CN114366998A - Preparation process of variable-diameter intracranial balloon - Google Patents

Preparation process of variable-diameter intracranial balloon Download PDF

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Publication number
CN114366998A
CN114366998A CN202210061560.2A CN202210061560A CN114366998A CN 114366998 A CN114366998 A CN 114366998A CN 202210061560 A CN202210061560 A CN 202210061560A CN 114366998 A CN114366998 A CN 114366998A
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China
Prior art keywords
balloon
variable
tube
diameter
welding
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Pending
Application number
CN202210061560.2A
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Chinese (zh)
Inventor
方晟东
涂坚慧
周雁飞
涂迎春
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Huizhou Shunmei Medical Technology Co ltd
Shenzhen Shunmei Medical Co ltd
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Shenzhen Shunmei Medical Co ltd
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Priority to CN202210061560.2A priority Critical patent/CN114366998A/en
Publication of CN114366998A publication Critical patent/CN114366998A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • A61M25/1029Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • A61M25/1034Joining of shaft and balloon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • A61M25/1036Making parts for balloon catheter systems, e.g. shafts or distal ends
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • A61M25/1038Wrapping or folding devices for use with balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • A61M25/1029Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A61M2025/1031Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/06Head
    • A61M2210/0687Skull, cranium

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

Abstract

The invention discloses a preparation process of a variable-diameter intracranial balloon, wherein the preparation process of the variable-diameter intracranial balloon comprises the steps of carrying out extrusion molding on mixed material particles and forming an outer tube; stretching the variable-diameter section in the outer pipe in a stretching die; welding the outer tube to the near end of the balloon, and highlighting the variable-diameter section; welding an inner tube at the far end of the balloon, and performing tip molding on the inner tube; coating hydrophilic coatings on the balloon, the outer tube and the inner tube; the balloon is folded, a protective tube and a lining wire are sleeved on the balloon to form a variable-diameter intracranial balloon, wherein the variable-diameter section of the outer tube is protruded from the balloon and is welded at the near end of the balloon through the outer tube, and the balloon is folded so as to ensure the flexibility, the compliance and the pressure resistance of the balloon, can pass through narrow blood vessels or tiny blood vessels and is adaptive to passing spaces of various blood vessels.

