Implants and methods for manufacturing same
First Claim
1. A method of making a shell of an implantable breast prosthesis having a textured surface, the method comprising the steps of:
- (a) providing an implantable shell;
(b) applying a curable fluid composition to the shell, the composition comprising a mixture containing an elastomer component, a leachable agent comprising a water soluble polymer in the form of droplets in the mixture, and a solvent component;
(c) applying a layer of particles to the composition;
(d) allowing the composition to stabilize; and
(e) removing the particles and the leachable agent from the stabilized composition, to form a composite material having an external surface at least a portion of which is an open-cell porous structure defined by relatively large pores left by the removed particles and relatively smaller pores, forming connections between the relatively large pores, left by the removed leachable agent.
2 Assignments
0 Petitions
Accused Products
Abstract
Implantable prosthesis, components of prosthesis, and methods of making same are provided. The methods generally include the steps of providing an implant shell, applying a curable fluid composition to the shell to form a coating thereon and applying a particulate component to the composition. The composition is a mixture, for example, an emulsion, containing a silicone-based elastomer dispersion and droplets of a suspended leachable agent. After the elastomer is stabilized and cured, the particulate component and leachable agent are removed, resulting in an implantable member having a porous, open-cell surface texture designed to be effective in reducing incidence of capsular formation or contraction.
276 Citations
20 Claims
-
1. A method of making a shell of an implantable breast prosthesis having a textured surface, the method comprising the steps of:
-
(a) providing an implantable shell; (b) applying a curable fluid composition to the shell, the composition comprising a mixture containing an elastomer component, a leachable agent comprising a water soluble polymer in the form of droplets in the mixture, and a solvent component; (c) applying a layer of particles to the composition; (d) allowing the composition to stabilize; and (e) removing the particles and the leachable agent from the stabilized composition, to form a composite material having an external surface at least a portion of which is an open-cell porous structure defined by relatively large pores left by the removed particles and relatively smaller pores, forming connections between the relatively large pores, left by the removed leachable agent. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
-
-
10. A method of making a shell of an implantable breast prosthesis having a textured surface, the method comprising the steps of:
-
(a) providing an implantable shell; (b) applying a curable fluid composition to the shell, the composition comprising a mixture containing an elastomer component, a leachable agent in the form of droplets in the mixture, and a solvent component; (c) applying a layer of particles to the composition; (d) allowing the composition to stabilize; and (e) removing the particles and the leachable agent from the stabilized composition, to form a composite material having an external surface at least a portion of which is an open-cell porous structure defined by relatively large pores left by the removed particles and relatively smaller pores, forming connections between the relatively large pores, left by the removed leachable agent; wherein the leachable agent is an agent selected from the group of agents consisting of polyvinyl alcohol, polyethylene glycol, polyacrylic acid, polymethacrylate, poly-lactide, polyglycolide, polycaprolactone, polydioxanone, derivatives thereof, blends thereof, copolymers thereof, terpolymers thereof, and combinations thereof. - View Dependent Claims (11, 12, 13, 14, 15)
-
-
16. A method of making a shell of an implantable breast prosthesis having a textured surface, the method comprising the steps of:
-
(a) providing an implantable shell; (b) applying a curable fluid composition to the shell, the composition comprising a mixture containing an elastomer component, a leachable agent in the form of droplets in the mixture, and a solvent component; (c) applying a layer of particles to the composition; (d) allowing the composition to stabilize; and (e) removing the particles and the leachable agent from the stabilized composition, to form a composite material having an external surface at least a portion of which is an open-cell porous structure defined by relatively large pores left by the removed particles and relatively smaller pores, forming connections between the relatively large pores, left by the removed leachable agent, wherein the step of removing comprises contacting the stabilized composition with a solvent for the particles and the leachable agent. - View Dependent Claims (17, 18, 19, 20)
-
Specification