WO2020250611A1 - バルーンカテーテル用のバルーンおよびバルーンカテーテルの製造方法 - Google Patents

バルーンカテーテル用のバルーンおよびバルーンカテーテルの製造方法 Download PDF

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Publication number
WO2020250611A1
WO2020250611A1 PCT/JP2020/018980 JP2020018980W WO2020250611A1 WO 2020250611 A1 WO2020250611 A1 WO 2020250611A1 JP 2020018980 W JP2020018980 W JP 2020018980W WO 2020250611 A1 WO2020250611 A1 WO 2020250611A1
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WO
WIPO (PCT)
Prior art keywords
balloon
section
parison
groove
mold
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2020/018980
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English (en)
French (fr)
Japanese (ja)
Inventor
真弘 小嶋
良紀 中野
古賀　陽二郎
昌人 杖田
真太郎 大角
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kaneka Corp
Original Assignee
Kaneka Corp
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 Kaneka Corp filed Critical Kaneka Corp
Priority to EP20822806.4A priority Critical patent/EP3984584A4/en
Priority to US17/615,663 priority patent/US12186507B2/en
Priority to JP2021525947A priority patent/JP7428709B2/ja
Priority to CN202080042127.3A priority patent/CN114096303B/zh
Publication of WO2020250611A1 publication Critical patent/WO2020250611A1/ja
Anticipated expiration legal-status Critical
Priority to US18/964,235 priority patent/US20250090815A1/en
Ceased legal-status Critical Current

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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
    • A61M25/1027—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
    • 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
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • 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
    • 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
    • A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • 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
    • A61M2025/1088—Balloon catheters with special features or adapted for special applications having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
    • 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 balloon for a balloon catheter and a method for manufacturing a balloon catheter using a tubular resin parison.
  • a balloon catheter is used to dilate the stenosis formed in the blood vessel, and a protrusion or a blade for biting into the stenosis is preferably provided on the surface of the balloon.
  • a balloon having a convex portion and a portion where the inner surfaces of the balloons are arranged facing each other form a convex portion by welding at least a part of the adjacent inner surfaces to each other.
  • a method for producing a balloon having a process is disclosed.
  • Patent Document 2 discloses a balloon in which folds are formed as protrusions, and a mold is used to form folds in the balloon.
  • an object of the present invention is to provide a balloon and a method for manufacturing a balloon catheter for a balloon catheter, which easily cracks a calcified lesion in a stenosis or a plaque.
  • One embodiment of the balloon for a balloon catheter of the present invention that has been able to solve the above problems is a protrusion formed on the balloon body and the outer surface of the balloon body and made of the same material as the balloon body. It is characterized in that the surface roughness of the outer surface of the protruding portion is smaller than the surface roughness of the outer surface of the balloon body.
  • a balloon catheter is usually delivered to a constricted portion with a balloon folded so as to cover a protruding portion with a balloon membrane in a protective tube.
  • the coating layer attached to the outer surface of the balloon body may be peeled off.
  • the surface roughness of the protruding portion is smaller than that of the balloon body, it is possible to prevent the coating layer from peeling off even if the protruding portion comes into contact with the outer surface of the balloon body. Therefore, when the balloon is taken out of the protective tube and the catheter is used, it is possible to maintain a highly passable state in the body.
  • the protruding portion is a group located in the tip region including the radial outer end of the protruding portion and radially inward from the tip region and having a larger surface roughness than the tip region. It is preferable to have an edge region.
  • the present invention also provides a method for manufacturing a balloon catheter.
  • One embodiment of the method for manufacturing a balloon catheter of the present invention that has been able to solve the above problems is a tubular parison made of resin and a mold having a cavity into which the parison is inserted.
  • the above manufacturing method includes a step of removing the parison from the mold before the resin reaches the bottom of the first groove, the uneven shape of the inner wall surface of the first groove is transferred to the tip side of the protruding portion. Not done. Therefore, the resistance friction force when the protrusion bites into the calcified lesion or plaque formed in the stenosis can be suppressed low. As a result, it becomes easier to make cuts in calcified lesions and plaques in the stenosis, and it becomes easier to form cracks. Therefore, the stenosis can be dilated while preventing dissection of the intima of the blood vessel.
  • the protrusion formed on the outer surface of the parison after the step of inserting the resin into the first groove is a base that closes the entrance of the first groove by abutting with the inner wall surface of the first groove. It is preferable to have an end region and a tip region located on the outer side in the radial direction from the base end region and separated from the inner wall surface of the first groove.
  • the surface roughness of the tip region of the protruding portion is preferably smaller than the surface roughness of the outer surface of the parison measured after the step of inserting the resin into the first groove.
  • the above manufacturing method further includes a step of polishing the outer surface of the protruding portion. It is preferable that the manufacturing method further includes a step of sharpening the protruding portion. The manufacturing method preferably further includes a step of roughening the outer surface of the protruding portion.
  • the protruding portion extends along the longitudinal direction of the parison, and the manufacturing method further includes a step of varying the height of the protruding portion depending on the position of the parison in the longitudinal direction. Is preferable.
  • the protruding portion extends along the longitudinal direction of the parison, and the manufacturing method further includes a step of making a notch in the outer surface of the protruding portion.
  • the first groove of the mold has a contact region that is in contact with the base end region of the parison and a non-contact region that is separated from the tip region of the parison, and the contact region is , It is preferable to have an arc-shaped portion formed in an arc shape in a cross section perpendicular to the longitudinal direction of the mold.
  • the mold extends in the longitudinal direction thereof and has a first section for forming a straight tube portion of the balloon, and a first groove is formed in the first section.
  • the molds are present on both sides of the first section in the longitudinal direction thereof, the second section forming the tapered portion of the balloon, and the end side of the mold in the longitudinal direction from the second section. It has a third section that exists in the balloon and forms a sleeve portion of the balloon, and the second section is a second section on the distal side that exists at a position corresponding to the distal side of the balloon from the first section. And the second section on the proximal side, which exists at a position corresponding to the proximal side of the balloon from the first section, and the third section corresponds to the distal side of the balloon from the second section on the distal side.
