CN111012999A - Small-diameter balloon catheter and manufacturing method thereof - Google Patents

Small-diameter balloon catheter and manufacturing method thereof Download PDF

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Publication number
CN111012999A
CN111012999A CN201911315408.7A CN201911315408A CN111012999A CN 111012999 A CN111012999 A CN 111012999A CN 201911315408 A CN201911315408 A CN 201911315408A CN 111012999 A CN111012999 A CN 111012999A
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China
Prior art keywords
expansion
cavity channel
balloon
finished material
side cavity
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CN201911315408.7A
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Chinese (zh)
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CN111012999B (en
Inventor
施猛
刘兴华
李好雨
高飞
王文渊
杨中科
施磊
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Sichuan Yangzijiang Medical Instrument Co ltd
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Sichuan Hairong Pharmaceutical Co Ltd Yangtze River Pharmaceutical Group
Sichuan Haihui Pharmaceutical Co ltd
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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
    • A61M25/104Balloon 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
    • A61M25/1006Balloons formed between concentric tubes
    • 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
    • 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
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • 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
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1079Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon

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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)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Vascular Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention discloses a small-diameter balloon catheter and a manufacturing method thereof, and the small-diameter balloon catheter comprises a catheter body, wherein a catheter seat is arranged at the tail end of the catheter body, and an expansion balloon is sleeved on the periphery of the head of the catheter body; the tube body comprises a main cavity channel and a side cavity channel, the side cavity channel is communicated with the expansion saccule, and the main cavity channel is communicated with the head end of the tube body; the catheter seat comprises a main cavity joint and a side cavity joint, the main cavity joint is communicated with the main cavity channel, and the side cavity joint is communicated with the side cavity channel; the expansion sacculus and the pipe body are coaxially arranged, the two ends of the expansion sacculus are fixedly connected with the outer wall of the pipe body, and the expansion sacculus is internally provided with a developing mark. The invention has small product size, easy control of product quality and high yield.