Description

Preparation process of variable-diameter intracranial balloon
Technical Field
The invention relates to the technical field of a preparation process of a variable-diameter intracranial balloon, in particular to a preparation process of a variable-diameter intracranial balloon.
Background
With the development of science and technology, a common intracranial balloon is applied to various blood vessels and is formed by connecting the balloon with various pipelines, wherein various pipelines are welded on the balloon, but the pipelines are not subjected to diameter-changing treatment in the processing process, so that the existing common intracranial balloon cannot adapt to the spaces of various blood vessels.
Disclosure of Invention
In order to solve the technical problems, the invention adopts the following technical scheme:
according to one aspect of the invention, the invention provides a process for preparing a variable-diameter intracranial balloon, which comprises the following steps:
performing extrusion molding on the mixed material particles to form an outer pipe;
stretching the variable-diameter section in the outer pipe in a stretching die;
welding the outer tube to the near end of the balloon, and highlighting the variable-diameter section;
welding an inner tube at the far end of the balloon, and performing tip molding on the inner tube;
coating hydrophilic coatings on the balloon, the outer tube and the inner tube;
and folding the saccule, and sleeving a protective tube and a lining wire to form the variable-diameter intracranial saccule.
Optionally, the extruding the mixture granules and forming the outer tube includes:
nylon11 and Pebax7233 were mixed at 6: 4, mixing to form a first mixture;
performing extrusion molding on the first mixture in a first extrusion molding die to form an outer tube, wherein the extrusion temperature is 190 ℃, and the cooling temperature is 28 ℃;
the outer tube had an inner diameter of 0.72mm and an outer diameter of 0.85 mm.
Optionally, the welding the outer tube to the proximal end of the balloon and highlighting the tapered section comprises:
pebax7033 and Pebax6333 were mixed at 8: 2, mixing to form a second mixture;
performing extrusion molding on the second mixture in a second extrusion molding die to form the balloon, wherein the extrusion molding temperature is 180 ℃, and the cooling temperature is 25 ℃;
the inner diameter of the material pipe of the balloon is 0.17mm, and the outer diameter is 0.30 mm.
Optionally, the welding the inner tube to the distal end of the balloon, and performing tip shaping on the inner tube, includes:
carrying out oven treatment on the inner tube, and welding the inner tube and the tip tube;
carrying out developing ring pressing and holding on the inner tube and the tip tube;
and welding the formed inner tube to the far end of the balloon.
Optionally, after welding the inner tube to the distal end of the balloon and performing tip shaping on the inner tube, the method further includes:
welding a wire guide opening of the inner pipe;
sleeving the outer sleeve with a pressure reducing pipe and performing transition welding;
the balloon was subjected to a positive pressure test.
Optionally, the folding the balloon and sleeving the protective tube and the lining wire to form the variable-diameter intracranial balloon, includes:
folding the balloon;
sleeving a protection tube and a lining wire on the folded balloon;
and carrying out negative pressure side leakage test on the saccule which is sleeved with the protective tube and the lining wire.
Optionally, the folding of the balloon and the sleeving of the protective tube and the lining wire to form the variable-diameter intracranial balloon further include:
cutting the protective tube, and adapting to the length of the folded saccule;
the opening of the protective tube is widened.
Optionally, the folding of the balloon and the sleeving of the protective tube and the lining wire to form the variable-diameter intracranial balloon further include:
and (4) filling the saccule subjected to the negative pressure side leakage test into a coil pipe, and packaging.
According to the technical scheme, the embodiment of the invention at least has the following advantages and positive effects:
in the preparation process of the variable-diameter intracranial balloon, the mixed material particles are subjected to extrusion molding to form an outer tube; stretching the variable-diameter section in the outer pipe in a stretching die; welding the outer tube to the near end of the balloon, and highlighting the variable-diameter section; welding an inner tube at the far end of the balloon, and performing tip molding on the inner tube; coating hydrophilic coatings on the balloon, the outer tube and the inner tube; the balloon is folded, a protective tube and a lining wire are sleeved on the balloon to form a variable-diameter intracranial balloon, wherein the variable-diameter section of the outer tube is protruded from the balloon and is welded at the near end of the balloon through the outer tube, and the balloon is folded so as to ensure the flexibility, the compliance and the pressure resistance of the balloon, can pass through narrow blood vessels or tiny blood vessels and is adaptive to passing spaces of various blood vessels.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the structures shown in the drawings without creative efforts.
FIG. 1 is a schematic view of a process for making a variable-diameter intracranial balloon according to the present invention;
the implementation, functional features and advantages of the objects of the present invention will be further explained with reference to the accompanying drawings.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It should be noted that all the directional indicators (such as up, down, left, right, front, and rear … …) in the embodiment of the present invention are only used to explain the relative position relationship between the components, the movement situation, etc. in a specific posture (as shown in the drawing), and if the specific posture is changed, the directional indicator is changed accordingly.
In the present invention, unless otherwise expressly stated or limited, the terms "connected," "secured," and the like are to be construed broadly, and for example, "secured" may be a fixed connection, a removable connection, or an integral part; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
In addition, if there is a description of "first", "second", etc. in an embodiment of the present invention, the description of "first", "second", etc. is for descriptive purposes only and is not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In addition, the meaning of "and/or" appearing throughout includes three juxtapositions, exemplified by "A and/or B" including either A or B or both A and B. In addition, technical solutions between various embodiments may be combined with each other, but must be realized by a person skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination should not be considered to exist, and is not within the protection scope of the present invention.
With the development of science and technology, a common intracranial balloon is applied to various blood vessels and is formed by connecting the balloon with various pipelines, wherein various pipelines are welded on the balloon, but the pipelines are not subjected to diameter-changing treatment in the processing process, so that the existing common intracranial balloon machine cannot adapt to the spaces of various blood vessels.
Referring to fig. 1, the invention provides a process for preparing a variable-diameter intracranial balloon, which comprises the following steps:
step S11, performing extrusion molding on the mixture particles to form an outer tube;
step S12, stretching the variable-diameter section in the outer pipe in a stretching die;
step S13, welding the outer tube to the near end of the balloon, and highlighting the variable-diameter section;
step S14, welding an inner tube at the far end of the balloon, and performing tip molding on the inner tube;
step S15, coating hydrophilic coatings on the balloon, the outer tube and the inner tube;
and step S16, folding the balloon, and sleeving a protection tube and a lining wire to form the variable-diameter intracranial balloon.
In the preparation process of the variable-diameter intracranial balloon, the mixed material particles are subjected to extrusion molding to form an outer tube; stretching the variable-diameter section in the outer pipe in a stretching die; welding the outer tube to the near end of the balloon, and highlighting the variable-diameter section; welding an inner tube at the far end of the balloon, and performing tip molding on the inner tube; coating hydrophilic coatings on the balloon, the outer tube and the inner tube; the balloon is folded, a protective tube and a lining wire are sleeved on the balloon to form a variable-diameter intracranial balloon, wherein the variable-diameter section of the outer tube is protruded from the balloon and is welded at the near end of the balloon through the outer tube, and the balloon is folded so as to ensure the flexibility, the compliance and the pressure resistance of the balloon, can pass through narrow blood vessels or tiny blood vessels and is adaptive to passing spaces of various blood vessels.
In step S11; carry out extrusion molding with the mixture grain to form the outer tube, specifically include:
nylon11 and Pebax7233 were mixed at 6: 4, mixing to form a first mixture;
performing extrusion molding on the first mixture in a first extrusion molding die to form an outer tube, wherein the extrusion temperature is 190 ℃, and the cooling temperature is 28 ℃;
the outer tube had an inner diameter of 0.72mm and an outer diameter of 0.85 mm.
In step S12; the variable-diameter section in the outer tube is stretched in a stretching die, wherein the variable-diameter section of the outer tube is stretched to have a variable-diameter function, so that the variable-diameter intracranial balloon can conveniently pass through a narrow blood vessel or a tiny blood vessel and is adaptive to passing spaces of various blood vessels.
In step S13; the welding of outer tube in the near-end of sacculus to highlight the reducing section specifically includes:
pebax7033 and Pebax6333 were mixed at 8: 2, mixing to form a second mixture;
performing extrusion molding on the second mixture in a second extrusion molding die to form the balloon, wherein the extrusion molding temperature is 180 ℃, and the cooling temperature is 25 ℃;
the inner diameter of the material pipe of the balloon is 0.17mm, and the outer diameter is 0.30 mm.
In step S14, welding the inner tube to the distal end of the balloon, and performing tip molding on the inner tube, specifically including:
carrying out oven treatment on the inner tube, and welding the inner tube and the tip tube;
carrying out developing ring pressing and holding on the inner tube and the tip tube;
and welding the formed inner tube to the far end of the balloon.
In addition, after welding the inner tube to the distal end of the balloon and performing tip shaping on the inner tube, the method further comprises the following steps:
welding a wire guide opening of the inner pipe;
sleeving the outer sleeve with a pressure reducing pipe and performing transition welding;
the balloon was subjected to a positive pressure test.
In step S15, the balloon, the outer tube and the inner tube are coated with a hydrophilic coating, wherein the hydrophilic coating covers the balloon, the outer tube and the inner tube, so that the balloon, the outer tube and the inner tube can swim to the vascular space under the action of the hydrophilic coating.
In step S16, folding the balloon, and sleeving a protection tube and a lining wire to form a variable diameter intracranial balloon, specifically comprising:
folding the balloon;
sleeving a protection tube and a lining wire on the folded balloon;
and carrying out negative pressure side leakage test on the saccule which is sleeved with the protective tube and the lining wire.
Optionally, the folding of the balloon and the sleeving of the protective tube and the lining wire to form the variable-diameter intracranial balloon further include:
cutting the protective tube, and adapting to the length of the folded saccule;
the opening of the protective tube is widened.
Optionally, the folding of the balloon and the sleeving of the protective tube and the lining wire to form the variable-diameter intracranial balloon further include:
and (4) filling the saccule subjected to the negative pressure side leakage test into a coil pipe, and packaging.
According to the technical scheme, the embodiment of the invention at least has the following advantages and positive effects:
in the preparation process of the variable-diameter intracranial balloon, the mixed material particles are subjected to extrusion molding to form an outer tube; stretching the variable-diameter section in the outer pipe in a stretching die; welding the outer tube to the near end of the balloon, and highlighting the variable-diameter section; welding an inner tube at the far end of the balloon, and performing tip molding on the inner tube; coating hydrophilic coatings on the balloon, the outer tube and the inner tube; the balloon is folded, a protective tube and a lining wire are sleeved on the balloon to form a variable-diameter intracranial balloon, wherein the variable-diameter section of the outer tube is protruded from the balloon and is welded at the near end of the balloon through the outer tube, and the balloon is folded so as to ensure the flexibility, the compliance and the pressure resistance of the balloon, can pass through narrow blood vessels or tiny blood vessels and is adaptive to passing spaces of various blood vessels.
The above description is only an alternative embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications and equivalents of the present invention, which are made by the contents of the present specification and the accompanying drawings, or directly/indirectly applied to other related technical fields, are included in the scope of the present invention.

