGS. 1 and 2, in the process of arranging the balloon 1, the portion of the balloon 1 located at the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is long is the blade. The tip portion 3a of the shape portion 3, and the portion of the balloon 1 located at the portion P2 where the distance from the center of gravity P1 of the tubular object 10 to the inner side surface of the tubular object 10 is short is adjacent to the plurality of blade-shaped portions 3. It is preferable that the valley portion 3b is between them. The portion of the balloon 1 located at the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is long becomes the tip portion 3a of the blade-shaped portion 3, and the center of gravity of the tubular object 10 The portion of the balloon 1 located at the portion P2 where the distance from P1 to the inner surface of the tubular object 10 is short becomes the valley portion 3b of the blade-shaped portion 3, so that the tip portion 3a of the blade-shaped portion 3 of the balloon 1 is formed. And the position of the valley 3b can be controlled. Therefore, the balloon 1 can be folded more neatly, and the diameter of the balloon 1 can be further reduced.
　図３は本発明の他の実施の形態におけるバルーンカテーテルの製造方法のバルーン配置工程での断面図を表し、図４はバルーン収縮工程での断面図を表す。図３および図４に示すように、筒状物１０は、遠近方向に延在する溝部２０を内部に有していることが好ましい。筒状物１０が内部に溝部２０を有していることにより、バルーン配置工程においてバルーン１を膨張させた際に、溝部２０の付近にて筒状物１０の内表面とバルーン１の外表面との間に隙間ができやすくなる。その結果、バルーン収縮工程においてバルーン１を収縮させた際に、溝部２０付近に配置されているバルーン１の部分が筒状物１０の重心Ｐ１に向かって引っ張られやすくなり、羽根形状部３の谷部３ｂの位置が制御しやすくなる。 FIG. 3 shows a cross-sectional view in the balloon placement step of the method for manufacturing a balloon catheter according to another embodiment of the present invention, and FIG. 4 shows a cross-sectional view in the balloon contraction step. As shown in FIGS. 3 and 4, the tubular object 10 preferably has a groove portion 20 extending in the perspective direction inside. Since the tubular object 10 has a groove portion 20 inside, when the balloon 1 is inflated in the balloon arranging step, the inner surface of the tubular object 10 and the outer surface of the balloon 1 are formed in the vicinity of the groove portion 20. It becomes easy to create a gap between the two. As a result, when the balloon 1 is contracted in the balloon contraction step, the portion of the balloon 1 arranged near the groove 20 is easily pulled toward the center of gravity P1 of the tubular object 10, and the valley of the blade-shaped portion 3 is easily pulled. The position of the portion 3b can be easily controlled.
　図５は本発明のさらに他の実施の形態におけるバルーンカテーテルの製造方法のバルーン配置工程での断面図を表し、図６はバルーン収縮工程での断面図を表す。図５および図６に示すように、溝部２０は、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３付近にあり、突出部配置工程において、溝部２０の内部に突出部２を配置してもよい。溝部２０が筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３付近にあることにより、羽根形状部３に突出部２がある状態にてバルーン１を折り畳むことが可能である。突出部２が羽根形状部３に配置されていることにより、バルーンカテーテルの使用時においてバルーン１を拡張する際に、バルーン１の拡張途中の段階であっても狭窄部等の病変部に突出部２が引っ掛かりやすくなる。そのため、病変部にバルーン１を固定しやすく、狭窄部等の拡張が行いやすいバルーンカテーテルとすることができる。 FIG. 5 shows a cross-sectional view in the balloon placement step of the method for manufacturing a balloon catheter according to still another embodiment of the present invention, and FIG. 6 shows a cross-sectional view in the balloon contraction step. As shown in FIGS. 5 and 6, the groove portion 20 is located in the vicinity of the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner side surface of the tubular object 10 is long, and is inside the groove portion 20 in the projecting portion arranging step. The protrusion 2 may be arranged on the. Since the groove 20 is near the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is long, the balloon 1 can be folded with the protruding portion 2 on the blade-shaped portion 3. It is possible. Since the protruding portion 2 is arranged in the blade-shaped portion 3, when the balloon 1 is expanded when the balloon catheter is used, the protruding portion is formed in a lesion portion such as a stenosis even in the middle of expansion of the balloon 1. 2 is easy to get caught. Therefore, it is possible to obtain a balloon catheter in which the balloon 1 can be easily fixed to the lesion and the stenosis or the like can be easily expanded.
