Abstract: The invention relates to compositions comprising a hydrogel material that comprises a glycosaminoglycan polymer, adipose tissue and a compound of the structure where X1 and X5 are independently CH or N; X7 is NH, O or S; X8 and X9 are independently CH or N; R13 is an optionally substituted aryl or optionally substituted heteroaryl and R14 is C1-6 alkyl, optionally substituted aryl or optionally substituted heteroaryl. The composition is administered to a site of a soft tissue condition including those of breast tissue. The hydrogel material can be porous or of solid particles. The glycosaminoglycan polymer can be a hyaluronan polymer.

Abstract: An implantable nipple and areola prosthesis for post-mastectomy breast cancer patients includes a conical areola position bearing a matrix of suture holes and a protruding nipple portion. During post-mastectomy breast reconstruction surgery, a surgeon implants the prosthesis under the pectoralis major muscle, placing the implant with the nipple prominence anterior and areola portion posterior. The prosthesis is fixed with dissolving sutures in a circumferential fashion through suture holes in the areola portion of the implant. Scar tissue stabilizes the implant and once healed, cosmetic tattooing may be performed to create a realistic areola and nipple.

Abstract: The invention relates to an implantable prosthesis and a shell for an implantable prosthesis and methods for making them, in particular a light weight implantable prosthesis containing a biocompatible filler which is suitable for use as a breast implant.

Abstract: The invention relates to compositions comprising a hydrogel material that comprises a glycosaminoglycan polymer, adipose tissue and a compound of the structure The composition is administered to a site of a soft tissue condition including those of breast tissue. The hydrogel material can be porous or of solid particles. The glycosaminoglycan polymer can be a hyaluronan polymer.

Abstract: A medical implant assembly and method having a medical implant, e.g. a breast prostheses, attached to a biological interface. The biological interface is comprised of a dermal material with capsular contracture inhibiting properties so that once the medical assembly is inserted into the host, the biological interface, which is intimately coupled to the implant, prevents/reduces capsular contracture formation around the implant. The biological interface comprises a plurality of apertures along its periphery, and attaches to the medical implant by receiving a plurality of attachment flaps or appendages located on the exterior surface of the medical implant within or through the apertures. The attachment of the biological interface is such that the assembly remains intact even where the attachment flaps loosen upon expansion of the implant after insertion into a host, as where the implant is therein injected to a desired dimension.

Abstract: A single opening permanent breast prosthesis includes an envelope made of a flexible, hermatic and biologically inert material having a flat rear surface (3) and a curved front surface (2). The prosthesis thus defines a closed pocket (5) which contains a physiological serum. There are at least two compartments (6, 7, 8) in the pocket (5) which are separated by at least one membrane (10, 11, 12) extending in the form of an arch from the front surface (2) to the rear surface (3) of the prosthesis.

Abstract: An expandable implant includes an implant shell having an opening and a valve assembly closing the opening. The valve assembly has a first elastic patch, and a second elastic patch juxtaposed with the first elastic patch. A major face of the first elastic patch opposes a major face of the second elastic patch, and the opposing major faces have a bonded area in which the opposing faces are joined together and an unbonded area in which the opposing faces are not joined together and are free to move away from one another. A plug is disposed between the opposing major faces. A first opening extends through the first elastic patch and a second opening extends through the second elastic patch. The first and second openings are offset from one another and the unbonded area defines an elongated channel extending between the first and second openings.

Abstract: An implantable prosthesis is provided for reconstructing an anatomical feature, such as a breast nipple. The prosthesis may be formed from a biologic and/or synthetic material. The prosthesis may include a body with a shape that is suitable for reconstructing the anatomical feature. A base may be located at an end of the body to facilitate anchoring the prosthesis in position. The prosthesis may be provided with openings that allow fluid flow therethrough, tissue ingrowth, revascularization, neovascularization and/or fat or stem cell deposition. The prosthesis may include a plurality of layers of biocompatible material arranged in a stacked configuration. The layers may be in spaced relation relative to each other and secured or fixed in position to maintain the spacing therebetween. Each layer may have one or more openings extending therethrough. The spaced layer arrangement may provide a desired tactile response and/or natural movement for the prosthesis.

