Abstract: The invention deals with an implant, in particular, an intervertebral prosthesis, which consists of an elongated elastic body which is form-elastic and takes on the form of a spiral S in the force-free state. The spiral can be drawn by a reverse winding up into an insertion instrument which is only unsubstantially larger in the insertion region than the cross-section of the elongated elastic body in order to reach the inner space of an intervertebral disc through a small opening in the annulus fibrosus and to push in and sever off the self-winding spiral when the interior is filled. This has the advantage that inner spaces of differing sizes can be filled with the same spiral.

Abstract: A system and method for molding the shell of a medical device or other molded article is disclosed. 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 disclosed.

Abstract: The present invention relates to the field of prostheses for plastic reconstruction, especially to mammary and muscular prostheses.

Abstract: A system and method for augmenting a woman's breasts is claimed. The system includes two separate breast prostheses that are used to enhance each single breast. A first breast prosthesis is surgically implanted under the pectoral muscle behind the breast. The first breast prothesis augments the posterior section of the breast nearest the chest. A second breast prosthesis is provided that is surgically implanted between the breast tissue and the pectoral muscle. The second breast prosthesis augments the anterior section of the breast in front of the pectoral muscle. The second breast prosthesis provides the breast with a large size and soft texture, while the first breast prosthesis helps blend the augmented breast into the chest for a more natural appearance.

Abstract: The prosthesis of the invention are configured such that the average thickness of the shell in the region where the posterior and anterior faces meet is greater, e.g., at least twice, the average thickness of the shell in the region of the anterior face. This reinforcement can reduce or eliminate undesirable scalloping effects along the upper perimeter of the prosthesis that can otherwise occur when gravity pulls downward on a filled prosthesis. Moreover, because the reinforcement is preferably confined to a radius/posterior region extending at least part of the way around the perimeter of the prosthesis, it is possible for the shell of the prosthesis in nearly the entire anterior face of the prosthesis to be formed of relatively thin material. This preserves a natural appearance of the prosthesis when it is implanted.

Abstract: The invention relates to a breast prosthesis for breast-amputated women with a flexible plastic body comprising two plastic sheets connected to each other along their common edge and a plastic mass enclosed between the two plastic sheets, wherein the plastic body has a front side formed to resemble the contour of the natural breast and a back side capable of facing the torso of the person, and an elastically deformeable thin part secured with its edge to the back side of the plastic body. In order to improve the wear comfort of the breast prosthesis, the thin part is secured to the plastic body inside the common edge of the connected plastic sheets.

Abstract: The present invention is directed to a self-forming prosthetic device. The present invention is further directed to a method of making the self-forming prosthetic device. In addition, the present invention is directed to a new bra for use with a prosthetic device in the form of a breast prosthesis.

Abstract: A biocompatable nonbiodegradable breast prosthesis comprises a generally conical shell filled with a resilient mass comprised of a multiplicity of layers of resiliently compressible fabric. The shell fabric provides a pore size in the range of from about 2 to 15 microns, 5 microns being preferred. The filler fabric layers define a void content from 70 to 90% or more and are resilient when subjected to compressive forces in both wet and dry conditions. The layers preferably are a honeycomb weave and are formed of monofilament yarns.

Abstract: Crosslinked compositions formed from a water-insoluble copolymer are disclosed. These compositions are copolymers having a bioresorbable region, a hydrophilic region and at least two crosslinkable functional groups per polymer chain. These compositions are able to form hydrogels in aqueous environments when crosslinked. These hydrogels are good sealants for implantable prostheses when in contact with an aqueous environment. In addition, such hydrogels can be used as delivery vehicles for therapeutic agents.

