CN111012999B - 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
CN111012999B
CN111012999B CN201911315408.7A CN201911315408A CN111012999B CN 111012999 B CN111012999 B CN 111012999B CN 201911315408 A CN201911315408 A CN 201911315408A CN 111012999 B CN111012999 B CN 111012999B
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China
Prior art keywords
cavity channel
pipe
expansion
tube body
saccule
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CN201911315408.7A
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CN111012999A (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 Yangzijiang Medical Instrument 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)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pulmonology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention discloses a small-diameter balloon catheter and a manufacturing method thereof, comprising a catheter body, wherein the tail end of the catheter body is provided with a catheter seat, 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 sacculus, and the main cavity channel is communicated with the head end of the tube body; the catheter seat comprises a main cavity connector and a side cavity connector, the main cavity connector is communicated with the main cavity channel, and the side cavity connector is communicated with the side cavity channel; the expanding saccule and the tube body are coaxially arranged, the two ends of the expanding saccule are fixedly connected with the outer wall of the tube body, and developing marks are arranged in the expanding saccule. 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 incidence of cardiovascular diseases is extremely high, wherein the cerebral apoplexy is more than 1300 ten thousand, and the coronary heart disease is more than 1100 ten thousand. The amount of the Chinese PCI surgery in 2018 is 91.5 ten thousand. The stent incidence rate is as high as 90%, and the treatment operation of the cerebral vascular stenosis is also greatly developed every year. At present, the endovascular stenosis and blockage 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, the balloon catheter is conveyed to the narrow part of a blood vessel by using a percutaneous puncture technology, and balloon expansion and inflation are carried out under strict monitoring, so that the narrow part of the blood vessel is expanded, the diameter of a lumen is recovered, the blood flow is improved, and the stent implantation is convenient. After the stent is smoothly implanted, the balloon is expanded to prevent restenosis.
Balloon catheters are an indispensable medical instrument for vascular interventional therapy. Under the existing production process, the forming rate of the small-diameter balloon with the diameter of 1.0-10.0mm is extremely low, and the small-diameter balloon is mostly broken in the manufacturing and forming process of the balloon, the detection and the expansion of the balloon, and the like in clinical use. Raw materials are wasted greatly, mass production is not facilitated, and risks in clinical operations are increased. By analyzing the extrusion of the balloon material pipe in the existing technological process, the manufacturing influence on the balloon is the largest, and the extrusion has the following steps: deformation, eccentricity, shrinkage, protrusion, surface roughness, microcracks and the like can also seriously affect the molding 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, easy control of product quality and high yield.
In order to achieve the above 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 part 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 sacculus, and the main cavity channel is communicated with the head end of the tube body;
the catheter seat comprises a main cavity connector and a side cavity connector, the main cavity connector is communicated with the main cavity channel, and the side cavity connector is communicated with the side cavity channel;
The expansion saccule and the tube body are coaxially arranged, the two ends of the expansion saccule are fixedly connected with the outer wall of the tube body, the expansion saccule is internally provided with a developing mark,
The diameter of the expanding saccule is 0.8 mm-2.0 mm in the folded state,
The diameter of the expansion saccule is 1.0 mm-10.0 mm in the expansion state.
Preferably, the head end of the tube body is of a conical structure.
Preferably, the developing marks are arranged on the outer wall of the tube body, and the two developing marks are arranged along the axial direction of the tube 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 dilation 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-extrusion is carried out by using a mandrel with fixed size and a balloon material to obtain a semi-finished product pipe;
S200, rolling the extruded semi-finished product pipe by using a roller, controlling the outer diameter and the surface smoothness of the semi-finished product pipe, and removing micro defects and cracks to obtain the finished product pipe;
S300, extracting the core rod, and reserving a finished product pipe;
S400, blow molding the finished product pipe in a balloon mold with a specific shape to obtain an expanded balloon;
S500, assembling the obtained expansion saccule, the pipe body and the catheter seat, and spraying the medicine on the surface of the saccule by using spraying equipment to obtain the small-diameter saccule 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 fixed-size mandrel may be a single-component metal mandrel, an alloy metal mandrel, a plastic mandrel, a composite mandrel, or the like.
Preferably, in step S200, the semifinished material tube is subjected to a plurality of rolling processes, and adjacent pairs of rollers are disposed obliquely, i.e., non-parallel.
Preferably, in step S200, the semifinished material tube is subjected to a plurality of rolling processes, with adjacent pairs of rollers being arranged in parallel.
Preferably, after step S200, the semi-finished product pipe is cooled to obtain a finished product pipe.
Preferably, in step S200, the temperature of the rolling is 0-400 degrees celsius.
Preferably, in step S200, the rolling method of rolling is normal temperature rolling.
Preferably, in step S200, the rolling method of rolling 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 roll surface may be self-contained with a rolled profiled bore.
Preferably, in step S400, the temperature of the hot roll is 0-400 ℃.
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 that the conditions of deformation, eccentricity, shrinkage, bulge, surface roughness, microcrack and the like in the production process are reduced, the yield is improved, the reliability of the device is improved, the dimensional accuracy of the balloon material pipe is improved, and the control of the size during extrusion is facilitated.
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 of A-A of FIG. 1
FIG. 3 is a cross-sectional view of a second embodiment of a small diameter balloon catheter;
fig. 4 is a cross-sectional view of B-B in fig. 3.
In the figure: 1-tube, 2-catheter holder, 3-dilation balloon, 4-main lumen channel, 5-side lumen channel, 6-main lumen connector, 7-side lumen connector, 8-visualization mark.
Detailed Description
The present invention will be described in further detail with reference to the accompanying drawings, in order to make the objects, technical solutions and advantages of the present invention more apparent.
As shown in fig. 1 and 2, an embodiment of the small-diameter balloon catheter comprises a catheter body 1, a catheter seat 2 is arranged at the tail end of the catheter body 1, and an expanding 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 sacculus 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 saccule 3 and the tube body 1 are coaxially arranged, the two ends of the expansion saccule 3 are fixedly connected with the outer wall of the tube body 1, the expansion saccule 3 is internally provided with development marks 8, the development marks 8 are arranged on the outer wall of the tube body 1, the two development marks 8 are axially arranged along the tube body 1,
The diameter of the expansion sacculus 3 is 0.8 mm-2.0 mm in the folded state,
The diameter of the expansion sacculus 3 is 1.0 mm-10.0 mm in the expansion state,
The outer surface of the dilating balloon 3 is provided with a drug coating, such as paclitaxel, rapamycin, a paclitaxel derivative or a rapamycin derivative, etc.
As shown in fig. 3 and 4, the second embodiment of the small diameter balloon catheter is different 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-extrusion is carried out by using a mandrel with fixed size and a balloon material to obtain a semi-finished product pipe;
S200, rolling the extruded semi-finished product pipe by using a roller, controlling the outer diameter and the surface smoothness of the semi-finished product pipe, and removing micro defects and cracks to obtain the finished product pipe;
S300, extracting the core rod, and reserving a finished product pipe;
S400, blow molding the finished product pipe in a balloon mold with a specific shape to obtain an expansion balloon 3;
S500, assembling the obtained expansion saccule 3, the pipe body 1 and the catheter seat 2, and spraying medicines on the surface of the expansion saccule 3 by using spraying equipment to obtain the small-diameter saccule catheter.
In order to ensure that the thickness of the expansion balloon 3 is uniform, in step S200, the semi-finished product pipe is rolled multiple times, and adjacent roller pairs are arranged at a certain angle, such as a right angle, an acute angle, etc.
Of course, the present invention is capable of other various embodiments and its several details are capable of modification and variation in light of the present invention by one skilled in the art without departing from the spirit and scope of the invention as defined in the appended claims.

