WO2021049261A1 - Procédé de fabrication de cathéter à ballonnet - Google Patents

Procédé de fabrication de cathéter à ballonnet Download PDF

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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
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WO
WIPO (PCT)
Prior art keywords
balloon
tubular object
distance
gravity
center
Prior art date
Application number
PCT/JP2020/031104
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English (en)
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
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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/fr

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    • 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

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  • 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)
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  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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Abstract

L'invention concerne un procédé de fabrication d'un cathéter à ballonnet comportant : une étape de préparation d'objet cylindrique consistant à préparer un objet cylindrique (10) ayant une partie spatiale (11) s'étendant dans une direction lointaine/proche ; une étape de préparation de ballonnet consistant à préparer un ballonnet (1) ; une étape d'agencement de ballonnet consistant à agencer le ballonnet (1) dans l'objet cylindrique (10) et à mettre sous pression l'intérieur du ballonnet (1) pour dilater le ballonnet (1) ; et une étape de contraction de ballonnet consistant à dépressuriser l'intérieur du ballonnet (1) et à contracter le ballonnet (1) pour former une partie de forme de lame (3). Dans une section transversale orthogonale vers la direction lointaine/proche de l'objet cylindrique (10) dans l'étape d'agencement de ballonnet, l'objet cylindrique (10) possède une partie P2 à laquelle une distance à partir d'un point de gravité P1 de l'objet cylindrique (10) vers une surface interne de l'objet cylindrique (10) est courte et une partie P3 à laquelle une distance du point de gravité P1 de l'objet cylindrique (10) vers la surface interne de l'objet cylindrique (10) est longue. Une distance D1 du point de gravité P1 à la partie P2 représente 50 % ou plus et 95 % ou moins de la distance D2 du point de gravité P1 à la partie P3.
PCT/JP2020/031104 2019-09-09 2020-08-18 Procédé de fabrication de cathéter à ballonnet WO2021049261A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023079906A1 (fr) * 2021-11-08 2023-05-11 株式会社カネカ Ballonnet pour cathéter à ballonnet

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05293174A (ja) * 1992-04-17 1993-11-09 Interventional Technol Inc 折りたたみ式バルーンカテーテルを作る方法
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 (ja) * 2013-01-23 2014-08-07 Sumitomo Bakelite Co Ltd バルーン収縮用補助具、カテーテルセットおよびバルーン収縮方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05293174A (ja) * 1992-04-17 1993-11-09 Interventional Technol Inc 折りたたみ式バルーンカテーテルを作る方法
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 (ja) * 2013-01-23 2014-08-07 Sumitomo Bakelite Co Ltd バルーン収縮用補助具、カテーテルセットおよびバルーン収縮方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023079906A1 (fr) * 2021-11-08 2023-05-11 株式会社カネカ Ballonnet pour cathéter à ballonnet

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