CA2093276A1 - Gel-filled implants - Google Patents
Gel-filled implantsInfo
- Publication number
- CA2093276A1 CA2093276A1 CA002093276A CA2093276A CA2093276A1 CA 2093276 A1 CA2093276 A1 CA 2093276A1 CA 002093276 A CA002093276 A CA 002093276A CA 2093276 A CA2093276 A CA 2093276A CA 2093276 A1 CA2093276 A1 CA 2093276A1
- Authority
- CA
- Canada
- Prior art keywords
- implant
- gel
- agent
- cellulose
- medical
- 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.)
- Abandoned
Links
Classifications
-
- 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
- A61L27/14—Macromolecular materials
- A61L27/20—Polysaccharides
Abstract
Title: GEL-FILLED IMPLANTS
Abstract of the Invention This invention relates to a medical implant, which comprises an outer envelope and a gel filler material, wherein the gel comprises water and a cellulose gelling agent. The gel in the implant may further contain a lubricating agent. The components of the gel are a biocompatible and do not adversely affect human beings.
Implants containing the lubricating agent have a decreased tendency of failure caused by internal friction on the envelope. The implants of the present invention havesimilar characteristics of the human breast.
Abstract of the Invention This invention relates to a medical implant, which comprises an outer envelope and a gel filler material, wherein the gel comprises water and a cellulose gelling agent. The gel in the implant may further contain a lubricating agent. The components of the gel are a biocompatible and do not adversely affect human beings.
Implants containing the lubricating agent have a decreased tendency of failure caused by internal friction on the envelope. The implants of the present invention havesimilar characteristics of the human breast.
Description
MAXW-OOl Title: GEL-FILLED IMPLANTS
Technical Field of the I~yç~Qn SThis invention relates to medical prostheses, especially those used for a breast or a testicular prosthesis.
Back~round of the InventiQ~
The reconstruction or cosmetic variation of a breast, such is often performed following mastectomy, has become an increasingly frequent surgical procedure. The 10development and use of silicon-gel and silicon-filled implants have contributed to the popularity of this procedure. Recent concern over the effects of the filler of these implants, e.g. silicon-gel, on the health of women has lead to a decrease in their use.
Therefore, it is desirable to provide a filler ma~erial for an implant which simulates or duplicates the characteristics of a natural breast. Further, it is desirable 15to provide a material that does not have an advase effect on the human body containing the implants.
U.S. Patent 4,772,284 relates to a breast prosthesis with improved bio-compatibility and methods of making the same. The breast prosthesis is a single lumen implantable and biocompatible breast prosthesis composed of an outer 20membrane of silastic, medical grade silicon, and an inner material selected from the group consisting of purified reconstructive collagen gel and a purified gel of poly-alpha amino homopolymers or random copolymers having a molecular weight of from 5,000 to 400,000 U.S. Patent 4,787,905 relates to gel for breast prosthesis. The gel is a 25mixture of hydroxy-terminated polybutadiene resin, diundecylph~alate, polymethylenepolyphenyl isocyanate, and dibutyltin dilaurate catalyst, wherein the mixture is cured to form the gel.
- U.S. Patent 4,790,848 relates to a breast prosthesis with multiple lumens.
The implant comprises an ;nner lumen of substantially spherical shape. The inner30lumen is unattached, or free-floating. The lumens are filled with silicon gel or similar fluid material.
... . .
.. . . . . . . .
U.S. Patent 4,995,885 relates to a radiolucent breast implant. The radiolucent breast implant is composed of a silicon envelope filled with any biocompatible triglyceride such as peanut oil or sunflower oil or any other material having aneffective atomic number of 5.9, which is the effective atomic number of fat. This S breast implant is radiolucent in that it duplicates the photo-electric interference of fat which is the major effect producing subject at low radiation levels as used in mammography.
Summary of the Inventi~
This invention relates to a medical implant, comprising an outer envelope and a gel filler material, wherein the gel comprises water and a cellulose gelling agent.
The gel in the implant may further contain a lubricating agent. The invention also relates to a method of augmenting or reconstructing a human breast comprising the steps of subcutaneously implanting a medical implant, comprising an outer envelope and a gel filler material, wherein the gel comprises water and a cellulose gelling agent lS into a human body. In another aspect, the invention relates to a method of preparing medical implants comprising the steps of filling an outer envelope of a medical-grade elastomer with a gel filler material, wherein the gel comprises water and a ceJlulose gelling agent, and sealing the envelope to form a medical implant. The components of the gel are preferably biocompatible so as not adversely to affect human beings.
