CN101711901A - Disposable non-PVC infusion set and preparation method thereof - Google Patents
Disposable non-PVC infusion set and preparation method thereof Download PDFInfo
- Publication number
- CN101711901A CN101711901A CN200810157365A CN200810157365A CN101711901A CN 101711901 A CN101711901 A CN 101711901A CN 200810157365 A CN200810157365 A CN 200810157365A CN 200810157365 A CN200810157365 A CN 200810157365A CN 101711901 A CN101711901 A CN 101711901A
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- China
- Prior art keywords
- pvc
- controlled
- preparation
- temperature
- infusion set
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/92—Measuring, controlling or regulating
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C2948/00—Indexing scheme relating to extrusion moulding
- B29C2948/92—Measuring, controlling or regulating
- B29C2948/92504—Controlled parameter
- B29C2948/92704—Temperature
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C2948/00—Indexing scheme relating to extrusion moulding
- B29C2948/92—Measuring, controlling or regulating
- B29C2948/92819—Location or phase of control
- B29C2948/92857—Extrusion unit
- B29C2948/92876—Feeding, melting, plasticising or pumping zones, e.g. the melt itself
- B29C2948/92895—Barrel or housing
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C2948/00—Indexing scheme relating to extrusion moulding
- B29C2948/92—Measuring, controlling or regulating
- B29C2948/92819—Location or phase of control
- B29C2948/92857—Extrusion unit
- B29C2948/92904—Die; Nozzle zone
Landscapes
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Materials For Medical Uses (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
The invention relates to a disposable non-PVC infusion set and a preparation method thereof. The main body of infusion set is made of thermoplastic elastomer. The disposable non-PVC infusion set has the advantages of no toxic or side effects, safety and reliability. The method for preparing an infusion conduit is simple and feasible. When an injection molding method is adopted for molding, the temperature of the spray nozzle is controlled to be between 220 DEG C and 240 DEG C; and when an extrusion molding method is adopted for molding, the temperature of the extruder cylinder is controlled to be between 220 DEG C and 240 DEG C, and the temperature of the extrusion die is controlled to be between 40 DEG C and 50 DEG C.
Description
Technical field
The present invention relates to a kind of disposable use non-PVC infusion device and preparation method thereof, belong to the clinical treatment apparatus.
Background technology
For these years, blood bag, blood transfusion tube, catheter nearly all are the PVC goods, and these medical supplies have used many decades, have proved the suitability of PVC in medical device, as drug resistance, the transparency, oxygen barrier property, flexibility etc.Because of the PVC goods can satisfy most of characteristics of medical macromolecular materials, cost is low again, thereby is used for the transfusion bag of splendid attire normal saline, glucose saline, water for injection, peritoneal dialysis solution in a large number; The blood bag that uses in the collection of human blood and composition thereof, separation, storage and the infusion; Disposable syringe, transfusion device, blood exchange transfusion set, drainage tube, conduit, intubate, trier, patient's apparatus, operating room apparatus and diagnosis and treatment apparatus.
Because the PVC material is harder, produce the flexible PVC product needed and add plasticizer, can make the softening and reinforced plastics elasticity of plastics, satisfy the instructions for use of medical supplies.Existing plasticizer is a phthalate, the about 1,000,000 tons of phthalates of annual production in West Europe, and wherein 900,000 tons are used as the PVC plasticizer, and that the most frequently used is DEHP, DIDP and DINP.
As a large amount of phthalic acid two (2-ethylhexyl) esters (abbreviating DEHP as) that use of plasticizer, name is called Di (2-ethylhexyl) phthalate, can make that PVC has transparent, soft, withstand voltage, easy processing, performance such as can sterilize, so widely use so far the sixties always.But recently find that form the problem of microgranule to the medicinal liquid for the DEHP migration of plasticizer, a lot of countries have done to limit with control of quality to the size and the quantity of microgranule by standard.PVC-DEHP blood bag mainly is widely used in storages such as whole blood and Red Blood Cells Concentrate, yet to the safe toxicity problem of DEHP at the blood leachable, has caused people's attention.Checking DEHP is a kind of carcinogen, and its metabolite and degradation products can cause the negative effect to health.European Union has just taked the interim urgent restriction of phthalate or ester as far back as 1999, promptly in all toys and other articles for children, the content of above-mentioned various plasticizers all must not surpass 0.1% of its plastic components; Can be placed into the plasticizer loading of plastic components of the articles for use (as nipple, water tumbler, soupspoon etc.) of mouth to all that are used for child below 3 years old, can not surpass 0.1%.
Develop the nontoxic transfusion device of disposable use, extremely urgent.
Summary of the invention
The object of the present invention is to provide a kind of disposable use non-PVC infusion device, have no side effect, safe and reliable; The present invention provides the preparation method of simple possible simultaneously.
