CN110975112B - Preparation method of balloon catheter - Google Patents
Preparation method of balloon catheter Download PDFInfo
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- CN110975112B CN110975112B CN201911297389.XA CN201911297389A CN110975112B CN 110975112 B CN110975112 B CN 110975112B CN 201911297389 A CN201911297389 A CN 201911297389A CN 110975112 B CN110975112 B CN 110975112B
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- balloon
- saccule
- preformed
- controlled
- temperature
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- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- 239000000463 material Substances 0.000 claims abstract description 26
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims abstract description 24
- 210000005077 saccule Anatomy 0.000 claims abstract description 18
- 229910052757 nitrogen Inorganic materials 0.000 claims abstract description 12
- 238000000465 moulding Methods 0.000 claims abstract description 6
- 238000000071 blow moulding Methods 0.000 claims abstract description 5
- 239000008187 granular material Substances 0.000 claims description 20
- 229920000728 polyester Polymers 0.000 claims description 10
- 239000004721 Polyphenylene oxide Substances 0.000 claims description 9
- 229920000570 polyether Polymers 0.000 claims description 9
- 238000001816 cooling Methods 0.000 claims description 6
- 238000004519 manufacturing process Methods 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 238000001125 extrusion Methods 0.000 claims description 5
- 229920002635 polyurethane Polymers 0.000 claims description 5
- 239000004814 polyurethane Substances 0.000 claims description 5
- 239000004952 Polyamide Substances 0.000 claims description 4
- 229920002647 polyamide Polymers 0.000 claims description 4
- 230000006835 compression Effects 0.000 claims description 3
- 238000007906 compression Methods 0.000 claims description 3
- 239000000498 cooling water Substances 0.000 claims description 3
- 238000007599 discharging Methods 0.000 claims description 3
- 210000003128 head Anatomy 0.000 claims description 3
- 238000010438 heat treatment Methods 0.000 claims description 3
- 238000001291 vacuum drying Methods 0.000 claims description 3
- 238000007917 intracranial administration Methods 0.000 abstract description 8
- 230000009172 bursting Effects 0.000 abstract description 4
- 208000027418 Wounds and injury Diseases 0.000 abstract description 2
- 210000004204 blood vessel Anatomy 0.000 abstract description 2
- 230000006378 damage Effects 0.000 abstract description 2
- 208000014674 injury Diseases 0.000 abstract description 2
- 230000003902 lesion Effects 0.000 abstract description 2
- 238000000034 method Methods 0.000 description 4
- 230000002411 adverse Effects 0.000 description 1
- 230000002490 cerebral effect Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000004880 explosion Methods 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000005036 nerve Anatomy 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 231100000216 vascular lesion Toxicity 0.000 description 1
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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Child & Adolescent Psychology (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Manufacturing & Machinery (AREA)
- Materials For Medical Uses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The invention provides a preparation method of a balloon catheter, which comprises the following steps: performing a saccule, namely passing a saccule material pipe through a gauge with the inner diameter of 0.4mm-0.7mm, thinning two ends of the saccule material pipe, and reserving a bubble length with the bubble length ratio of 40% -60% in the middle to obtain a preformed saccule; and (3) balloon molding, namely placing the preformed balloon into a balloon mold for blow molding, and injecting nitrogen into the preformed balloon, wherein the temperature of the balloon mold is controlled at 110-400 psi and the pressure of the nitrogen in the preformed balloon is controlled at 350-400 ℃. The balloon catheter 1 obtained by adopting the technical scheme has the advantages that the balloon can reach the nominal diameter under the pressure of 4atm, the wall adhesion of the balloon can be realized under the specific lower pressure, and the double-layer wall thickness of the balloon is ultrathin and is only 0.0008-0.0009 inch. The diameter of the balloon is ultra-small after the three wings are folded, and the balloon can easily reach the position of a lesion through a tortuous intracranial blood vessel. 3. The balloon bursting pressure is about 12atm-14atm, which can greatly reduce the injury to intracranial vessels when the balloon is broken.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a preparation method of a balloon catheter.
Background
In the process of intracranial neurovascular intervention, the catheter cannot smoothly pass through pathological changes and balloon rupture to have adverse effects on the cerebral vessels, which is a problem faced by most products. The reason is that the high-pressure compliance saccule is used for most intracranial nerve catheters on the market, and the saccule has the following defects clinically:
1. the double-layer wall thickness of the balloon is thicker, and the outer diameter is relatively larger after the balloon is folded. The pushing force is poor in the operation process, and the intracranial vascular lesion is not easy to pass through.