Implants containing the lubricating agent have a decreased tendency of failure caused by internal friction on the envelope. The implants of the present invention havesimilar characteristics to the human breast. These implants may be used for breast augmentation or reconstruction.
Detailed Descril~tion of the Invention As used in the specification and appended claims, the use of the term "gel"
refers to gelatinous and "jelly-like" materials which proYide the physical characteristics of the medical implants of the present invention.
The implants of the present invention may be used as an implant anywhere in the human body, especially as replacements for breasts and testicles. These implants are also useful for augmentation of the breasts. It should be recognized that the 209327~
characteristics of the implant may be altered by altering the density of the gel of the implant. In one embodiment, the density of the gel of the implant approximates that of the human breast. The gel of the implant generally has a density from about 0.8, or about 0.9, or about 0.95 up to about 1.5, or to about 1.4, or to about 1.3 or to 5 about 1.2.
The implant is compdsed of an outer envelope. The envelope is generally a medical-grade elastomeric material. An example of a particularly useful envelope is a silicon envelope.
The filler material of the implants comprises a gel formed from water and a 10 cellulose thickening agent. The water is generally present in a major amount, usually an amount greater than 70%, or about 75%, or about 80% by weight of the gel. In one embodiment, the water is present in an amount from about 80%, or about 85%
up to about 95%, or about 93% by weight of the gel. The water is preferably purified and sterile as is known to those in the art.
The cellulose thickening agent or cellulose derivative provides thickening of the water to form the gel of the present invention. As is known, cellulose is a polymer of glucose rings derived from plants. In one embodiment, the cellulose thickening agent is a cellulose ether. Examples of cellulose thickening agents include methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, 20 hydroxyethyl,ethylcellulose, sodium carboxymethylcellulose, and sodiumcarboxy-methyl,hydroxyethylcellulose. Preferably, the cellulose thickening agent is hydroxyethylcellulose, hydroxypropylcellulose or methylcellulose, more preferably methylcellulose.
The cellulose thickening agent is present in an amount sufficient to gel the 25 water. In one embodiment, the cellulose thickening agent is present in an amount to produce a density which approximates the density of the human breast. The cellulose thickening agent is generally present in an amount from about 0.5%, or about 1%,up to about 15%, or to about 10%, or to about 8% by weight of the gel.
In one embodiment, the gel further comprises a lubricating agent. The 30 lubricating agent can be any agent which reduces the internal friction in the envelope.
209327~
The lubricating agent may be a polyol. Examples of useful polyols include ethyleneglycol, propyleneglycol, butanetriol, butanediol, hexanediol, hexanetriol and the like. Preferably, the lubricating agent is glycerol or propyleneglycol. ln another embodiment, the lubricating agent may be any glyceride, preferably a triglyceride.
Examples of glyceride lubricants include coconut triglycerides, and oleyltriglycerides.
In addition to the water, cellulose thickening agents and optionally lubricatingagents, may additionally contain other additives which act as preservatlves, antioxidants, pH controlling agents and antibacterial agents in the gel. Examples of these agents include methylparaben, propylparaben, sodium hydroxide, glucono delta lactate, chlorhexidine gluconate, propyleneoxide and the like.
In one embodiment, the implants of the present invention may be commercially available surgical and personal lubricant gels. E~camples of these gels include Surgilube0 surgical lubricant available commercially from E. Pougera &
Company, HR~ Lubricating Jelly available commercially from Carter-Wallace, Inc.
and K-Y Lubricating Jelly available commercially from Johnson & Johnson.
As described above the implants of the present invendon may be used as replacements for body tissues or augmentation of body tissues. In one embodiment, the implants are used for breast reconstruction and/or augmentation. The process for using the implants involves placing the implants of the present invention subcutaneously in a human being in a region where replacement and/or augmentation is desired. Por instance, for breast augmentation, the implant is subcutaneouslyplaced into the breast region. The process for placing the implant into a human is known to those skilled in the art and generally involved inserting the implant through an incision in the chest. Methods of placing implants is known to those in the art.
The invention further comprises the process of preparing medical implants which involves the steps of filling an outer envelope of a medical grade elastomer with a gel as described herein. The envelope is sealed to form the medical implant.
The envelopes in the sealing procedure is known to those sl~lled in the art.
