Abstract: A system and method for molding the shell of a medical device or other molded article is provided. The system includes a multi-axis rotational molding machine in which a mold is mounted. The mold has a cavity in the shape of the article to be molded. The mold seals to hold a vacuum. In operation, silicone or other molding material is inserted into the mold, vacuum is applied to the mold, the mold is rotated about at least two axes and a molding material coats the inside walls of the mold to form the shell or other desired article. A rotationally molded medical article is also provided.

Abstract: A universal implant fill connector for coupling a fill tubing to an implant is disclosed. A barb, or other leakproof fill tubing connection, couples to the fill tubing, and a fill tip couples to the implant. The barb and the fill tip each have a passage therethrough, and each of these passages have an axis. A joint connects the barb to the fill tip so that said barb may rotate from a position where the barb axis is approximately parallel to the fill tip axis to a position where the barb axis is approximately perpendicular to the fill tip axis. Another form of the disclosed connector includes a joint that connects the barb to the fill tip so that the barb may rotate approximately 360 degrees about the fill tip axis.

Abstract: A filler material for a surgically implantable prosthesis comprised of a synthetic triglyceride having a viscosity substantially greater than that of naturally occurring triglycerides is provided. The triglyceride composition is formed of saturated alkyl chains to reduce or limit the potential for oxidation of the alkyl chains to form peroxide groups which adversely affect the biocompatibility of the filler material and the implant. Preferably, the filler material has a viscosity substantially the equivalent of a normal human breast. The synthetic triglyceride filler material may also have a lower viscosity which is a liquid at room temperature for use in inflatable devices. Prostheses containing filler material having the desired viscosity and antioxidation characteristics are also provided as well as a method for preparing the filler material.

Abstract: A device for forming a leakproof closure on the terminus of a tubing having an elastic wall. The device consists of a plug insertion tool and a plug. The plug is a elongate member having a convex distal end and a proximal end. The plug insertion tool has a handle portion which is dimensioned to be grasped by a user for manipulation. The distal end of the insertion tool has a rod projecting axially therefrom which is adapted to releasably engage the proximal end of the plug. The plug is dimensioned to fit snugly within the elastically distended lumen of the tubing. In operation, the plug insertion tool is releasably attached to the proximal end of the plug by engagement means such as mating threads and the distal end of the plug inserted into the open end of the tubing and advanced by means of the insertion tool. The intralumenal portion of the plug forms a leakproof seal with the elastic wall of the tubing.

Abstract: A fluid-filled mammary prosthesis for implantation beneath the skin of a patient comprising a shell and an adjunctive filler. The shell is preferably a closed silicone elastomer envelope having an interior volume and valve for filling. The filler material is a mixture of a fluid such as saline and an adjunct consisting of a plurality of hollow silicone beads having two or more fenestrations within the wall of each bead which provide fluid communication between the outside of the bead and the hollow interior. The beads are packed into the shell prior to the introduction of fluid into the interior of the shell. The beads serve as a baffle to prevent unwanted hydraulic behavior of the fluid portion of the filler material and also serve to help maintain the anatomical profile of the implant. The hollow beads, which range in size from about 7/32 inch to 1/2 inch in inside diameter, may be conveniently made by injection molding.

Abstract: A fluid-filled breast prosthesis for surgical implantation beneath the skin having a wrinkle resistent, elastic outer shell which is adapted to resist deformation or wrinkling during movement of the fluid filler. The outer shell, or envelope, has superior and inferior portions. The wall of the superior portion of the shell is substantially thickened with respect to the wall thickness of the inferior portion of the shell. The shell forms an envelope with an inner cavity which is filled with a biocompatible liquid such as saline. The presence of the thickened superior portion of the shell prevents wrinkles from forming in the breast prosthesis during fluid displacement such as occurs when the breast prosthesis recipient changes her anatomical position. The differentially thickened shell has a posterior base portion which may be reinforced to further stabilize the prosthesis.

