CA1296840C - Prosthesis of female mamma and the method of producing thereof - Google Patents
Prosthesis of female mamma and the method of producing thereofInfo
- Publication number
- CA1296840C CA1296840C CA000509646A CA509646A CA1296840C CA 1296840 C CA1296840 C CA 1296840C CA 000509646 A CA000509646 A CA 000509646A CA 509646 A CA509646 A CA 509646A CA 1296840 C CA1296840 C CA 1296840C
- Authority
- CA
- Canada
- Prior art keywords
- spongy
- prosthesis
- mold
- mamma
- female
- Prior art date
- 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.)
- Expired - Fee Related
Links
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 and implants
-
- 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)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Biomedical Technology (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
ABSTRACT OF THE DISCLOSURE:
A prosthesis of the female mamma comprises a spongy hydrophilic polymeric material (advantageously based on methacrylate or acrylate) surrounded by a surface formed from a layer of homogeneous film having a similar composition to the spongy hydrophilic polymeric material.
This film continuously passes into the spongy structure and is connected with it by chemical bonds. The thickness of the homogeneous film may be controlled and is advantageously less than 0.5 mm. A method for producing this prosthesis of the female mamma is by polymerization of a monomer mixture for preparation of the spongy polymer in an open mold in such a way, that a film from a soluble polymer based on methacrylate or acrylate is formed in the mold, before its charging with the monomer mixture. This is done by casting the mold with a solution of the soluble polymer. Then, after removing any solvent, the mold is charged with the monomer mixture for preparation of the spongy polymer and the mixture is allowed to polymerize in the presence of oxygen, advantageously in air.
A prosthesis of the female mamma comprises a spongy hydrophilic polymeric material (advantageously based on methacrylate or acrylate) surrounded by a surface formed from a layer of homogeneous film having a similar composition to the spongy hydrophilic polymeric material.
This film continuously passes into the spongy structure and is connected with it by chemical bonds. The thickness of the homogeneous film may be controlled and is advantageously less than 0.5 mm. A method for producing this prosthesis of the female mamma is by polymerization of a monomer mixture for preparation of the spongy polymer in an open mold in such a way, that a film from a soluble polymer based on methacrylate or acrylate is formed in the mold, before its charging with the monomer mixture. This is done by casting the mold with a solution of the soluble polymer. Then, after removing any solvent, the mold is charged with the monomer mixture for preparation of the spongy polymer and the mixture is allowed to polymerize in the presence of oxygen, advantageously in air.
Description
i The present invention pertains to a prosthesis of the female mamma and to a method of producing it.
Until now, silicon rubber has been most often used for producing a substitution of the woman's breast. However this material is impermeable to body liquors and metabolites and therefore rather unsuitable as a prosthesis of the female mamma. The above mentioned disadvantages were avoided in Czechoslovak Patent no. 140,155, which describes the manufacturing of prostheses of -the female mamma from spongy gels based on glycol methacrylate. A disadvantage of the latter prostheses is that tissues grow into the sponge and calcificates are deposited causing hardening and weight increase of the prosthesis.
A prosthesis of the female mamma through which a newly formed ligament does not grow, is knownfrom Czechoslovak Patent no. 177,661. This prosthesis consists of a coat formed from a homogeneous gel which is filled with a spongy gel or a liquid gel of the vitrous-body type to form a separate part not connected with the coa-t. The complex and expensive preparation of this prosthesis and also the fact that the core and coat do not form an inseparable part and that the core is released from the coat during motion (which may lead to damage of the coat) are the disadvantages of this prosthesis.
A subject of this invention is a prosthesis of female mamma from a spongy hydrophilic polymeric material, advantageously based on methacrylate or acrylate, where the whole surface of the said prosthesis is formed from a layer of a ~ homogeneous film having the similar composition as the spongy hydrophilic polymeric material. This film ; continuously passes into the spongy structure and is : .
~. -- 1 -- -~' ~
connected with -the spongy hydrophilic polymeric material by chemical bonds. The thickness of the homogeneous film may be con-trolled and advantageously amounts to less than 0.5 mm.
The prosthesis oE female mamma according to -the invention is produced by polymerization of a monomer mixture for the preparation of spongy polymer in an open mold in such a way, that the film from a soluble polymer based on methacrylate or acrylate is formed in the mold before its charging with the monomer mixture by casting the mold with a solution of the said soluble polymer and, after removing a solvent, the mold is charged with the monomer mixture for preparation of the spongy polymer, which is allowed to polymerize in the presence of oxygen, advantageously in air.
During the polymerization of the spongy structure, a firm chemical bond with the film of soluble polymer occurs and a crosslinking agent, preferably present in the monomer mixture for the spongy polymer, induces the subsequent crosslinking oE the film from the soluble polymer. The film in this way becomes no longer soluble. The polymerization in the presence of oxygen (preferably in air), instead of the commonly used polymerization in an inert atmosphere, creates a layer of a homogeneous non-spongy polymer even at the third free surface (back side) of the prosthesis. The mold may be advantageously inclined from the vertical axis by 1 to 45 during polymerization to create a slant surface on the final product. The prosthesis than corresponds by shape to a natural woman's breast. After completion of the polymerization, the prosthesis is thoroughly washed in water.