While the invention has been explained in relation to its preferred embodiments, it is to be understood that various modifications thereof will become .. ....... .
........ .... .. .
-s-apparent to those skilled in the art upon reading the specification. Therefore, it is to be understood that the invention disclosed herein is intended to cover such modifications as fall within the scope of the appended claims.
Technical Field of the I~yç~Qn SThis invention relates to medical prostheses, especially those used for a breast or a testicular prosthesis.
Back~round of the InventiQ~
The reconstruction or cosmetic variation of a breast, such is often performed following mastectomy, has become an increasingly frequent surgical procedure. The 10development and use of silicon-gel and silicon-filled implants have contributed to the popularity of this procedure. Recent concern over the effects of the filler of these implants, e.g. silicon-gel, on the health of women has lead to a decrease in their use.
Therefore, it is desirable to provide a filler ma~erial for an implant which simulates or duplicates the characteristics of a natural breast. Further, it is desirable 15to provide a material that does not have an advase effect on the human body containing the implants.
U.S. Patent 4,772,284 relates to a breast prosthesis with improved bio-compatibility and methods of making the same. The breast prosthesis is a single lumen implantable and biocompatible breast prosthesis composed of an outer 20membrane of silastic, medical grade silicon, and an inner material selected from the group consisting of purified reconstructive collagen gel and a purified gel of poly-alpha amino homopolymers or random copolymers having a molecular weight of from 5,000 to 400,000 U.S. Patent 4,787,905 relates to gel for breast prosthesis. The gel is a 25mixture of hydroxy-terminated polybutadiene resin, diundecylph~alate, polymethylenepolyphenyl isocyanate, and dibutyltin dilaurate catalyst, wherein the mixture is cured to form the gel.
- U.S. Patent 4,790,848 relates to a breast prosthesis with multiple lumens.
The implant comprises an ;nner lumen of substantially spherical shape. The inner30lumen is unattached, or free-floating. The lumens are filled with silicon gel or similar fluid material.
... . .
.. . . . . . . .
U.S. Patent 4,995,885 relates to a radiolucent breast implant. The radiolucent breast implant is composed of a silicon envelope filled with any biocompatible triglyceride such as peanut oil or sunflower oil or any other material having aneffective atomic number of 5.9, which is the effective atomic number of fat. This S breast implant is radiolucent in that it duplicates the photo-electric interference of fat which is the major effect producing subject at low radiation levels as used in mammography.
Summary of the Inventi~
This invention relates to a medical implant, comprising an outer envelope and a gel filler material, wherein the gel comprises water and a cellulose gelling agent.
The gel in the implant may further contain a lubricating agent. The invention also relates to a method of augmenting or reconstructing a human breast comprising the steps of subcutaneously implanting a medical implant, comprising an outer envelope and a gel filler material, wherein the gel comprises water and a cellulose gelling agent lS into a human body. In another aspect, the invention relates to a method of preparing medical implants comprising the steps of filling an outer envelope of a medical-grade elastomer with a gel filler material, wherein the gel comprises water and a ceJlulose gelling agent, and sealing the envelope to form a medical implant. The components of the gel are preferably biocompatible so as not adversely to affect human beings.
Implants containing the lubricating agent have a decreased tendency of failure caused by internal friction on the envelope. The implants of the present invention havesimilar characteristics to the human breast. These implants may be used for breast augmentation or reconstruction.
Detailed Descril~tion of the Invention As used in the specification and appended claims, the use of the term "gel"
refers to gelatinous and "jelly-like" materials which proYide the physical characteristics of the medical implants of the present invention.
The implants of the present invention may be used as an implant anywhere in the human body, especially as replacements for breasts and testicles. These implants are also useful for augmentation of the breasts. It should be recognized that the 209327~
characteristics of the implant may be altered by altering the density of the gel of the implant. In one embodiment, the density of the gel of the implant approximates that of the human breast. The gel of the implant generally has a density from about 0.8, or about 0.9, or about 0.95 up to about 1.5, or to about 1.4, or to about 1.3 or to 5 about 1.2.
The implant is compdsed of an outer envelope. The envelope is generally a medical-grade elastomeric material. An example of a particularly useful envelope is a silicon envelope.
The filler material of the implants comprises a gel formed from water and a 10 cellulose thickening agent. The water is generally present in a major amount, usually an amount greater than 70%, or about 75%, or about 80% by weight of the gel. In one embodiment, the water is present in an amount from about 80%, or about 85%
up to about 95%, or about 93% by weight of the gel. The water is preferably purified and sterile as is known to those in the art.
