Abstract: A system and device for providing enhanced delivery of an implant into a surgical pocket is described.

Abstract: A method for coating a sterile breast prosthesis packaged within a sterile blister package with a lubricious material while maintaining the sterility of the breast prosthesis is described.

Abstract: A method for coating a sterile breast prosthesis packaged within a sterile blister package with a lubricious material while maintaining the sterility of the breast prosthesis is described.

Abstract: A method for injection molding thin materials (sub-millimeter) having low green strength could make certain manufacturing processes significantly more efficient yet has heretofore been unavailable. Provided herein is a method that enables injection molding of thin materials by using a mold with contact surfaces having a low surface energy release agent disposed thereon. The low surface energy release agent may be applied as a coating on a conventional mold or the mold itself or just the contact surfaces thereof may be formed of a low surface energy release material. The method finds particular applicability in making special contour patches for medical and cosmetic implants and prosthetics. A preferred approach involves injection molding a thin layer of unvulcanized material on a cold mold, injection molding a thin layer of vulcanized material on a hot mold, transferring the vulcanized layer to the unvulcanized layer on the cold mold, and removing the combined layers.

Abstract: A system and method for manufacture of prosthesis shells using a hot liquid bath to cure the shells is described. The shell is formed on a mold or mandrel, and is then immersed in a hot liquid bath to cure the shell material. Multiple layers of material, such a silicone, may be formed by immersing the layer into a hot liquid bath, cooling the cured layer, applying another layer of uncured material to the cured layer, and then curing the uncured layer in a hot liquid bath. A textured surface may be imparted to the shell by incorporating a texture component into the last layer formed, such that immersing the uncured layer incorporating the texture component in the hot liquid bath cures the last layer formed and dissolves the texture component.

Abstract: A system and method for automated manufacture of prosthesis shells using removably mountable mandrel is described. The mandrels are mounted onto cassettes, which are then moved through various dipping, devolatilization and curing steps by a robot, improving the uniformity of the shells and reducing cost of manufacture. The cassettes may include a motor to rotatably drive spindles upon which the mandrels are mounted on the cassette. The motor may be driven by a battery housed within the cassette to provide for untethered use of the cassette.

Abstract: A method for injection molding thin materials (sub-millimeter) having low green strength could make certain manufacturing processes significantly more efficient yet has heretofore been unavailable. Provided herein is a method that enables injection molding of thin materials by using a mold with contact surfaces having a low surface energy release agent disposed thereon. The low surface energy release agent may be applied as a coating on a conventional mold or the mold itself or just the contact surfaces thereof may be formed of a low surface energy release material. The method finds particular applicability in making special contour patches for medical and cosmetic implants and prosthetics. A preferred approach involves injection molding a thin layer of unvulcanized material on a cold mold, injection molding a thin layer of vulcanized material on a hot mold, transferring the vulcanized layer to the unvulcanized layer on the cold mold, and removing the combined layers.

Abstract: A method for injection molding thin materials (sub-millimeter) having low green strength could make certain manufacturing processes significantly more efficient yet has heretofore been unavailable. Provided herein is a method that enables injection molding of thin materials by using a mold with contact surfaces having a low surface energy release agent disposed thereon. The low surface energy release agent may be applied as a coating on a conventional mold or the mold itself or just the contact surfaces thereof may be formed of a low surface energy release material. The method finds particular applicability in making special contour patches for medical and cosmetic implants and prosthetics. A preferred approach involves injection molding a thin layer of unvulcanized material on a cold mold, injection molding a thin layer of vulcanized material on a hot mold, transferring the vulcanized layer to the unvulcanized layer on the cold mold, and removing the combined layers.

Abstract: A method for injection molding thin materials (sub-millimeter) having low green strength could make certain manufacturing processes significantly more efficient yet has heretofore been unavailable. Provided herein is a method that enables injection molding of thin materials by using a mold with contact surfaces having a low surface energy release agent disposed thereon. The low surface energy release agent may be applied as a coating on a conventional mold or the mold itself or just the contact surfaces thereof may be formed of a low surface energy release material. The method finds particular applicability in making special contour patches for medical and cosmetic implants and prosthetics. A preferred approach involves injection molding a thin layer of unvulcanized material on a cold mold, injection molding a thin layer of vulcanized material on a hot mold, transferring the vulcanized layer to the unvulcanized layer on the cold mold, and removing the combined layers.

Abstract: A gas sterilizable delivery system for a two-part polymer system is provided. The delivery system includes at least two syringe barrels, each barrel being sealed with a gas permeable plunger seal allowing permeation of a sterilant gas to permeate through the plunger seal allowing the entire assembly to be gas sterilized.

Abstract: The present invention provides a system and method for curing, sterilization and aseptic packaging of products, especially medical devices, in a single unit. The process is streamlined with an aseptic packaging step eliminating the need for a second sterilization cycle following packaging. The ability to sterilize and cure products in a dry heat sealed autoclave tube prior to packaging, transfer the products in a sterile airtight environment to the packaging chamber, and to place the products into packages in an aseptic chamber prevents recontamination of the products during packaging and results in a savings of time, product, and packaging expenses.

Abstract: A gas sterilizable delivery system for a two-part polymer system is provided. The delivery system includes at least two syringe barrels, each barrel being sealed with a gas permeable plunger seal allowing permeation of a sterilant gas to permeate through the plunger seal allowing the entire assembly to be gas sterilized.

Abstract: A surgically implantable prosthesis, such as a mammary implant, that is rendered rupture-resistant by injecting a liquid with uniformly dispersed lubricating material into a flexible creasable shell during manufacture or surgical implantation. The lubricating material, such as polyvinylpyrrolidone, polyvinyl alcohol, hydroxyethyl starch, or lecithin is uniformly dispersed in a carrier inflating liquid such as normal saline. The lubricating material reduces frictional wear along opposed inner surfaces during sliding contact in a creased area in the shell wall after surgical implantation.

Abstract: A method of forming a hydrophlic coating on a substrate comprised of applying a hydrophilic copolymer capable of chemically reacting with a coupling agent which will promote adhesion to the substrate. A polyisocyanate coupling agent is applied to the surface from a solvent solution followed by applying the hydrophilic copolymer from solvent solution. In certain instances, the copolymer and isocyanate can be simultaneously applied from a solvent solution. The resulting hydrophilic coating is thrombo resistant, biocompatable and stable.