CN102276985A - Method for casting external capsule of breast product - Google Patents
Method for casting external capsule of breast product Download PDFInfo
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- CN102276985A CN102276985A CN 201110189274 CN201110189274A CN102276985A CN 102276985 A CN102276985 A CN 102276985A CN 201110189274 CN201110189274 CN 201110189274 CN 201110189274 A CN201110189274 A CN 201110189274A CN 102276985 A CN102276985 A CN 102276985A
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- external capsule
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- sherwood oil
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Abstract
The invention relates to a method for casting an external capsule of a breast product. According to casting steps of the external capsule, a compounded rubber is dissolved into an organic solvent before vulcanization, wherein the compounded rubber is prepared by polydimethylsiloxane, a reinforcing filler, an increment filler, and an additive. The reinforcing filler is white carbon black; and according to weight proportion, the compounded rubber contains 5% to 10% of white carbon black. According to the invention, a novel compounded rubber product is employed, so that solubility of materials in a solvent is substantially improved and a solid content of material liquid is improved; during the casting process of the external capsule,
Description
Technical field
The present invention relates to a kind of external capsule and cast method, the external capsule that particularly relates to a kind of breast product is cast method.
Background technology
As everyone knows, it is that material is prepared that external capsule is cast flow process, casts, and typing is smoked, external capsule stripping and self check and deposit.Wherein the material preparation is the important step during external capsule is cast.At first to choose suitable mould.Secondly, the dissolving of rubber unvulcanizate.And then filter, filtration is the processing method that the impurity in the feed liquid and big particle are removed, and also can reach the thorough mixing of feed liquid simultaneously.After the filtration, after feed liquid stirred, need to use the vacuum outgas case to remove bubble or leave standstill a night after can use.
Cast is that the material that dissolving is good is in layer wrapped up in the process on the mould.The process of casting is a patient and careful job of very long needs.To check while casting whether impurity is arranged, whether have inhomogeneously whether bubble etc. is arranged.The material of using when casting must have suitable flowability and stable solubleness.With its viscosity of viscosity instrumentation, make feed liquid remain on a viscosity that is fit to cast before casting.
So it is extremely important to cast in the process solubleness of compound manufacture in solvent at external capsule, if dissolve insufficient, to cause sulfuration not exclusively, product strength does not reach requirement, so just directly cause the solid content of feed liquid on the low side, need to cast a lot casting of external capsule in the process all over the external capsule thickness that just can reach quality standards and require.
Thereby, to cast in the process at external capsule, compound manufacture and choice of Solvent play important effect.Existing compound manufacture is generally melting silicone rubber, and it is for cooperating reinforced filling, increment filler and giving the sizing that the additive of various performances is mixed with by the organopolysiloxane that contains the vinyl linear superpolymer (being commonly called as rubber).
Existing compound manufacture comprises the shortcoming of two aspects: one, its solubleness in solvent is relatively low, and its viscosity can be than higher under the same solubility condition, and viscosity is high to a certain degree being unfavorable for casting of external capsule, causes the thickness of external capsule to differ; Two, the component of its product, vulcanization system and catalyst system have been added in respectively in the sizing material, may cause raw material to shift to an earlier date the part self cure, are unfavorable for standing storage.
Summary of the invention
The technical problem to be solved in the present invention is: in order to solve the problems of the technologies described above, provide a kind of external capsule of breast product to cast method, adopt new compound manufacture, and the ratio of regulating compound manufacture and solvent, improve the solubleness in solvent greatly, improved the solid content of feed liquid.
The technical solution adopted for the present invention to solve the technical problems is: a kind of external capsule of breast product is cast method, cast in the step at external capsule and before sulfuration, rubber unvulcanizate to be dissolved in the organic solvent, described rubber unvulcanizate is formulated by polydimethylsiloxane, reinforced filling, increment filler and additive, described reinforced filling is a white carbon black, wherein, calculate by weight proportion, contain the white carbon black of 5%-10% in the described rubber unvulcanizate.Another aspect of the present invention, described organic solvent is selected from dimethylbenzene, hexahydro furyl, one or more of normal hexane and sherwood oil.Preferably, described organic solvent is a sherwood oil.
Another aspect of the present invention, rubber unvulcanizate and organic solvent part by weight are: 1: 1.5～1: 3.Preferably part by weight is: 1: 2.
Another aspect of the present invention, described rubber unvulcanizate and sherwood oil part by weight are: 1: 1.5～1: 3.Preferably part by weight is: 1: 2.
Another aspect of the present invention, the solubleness of described rubber unvulcanizate are 30～35%.