The cellulose thickening agent or cellulose derivative provides thickening of the water to form the gel of the present invention. As is known, cellulose is a polymer of glucose rings derived from plants. In one embodiment, the cellulose thickening agent is a cellulose ether. Examples of cellulose thickening agents include methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, 20 hydroxyethyl,ethylcellulose, sodium carboxymethylcellulose, and sodiumcarboxy-methyl,hydroxyethylcellulose. Preferably, the cellulose thickening agent is hydroxyethylcellulose, hydroxypropylcellulose or methylcellulose, more preferably methylcellulose.
The cellulose thickening agent is present in an amount sufficient to gel the 25 water. In one embodiment, the cellulose thickening agent is present in an amount to produce a density which approximates the density of the human breast. The cellulose thickening agent is generally present in an amount from about 0.5%, or about 1%,up to about 15%, or to about 10%, or to about 8% by weight of the gel.
In one embodiment, the gel further comprises a lubricating agent. The 30 lubricating agent can be any agent which reduces the internal friction in the envelope.
209327~
The lubricating agent may be a polyol. Examples of useful polyols include ethyleneglycol, propyleneglycol, butanetriol, butanediol, hexanediol, hexanetriol and the like. Preferably, the lubricating agent is glycerol or propyleneglycol. ln another embodiment, the lubricating agent may be any glyceride, preferably a triglyceride.
Examples of glyceride lubricants include coconut triglycerides, and oleyltriglycerides.
In addition to the water, cellulose thickening agents and optionally lubricatingagents, may additionally contain other additives which act as preservatlves, antioxidants, pH controlling agents and antibacterial agents in the gel. Examples of these agents include methylparaben, propylparaben, sodium hydroxide, glucono delta lactate, chlorhexidine gluconate, propyleneoxide and the like.
In one embodiment, the implants of the present invention may be commercially available surgical and personal lubricant gels. E~camples of these gels include Surgilube0 surgical lubricant available commercially from E. Pougera &
Company, HR~ Lubricating Jelly available commercially from Carter-Wallace, Inc.
and K-Y Lubricating Jelly available commercially from Johnson & Johnson.
As described above the implants of the present invendon may be used as replacements for body tissues or augmentation of body tissues. In one embodiment, the implants are used for breast reconstruction and/or augmentation. The process for using the implants involves placing the implants of the present invention subcutaneously in a human being in a region where replacement and/or augmentation is desired. Por instance, for breast augmentation, the implant is subcutaneouslyplaced into the breast region. The process for placing the implant into a human is known to those skilled in the art and generally involved inserting the implant through an incision in the chest. Methods of placing implants is known to those in the art.
The invention further comprises the process of preparing medical implants which involves the steps of filling an outer envelope of a medical grade elastomer with a gel as described herein. The envelope is sealed to form the medical implant.
The envelopes in the sealing procedure is known to those sl~lled in the art.
While the invention has been explained in relation to its preferred embodiments, it is to be understood that various modifications thereof will become .. ....... .
........ .... .. .
-s-apparent to those skilled in the art upon reading the specification. Therefore, it is to be understood that the invention disclosed herein is intended to cover such modifications as fall within the scope of the appended claims.
Claims (21)
1. A medical implant, comprising an outer envelope and a gel filler material, wherein the gel comprises water and a cellulose gelling agent.
2. The implant of claim 1 wherein cellulose thickening agent is a cellulose ether.
3. The implant of claim 1 wherein the cellulose thickening agent is methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxyethyl,ethylcellulose, sodium carboxymethylcellulose, or sodiumcarboxy-methyl,hydroxyethylcellulose.
4. The implant of claim 1 wherein the cellulose thickening agent is hydroxyethylcellulose, hydroxypropylcellulose or methylcellulose.
5. The implant of claim 1 wherein the envelope is a medical-grade elastomer.
6. The implant of claim 1 wherein the envelope is a medical-grade silicon.
7. The implant of claim 1 further comprising (C) a lubricating agent.
8. The implant of claim 7 wherein the lubricating agent is a polyol lubricating agent.
9. The implant of claim 7 wherein the lubricating agent is propyleneglycol or glycerol.
10. A medical implant comprising a silicon envelope filled with a gel comprising water and a thickening agent selected from the group consisting of hydroxyethylcellulose and hydroxypropylcellulose.
