Breast prostheses
First Claim
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.
0 Assignments
0 Petitions
Accused Products
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.
-
Citations
14 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. - View Dependent Claims (3, 4)
-
-
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. - View Dependent Claims (6, 7)
-
-
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. - View Dependent Claims (9, 10, 11)
-
-
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. - View Dependent Claims (14)
-
Specification