  • the step of preparing the parison in the step of preparing the parison, in the step of preparing the parison having the guide portion protruding outward in the radial direction on the outer surface, and inserting the parison into the cavity of the mold. , It is preferable to arrange the guide portion in the third groove.
  • the mold exists on both sides of the first section in the longitudinal direction thereof and has a second section forming a tapered portion of the balloon, and the second section is a balloon rather than the first section. It consists of a second section on the distal side that exists at a position corresponding to the distal side of the balloon and a second section on the proximal side that exists at a position corresponding to the proximal side of the balloon from the first section. It is preferable that no groove is formed on the inner wall surface of at least one of the second section on the position side and the second section on the proximal side.
  • the first groove has a portion whose width becomes wider toward the outside in the radial direction.
  • the first groove has a portion whose width narrows outward in the radial direction.
  • the above-mentioned method for manufacturing a balloon for a balloon catheter and a balloon catheter it is possible to suppress the resistance friction force when the protruding portion of the balloon bites into a calcified lesion or plaque formed in a stenotic portion. Therefore, it becomes easy to make a cut in the calcified lesion or plaque in the stenosis part, and it becomes easy to form a crack, so that the stenosis part can be expanded while preventing the dissection of the intima of the blood vessel.
  • a side view of a balloon for a balloon catheter according to an embodiment of the present invention is shown.
  • a cross-sectional view taken along the line II-II of FIG. 1 is shown.
  • a cross-sectional view showing a modified example of FIG. 2 is shown.
  • a cross-sectional view showing an enlarged P portion of FIG. 2 is shown.
  • the perspective view of the parison before expansion which concerns on one Embodiment of this invention is shown.
  • a cross-sectional view (partial side view) showing a state in which a parison before expansion is arranged in a mold according to an embodiment of the present invention is shown.
  • the cross-sectional view of VII-VII of FIG. 6 is shown, and the cross-sectional view of the first section forming the straight tube portion of the balloon is shown.
  • FIG. 7 The cross-sectional view of the expanded state of the parison shown in FIG. 7 is shown.
  • a cross-sectional view showing an enlarged Q portion of FIG. 8 is shown.
  • a cross-sectional view of a modified example of FIG. 9 is shown.
  • a cross-sectional view of another modified example of FIG. 9 is shown.
  • the cross-sectional view of XII-XII of FIG. 6 is shown, and the cross section of the second section on the distal side forming the tapered portion on the distal side of the balloon is shown.
  • the cross-sectional view of XIII-XIII of FIG. 6 is shown, and the cross-sectional view of the proximal side second section forming the proximal side taper portion of the balloon is shown.
  • the cross-sectional view of XIV-XIV of FIG. 6 is shown, and the cross-sectional view of the third section on the distal side forming the sleeve portion on the distal side of the balloon is shown.
  • the cross-sectional view of XV-XV of FIG. 6 is shown, and the cross-sectional view of the third section on the proximal side forming the sleeve portion on the proximal side of the balloon is shown.
  • the cross-sectional view of XVI-XVI of FIG. 6 is shown, and the cross-sectional view of the fourth section on the distal side forming the outside of the sleeve on the distal side of the balloon is shown.
  • the cross-sectional view of XVII-XVII of FIG. 6 is shown, and the cross-sectional view of the fourth section on the proximal side forming the outside of the sleeve on the proximal side of the balloon is shown.
  • a balloon for a balloon catheter of the present invention comprises a balloon body and a protrusion formed on the outer surface of the balloon body and made of the same material as the balloon body. It is characterized in that the surface roughness of the outer surface of the protruding portion is smaller than the surface roughness of the outer surface of the balloon body.
  • a balloon catheter is usually delivered to a constricted portion with a balloon folded so as to cover a protruding portion with a balloon membrane in a protective tube.
  • the coating layer attached to the outer surface of the balloon body may be peeled off.
  • a balloon for a balloon catheter may be simply referred to as a "balloon".
  • FIG. 1 shows a side view of a balloon for a balloon catheter according to an embodiment of the present invention
  • FIG. 2 shows a sectional view taken along line II-II of FIG.
  • a balloon catheter is a medical device used in angioplasty (PTA, PTCA, etc.) that dilates a stenosis, which is mainly performed in the treatment of a stenosis of a blood vessel.
  • PTA angioplasty
  • PTCA PTCA
  • 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.
  • stenosis of the coronary arteries that supply blood to the heart may lead to serious diseases such as angina pectoris and myocardial infarction.
  • Angioplasty is widely used because it is a minimally invasive therapy that does not require thoracotomy such as bypass surgery.
  • the balloon catheter has a shaft and a balloon provided on the outside of the shaft.
  • the balloon catheter has a proximal side and a distal side, a balloon is provided on the distal side of the shaft, and a hub is provided on the proximal side of the shaft.
  • the proximal side of the balloon refers to the direction of the user or the operator's hand with respect to the extending direction of the balloon catheter or the longitudinal axis direction of the shaft, and the direction opposite to the distal side. That is, it points in the direction of the treatment target side. Further, the direction from the proximal side to the distal side of the balloon is referred to as a perspective direction.
  • the balloon 1 has a balloon body 6 and a protruding portion 10 formed on the outer surface 7 of the balloon body 6 and made of the same material as the balloon body 6. doing.
  • the balloon body 6 defines the basic shape of the balloon 1 and is preferably formed in a bag shape having openings on the proximal side and the distal side, respectively.
  • the protrusion 10 is preferably provided on the outer surface 7 of the balloon body 6 in a dot-like, linear, or net-like pattern.
  • the protruding portion 10 can be provided with a scoring function, and the calcified stenosis portion can be cracked and expanded in angioplasty.