Abstract: A method for modifying the surface of a material adapted for contact with tissue of a human or non-human animal to impart biofunctional, bioactive or biomimetic properties to the surface comprising: (a) exposing the surface to a solution comprising (1) an ethylenically unsaturated monomer or mixture thereof capable, via the ethylenic unsaturation, of gamma irradiation or electron beam induced polymerization, and (2) at least one biofunctional agent; and (b) irradiating the surface with gamma or electron beam irradiation in the presence of the solution to thereby form on the surface a graft polymerized coating, the coating having physically entrapped therein or chemically bonded thereto molecules of the at least one biofunctional agent which imparts biofunctional or biomimetic properties to the surface; wherein the gamma or electron beam irradiation induced polymerization is conducted under one of the following conditions: A. (i) monomer concentration in the solution in the range of from about 0.

Abstract: A reconstruction implant (10) of predetermined shape has a deformable outer envelope (12) containing a filler liquid (15) whose viscosity is substantially equal to that of water. The thickness of the envelope (12) is sufficient to confer on the envelope a shape substantially identical to the predetermined shape in the absence of the filler liquid. The pressure of the filler liquid contained in the envelope (12) is substantially equal to the pressure outside the envelope. The implant can be used as a testicle prosthesis.

Abstract: An improved permanently implantable breast tissue prosthesis comprising angularly and immutably attached base and dome envelopes wherein the base envelope is of a substantially triangular shape and the dome envelope is of a substantially discoid shape, each envelope having a shell defining an inner fluid containable chamber and an outer textured surface to be in direct contact with breast tissue and a valve formed as a part of a wall in base and dome envelopes, the valve facilitating the introduction, containment or removal of fluid within the containable chamber of each envelope.

Abstract: The invention provides a biocompatible composite for use in a living subject for purposes of repairing damaged tissues and reconstructing a new tissue. The composite includes a biodegradable or absorbable three-dimensional support construct, a liquid or viscous fluid forming a gel matrix or viscous fluid when delivered to an area of interest in a living subject. The biodegradable construct provides an ideal surface for cell or cell extract attachment, while the gel matrix or viscous fluid acts as both a carrier material and a separator for maintaining the space between the constructs as well as the structural integrity of the developing issue.

Abstract: The invention relates to an absorbable implantable tissue expander device that can be used in surgeries as a gradually diminishing space filler. The absorbable tissue expander has a fluid-tight or semipermeable envelope having a bio-absorbable biocompatible shell defining a chamber. The envelope is inflatable upon infusion of a fluid into said chamber and deflatable upon removal of the fluid from said chamber. The tissue expander also has a means for the controlled inflation and deflation of the envelope after the device is implanted in a tissue.

Abstract: A breast implant has at least an outer shell which is composed of a resorbable material. The implant, which can be formed entirely of bioresorbable material such as a collagen foam, is sized and shaped to replace excised tissue. The implant supports surrounding tissue upon implantation, while allowing for in-growth of fibrous tissue to replace the implant. According to various alternative embodiments, the implant is elastically compressible, or can be formed from self-expanding foam or sponges, and can be implanted through a cannula or by injection, as well as by open procedures. The implant can carry therapeutic and diagnostic substances.

Abstract: Crosslinked compositions formed from water-insoluble copolymers are disclosed. These compositions are copolymers having a bioresorbable region, a hydrophilic region and at least two cross-linkable functional groups per polymer chain. Crosslinking of these polymers can be effected in solution in organic solvents or in solvent-free systems. If crosslinking occurs in a humid environment, a hydrogel will form. If crosslinking occurs in a non-humid environment, a xerogel will form which will form a hydrogel when exposed to a humid environment and the resulting crosslinked materials form hydrogels when exposed to humid environments. These hydrogels are useful as components in medical devices such as implantable prostheses. In addition, such hydrogels are useful as delivery vehicles for therapeutic agents and as scaffolding for tissue engineering applications.

