CN1732868A - Anti-seepage freeze gel artificial prosthesis and method for manufacturing the same - Google Patents
Anti-seepage freeze gel artificial prosthesis and method for manufacturing the same Download PDFInfo
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- CN1732868A CN1732868A CNA2004100533820A CN200410053382A CN1732868A CN 1732868 A CN1732868 A CN 1732868A CN A2004100533820 A CNA2004100533820 A CN A2004100533820A CN 200410053382 A CN200410053382 A CN 200410053382A CN 1732868 A CN1732868 A CN 1732868A
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- antiseep
- glue
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- polysiloxane
- artificial prosthesis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/12—Mammary prostheses and implants
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Prostheses (AREA)
Abstract
The invention relates to medical material tech field. It refers to a artificial prosthesis of ice gel for antiseep, and said artificial prosthesis includes external capsule1, filelrs2 and cover board3. Said artificial prosthesis in the invention is high in shape fidelity, resilience, hand feelings. It reinforces leak-proof measures through the method of ice gel for antiseep and it's making, and is better in practical values. The invention offers its making method.
Description
Technical field:
The invention belongs to medical material tech field, be specifically related to congeal glue antiseep artificial prosthesis and manufacture method.
Background technology:
Liking to be beautiful originally is people's nature, and graceful well-balanced body more makes the people confident.The women pursues well-balanced health and the bodily form also becomes fashion gradually, therefore develops various shaping and beauty medical supplies, comprises that breast prosthesis, artificial testis, ARTIFICIAL EYELID, nose prosthesis, cheek, bone prosthese etc. have become the exploitation focus of medical material.
Artificial breast prosthesis commonly used in the present medical shaping and beauty can be divided into by the charges difference in the utricule: silicon gel artificial breast prosthesis, brine type artificial breast prosthesis, hydrogel artificial breast prosthesis etc.By contrast, silica-gel breast prosthesis is true to nature because of its moulding, high resilience, good hand touch and be subjected to plastic surgeon and shaping user's welcome deeply.But also there are some shortcomings in silica-gel breast prosthesis at present, analyze from follow-up of product quality and clinical use feedback opinion, seepage often takes place in silica-gel breast prosthesis easily, charges silicon gel and a small amount of low molecular weight polyorganosiloxane can be slowly to exosmosis by cyst wall, under the effect of penetrant, cyst wall is yielding, the prosthese flexibility decrease.In a single day utricule breaks, and the silicon gel adheres to tissue after leaking and spreading, and forms the peplos capsule, tissue is damaged and is difficult to remove.
Summary of the invention:
Technical problem to be solved by this invention is to overcome above-mentioned weak point, develops the artificial prosthesis of antiseep.
The invention provides a kind of glue antiseep artificial prosthesis of congealing.Artificial prosthesis of the present invention comprises external capsule 1, implant 2 and capping plate 3 compositions, as shown in Figure 1.
External capsule 1 is made by the cast of multilamellar (4～12 layers) macromolecular material, this macromolecular material is a good biocompatibility, the medical grade macromolecular material that the certain air permeability energy is arranged, the most frequently used is medical polysiloxane, and wherein the 2nd～5 layer adds impermeable medical grade material, this impermeable medical material belongs to organosiloxane series, is specially fluorine-containing or contains the impervious material of the polysiloxane of phenyl.With the capsule material the good compatibility is arranged, harmless.Fit tightly between this multilamellar cyst wall; The compatibility, caking property is good, and multilamellar (4～12 layers) cyst wall structure has strengthened the toughness and the wearability of cyst wall, keeps better elastic and tear resistance simultaneously, has barrier performance, erects the barrier of one antiseep for whole breast prosthesis.
Because utricule, the combination of charges and capping plate makes whole prosthese be in the dual fail-safe state, can prevent that charges silicon gel from leaking from two aspects.
The glue antiseep artificial prosthesis of congealing of the present invention can be made breast prosthesis, artificial testis and ARTIFICIAL EYELID etc.
The shape of this prosthese can be made garden shape, taper, the shape of dripping, testis shape, eyeball shape or dissect shape etc., to meet different shaping persons' requirement.
This prosthese can be made bright finish, and appearance frosting or villous is to satisfy the needs of different crowd.
This prosthese can be made the different size size according to the demand of different crowd.