  • the protruding portion 10 of the balloon 1 refers to a portion of the balloon body 6 formed to be higher in the radial direction than the film thickness at a predetermined position.
  • the predetermined position is the radial outer end 11 of the protrusion 10 in the circumferential direction of the balloon 1 as shown in FIG.
  • the circumference of the balloon 1 at the outer end 11 of the protrusions 10 adjacent to each other in the circumferential direction is as shown in FIG. It is the position B corresponding to the midpoint in the direction.
  • the maximum height of the protruding portion 10 in the radial direction is preferably 1.2 times or more, more preferably 1.5 times or more, still more preferably 2 times or more the film thickness of the balloon body 6 at the predetermined position. Yes, and it is also permissible to be 100 times or less, 50 times or less, 30 times or less, or 10 times or less. This makes it easier to make an appropriate depth of cut in the calcified lesion or plaque in the stenosis, and makes it easier to form a crack.
  • the protruding portion 10 is formed in a dot shape or a linear shape, it is preferable that the protruding portion 10 is arranged so as to extend along the perspective direction of the balloon 1. Further, the protruding portion 10 may be arranged so as to extend spirally around the center of the long axis of the balloon 1. Further, the protruding portion 10 may be arranged so as to extend along the circumferential direction of the balloon 1. As a result, the contact area between the protruding portion 10 and the narrowed portion can be adjusted, so that both the passage performance of the catheter in the body cavity and the non-slip performance of the balloon 1 with respect to the narrowed portion can be achieved at the same time.
  • the balloon 1 has a straight pipe portion 2, a tapered portion 3 located on both sides of the straight pipe portion 2, and a tapered portion 3 whose outer diameter decreases toward the end side in the perspective direction x1 and a taper.
  • the sleeve portion 4 located on the end side of the perspective direction x1 from the portion 3 and connected to the shaft of the balloon catheter, and the balloon portion 1 located on the end side of the perspective direction x1 from the sleeve portion 4 and to the shaft. It has a sleeve outer 5 that is cut before attachment.
  • the tapered portion 3 located on the distal side of the straight pipe portion 2 is referred to as the distal tapered portion 3D
  • the tapered portion 3 located on the proximal side of the straight pipe portion 2 is referred to as the proximal tapered portion 3P.
  • the sleeve portion 4 located on the distal side of the distal taper portion 3D is closer to the distal sleeve portion 4D and the sleeve portion 4 located on the proximal side of the proximal taper portion 3P. It is called the position side sleeve part 4P.
  • the sleeve outer 5 located distal to the distal sleeve portion 4D is closer to the distal sleeve outer 5D, and the sleeve outer 5 located proximal to the proximal sleeve portion 4P is closer. It is called 5P outside the sleeve on the position side.
  • the protruding portion 10 is arranged in the straight pipe portion 2. As a result, when the balloon 1 is expanded, the protruding portion 10 easily bites into the narrowed portion.
  • the protruding portion 10 may be arranged in the straight pipe portion 2 and the tapered portion 3 so that the narrowed portion is easily cracked.
  • FIG. 3 shows a cross-sectional view showing a modified example of FIG.
  • only one protrusion 10 may be provided.
  • a plurality of protruding portions 10 may be provided.
  • a plurality of protruding portions 10 are provided side by side in the circumferential direction, and more preferably they are arranged at equal intervals in the circumferential direction.
  • the plurality of protruding portions 10 are preferably arranged apart from each other in the circumferential direction, and the separation distance between the protruding portions 10 adjacent to each other in the circumferential direction is more preferably longer than the maximum peripheral length of the protruding portions 10. ..
  • the balloon body 6 and the protrusion 10 are made of the same material, it is possible to prevent the protrusion 10 from damaging the outer surface 7 of the balloon body 6 while maintaining the flexibility of the balloon 1. It is preferable that the balloon body 6 and the protruding portion 10 are integrally molded. As a result, it is possible to prevent the protruding portion 10 from falling off from the balloon body 6.
  • Such a balloon 1 can be manufactured, for example, by arranging a parison extruded by extrusion molding in a die having a groove and performing biaxial stretching blow molding. A preferred method for manufacturing a balloon will be described later in the section “2. Method for manufacturing a balloon catheter”.
  • Examples of the resin constituting the balloon body 6 and the projecting portion 10 include polyolefin resins such as polyethylene, polypropylene and ethylene-propylene copolymer, polyester resins such as polyethylene terephthalate and polyester elastomer, and polyurethane such as polyurethane and polyurethane elastomer.
  • Examples thereof include polyamide-based resins, polyphenylene sulfide-based resins, polyamide-based resins such as polyamide and polyamide elastomer, fluorine-based resins, silicone-based resins, and natural rubbers such as latex rubber. Only one of these may be used, or two or more thereof may be used in combination.
  • polyamide-based resins polyester-based resins, and polyurethane-based resins are preferably used.
  • an elastomer resin from the viewpoint of thinning the balloon 1 and flexibility.
  • nylon 12 nylon 12 is preferably used because it can be molded relatively easily during blow molding.
  • a polyamide elastomer such as a polyether ester amide elastomer and a polyamide ether elastomer is preferably used.
  • the polyether ester amide elastomer is preferably used because of its high yield strength and good dimensional stability of the balloon 1.
  • the surface roughness of the outer surface 12 of the protruding portion 10 is smaller than the surface roughness of the outer surface 7 of the balloon body 6.
  • the surface roughness of the outer surface 12 of the protruding portion 10 is preferably 0.01 times or more, more preferably 0.05 times or more, still more preferably 0, the surface roughness of the outer surface 7 of the balloon body 6.
  • the surface roughness of the outer surface 7 of the balloon body 6 is the outer surface 7 of the balloon body 6 and the position A is set as shown in FIG. Obtained by measuring the included part.
  • the surface roughness of the outer surface 7 of the balloon body 6 is a portion of the outer surface 7 of the balloon body 6 including the position B as shown in FIG. It is obtained by measuring.