Abstract: A flexible, seamless tissue expanding implant with predetermined memory shape to augment tissue for accurate anatomical restoration for alloplastic reconstruction. The implant is a hollow shape formed from a material that tends to resume its molded shape even when collapsed and when reinflated resumes the desired shape. A minimal incision is made in the patient. From the incision a pocket is formed under the skin of the patient. The pocket is sized to hold the implant, which is inserted, in a collapsed deflated condition. The incision is then closed and allowed to heal. The implant is provided with a one-way, self-sealing valve for periodic inflation. The one-way valve is a latex plug encapsulated with silastic and incorporated into the implant. The valve can be palpated by the surgeon so that inflation can be performed with the implant in place by inserting a hypodermic needle through the skin of the patient, through the valve and into the interior of the implant.

Abstract: There is disclosed medical prostheses filled with an aqueous solution of polyethylene glycol. The aqueous solution can be a saline solution. There is also disclosed a method of making such medical prostheses. The novel prostheses are useful, for example, as breast implants.

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: The invention describes the possibility of the biofunctionalization of biomaterials, in particular implants, by their made-to-measure coating with synthesized cell- or tissue-selective RGD peptides which in vitro stimulate the adhesion of mainly those cell species which in each case are intended to accomplish the tissue integration of the appropriate biomaterial.

Abstract: A soft tissue expander has enhanced performance through use of differential and directional expandability, continuous expansion capability, increased base and dimensional stability, increased soft tissue purchase by virtue of unique surface topography, and results in improved cavity contour after expansion. Expansion means may be provided to expand the implant in a desired direction. In the preferred embodiment, an expander or implant has an exterior surface defining a volume, the exterior surface including a base portion, a first wall and a second wall, wherein the second wall is relatively thinner than the first wall. A fill port, which may be integrally molded into the expander, is included. As the expander is inflated, differential expansion occurs with the relatively thin second wall section expanding more than that of the first wall section. The base may include ribs or other molded-in structures to increase structural integrity.

Abstract: The present invention is directed to the assessment of ischemic wound therapeutics by characterizing wound healing parameters such as epithelialization, granulation tissue formation and contraction. The present invention is also directed to an animal model for assessing ischemic wound therapeutics.

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: Devices with sites that are located using a magnetic field.

Abstract: A soft tissue expander has enhanced performance through use of differential and directional expandability, continuous expansion capability, increased base and dimensional stability, increased soft tissue purchase by virtue of unique surface topography, and results in improved cavity contour after expansion. Expansion means may be provided to expand the implant in a desired direction. In the preferred embodiment, an expander or implant has an exterior surface defining a volume, the exterior surface including a base portion, a first wall and a second wall, wherein the second wall is relatively thinner than the first wall. A fill port, which may be integrally molded into the expander, is included. As the expander is inflated, differential expansion occurs with the relatively thin second wall section expanding more than that of the first wall section. The base may include ribs or other molded-in structures to increase structural integrity.

Abstract: A breast implant has at least an outer shell which is composed of a resorbable material. The implant, which can be formed entirely of bioresorbable material, is sized and shaped to replace excised tissue. The implant supports surrounding tissue upon implantation, while allowing for in-growth of fibrous tissue to replace the implant. According to various alternative embodiments, the implant is elastically compressible, or can be formed from self-expanding foam or sponges, and can be implanted through a cannula or by injection, as well as by open procedures. The implant also is capable of carrying therapeutic and diagnostic substances.

Abstract: A solvent mixture to disperse or dissolve a copolymer of methyl-trifluoropropyl siloxane and dimethylsiloxane, the solvent mixture comprising perchlorethylene, a selected acid ester, and a selected ketone. The invention also comprehends the combination of copolymer and solvent mixture.

Abstract: A subcutaneous prosthesis for mammaplasty repair comprising a netting having a generally circular shape with a V shaped opening extending from its center. The prosthesis having a metallic reinforcing wire that extends around the periphery of the circular netting. The ends of the reinforcing wire being maintained in position by a blocking piece. When the prosthesis is deployed, by tightening the reinforcing wire the prosthesis can be formed into a conical shape suitable for mammary repair.