Description

Small-diameter balloon catheter and manufacturing method thereof
Technical Field
The invention relates to the field of medical instruments, in particular to a small-diameter balloon catheter and a manufacturing method thereof.
Background
In China, the number of people with cardiovascular diseases is extremely high, wherein more than 1300 ten thousand of cerebral apoplexy and more than 1100 ten thousand of coronary heart disease occur. The number of PCI operations in China in 2018 is 91.5 ten thousand. The stent penetration rate is as high as 90%, and the treatment operation of cerebrovascular stenosis is also carried out in large quantities every year. At present, the endovascular stenosis and obstruction lesions are treated mainly by endovascular balloon dilatation and stent implantation.
Balloon catheters are a tool for angioplasty. Under the guidance of medical imaging equipment, a balloon catheter is conveyed to a narrow part of a blood vessel by a percutaneous puncture technology, and the balloon is expanded under strict monitoring to expand the narrow part of the blood vessel, so that the diameter of a lumen is recovered, the blood flow is improved, and the stent is convenient to implant. After the stent is implanted successfully, the balloon is expanded to prevent restenosis.
The balloon catheter is an indispensable medical instrument for vascular interventional therapy. Under the condition of the existing production process, the forming rate of the small-diameter saccule with the diameter of 1.0-10.0mm is extremely low, and the saccule is broken in the manufacturing and forming process, the detection and expansion process of the saccule, the rupture during clinical use and the like. Raw materials are greatly wasted, mass production is not facilitated, and risks in clinical operations are increased. Through the extrusion of analysis sacculus material pipe among the current technological process, it is the biggest to the preparation of sacculus influence, exists like in extruding: deformation, eccentricity, shrinkage, protrusion, rough surface, microcrack and the like also seriously affect the forming rate and performance of the later-stage balloon.
Disclosure of Invention
The invention aims to provide a small-diameter balloon catheter and a manufacturing method thereof, which have the advantages of stable pressure resistance value, easy control of product quality and high yield.
In order to achieve the purpose, the invention is realized by adopting the following technical scheme:
the invention discloses a small-diameter balloon catheter which comprises a catheter body, wherein a catheter seat is arranged at the tail end of the catheter body, and an expansion balloon is sleeved on the periphery of the head of the catheter body;
the tube body comprises a main cavity channel and a side cavity channel, the side cavity channel is communicated with the expansion saccule, and the main cavity channel is communicated with the head end of the tube body;
the catheter seat comprises a main cavity joint and a side cavity joint, the main cavity joint is communicated with the main cavity channel, and the side cavity joint is communicated with the side cavity channel;
the expansion saccule and the pipe body are coaxially arranged, two ends of the expansion saccule are fixedly connected with the outer wall of the pipe body, a developing mark is arranged in the expansion saccule,
the diameter of the expansion saccule is 0.8 mm-2.0 mm under the folding state,
the diameter of the expansion saccule is 1.0 mm-10.0 mm under the expansion state.
Preferably, the head end of the pipe body is of a conical structure.
Preferably, the developing marks are arranged on the outer wall of the pipe body, and the two developing marks are arranged along the axial direction of the pipe body.
Preferably, the side cavity channel is provided in the side wall of the tube body.
Preferably, the side cavity channel is sleeved outside the main cavity channel, and the side cavity channel and the main cavity channel are coaxially arranged.
Preferably, the outer surface of the dilatation balloon is provided with a drug coating.
The invention also discloses a manufacturing method of the small-diameter balloon catheter, which comprises the following steps:
s100, co-extruding a core rod and a balloon material with fixed sizes to obtain a semi-finished material pipe;
s200, rolling the extruded semi-finished material pipe by using a roller, controlling the outer diameter and the surface smoothness of the semi-finished material pipe, and removing micro-defects and cracks to obtain a finished material pipe;
s300, extracting the core rod, and reserving a finished material pipe;
s400, blow-molding a finished material pipe in a balloon mold with a specific shape to obtain an expanded balloon;
s500, assembling the obtained expansion balloon, the tube body and the catheter seat, and spraying the medicine on the surface of the balloon by using spraying equipment to obtain the small-diameter balloon catheter.
Preferably, in step S100, the balloon material is plastic or a composite thereof, including but not limited to nylon.
Preferably, in step S100, the mandrel with a fixed size may be a single component metal mandrel, an alloy metal mandrel, a plastic mandrel, a composite material mandrel, or the like.
Preferably, in step S200, the semi-finished material tube is rolled for a plurality of times, and the adjacent roller pairs are arranged in an inclined manner, that is, in a non-parallel manner.
Preferably, in step S200, the semi-finished material tube is rolled for multiple times, and the adjacent roller pairs are arranged in parallel.
Preferably, after step S200, the semi-finished material tube is cooled to obtain a finished material tube.
Preferably, in step S200, the rolling temperature is 0-400 ℃.
Preferably, in step S200, the rolling mode is normal temperature rolling.
Preferably, in step S200, the rolling mode is high-temperature rolling.
Preferably, in step S200, the rolled roll profile may be cylindrical.
Preferably, in step S200, the rolled roll profile may be a profiled roll.
Preferably, in step S200, the rolled surface of the roll may be a profile hole rolled.
Preferably, in step S400, the temperature of the hot roll is 0 to 400 ℃.
The invention has the beneficial effects that:
1. the invention can manufacture the balloon catheter with smaller diameter under the condition of ensuring the yield and the product quality.
2. The invention uses the roller technology to manufacture the material pipe, can ensure to reduce the conditions of deformation, eccentricity, shrinkage, bulge, rough surface, microcrack and the like in the production process, improves the yield and the reliability of the device, improves the dimensional precision of the balloon material pipe, and is convenient for controlling the size during extrusion.
Drawings
FIG. 1 is a cross-sectional view of a first embodiment of a small diameter balloon catheter;
FIG. 2 is a cross-sectional view taken along line A-A in FIG. 1
FIG. 3 is a cross-sectional view of a second embodiment of a small diameter balloon catheter;
fig. 4 is a sectional view of B-B in fig. 3.
In the figure: 1-tube body, 2-catheter seat, 3-expansion balloon, 4-main cavity channel, 5-side cavity channel, 6-main cavity joint, 7-side cavity joint and 8-developing mark.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to the accompanying drawings.
As shown in fig. 1 and 2, an embodiment of the small-diameter balloon catheter includes a catheter body 1, a catheter seat 2 is arranged at the tail end of the catheter body 1, and an expansion balloon 3 is sleeved on the periphery of the head of the catheter body 1;
the tube body 1 comprises a main cavity channel 4 and a side cavity channel 5, the side cavity channel 5 is communicated with the expansion saccule 3, the main cavity channel 4 is communicated with the head end of the tube body 1, and the head end of the tube body 1 is of a conical structure;
the catheter seat 2 comprises a main cavity joint 6 and a side cavity joint 7, the main cavity joint 6 is communicated with the main cavity channel 4, the side cavity joint 7 is communicated with the side cavity channel 5, and the side cavity channel 5 is arranged in the side wall of the catheter body 1;
the expansion sacculus 3 is arranged coaxially with the pipe body 1, two ends of the expansion sacculus 3 are fixedly connected with the outer wall of the pipe body 1, the development marks 8 are arranged in the expansion sacculus 3, the development marks 8 are arranged on the outer wall of the pipe body 1, the two development marks 8 are arranged along the axial direction of the pipe body 1,
the diameter of the expansion saccule 3 is 0.8 mm-2.0 mm under the folding state,
the diameter of the expansion saccule 3 is 1.0 mm-10.0 mm under the expansion state,
the outer surface of the expansion saccule 3 is provided with a drug coating, such as paclitaxel, rapamycin, paclitaxel derivatives or rapamycin derivatives.
As shown in fig. 3 and 4, the second embodiment of the small-diameter balloon catheter differs from the first embodiment in that the side cavity channel 5 is sleeved outside the main cavity channel 4, and the side cavity channel 5 and the main cavity channel 4 are coaxially arranged.
The manufacturing method of the small-diameter balloon catheter comprises the following steps:
s100, co-extruding a core rod and a balloon material with fixed sizes to obtain a semi-finished material pipe;
s200, rolling the extruded semi-finished material pipe by using a roller, controlling the outer diameter and the surface smoothness of the semi-finished material pipe, and removing micro-defects and cracks to obtain a finished material pipe;
s300, extracting the core rod, and reserving a finished material pipe;
s400, blow-molding a finished material pipe in a balloon mold with a specific shape to obtain an expansion balloon 3;
s500, assembling the obtained expansion balloon 3, the tube body 1 and the catheter seat 2, and spraying the medicine on the surface of the expansion balloon 3 by using spraying equipment to obtain the small-diameter balloon catheter.
In order to ensure that the thickness of the expansion balloon 3 is uniform, in step S200, the semi-finished material tube is rolled for a plurality of times, and the adjacent roller pairs are arranged at a certain angle, such as a right angle, an acute angle, and the like.
The present invention is capable of other embodiments, and various changes and modifications may be made by one skilled in the art without departing from the spirit and scope of the invention.

