IMPLANTS AND METHDOS FOR MANUFACTURING SAME
First Claim
1. An implantable member having an external surface at least a portion of which is an open-cell porous structure, the member made by 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 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.
1 Assignment
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.
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Citations
20 Claims
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1. An implantable member having an external surface at least a portion of which is an open-cell porous structure, the member made by 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 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. An implantable composite member having an external surface at least a portion of which is an open-cell porous structure, the member made by 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. - View Dependent Claims (15)
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16. An article suitable for use in as a laminate for an implant, the article comprising:
a flexible sheet made by the process of; (a) applying a particulate component and a curable fluid composition to a mold surface, the fluid composition comprising a mixture containing an elastomer component, a leachable agent and a solvent component; (b) allowing the fluid composition component to stabilize; and (c) removing at least one of the particulate component and the leachable agent from the stabilized composition to form a sheet having an external surface at least a portion of which is an open-cell porous structure; and (d) removing the sheet from the mold surface.
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17. An article comprising:
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a sheet suitable for use as a laminate on an implantable object to enhance tissue adhesion or ingrowth when the implantable object is implanted in a patient; the sheet made by a process comprising the steps of; applying a fluid/particulate mixture to a substrate or mold surface, the fluid/particulate mixture comprising a particulate component and a curable fluid component, the curable fluid component containing an elastomer component, a leachable agent and a solvent component; allowing the fluid/particulate mixture to stabilize; and removing the sheet from the substrate or mold surface. - View Dependent Claims (18, 19, 20)
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Specification