Abstract: The invention relates to an absorbable implantable tissue expander device that can be used in surgeries as a gradually diminishing space filler. The absorbable tissue expander has a fluid-tight or semipermeable envelope having a bio-absorbable biocompatible shell defining a chamber. The envelope is inflatable upon infusion of a fluid into the chamber and deflatable upon removal of the fluid from the chamber. The tissue expander also enables the controlled inflation and deflation of the envelope after the device is implanted in a tissue.

Abstract: An improved breast implant prosthesis provides fastening components to anchor the implant to retroglandular or retromuscular tissue and secure the implant in place. Location markers are also provided to ensure correct orientation of the prosthesis during the augmentation mammaplasty procedure and provide postoperative orientation information without the use of invasive procedures.

Abstract: Compositions and methods are disclosed for filling prostheses for implantation into human soft tissue. The compositions comprise at least one nonionic surfactant, such as a polysorbate, which can be provided to fill a physiologically compatible shell or containment sac of the prosthesis. The liquid compositions of the present invention have a relatively high viscosity and are quickly absorbed from body tissues, metabolized and excreted with no known adverse effect. The compositions can be injected into the physiologically compatible shell either before, during or after the surgical implantation procedure.

Abstract: An implant and coverings for an implant for use in the human body are disclosed. Coverings for implants are constructed to present a biocompatible surface to the body and to provide a textured surface which serves to disorganize scar tissue which forms around the implant. Filaments of expanded PTFEe are attached to a stretch fabric backing in a loose weave configuration. Silicone molded in geometric patterns may be employed to present a textured surface. Compressive structures may be beneficially used on the surface of the implant or in the interior of the implant. Foam is one such compressive structure. Hexagonally shaped compressive cells containing fluid, gas, gel or foam are adapted to receive an insert which contains an outer biocompatible coating. A valve or port is provided to communicate between the cell and the body. Expansion means may be provided to expand the implant in a desired direction.

Abstract: A dual lumen gravity oriented breast prosthesis or implant for surgical implantation includes inner and outer lumens which are defined by inner and outer closed envelopes of a medical grade elastomer. The outer closed envelope or lumen defines a generally oval or tear-shape with upper and lower portions. The outer envelope also contains a quantity of fluid material as for example a silicone gel having a first density. The prosthesis also includes a second or inner lumen defined by a second closed envelope of medical grade elastomer which is disposed in and fixed in the lower portion of the outer closed envelope. The inner lumen may be of various shapes such as generally spherical or preferably crescent shape. The second lumen is filled with a saline solution which has a density which is greater than the density in the outer lumen.

Abstract: An implant that includes an envelope, a saline based fill material in the envelope, and a single valve. The envelope is formed by a mandrel dipping process and includes an opening formed by a support rod for the mandrel. To remove the envelope from the mandrel, the opening is stretched over the mandrel. This opening, a natural port, is sealed by a single valve structure. The valve structure includes the valve through which the saline based fill material is introduced. The valve is two piece, and the two pieces mechanically interlock to bias and draw a diaphragm tightly against a valve seat, which provides a primary resilient closure for the valve. The valve further includes a secondary resilient closure where two confronting faces form a slit through which a filling tube is inserted and where end portions of the two confronting faces are bonded to each other to minimize the chances of the slit tearing at its ends.

Abstract: A breast prosthesis envelope formed from flexible, non-absorbable material containing a filler material which is substantially shortening. Shortening composition is mainly any or a mixture of any of the following modified oils or fats such as derivatives of vegetable oil, soy bean oil, peanut oil, olive oil, cannula oil, and animal and human fat and approximately 10 percent laird have been found suitable for use.

Abstract: A human body implant has a separate bladder made from a bio-compatible flexible polymer into which a mobile device or prosthesis is placed after the bladder has been introduced into a subcutaneous body pocket. The bladder completely forms an artificial scar by ingrowth of body tissue into pores in the bladder to form an artificial scar. In the case of a breast implant, a breast prosthesis of many different types can be used. The prosthesis is isolated from but is mobile in the bladder. Fluids can be withdrawn from the prosthesis without contaminating the body.

Abstract: A brassiere pad is used in a cup of a brassiere, with the brassiere pad retaining a non-flammable liquid and positioned within the cup for enhancing the appearance of the breast. The non-flammable liquid includes a humectant and a glycerine-based fluid, and the brassiere pad may include a main chamber for retaining the non-flammable liquid, and a tapered chamber connected to the main chamber by a canal to allow the liquid to pass between the tapered chamber and the main chamber. The brassiere pad may be composed of polyurethane.

Abstract: Novel crystal gels and articles are formed from one or more block copolymers having at least one crystalline midblock and high levels of a plasticizer, said midblock segment having an amount of crystallinity sufficient to achieve improvements in one or more physical properties including improved crack propagation resistance, improved tear resistance, improved resistance to fatigue and resistance to catastrophic failure not obtainable in amorphous gels.

Abstract: The invention relates to a breast prosthesis for breast-amputated women with a flexible plastic body (1) comprising two plastic sheets (2, 3) connected to each other along their common edge (23) and a plastic mass (4) enclosed between the two plastic sheets (2, 3), wherein the plastic body (1) has a front side (21) formed to resemble the contour of the natural breast and a back side (31) capable of facing the torso of the person, and an elastically deformeable thin part (6) secured with its edge (611) to the back side (31) of the plastic body (1). In order to improve the wear comfort of the breast prosthesis, the thin part (6) is secured to the plastic body (1) inside the common edge (23) of the connected plastic sheets (2, 3).

Abstract: The invention relates to an epithesis consisting of a sheath adapted to a body part on the back and simulating the desired body surface on the front, and a filling inside the sheath, wherein the filling consists of an elastic material with a density of d<0.25 g/cm.sup.3.

Abstract: A functional bra with a silicone gum cup padding in a design consistent with human body engineering. The silicone gum cup padding includes a silicone gum body, a polyurethane (PU) film, and a seaming cloth. The silicone gum body is thin in an upper part and thick toward the lower part. The silicone gum cup padding is made by covering the silicone gum body with said PU film, evacuating the inside of the PU film, sealing said PU film, and securing the seaming cloth on the sealed silicone gum body.

Abstract: A valve cover for a prosthetic implant. The valve cover is adhered to the prosthetic implant and covers the fill valve. The valve cover has a flexible body having an upper portion, a central portion and a lower portion. A plug extends from the bottom surface of the central portion of the valve cover body. A continuous textured peripheral area is disposed on the bottom surface of the flexible body and which extends through the upper portion and to the lower portion through an axis intersecting the valve entrance. The continuous peripheral area is adhered to the prosthetic implant body whereby the plug is aligned with the fill valve entrance. Lifting of the lower portion of the valve cover provides access to the fill valve of the prosthetic implant.

Abstract: A biologically compatible human breast implant is disclosed which has improved natural feel and is resistant to leakage. In the disclosed implant, a large quantity of small, pliable hollow spheroids of polymeric material are used as a filler within the implant shell. The hollow spheroids are partially filled with a fluid when in an uncompressed state, and provide a cushioning effect by being compressible to the point where the resulting reduction in the interior space causes the interior to become essentially filled by the fluid and where further compression is resisted due to the relative non-compressibility of the contained fluid. The described spheroids are made of silicone rubber and are partially filled with saline solution. The spheroids have an outside diameter of from about 1 mm to 5 mm, an outer wall thickness of about 75 to 225 microns, and the fluid contained therein is filled to about 80 to 90% of capacity when the spheroids are in their naturally uncompressed spherical state.