  • the surface roughness of the outer surface 12 of the protruding portion 10 is the outer surface 12 of the protruding portion 10 as shown in FIGS. 2 to 3, and the outer end 11 in the radial direction of the protruding portion 10 (that is, the protruding portion 10). It is obtained by measuring the part including the tip).
  • measurement may be performed for any one of the protruding portions 10.
  • the surface roughness is the arithmetic mean roughness Ra between the reference lengths of the roughness curves on the outer surface of the balloon body 6 or the protrusion 10, and the reference length is 0.1 mm.
  • the arithmetic average roughness Ra corresponds to the arithmetic average roughness Ra defined in JIS B 0601 (2001), and is measured according to JIS B 0633 (2001).
  • a measuring machine specified in JIS B 0651 (2001) for example, a laser microscope manufactured by KEYENCE VK-9510) is used.
  • the surface roughness of the entire outer surface 12 of the protruding portion 10 is smaller than the surface roughness of the outer surface 7 of the balloon body 6. This makes it easier to make incisions in calcified lesions and plaques in the stenosis, further promoting the formation of cracks.
  • the surface roughness of the outer surface 12 of all the protrusions 10 is smaller than the surface roughness of the outer surface 7 of the balloon body 6. It is preferable that This makes it easier to make cuts in calcified lesions and plaques in the stenosis, further promoting the formation of cracks.
  • FIG. 4 shows an enlarged cross-sectional view of a portion P of the balloon 1 of FIG. 2 in which the protruding portion 10 is provided.
  • the protruding portion 10 is located in the tip region 13 including the radial outer end 11 of the protruding portion 10 and in the radial direction from the tip region 13, and is more surface than the tip region 13. It is preferable to have a proximal region 14 having a large roughness.
  • the tip region 13 makes it easier to make a cut in the calcified lesion or plaque in the stenosis, and makes it easier to form a crack, so that the stenosis can be expanded while preventing dissection of the intima of the blood vessel.
  • the resistance frictional force with the narrowed portion can be increased in the proximal region 14, the non-slip performance of the balloon 1 with respect to the narrowed portion can be improved.
  • the surface roughness of the base end region 14 is preferably 2 times or more, more preferably 3 times or more, still more preferably 5 times or more, and 20 times or less, 18 times or more the surface roughness of the tip region 13. It is also permissible to have a fold or less and a fold or less.
  • the surface roughness of the proximal region 14 may be the same as the surface roughness of the outer surface 7 of the balloon body 6, or 0.1 times or more the surface roughness of the outer surface 7 of the balloon body 6. It is preferable, more preferably 0.2 times or more, further preferably 0.3 times or more, and 0.9 times or less, 0.8 times or less, 0.7 times or less is also allowed.
  • the orientation of the molecules may be different between the distal region 13 and the proximal region 14.
  • the molecules are oriented radially outward or parallel to the movement direction of the resin during blow molding, and in the proximal region 14, the resin moves outward in the radial direction or during blow molding.
  • the molecules may be oriented in a direction perpendicular to the direction.
  • X-ray diffraction or Raman spectroscopy can be used to measure the orientation of the molecule.
  • the crystallinity may be different between the tip region 13 and the proximal region 14.
  • the crystallinity of the tip region 13 is preferably higher than the crystallinity of the base region 14. As a result, cooling strain is less likely to occur in the tip region 13 during manufacturing of the protrusion 10, so that excessive deformation of the tip region 13 can be prevented.
  • the crystallinity can be calculated from, for example, the calorific value obtained from the DSC curve obtained by differential scanning calorimetry.
  • One embodiment of the method for manufacturing a balloon catheter of the present invention is a mold having a tubular parison made of resin and a cavity into which the parison is inserted.
  • the above manufacturing method includes a step of removing the parison from the mold before the resin reaches the bottom of the first groove, the uneven shape of the inner wall surface of the first groove is transferred to the tip side of the protruding portion. Not done. Therefore, the resistance friction force when the protrusion bites into the calcified lesion or plaque formed in the stenosis can be suppressed low. As a result, it becomes easier to make cuts in calcified lesions and plaques in the stenosis, and it becomes easier to form cracks. Therefore, the stenosis can be dilated while preventing dissection of the intima of the blood vessel. Further, the balloon described in "1. Balloon for balloon catheter" can be manufactured by the above manufacturing method.
  • FIG. 5 is a perspective view of the parison before expansion according to the embodiment of the present invention
  • FIG. 6 is a cross-sectional view showing a state in which the parison before expansion is arranged in the mold according to the embodiment of the present invention. Partial side view) is shown.
  • FIG. 7 shows a cross-sectional view of VII-VII of FIG. 6, and shows a cross-sectional view of the first section forming the straight tube portion of the balloon.
  • FIG. 8 shows a cross-sectional view of the parison shown in FIG. 7 in an expanded state
  • FIG. 9 shows an enlarged cross-sectional view of the Q portion of FIG.
  • the parison 20 is a tubular member made of resin.
  • the parison 20 is made, for example, by extrusion molding.
  • the parison 20 has a first end 21 and a second end 22, extending in the longitudinal direction x2 from the first end 21 to the second end 22.
  • the cross-sectional shape of the parison 20 in the direction perpendicular to the longitudinal direction x2 may be substantially uniform in the longitudinal direction x2. This makes it possible to increase the productivity of the parison 20. Further, the cross-sectional shape of the parison 20 in the direction perpendicular to the longitudinal direction x2 may differ depending on the position in the longitudinal direction x2. The outer diameter of a part of the parison 20 in the longitudinal direction x2 (for example, a part corresponding to the straight tube part and the tapered part of the balloon) may be larger than the other part other than the part. In order to make the cross-sectional shape of the parison 20 different in the longitudinal direction x2 in this way, blow molding may be performed using another mold in advance.