Another aspect of the present invention is cast the number of times cast in the step 5～6 times at external capsule.
The organic solvent that the present invention can be dissolved polydimethylsiloxane includes but not limited to toluene, dimethylbenzene, hexahydro furyl, normal hexane, sherwood oil.Consider solvent toxicity, solubleness, the preferred sherwood oil of the present invention.
The present invention is mixed in this polydimethylsiloxane in the solvent sherwood oil according to a certain percentage, utilizes high-speed stirring apparatus to make it quick dissolving.Dissolving adds inhibition system and vulcanization system afterwards and stirs fully.
The white carbon black content of polydimethylsiloxane of the present invention is fewer, white carbon black is the important strengthening agent of silicon rubber, and the viscosity in the content of white carbon black high more when dissolving can be high more, dissolved that we think well mainly is meant under the identical solubility condition, the viscosity of feed liquid is low more good more, general viscosity surpasses 450cp and will exert an influence to casting, so select the white carbon black of proper ratio that solubleness has been produced important effect.
On the other hand, prior art feed liquid solubleness generally can only be fitted on about 15-18%, and use feed liquid solubleness of the present invention generally can be fitted on about 30-35%, and this moment, both viscosity was basic identical, only need cast 5-6 for 10 times now all over just reaching same external capsule thickness so will cast originally.
The invention has the beneficial effects as follows: the present invention adopts new compound manufacture to improve solubleness in solvent greatly, has improved the solid content of feed liquid, can reach the external capsule thickness requirement of regulation than the pass that had reduced half in the past in the process of casting of external capsule.Improved the efficient of producing greatly.The present invention simplifies the operation sequence that breast prosthesis's product is cast at external capsule, has improved external capsule and has cast work efficiency of workers.
Embodiment
Embodiment
One, starting material essential information
1. material name: implant a level dimethyl siloxane rubber unvulcanizate, trade mark X-1
2. purposes: the external capsule housing that is used for breast prosthesis's product is cast
This raw material product is the sizing that cooperation white carbon black, increment filler and the additive of giving various performances are mixed with by polydimethylsiloxane, wherein increment filler and the additive of giving various performances are joined and are conventional raw material, and they provide by Arlon Silicone Technologies Division.This raw material prepares according to existing method, and it is 5%-10% that the white carbon black of this raw material accounts for this raw material ratio.
Two, definite process of the starting material processing method that is applied to produce
1. lab scale stage (2010.12.10-2011.2.15)
1.1 the experiment purpose of lab scale:
1. understand the solubility property of sizing material, select suitable solvent and dissolving ratio roughly;
2. regulate the viscosity of glue, tentatively grasp viscosity, cast pass, the relation between the external capsule thickness.
1.2 the experiment content of lab scale:
December 10
Configuration external capsule glue/squeegee solution
1. X-1 material/sherwood oil=250 (g)/500 (g)
2. X-1 material/dimethylbenzene=150 (g)/300 (g)
3. X-2 material/ethyl acetate=18 (g)/82 (g)
The X-2 material is provided by Arlon Silicone Technologies Division for fluorine silicon intercepts material, and its purposes is the intermediate course of casting at external capsule, prevents separating out of the inner small molecules thing of external capsule, for casting the material that is used in the external capsule process.
December 15
The configuration workshop is now used
4. L-1 expects that it is 575cp that A/B=1/1 records viscosity
Give 1. 2. 3. that solution adds an amount of inhibitor and vulcanizing agent respectively, adding proportion sees the following form, and this ratio is provided by Arlon Silicone Technologies Division.
| X-1 expects (g) | Inhibitor (ml) | Vulcanizing agent (ml) |
| 100 | 0.3 | 0.7 |
| X-2 expects (g) | Inhibitor (ml) | Vulcanizing agent (ml) |
| 100 | 0.3 | 1.0 |
And record 1. 2. that soltion viscosity is respectively 750cp and 1275cp
December 16
Use 1. X-1 material/sherwood oil=250 (g)/500 (g) (viscosity 750cp) to cast two external capsules respectively and respectively cast twice, mould number is respectively CP350-20 and AP360-13, and 150 ℃ of sulfurations one hour record thickness 0.21-0.25.
Use 2. X-1 material/dimethylbenzene=150 (g)/300 (g) (viscosity 1275cp) to cast two external capsules respectively, one is watered one time, and another waters twice, and mould number is respectively CP350-29 and AP360-11,150 ℃ were vulcanized one hour, and recorded thickness and be respectively 0.11-0.12 and 0.3-0.32.