　溝部２０は、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が長い部分Ｐ３付近にあってもよいが、図３および図４に示すように、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２にあることが好ましい。この際、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２を決定するにあたり、溝部２０の深さｄ１は、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離に加えないこととする。つまり、図３および図４に示すように、筒状物の遠近方向に垂直な断面において、溝部２０の開口部の両端部を通る直線を引き、溝部２０がある部分においては、筒状物１０の重心Ｐ１から溝部２０の開口部の両端部を通る直線上の地点との距離を測定し、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２を決定する。溝部２０が筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２にあることにより、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２の筒状物１０の内表面と、筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２に配置されているバルーン１の部分の外表面との間に隙間ができやすくなる。そのために、バルーン収縮工程において筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２に配置されているバルーン１の部分が筒状物１０の重心Ｐ１に向かって引っ張られて羽根形状部３の谷部３ｂとなりやすく、バルーン１の折り畳み形状を制御することが容易となる。 The groove 20 may be near the portion P3 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is long, but as shown in FIGS. 3 and 4, the center of gravity of the tubular object 10 may be located. It is preferable that the distance from P1 to the inner surface of the tubular object 10 is short in the portion P2. At this time, in determining the portion P2 in which the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short, the depth d1 of the groove portion 20 is set from the center of gravity P1 of the tubular object 10 to the tubular object 10. It shall not be added to the distance to the inner surface of. That is, as shown in FIGS. 3 and 4, in a cross section perpendicular to the perspective direction of the tubular object, a straight line passing through both ends of the opening of the groove 20 is drawn, and in the portion where the groove 20 is present, the tubular object 10 is drawn. The distance from the center of gravity P1 of the above to a point on a straight line passing through both ends of the opening of the groove 20 is measured, and a portion P2 having a short distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is determined. .. Since the groove 20 is located in the portion P2 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short, the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short. Between the inner surface of the tubular object 10 of the portion P2 and the outer surface of the portion of the balloon 1 arranged in the portion P2 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short. It becomes easy to create a gap. Therefore, in the balloon contraction step, the portion of the balloon 1 arranged in the portion P2 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short is pulled toward the center of gravity P1 of the tubular object 10. Therefore, the valley portion 3b of the blade shape portion 3 is likely to be formed, and the folded shape of the balloon 1 can be easily controlled.
　図３および図４に示すように、バルーン１は、バルーン本体１ａと、該バルーン本体１ａの外側面に形成されている突出部２と、を有しており、バルーン収縮工程の前に、溝部２０の内部に突出部２を配置する突出部配置工程を有していることが好ましい。バルーンカテーテルの製造方法において、バルーン収縮工程の前に突出部配置工程を有していることにより、バルーン配置工程においてバルーン１の内部を加圧した際に突出部２が筒状物１０の内側面に押し付けられにくく、突出部２が押し潰されることを防止できる。突出部２を溝部２０の内部に配置するには、例えば、バルーン１の内部を加圧することによって、溝部２０の内部に突出部２を挿入すること等が挙げられる。 As shown in FIGS. 3 and 4, the balloon 1 has a balloon body 1a and a protrusion 2 formed on the outer surface of the balloon body 1a, and the groove portion is formed before the balloon contraction step. It is preferable to have a projecting portion arranging step of arranging the projecting portion 2 inside the 20. In the method for manufacturing a balloon catheter, since the protrusion placement step is provided before the balloon contraction step, the protrusion 2 is formed on the inner surface of the tubular object 10 when the inside of the balloon 1 is pressurized in the balloon placement step. It is difficult to be pressed against the surface, and the protruding portion 2 can be prevented from being crushed. In order to arrange the protrusion 2 inside the groove 20, for example, the protrusion 2 is inserted into the groove 20 by pressurizing the inside of the balloon 1.
　バルーン１が外側面に突出部２を有していることにより、突出部２が石灰化して硬化した病変部に亀裂を入れることができ、石灰化病変であってもバルーン１が十分に病変部を拡張することができる。また、例えば、ＩＳＲ病変等が発生した場合においてバルーン１を拡張することにより、柔らかく、表面が滑りやすい新生内膜に突出部２が引っ掛かりやすく、ＩＳＲ病変等の拡張時にバルーン１の位置ずれが起こりにくい。 Since the balloon 1 has a protrusion 2 on the outer surface, a crack can be formed in a lesion where the protrusion 2 is calcified and hardened, and even if the lesion is a calcified lesion, the balloon 1 is sufficiently lesioned. Can be extended. Further, for example, by expanding the balloon 1 when an ISR lesion or the like occurs, the protrusion 2 is likely to be caught in the new intima which is soft and the surface is slippery, and the position of the balloon 1 is displaced when the ISR lesion or the like is expanded. Hateful.