Another object of the present invention provides the manufacture method of manually congealing glue antiseep artificial prosthesis, and this method comprises the following steps:
(1) making of utricule 1: cryogenic vulcanization type polysiloxane A material (add 0.1～5% the platinum compounds that is equivalent to polysiloxane base material weight % and be made into the A material in the polysiloxane base material) and B material (add in the polysiloxane base material 0.5～15% polysiloxane that contains the hydrogen functional group that is equivalent to polysiloxane base material weight % be made into B expect) are used organic solvent (petroleum ether respectively, benzene or acetone etc.) dissolving makes 3～12% liquid and selects the suitable mold moulding by casting by 1: 1 mixing, put treat in the fume hood that organic solvent volatilizees substantially after, change in the low-temperature bake oven and vulcanize, temperature is controlled at 80 ℃～150 ℃, 2～8 hours time, repeat aforesaid operations, carry out multilamellar (4～12 layers) cast, wherein 2～5 layers add impermeable polysiloxane, carry out cooling and demolding behind the sulfidization molding, make utricule, it is standby to detect qualified back;
(2) making of capping plate 3:
High temperature vulcanized type or cryogenic vulcanization type polysiloxane are carried out the suitable mould of mixing selection carry out hot-forming (120～180 ℃ of temperature, 5～30 minutes time) on mixing roll;
Can be on the end skin of making (1) method cast layer high molecule thin film set by step, make the capping plate, standby after the passed examination;
(3) bonding: with capping plate 3 and utricule 1 bonding, standby after the passed examination with the medical grade silicon rubber binding agent;
(4) silicon preparing gel: add-on type silica gel A material (add 0.1～5% chloroplatinic acid or other solubility platinum compounds etc. and be made into the A material in the silica gel base material) and B material (add 0.5～15% polysiloxanes that contains the hydrogen functional group and be made into the material for B in the silica gel base material) are stirred evenly by suitable proportioning (0.5: 1～2: 1) mixing, standby;
(5) filling: with syringe above-mentioned silicon gel quantitative filling is gone in the above-mentioned utricule after bonding, injection port is sealed, put in the low-temperature bake oven and vulcanize, make the gelation glue with binding agent;
(6) pack into after the passed examination in the fixing and packaging box, as semi-finished product;
(7) semi-finished product are through Co60 irradiation sterilization or ethylene oxide sterilizing;
(8) make product through after the assay was approved.
Above-mentioned being produced in 100,000 grades of (local 100 grades) environment purifications carried out.
Above-mentioned manufacture method can be used for making breast prosthesis, artificial testis or ARTIFICIAL EYELID etc.
Moulding of congealing glue antiseep artificial prosthesis of the present invention is true to nature, high resilience, good hand touch, and congeal glue antiseep manufacture method because of having adopted, reinforced leak-proof measure, set up the capping plate simultaneously, leakproof is strengthened, overcome the defective of existing artificial prosthesis, good practical values has been arranged.
Description of drawings:
Fig. 1 artificial prosthesis section of structure,
Fig. 2 artificial breast prosthesis
Fig. 3 ARTIFICIAL EYELID prosthese
The artificial testicular prosthesis of Fig. 4
Above figure includes 1, utricule 2, charges 3, capping plate
The specific embodiment:
The making (see figure 2) of embodiment 1, circular bright finish antiseep artificial breast prosthesis
(1) cryogenic vulcanization type polysiloxanes and chloroplatinic acid being made into A material and polysiloxanes and containing hydrogen silicone oil is made into the B material and makes 5% solution by 1: 1 mixing with petroleum ether dissolution respectively, select for use round mould to pour into a mould, 80 ℃ of cryogenic vulcanizations 3 hours, water the second layer again after solidifying cooling, water 4 layers altogether, add 10% permeability-reducing admixture in 2 layers of its invading the interior, treat whole cast cured explosives after, cooling and demolding, it is standby to make utricule 1;
(2) with above-mentioned polysiloxanes A material and B material by mixing repeatedly on mixing roll after 1: 1 proportioning, with flat plate mold hot pressing (120 ℃ * 10 minutes) molding, the silicone rubber solution cast that is added with permeability-reducing admixture in the reuse (1) is two-layer, and is standby as capping plate 3 after the sulfuration;
(3) capping plate 3 and utricule 1 usefulness silicone rubber adhesive is bonding;
(4) addition type polysiloxane A material, B material are pressed 1: 0.8 proportioning furnishing silicon gel material;
(5) with syringe above-mentioned silicon gel quantitative filling is gone in the good utricule of above-mentioned involution, injection port made with the rearmounted 60 ℃ of baking ovens sulfuration of adhesive seal in 36 hours becomes the frozen glue shape;
(6) above-mentioned semi-finished product are through the Co60 irradiation sterilization, and being up to the standards then becomes.
