Abstract: A breast implant injector device comprising a hollow guide cylinder having an open injection end and an opposed filling end, the cylinder having an elongated slot extending from the injection end toward the filling end, and an elongated plunger which can be pushed through the interior of the hollow cylinder. An unfilled breast implant can be inserted in the cylinder and a fill tube extending from the implant can extend from the interior of the cylinder through the elongated slot. Pushing the plunger through the cylinder pushes the implant through the open injection end, which can be directed into the open incision for injecting the implant therein.

Abstract: A breast prosthesis has an adhesive element which forms a continuous surface conforming to the back section of the prosthesis which faces the user. One side of the adhesive element is detachably secured to the back section of the prosthesis and the other side of the adhesive element is detachably adhered to the user. The adhesive element is formed from an inner body which is lined with material. The breast prosthesis has a flat annular region on its back section and an elevated edge along the perimeter of the flat annular region. A gap is provided in the elevated edge at an upper region of the prosthesis. The adhesive element extends to the inner surface of the elevated edge and has a projection conforming to the gap.

Abstract: An apparatus and method for mastopexy surgeries correcting a ptosis condition caused by tissue stretching, in the breast as a result of pregnancy, time, aging, and the effects of gravity and athletic activity provide an implant having homogeneously formed connectors extending from inside an implant wall for anchoring to the chest wall or chest muscles of a patient. Embedded reinforcements and anchoring tabs or sutures may be readily oriented along a rib or other defining physiological location in order to provide immediate, permanent, and symmetric installation of implants in a mastopexy reconstruction.

Abstract: An adjustable gel filled mammary implant includes inner and outer envelopes with the outer envelope containing about 95% of its volume filled with a silicone gel or the like. The inner envelope is attached to a bottom portion of the outer envelope and defines a volume of about 5%–10% of the volume of the outer envelope and is filled with saline. The implant also includes a self-sealing valve, filling tube and mini-reservoir for adjusting the size of the implant. A method for implanting, adjusting the size and removal of the filling tube and mini-reservoir are also disclosed.

Abstract: A breast prosthesis may be formed by forming an outer layer on a mold, and filling the mold with a polymerizable foaming composition. The mold may be formed by forming a computer model of the prosthesis based on scanning a patient. The computer model may be used to form a solid model. A prosthesis may be coupled to the patient by coupling at least one metallic insert to the prosthesis and at least one magnet to the patient. Alternately, the prosthesis may be formed with a retaining harness integral to the prosthesis. In still another method, the prosthesis may be coupled to a retaining device surgically implanted in the patient.

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: A method for selecting a properly sized breast implant by first providing a breast ruler, at least one pair of flexible, fillable implant devices, and a liquid measuring device adapted to fill the implant devices. Next, the breast ruler is placed over a breast of a user and a breast width is measured. Then the liquid measuring device is used to fill the implant devices with an approximate amount of liquid corresponding to the earlier measured breast width. Then the filled implants are placed over the breasts with an item of clothing. Finally, the amount of liquid in the implant devices may be adjusted for the desired breast size and appearance.

Abstract: Provided are crosslinked polymer compositions that include a first synthetic polymer containing multiple nucleophilic groups covalently bound to a second synthetic polymer containing multiple electrophilic groups. The first synthetic polymer is preferably a synthetic polypeptide or a polyethylene glycol that has been modified to contain multiple nucleophilic groups, such as primary amino (—NH2) or thiol (—SH) groups. The second synthetic polymer may be a hydrophilic or hydrophobic synthetic polymer, which contains or has been derivatized to contain, two or more electrophilic groups, such as succinimidyl groups. The compositions may further include other components, such as naturally occurring polysaccharides or proteins (such as glycosaminoglycans or collagen) and/or biologically active agents.

Abstract: The present invention relates to a mammary prosthesis made of polyacrylamide hydrogel. Said prosthesis include a shell which is made of medical high polymer elastic material, such as silicone, and said shell have a round curved surface. The shell is filled with polyacrylamide hydrogel, or with hydrogel powder, and the weight of the filled powder is matched with the volume of the circular shell, that is to say, each 100 ml volumes of the shell could be filled with about 2.5–5 g hydrogel powder.

Abstract: A human or animal implant device including a first, inner sealed silicone sheet sac, a second, intermediate sealed silicone sheet sac completely surrounding the first, inner sac, and a third, outer sealed silicone sheet sac completely surrounding the second sac. Each sac has a coating of beeswax on inner and outer walls thereof, and the first, inner sac is filled with a substantially sterile liquid material, preferably of viscosity at least 15 cp. The second, intermediate sac and the third, outer sac are filled with aqueous saline solution.