　突出部２の数は、１つであってもよいが、複数であることが好ましい。つまり、バルーン１の外側面に複数の突出部２が設けられていることが好ましい。突出部２の数が複数であることにより、石灰化によって硬化した病変部に亀裂を入れやすくなる。また、ＩＳＲ病変に対してバルーン１の位置ずれをより起こりにくくすることもできる。 The number of protrusions 2 may be one, but it is preferably plural. That is, it is preferable that a plurality of projecting portions 2 are provided on the outer surface of the balloon 1. When the number of the protrusions 2 is plurality, it becomes easy to crack the lesion portion hardened by calcification. In addition, the position of the balloon 1 can be made less likely to shift with respect to the ISR lesion.
　突出部２は、遠近方向に延在している。突出部２の遠近方向の長さは、バルーン１の遠近方向の長さよりも短いことが好ましい。突出部２の遠近方向の長さがバルーン１の遠近方向の長さよりも短いことにより、バルーン１の遠近方向の一部に突出部２が設けられていない箇所があり、バルーン１が曲がりやすくなる。そのため、湾曲した血管等でのバルーンカテーテルの挿通性を高めることができる。 The protrusion 2 extends in the perspective direction. The perspective length of the protrusion 2 is preferably shorter than the perspective length of the balloon 1. Since the length of the protrusion 2 in the perspective direction is shorter than the length of the balloon 1 in the perspective direction, there is a portion where the protrusion 2 is not provided in a part of the balloon 1 in the perspective direction, and the balloon 1 is easily bent. .. Therefore, it is possible to improve the insertability of the balloon catheter in a curved blood vessel or the like.
　突出部２を構成する材料は、例えば、ポリ塩化ビニル、ポリエチレン、ポリプロピレン、環状ポリオレフィン等のポリオレフィン系樹脂、ポリスチレン系樹脂、ポリ－（４－メチルペンテン－１）等のポリメチルペンテン系樹脂、ポリカーボネート系樹脂、アクリル系樹脂、ＡＢＳ系樹脂、ポリエチレンテレフタレート、ポリエチレンナフタレート等のポリエステル系樹脂、ブタジエン－スチレン共重合体、ポリアミドエラストマー、ナイロン６、ナイロン６・６、ナイロン６・１０、ナイロン１２等のポリアミド系樹脂等の合成樹脂、ステンレス鋼、アルミニウム、アルミニウム合金、チタン、チタン合金、銅、銅合金、タンタル、コバルト合金等の金属等が挙げられる。これらは１種のみを用いてもよく、２種以上を併用してもよい。なお、突出部２は、バルーン１を構成する材料と同一の材料にて一体成形によってバルーン１の外側面に設けられていてもよく、バルーン１を構成する材料とは異なる材料にてバルーン１とは別途形成してバルーン１の外側面に設けられていてもよい。 The material constituting the protrusion 2 is, for example, a polyolefin resin such as polyvinyl chloride, polyethylene, polypropylene or cyclic polyolefin, a polystyrene resin, a polymethylpentene resin such as poly- (4-methylpentene-1), or a polycarbonate. Based resin, acrylic resin, ABS resin, polyethylene terephthalate, polyester resin such as polyethylene naphthalate, butadiene-styrene copolymer, polyamide elastomer, nylon 6, nylon 6.6, nylon 6/10, nylon 12, etc. Examples thereof include synthetic resins such as polyamide resins, metals such as stainless steel, aluminum, aluminum alloys, titanium, titanium alloys, copper, copper alloys, tantalums, and cobalt alloys. Only one of these may be used, or two or more thereof may be used in combination. The protruding portion 2 may be provided on the outer surface of the balloon 1 by integral molding with the same material as the material constituting the balloon 1, and the material different from the material constituting the balloon 1 may be provided with the balloon 1. May be separately formed and provided on the outer surface of the balloon 1.
　突出部２は、バルーン本体１ａと同一材料から構成されていることが好ましい。突出部２を構成する材料と、バルーン本体１ａを構成する材料が同じであることにより、バルーン本体１ａと突出部２との接合強度を高めることが可能となる。 The protrusion 2 is preferably made of the same material as the balloon body 1a. Since the material constituting the protruding portion 2 and the material constituting the balloon main body 1a are the same, it is possible to increase the joint strength between the balloon main body 1a and the protruding portion 2.
　また、バルーン本体１ａと突出部２は、一体成形品であることが好ましい。バルーン本体１ａと突出部２とが一体成形品であることにより、バルーン本体１ａと突出部２との接合力をさらに高めることができる。さらに、バルーン本体１ａに突出部２を接合する工程が不要となるため、バルーン１の成形にかかる時間を短縮して製造効率を高めることができる。 Further, it is preferable that the balloon body 1a and the protruding portion 2 are integrally molded products. Since the balloon main body 1a and the protruding portion 2 are integrally molded products, the bonding force between the balloon main body 1a and the protruding portion 2 can be further increased. Further, since the step of joining the protruding portion 2 to the balloon body 1a is not required, the time required for forming the balloon 1 can be shortened and the manufacturing efficiency can be improved.