In remaining 1. X-1 material/sherwood oil, continue to add the sherwood oil dilution, obtain viscosity 575cp, compile and be 5. X-1 material/sherwood oil.
In remaining 2. X-1 material/dimethylbenzene, continue to add the dimethylbenzene dilution, obtain viscosity 800cp, compile and be 6. X-1 material/dimethylbenzene.
December 17
Use 5. X-1 material/sherwood oil (viscosity 575cp) to cast two external capsules respectively and respectively water three times, middle with 3. X-2 material/ethyl acetate=18 (g)/82 (g) casting one time, water again twice with 5. X-1 material/sherwood oil at last.(3+1+2) 150 ℃ were vulcanized one hour, recorded thickness and were respectively AP360-13 (0.50-0.70) and CP350-29 (0.76-0.85).
Configuration external capsule glue/squeegee solution
7. X-1 material/sherwood oil=300 (g)/900 (g)
8. X-2 material/ethyl acetate=54 (g)/246 (g)
December 20
In remaining 5. X-1 material/sherwood oil (viscosity 575cp), continue to add the sherwood oil dilution, obtain viscosity 400cp, compile and be 9. X-1 material/sherwood oil.
Use 9. X-1 material/sherwood oil (viscosity 400cp) to cast two external capsules respectively and respectively water three times, middle with 3. X-2 material/ethyl acetate=18 (g)/82 (g) casting one time, water again twice with 9. SX-1 material/sherwood oil at last.(3+1+2) 150 ℃ were vulcanized one hour, recorded thickness and were respectively AP360-11 (0.60) and CP350-29 (0.65).
December 21
In remaining 9. X-1 material/sherwood oil (viscosity 32.0), continue to add the sherwood oil dilution, obtain viscosity 21.0, compile and be 10. X-1 material/sherwood oil.
Use 10. X-1 material/sherwood oil (viscosity 21.0) to cast two external capsules respectively and respectively water twice, middle with 3. X-2 material/ethyl acetate=18 (g)/82 (g) casting one time, water again twice with 10. X-1 material/sherwood oil at last.(2+1+2) 150 ℃ were vulcanized one hour, recorded thickness and were respectively AP360-11 (0.60) and CP350-29 (0.65).
December 22
Record 7. that X-1 material/sherwood oil=150 (g)/450 (g) viscosity is 15.0 (18 ℃ of temperature), add inhibitor and vulcanizing agent in proportion.Find during filtration that trickling is very slow, have a lot of small blob of viscoses not dissolve fully, the plan of abandoning casting external capsule, material is deposited in the refrigerator.
December 23
To remain about 100ml 10. that X-1 material/sherwood oil joins in the new a collection of 7. X-1 material/sherwood oil, recording viscosity is 15.0.
Use 7. X-1 material/sherwood oil (viscosity 15.0) to cast two external capsules respectively and respectively water three times, middle with 3. X-2 material/ethyl acetate=18 (g)/82 (g) casting one time, water again three times with 7. X-1 material/sherwood oil at last.(3+1+3) 150 ℃ were vulcanized one hour, recorded thickness and were respectively No. 3 moulds (0.68) and No. 4 moulds (0.65).
December 24
Use 7. X-1 material/sherwood oil (viscosity 400cp) to cast four external capsules respectively and respectively water three times, middle with 8. X-2 material/ethyl acetate=18 (g)/82 (g) casting one time, water again twice with 7. X-1 material/sherwood oil at last.(3+1+2) 150 ℃ were vulcanized one hour, recorded thickness and were respectively No. 1 mould (0.45), No. 2 moulds (0.44), No. 3 moulds (0.44) and No. 4 moulds (0.47).
December 27
Use 4. L-1 material A/B=1/1 (added a spot of sherwood oil before casting, practical viscosity is lower than 500cp) to cast 4 external capsules 8 times, a workshop is watered now with intercepting material in the centre, records mean thickness about 0.35.
Configuration external capsule sol solution
(11) S009 material/sherwood oil=200 (g)/450 (g)
(12) S009 material/sherwood oil=200 (g)/450 (g)
27-January 4 December
The external capsule of casting on December 17, December 21 and December 24 respectively label be X-1-1, X-1-3 and X-1-2, X-1-1 and X-1-2 are carried out six chemical detection, X-1-2 and X-1-3 are carried out three mechanics detect.
January 7
Use virgin material to cast 1 external capsule in the workshop, viscosity is about 375cp, adopts 2 times X-1 material to add one deck X-2 and intercepts material, and 2 times X-1 expect again, and (2+1+2) 150 degree sulfurations are 1 hour, and external capsule thickness is about 0.32 as a result.