Abstract: A mastopexy implant for maintaining the breast in an elevated and aesthetically pleasing position includes a lower pole support comprising end portions which may be affixed to the chest wall or to a previously installed upper suspension strut. The implant is loaded in an insertion device. The insertion device is inserted through a small incision and into a subcutaneous pocket created in an inferior half of the breast. The lower pole support may have various constructs and in one embodiment includes a unitary conformable mesh having a plurality of arm or band members which are attached across the breast parenchyma and to the chest wall.

Abstract: A tissue expansion device implanted in a non-activated state over a region of desired tissue growth. Once implanted and positioned the device is activated creating a supporting structure that creates a convex shaped dome over the underlying tissue. The convex shaped dome formed by the tissue expansion device places a tensile stress against the underlying tissue that promotes tissue growth. Alone or with the introduction of tissue enhancing agents and/or adipose tissue, new tissue within the convex shaped void grows until a balance is achieved eliminating the induced stress. Periodically the tissue expansion devices is again activated and enlarged creating an even larger void. Again, the newly enlarged void places additional tensile stress on the underlying tissue thus repeating the cycle of new tissue growth. Once the desired amount of tissue growth has been achieved the device is deactivated and removed.

Abstract: A variable cohesive gel form stabilizing implant is provided for augmentation or reconstruction of the breast. The prosthesis includes a shell filled with a gel having variations in cohesiveness to maintain stable form, shape, and dimension after surgical implantation.

Abstract: A tapered sleeve is provided that includes a hydrophilic coating on an inner surface. In use, the device is typically removed from sterile packaging and soaked to activate the lubricous properties of the coating. An implant (e.g., a pre-filled silicon breast implant) is introduced into a large end of the sleeve and extruded into a surgical pocket of minimal access incision size through a small-sized end of the device.

Abstract: Disclosed herein is a sizer for use in cosmetic surgery augmentation procedures, along with methods for using same. The sizer includes an inflatable shell that can be pressurized to assume a shape and size to guide an augmentation procedure, and then deflated for insertion to or removal from the surgical side. The sizer also includes a reinforcing mesh to prevent puncture of the inflatable shell during a surgical procedure.

Abstract: Breast implants including sensor modules and related methods are described herein. Breast implants include those with: a shell configured to be substantially filled with a viscous material; at least one fluid-permeable cover, the cover completely enveloping the shell; and a plurality of sensor modules attached to the shell and positioned at a distance from each other, each of the sensor modules oriented to detect one or more analytes in a fluid between the shell and the cover, wherein each of the plurality of sensor modules includes a unique identifier and is configured to utilize energy transmitted from an external source.

Abstract: Breast implants including sensor modules and related methods are described herein. Breast implants include those with: a shell configured to be substantially filled with a viscous material; a plurality of projections extending from an external surface of the shell, the projections forming a plurality of compartments adjacent to the external surface of the shell; at least one fluid-permeable cover attached to the projections, the cover completely enveloping the shell and the plurality of projections; a plurality of sensor modules attached to the shell, each of the sensor modules oriented to detect one or more analytes in a fluid within one of the plurality of compartments, wherein each of the plurality of sensor modules includes a unique identifier; and at least one power source operably attached to the plurality of sensor modules.

Abstract: Breast implants including sensor modules and related methods are described herein. Breast implants include those with: a shell configured to be substantially filled with a viscous material; a plurality of projections extending from an external surface of the shell, the projections forming a plurality of compartments adjacent to the external surface of the shell; at least one fluid-permeable cover attached to the projections, the cover completely enveloping the shell and the plurality of projections; and a plurality of sensor modules attached to the shell and positioned at a distance from each other, each of the sensor modules oriented to detect one or more analytes in a fluid within one of the plurality of compartments, wherein each of the plurality of sensor modules includes a unique identifier and is configured to utilize energy transmitted from an external source.

Abstract: A device for maintaining or achieving soft tissue expansion applicable to any body region already temporarily expanded including: an adhesive element deformable and capable of adapting to the shape of this body region, and which can then itself become mechanically rigid enough to resist tendency of the expanded tissue to recoil or to which a second material can be applied to form a stent adapted to the shape of the body area to provide the necessary structural rigidity to prevent recoil of the expansion and thereby induce its retention of its expanded shape after the stent is removed.

