CN1040742A - The making of medical polyethylene dilating sacculus - Google Patents
The making of medical polyethylene dilating sacculus Download PDFInfo
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- CN1040742A CN1040742A CN 89107579 CN89107579A CN1040742A CN 1040742 A CN1040742 A CN 1040742A CN 89107579 CN89107579 CN 89107579 CN 89107579 A CN89107579 A CN 89107579A CN 1040742 A CN1040742 A CN 1040742A
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- sacculus
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- vinyon
- dilating sacculus
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Abstract
Balloon expanding technology is the novel medical skill of the usefulness internal medicine method lieu of surgery that grows up of the eighties in the world, the present invention is a kind of method of making dilating sacculus, the employing melt index is 0.1～1.0 vinyon, extrusion molding is a tubulose, make polyethylene crosslinking with cobalt source gamma-ray irradiation, then pipe is placed in the mould, heating, inflation, inflation molding under suitable temperature and pressure, last cooling and shaping, the dilating sacculus made from this law has high strength, the non-expansibility characteristics can be used for the treatment of pulmonary stenosis and other valve and vascular stenosis.Be specially adapted to the patient that should not operate on.Can shorten treatment time, reduce medical expense.
Description
The present invention relates to a kind of manufacture method of medical polyethylene dilating sacculus.
Balloon expanding technology is the novel medical skill of the usefulness internal medicine method lieu of surgery that grows up of the eighties in the world, can be used for treating pulmonary stenosis and other valve and vascular stenosis.Enlarge and the popularization balloon expanding technology, one of key is to produce the sacculus that meets clinical requirement, and this sacculus will have the characteristics of higher-strength and non-expansibility.Usually adopt blowing method to make sacculus, but often because the material selection is improper, the blowing pressure and temperature is grasped bad, makes the sacculus insufficient strength, just breaks in the blowing process, perhaps can not molding.
The manufacture method that the purpose of this invention is to provide that a kind of process conditions are easy to grasp, yield rate height, product meets the medical dilating sacculus of clinical requirement.
The present invention includes the choosing of balloon material, to steps such as the blowing of the processing of material, sacculus and typings.The present invention adopts LDPE, extrudes to be processed into tubulose.The melt index of vinyon is: 0.1～1.0, and make the sacculus of making that enough intensity be arranged; The internal diameter of vinyl tube is 1～3mm, and external diameter is 2～6mm, makes the sacculus of big specification, and the pipe diameter of selecting for use is suitable big, otherwise then littler; Above-mentioned plastic tube is carried out gamma-ray irradiation with the cobalt source, make it cross-linking modified, irradiation dose and crosslinking degree have substantial connection, if irradiation dose deficiency, do not make material reach the requirement of modification,, can make material degradation if irradiation is excessive, therefore must grasp suitable irradiation dose, generally be controlled at 10
4～10
6The Gy(gray(Gy)) is advisable within; Then crosslinked polyethylene pipe is placed and carry out hot blow in the mould and expand, mould is determined according to the shape of the specification size of required sacculus.After pipe placed in the mould, the energising heating filled gas (nitrogen or air) in the pipe in the time of heating, by instrument control temperature, by precision pressure instrumentation buret internal gas pressure.General temperature is controlled at 70～170 ℃, and intraductal atmospheric pressure is controlled at 0.5～1.5kg/cm
2Specifically can grasp according to making the volumetrical flexible in size of sacculus.When plastic pipe through inflation, stop heating after forming sacculus according to mold shape, be cooled to sacculus below 60 ℃ and promptly finalize the design, but the demoulding.In order to accelerate rate of cooling, improve make efficiency, can take blowing or other cooling measure.
The sacculus utricule of making of the present invention is a polyethylene plastic film, and scrotiform is olive-shaped, and balloon diameter is 4～20mm, and length is 20～100mm, has the characteristics of high strength and non-expansibility, withstand voltage 3-7atm, vary in diameter during expansion＜5%.
By the medical polyethylene dilating sacculus that the present invention makes, two medical universities carry out toxicity inspection through Shanghai, and parameters all meets state specified standards.
The present invention more suitable process conditions is: the selection melt index is 0.3～0.6 LDPE; Gamma-ray irradiation dose is controlled at 1 * 10
5～3 * 10
5Gy, the temperature that hot blow expands is controlled at 100-130 ℃, and intraductal atmospheric pressure is controlled at 0.8～1.2kg/cm
2
Form expansion of balloon catheter as shown in drawings with sacculus and medical catheter that the inventive method is made, the sacculus 1 of two openings is fixed on the medical catheter 2 among the figure, and the 3rd, insert " guide wire " pipe, the 4th, the injecting contrast liquid pipe that communicates with sacculus.
When clinical use (as the treatment pulmonary stenosis), need under the x rayed, insert " guide wire " to therapentic part, insert the polyethylene dilating sacculus conduit along steel wire then from femoral artery, from conduit, inject contrast solution again to sacculus, make the therapentic part expansion.Treatment finishes, and takes out contrast solution, extracts expansion of balloon catheter.
The medical plastic dilating sacculus of all size of making of the present invention, can be respectively applied for treatment ventral aorta, renal artery, iliac artery, femoral artery stenosis disease, also can be used for treatment because of atherosclerosis, the angiostenosis that causes after fibromuscular dysplasia, wound or the operation, dilating urethra treatment prostatic hyperplasia is at present just in the developing application of positions such as nose, larynx, esophagus.It is specially adapted to the patient that should not operate on, and shortens treatment time, reduces medical expense.