Claims (10)

1. A small diameter balloon catheter characterized by: comprises a tube body (1), a catheter seat (2) is arranged at the tail end of the tube body (1), and an expansion balloon (3) is sleeved on the periphery of the head of the tube body (1);
the tube body (1) comprises a main cavity channel (4) and a side cavity channel (5), the side cavity channel (5) is communicated with the expansion saccule (3), and the main cavity channel (4) is communicated with the head end of the tube body (1);
the catheter seat (2) comprises a main cavity joint (6) and a side cavity joint (7), the main cavity joint (6) is communicated with the main cavity channel (4), and the side cavity joint (7) is communicated with the side cavity channel (5);
the expansion saccule (3) and the pipe body (1) are coaxially arranged, two ends of the expansion saccule (3) are fixedly connected with the outer wall of the pipe body (1), a developing mark (8) is arranged in the expansion saccule (3),
the diameter of the expansion saccule (3) is 0.8 mm-2.0 mm under the folding state,
the diameter of the expansion saccule (3) is 1.0 mm-10.0 mm under the expansion state.
2. The small diameter balloon catheter according to claim 1, wherein: the head end of the pipe body (1) is of a conical structure.
3. The small diameter balloon catheter according to claim 1, wherein: the developing marks (8) are arranged on the outer wall of the pipe body (1), and the two developing marks (8) are arranged along the axial direction of the pipe body (1).
4. The small diameter balloon catheter according to claim 1, wherein: the side cavity channel (5) is arranged in the side wall of the tube body (1).
5. The small diameter balloon catheter according to claim 1, wherein: the side cavity channel (5) is sleeved outside the main cavity channel (4), and the side cavity channel (5) and the main cavity channel (4) are coaxially arranged.
6. The small diameter balloon catheter according to claim 1, wherein: the outer surface of the expansion sacculus (3) is provided with a medicine coating.
7. The method of manufacturing a small diameter balloon catheter according to any one of claims 1 to 6, characterized by comprising the steps of:
s100, extruding raw materials by using a core rod and a balloon material tube with fixed sizes, and co-extruding to obtain a semi-finished material tube;
s200, rolling the extruded semi-finished material pipe by using a roller, controlling the outer diameter and the surface smoothness of the semi-finished material pipe, and removing micro-defects and cracks to obtain a finished material pipe;
s300, extracting the core rod, and reserving a finished material pipe;
s400, blow-molding a finished material pipe in a balloon mold with a specific shape to obtain an expansion balloon (3);
s500, assembling the obtained expansion balloon (3), the tube body (1) and the catheter seat (2), and spraying a medicine on the surface of the expansion balloon (3) by using a spraying device to obtain the small-diameter balloon catheter.
8. The manufacturing method according to claim 7, characterized in that: in step S200, the semi-finished material pipe is rolled for a plurality of times, and the adjacent roller pairs are arranged in an inclined manner.
9. The manufacturing method according to claim 7, characterized in that: and after the step S200, cooling the semi-finished material pipe to obtain a finished material pipe.
10. The manufacturing method according to claim 7, characterized in that: in step S200, the rolling temperature is 0-400 ℃.
CN201911315408.7A 2019-12-18 2019-12-18 Small-diameter balloon catheter and manufacturing method thereof Active CN111012999B (en)