The making (see figure 2) of embodiment 2, conical matte antiseep artificial breast prosthesis
(1) cryogenic vulcanization type polysiloxanes and chloroplatinic acid being made into A material and polysiloxanes and containing hydrogen silicone oil is made into the B material and makes 8% solution by 1: 1 mixing with petroleum ether dissolution respectively, select for use the pyramid type mould to pour into a mould, 100 ℃ were vulcanized 3 hours, water the second layer again after solidifying cooling, the 3rd layer ..., water 6 layers altogether, wherein by adding 15% permeability-reducing admixture in 3 layers of lining, after treating whole cast cured explosive coolings, the demoulding is standby;
(2) with above-mentioned polysiloxanes A material and B material by mixing repeatedly on mixing roll after 1: 1 proportioning, with flat plate mold hot pressing (120 ℃ * 6 minutes) molding, be added with three layers of the silicone rubber solution cast of permeability-reducing admixture in the reuse (1), standby after the sulfuration as capping plate 3;
(3) capping plate 3 and utricule 1 usefulness silicone rubber adhesive is bonding;
(4) addition type polysiloxane A material and B material are pressed 1: 1 proportioning furnishing silicon gel material;
(5) with syringe above-mentioned silicon gel quantitative filling is gone in the good utricule of above-mentioned involution, injection port with adhesive seal after, put the sulfuration of 80 ℃ of baking ovens and made in 24 hours and become the frozen glue shape;
(6) above-mentioned semi-finished product ethane via epoxyethane sterilization, being up to the standards then becomes.
The making (see figure 4) of embodiment 3, the artificial testis of gel antiseep
(1) use petroleum ether (acetone) dissolving to make 6% solution respectively in cryogenic vulcanization type polysiloxanes A material and B material by 1: 1 mixing, select for use the testis mould to pour into a mould, 80 ℃ of cryogenic vulcanizations 4 hours water the second layer after solidifying cooling again, water 4 layers altogether, add 10% permeability-reducing admixture in 2 layers of its invading the interior.After treating whole cast cured explosives, cooling and demolding, it is standby to make utricule 1;
(2) cryogenic vulcanization type polysiloxanes A material and B material are pressed after 1: 1 proportioning mixing repeatedly on mixing roll, with flat plate mold hot pressing (120 ℃ * 8 minutes) molding, the silicone rubber solution cast that is added with permeability-reducing admixture in the reuse (1) is two-layer, and the sulfuration back is standby as capping plate 3;
(3) capsuling machine 3 and utricule 1 usefulness silicone rubber adhesive is bonding;
(4) add-on type silicon gel A material and B material are pressed 1: 0.9 proportioning furnishing silicon gel material;
(5) with syringe above-mentioned silicon gel quantitative filling is gone in the good utricule of above-mentioned involution, injection port made with the rearmounted 80 ℃ of baking ovens sulfuration of adhesive seal in 24 hours becomes the frozen glue shape;
(6) above-mentioned semi-finished product are through the Co60 irradiation sterilization, and being up to the standards then becomes.
Embodiment 4, congeal the making (see figure 3) of glue antiseep ARTIFICIAL EYELID
(1) cryogenic vulcanization type polysiloxanes is made 7% solution with petroleum ether dissolution, by 1: 1 mixing, select for use eyeball shape mould to pour into a mould, 90 ℃ of cryogenic vulcanizations 4 hours water the second layer again after the cooling, water 8 layers altogether, add 10% permeability-reducing admixture in 3 layers of its invading the interior.All watered and solidified the cooling rear demoulding, the preceding hemisphere of utricule pattern handle waters white, makes the white of the eye;
(2) cryogenic vulcanization type polysiloxanes A material and B are expected by proportioning after adding appropriate colouring agent mixing at 1: 1, mixing repeatedly on mixing roll, with flat plate mold hot pressing (120 ℃ * 8 minutes) molding, the silicone rubber solution that is added with permeability-reducing admixture in the cooling back reuse (1) is poured into a mould three layers, the sulfuration back is standby as capping plate 3, and the capping plate is designed to black-eyed form;
(3) capsuling machine (iris) is partly carefully bonding with the white of the eye of utricule;
(4) addition type polysiloxane A material and B material are pressed 1: 1 proportioning furnishing silicon gel material;
(5) with syringe above-mentioned silicon gel is quantitatively filled in the good utricule of above-mentioned involution, injection port made with the rearmounted 80 ℃ of baking ovens sulfuration of adhesive seal in 24 hours becomes the frozen glue shape;
(6) above-mentioned semi-finished product are through the Co60 irradiation sterilization, and being up to the standards then becomes.