Abstract: A method for forming the outer surface of a breast prosthesis is disclosed. A digital, three-dimensional image is formed of a patient's breast using a computerized scanner. A computer-controlled milling machine utilizes the image to form a solid model of the breast. A sheet of flexible, moldable material having a uniform, precise thickness is then vacuum-formed over the breast model. A hard, two-piece mold is cast from the flexible sheet. A soft, curable material is then either poured or injected between the two pieces of the mold to form the breast prosthesis outer surface. The breast prosthesis outer surface is then turned inside out to form a shape that is a mirror image of the patient's breast.

Abstract: The breast prosthesis has a bag 1 made of a silicone polymer fitted with a closure disc 2 which is head sealed onto it. The bag 1 contains silicone polymer balls 3 of 2 mm diameter and which fill to the whole bag 1 whilst being in contact with one another and forming interstices 4 between them filled with physiological saline solution.

Abstract: An external prosthesis and a method for affixing the prosthesis to the user by means compliantly housed magnets interacting with surgical steel implants inserted beneath the skin of the user. The implants are surgical steel buttons coated with methylmethacrylate to avoid the release of corrosion products and silastic, a biocompatible material. The implant is inserted beneath the patient's skin along with a biocompatible mesh material to provide additional strength. A flexible carrier is formed with a hollow cylindrical shape to allow a magnet to move freely within the carrier. The opening of the flexible carrier is covered with a mesh. The flexible carrier/magnet/mesh combination is formed into the prosthesis so that the prosthesis aligns with the surgical steel implants and allows freedom of movement within the flexible carrier. The mesh material allows for breathability and also avoids skin strangulation from excess pressure of the magnet on the surgical steel implant.

Abstract: An improved breast prosthesis or mammary implant (20), is provided of a type known per se, comprising a single or multiple lumen elastic shell or envelope (23), for example of molded silicone, in which an aperture formed in the shell for removal from a mold is subsequently sealed with a silicone patch (24), thus forming internal lumen(s) which can then be filled by either the manufacturer or the surgeon with a fluid or gel. A substantially seamless join between the patch and the shell is formed by means of an aperture with a chamfered edge (22), and applying and bonding a patch to one side, preferably the inside, of the shell such that a seamless and ridgeless join between the patch and the shell is formed to the exterior. A method and apparatus for performing a chamfer trimming operation and applying the patch are also disclosed. A double chamfer aperture edge construction filled in with an overlay patch and an underlay patch is also disclosed.

Abstract: A segmental breast expander apparatus includes an inflatable member defining a lumen and having a least a portion of a wall with a variable elastic limit. The inflatable member is configured for performing segmental expansion of a tubular portion of a breast skin envelope. The member can be configured to sufficiently expand the tubular portion of the breast skin envelope to use the tubular portion to recreate a nipple-areolar complex. The member can also have a deflated shape and an inflated shape with the inflated shape having a protruding portion that at least partially corresponds to a shape of the tubular portion of the breast skin envelope.

Abstract: The present invention is a bioimplantable device for adjusting the position of and/or shielding selected tissues of a human body during radiation therapy. The device includes a selectively inflatable hollow structure formed from a biocompatible material, an inflation port in communication with the hollow structure effective to communicate an inflation material to within the hollow structure and at least one tissue fixation element disposed on the hollow structure.In another embodiment, the device is a multi-layer structure which can be implanted to block radiation and/or displace tissues from the path of the radiation.

Abstract: A method for surgical dissection, sizing and for expansion of a tissue pocket in a naturally occurring fascial cleft for use in plastic surgery applications and other applications where it is desirable to dissect an anatomically defined and bounded tissue pocket, determine the appropriate size of a prosthesis to be implanted into the tissue pocket and, if necessary, further expand the tissue overlying the tissue pocket. An inflatable device which performs the three distinct functions of dissection, sizing and tissue expansion is used. In a preferred method, a dissecting balloon device is tunneled bluntly to a desired location within a fascial cleft in the female breast. The device is then inflated to dissect tissue layers adjacent the fascial cleft until ligaments defining boundaries of the fascial cleft are reached, to create a tissue pocket extending to the ligamentous boundaries.