Abstract: A target having a characteristic ultrasonic signature for implantation beneath the skin is described. The target, when placed within an implanted injection port enables ultrasonic echographic discrimination of the target from surrounding tissue. In particular, the target enables one to locate its position beneath the skin non-invasively by means of ultrasonic echograpy. In practice, the signature comprises reflections of ultrasonic waves from a target comprising varying thicknesses of a material having sound transmission characteristics different from human tissue. Ultrasonic sound waves reflected from different surfaces of the target arrive at a detector with a characteristic time delay thereby providing a signature. Biocompatible plastics, such as methacrylate, polysulfone, polytetrafluoroethylene or polyethylene, or elastomers such as silicone may be used for the target.

Abstract: An implantable tissue expansion device with an external surface layer of silicon elastomer, at least a portion of which contains a texture or open cell sturcture. The textured surface is expected to decrease subsequent capsular contracture and provide a non-skid surface to hold the device in position and permit differential expansion.

Abstract: A leaf valve folds upon itself to provide positive sealing of a pressurized chamber under a variety of pressure conditions. In particular, the valve stem folds to effectively close the lumen and provide a positive seal even at low differential pressure. A method of making the valve is descirbed.

Abstract: A tissue expander device comprising a thin expandable cover and a concave base is disclosed. Together, the cover and the base form an envelope with a cambered interior chamber concave on the base and convex on the cover. The volume of the envelope is adjusted by introducing fluid into the chamber. As the device is inflated, the radius of curvature of the cambered base is gradually increased until the base becomes substantially planar when the device is fully inflated. Since the concave base becomes planar when the device is fully inflated, the surface of the device contacting the thin overlying skin is smooth and continuous thus reducing erosion of the skin flap by the edge of the base.

Abstract: An injection reservoir or button is adapted for implantation beneath the skin of human and animal patients in conjuction with tissue expanders and drug delivery devices. The injection reservoir includes a base and an exterior wall which define a chamber of liquid reservoir. A duct connects the chamber with an expandable bag of the tissue expander. An elastic rubber member is affixed within the interior of the chamber to act as a sealing member. The rubber member is an inverted dome and is self-sealing to needle punctures because it has a concave interior side which is under compression as a result of having been manufactured into a substantially dome-shaped configuration and thereafter inverted. A metal guard plate is included within the interior of the chamber to guard the base against accidental puncture by an over extended hypodermic needle.

Abstract: An injection reservoir or button is disclosed which is adapted for implantation beneath the skin of human and animal patients in conjunction with tissue expanders and drug delivery devices. The injection reservoir includes a base and an exterior wall which define a chamber or liquid reservoir. A suitable duct connects the chamber with an expandable bag of the tissue expander. An elastic rubber member is affixed within the interior of the chamber in a configuration wherein its side abutting the chamber is in compression, thereby rendering the member self-sealing to punctures by a hypodermic needle. A metal guard plate is included within the interior of the chamber to guard the base against accidental puncture by an over-extended hypodermic needle.

Abstract: An injection reservoir or button is disclosed which is adapted for implantation beneath the skin of human and animal patients in conjunction with tissue expanders and drug delivery devices. The injection reservoir includes a base and an exterior wall which define a chamber or liquid reservoir. A suitable duct connects the chamber with an expandable bag of the tissue expander. An elastic rubber member is affixed within the interior of the chamber in a configuration wherein its side abutting the chamber is in compression, thereby rendering the member self-sealing to punctures by a hypodermic needle. A metal guard plate is included within the interior of the chamber to guard the base against accidental puncture by an over-extended hypodermic needle.

Abstract: A tissue expander, of the type containing within the interior of its expandable shell an injection reservoir self-sealing to punctures by a hypodermic needle, is disclosed. The tissue expander includes a reinforcing member or insert which is substantially more rigid than the expandable shell, is larger than the injection reservoir, and is mounted to the expandable shell with its center substantially at the apex of the shell and substantially superimposed with the center of injection reservoir. The reinforcing member substantially prevents folding of the expandable shell over the injection reservoir and thereby substantially prevents inadvertent puncture of the expandable shell by a needle which is directed into the injection reservoir. Magnetically detectable material is mounted into the injection reservoir to enable an externally applied magnet locator to find the injection reservoir when the entire tissue expander assembly is temporarily implanted in a patient.