A material in the above-mentioned example 2～4 is identical with example 1 with the B material.
Claims (7)
1, a kind of glue antiseep artificial prosthesis of congealing is characterized in that this artificial prosthesis comprises external capsule 1, charges 2 and capping plate 3 compositions.
2, a kind of a kind of glue antiseep artificial prosthesis of congealing as claimed in claim 1, it is characterized in that wherein said external capsule is that 4～12 layers of medical polysiloxane materials cast are made, wherein 2～5 layers for fluorine-containing or contain the impervious material of the polysiloxane of phenyl.
3, a kind of glue antiseep artificial prosthesis of congealing according to claim 1 is characterized in that wherein said charges are that cohesiveness is the gel that silicon gel, hydrogel or the collagen protein of 30 minutes 5mm～60mm made.
4, a kind of glue antiseep artificial prosthesis of congealing according to claim 1, it is characterized in that wherein said capping plate is that compacting of the medical polysiloxane material of multilamellar or cast are made, wherein 2～5 layers for fluorine-containing or contain the impervious material of the polysiloxane of phenyl.
5, a kind of manufacture method of congealing glue antiseep artificial prosthesis is characterized in that this method comprises the following steps:
(1) making of utricule 1: cryogenic vulcanization type polysiloxane A material and B material are used organic solvent respectively, petroleum ether, benzene or acetone, dissolving is made 3～12% liquid by 1: 1 mixing selection suitable mold moulding by casting, put treat in the fume hood that organic solvent volatilizees substantially after, change in the low-temperature bake oven and vulcanize, temperature is controlled at 80 ℃～150 ℃, 2～8 hours time, repeat aforesaid operations, carry out 4～12 layers of cast, cast, wherein 2～5 layers for fluorine-containing or contain the impervious material sulfidization molding of polysiloxane of phenyl after carry out cooling and demolding, make utricule, it is standby to detect qualified back;
(2) making of capping plate 3:
High temperature vulcanized type or cryogenic vulcanization type polysiloxane are carried out mixing on mixing roll, it is hot-forming to select suitable mould to carry out, 120～180 ℃ of temperature, 5～30 minutes time;
Can be on the end skin of making (1) method cast layer high molecule thin film set by step, make the capping plate, standby after the passed examination;
(3) bonding: with capping plate 3 and utricule 1 bonding, standby after the passed examination with the medical grade silicon rubber binding agent;
(4) silicon preparing gel: add-on type silica gel A material and B material are stirred evenly by the mixing in 0.5: 1～2: 1 of suitable proportioning, standby;
(5) filling: with syringe above-mentioned silicon gel quantitative filling is gone in the above-mentioned utricule after bonding, injection port is sealed, put in the low-temperature bake oven and vulcanize, make the gelation glue with binding agent;
(6) pack into after the passed examination in the fixing and packaging box, as semi-finished product;
(7) semi-finished product are through Co60 irradiation sterilization or ethylene oxide sterilizing;
(8) make product through after the assay was approved.
Above-mentionedly be produced on 100,000 grades, local 100 grades, carry out in the environment purification.
6, a kind of manufacture method of congealing glue antiseep artificial prosthesis according to claim 5, it is characterized in that wherein said A material package draw together in the silica gel base material add with silica gel base material percentage by weight be that 0.1～5% chloroplatinic acid or other solubility platinum compounds are formed; The B material package is drawn together the polysiloxanes that contains the hydrogen functional group of silica gel base material adding 0.5～15% and is formed.