　溝部２０の幅Ｗ１は突出部２の幅Ｗ２よりも大きいことが好ましい。溝部２０の幅Ｗ１が突出部２の幅Ｗ２よりも大きいことにより、突出部配置工程において、溝部２０の内部に突出部２を配置することが容易となって、バルーンカテーテルの製造効率を向上させることが可能となる。 The width W1 of the groove 20 is preferably larger than the width W2 of the protrusion 2. Since the width W1 of the groove 20 is larger than the width W2 of the protrusion 2, it becomes easy to arrange the protrusion 2 inside the groove 20 in the protrusion placement step, and the manufacturing efficiency of the balloon catheter is improved. It becomes possible.
　溝部２０の幅Ｗ１は、突出部２の幅Ｗ２の１．１倍以上であることが好ましく、１．２倍以上であることがより好ましく、１．３倍以上であることがさらに好ましい。溝部２０の幅Ｗ１と突出部２の幅Ｗ２との比率の下限値を上記の範囲に設定することにより、突出部配置工程において、溝部２０の内部に突出部２を配置する工程が行いやすくなる。そのため、バルーンカテーテルの製造の効率を高めることが可能となる。また、溝部２０の幅Ｗ１と突出部２の幅Ｗ２との比率の上限値は特に限定されないが、例えば、１０倍以下、７倍以下、５倍以下とすることができる。 The width W1 of the groove portion 20 is preferably 1.1 times or more, more preferably 1.2 times or more, and further preferably 1.3 times or more the width W2 of the protruding portion 2. By setting the lower limit of the ratio of the width W1 of the groove 20 to the width W2 of the protrusion 2 within the above range, the step of arranging the protrusion 2 inside the groove 20 becomes easier in the protrusion placement step. .. Therefore, it is possible to increase the efficiency of manufacturing the balloon catheter. The upper limit of the ratio between the width W1 of the groove 20 and the width W2 of the protrusion 2 is not particularly limited, but can be, for example, 10 times or less, 7 times or less, 5 times or less.
　溝部２０の深さｄ１は、突出部２の高さＨ１よりも大きいことが好ましい。溝部２０の深さｄ１が突出部２の高さＨ１よりも大きいことにより、バルーン１の内部を加圧した際に突出部２が筒状物１０の内側面に強く押し付けられることを妨げ、突出部２が押し潰されにくくなる。 The depth d1 of the groove portion 20 is preferably larger than the height H1 of the protruding portion 2. Since the depth d1 of the groove 20 is larger than the height H1 of the protrusion 2, the protrusion 2 is prevented from being strongly pressed against the inner surface of the tubular object 10 when the inside of the balloon 1 is pressurized, and the protrusion 2 is prevented. Part 2 is less likely to be crushed.
　溝部２０の深さｄ１は、突出部２の高さＨ１の１．１倍以上であることが好ましく、１．２倍以上であることがより好ましく、１．３倍以上であることがさらに好ましい。溝部２０の深さｄ１と突出部２の高さＨ１との比率の下限値を上記の範囲に設定することにより、バルーン配置工程において突出部２が溝部２０に押し付けられにくくなり、突出部２が潰れてしまうことを防止できる。また、溝部２０の深さｄ１と突出部２の高さＨ１との比率の上限値は特に限定されないが、例えば、１０倍以下、７倍以下、５倍以下とすることができる。 The depth d1 of the groove portion 20 is preferably 1.1 times or more, more preferably 1.2 times or more, and further preferably 1.3 times or more the height H1 of the protruding portion 2. .. By setting the lower limit of the ratio of the depth d1 of the groove 20 to the height H1 of the protrusion 2 within the above range, the protrusion 2 is less likely to be pressed against the groove 20 in the balloon arranging process, and the protrusion 2 becomes difficult to press. It can be prevented from being crushed. The upper limit of the ratio between the depth d1 of the groove 20 and the height H1 of the protrusion 2 is not particularly limited, but may be, for example, 10 times or less, 7 times or less, or 5 times or less.
　溝部２０が筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２にあり、バルーン収縮工程の前に、溝部２０の内部に突出部２を配置する突出部配置工程を有していることが好ましい。筒状物１０の重心Ｐ１から筒状物１０の内側面までの距離が短い部分Ｐ２にある溝部２０の内部に突出部２を配置することにより、バルーン収縮工程においてバルーン１の内部を減圧した際に突出部２が筒状物１０の重心Ｐ１に他のバルーン１の部分よりも早く到達することができる。その結果、突出部２が存在している部分の付近が羽根形状部３の谷部３ｂとなって、突出部２の位置を制御しながらバルーン１を折り畳むことが可能となる。また、突出部２が複数の羽根形状部３の間に配置されるため、羽根形状部３を巻き畳む際に突出部２が潰れにくいという効果も有している。 The groove portion 20 is located in the portion P2 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short, and the protrusion portion 2 is arranged inside the groove portion 20 before the balloon contraction step. It is preferable to have. When the inside of the balloon 1 is depressurized in the balloon contraction step by arranging the protrusion 2 inside the groove 20 in the portion P2 where the distance from the center of gravity P1 of the tubular object 10 to the inner surface of the tubular object 10 is short. The protrusion 2 can reach the center of gravity P1 of the tubular object 10 earlier than the other balloon 1. As a result, the vicinity of the portion where the protruding portion 2 exists becomes the valley portion 3b of the blade-shaped portion 3, and the balloon 1 can be folded while controlling the position of the protruding portion 2. Further, since the protruding portion 2 is arranged between the plurality of blade-shaped portions 3, it also has an effect that the protruding portion 2 is not easily crushed when the blade-shaped portion 3 is wound and folded.