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Application Number Priority Date Filing Date Title
CN201911315408.7A CN111012999B (en) 2019-12-18 2019-12-18 Small-diameter balloon catheter and manufacturing method thereof

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Application Number Priority Date Filing Date Title
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CN111012999B CN111012999B (en) 2024-04-19

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5833657A (en) * 1995-05-30 1998-11-10 Ethicon, Inc. Single-walled balloon catheter with non-linear compliance characteristic
CN201350280Y (en) * 2009-02-24 2009-11-25 赛诺医疗科学技术有限公司 Peripheral vascular balloon dilatation catheter
US20100057001A1 (en) * 2008-09-03 2010-03-04 Boston Scientific Scimed, Inc. Multilayer Medical Balloon
CN103055411A (en) * 2013-01-25 2013-04-24 业聚医疗器械(深圳)有限公司 Balloon catheter and manufacturing method thereof
WO2013094541A1 (en) * 2011-12-20 2013-06-27 株式会社カネカ Production method for expansion balloon
US20140276530A1 (en) * 2013-03-12 2014-09-18 Abbott Cardiovascular Systems Inc. Length and diameter adjustable balloon catheter for drug delivery
CN108606868A (en) * 2018-03-07 2018-10-02 广州锐澄医疗技术有限公司 The preparation method of sacculus is isolated in a kind of anterior chamber
US20190351201A1 (en) * 2018-05-16 2019-11-21 Surmodics, Inc. High-pressure balloon catheters and methods
CN211434684U (en) * 2019-12-18 2020-09-08 四川海汇药业有限公司 Small-diameter balloon catheter

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5833657A (en) * 1995-05-30 1998-11-10 Ethicon, Inc. Single-walled balloon catheter with non-linear compliance characteristic
US20100057001A1 (en) * 2008-09-03 2010-03-04 Boston Scientific Scimed, Inc. Multilayer Medical Balloon
CN201350280Y (en) * 2009-02-24 2009-11-25 赛诺医疗科学技术有限公司 Peripheral vascular balloon dilatation catheter
WO2013094541A1 (en) * 2011-12-20 2013-06-27 株式会社カネカ Production method for expansion balloon
CN103055411A (en) * 2013-01-25 2013-04-24 业聚医疗器械(深圳)有限公司 Balloon catheter and manufacturing method thereof
US20140276530A1 (en) * 2013-03-12 2014-09-18 Abbott Cardiovascular Systems Inc. Length and diameter adjustable balloon catheter for drug delivery
CN108606868A (en) * 2018-03-07 2018-10-02 广州锐澄医疗技术有限公司 The preparation method of sacculus is isolated in a kind of anterior chamber
US20190351201A1 (en) * 2018-05-16 2019-11-21 Surmodics, Inc. High-pressure balloon catheters and methods
CN211434684U (en) * 2019-12-18 2020-09-08 四川海汇药业有限公司 Small-diameter balloon catheter

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Effective date of registration: 20221104

Address after: Building 3 and 6, No. 2899, Section 4, Xihanggang Avenue, Shuangliu District, Chengdu, Sichuan 610000

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Applicant before: SICHUAN HAIRONG PHARMACEUTICAL CO., LTD., YANGTZE RIVER PHARMACEUTICAL Group

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