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 invention concerns an implantable breast prosthesis comprising a soft pouch capable of a containing filler substance such as a physiological serum or a silicone gel and which is made side-specific, so as to satisfy aesthetic requirements and for better matching the convexity of the thorax.

Abstract: A hybrid medical implant having a biocompatible, nonabsorbable core portion and a bioabsorbable textured outer surface portion overlying the core portion. The hybrid implant is useful as a prosthesis for tissue augmentation and/or reconstruction. The core portion of the implant includes a body formed from a nonabsorbable, biocompatible implantable material such as silicone or urethane elastomer. The core portion may be either a solid body, a viscous gel body or a fluid-filled shell. The textured outer surface portion envelops the core portion and presents an irregular, bioabsorbable textured surface to the exterior environment. As a capsule forms around the implant following implantation, the irregular contour of the outer surface of the implant disorients structural proteins in the capsule to impede spherical contraction thereof. Either during the formation of the capsule and/or after the capsule is formed, the outer bioabsorbable surface portion of the implant is absorbed by the body of the host.

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: A hinging breast implant capable a being variably sized and that includes an exterior shell and an inner bladder is described. The exterior shell is typically a bellows having a plurality of pleats so that the outer size of the implant is variable so that different sizes and shapes can be obtained. The rear of the housing closest to the patient's interior is typically shaped in order to conform to the patient's rib cage and internal connective tissues. Conversely, the front of the housing is shaped to naturally conform to the outer shape of the patient. The inner bladder can be filled with a suitable filling material, liquid, gas or solid. As the bladder is filled, the exterior shell expands in a manner that creates a lifting effect and a ballooning effect. An appendage, used to fill the bladder external to the patient, is connected to both the exterior shell and the inner bladder.

Abstract: An apparatus and method for mastopexy surgeries correcting a ptosis condition caused by tissue stretching, in the breast as a result of pregnancy, time, aging, and the effects of gravity and athletic activity provide an implant having homogeneously formed connectors extending from inside an implant wall for anchoring to the chest wall or chest muscles of a patient. Embedded reinforcements and anchoring tabs or sutures may be readily oriented along a rib or other defining physiological location in order to provide immediate, permanent, and symmetric installation of implants in a mastopexy reconstruction.

Abstract: A composition, suitable for surgical or dental use, which can expand and/or contract in at least one direction without similar expansion or contraction in another direction, comprises an inner and an outer portion, the portions differing in their expansion properties and/or the extent to which they are prestressed.

Abstract: The invention relates to an implant, especially a breast implant, which is made of a biocompatible material with a pore structure. The biocompatible material is preferably designed to be reabsorbable.

Abstract: A surgically implantable prosthetic device includes a first shell having an exterior surface, an interior surface, and enclosing a lumen, wherein the lumen enclosed by the first shell is able to accommodate a first fluid therein. The prosthetic device further includes a second shell having an exterior surface, an interior surface, and enclosing a lumen, wherein the lumen enclosed by the second shell is able to accommodate a second fluid therein. One or more fitted shells arranged adjacent to and in a graduated relation to each other are situated between the exterior surface of the second shell and the interior surface of the first shell. The one or more shells include an innermost fitted shell and an outermost fitted shell, wherein the innermost fitted shell is adjacent to the exterior surface of the second shell and the outermost fitted shell is adjacent to the interior surface of the first shell.

Abstract: A cosmetic and reconstructive prosthesis containing a rupture indicator is provided, which includes an external envelope of medical grade elastomer containing a fluid material and a biologically compatible chemical indicator for indicating rupture of the prosthesis, and an internal envelope of medical grade elastomer disposed within the external envelope, the internal envelope containing an implant filling material. Also provided is a method of detecting rupture of a prosthesis, which includes surgically implanting a prosthesis containing a biologically compatible chemical indicator in a location of a patient body in need of the prosthesis; and detecting a change of a body secretion or peripheral blood, or a change locally around the prosthesis for indication of leaking out of the indicator from the prosthesis.

Abstract: A breast prosthesis which, using a widely known material such as silicon, establishes a trabecular body (1) or one of micro-cells (3), with or without a covering (2), provides a prosthesis eliminating the risks of puncture as well as extravasation of the inner fluid, being possible to obtain a lower density than conventional ones, and therefore a lower weight, also eliminating problems due to sagging.

Abstract: The present invention provides a soft tissue implant comprising an outer shell including at least one layer of biostable impervious polyurethane, wherein the outer surface of the outer shell comprises undulations to encourage tissue adaptation to the implant whilst preventing tissue ingrowth and wherein the implant is gel free. The outer shell may comprise multiple concentric layers and a core of polymer fabricated as a closed cell foam.

