SCAR TISSUE INHIBITION AROUND SOFT TISSUE IMPLANTS

THE OBJECTIVE OF THIS PROGRAM IS THE DEVELOPMENT OF AN IMPROVED MAMMARY PROSTHESIS SIGNIFICANTLY LESS PRONE TO THE MAJOR COMPLICATION OF CURRENT DEVICES: THE FORMATION OF A THICKENED FIBROUS TISSUE CAPSULE AROUND THE IMPLANT. THE BASIC APPROACH IS TO ALTER THE SURFACE MORPHOLOGY OF THE IMPLANT FROM SMOOTH SILICONE RUBBER TO A TEXTURED SURFACE, WHICH PROMOTES TISSUE ADHESION AND ATTACHMENT. THIS SURFACEWILL BE GENERATED BY EXTRUDING SILICONE RUBBER FIBRILS AND FORMING THEM INTO A MATRIX BONDED TO THE EXTERIOR OF THE IMPLANT. BASED ON EXPERIENCE WITH IMPLANTABLE COMPLIANCE CHAMBERS FOR ARTIFICIAL HEART SYSTEMS, SURFACE MORPHOLOGY WAS SHOWN TO BE A MAJOR DETERMINANT OF TISSUE CAPSULE THICK-NESS FORMED AROUND THOSE DEVICES. TEST SPECIMENS OF SMOOTH SILICONE RUBBER, A TEXTURED SURFACE PREVIOUSLY CHARACTER- IZED, AND THE TEXTURED SILICONE RUBBER WILL BE EVALUATED IN VIVO FOR TISSUE CAPSULE THICKNESS AND COMPOSITION HISTOLOGY.OTHER USES FOR THE TECHNOLOGY DEVELOPED INCLUDE IMPROVED COMPLIANCE CHAMBER SYSTEMS, CARDIAC PACEMAKER CASINGS, IMPLANTABLE POLYMERIC DRUG DELIVERY SYSTEMS, OR ANY APPLICA-TION IN WHICH EXCESSIVE SCAR TISSUE FORMATION CAN CAUSE UNDESIRABLE SYMPTOMS OR INTERFERE WITH THE PERFORMANCE OF THE DEVICE.