Claims (8)

1. A small diameter balloon catheter, characterized by: comprises a tube body (1), wherein the tail end of the tube body (1) is provided with a catheter seat (2), and an expansion saccule (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 sacculus (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 tube body (1) are coaxially arranged, the two ends of the expansion saccule (3) are fixed with the outer wall of the tube body (1), the expansion saccule (3) is internally provided with a developing mark (8),
The diameter of the expanding saccule (3) is 0.8 mm-2.0 mm in the folded state,
The diameter of the expansion sacculus (3) is 1.0 mm-10.0 mm in the expansion state;
The manufacturing method comprises the following steps:
S100, extruding raw materials by using a mandrel with a fixed size and a balloon material pipe to obtain a semi-finished material pipe through coextrusion;
s200, rolling the extruded semi-finished product pipe by using a roller, controlling the outer diameter and the surface smoothness of the semi-finished product pipe, removing micro defects and cracks, and cooling the semi-finished product pipe to obtain the finished product pipe;
S300, extracting the core rod, and reserving a finished product pipe;
s400, blow molding the finished product pipe in a balloon mold with a specific shape to obtain an expanded balloon (3);
s500, assembling the obtained expansion saccule (3), the pipe body (1) and the pipe seat (2), and spraying medicines on the surface of the expansion saccule (3) by using spraying equipment to obtain the small-diameter saccule pipe.
2. The small diameter balloon catheter of claim 1, wherein: the head end of the pipe body (1) is of a conical structure.
3. The small diameter balloon catheter of 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 axially arranged along the pipe body (1).
4. The small diameter balloon catheter of claim 1, wherein: the side cavity channel (5) is arranged in the side wall of the pipe body (1).
5. The small diameter balloon catheter of 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 of claim 1, wherein: the outer surface of the expansion saccule (3) is provided with a drug coating.
7. The small diameter balloon catheter of claim 1, wherein: in step S200, the semi-finished product pipe is rolled multiple times, and adjacent roller pairs are obliquely arranged.
8. The small diameter balloon catheter of claim 1, wherein: 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
CN201911315408.7A CN111012999B (en) 2019-12-18 2019-12-18 Small-diameter balloon catheter and manufacturing method thereof

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CN111012999B true CN111012999B (en) 2024-04-19

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Citations (6)

* 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
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
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
CN211434684U (en) * 2019-12-18 2020-09-08 四川海汇药业有限公司 Small-diameter balloon catheter

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9265918B2 (en) * 2008-09-03 2016-02-23 Boston Scientific Scimed, Inc. Multilayer medical balloon
US9623216B2 (en) * 2013-03-12 2017-04-18 Abbott Cardiovascular Systems Inc. Length and diameter adjustable balloon catheter for drug delivery
US20190351201A1 (en) * 2018-05-16 2019-11-21 Surmodics, Inc. High-pressure balloon catheters and methods

Patent Citations (6)

* 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
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
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
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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Applicant before: SICHUAN HAIHUI PHARMACEUTICAL CO.,LTD.

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

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