Abstract: An implantable prosthesis comprised of a solid elastomer made from a synthetic organic polymer that is biocompatible, compliant, and has water content greater than 5%. The solid construction prevents leaks and ruptures that are prevalent in other implants. The implant has the look, fit and feel of human tissue from various parts of the body.

Abstract: Devices and methods for gradual displacing of the periosteal tissue covering bones. The gap developing between the bone and the displaced periosteal tissue will be filled with bone callus as it is in distraction osteogenesis. The devices and methods allow formation of bone in distraction osteogenesis without cutting a segment of the bone.

Abstract: A non-rotating anatomical-shaped breast implant having a front side with a smooth surface and a rear side with a textured surface. A smooth surface ripples or wrinkles little, if at all. Rippling or wrinkling of the implant may undesirably produce a visible or palpable waviness on the skin of the breast. A smooth surface is more likely to produce the look and feel of a natural breast. A rear side with a textured surface is desirable because tissue growth of the body, after the implant has been implanted, engages the textured surface to anchor the implant in place such that the front side with the smooth surface remains matched with the front side of the body and such that the anatomical-shaped breast implant with its tear drop shaped fullness remains at a natural position within the breast. The disclosure further includes a method for minimizing the rotation of an implant within the body and a method for making an implant envelope that has different thicknesses.

Abstract: A method of breast reconstruction utilizes a breast prosthesis having a plurality of chambers or compartments distributed through a body member or shell in the form of a breast. The chambers are disposed along the superior, lateral and inferior surfaces, as well as in the interior, of the body member. The chambers are differentially pressurized or filled in order to control the shape of the prosthesis upon implantation thereof. Valves are provided for regulating the flow of fluid into and from the chambers. The prosthesis and the fill levels of the respective chambers may be selected by computer.

Abstract: The mammary prostheses of the invention have a self-sealing area in the upper pole region of the anterior face. The self-sealing area is greater than that of a traditional filling port, and reduces the severity of the consequences of an inadvertent puncture by a hypodermic needle during the filling process. Also, this self-sealing area is thicker than the material in the other areas of the prosthesis, causing fluid introduced to the prosthesis to stay in the lower pole region of the prosthesis, making the shape of the prosthesis appear more like that of a natural breast.

Abstract: An implant for medical purposes based on a physiologically compatible plastic is composed of thin foldable structural elements having a surface that can be wetted by a fluid lubricant and is preferably surrounded by a covering that contains a lubricant such as e.g. an aqueous fluid.

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: A non-rotating anatomical-shaped breast implant having a front side with a smooth surface and a rear side with a textured surface. A smooth surface ripples or wrinkles little, if at all. Rippling or wrinkling of the implant may undesirably produce a visible or palpable waviness on the skin of the breast. A smooth surface is more likely to produce the look and feel of a natural breast. A rear side with a textured surface is desirable because tissue growth of the body, after the implant has been implanted, engages the textured surface to anchor the implant in place such that the front side with the smooth surface remains matched with the front side of the body and such that the anatomical-shaped breast implant with its tear drop shaped fullness remains at a natural position within the breast. The disclosure further includes a method for minimizing the rotation of an implant within the body and a method for making an implant envelope that has different thicknesses.

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: A method for surgical dissection, sizing and for expansion of a tissue pocket in a naturally occurring fascial cleft is disclosed 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 ligmentous boundaries.

Abstract: A method of increasing the rate of expansion of tissue area and volume, either in vivo or in vitro, which comprises preparing a tissue for expansion and subjecting the tissue to stretching forces, wherein the stretching forces are alternatively increased and decreased to provide alternating periods of stretch and relax cycles.

Abstract: A method of reconstructing tissue is provided. The method includes implanting an absorbable tissue expander having a fluid-tight or semipermeable envelope and 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 has an injection port for the controlled inflation and deflation of the envelope after the device is implanted in a tissue. The method also may include a plurality of envelopes.

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 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: 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 mammary prostheses of the invention have a self-sealing area in the upper pole region of the anterior face. The self-sealing area is greater than that of a traditional filling port, and reduces the severity of the consequences of an inadvertent puncture by a hypodermic needle during the filling process. Also, this self-sealing area is thicker than the material in the other areas of the prosthesis, causing fluid introduced to the prosthesis to stay in the lower pole region of the prosthesis, making the shape of the prosthesis appear more like that of a natural breast.

Abstract: An implantable breast tissue prosthesis assembly comprising an envelope having a shell defining an inner fluid containable chamber and an outer surface, a valve, formed as part of a wall in the envelope, for facilitating the introduction, containment, or removal of fluid within the chamber, and a backing plate comprising material detectable by ultrasound detection technology and shaped to guide a needle into the valve.