　突出部２の数は、複数であり、溝部２０の数は、突出部２の数と等しいことが好ましい。突出部２の数と溝部２０の数がいずれも複数であって同じ数であることにより、石灰化病変やＩＳＲ病変の狭窄部を十分に拡張できる突出部２を有するバルーンカテーテルを製造することができる。また、バルーンカテーテルの製造の際に突出部２が筒状物１０の内側面に押し付けられて、突出部２が押し潰されてしまうことを防止できる。 It is preferable that the number of the protruding portions 2 is a plurality and the number of the groove portions 20 is equal to the number of the protruding portions 2. Since the number of protrusions 2 and the number of grooves 20 are both a plurality and the same number, it is possible to manufacture a balloon catheter having a protrusion 2 capable of sufficiently dilating a narrowed portion of a calcified lesion or an ISR lesion. it can. Further, it is possible to prevent the protruding portion 2 from being crushed by being pressed against the inner surface of the tubular object 10 during the manufacture of the balloon catheter.
　バルーン１は、外表面に親水性コーティングが施されており、突出部２の頂部の親水性コーティングを除去するコーティング除去工程を有することが好ましい。バルーン１の外表面に親水性コーティングを施し、突出部２の頂部の親水性コーティングを除去することにより、突出部２の頂部は滑り性が低いために病変部へ突出部２が引っ掛かりやすく、かつ、突出部２の頂部を除くバルーン１の外表面は親水性コーティングによって滑り性が高いため、手技を行いやすいバルーンカテーテルとすることができる。 It is preferable that the balloon 1 has a hydrophilic coating on the outer surface and has a coating removing step of removing the hydrophilic coating on the top of the protrusion 2. By applying a hydrophilic coating to the outer surface of the balloon 1 and removing the hydrophilic coating on the top of the protrusion 2, the top of the protrusion 2 has low slipperiness, so that the protrusion 2 can easily be caught in the lesion. Since the outer surface of the balloon 1 excluding the top of the protruding portion 2 is highly slippery due to the hydrophilic coating, it is possible to obtain a balloon catheter that is easy to perform the procedure.
　コーティング除去工程は、バルーン配置工程の後に行い、コーティング除去工程において、バルーン１を遠近方向に摺動させ、突出部２の外表面と筒状物１０の内表面とを接触させていることが好ましい。つまり、突出部２の外表面に施された親水性コーティングを、筒状物１０の内表面と接触させながら摺動させることにより、突出部２の外表面の親水性コーティングを除去することが好ましい。コーティング除去工程を、バルーン１を遠近方向に摺動させ、突出部２の外表面と筒状物１０の内表面とを接触させて行うことにより、バルーン１を筒状物１０内に配置したまま、簡単な操作でコーティング除去工程を行うことができる。そのため、バルーンカテーテルの製造効率を向上させることが可能である。 The coating removing step is performed after the balloon arranging step, and in the coating removing step, it is preferable that the balloon 1 is slid in the perspective direction so that the outer surface of the protruding portion 2 and the inner surface of the tubular object 10 are brought into contact with each other. .. That is, it is preferable to remove the hydrophilic coating on the outer surface of the protruding portion 2 by sliding the hydrophilic coating applied to the outer surface of the protruding portion 2 while contacting the inner surface of the tubular object 10. .. The coating removing step is performed by sliding the balloon 1 in the perspective direction and bringing the outer surface of the protrusion 2 into contact with the inner surface of the tubular object 10, so that the balloon 1 remains arranged in the tubular object 10. , The coating removal process can be performed with a simple operation. Therefore, it is possible to improve the manufacturing efficiency of the balloon catheter.
　筒状物１０の内表面のうち、突出部２の外表面と接触する部分は、他の部分よりも表面平均粗さＲｚが高いことが好ましい。筒状物１０の内表面のうち、突出部２の外表面と接触する部分の表面平均粗さＲｚが、他の部分の表面平均粗さＲｚよりも高いことにより、突出部２の外表面の親水性コーティングは効率的に除去することができる一方、突出部２を除くバルーン１の外表面の親水性コーティングは除去されにくくなる。その結果、突出部２のみ表面の滑り性を低下させたバルーンカテーテルを製造しやすくすることができる。 Of the inner surface of the tubular object 10, the portion in contact with the outer surface of the protruding portion 2 preferably has a higher surface average roughness Rz than the other portions. Of the inner surface of the tubular object 10, the surface average roughness Rz of the portion in contact with the outer surface of the protruding portion 2 is higher than the surface average roughness Rz of the other portion, so that the outer surface of the protruding portion 2 While the hydrophilic coating can be removed efficiently, the hydrophilic coating on the outer surface of the balloon 1 excluding the protrusion 2 is difficult to remove. As a result, it is possible to facilitate the manufacture of a balloon catheter in which the slipperiness of the surface of only the protruding portion 2 is reduced.