January 10
Receiving 15 moulds uses virgin material to cast 15 external capsules (specifically casting the work report that situation sees that it is write) by the plant operations personnel in the workshop, viscosity is about 425cp, adopt 3 times X-1 material to add one deck X-2 and intercept material, 2 times X-1 expect again, (3+1+2) 150 degree sulfurations are 1 hour, and external capsule thickness (is specifically seen inspector's external capsule survey report) about 0.45 as a result.
January 11
Use 5,6,9 and No. 10 mould, cast 8 times with L-1 with the workshop is existing, wherein cast 1 layer of existing using and intercept material (4+1+4) by Wang Tiantian.Thickness is 0.45-0.50.
1.3 the experimental result of lab scale:
Infusion X-1 housing material is selected be sherwood oil as solvent, preliminary dissolving ratio is X-1 material/sherwood oil=250 (g)/500 (g); Adjusting viscosity is cast 5 times to 375cp and can be reached thickness requirement, and adjusting viscosity is cast 4 times to 450cp and can be reached thickness requirement.
2. pilot scale stage
2.1 the experiment purpose of pilot scale:
1. determine dissolving of bubble material and filtering scheme;
2. determine viscosity and the pass that sizing material is cast;
3. carry out the experiment of casting of one-time continuous according to the experimental result of lab scale in earlier stage, with the feasibility of checking new raw material system serialization production.
4. starting material security test specifically comprises: five micronutrient levels tests; The test of external capsule chemical property; The external capsule Mechanics Performance Testing.(concrete detected result is seen appendix)
2.2 the experiment content of pilot scale:
A, bubble material
Use the clean wide-necked bottle (2 bottles) of 5L, every bottle of weighing X-1 material 800g adds 5 bottles of 2500ml of sherwood oil (about 1650g), open it with agitator, and dissolving fully.
Use the clean wide-necked bottle (2 bottles) of 1L, every bottle of weighing X-2 material 140g adds 1 bottle of half 750ml of ethyl acetate (about 675g), open it with agitator, and dissolving fully.
B, adjusting viscosity
By adding sherwood oil the X-1 viscosity of sludge is adjusted to (use No. 2 rotor, rotating speed 12 is measured) about 375cp.
(proportioning is by Arlon Silicone Technologies Division for c, interpolation inhibitor and vulcanizing agent
Provide)
It is 2.4ml that S009 material (800g) adds inhibition dosage, and adding sulfuration dosage is 5.6ml
It is 0.42ml that S038 material (140g) adds inhibition dosage, and adding sulfuration dosage is 1.40ml
| X-1 expects (g) | Inhibitor (ml) | Vulcanizing agent (ml) |
| 100 | 0.3 | 0.7 |
| X-2 expects (g) | Inhibitor (ml) | Vulcanizing agent (ml) |
| 100 | 0.3 | 1.0 |
D, packing and storage
The feed liquid of having added the sulfuration inhibition system is divided in the Brown Glass Brown glass bottles and jars only, and carries out sign, should put into refrigerator behind the adding sulfuration inhibition system and store.
Casting of e, external capsule
The production assistant is responsible for the arrangement personnel and casts 60 Helen's external capsules, 10 light face external capsules and 2 Margarita products.60 Helen's external capsules require to use mould to be awl hair side mould (200ml-300ml) among the Helen, and prod cast tool (220ml-240ml) filtered material before casting in 2 Margarita product requirements, used the used filter type in workshop to filter twice.
2.3 the experimental result of pilot scale:
72 external capsule overall products are apparent to look good, and the external capsule mean thickness is 0.49mm, and part external capsule thickness is thick partially, and reason is that the glue gel content is bigger.
3. producing and manufacturing technique is determined
3.1 bubble material and stirring arrange the special messenger to operate, main operation is operated with reference to the operation steps of pilot scale, and the interpolation of sulfuration inhibition system needs the special messenger and checks.
3.2 the viscosity to sizing material when producing requires than higher, external capsule is cast personnel according to the sizing material that every day, output was received, and will confirm as 375 ± 25cp (No. 2 spinner velocity 12 scales 15.0) to the viscosity of sizing material and check before casting.Casting pass is 3 times housing glue, 1 time squeegee, 2 times housing glue again.
Three, the starting material safety and effectiveness is confirmed
1. ingredient inspection
According to YY0334-2002 " the general requirement of silicon rubber surgical implant " raw material is carried out iron; Cadmium; Arsenic; Chromium; Plumbous five micronutrient levelss test, detected result is qualified.