2. The balloon nominal diameter filling pressure is higher, the balloon can be filled to the nominal diameter only under the pressure of 6atm, and the pressure when the balloon is burst is higher. Intracranial vessels are fragile and can be damaged when they are ruptured by high pressure.
Disclosure of Invention
It is an object of the present invention to provide a low pressure compliant balloon catheter.
The technical scheme of the invention is as follows:
a method of making a balloon catheter comprising the steps of:
1. preparing balloon granules:
the preparation of the balloon granules comprises the following steps
S1: stirring and reacting polyester and polyether for 3 hours under the protection of nitrogen, and controlling the temperature at 80 ℃ to obtain a prepolymer;
s2: heating the prepolymer to 90 ℃, adding molten polyamide, and stirring for 30 min;
s3: and plasticizing for 4 hours at 75 ℃ after discharging to obtain the balloon granules.
The balloon material pipe is formed by extruding balloon granules through an extruder, and the weight ratio of polyurethane, polyester and polyether in the balloon granules is 4:2: 3.
In the preparation of the granules, the proportion of polyamide, polyester and polyether is different, and the hardness of the extruded balloon tube is different, so that the compliance of the formed balloon is influenced. The weight ratio of polyurethane, polyester and polyether in the balloon granules is 4:2:3, and the hardness of the obtained balloon material pipe is 70-75A, which is acceptable.
2. Extrusion of balloon material tubes
The preparation method of the balloon material tube comprises the following steps:
s1: vacuum drying the balloon granules of polyurethane, polyester and polyether in a weight ratio of 4:2:3 at 50 ℃ for 5 hours, adding the dried balloon granules into an extruder, and extruding a balloon tube with the inner diameter of 0.5mm and the outer diameter of 1.0 mm;
s2: after the sacculus tube is extruded, the sacculus tube is cooled and shaped by the water jacket to form the sacculus tube.
3. Balloon molding
The method comprises the following steps:
s1: performing a saccule, namely passing a saccule material pipe through a gauge with the inner diameter of 0.4mm-0.7mm, thinning two ends of the saccule material pipe, and reserving a bubble length with the bubble length ratio of 40% -60% in the middle to obtain a preformed saccule;
s2: and (3) balloon molding, namely placing the preformed balloon into a balloon mold for blow molding, and injecting nitrogen into the preformed balloon, wherein the temperature of the balloon mold is controlled at 110-400 psi and the pressure of the nitrogen in the preformed balloon is controlled at 350-400 ℃.
Preferably, in the S1 balloon preforming step, the bubble length ratio is 45%.
One end of the sacculus material pipe is thinned by a pliers, the oversize is inserted, the exposed part is pulled out by the pliers, and the thinning of one end of the sacculus material pipe is realized. In the same manner, the other end was thinned. In the middle part, bubbles are formed, and the bubble length ratio is the bubble length: the length of the balloon.
The pre-formed balloon has different bubble lengths and different wall thicknesses after balloon blow molding, and accordingly the balloon explosion pressure is affected. Comparing the bubble length by 40% and the bubble length by 60%, after the balloon is blow-molded, the ratio of the wall thickness of the former double layer to the wall thickness of the latter double layer is 3:5, and the ratio of the bursting pressure is 14: 17. The present invention tends to have a lower bubble length in the normal range and a thinner wall thickness for the blown balloon. Bubble length is 45%, the double-layer wall thickness of the balloon fluctuates within the range of 0.0008-0.0009 inches, the nominal pressure can reach 4atm, and the bursting pressure is 11atm-12atm, which is considered as an ideal conclusion
The extrusion conditions of the extruder in S1 in the preparation method of the balloon material tube are as follows: the temperature of the feeding section of the extruder cylinder is controlled to be 215 ℃ plus or minus 5 ℃, the temperature of the compression section is controlled to be 220 ℃ plus or minus 5 ℃, the temperature of the metering section is controlled to be 220 ℃ plus or minus 5 ℃, the temperature of the head part is controlled to be 215 ℃ plus or minus 5 ℃, and the screw rotation speed is 10 r/min.
In the preparation method of the balloon material tube, the cooling parameters of water jacket cooling in S2 are as follows: the cooling water temperature is 20 ℃, and the traction speed is 600cm/min under the condition that the screw rotation speed is 10.6 r/min.
The invention has the advantages and positive effects that: by adopting the technical scheme, the obtained balloon catheter
1. The balloon can reach the nominal diameter only under the pressure of 4atm, and the adherence of the balloon can be realized at lower pressure
2. The double-layer wall thickness of the balloon is ultrathin and is only 0.0008-0.0009 inches. The diameter of the balloon is ultra-small after the three wings are folded, and the balloon can easily reach the position of a lesion through a tortuous intracranial blood vessel.