　以上のように、バルーンカテーテルの製造方法は、遠近方向に延在しているシャフトと、シャフトの遠位側に設けられているバルーンと、を有するバルーンカテーテルの製造方法であって、遠近方向に延在する空間部を内部に有する筒状物を準備する筒状物準備工程と、バルーンを準備するバルーン準備工程と、筒状物内にバルーンを配置しバルーンの内部を加圧してバルーンを膨張させるバルーン配置工程と、バルーンの内部を減圧しバルーンを収縮させて羽根形状部を形成するバルーン収縮工程と、を有しており、バルーン配置工程での筒状物の遠近方向に垂直な断面において、筒状物は筒状物の重心から筒状物の内側面までの距離が短い部分と、筒状物の重心から筒状物の内側面までの距離が長い部分とを有し、筒状物の重心から筒状物の内側面までの距離が短い部分までの距離は筒状物の重心から筒状物の内側面までの距離が長い部分までの距離の５０％以上９５％以下である。筒状物内にバルーンを配置し、バルーンの内部を加圧してバルーンを膨張させるバルーン配置工程での筒状物の遠近方向に垂直な断面において、筒状物は筒状物の重心から筒状物の内側面までの距離が短い部分と、筒状物の重心から筒状物の内側面までの距離が長い部分があり、筒状物の重心から筒状物の内側面までの距離が短い部分までの距離は筒状物の重心から筒状物の内側面までの距離が長い部分までの距離の５０％以上９５％以下であることにより、バルーンを収縮させた状態において羽根形状部が形成される位置を制御することが可能となり、バルーンを綺麗に折り畳むことができ、折り畳まれた状態のバルーンの外径を小さくすることができる。 As described above, the method for manufacturing a balloon catheter is a method for manufacturing a balloon catheter having a shaft extending in the perspective direction and a balloon provided on the distal side of the shaft, and is a method for manufacturing the balloon catheter in the perspective direction. A tubular object preparation step for preparing a tubular object having an extending space inside, a balloon preparation step for preparing a balloon, and a balloon being placed inside the tubular object to pressurize the inside of the balloon to inflate the balloon. It has a balloon arranging step of squeezing the balloon and a balloon squeezing step of depressurizing the inside of the balloon to contract the balloon to form a wing-shaped portion. The tubular object has a portion in which the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short and a portion in which the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long. The distance from the center of gravity of the object to the portion where the distance from the inner surface of the tubular object is short is 50% or more and 95% or less of the distance from the center of gravity of the tubular object to the portion where the distance from the inner surface of the tubular object is long. .. In the balloon placement process in which the balloon is placed inside the tubular object and the inside of the balloon is pressurized to inflate the balloon, the tubular object is tubular from the center of gravity of the tubular object in the cross section perpendicular to the perspective direction of the tubular object. There is a part where the distance to the inner surface of the object is short and a part where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long, and the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short. The distance to the portion is 50% or more and 95% or less of the distance from the center of gravity of the tubular object to the inner surface of the tubular object to the long portion, so that the blade-shaped portion is formed in the state where the balloon is contracted. It becomes possible to control the position to be formed, the balloon can be neatly folded, and the outer diameter of the folded balloon can be reduced.
　本願は、２０１９年９月９日に出願された日本国特許出願第２０１９－１６３８５７号に基づく優先権の利益を主張するものである。２０１９年９月９日に出願された日本国特許出願第２０１９－１６３８５７号の明細書の全内容が、本願に参考のため援用される。 This application claims the benefit of priority based on Japanese Patent Application No. 2019-163857 filed on September 9, 2019. The entire contents of the specification of Japanese Patent Application No. 2019-163857 filed on September 9, 2019 are incorporated herein by reference.
　１：バルーン
　１ａ：バルーン本体
　２：突出部
　３：羽根形状部
　３ａ：羽根形状部の先端部
　３ｂ：羽根形状部の谷部
　１０：筒状物
　１１：空間部
　２０：溝部
　Ｐ１：筒状物の重心
　Ｐ２：筒状物の重心から筒状物の内側面までの距離が短い部分
　Ｐ３：筒状物の重心から筒状物の内側面までの距離が長い部分
　Ｄ１：筒状物の重心から筒状物の内側面までの距離が短い部分の距離
　Ｄ２：筒状物の重心から筒状物の内側面までの距離が長い部分の距離
　Ｗ１：溝部の幅
　Ｗ２：突出部の幅
　ｄ１：溝部の深さ
　Ｈ１：突出部の高さ 1: Balloon 1a: Balloon body 2: Protruding part 3: Blade-shaped part 3a: Tip part of blade-shaped part 3b: Valley part of blade-shaped part 10: Cylindrical object 11: Space part 20: Groove part P1: Cylindrical object Center of gravity P2: The part where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short P3: The part where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long D1: From the center of gravity of the tubular object to the cylinder Distance of the part where the distance to the inner surface of the object is short D2: Distance of the part where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long W1: Width of the groove W2: Width of the protrusion d1: Of the groove Depth H1: Height of protrusion

