CS255405B1 - Female mamma prosthesis and method of its production - Google Patents
Female mamma prosthesis and method of its production Download PDFInfo
- Publication number
- CS255405B1 CS255405B1 CS853662A CS366285A CS255405B1 CS 255405 B1 CS255405 B1 CS 255405B1 CS 853662 A CS853662 A CS 853662A CS 366285 A CS366285 A CS 366285A CS 255405 B1 CS255405 B1 CS 255405B1
- Authority
- CS
- Czechoslovakia
- Prior art keywords
- prosthesis
- polymer
- mold
- sponge
- spongy
- Prior art date
Links
- 210000000481 breast Anatomy 0.000 title claims abstract description 13
- 238000000034 method Methods 0.000 title claims description 6
- 238000004519 manufacturing process Methods 0.000 title claims description 5
- 229920000642 polymer Polymers 0.000 claims abstract description 21
- 239000000203 mixture Substances 0.000 claims abstract description 17
- 239000000178 monomer Substances 0.000 claims abstract description 13
- 239000000463 material Substances 0.000 claims abstract description 8
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 claims abstract description 7
- CERQOIWHTDAKMF-UHFFFAOYSA-M Methacrylate Chemical compound CC(=C)C([O-])=O CERQOIWHTDAKMF-UHFFFAOYSA-M 0.000 claims abstract description 7
- 238000006116 polymerization reaction Methods 0.000 claims abstract description 7
- 238000002360 preparation method Methods 0.000 claims abstract description 6
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims abstract description 4
- 239000001301 oxygen Substances 0.000 claims abstract description 4
- 229910052760 oxygen Inorganic materials 0.000 claims abstract description 4
- 230000000379 polymerizing effect Effects 0.000 claims description 2
- 229920002959 polymer blend Polymers 0.000 claims 1
- 239000002861 polymer material Substances 0.000 claims 1
- 239000002904 solvent Substances 0.000 abstract description 4
- 239000000126 substance Substances 0.000 abstract description 3
- 238000005266 casting Methods 0.000 abstract description 2
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 6
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 5
- 239000000499 gel Substances 0.000 description 5
- WOBHKFSMXKNTIM-UHFFFAOYSA-N Hydroxyethyl methacrylate Chemical compound CC(=C)C(=O)OCCO WOBHKFSMXKNTIM-UHFFFAOYSA-N 0.000 description 4
- 229920002818 (Hydroxyethyl)methacrylate Polymers 0.000 description 3
- ZMXDDKWLCZADIW-UHFFFAOYSA-N N,N-Dimethylformamide Chemical compound CN(C)C=O ZMXDDKWLCZADIW-UHFFFAOYSA-N 0.000 description 3
- DKGAVHZHDRPRBM-UHFFFAOYSA-N Tert-Butanol Chemical compound CC(C)(C)O DKGAVHZHDRPRBM-UHFFFAOYSA-N 0.000 description 3
- 229920002338 polyhydroxyethylmethacrylate Polymers 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- ZHNUHDYFZUAESO-UHFFFAOYSA-N Formamide Chemical compound NC=O ZHNUHDYFZUAESO-UHFFFAOYSA-N 0.000 description 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- STVZJERGLQHEKB-UHFFFAOYSA-N ethylene glycol dimethacrylate Chemical compound CC(=C)C(=O)OCCOC(=O)C(C)=C STVZJERGLQHEKB-UHFFFAOYSA-N 0.000 description 2
- GPRLSGONYQIRFK-UHFFFAOYSA-N hydron Chemical compound [H+] GPRLSGONYQIRFK-UHFFFAOYSA-N 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 239000004160 Ammonium persulphate Substances 0.000 description 1
- 239000004971 Cross linker Substances 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 description 1
- ROOXNKNUYICQNP-UHFFFAOYSA-N ammonium persulfate Chemical compound [NH4+].[NH4+].[O-]S(=O)(=O)OOS([O-])(=O)=O ROOXNKNUYICQNP-UHFFFAOYSA-N 0.000 description 1
- 235000019395 ammonium persulphate Nutrition 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 230000002538 fungal effect Effects 0.000 description 1
- 235000011187 glycerol Nutrition 0.000 description 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 1
- 239000003999 initiator Substances 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 229920000151 polyglycol Polymers 0.000 description 1
- 239000010695 polyglycol Substances 0.000 description 1
- 229920002379 silicone rubber Polymers 0.000 description 1
- 239000004945 silicone rubber Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
Classifications
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
- A61L27/34—Macromolecular materials
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Transplantation (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
Description
Vynález se týká protézy ženského prsu a způsobu její výroby.The present invention relates to a female breast prosthesis and a method for its manufacture.
Dosud se к výrobě náhrady ženského prsu nejčastěji používalo silikonového kaučuku, který je však nepropustný pro tělní tekutiny a zplodiny metabolismu, což je u protéz ženského prsu značně nevýhodná. Je známo též vyrábět protézy ženského prsu z houbovitých gelů na bázi glykolmetakrylátu, které shora uvedené nevýhody nemá. Nevýhodou těchto protéz je však, že do houby prorůstá tkáň a usazují se kalcifikáty, čímž protéza tvrdne a zvyšuje se její hmotnost.Until now, silicone rubber has been used most frequently in the manufacture of female breast replacement, but it is impermeable to body fluids and metabolic products, which is a considerable disadvantage in female breast prostheses. It is also known to produce female breast prostheses from sponge-like glycol methacrylate gels, which does not have the above-mentioned disadvantages. The disadvantage of these prostheses, however, is that the tissue grows into the fungus and calcites settle, thereby hardening the prosthesis and increasing its weight.
Dále je známa protéza ženského prsu neprorůstající novotvořeným mazivem, která sestává z obalu tvořeného homogenním gelem, který je vyplněný houbovitým gelem nebo tekutým gelem sklivcového typu tvořících samostatnou součást nespojenou s obalem. Nevýhodou této protézy je její složitá a neekonomická příprava a taká to, že jádro s obalem netvoří neoddělitelnou součást a při pohybu dochází к uvolňování jádra od obalu a může dojít к poškození obalu.Furthermore, a female breast prosthesis not known to grow through a newly formed lubricant is known, which consists of a package consisting of a homogeneous gel which is filled with a sponge gel or vitreous-type liquid gel forming a separate component not connected to the package. The disadvantage of this prosthesis is its complicated and uneconomical preparation and such that the core with the sheath does not form an integral part and during movement the core is released from the sheath and may damage the sheath.
Předmětem vynálezu je protéza ženského prsu z houbovitého hydrofilního polymerního materiálu, s výhodou na bázi metakrylátu nebo akrylátu, u níž je celý její povrch tvořen vrstvou homogenního filmu na bázi metakrylátu nebo akrylátu, {podobné složení jako houbovitý hydrofilní polymerní materiál), který plynule přechází do houbovité struktury a je s houbovitým hydrofilním polymerním materiálem spojen chemickou vazbou. Tloušťku homogenního filmu lze regulovat. S výhodou se používá tloušťky menší než 0,5 mm.The subject of the invention is a female breast prosthesis of sponge-like hydrophilic polymeric material, preferably based on methacrylate or acrylate, in which its entire surface is formed by a layer of homogeneous methacrylate or acrylate-based film (similar to sponge-like hydrophilic polymeric material). of the sponge-like structure and is bonded to the sponge-like hydrophilic polymeric material by chemical bonding. The thickness of the homogeneous film can be controlled. Preferably, a thickness of less than 0.5 mm is used.
Protéza ženského prsu podle vynálezu se vyrábí polymerací monomerní směsi pro přípravu houbovitého polymeru v otevřené formě tak, že se ve formě před naplněním monomerní sniěsí vytvoří film z rozpustného poLymeru na bázi metakrylátu nebo akrylátu tím, že se forma vyleje roztokem rozpustného polymeru, načež se po odstranění rozpouštědla forma naplní monomerní směsí pro přípravu houbovitého polymeru a tato směs se nechá zpolymerovcl v přítomnosti kyslíku, na vzduchu.The female breast prosthesis of the present invention is produced by polymerizing a monomer blend for the preparation of a sponge-like polymer in an open form by forming a film of soluble methacrylate or acrylate-based polymer in the mold before filling the monomer blend by pouring the mold with a soluble polymer solution. solvent removal, the mold is filled with the sponge polymer monomer blend and the blend is allowed to polymerize in the presence of oxygen, in air.
Během polymerace houbovité struktury dochází к pevnému chemickému spojení s folií rozpustného polymeru a síťovadlo, které je.obsaženo v monomerní směsi pro houbovitý polymer, způsobí dodatečné zesíťění folie rozpustného polymeru^ Tím přestává být tato folie rozpustná. Polymerací v přítomnosti kyslíku (na vzduchu), namísto běžně používané polymerace v inertní atmosféře, se vytvoří vrstva homogenního nehoubovitého polymeru také na zadní straně protézy.During the polymerization of the sponge structure, there is a strong chemical bond with the soluble polymer sheet and the crosslinker contained in the sponge polymer monomer mixture causes the crosslinking of the soluble polymer sheet to cease to be soluble. Polymerization in the presence of oxygen (in air), instead of the commonly used polymerization in an inert atmosphere, also forms a layer of homogeneous non-fungal polymer also on the back of the prosthesis.