Disposable use non-PVC infusion device of the present invention, the transfusion device main body is arranged, it is characterized in that the transfusion device material of main part adopts thermoplastic elastomer (TPE) (Thermoplastic elastomer), also claim thermoplastic elastomer (Thermoplastic rubber), be a kind of with rubber and thermoplastic characteristic, at normal temperatures show under the high resiliency, high temperature of rubber again can plasticizing forming macromolecular material, also be called for short TPU.Detection meets the medical and clinical requirement fully through medical device product quality supervision and test center, State Food and Drug Administration Jinan.
Each transfusion device Related product is continued to use original production technology production substantially, just can do suitable adjustment for the production of transfusion catheter, guarantees to produce higher qualification rate, can adopt the injection molding forming method molding, and nozzle temperature is 220-240 ℃; Also can adopt the extruding forming method molding, the extruder barrel temperature is: 220-240 ℃, extruder die temperature is: 40-50 ℃.
The disposable use non-PVC infusion device of the present invention has replaced the PVC material with thermoplastic elastomer (TPE), has avoided the poisonous plasticizer that adds with in the PVC material preparation production process, have no side effect, safe and reliable, belong to the renewal product of transfusion device, have a extensive future economic benefit and obvious social benefit; Transfusion catheter preparation method simple possible provided by the invention, easy to implement, the qualification rate height.
The specific embodiment
The invention will be further described below in conjunction with embodiment.
Embodiment 1
Disposable use non-PVC infusion device of the present invention, the transfusion device material of main part adopts thermoplastic elastomer (TPE).
Each transfusion device Related product is continued to use original production technology production substantially, and is as follows for the special adjustment of the production of transfusion catheter:
Can adopt the injection molding forming method molding, nozzle temperature is controlled to be 232 ± 2 ℃.
Also can adopt the extruding forming method molding, the extruder barrel temperature is controlled to be: 222 ± 2 ℃, extruder die temperature is controlled to be: 45 ± 2 ℃.
Embodiment 2
Production for transfusion catheter is adjusted as follows:
When adopting the injection molding forming method molding, nozzle temperature is controlled to be made as 225 ± 2 ℃, 230 ± 2 ℃ or 235 ± 2 ℃ etc.
When adopting the extruding forming method molding, the extruder barrel temperature is controlled to be: 225 ± 2 ℃, 230 ± 2 ℃ or 235 ± 2 ℃ etc., extruder die temperature is controlled to be: 42 ± 2 ℃, 46 ± 2 ℃ or 47 ± 2 ℃ etc.
Other is with embodiment 1.
Claims (3)
1. a disposable use non-PVC infusion device has the transfusion device main body, it is characterized in that the transfusion device material of main part is a thermoplastic elastomer (TPE).
2. the preparation method of the described disposable use non-PVC infusion conduit of claim 1 is characterized in that adopting the injection molding forming method molding, and nozzle temperature is controlled to be 220-240 ℃.
3. the preparation method of the described disposable use non-PVC infusion conduit of claim 1 is characterized in that adopting the extruding forming method molding, and the extruder barrel temperature is controlled to be: 220-240 ℃, extruder die temperature is controlled to be: 40-50 ℃.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810157365A CN101711901A (en) | 2008-09-29 | 2008-09-29 | Disposable non-PVC infusion set and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810157365A CN101711901A (en) | 2008-09-29 | 2008-09-29 | Disposable non-PVC infusion set and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101711901A true CN101711901A (en) | 2010-05-26 |
Family
ID=42416141
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200810157365A Pending CN101711901A (en) | 2008-09-29 | 2008-09-29 | Disposable non-PVC infusion set and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101711901A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110075382A (en) * | 2019-05-29 | 2019-08-02 | 浙江伏尔特医疗器械股份有限公司 | A kind of multi-functional non-PVC material infusion apparatus |
| CN112237681A (en) * | 2020-09-15 | 2021-01-19 | 安徽通灵仿生科技有限公司 | Integrated minimally invasive catheter type heart auxiliary device |
-
2008
- 2008-09-29 CN CN200810157365A patent/CN101711901A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110075382A (en) * | 2019-05-29 | 2019-08-02 | 浙江伏尔特医疗器械股份有限公司 | A kind of multi-functional non-PVC material infusion apparatus |
| CN110075382B (en) * | 2019-05-29 | 2024-04-19 | 浙江伏尔特医疗器械股份有限公司 | Multifunctional non-PVC material transfusion system |
| CN112237681A (en) * | 2020-09-15 | 2021-01-19 | 安徽通灵仿生科技有限公司 | Integrated minimally invasive catheter type heart auxiliary device |
| CN112237681B (en) * | 2020-09-15 | 2023-09-22 | 安徽通灵仿生科技有限公司 | Integrated minimally invasive catheter type heart auxiliary device |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C12 | Rejection of a patent application after its publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20100526 |