A known monomer mixture is used in the preparation of the .
, ~2~
spongy polymer. The mixture is, Eor example, 10 to 40% by volurne of 2-hydroxye-thyl methacryla-te containing 0.1 to 2%
by volume of ethylene dimethacrylate and 60 to 90% by volume of a water-miscible liquid, for example, glycerol.
The soluble polymer advantageously used is the polymer produced according to the Czechoslovak Patent no. 141,101 (Hydron S) by polymerization of glycol methacrylate or poly(glycol) methacrylate or the corresponding glycol acrylate, containing 0.05 to 50% by weight of glycol dimethacrylate or poly (glycol) dimethacrylate, up to a conversion ratio higher than 90% in solvents whose interaction parameter (with respect to the formed copolymer) are lower than 0.5. The polymer is perfectly soluble in cold methanol, dimethylformamide, formamide, tertbutylal-cohol, dimethylsulfoxide, ethylene glycol and in hot ethanol and n-propanol.
The prosthesis according to the invention meets all requirements for biomedical materials. HumantiSSUeS do not ; grow into the prosthesis but form a ligament casing around it which is not firmly connected with the prosthesis. This prevents calcification of the prosthesis. The method for producing the prosthesis is very simple and economically advantageous.
The invention is further illustrated by the following non-limiting examples of performance.
' An~ open glass mold having the shape of awoman's breast is cast with a 10% solution of the soluble polymer prepared according to Czechoslovak Patent no. 141,101, U.S. Patent ; 3 -:, no. 3,575,946 (Hydron S) in cellosolve (trade mark) or methanol. The whole inner surface of the mold is wetted, and the solvent is allowed to evaporate. A strong film results.
The mold prepared in this way is charged with a monomer mixture consis-ting of 30 vol. -% of 2-hydroxyethyl metha-crylate, containing 1 vol. -% of ethylene dimethacrylate, and 70 vol. -% of a 10% aqueous solution of ammonium peroxosulfate. The mixture is allowed to polyrnerize at a temperature of 60 to 70C for 20-30 min in the presence of air. After completion of the polymerization, the resulting prosthesis is carefully removed from the mold. Residues of the initiator and monomers are removed by washing in distilled water. This operation is carried out until the washings do not demonstrate any reaction for sulfate ions and organic impurities. The final molding has a continuous layer of a clear homogeneous gel on the whole surface, which layer continuously passes into the inner spongy structure.
EX~MPLE 2 The procedure is the same as in example 1, with the distinction that the mold, after charging with the monomer mixture for spongy polymer, is inclined from the vertical axis by 15. The resulting prosthesis has a bevelled back surface and corresponds by its shape to a natural woman's breast.
.
, ~ . , ~ ., ~,
Until now, silicon rubber has been most often used for producing a substitution of the woman's breast. However this material is impermeable to body liquors and metabolites and therefore rather unsuitable as a prosthesis of the female mamma. The above mentioned disadvantages were avoided in Czechoslovak Patent no. 140,155, which describes the manufacturing of prostheses of -the female mamma from spongy gels based on glycol methacrylate. A disadvantage of the latter prostheses is that tissues grow into the sponge and calcificates are deposited causing hardening and weight increase of the prosthesis.
A prosthesis of the female mamma through which a newly formed ligament does not grow, is knownfrom Czechoslovak Patent no. 177,661. This prosthesis consists of a coat formed from a homogeneous gel which is filled with a spongy gel or a liquid gel of the vitrous-body type to form a separate part not connected with the coa-t. The complex and expensive preparation of this prosthesis and also the fact that the core and coat do not form an inseparable part and that the core is released from the coat during motion (which may lead to damage of the coat) are the disadvantages of this prosthesis.
A subject of this invention is a prosthesis of female mamma from a spongy hydrophilic polymeric material, advantageously based on methacrylate or acrylate, where the whole surface of the said prosthesis is formed from a layer of a ~ homogeneous film having the similar composition as the spongy hydrophilic polymeric material. This film ; continuously passes into the spongy structure and is : .
~. -- 1 -- -~' ~
connected with -the spongy hydrophilic polymeric material by chemical bonds. The thickness of the homogeneous film may be con-trolled and advantageously amounts to less than 0.5 mm.
The prosthesis oE female mamma according to -the invention is produced by polymerization of a monomer mixture for the preparation of spongy polymer in an open mold in such a way, that the film from a soluble polymer based on methacrylate or acrylate is formed in the mold before its charging with the monomer mixture by casting the mold with a solution of the said soluble polymer and, after removing a solvent, the mold is charged with the monomer mixture for preparation of the spongy polymer, which is allowed to polymerize in the presence of oxygen, advantageously in air.