Example 1:
Selecting melt index for use is 0.5 LDPE, extrudes and is processed into tubulose, and bore is 2.5mm, and external diameter is 4.5mm, is 2.0 * 10 through dosage then
5The Gy cobalt-60 radiosterilize is crosslinked.It is 15mm that polyethylene pipe after crosslinked is put into diameter, and length is the sacculus mould of 30mm, and energising heating makes mould be warming up to 100 ℃, in the time of intensification with nitrogen pressure in the Pressure gauge control polyethylene tube to 1.0kg/cm
2, in order to be blown into sacculus.Promptly stop heating after sacculus forms, begin to cool down, finalized the design during to 60 ℃, but the demoulding.Promptly make diameter 15mm, length 30mm, the sacculus of compressive resistance 3.1atm.
Example 2:
Selecting melt index for use is 0.5 LDPE, extrudes and is processed into tubulose, and through being 1.2mm, external diameter is 2.4mm, is 2.5 * 10 through dosage then in the pipe
5The Gy cobalt-60 radiosterilize is crosslinked.It is 6mm that polyethylene pipe after crosslinked is put into diameter, and length is the sacculus mould of 30mm, and energising heating makes mould be warming up to 110 ℃, in the time of intensification with nitrogen pressure in the Pressure gauge control polyethylene tube to 1.2kg/cm
2, in order to be blown into sacculus.Promptly stop heating after sacculus forms, begin to cool down, finalized the design during to 60 ℃, but diameter 6mm is promptly made in the demoulding length 30mm, the sacculus of compressive resistance 6.0atm.
Claims (2)
1, a kind of manufacture method of medical polyethylene dilating sacculus comprises that with the vinyon extrusion molding be tubulose, and modification carries out that hot blow expands, cold formed several steps, it is characterized in that:
(1) melt index of vinyon is 0.1～1.0;
(2) internal diameter of vinyl tube is 1～3mm, and external diameter is 2～6mm;
(3) gamma-ray irradiation is carried out in the effective cobalt of above-mentioned vinyon source, make it crosslinked, irradiation dose is 10
4～10
6Gy;
(4) crosslinked vinyl tube is placed mould interior-heat inflation, temperature is controlled at 70～170 ℃, and intraductal atmospheric pressure is controlled at 0.5～1.5kg/cm
2In the scope.
2, according to the manufacture method of the said medical polyethylene dilating sacculus of claim 1, it is characterized in that:
(1) melt index of above-mentioned vinyon is 0.3～0.6;
(2) gamma-ray irradiation dose is controlled at 1 * 10
5～3 * 10
5Gy;
Temperature was controlled at 100～130 ℃ when (3) hot blow expanded, and intraductal atmospheric pressure is controlled at 0.8～1.2kg/cm
2
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 89107579 CN1018237B (en) | 1989-09-23 | 1989-09-23 | Making method of medical polyethylene dilating sacculus |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 89107579 CN1018237B (en) | 1989-09-23 | 1989-09-23 | Making method of medical polyethylene dilating sacculus |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1040742A true CN1040742A (en) | 1990-03-28 |
| CN1018237B CN1018237B (en) | 1992-09-16 |
Family
ID=4857257
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 89107579 Expired CN1018237B (en) | 1989-09-23 | 1989-09-23 | Making method of medical polyethylene dilating sacculus |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1018237B (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101208118B (en) * | 2005-04-26 | 2010-04-14 | 日本瑞翁株式会社 | Intra-aortic balloon pumping set |
| CN106983574A (en) * | 2017-05-02 | 2017-07-28 | 南京医科大学第附属医院 | A kind of small balloon-system of zoopery heart infarction model and preparation method |
| CN108144130A (en) * | 2016-12-02 | 2018-06-12 | 先健科技(深圳)有限公司 | Anti- high pressure sacculus and its preparation method on surface layer |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1305939C (en) * | 2005-08-17 | 2007-03-21 | 威高集团有限公司 | Preparation method and uses of radiation modified polyolefinic thermoplastic elastomer blending resin |
| CN105599284B (en) * | 2016-01-14 | 2017-03-08 | 山东吉威医疗制品有限公司 | A kind of Apparatus and method for making the continuous automatic running of sacculus forming process |
-
1989
- 1989-09-23 CN CN 89107579 patent/CN1018237B/en not_active Expired
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101208118B (en) * | 2005-04-26 | 2010-04-14 | 日本瑞翁株式会社 | Intra-aortic balloon pumping set |
| CN108144130A (en) * | 2016-12-02 | 2018-06-12 | 先健科技(深圳)有限公司 | Anti- high pressure sacculus and its preparation method on surface layer |
| CN106983574A (en) * | 2017-05-02 | 2017-07-28 | 南京医科大学第附属医院 | A kind of small balloon-system of zoopery heart infarction model and preparation method |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1018237B (en) | 1992-09-16 |
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Legal Events
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| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C06 | Publication | ||
| PB01 | Publication | ||
| CI01 | Correction of invention patent gazette |
Correction item: Inventor Correct: Ma Ruishen False: Ma Ruishen Number: 13 Page: 7 Volume: 6 |
|
| CI02 | Correction of invention patent application |
Correction item: Inventor Correct: Ma Ruishen False: Ma Ruishen Page: 1 |
|
| C13 | Decision | ||
| GR02 | Examined patent application | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C19 | Lapse of patent right due to non-payment of the annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |