Breast prostheses

• US 5,376,117 A
• Filed: 11/13/1992
• Issued: 12/27/1994
• Est. Priority Date: 10/25/1991
• Status: Expired due to Fees

• Current Assignee: Corvita Corporation (Boston Scientific Corporation)
• Original Assignee: Corvita Corporation (Boston Scientific Corporation)
• Inventors: Maurin, Anne A., Pinchuk, Leonard, Martin, John B. Jr.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US07/975,979
• Time in Patent Office: 774 Days
• Field of Search: 623/8, 623/7, 623/11, 623/12, 623/1, 623/66
• US Class Current: 623/8
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: B29C 41/06 about two or more axes
• CPC Class Codes: B29C 41/08 Coating a former, core or other substrate by spraying or fluidisation, e.g. spraying powder spray-up of reinforcing fibres B29C70/305
• CPC Class Codes: B29C 41/20 incorporating preformed parts or layers, e.g. moulding inserts or for coating articles
• CPC Class Codes: B29K 2083/00 Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

Breast prostheses for subcutaneous implantation for breast augmentation. The prostheses include an outer shell having a smooth non-porous outer envelope and a non-woven porous outer layer affixed to the envelope. The outer layer is preferably manufactured by an electrostatic spinning process to deposit biocompatible polymeric fibers on the smooth outer envelope of the prosthesis to build up a porous surface which promotes tissue ingrowth therein. In a preferred embodiment, the biocompatible porous outer layer and the non-porous outer envelope are manufactured with a polyurethane polymer material. Most preferably, a polycarbonate urethane polymer is used to manufacture the outer layer. The outer envelope and the porous outer layer may be further treated with an acetoxy-terminated siloxane to render them more crack-resistant under in vivo use.

Claims

1. A mammary prosthesis for surgical implantation, comprising:

an outer shell including a non-porous outer envelope made of a biocompatable polymeric material and a porous outer layer surrounding said non-porous envelope;

said biocompatible polymeric material of said non-porous outer envelope being selected from the group consisting essentially of a polyurethane, a polycarbonate urethane, an elastomeric silicone material or a combination thereof, said outer envelope being resistant to in vivo cracking and to prevent leakage therethrough of any filler materials contained therein;

said porous outer layer composed of extruded fibers of a polycarbonate urethane polymer material which is resistant to cracking under in vivo conditions, said fibers positioned on said outer layer in layers overlying and affixed to each other to form a non-woven surface having a network of pores conducive to tissue ingrowth thereinto, said polycarbonate urethane polymer material comprises the reaction product of a reactant charge, said reactant charge including a polycarbonate glycol reactant having terminal hydroxyl groups, a diisocyanate reactant having terminal isocyanate groups, and a chain extender reactant having terminal hydroxyl or amine groups, said reaction product having a hardness of at least about Shore 70 A and having a polymeric backbone having recurring groups selected from a group consisting of urethane groups, urea groups, carbonate groups and combinations thereof; and

a soft filler material contained within said outer envelope.

3. The prosthesis of claim 1 wherein said filler material is selected from a group consisting essentially of silicone gels, saline, gelatin, collagen, chiten, starch, abumin, glycerin, hyaluronic acid and hydrogels of polyacrylamide, poly (2-hydroxyethyl methacrylate), polymethacrylic acid, polyvinyl alcohol, polyvinylpyrrolidone, and mixtures thereof.

4. The prosthesis of claim 1 wherein said porous outer layer includes a crack preventative material absorbed to and grafted on to said fibers so that there is bonding between said polycarbonate urethane polymer material and said crack preventative, said crack preventative being a siloxane including recurring ##STR4## groups, said polycarbonate urethane polymer material having a surface tension greater than the predetermined surface tension of said crack preventative.

2. A mammary prosthesis for surgical implantation, comprising:

an outer shell including a non-porous outer envelope made of a biocompatable polymeric material and a porous outer layer surrounding said non-porous envelope;

said biocompatible polymeric material of said non-porous outer envelope being selected from the group consisting essentially of a polyurethane a polycarbonate urethane, an elastomeric silicone material or a combination thereof, said outer envelope being resistant to in vivo cracking and to prevent leakage therethrough of any filler materials contained therein;

wherein said polycarbonate urethane polymer of said non-porous outer envelope comprises the reaction product of a reactant charge, said reactant charge including a polycarbonate glycol reactant having terminal hydroxyl groups, a diisocyanate reactant having terminal isocyanate groups, and a chain extender reactant having terminal hydroxyl or amine groups, said reaction product having a hardness of at least about Shore 70 A and having a polymeric backbone having recurring groups selected from a group consisting of urethane groups, urea groups, carbonate groups and combinations thereof;

said porous outer layer is composed of extruded fibers of a polycarbonate urethane polymer material which is resistant to cracking under in vivo conditions, said fibers positioned on said outer layer in layers overlying and affixed to each other to form a non-woven surface having a network of pores conducive to tissue ingrowth thereinto; and

a soft filler material contained within said outer envelope.

5. A mammary prosthesis for surgical implantation, comprising:

an outer shell including a non-porous outer envelope made of a biocompatible polymeric material and a porous outer layer surrounding said non-porous outer envelope, said outer envelope being made from a polycarbonate urethane material resistant to cracking under in vivo conditions when said prosthesis is implanted within a patient;

said porous layer being composed of extruded fibers selected from the group consisting essentially of a polycarbonate urethane polymer, a polyurethane polymer, an elastomeric silicone material or a combination thereof, said fibers being resistant to in vivo cracking when the prosthesis is implanted within a patient, said fibers positioned on said outer layer in layers overlying and affixed to each other to form a non-woven surface having a plurality of pores conducive to tissue ingrowth thereinto;

said polycarbonate urethane polymer comprising the reaction product of a reactant charge, said reactant charge including a polycarbonate glycol reactant having terminal hydroxyl groups, a diisocyanate reactant having terminal isocyanate groups, and a chain extender reactant having terminal hydroxyl or amine groups, said reaction product having a hardness of at least about Shore 70 A and having a polymeric backbone having recurring groups selected from a group consisting of urethane groups, urea groups, carbonate groups and combinations thereof; and

a soft filler material contained in said outer envelope.

6. The prosthesis of claim 5 wherein said polycarbonate urethane polymer of said outer envelope comprises, the reaction product of a reactant charge, said reactant charge including a polycarbonate glycol reactant having terminal hydroxyl groups, a diisocyanate reactant having terminal isocyanate groups, and a chain extender reactant having terminal hydroxyl or amine groups, said reaction product having a hardness of at least about Shore 70 A and having a polymeric backbone having recurring groups selected from a group consisting of urethane groups, urea groups, carbonate groups and combinations thereof.

7. The prosthesis of claim 5 wherein said filler material is selected from a group consisting essentially of silicone gels, saline, gelatin, collagen, chiten, starch, abumin, glycerin, hyaluronic acid and hydrogels of polyacrylamide, poly (2-hydroxyethyl methacrylate), polymethacrylic acid, polyvinyl alcohol, polyvinylpyrrolidone, and mixtures thereof.

8. A mammary prosthesis for surgical implantation, comprising:

an outer shell including a non-porous polymeric shell and an elastomeric silicone based shell surrounding said polymeric shell;

said outer shell preventing migration therethrough of any filler material contained therein and being resistant to cracking under in vivo use when the prosthesis is implanted in a patient, said outer shell being made from a polycarbonate urethane material;

said non-porous polymeric shell being selected from the group consisting essentially of a polyurethane material, a polycarbonate urethane material or a combination thereof and said polycarbonate urethane polymer comprises the reaction product of a reactant charge, said reactant charge including a polycarbonate glycol reactant having terminal hydroxyl groups, a diisocyanate reactant having terminal isocyanate groups, and a chain extender reactant having terminal hydroxyl or amine groups, said reaction product having a hardness of at least about Shore 70 A and having a polymeric backbone having recurring groups selected from a group consisting of urethane groups, urea groups, carbonate groups and combinations thereof;

a porous layer surrounding said silicone based shell, said porous layer being composed of extruded fibers of a biocompatible material, said fibers positioned on said silicone based shell in layers overlying and affixed to each other to form a non-woven surface having a plurality of pores conducive to tissue ingrowth thereinto; and

a soft filler material contained within said outer shell.

9. The prosthesis of claim 8 wherein said elastomeric silicone based shell is composed of an elastomeric siloxane having recurring ##STR5## groups.

10. The prosthesis of claim 8 further comprising a porous layer surrounding said silicone based shell, said porous layer being composed of fibers of a polyurethane polymer, a polycarbonate urethane polymer, an elastomeric silicone based material or a combination thereof, said fibers overlying each other to form a non-woven porous surface which is conducive to tissue ingrowth;

said polycarbonate urethane polymer is the reaction product of a reactant charge, said reactant charge including a polycarbonate glycol reactant having terminal hydroxyl groups, a diisocyanate reactant having terminal isocyanate groups, and a chain extender reactant having terminal hydroxyl or amine groups, said reaction product having a hardness of at least about Shore 70 A and having a polymeric backbone having recurring groups selected from a group consisting of urethane groups, urea groups, carbonate groups and combinations thereof.

11. The prosthesis of claim 10 wherein said porous layer includes a crack preventative absorbed to and grafted on to said fibers so that there is bonding between said extruded biocompatible polymer material and said crack preventative, said crack preventative being an elastomeric silicone material having a predetermined surface tension, said crack preventative being a siloxane including recurring ##STR6## groups, said biocompatible polymeric material having a surface tension greater than the predetermined surface tension of said crack preventative;

and said fibers of an extruded biocompatible polymer material consisting essentially of a polyurethane.

12. The prosthesis of claim 28 wherein said filler material is selected from a group consisting essentially of silicone gels, saline, gelatin, collagen, chiten, starch, abumin, and hydrogels of polyacrylamide, poly (2-hydroxyethyl methacrylate), polymethacrylic acid, polyvinyl alcohol, polyvinylpyrrolidone, and mixtures thereof.

13. A mammary prosthesis for surgical implantation, comprising:

an outer shell including a non-porous polymeric shell made from a polycarbonate urethane material and a silicone elastomer shell surrounding and affixed to said polymeric shell;

a porous layer affixed to said silicone elastomer, said porous layer composed of extruded fibers of a biocompatible material resistant to cracking under in vivo conditions, said fibers positioned on said silicone elastomer shell in layers, said fibers overlying and affixed to each other to form a non-woven surface having a plurality of pores conducive to tissue ingrowth thereinto; and

a filler material contained within said outer shell;

said outer shell being resistant to cracking under in vivo conditions and preventing the migration therethrough of said filler material contained therein.

14. The prosthesis of claim 13 wherein said extruded fibers of said porous layer are made from materials selected from the group consisting essentially of silicone based elastomers, polyurethanes, polycarbonate urethanes and combinations thereof.