2. and 40038 intercept material and with the check of casting external capsule
The external capsule that " the general requirement of silicon rubber surgical implant " casts X-1/X-2 according to YY0334-2002 carries out iron; Cadmium; Arsenic; Chromium; Plumbous five micronutrient levelss test, detected result is qualified.
The external capsule that " the general requirement of silicon rubber surgical implant " casts X-1/X-2 according to YY0334-2002 carries out weight loss on drying; Reducing substance; Heavy metal; Uv-absorbing; Six chemical properties of potential of hydrogen and residue on evaporation are tested, and detected result is qualified.
The external capsule that " the general requirement of silicon rubber surgical implant " casts X-1/X-2 according to YY0334-2002 carries out tensile yield; Draw high tension set; Tear strength is tested, and detected result is qualified.
Biocompatibility test is treated the detection affirmation of Jinan medicine equipment inspection center, the supplier's biocompatibility report reference of can supplying raw materials at present.
Those skilled in the art should recognize change and the retouching of being done under the situation that does not break away from the appended scope and spirit of the present invention that claim disclosed of the present invention, all belong within the protection domain of claim of the present invention.
Claims (9)
1. the external capsule of a breast product is cast method, cast in the step at external capsule and before sulfuration, rubber unvulcanizate to be dissolved in the organic solvent, described rubber unvulcanizate is formulated by polydimethylsiloxane, reinforced filling, increment filler and additive, it is characterized in that: described reinforced filling is a white carbon black, wherein, calculate by weight proportion, contain the white carbon black of 5%-10% in the described rubber unvulcanizate.
2. the external capsule of breast product as claimed in claim 1 is cast method, it is characterized in that: described organic solvent is selected from dimethylbenzene, hexahydro furyl, one or more of normal hexane and sherwood oil.
3. the external capsule of breast product as claimed in claim 2 is cast method, it is characterized in that: described organic solvent is a sherwood oil.
4. the external capsule of breast product as claimed in claim 1 is cast method, it is characterized in that: described rubber unvulcanizate and organic solvent part by weight are: 1: 1.5～1: 3.
5. the external capsule of breast product as claimed in claim 4 is cast method, it is characterized in that: described rubber unvulcanizate and organic solvent part by weight are: 1: 2.
6. the external capsule of breast product as claimed in claim 3 is cast method, it is characterized in that: described rubber unvulcanizate and sherwood oil part by weight are: 1: 1.5～1: 3.
7. the external capsule of breast product as claimed in claim 6 is cast method, it is characterized in that: described rubber unvulcanizate and sherwood oil part by weight are: 1: 2.
8. the external capsule of breast product as claimed in claim 1 is cast method, it is characterized in that: the solubleness of described rubber unvulcanizate is 30～35%.
9. cast method as the external capsule of the arbitrary described breast product of claim 1 to 8, it is characterized in that: cast the number of times cast in the step 5～6 times at external capsule.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201110189274 CN102276985B (en) | 2011-07-07 | 2011-07-07 | Method for casting external capsule of breast product |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201110189274 CN102276985B (en) | 2011-07-07 | 2011-07-07 | Method for casting external capsule of breast product |
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| Publication Number | Publication Date |
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| CN102276985A true CN102276985A (en) | 2011-12-14 |
| CN102276985B CN102276985B (en) | 2012-12-12 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010045579A2 (en) * | 2008-10-17 | 2010-04-22 | Allergan, Inc. | Prosthetic implant shell |
| CN101864174A (en) * | 2010-06-22 | 2010-10-20 | 吴江朗科化纤有限公司 | Method for preparing liquid silicon rubber |
| EP2301485A2 (en) * | 2009-09-23 | 2011-03-30 | AMOENA Medizin-Orthopädie-Technik GmbH | Breast prosthesis |
| WO2011046273A1 (en) * | 2009-10-16 | 2011-04-21 | Yu Won-Seok | Silicone artificial breast prosthesis which minimizes stress concentration, and production method therefor |
-
2011
- 2011-07-07 CN CN 201110189274 patent/CN102276985B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010045579A2 (en) * | 2008-10-17 | 2010-04-22 | Allergan, Inc. | Prosthetic implant shell |
| EP2301485A2 (en) * | 2009-09-23 | 2011-03-30 | AMOENA Medizin-Orthopädie-Technik GmbH | Breast prosthesis |
| WO2011046273A1 (en) * | 2009-10-16 | 2011-04-21 | Yu Won-Seok | Silicone artificial breast prosthesis which minimizes stress concentration, and production method therefor |
| CN101864174A (en) * | 2010-06-22 | 2010-10-20 | 吴江朗科化纤有限公司 | Method for preparing liquid silicon rubber |
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