  • the mold 30 has a lumen 35 into which the parison 20 is inserted. Specifically, it is preferable that a part of the parison 20 in the longitudinal direction x2 is arranged in the mold 30. As shown in FIG. 6, the mold 30 has a longitudinal direction x3 corresponding to a longitudinal direction x2 of the parison 20. In order to facilitate the arrangement of the parison 20 in the mold 30, it is preferable that the longitudinal direction x3 of the mold 30 coincides with the longitudinal direction x2 of the parison 20.
  • the mold 30 exists on both sides of the first section 31 forming the straight tube portion of the balloon and the first section 31 in the longitudinal direction x3 thereof, and forms the tapered portion of the balloon. It is preferable to have 32. Further, the mold 30 exists on the end side in the longitudinal direction x3 from the second section 32, and forms the sleeve portion of the balloon in the third section 33 and the end side in the longitudinal direction x3 from the third section 33. It may have a fourth section 34 which is present in and forms the outside of the sleeve of the balloon.
  • the second section 32 exists at a position corresponding to the distal side of the balloon from the first section 31 and a position corresponding to the proximal side of the balloon from the distal side second section 32D and the first section 31. It is preferably composed of the proximal side second section 32P.
  • the third section 33 is located at a position corresponding to the distal side of the balloon with respect to the distal second section 32D, and forms the distal sleeve portion of the balloon with the distal third section 33D and the proximal third section 33D.
  • the fourth section 34 is located at a position corresponding to the distal side of the balloon with respect to the distal third section 33D, and forms the distal sleeve outer side of the balloon with the distal fourth section 34D and the proximal side. It is preferably located at a position corresponding to the proximal side of the balloon with respect to the third section 33P, and is preferably composed of the proximal side fourth section 34P forming the outside of the proximal sleeve of the balloon.
  • the mold 30 may be formed of one member or may be formed of a plurality of members.
  • the mold 30 may be formed from a plurality of halves, or may be formed by connecting a plurality of mold members to each other in the perspective direction.
  • the mold 30 is formed of a plurality of mold members whose lumen cross-sectional shape is changed stepwise.
  • the mold 30 has a first mold 30A, a second mold 30B, a third mold 30C, a fourth mold 30D, a fifth mold 30E, and a sixth mold 30F in order from the proximal side. doing.
  • adjacent mold members may be connected by engaging with each other.
  • magnets may be attached to each of adjacent mold members and connected by attracting them to each other.
  • the cross-sectional shape of the cavity of the mold 30 can be circular, oval, polygonal, or a combination thereof.
  • the oval shape includes an elliptical shape, an egg shape, and a rectangular shape with rounded corners.
  • the first groove 41 is formed on the inner wall surface 36 forming the lumen 35 of the mold 30.
  • the parison 20 is inserted into the lumen 35 of the mold 30.
  • a fluid is introduced into the cavity 23 of the parison 20 to inflate the parison 20, and the resin is allowed to enter the first groove 41 as shown in FIG. In this way, by expanding the parison 20, the resin constituting the parison 20 enters the first groove 41, and the protruding portion 25 can be formed on the outer surface of the parison 20.
  • the protruding portion 25 of the parison 20 refers to a portion formed higher in the radial direction than the film thickness at a predetermined position of the parison 20 after expansion.
  • the above-mentioned predetermined position can be referred to by replacing “balloon body” with “parison” in the description of the predetermined position of the balloon body 6 described in "1. Balloon for balloon catheter”.
  • the inflated parison 20 can be used as a balloon for a balloon catheter.
  • a balloon catheter can be manufactured by attaching the inflated parison 20 to the distal side of the shaft.
  • first grooves 41 can be provided.
  • a plurality of first grooves 41 may be provided side by side in the circumferential direction.
  • the first grooves 41 are preferably arranged at equal intervals in the circumferential direction.
  • the first grooves 41 are preferably arranged apart from each other in the circumferential direction, and the separation distance between the first grooves 41 adjacent to each other in the circumferential direction is longer than the maximum peripheral length of the first groove 41. preferable.
  • the first groove 41 preferably extends in the longitudinal direction x3 of the mold 30.
  • the protruding portion 25 can be extended in the longitudinal direction x3 of the mold 30.
  • the depth of the first groove 41 may be the same in the longitudinal direction x3 of the mold 30, or may differ depending on the position in the longitudinal direction x3.
  • the protruding portion 25 formed on the outer surface of the parison 20 after the step of inserting the resin into the first groove 41 comes into contact with the inner wall surface of the first groove 41, so that the first groove 41 It has a proximal region 29 that closes the entrance of the first groove 41, and a distal region 28 that is located outward in the radial direction from the proximal region 29 and is separated from the inner wall surface of the first groove 41. Is preferable.
  • the tip region 28 preferably includes the radial outer end 26 of the protrusion 25. Since the base end region 29 is a portion that is in contact with the inner wall surface of the first groove 41, the uneven shape of the inner wall surface of the first groove 41 is transferred.
  • the tip region 28 is a portion separated from the inner wall surface of the first groove 41 of the mold 30, the uneven shape of the inner wall surface of the first groove 41 is not transferred.
  • the uneven shape of the outer surface of the tip region 28 and the base end region 29 of the protrusion 25 can be made different.
  • the first groove 41 preferably has a portion 41b whose width is narrowed outward in the radial direction.
  • the protruding portion 25 is easily sharpened, and the protruding portion 25 is likely to make a cut in the calcified lesion or plaque in the narrowed portion, so that a crack is easily formed.
  • the width may be narrowed outward in the radial direction over the entire depth of the first groove 41.
  • the portion 41b whose width is narrowed outward in the radial direction may be arranged on the entrance side of the first groove 41.
  • FIG. 10 shows a cross-sectional view of a modified example of FIG.
  • the first groove 41 preferably has a portion 41c whose width increases outward in the radial direction.
  • the portion 41c whose width increases outward in the radial direction is arranged on the bottom portion 41a side of the first groove 41.