Formu lze při polymerací s výhodou odklonit od svislé osy o 1 až 45°, čímž na hotovém výrobku vznikne šikmá plocha. Protéza potom tvarově odpovídá přirozenému ženskému prsu. Po skončení polymerace se protéza dokonale vypere ve vodě.The mold can advantageously be deflected from the vertical axis by 1 to 45 [deg.] To form an inclined surface on the finished product. The prosthesis then corresponds in shape to the natural female breast. After the polymerization is complete, the prosthesis is thoroughly washed in water.
Pro přípravu houbovitého polymeru se používá o sobě známé monomerní směsi tvořené například 10 až 40 % obj. glykolmetakrylátu obsahujícího 0,1 až 2 % obj. glykoldimetakrylátu, se 60 až 90 % obj. vody nebo kapaliny mísitelné s vodou, jako je například glycerin.For the preparation of the sponge-like polymer, the monomer mixtures known per se comprise, for example, 10 to 40% by volume of glycol methacrylate containing 0.1 to 2% by volume of glycol dimethacrylate, 60 to 90% by volume of water or a water-miscible liquid such as glycerin.
Jako rozpustného polymeru se výhodně používá polymeru vyrobeného podle čs. patentu č. 141 101 (Hydron S), podle kterého se glykolmetakrylát nebo polyglykolmetakrylát nebo příslušný glykolakrylát s obsahem 0,05 až 50 % hmot, glykol-bis-metakrylátu nebo polyglykol-bis-metakrylátu polymerují do konverzí nad 90 % v rozpouštědlech s interakčním parametrem menším než 0,5 vzhledem ke vznikajícímu kopolymerů. Polymer je dokonale rozpustný za studená v metanolu, dimetylformamidu, formamidu, terc-butyl-alkoholu, dimetylsulfoxidu, etylenglykolu, za horka pak v etanolu a n-propanolu.The soluble polymer used is preferably a polymer produced according to U.S. Pat. No. 141,101 (Hydron S) according to which glycol methacrylate or polyglycol methacrylate or the corresponding glycoacrylate containing from 0.05 to 50% by weight, glycol bis-methacrylate or polyglycol bis-methacrylate are polymerized to conversions above 90% in interaction solvents a parameter of less than 0.5 relative to the copolymers formed. The polymer is perfectly cold soluble in methanol, dimethylformamide, formamide, tert-butyl alcohol, dimethylsulfoxide, ethylene glycol, hot in ethanol and n-propanol.
Protéza podle vynálezu vyhovuje všem požadavkům kladeným na bjolékařské materiály. Lidská tkáň do protézy neprorůstá, ale vytváří okolo ní vazivové pouzdro, které není s protézou pevně spojeno. Tím nemůže dojít ke kalcifikaci protézy. Způsob její výroby je velmi jednoduchý a ekonomicky výhodný.The prosthesis according to the invention satisfies all the requirements imposed on biomedical materials. Human tissue does not grow into the prosthesis, but forms a fibrous capsule around it that is not firmly attached to the prosthesis. This prevents the prosthesis from calcifying. The method of its manufacture is very simple and economically advantageous.
s protézouwith a prosthesis
V dalším je vynález blíže objasněn na příkladech provedení.In the following, the invention is illustrated in more detail by means of exemplary embodiments.
