Abstract: A method of making a permeation-resistant silicone elastomer-containing laminate useful for making fluid-containing implants such as mammary prostheses and gastric balloons. The method is accomplished by (a) applying a layer of an unvulcanized heat-curable silicone elastomer composition to a cured silicone elastomer substrate, (b) applying a layer of a solvent dispersion of a permeation-resistant elastomer and a solvent on the layer of unvulcanized silicone elastomer composition to form a three-layered laminate, and (c) exposing the three-layered laminate to heat until the unvulcanized silicone elastomer composition is vulcanized.

Abstract: The invention provides an improved prosthetic toe joint adapted for replacement of a human toe joint which includes at least one one-piece member for implantation into the bone of the joint. The implant has a concave articulating surface which articulates against another one-piece component having a mating convex surface or against a mating convex bone surface. This one part component is provided with a flexible hinge section at the junction of its stem and the enlarged head portions. The hinge section is formed from a section of the stem which extends laterally outwardly on both sides of the stem portion adjacent the junction with the head. The laterally enlarged section is provided with a longitudinal channel extending through its midsection to form a hinge. Each of the one-piece components is preferably molded of a flexible elastomeric, physiologically inert material, for example medical grade silicone rubber.

Abstract: A method of making a polymeric body having a porous surface by (a) applying a fluid polymeric composition to a mold surface of a leachable foam having open pores thereon, (b) curing the composition to form the polymeric body, and (c) leaching the foam from the polymeric body with a suitable solvent which does not dissolve the polymeric body. The method is especially suitable for making porous silicone elastomer bodies by using polystyrene foam as the mold material and the method is useful for forming hollow, porous-surfaced polymeric bodies, e.g. mammary and vascular prostheses.

Abstract: A method of forming hollow, porous elastomeric bodies and hollow, duo-layered elastomeric bodies wherein one layer is porous and contiguous with the other layer which is solid by (a) coating a surface of a mandrel with a coating liquid, (b) adhering a layer of water-elutable particles onto the coated mandrel surface, (c) applying a layer of fluid elastomer composition to the particle-coated mandrel surface wherein the elastomeric composition is capable of forming a water-insoluble elastomer, (d) causing said elastomeric composition to form a cohesive mass while in contact with the particle-coated mandrel surface, (e) dissolving said elutable particles from the cohesvie mass with a water-based solvent, and (f) removing the cohesive mass from the mandrel. The coating liquid comprises water and may also further comprise a wetting agent and/or a sugar. The invention also relates to the method wherein the water-elutable particles are adhered to the mandrel surface by heating the mandrel surface.

Abstract: A combination is provided of a percutaneous lead designed for implantation in the human body, which lead has a surface which is adapted to pass through and be exposed to the dermis of a patient when the device is implanted. Said surface is adapted to receive the growth of a cultured autogenous fibroblast coating on an etched, nanoporous surface. A liquid tight sealed removable, disposable chamber encloses said surface, said chamber being provided with openings for introduction therein of finely divided living dermal tissue suspended in a liquid carrier, thus providing a means for formation of the cultured surfaces which can be easily handled. The disposable chamber is removed and discarded at the time of surgery.

Abstract: This invention relates to a method of making an inflatable bone plug for plugging the open end of an intramedullary bone canal which is capable of restricting the flow of bone cement, particularly, during the insertion of bone cement, particularly during the pressurized injection of such a cement, during an operative procedure involving the fixation of the stem of an artificial joint prosthesis such as a femoral hip joint prosthesis to the end of a bone such as a femur. The bone plug is designed to be pressurized with a biocompatible fluid and to thereafter deflate in a controlled manner after the cement hardens. Preferably, the bone plug is made by forming a hollow expandable container of a silicone elastomer permeable to carbon dioxide gas which has a valve stem attached to one end of the container and an opening at the opposite end of the container. A shrinkable elastomeric band is placed over the valve stem in which a channel has been made to receive a further cooperating injection means such as a needle.

Abstract: This invention relates to an implantable, inflatable dual chamber shape retention tissue expander having a resilient annular base and a generally hemispherical shape after inflation which is used to form a generally hemispherical pocket beneath the tissue to be expanded to, for example, provide an appropriately shaped pocket for the receipt of an implantable mammary prosthesis and to a method of using such a tissue expander.

Abstract: An improvement in the implantable shunt device of the type disclosed in U.S. Pat. No. 4,181,132 wherein each valving slit within the elastomeric body of the shunt is formed by a flattened sleeve of woven vascular prosthesis material presenting opposed interior surfaces interengaged when the valving slit is in a closed condition and spaced apart when the valving slit is in an open condition. The opposed surfaces of the sleeve are formed by a material having a coefficient of friction with respect to the material of the cannula insertable therethrough less than that of the elastomeric material of the body. A separate yieldable bias operable in addition to the bias provided by the elastomeric material of the body is provided for yieldably biasing the opposed surfaces of the flattened sleeve into sealed relation when in the closed interengaged condition and into sealed relation to the exterior periphery of the portion of the cannula extending therethrough when in the open spaced apart condition.

Abstract: A surgically implantable mammary prosthesis comprises a sac containing a filler material. The filler material is present in an amount sufficient to give the sac a relatively low profile shape and a pliant, responsive nature. The prosthesis includes a restraining means for resisting the tendancy of tissue to form the prosthesis into a sphere. The restraining means functions reactive to tissue pressure and does not substantially reduce the pliant, responsive nature of the prosthesis.

Abstract: In accordance with a preferred embodiment of this invention, there is provided a new and improved method of forming a four-lumen gastrointestinal tube. This tube may be characterized as having two lumens which extend nearly the full length of the tube and two lumens which extend through only a portion of the tube.