3. The balloon bursting pressure is about 12atm-14atm, which can greatly reduce the injury to intracranial vessels when the balloon is broken.
Detailed Description
Example 1
A method of making a balloon catheter comprising the steps of:
1. preparing balloon granules:
the preparation of the balloon granules comprises the following steps
S1: stirring polyester and polyether in a weight ratio of 2:3 for reaction for 3 hours under the protection of nitrogen, and controlling the temperature to be 80 ℃ to obtain a prepolymer;
s2: heating the prepolymer to 90 ℃, adding molten polyamide with the mass 2 times that of the polyester in S1, and stirring for 30 min;
s3: and plasticizing for 4 hours at 75 ℃ after discharging to obtain the balloon granules.
2. Extrusion of balloon material tubes
The preparation method of the balloon material tube comprises the following steps:
s1: vacuum drying the balloon granules at 50 ℃ for 5h, adding the dried balloon granules into an extruder, and extruding a balloon tube with the inner diameter of 0.5mm and the outer diameter of 1.0 mm;
s2: after the sacculus tube is extruded, the sacculus tube is cooled and shaped by the water jacket to form the sacculus tube.
The extrusion conditions of the extruder in S1 in the preparation method of the balloon material tube are as follows: the temperature of the feeding section of the extruder cylinder is controlled to be 215 ℃ plus or minus 5 ℃, the temperature of the compression section is controlled to be 220 ℃ plus or minus 5 ℃, the temperature of the metering section is controlled to be 220 ℃ plus or minus 5 ℃, the temperature of the head part is controlled to be 215 ℃ plus or minus 5 ℃, and the screw rotation speed is 10 r/min.
In the preparation method of the balloon material tube, the cooling parameters of water jacket cooling in S2 are as follows: the cooling water temperature is 20 ℃, and the traction speed is 600cm/min under the condition that the screw rotation speed is 10.6 r/min.
3. Balloon molding
The method comprises the following steps:
s1: performing a saccule, namely passing a saccule material pipe through a gauge with the inner diameter of 0.4mm-0.7mm, thinning two ends of the saccule material pipe, and reserving a bubble length with the bubble length ratio of 40% -60% in the middle to obtain a preformed saccule; one end of the sacculus material pipe is thinned by a pliers, the oversize is inserted, the exposed part is pulled out by the pliers, and the thinning of one end of the sacculus material pipe is realized. In the same manner, the other end was thinned.
S2: and (3) balloon molding, namely placing the preformed balloon into a balloon mold for blow molding, and injecting nitrogen into the preformed balloon, wherein the temperature of the balloon mold is controlled at 110-400 psi and the pressure of the nitrogen in the preformed balloon is controlled at 350-400 ℃.
The performance parameters of the obtained balloon catheter are as follows
3.0 × 20 gauge balloon size and performance
Performance parameters of balloon catheters of different bubble length ratios
Performance parameters of balloon catheter at nitrogen pressure and mold temperature of example 1
While one embodiment of the present invention has been described in detail, the description is only a preferred embodiment of the present invention and should not be taken as limiting the scope of the invention. All equivalent changes and modifications made within the scope of the present invention shall fall within the scope of the present invention.
Claims (4)
1. A method of making a balloon catheter, comprising the steps of:
s1: performing a saccule, namely passing a saccule material pipe through a gauge with a specific inner diameter of 0.4mm-0.7mm, thinning two ends of the saccule material pipe, and reserving a bubble length with a bubble length ratio of 40% -60% in the middle to obtain a preformed saccule;
s2: balloon molding, namely placing the preformed balloon into a balloon mold for blow molding, and injecting nitrogen into the preformed balloon, wherein the temperature of the balloon mold is controlled to be 110-400 psi and the pressure of the nitrogen in the preformed balloon is controlled to be 350-400 ℃ respectively,
the balloon material pipe is formed by extruding balloon granules through an extruder, the weight ratio of polyurethane to polyester to polyether in the balloon granules is 4:2:3,
the preparation of the balloon granules comprises the following steps:
s1: stirring and reacting polyester and polyether for 3 hours under the protection of nitrogen, and controlling the temperature at 80 ℃ to obtain a prepolymer;
s2: heating the prepolymer to 90 ℃, adding molten polyamide, and stirring for 30 min;
s3: plasticizing for 4h at 75 ℃ after discharging to obtain balloon granules,
the preparation method of the balloon material tube comprises the following steps:
s1: vacuum drying the balloon granules of polyurethane, polyester and polyether in a weight ratio of 4:2:3 at 50 ℃ for 5 hours, adding the dried balloon granules into an extruder, and extruding a balloon tube with the inner diameter of 0.5mm and the outer diameter of 1.0 mm;
s2: after the sacculus tube is extruded, the sacculus tube is cooled and shaped by the water jacket to form the sacculus tube.