Příklad 1Example 1
Do otevřené skleněné formy mající tvar ženského prsu se naleje 10% roztok rozpustného polymeru vyrobeného podle čs. patentu č. 141 101 (Hydron S) v celosolvu nebo metanolu a po smočení celého vnitřního povrchu formy se nechá rozpouštědlo odpařit. Tím vznikne pevný film. Do takto připravené formy se naleje monomerní směs obsahující 30 % obj. monoetylenglykolmononietakrylátu obsahujícího 1 % obj. monoetylenglykol-bis-metakrylátu, a 70 % obj. 10% vodného roztoku persíranu amonného. Tato směs se nechá při teplotě 60 až 70 °C /polymerovat po dobu 20 až 30 minut za přístupu vzduchu. Po dokončení polymerace se hotová protéza opatrné vyjme z formy. Zbytky iniciátoru, případně zbytky monomerů se z hotové protézy odstraní vypráním v destilované vodě. Tato operace se provádí tak dlouho, až odcházející kapalina nedává žádnou reakci na síranové ionty a organické znečištěniny. Konečný odlitek má po celém povrchu souvislou vrstvu čirého homogenního gelu, která plynule přechází do vnitřní houbovité struktury.A 10% solution of the soluble polymer produced according to U.S. Pat. No. 141,101 (Hydron S) in cellulose or methanol and after wetting the entire inner surface of the mold, the solvent is allowed to evaporate. This creates a solid film. A monomer mixture comprising 30% by volume of monoethylene glycol mono-methacrylate containing 1% by volume of monoethylene glycol bis-methacrylate and 70% by volume of a 10% aqueous solution of ammonium persulphate is poured into the mold thus prepared. The mixture is allowed to polymerize at 60 to 70 ° C / polymer for 20 to 30 minutes under air. Upon completion of the polymerization, the finished prosthesis is carefully removed from the mold. The initiator residues or monomer residues are removed from the finished prosthesis by washing in distilled water. This operation is carried out until the effluent has no reaction to sulfate ions and organic contaminants. The finished casting has a continuous layer of clear homogeneous gel over the entire surface, which smoothly passes into the inner sponge structure.
Příklad 2Example 2
Postupuje se stejně jako v příkladu 1 s tím rozdílem, že po nalití monomerní směsi pro houbovitý polymer do formy se osa formy odkloní od svislé osy o 15°. Vzniklá protéza má na zadní straně zkosení, které tvarově odpovídá přirozenému ženskému prsu.The procedure is as in Example 1, except that after pouring the sponge polymer monomer mixture into the mold, the mold axis deviates from the vertical axis by 15 °. The resulting prosthesis has a chamfer on the back that corresponds to the natural female breast.
Claims (3)
Priority Applications (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CS853662A CS255405B1 (en) | 1985-05-22 | 1985-05-22 | Female mamma prosthesis and method of its production |
| GB8612102A GB2176708B (en) | 1985-05-22 | 1986-05-19 | Female mammary prosthesis and a method of producing it |
| CA000509646A CA1296840C (en) | 1985-05-22 | 1986-05-21 | Prosthesis of female mamma and the method of producing thereof |
| DE19863617181 DE3617181A1 (en) | 1985-05-22 | 1986-05-22 | MAMMAL PROSTHESIS AND METHOD FOR THEIR PRODUCTION |
| JP11628786A JPS625342A (en) | 1985-05-22 | 1986-05-22 | Prosthesis of woman breast and its production |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CS853662A CS255405B1 (en) | 1985-05-22 | 1985-05-22 | Female mamma prosthesis and method of its production |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CS366285A1 CS366285A1 (en) | 1987-07-16 |
| CS255405B1 true CS255405B1 (en) | 1988-03-15 |
Family
ID=5377316
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CS853662A CS255405B1 (en) | 1985-05-22 | 1985-05-22 | Female mamma prosthesis and method of its production |
Country Status (5)
| Country | Link |
|---|---|
| JP (1) | JPS625342A (en) |
| CA (1) | CA1296840C (en) |
| CS (1) | CS255405B1 (en) |
| DE (1) | DE3617181A1 (en) |
| GB (1) | GB2176708B (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH01118418A (en) * | 1987-10-31 | 1989-05-10 | Ikeda Bussan Co Ltd | Method for foam-molding foam integral with skin material |
| DE9114512U1 (en) * | 1991-11-14 | 1993-01-14 | "Amoena" Medizin-Orthopädie-Technik GmbH, 83064 Raubling | Breast prosthesis |
| JP3095386B1 (en) * | 1999-06-01 | 2000-10-03 | 豊 広田 | Pseudo-breast and method for forming the same |
-
1985
- 1985-05-22 CS CS853662A patent/CS255405B1/en unknown
-
1986
- 1986-05-19 GB GB8612102A patent/GB2176708B/en not_active Expired
- 1986-05-21 CA CA000509646A patent/CA1296840C/en not_active Expired - Lifetime
- 1986-05-22 JP JP11628786A patent/JPS625342A/en active Pending
- 1986-05-22 DE DE19863617181 patent/DE3617181A1/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| CA1296840C (en) | 1992-03-10 |
| DE3617181A1 (en) | 1986-11-27 |
| GB2176708A (en) | 1987-01-07 |
| GB2176708B (en) | 1989-04-26 |
| GB8612102D0 (en) | 1986-06-25 |
| JPS625342A (en) | 1987-01-12 |
| CS366285A1 (en) | 1987-07-16 |
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