  • the first groove 41 includes both a portion 41b whose width is narrowed outward in the radial direction and a portion 41c whose width is widened outward in the radial direction. You may have.
  • the portion 41c whose width is wider toward the outside in the radial direction is radially outer (that is, the first groove 41) than the portion 41b whose width is narrower toward the outside in the radial direction. It is preferably located on the bottom 41a side of the.
  • the uneven shape of the inner wall surface of the first groove 41 can be transferred to the parison 20 on the entrance side of the first groove 41 while making it difficult for the resin to reach the bottom portion 41a of the first groove 41. Therefore, it becomes easy to form the parison 20 having the tip end region 28 and the base end region 29.
  • the surface roughness of the tip region 28 of the protruding portion 25 is smaller than the surface roughness of the outer surface of the parison 20 measured after the step of inserting the resin into the first groove 41.
  • Balloon body In the measurement location of the surface roughness of the outer surface of the parison 20, refer to "balloon body” in the description of the measurement location of the surface roughness of the outer surface 7 of the balloon body 6 described in “1. Balloon for balloon catheter”. It can be read and referred to as "parison”.
  • the surface roughness is the arithmetic mean roughness Ra between the reference lengths of the roughness curves on the inner wall surface of the mold 30 or the outer surface of the parison 20, and the reference length is 0.1 mm.
  • the arithmetic average roughness Ra corresponds to the arithmetic average roughness Ra defined in JIS B 0601 (2001), and is measured according to JIS B 0633 (2001).
  • a measuring machine specified in JIS B 0651 (2001) for example, a laser microscope manufactured by KEYENCE VK-9510) is used.
  • Examples of the method for increasing the surface roughness of the inner wall surface of the mold 30 and the outer surface of the parison 20 include a method of mechanically or chemically roughening these surfaces, for example, etching, blasting, wire brushing, and the like. A method using sandpaper can be mentioned.
  • the surface roughness of the base end region 29 is preferably 2 times or more, more preferably 3 times or more, still more preferably 5 times or more, and 20 times or less, 18 times or more the surface roughness of the tip region 28. It is also permissible to make it less than double and less than 15 times.
  • the surface roughness of the proximal region 29 may be the same as the surface roughness of the outer surface of the parison 20 measured after the step of inserting the resin into the first groove 41, or the surface roughness of the outer surface of the parison 20. It is preferably 0.1 times or more, more preferably 0.2 times or more, still more preferably 0.3 times or more, and 0.9 times or less, 0.8 times or less, 0.7. It is acceptable that it is less than double.
  • the above manufacturing method further includes a step of polishing the outer surface 27 of the protruding portion 25.
  • the uneven shape of the outer surface 27 of the protruding portion 25 can be changed.
  • the tip of the protruding portion 25 may be formed sharply, and the surface roughness of the tip region 28 of the protruding portion 25 allows the resin to enter the first groove 41. It may be formed so as to be smaller than the surface roughness of the outer surface of the parison 20 measured after the step of polishing.
  • a grinder or a file can be used for polishing.
  • the above manufacturing method may further include a step of sharpening the protruding portion 25.
  • the protruding portion 25 makes it easier to make a cut in the calcified lesion or plaque in the narrowed portion, and makes it easier to form a crack. Therefore, the stenosis can be expanded while preventing the dissection of the intima of the blood vessel.
  • Examples of the method of sharpening the protruding portion 25 include a method of polishing the outer surface 27 of the protruding portion 25 and a method of sharpening the outer surface 27 of the protruding portion 25 with a laser processing device or a cutting tool.
  • the above manufacturing method may further include a step of roughening the outer surface 27 of the protruding portion 25.
  • a step of roughening the outer surface 27 of the protruding portion 25 As a result, the resistance friction force when the narrowed portion and the protruding portion 25 come into contact with each other can be increased, so that the non-slip performance of the balloon can be improved.
  • only a part of the protrusion 25 of the parison 20 in the circumferential direction may be roughened.
  • the protruding portion 25 extends along the longitudinal direction x2 of the parison 20, and further has a step of varying the height of the protruding portion 25 depending on the position of the parison 20 in the longitudinal direction x2.
  • the height of the protruding portion 25 means the height in the radial direction from the inner surface of the balloon body.
  • the protruding portion 25 extends along the longitudinal direction x2 of the parison 20 and that the manufacturing method further includes a step of making a notch in the outer surface 27 of the protruding portion 25.
  • a knife such as a cutter or a knife can be used to form the notch.
  • the protrusion 25 may be divided into a plurality of parts by making a notch.
  • One or more cuts may be provided for one protrusion 25.
  • the depth of cut may be shallower than the height of the protrusion 25. This makes it possible to prevent body fluids and the like from entering the inside of the balloon from the notched portion when the balloon formed from the expanded parison 20 is inserted into the body.
  • the width of the notch is not particularly limited, but is preferably smaller than the width of the protrusion 25.
  • the notch may be formed along the extending direction of the protruding portion 25. Above all, the notch preferably extends along the longitudinal direction x2 of the parison 20. Further, the notch may extend spirally around the center of the long axis of the parison 20. By extending the incision in this way, the passage performance of the catheter can be improved in the body cavity.
  • the notch may extend along the circumferential direction of the parison 20.
  • FIG. 11 shows a cross-sectional view showing another modification of FIG.
  • the first groove 41 of the mold 30 has a contact region 42 that is in contact with the proximal region 29 of the parison 20 and a non-contact region that is separated from the tip region 28 of the parison 20.
  • the contact region 42 preferably includes an arc-shaped portion 41d formed in an arc shape in a cross section perpendicular to the longitudinal direction x3 of the mold 30.
  • the arc-shaped portion 41d is preferably formed in a portion including the inner end in the radial direction of the contact region 42. As a result, it is possible to enhance the effect of mitigating the outer shape change from the outer surface of the parison 20 to the protruding portion 25.