During the polymerization of the spongy structure, a firm chemical bond with the film of soluble polymer occurs and a crosslinking agent, preferably present in the monomer mixture for the spongy polymer, induces the subsequent crosslinking oE the film from the soluble polymer. The film in this way becomes no longer soluble. The polymerization in the presence of oxygen (preferably in air), instead of the commonly used polymerization in an inert atmosphere, creates a layer of a homogeneous non-spongy polymer even at the third free surface (back side) of the prosthesis. The mold may be advantageously inclined from the vertical axis by 1 to 45 during polymerization to create a slant surface on the final product. The prosthesis than corresponds by shape to a natural woman's breast. After completion of the polymerization, the prosthesis is thoroughly washed in water.
A known monomer mixture is used in the preparation of the .
, ~2~
spongy polymer. The mixture is, Eor example, 10 to 40% by volurne of 2-hydroxye-thyl methacryla-te containing 0.1 to 2%
by volume of ethylene dimethacrylate and 60 to 90% by volume of a water-miscible liquid, for example, glycerol.
The soluble polymer advantageously used is the polymer produced according to the Czechoslovak Patent no. 141,101 (Hydron S) by polymerization of glycol methacrylate or poly(glycol) methacrylate or the corresponding glycol acrylate, containing 0.05 to 50% by weight of glycol dimethacrylate or poly (glycol) dimethacrylate, up to a conversion ratio higher than 90% in solvents whose interaction parameter (with respect to the formed copolymer) are lower than 0.5. The polymer is perfectly soluble in cold methanol, dimethylformamide, formamide, tertbutylal-cohol, dimethylsulfoxide, ethylene glycol and in hot ethanol and n-propanol.
The prosthesis according to the invention meets all requirements for biomedical materials. HumantiSSUeS do not ; grow into the prosthesis but form a ligament casing around it which is not firmly connected with the prosthesis. This prevents calcification of the prosthesis. The method for producing the prosthesis is very simple and economically advantageous.
The invention is further illustrated by the following non-limiting examples of performance.
' An~ open glass mold having the shape of awoman's breast is cast with a 10% solution of the soluble polymer prepared according to Czechoslovak Patent no. 141,101, U.S. Patent ; 3 -:, no. 3,575,946 (Hydron S) in cellosolve (trade mark) or methanol. The whole inner surface of the mold is wetted, and the solvent is allowed to evaporate. A strong film results.
The mold prepared in this way is charged with a monomer mixture consis-ting of 30 vol. -% of 2-hydroxyethyl metha-crylate, containing 1 vol. -% of ethylene dimethacrylate, and 70 vol. -% of a 10% aqueous solution of ammonium peroxosulfate. The mixture is allowed to polyrnerize at a temperature of 60 to 70C for 20-30 min in the presence of air. After completion of the polymerization, the resulting prosthesis is carefully removed from the mold. Residues of the initiator and monomers are removed by washing in distilled water. This operation is carried out until the washings do not demonstrate any reaction for sulfate ions and organic impurities. The final molding has a continuous layer of a clear homogeneous gel on the whole surface, which layer continuously passes into the inner spongy structure.
EX~MPLE 2 The procedure is the same as in example 1, with the distinction that the mold, after charging with the monomer mixture for spongy polymer, is inclined from the vertical axis by 15. The resulting prosthesis has a bevelled back surface and corresponds by its shape to a natural woman's breast.
.
, ~ . , ~ ., ~,
Claims (5)
1. Prosthesis of female mamma from a spongy hydrophilic polymeric material, wherein the whole surface of the said prosthesis is formed by a layer of a homogeneous film having a similar composition as the spongy hydrophilic polymeric material, while the film continuously passes into the spongy structure and is connected with the spongy polymeric material by chemical bond.
2. A prosthesis according to claim 1, wherein the thickness of the homogeneous film is less than 0.5 mm.
3. A prosthesis according to claim 1 or 2, wherein the spongy polymeric material is based on methacrylate or acrylate polymers.
4. Method for producing a prosthesis of female mamma by polymerization of a monomer mixture for preparation of a spongy polymer in an open mold, wherein a film of a soluble polymer based on methacrylate or acrylate is formed on the inner surface of the mold before charging with the monomer mixture and, after removing a solvent, the mold is charged with the monomer mixture for preparation of the spongy polymer and the mixture is allowed to polymerize in the presence of oxygen, advantageously in air.
5. The method according to claim 4, wherein the mold is declined from the vertical axis by 1 to 45° during polymerization.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CS853662A CS255405B1 (en) | 1985-05-22 | 1985-05-22 | Female mamma prosthesis and method of its production |
| CSPV3662-85 | 1985-05-22 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1296840C true CA1296840C (en) | 1992-03-10 |
Family
ID=5377316
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000509646A Expired - Fee Related CA1296840C (en) | 1985-05-22 | 1986-05-21 | Prosthesis of female mamma and the method of producing thereof |
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 - Fee Related
- 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 |
|---|---|
| DE3617181A1 (en) | 1986-11-27 |
| CS366285A1 (en) | 1987-07-16 |
| GB2176708A (en) | 1987-01-07 |
| JPS625342A (en) | 1987-01-12 |
| CS255405B1 (en) | 1988-03-15 |
| GB2176708B (en) | 1989-04-26 |
| GB8612102D0 (en) | 1986-06-25 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKLA | Lapsed |