Gel-filled implants

• US 5,282,857 A
• Filed: 04/13/1992
• Issued: 02/01/1994
• Est. Priority Date: 04/13/1992
• Status: Expired due to Term

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Larry C. Perry, Maxwell G. Patrick
• Inventors: Maxwell, G. Patrick, Perry, Larry C.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US07/867,417
• Time in Patent Office: 659 Days
• Field of Search: 623/7, 623/8, 623/11, 623/12, 623/16, 623/66
• US Class Current: 623/8
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2/26 Penis implants
• CPC Class Codes: A61L 27/20 Polysaccharides
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: C08L 1/28 Alkyl ethers
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

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 have similar characteristics of the human breast.

Claims

1. A sealed implantable prosthesis for implantation into soft tissue for replacing or augmenting the tissues, comprising an outer envelope forming a hollow sealed shell defining an enclosed volume, said hollow shell being filled with a gel filler with predetermined density which is a mixture of water and of a cellulose derivative selected from the group consisting of methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxyethyl, ethylcellulose, sodium caroboxymethylcellulose, and sodium carboxymethyl, hydroxyethylcellulose and which is retained in said sealed shell to maintain constant its predetermined density.

2. An implantable prosthesis according to claim 1, wherein said water is present in the gel in an amount greater than 70% by weight of the gel.

3. An implantable prosthesis according to claim 2, wherein the water is present in an amount of 75% to about 95% by weight of the gel.

4. An implantable prosthesis according to claim 2, wherein said cellulose derivative is present in an amount of 0.5% to about 15% by weight of the gel.

5. An implantable prosthesis according to claim 1, wherein the water is present in the gel in a major amount so that the volume of the gel is determined substantially by the volume of the water.

6. An implantable prosthesis according to claim 1, wherein the gel essentially consists of a mixture of water and of the cellulose derivative.

7. An implantable prosthesis according to claim 2, wherein the cellulose derivative is present in an amount from about 0.5% to about 8% by weight of gel.

8. An implantable prosthesis according to claim 1, wherein the gel has a density from about 0.8 to about 1.5 g/cm₃.

9. The implant of claim 1 wherein the cellulose cellulose derivative is hydroxyethylcellulose, hydroxypropylcellulose or methylcellulose.

10. The implant of claim 1 wherein the envelope is a medical-grade elastomer.

11. The implant of claim 1 wherein the envelope is a medical-grade silicon.

12. The implant of claim 1 further comprising a lubricating agent.

13. The implant of claim 12 wherein the lubricating agent is a polyol lubricating agent.

14. The implant of claim 12 wherein the lubricating agent is propyleneglycol or glycerol.

15. A method of augmenting or reconstructing a human breast, comprising the steps of subcutaneously implanting a sealed medical prosthesis into a human being, wherein the prosthesis comprises an outer envelope forming a hollow sealed shell defining an enclosed volume and a gel filler with predetermined density in said outer envelope, wherein the gel is a mixture of water and a cellulose gelling agent selected from the group consisting of methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxyethyl, ethylcellulose, sodium caroboxymethylcellulose, and sodium carboxymethyl, hydroxyethylcellulose, and wherein said shell is sealed to contain the gel within the medical prostheses and maintain constant said predetermined density.

16. A method of preparing medical implantable completely sealed prostheses, comprising the steps of mixing water and a cellulose derivative selected from the group consisting of methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxyethyl, ethylcellulose, sodium caroboxymethylcellulose, and sodium carboxymethyl, hydroxyethylcellulose to form a gel filler with predetermined density in which water is present in a major amount, filling with said gel filler an outer envelope of a medical-grade elastomer forming a hollow shell providing a substantially sealed internal surface to the gel, and sealing the outer envelope to form a medical implantable prosthesis in which the gel filter is retained and its predetermined density is maintained constant within the sealed envelope.