  • a linear portion may be formed on the outer side in the radial direction with respect to the arcuate portion 41d.
  • the mold 30 has a first section 31 extending in the longitudinal direction x3 and forming a straight tube portion of the balloon, and the first groove 41 is formed in the first section 31. Is preferably formed.
  • the protrusion 25 can be formed on the parison 20 at a position corresponding to the straight tube portion of the balloon.
  • the mold 30 exists on both sides of the first section 31 in the longitudinal direction x3 and has a second section 32 forming a tapered portion of the balloon, and the second section 32 has a balloon more than the first section 31. It consists of a second section 32D on the distal side located at a position corresponding to the distal side of the balloon and a second section 32P on the proximal side located at a position corresponding to the proximal side of the balloon with respect to the first section 31. It is preferable that the second groove 45 is formed in at least one of the distal side second section 32D and the proximal side second section 32P of the mold 30. As a result, the second protruding portion is formed at a position corresponding to the tapered portion of the balloon, so that the non-slip performance of the balloon with respect to the narrowed portion can be improved.
  • the mold 30 exists on both sides of the first section 31 in the longitudinal direction x3 and has a second section 32 forming a tapered portion of the balloon, and the second section 32 has a balloon more than the first section 31. It consists of a second section 32D on the distal side located at a position corresponding to the distal side of the balloon and a second section 32P on the proximal side located at a position corresponding to the proximal side of the balloon with respect to the first section 31. It is preferable that no groove is formed on the inner wall surface of at least one of the distal second section 32D and the proximal second section 32P of the mold 30. As a result, since the protruding portion is not formed at the position corresponding to the tapered portion of the balloon in the parison 20, the slipperiness of the tapered portion of the balloon is appropriately ensured, and the passage performance of the balloon can be further improved.
  • the mold 30 exists on both sides of the first section 31 in the longitudinal direction x3, and exists in the second section 32 forming the tapered portion of the balloon and on the end side in the longitudinal direction x3 with respect to the second section 32. It has a third section 33 forming a sleeve portion of the balloon, and the second section 32 is a distal second section 32D located at a position corresponding to the distal side of the balloon from the first section 31. And the proximal side second section 32P existing at a position corresponding to the proximal side of the balloon from the first section 31, the third section 33 is distal to the distal side second section 32D.
  • Distal third section 33D which exists at a position corresponding to the side and forms the distal sleeve portion of the balloon
  • proximal side second section 32P which exists at a position corresponding to the proximal side of the balloon and of the balloon.
  • the first groove 41 is formed on the inner wall surface of at least one of the distal third section 33D and the proximal third section 33P of the mold 30, which is composed of the proximal third section 33P forming the proximal sleeve portion. It is preferable that the third groove 47, which is shallower than the third groove 47, is formed, and the resin reaches the bottom of the third groove 47 in the step of inserting the resin into the first groove 41.
  • a third protrusion lower than the protrusion 25 (first protrusion) can be formed at a position corresponding to the sleeve portion of the balloon in the parison 20, and the sleeve portion of the balloon passes through the body. Performance can be improved.
  • the guide portion in the step of preparing the parison 20, in the step of preparing the parison 20 having a guide portion protruding outward in the radial direction on the outer surface, and inserting the parison 20 into the lumen 35 of the mold 30. , It is preferable to arrange the guide portion in the third groove 47. As a result, when a fluid is introduced into the cavity 35 of the parison 20 to expand the parison 20, the guide portion comes into contact with the third groove 47, so that the rotation of the parison can be prevented. Therefore, the protruding portion formed on the outer surface of the balloon or the balloon body can be manufactured in a desired shape.
  • FIG. 12 represents a cross-sectional view of XII-XII of FIG. 6 and shows a cross-sectional view of the second section 32D on the distal side forming the distal taper portion of the balloon.
  • FIG. 13 shows a cross-sectional view of XIII-XIII of FIG. 6, showing a cross section of the second section 32P on the proximal side forming the proximal side tapered portion of the balloon.
  • the parison 20 in the mold 30 is omitted. As shown in FIGS.
  • the second section 32 is composed of the distal side second section 32D and the proximal side second section 32P, and is formed on the inner wall surface 36 of the proximal side second section 32P. It is preferable that the second groove 45 is formed and no groove is formed on the inner wall surface 36 of the distal second section 32D.
  • FIG. 14 represents a cross-sectional view of the XIV-XIV of FIG. 6, showing a cross-sectional view of the distal third section 33D forming the distal sleeve portion of the balloon.
  • FIG. 15 shows a cross-sectional view taken along the line XV-XV of FIG. 6, showing a cross section of the third section 33P on the proximal side forming the sleeve portion on the proximal side of the balloon.
  • the third section 33 of the mold 30 includes a third section 33D on the distal side and a third section 33P on the proximal side, and the third section 33D on the distal side.
  • the third groove 47 is formed on the inner wall surface 36 of at least one of the proximal third section 33P. In that case, it is preferable that the resin reaches the bottom of the third groove 47 in the step of inserting the resin into the first groove 41. As a result, a protrusion can be provided at a position corresponding to the sleeve portion of the balloon in the parison 20.
  • FIG. 16 represents a cross-sectional view of the XVI-XVI of FIG. 6 and shows a cross-sectional view of the fourth section 34D on the distal side forming the outside of the sleeve on the distal side of the balloon.
  • FIG. 17 shows a cross-sectional view of XVII-XVII of FIG. 6, showing a cross-sectional view of the fourth section 34P on the proximal side forming the outside of the sleeve on the proximal side of the balloon.
  • the mold 30 has a fourth section 34D on the distal side and a fourth section 34P on the proximal side, and the fourth section 34D on the distal side and the proximal side.
  • the fourth groove 49 may be formed on the inner wall surface 36 of at least one of the fourth section 34P. In that case, it is preferable that the resin reaches the bottom of the fourth groove 49 in the step of inserting the resin into the first groove 41. As a result, the protrusion can be provided at a position corresponding to the outside of the sleeve of the balloon in the parison 20.