7, a kind of manufacture method of congealing glue antiseep artificial prosthesis according to claim 5 is characterized in that this method can be used to make breast prosthesis, artificial testis or ARTIFICIAL EYELID.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100533820A CN100469336C (en) | 2004-08-03 | 2004-08-03 | Anti-seepage freeze gel artificial prosthesis and method for manufacturing the same |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100533820A CN100469336C (en) | 2004-08-03 | 2004-08-03 | Anti-seepage freeze gel artificial prosthesis and method for manufacturing the same |
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| CN1732868A true CN1732868A (en) | 2006-02-15 |
| CN100469336C CN100469336C (en) | 2009-03-18 |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102120094A (en) * | 2011-01-17 | 2011-07-13 | 上海康宁医疗用品有限公司 | Method for removing small molecules from silicone gel by molecular distillation |
| CN102528989A (en) * | 2011-12-21 | 2012-07-04 | 中国电子科技集团公司第五十五研究所 | Manufacturing method of soft silicone rubber pad for multilayer ceramic cavity structure |
| CN102555033A (en) * | 2011-12-21 | 2012-07-11 | 中国电子科技集团公司第五十五研究所 | Flow filling lamination forming method of multilayer ceramic cavity body |
| CN102555128A (en) * | 2012-01-12 | 2012-07-11 | 上海康宁医疗用品有限公司 | Artificial breast prosthesis sealing and covering process |
| CN102699985A (en) * | 2012-04-25 | 2012-10-03 | 中国电子科技集团公司第五十五研究所 | Method for preparing minuteness cavity stricture multilayer ceramics by using laminating method filled gel |
| CN104069544A (en) * | 2014-06-09 | 2014-10-01 | 上海康宁医疗用品有限公司 | Method for manufacturing silicone gel breast implant with base cover made from unvulcanized colloid cast by fluorinated silicone rubber |
| CN105382985A (en) * | 2014-08-21 | 2016-03-09 | 应用硅树脂责任有限公司 | Installation system and automated manufacture of prosthesis shell |
| CN107412873A (en) * | 2017-05-02 | 2017-12-01 | 北京化工大学 | A kind of high anti-tear antibiotic property breast prosthesis impervious barrier material preparation method |
-
2004
- 2004-08-03 CN CNB2004100533820A patent/CN100469336C/en not_active Expired - Fee Related
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102120094A (en) * | 2011-01-17 | 2011-07-13 | 上海康宁医疗用品有限公司 | Method for removing small molecules from silicone gel by molecular distillation |
| CN102120094B (en) * | 2011-01-17 | 2013-06-12 | 上海康宁医疗用品有限公司 | Method for removing small molecules from silicone gel by molecular distillation |
| CN102528989A (en) * | 2011-12-21 | 2012-07-04 | 中国电子科技集团公司第五十五研究所 | Manufacturing method of soft silicone rubber pad for multilayer ceramic cavity structure |
| CN102555033A (en) * | 2011-12-21 | 2012-07-11 | 中国电子科技集团公司第五十五研究所 | Flow filling lamination forming method of multilayer ceramic cavity body |
| CN102555128A (en) * | 2012-01-12 | 2012-07-11 | 上海康宁医疗用品有限公司 | Artificial breast prosthesis sealing and covering process |
| CN102699985A (en) * | 2012-04-25 | 2012-10-03 | 中国电子科技集团公司第五十五研究所 | Method for preparing minuteness cavity stricture multilayer ceramics by using laminating method filled gel |
| CN102699985B (en) * | 2012-04-25 | 2015-04-22 | 中国电子科技集团公司第五十五研究所 | Method for preparing minuteness cavity stricture multilayer ceramics by using laminating method filled gel |
| CN104069544A (en) * | 2014-06-09 | 2014-10-01 | 上海康宁医疗用品有限公司 | Method for manufacturing silicone gel breast implant with base cover made from unvulcanized colloid cast by fluorinated silicone rubber |
| CN104069544B (en) * | 2014-06-09 | 2015-10-21 | 上海康宁医疗用品有限公司 | A kind of fluorosioloxane rubber waters makes the manufacture method that uncured rubber body does the silica-gel breast prosthesis of bottom |
| CN105382985A (en) * | 2014-08-21 | 2016-03-09 | 应用硅树脂责任有限公司 | Installation system and automated manufacture of prosthesis shell |
| CN105382985B (en) * | 2014-08-21 | 2019-02-15 | 应用硅树脂责任有限公司 | The automatic method of installation system and manufacture shells for prostheses |
| CN107412873A (en) * | 2017-05-02 | 2017-12-01 | 北京化工大学 | A kind of high anti-tear antibiotic property breast prosthesis impervious barrier material preparation method |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100469336C (en) | 2009-03-18 |
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