11. The implant of claim 10 further comprising a lubricating agent.
12. The implant of claim 11 wherein the lubricating agent is glycerol or propyleneglycol.
13. A medical implant comprising an envelope filled with a gel comprising (A) water, (B) a cellulose thiclcening agent and (C) a lubricating agent.
14. The implant of claim 13 wherein (3) a cellulose thickening agent is a cellulose ether.
15. The implant of claim 13 wherein the cellulose thickening agent is methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxyethyl,ethylcellulose, sodium carboxymethylcellulose, or sodium carboxy-methyl,hydroxyethylcellulose.
16. The implant of claim 13 wherein the cellulose thickening agent is hydroxyethylcellulose, hydroxypropylcellulose or methylcellulose.
17. The implant of claim 13 wherein the envelope is a medical-grade elastomer.
18. The implant of claim 13 wherein the lubricating agent is a polyol lubricating agent.
19. The implant of claim 19 wherein the lubricating agent is propyleneglycol or glycerol.
20. A method of augmenting or reconstructing a human breast comprising the steps of subcutaneously implanting a medical implant, comprising an outer envelope and a gel filler material, wherein the gel comprises water and a cellulose gelling agent into a human being
21. A method of preparing medical implants comprising the steps of filling an outer envelope of a medical-grade elastomer with a gel filler material, wherein the gel comprises water and a cellulose gelling agent, and sealing the envelope to form a medical implant.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US867,417 | 1992-04-13 | ||
US07/867,417 US5282857A (en) | 1992-04-13 | 1992-04-13 | Gel-filled implants |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2093276A1 true CA2093276A1 (en) | 1993-10-14 |
Family
ID=25349743
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002093276A Abandoned CA2093276A1 (en) | 1992-04-13 | 1993-04-02 | Gel-filled implants |
Country Status (7)
Country | Link |
---|---|
US (2) | US5282857A (en) |
EP (1) | EP0575035B1 (en) |
JP (1) | JPH06292714A (en) |
AT (1) | ATE158507T1 (en) |
AU (1) | AU665627B2 (en) |
CA (1) | CA2093276A1 (en) |
DE (1) | DE69314096D1 (en) |
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US5067965A (en) * | 1990-03-20 | 1991-11-26 | Bioplasty, Inc. | Bio-osmotic gel for implant prostheses |
US5116371A (en) * | 1990-07-06 | 1992-05-26 | Christensen James M | Prosthesis with improved biocompatibility |
US5192326A (en) * | 1990-12-21 | 1993-03-09 | Pfizer Hospital Products Group, Inc. | Hydrogel bead intervertebral disc nucleus |
US5116370A (en) * | 1991-03-22 | 1992-05-26 | Foglietti Mark A | Breast prosthesis with female and male adapter snaps |
US5282857A (en) * | 1992-04-13 | 1994-02-01 | Perry Larry C | Gel-filled implants |
US5344451A (en) * | 1992-06-24 | 1994-09-06 | Dayton Michael P | Synthetic reconstructive implant device |
-
1992
- 1992-04-13 US US07/867,417 patent/US5282857A/en not_active Expired - Lifetime
-
1993
- 1993-04-02 CA CA002093276A patent/CA2093276A1/en not_active Abandoned
- 1993-04-05 DE DE69314096T patent/DE69314096D1/en not_active Expired - Lifetime
- 1993-04-05 AT AT93302664T patent/ATE158507T1/en not_active IP Right Cessation
- 1993-04-05 EP EP93302664A patent/EP0575035B1/en not_active Expired - Lifetime
- 1993-04-07 AU AU36777/93A patent/AU665627B2/en not_active Ceased
- 1993-04-13 JP JP5086507A patent/JPH06292714A/en active Pending
-
1994
- 1994-01-28 US US08/188,107 patent/US5531786A/en not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
DE69314096D1 (en) | 1997-10-30 |
ATE158507T1 (en) | 1997-10-15 |
US5282857A (en) | 1994-02-01 |
JPH06292714A (en) | 1994-10-21 |
EP0575035A2 (en) | 1993-12-22 |
EP0575035A3 (en) | 1994-01-26 |
AU665627B2 (en) | 1996-01-11 |
EP0575035B1 (en) | 1997-09-24 |
US5531786A (en) | 1996-07-02 |
AU3677793A (en) | 1993-10-14 |
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EEER | Examination request | ||
FZDE | Discontinued |