Claims (9)

  1. 　遠近方向に延在しているシャフトと、前記シャフトの遠位側に設けられているバルーンと、を有するバルーンカテーテルの製造方法であって、
    　遠近方向に延在する空間部を内部に有する筒状物を準備する筒状物準備工程と、
    　前記バルーンを準備するバルーン準備工程と、
    　前記筒状物内に前記バルーンを配置し、前記バルーンの内部を加圧して前記バルーンを膨張させるバルーン配置工程と、
    　前記バルーンの内部を減圧し、前記バルーンを収縮させて羽根形状部を形成するバルーン収縮工程と、を有しており、
    　前記バルーン配置工程での、前記筒状物の遠近方向に垂直な断面において、前記筒状物は、前記筒状物の重心から前記筒状物の内側面までの距離が短い部分と、前記筒状物の重心から前記筒状物の内側面までの距離が長い部分とを有し、
    　前記筒状物の重心から前記筒状物の内側面までの距離が短い部分までの距離は、前記筒状物の重心から前記筒状物の内側面までの距離が長い部分までの距離の５０％以上９５％以下であることを特徴とするバルーンカテーテルの製造方法。     A method for manufacturing a balloon catheter having a shaft extending in the perspective direction and a balloon provided on the distal side of the shaft.
    A tubular object preparation process for preparing a tubular object having a space extending in the perspective direction inside, and a tubular object preparation process.
    The balloon preparation step for preparing the balloon and
    A balloon placement step of arranging the balloon in the tubular object and pressurizing the inside of the balloon to inflate the balloon.
    It has a balloon contraction step of decompressing the inside of the balloon and contracting the balloon to form a blade-shaped portion.
    In the cross section perpendicular to the perspective direction of the tubular object in the balloon arranging step, the tubular object has a portion in which the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short and the cylinder. It has a portion where the distance from the center of gravity of the object to the inner surface of the tubular object is long.
    The distance from the center of gravity of the tubular object to the portion where the distance from the inner surface of the tubular object is short is 50, which is the distance from the center of gravity of the tubular object to the portion where the distance from the inner surface of the tubular object is long. A method for producing a balloon catheter, which comprises% or more and 95% or less.
  2. 　前記バルーン収縮工程において、前記筒状物の重心から前記筒状物の内側面までの距離が長い部分に位置している前記バルーンの部分が前記羽根形状部の先端部となり、
    　前記筒状物の重心から前記筒状物の内側面までの距離が短い部分に位置している前記バルーンの部分が隣接する複数の前記羽根形状部の間の谷部となる請求項１に記載のバルーンカテーテルの製造方法。     In the balloon contraction step, the portion of the balloon located at a portion where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is long becomes the tip end portion of the blade-shaped portion.
    The first aspect of claim 1, wherein the balloon portion located at a portion where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short is a valley portion between a plurality of adjacent blade-shaped portions. How to manufacture a balloon catheter.
  3. 　前記筒状物は、遠近方向に延在する溝部を内部に有している請求項１または２に記載のバルーンカテーテルの製造方法。 The method for manufacturing a balloon catheter according to claim 1 or 2, wherein the tubular object has a groove extending in the perspective direction inside.
  4. 　前記溝部は、前記筒状物の重心から前記筒状物の内側面までの距離が短い部分にある請求項３に記載のバルーンカテーテルの製造方法。 The method for manufacturing a balloon catheter according to claim 3, wherein the groove portion is a portion where the distance from the center of gravity of the tubular object to the inner surface of the tubular object is short.
  5. 　前記バルーンは、バルーン本体と、該バルーン本体の外側面に形成されている突出部と、を有しており、
    　前記バルーン収縮工程の前に、前記溝部の内部に前記突出部を配置する突出部配置工程を有している請求項３または４に記載のバルーンカテーテルの製造方法。     The balloon has a balloon body and a protrusion formed on the outer surface of the balloon body.
    The method for manufacturing a balloon catheter according to claim 3 or 4, further comprising a protrusion arranging step of arranging the protrusion inside the groove before the balloon contraction step.
  6. 　前記突出部は、前記バルーン本体と同一材料から構成されている請求項５に記載のバルーンカテーテルの製造方法。 The method for manufacturing a balloon catheter according to claim 5, wherein the protruding portion is made of the same material as the balloon body.
  7. 　前記突出部の数は、複数であり、
    　前記溝部の数は、前記突出部の数と等しい請求項５または６に記載のバルーンカテーテルの製造方法。     The number of the protrusions is plural,
    The method for manufacturing a balloon catheter according to claim 5 or 6, wherein the number of grooves is equal to the number of protrusions.
  8. 　前記バルーンは、外表面に親水性コーティングが施されており、
    　前記突出部の頂部の親水性コーティングを除去するコーティング除去工程を有する請求項５～７のいずれか一項に記載のバルーンカテーテルの製造方法。     The balloon has a hydrophilic coating on the outer surface.
    The method for manufacturing a balloon catheter according to any one of claims 5 to 7, further comprising a coating removing step of removing the hydrophilic coating on the top of the protruding portion.
  9. 　前記コーティング除去工程は、前記バルーン配置工程の後に行っており、
    　前記コーティング除去工程において、前記バルーンを遠近方向に摺動させ、前記突出部の外表面と前記筒状物の内表面とを接触させている請求項８に記載のバルーンカテーテルの製造方法。     The coating removing step is performed after the balloon placement step.
    The method for manufacturing a balloon catheter according to claim 8, wherein in the coating removing step, the balloon is slid in a perspective direction to bring the outer surface of the protruding portion into contact with the inner surface of the tubular object.
PCT/JP2020/031104 2019-09-09 2020-08-18 Method for producing balloon catheter WO2021049261A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2021545185A JPWO2021049261A1 (en) 2019-09-09 2020-08-18

