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 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.
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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.
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Citations
14 Claims
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1. A method of making a shell of an implantable breast prosthesis having a textured surface, the method comprising the steps of:
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(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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A method of making a breast implant shell having an external surface at least a portion of which is an open-cell porous structure, the method comprising the steps of:
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(a) providing an implantable shell; (b) applying a first layer of a curable fluid composition to the shell, the composition comprising a mixture containing an elastomer component, a leachable agent and a solvent component; (c) applying a first layer of particles to the composition; (d) applying a second layer of the composition to the first layer of particles; (e) applying a second layer of particles to the second layer of the composition; (f) allowing the composition to stabilize; and (g) 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.
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Specification