2. The method for producing a balloon catheter according to claim 1, characterized in that: the bubble length ratio in S1 was 45%.
3. The method for producing a balloon catheter according to claim 1, characterized in that: the extrusion conditions of the extruder in S1 in the preparation method of the balloon material tube are as follows: the temperature of the feeding section of the extruder cylinder is controlled to be 215 ℃ plus or minus 5 ℃, the temperature of the compression section is controlled to be 220 ℃ plus or minus 5 ℃, the temperature of the metering section is controlled to be 220 ℃ plus or minus 5 ℃, the temperature of the head part is controlled to be 215 ℃ plus or minus 5 ℃, and the screw rotation speed is 10 r/min.
4. The method for producing a balloon catheter according to claim 1, characterized in that: in the preparation method of the balloon material tube, the cooling parameters of water jacket cooling in S2 are as follows: the cooling water temperature is 20 ℃, and the traction speed is 600cm/min under the condition that the screw rotation speed is 10.6 r/min.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911297389.XA CN110975112B (en) | 2019-12-17 | 2019-12-17 | Preparation method of balloon catheter |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911297389.XA CN110975112B (en) | 2019-12-17 | 2019-12-17 | Preparation method of balloon catheter |
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| Publication Number | Publication Date |
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| CN110975112A CN110975112A (en) | 2020-04-10 |
| CN110975112B true CN110975112B (en) | 2022-02-08 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201911297389.XA Active CN110975112B (en) | 2019-12-17 | 2019-12-17 | Preparation method of balloon catheter |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111701139A (en) * | 2020-05-29 | 2020-09-25 | 广州新诚生物科技有限公司 | Encephalic balloon catheter and preparation method thereof |
| CN114261080A (en) * | 2021-12-16 | 2022-04-01 | 科睿驰（深圳）医疗科技发展有限公司 | Balloon forming method |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5779730A (en) * | 1993-06-16 | 1998-07-14 | Cordis Corporation | Balloon catheter and inflation method |
| CN102274067A (en) * | 2011-04-26 | 2011-12-14 | 华东理工大学 | Developable inflatable balloon for kyphoplasty and manufacturing method thereof |
| CN104245035A (en) * | 2012-03-09 | 2014-12-24 | 明讯科技有限公司 | Parison for forming blow molded medical balloon with midified portion, medical balloon, and related methods |
| CN104645487A (en) * | 2013-11-21 | 2015-05-27 | 上海微创医疗器械（集团）有限公司 | Medical balloon and manufacturing method thereof, balloon dilatation catheter |
| CN107198813A (en) * | 2016-03-15 | 2017-09-26 | 上海微创医疗器械（集团）有限公司 | The preparation method and sacculus dilating catheter of sacculus dilating catheter |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2106820A1 (en) * | 2008-03-31 | 2009-10-07 | Torsten Heilmann | Expansible biocompatible coats comprising a biologically active substance |
| GB201202388D0 (en) * | 2012-02-13 | 2012-03-28 | Benedetti Internat Ltd | Two-fold cannula dressing |
| CN106994203A (en) * | 2016-01-22 | 2017-08-01 | 上海微创医疗器械（集团）有限公司 | Guiding catheter and preparation method thereof |
-
2019
- 2019-12-17 CN CN201911297389.XA patent/CN110975112B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5779730A (en) * | 1993-06-16 | 1998-07-14 | Cordis Corporation | Balloon catheter and inflation method |
| CN102274067A (en) * | 2011-04-26 | 2011-12-14 | 华东理工大学 | Developable inflatable balloon for kyphoplasty and manufacturing method thereof |
| CN104245035A (en) * | 2012-03-09 | 2014-12-24 | 明讯科技有限公司 | Parison for forming blow molded medical balloon with midified portion, medical balloon, and related methods |
| CN104645487A (en) * | 2013-11-21 | 2015-05-27 | 上海微创医疗器械（集团）有限公司 | Medical balloon and manufacturing method thereof, balloon dilatation catheter |
| CN107198813A (en) * | 2016-03-15 | 2017-09-26 | 上海微创医疗器械（集团）有限公司 | The preparation method and sacculus dilating catheter of sacculus dilating catheter |
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| CN110975112A (en) | 2020-04-10 |
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Denomination of invention: Preparation method of balloon catheter Effective date of registration: 20231106 Granted publication date: 20220208 Pledgee: Weihai Branch of Industrial Bank Co.,Ltd. Pledgor: HEMU (CHINA) BIOLOGICAL ENGINEERING Co.,Ltd. Registration number: Y2023980064037 |