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2019163857 2019-09-09
JP2019-163857 2019-09-09

Publications (1)

Publication Number Publication Date
WO2021049261A1 true WO2021049261A1 (en) 2021-03-18

Family

ID=74867236

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2020/031104 WO2021049261A1 (en) 2019-09-09 2020-08-18 Method for producing balloon catheter

Country Status (2)

Country Link
JP (1) JPWO2021049261A1 (en)
WO (1) WO2021049261A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023079906A1 (en) * 2021-11-08 2023-05-11 株式会社カネカ Balloon for balloon catheter

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05293174A (en) * 1992-04-17 1993-11-09 Interventional Technol Inc Method to manufacture foldable balloon catheter
US20010047149A1 (en) * 1998-03-04 2001-11-29 Scimed Life Systems, Inc. Balloon wrap device and method
US20060091585A1 (en) * 2004-10-29 2006-05-04 Kelley Greg S Medical balloon folding method and tooling
JP2014140462A (en) * 2013-01-23 2014-08-07 Sumitomo Bakelite Co Ltd Balloon contraction assisting tool, catheter set, and balloon contraction method

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05293174A (en) * 1992-04-17 1993-11-09 Interventional Technol Inc Method to manufacture foldable balloon catheter
US20010047149A1 (en) * 1998-03-04 2001-11-29 Scimed Life Systems, Inc. Balloon wrap device and method
US20060091585A1 (en) * 2004-10-29 2006-05-04 Kelley Greg S Medical balloon folding method and tooling
JP2014140462A (en) * 2013-01-23 2014-08-07 Sumitomo Bakelite Co Ltd Balloon contraction assisting tool, catheter set, and balloon contraction method

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023079906A1 (en) * 2021-11-08 2023-05-11 株式会社カネカ Balloon for balloon catheter

Also Published As

Publication number Publication date
JPWO2021049261A1 (en) 2021-03-18

Similar Documents

Publication Publication Date Title
WO2021049282A1 (en) Method for producing balloon catheter
US8021330B2 (en) Balloon catheter for crossing a chronic total occlusion
US20180140804A1 (en) Balloon catheter
JP5015772B2 (en) Balloon catheter
US10251766B2 (en) Balloon catheters and systems and methods for delivering stents using such catheters
WO2020195697A1 (en) Balloon catheter
US20040073162A1 (en) Balloon construction for occlusion device
US20200238057A1 (en) Balloon catheter
US10136905B2 (en) Balloon catheter
JP5671859B2 (en) Balloon catheter
WO2021049261A1 (en) Method for producing balloon catheter
WO2020195170A1 (en) Balloon catheter
JP7359853B2 (en) balloon catheter
JP7432360B2 (en) Balloon catheter manufacturing method and mold
JP5391663B2 (en) Catheter support with irregular cross section
JP2022040094A (en) Balloon catheter improved in flexibility
US20160000593A1 (en) Delivery system for a living body indwelling member
JP7100666B2 (en) Balloon catheter and its manufacturing method
WO2022102189A1 (en) Balloon for balloon catheter
WO2024106402A1 (en) Balloon-catheter balloon, balloon catheter equipped with same, and manufacturing method for balloon catheter
JP2022017978A (en) catheter
JP2016174878A (en) catheter
JP2024072607A (en) Balloon for balloon catheter, balloon catheter including same, and method for manufacturing balloon catheter
JP2022096940A (en) Medical long body and medical appliance set
JPH1176414A (en) Catheter tube and balloon catheter

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20863463

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2021545185

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 20863463

Country of ref document: EP

Kind code of ref document: A1