Abstract: The invention discloses a method of breast augmentation that allows for (i) an umbilical or other distant incision, (ii) rapid, blunt dissection of a properly-sized, hemostatically-controlled retro-mammary pocket using a balloon dissector, and (iii) the placement of properly-sized inflatable implants that have been tested, compressed, rolled, sterilized and wrapped by the manufacturer (i.e., implants that are ready for insertion into the incision without further handling or manipulation by the surgeon).

Abstract: A magnetic injection port assembly for a tissue expander system or similar inflatable medical device. The injection port assembly includes an injection port body having a cavity, a needle guard assembly, and a magnetic material therein. The needle guard assembly is positioned to prevent a hypodermic needle from passing through the medical device or interfering with the magnetic material. The magnetic material is affixed to the injection port body outside the cavity and the needle guard assembly. The magnetic material is spatially aligned with the region of the body into which the needle should be inserted so that this region may be located by locating the magnet with an external, non-invasive magnetic detection device.

Abstract: A pre-packaged inflatable breast implant that has been pre-tested, rolled, and encompassed in its own insertion sheath, complete with handle marked with indices to show how the implant is to be properly oriented in the retro-mammary space, by the manufacturer before being sterilized and shipped to the surgeon. The invention implant/insertion sheath complex is long enough and small enough in diameter to permit introduction of the implant in the retro-mammary space through a small, distant incision (e.g., the umbilicus). Use of the invention implant/insertion sheath complex simplifies the breast augmentation procedure and shortens the time in which the surgeon can perform the breast augmentation procedure.

Abstract: A surgical implantable mammary prosthesis adapted to resist capsular contracure comprises a flexible sac having a generally circular base and containing an appropriate gel or fluid, and a flexible sheet extending outwardly from said circular base and being peripherally integral with said circular base and forming a ring around said circular base. The unique design in this invention can effectively prevent the implanted mammary prosthesis from displacement, deformation and capsular contracture after breast augmentation. It can also be readily removed when desired by selecting suitable number of holes or of layers.

Abstract: A method of breasts reconstruction utilizes a breast prosthesis having a plurality of chambers or compartments distributed through a body member or shell in the form of a breast. The chambers are disposed along the superior, lateral and inferior surfaces, as well as in the interior, of the body member. The chambers are differentially pressurized or filled in order to control the shape of the prosthesis upon implantation thereof. Valves are provided for regulating the flow of fluid into and from the chambers. The prosthesis and the fill levels of the respective chambers may be selected by computer.

Abstract: A push-up bra has an envelope between the front panel and the rear panel of the bra cups, that receives a flexible pouch containing a mixture of water and a hygroscopic agent such as 70% glycerine-30% water. The hygroscopic agent will draw moisture into the envelope preventing the volume of liquid from decreasing.

Abstract: A container for a tissue implantable solid filler material is disclosed. The filler material can be directly inserted into a cavity within the tissue or into a shell can be inserted into the cavity which either already contains the filler or has the filler added thereto during implantation. Methods for packaging the filler material are also disclosed.

Abstract: A prosthetic device for implantation into a mammalian body comprised of a non-absorbable biocompatible flexible material shell or sac filled with various biocompatible gel filler materials. The gel filler materials are comprised of biocompatible glucomannan obtained from konjac hydrocolloid flour and other biocompatible hydrocolloids, producing a natural look and feel for the prosthetic implants, especially reconstructive prostheses such as breast implants.

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 hybrid medical implant having a biocompatible, nonabsorbable core portion and a bioabsorbable textured outer surface portion overlying the core portion. The hybrid implant is useful as a prosthesis for tissue augmentation and/or reconstruction. The core portion of the implant includes a body formed from a nonabsorbable, biocompatible implantable material such as silicone or urethane elastomer. The core portion may be either a solid body, a viscous gel body or a fluid-filled shell. The textured outer surface portion envelops the core portion and presents an irregular, bioabsorbable textured surface to the exterior environment. As a capsule forms around the implant following implantation, the irregular contour of the outer surface of the implant disorients structural proteins in the capsule to impede spherical contraction thereof. Either during the formation of the capsule and/or after the capsule is formed, the outer bioabsorbable surface portion of the implant is absorbed by the body of the host.

Abstract: A bioactive/biodegradable nucleus implant for repairing degenerated intervertebral discs that is inflated inside the nucleus space after the degenerated nucleus has been removed to re-pressurize the nuclear space within the intervertebral disc. The implant is inflated with a high molecular weight fluid, gel or combination of fluid and elastomer, preferably an under-hydrated HA hydrogel/growth factor mixture with or without host cells. The implant includes an internal, integral, self-sealing valve that allows one-way filling of the implant after it is placed within the disc, and is made from a material that allows fibrous in growth thereby stabilizing the implant. A variety of substances can be incorporated into the implant to promote healing, prevent infection, or arrest pain.