Claims (8)

1. A preparation process of a variable-diameter intracranial balloon is characterized by comprising the following steps of:
performing extrusion molding on the mixed material particles to form an outer pipe;
stretching the variable-diameter section in the outer pipe in a stretching die;
welding the outer tube to the near end of the balloon, and highlighting the variable-diameter section;
welding an inner tube at the far end of the balloon, and performing tip molding on the inner tube;
coating hydrophilic coatings on the balloon, the outer tube and the inner tube;
and folding the saccule, and sleeving a protective tube and a lining wire to form the variable-diameter intracranial saccule.
2. The process for preparing a variable diameter intracranial balloon as in claim 1, wherein the extruding the mixed pellet and forming the outer tube comprises:
nylon11 and Pebax7233 were mixed at 6: 4, mixing to form a first mixture;
performing extrusion molding on the first mixture in a first extrusion molding die to form an outer tube, wherein the extrusion temperature is 190 ℃, and the cooling temperature is 28 ℃;
the outer tube had an inner diameter of 0.72mm and an outer diameter of 0.85 mm.
3. The process for preparing a variable-diameter intracranial balloon according to claim 1, wherein the welding of the outer tube to the proximal end of the balloon and the highlighting of the variable-diameter section comprises:
pebax7033 and Pebax6333 were mixed at 8: 2, mixing to form a second mixture;
performing extrusion molding on the second mixture in a second extrusion molding die to form the balloon, wherein the extrusion molding temperature is 180 ℃, and the cooling temperature is 25 ℃;
the inner diameter of the material pipe of the balloon is 0.17mm, and the outer diameter is 0.30 mm.
4. The process for preparing a variable diameter intracranial balloon according to claim 1, wherein welding an inner tube to the distal end of the balloon and tip-forming the inner tube comprises:
carrying out oven treatment on the inner tube, and welding the inner tube and the tip tube;
carrying out developing ring pressing and holding on the inner tube and the tip tube;
and welding the formed inner tube to the far end of the balloon.
5. The process for preparing a variable diameter intracranial balloon according to claim 4, wherein the welding the inner tube to the distal end of the balloon and the tip-forming the inner tube further comprises:
welding a wire guide opening of the inner pipe;
sleeving the outer sleeve with a pressure reducing pipe and performing transition welding;
the balloon was subjected to a positive pressure test.
6. The process for preparing a variable diameter intracranial balloon as defined in claim 1, wherein folding the balloon and sleeving a protective tube and a liner wire to form the variable diameter intracranial balloon comprises:
folding the balloon;
sleeving a protection tube and a lining wire on the folded balloon;
and carrying out negative pressure side leakage test on the saccule which is sleeved with the protective tube and the lining wire.
7. The method of manufacturing a variable diameter intracranial balloon as recited in claim 6, wherein the folding the balloon and sleeving the protective tube and the liner wire to form the variable diameter intracranial balloon further comprises:
cutting the protective tube, and adapting to the length of the folded saccule;
the opening of the protective tube is widened.
8. The method of manufacturing a variable diameter intracranial balloon as recited in claim 6, wherein the folding the balloon and sleeving the protective tube and the liner wire to form the variable diameter intracranial balloon further comprises:
and (4) filling the saccule subjected to the negative pressure side leakage test into a coil pipe, and packaging.
CN202210061560.2A 2022-01-19 2022-01-19 Preparation process of variable-diameter intracranial balloon Pending CN114366998A (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1023913A1 (en) * 1997-10-08 2000-08-02 Kaneka Corporation Balloon catheter and method of production thereof
CN104936629A (en) * 2012-10-26 2015-09-23 优敦力公司 Drug coated balloon catheters for nonvascular strictures
CN108888849A (en) * 2018-03-26 2018-11-27 安徽富美医疗科技有限公司 A kind of PTA sacculus dilating catheter and its manufacturing process
CN208259999U (en) * 2018-09-30 2018-12-21 上海英诺伟医疗器械有限公司 Variable diameter expansion of balloon catheter
CN214074662U (en) * 2020-10-30 2021-08-31 威高奋威健康科技发展(上海)有限公司 High-pressure-resistance low-compliance balloon dilatation catheter

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1023913A1 (en) * 1997-10-08 2000-08-02 Kaneka Corporation Balloon catheter and method of production thereof
CN104936629A (en) * 2012-10-26 2015-09-23 优敦力公司 Drug coated balloon catheters for nonvascular strictures
CN108888849A (en) * 2018-03-26 2018-11-27 安徽富美医疗科技有限公司 A kind of PTA sacculus dilating catheter and its manufacturing process
CN208259999U (en) * 2018-09-30 2018-12-21 上海英诺伟医疗器械有限公司 Variable diameter expansion of balloon catheter
CN214074662U (en) * 2020-10-30 2021-08-31 威高奋威健康科技发展(上海)有限公司 High-pressure-resistance low-compliance balloon dilatation catheter

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