  • the depth of the third groove 47 and the fourth groove 49 is preferably shallower than that of the first groove 41.
  • the effect of fixing the position corresponding to the sleeve portion of the balloon or the outside of the sleeve can be enhanced. Therefore, when the fluid is introduced into the cavity 23 of the parison 20 to expand the parison 20, the rotation of the parison 20 can be prevented, and the protrusion 25 can be prevented from being crushed or the like.
  • the shapes of the second groove 45 to the fourth groove 49 may be the same or different from each other.
  • the description of the first groove 41 can be referred to.
  • Balloon 2 Straight tube part 3: Tapered part 4: Sleeve part 5: Sleeve outside 6: Balloon body 7: Outer surface of balloon body 10: Protruding part 11: Outer end 12: Outer surface of protruding part 13: Tip Region 14: Proximal region A, B, C: Position 20: Parison 21: First end 22: Second end 23: Cavity 25: Protrusion 26: Outer end 27: Outer surface of protrusion 28: Tip region 29: Base end region 30: Mold 30A: First mold 30B: Second mold 30C: Third mold 30D: Fourth mold 30E: Fifth mold 30F: Sixth mold 31: First section 32: Second section 32D: Distal second section 32P: Proximal second section 33: Third section 33D: Distal third section 33P: Proximal third section 34: Fourth section 34D: Far Fourth section 34P on the position side: Fourth section 35 on the proximal side: Cavity 36: Inner wall surface forming the lumen 41: First groove 41a: Bottom 41b: The width
  • Part 41c Part 41d that widens outward in the radial direction 41d: Arc-shaped part 42: Contact area 43: Non-contact area 45: Second groove 47: Third groove 49: Fourth groove x1 : Perspective direction x2: Longitudinal direction of parison x3: Longitudinal direction of mold

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PCT/JP2020/018980 2019-06-11 2020-05-12 バルーンカテーテル用のバルーンおよびバルーンカテーテルの製造方法 Ceased WO2020250611A1 (ja)

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EP20822806.4A EP3984584A4 (en) 2019-06-11 2020-05-12 Balloon for balloon catheter and method of manufacturing balloon catheter
US17/615,663 US12186507B2 (en) 2019-06-11 2020-05-12 Balloon for balloon catheter and method for manufacturing balloon catheter
JP2021525947A JP7428709B2 (ja) 2019-06-11 2020-05-12 バルーンカテーテル用のバルーンおよびバルーンカテーテルの製造方法
CN202080042127.3A CN114096303B (zh) 2019-06-11 2020-05-12 球囊导管用球囊以及球囊导管的制造方法
US18/964,235 US20250090815A1 (en) 2019-06-11 2024-11-29 Balloon for balloon catheter and method for manufacturing balloon catheter

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US18/964,235 Division US20250090815A1 (en) 2019-06-11 2024-11-29 Balloon for balloon catheter and method for manufacturing balloon catheter

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WO2023085150A1 (ja) * 2021-11-09 2023-05-19 株式会社カネカ バルーンカテーテル
JP2023070376A (ja) * 2021-11-09 2023-05-19 株式会社カネカ バルーンカテーテル
WO2023085112A1 (ja) * 2021-11-09 2023-05-19 株式会社カネカ バルーンカテーテル
WO2023085149A1 (ja) * 2021-11-09 2023-05-19 株式会社カネカ バルーンカテーテル
JP2023137349A (ja) * 2022-03-18 2023-09-29 テルモ株式会社 バルーンカテーテルおよびバルーンの形状付け方法
WO2024029272A1 (ja) * 2022-08-02 2024-02-08 株式会社カネカ バルーンカテーテル用バルーン及びそれを備えるバルーンカテーテル、並びにバルーンカテーテルの製造方法
WO2024042977A1 (ja) * 2022-08-24 2024-02-29 株式会社カネカ バルーンカテーテル用バルーン及びそれを備えるバルーンカテーテル
WO2024042978A1 (ja) * 2022-08-24 2024-02-29 株式会社カネカ バルーンカテーテル用バルーン及びそれを備えるバルーンカテーテル
JP2024034136A (ja) * 2022-08-31 2024-03-13 株式会社カネカ バルーンカテーテルの製造方法
JP2024034134A (ja) * 2022-08-31 2024-03-13 株式会社カネカ バルーンカテーテルの製造方法
JP2024034135A (ja) * 2022-08-31 2024-03-13 株式会社カネカ バルーンカテーテルの製造方法
WO2024116710A1 (ja) * 2022-11-30 2024-06-06 株式会社グッドマン バルーンカテーテル及びバルーンカテーテルの製造方法

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WO2024042978A1 (ja) * 2022-08-24 2024-02-29 株式会社カネカ バルーンカテーテル用バルーン及びそれを備えるバルーンカテーテル
WO2024042977A1 (ja) * 2022-08-24 2024-02-29 株式会社カネカ バルーンカテーテル用バルーン及びそれを備えるバルーンカテーテル
JP2024034136A (ja) * 2022-08-31 2024-03-13 株式会社カネカ バルーンカテーテルの製造方法
JP2024034134A (ja) * 2022-08-31 2024-03-13 株式会社カネカ バルーンカテーテルの製造方法
JP2024034135A (ja) * 2022-08-31 2024-03-13 株式会社カネカ バルーンカテーテルの製造方法
JP7841994B2 (ja) 2022-08-31 2026-04-07 株式会社カネカ バルーンカテーテルの製造方法
JP7853177B2 (ja) 2022-08-31 2026-04-28 株式会社カネカ バルーンカテーテルの製造方法
WO2024116710A1 (ja) * 2022-11-30 2024-06-06 株式会社グッドマン バルーンカテーテル及びバルーンカテーテルの製造方法
JPWO2024116710A1 (https=) * 2022-11-30 2024-06-06
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