Abstract: Disclosed is a self-sealing patch for use with a tissue expander implant. The self-sealing patch serves as protection for the tissue expander against a hypodermic needle inadvertently missing a fluid injection port thereof by sealing a puncture through the patch. The patch includes a first sheet having a first sheet perimeter, a second sheet having a second sheet perimeter attached to the first sheet perimeter to form a pocket between the first sheet and the second sheet. Material is disposed within the pocket, where the material is hydrophobic material having a viscosity high enough that the material is prevented from flowing outside the pocket when either the first or second sheet is punctured with a hypodermic needle but low enough that the material flows to close a track made by a hypodermic needle puncturing the first or second sheet.

Abstract: A novel human breast implant and method for using the same comprising a bioabsorbable implant into which native, autologous vascularized tissue and autologous fat is placed and propagated within a patient's chest as a breast implant.

Abstract: The present invention pertains to the development of Extracellular Matrix (ECM) scaffolds derived from the forestomach of a ruminant. Such scaffolds are useful in many clinical and therapeutic applications, including wound repair, tissue regeneration, and breast reconstruction. In addition, the present invention features methods of isolating ECM scaffolds from mammalian organs, including but not limited to the ruminant forestomach. The invention further features laminated ECM scaffolds containing a polymer positioned between individual ECM sheets. The polymer may optionally contain bioactive molecules to enhance the functionality of the scaffold.

Abstract: A valve assembly for an implant has an inner shell, a self-sealing material disposed within the inner shell, and an insertion pathway extending through the self-sealing material. At least one gap is formed in the self-sealing material that intersects with the insertion pathway to define a proximal pathway section and a distal pathway section. A filling tube is passed through the valve assembly for filling the outer shell of the implant with a fluid. After the implant is filled, the filling tube is removed. As the filling tube is removed, if the self-sealing material within the distal section of the pathway is unable to self-seal before the fluid reaches its proximal end, the fluid is diverted into the gap. The time that elapses before the gap is completely filled by the fluid provides sufficient time for the self-sealing material within the proximal section of the pathway to self-seal.

Abstract: A device for maintaining or achieving soft tissue expansion applicable to any body region already temporarily expanded including: an adhesive element deformable and capable of adapting to the shape of this body region, and which can then itself become mechanically rigid enough to resist tendency of the expanded tissue to recoil or to which a second material can be applied to form a stent adapted to the shape of the body area to provide the necessary structural rigidity to prevent recoil of the expansion and thereby induce its retention of its expanded shape after the stent is removed.

Abstract: A soft prosthetic implant shell, such as a silicone breast implant shell, that has discrete fixation surfaces thereon for tissue adhesion. The fixation surfaces may be provided on the posterior face of the shell, as well as either on the periphery or at discrete areas on the anterior face. Band-shaped fixation surfaces may be provided on the anterior face of the shell to generally match the angle of pectoralis major or pectoralis minor muscle groups. The fixation surfaces may be roughened areas of the shell, or may be separate elements adhered to the shell.

Abstract: A device comprising a kit and a method for using the kit are disclosed that warn a surgeon that the maximal grafting capacity of a recipient tissue has been reached. The increase in interstitial pressure is measured at the recipient site using any of several pressure sensor devices during the grafting process to alert the surgeon to stop grafting once a critical level has been reached, or a sudden increase in pressure is detected, indicative of a maximum graft size.

Abstract: Tissue expanders and their methods of use.

Abstract: The present disclosure provides improved devices and methods to treat periprosthetic breast implant infections.

Abstract: Breast implants including sensor modules and related methods are described herein. Breast implants include those with: a shell configured to be substantially filled with a viscous material; a plurality of projections extending from an external surface of the shell, the projections forming a plurality of compartments adjacent to the external surface of the shell; at least one fluid-permeable cover attached to the projections, the cover completely enveloping the shell and the plurality of projections; and a plurality of sensor modules attached to the shell and positioned at a distance from each other, each of the sensor modules oriented to detect one or more analytes in a fluid within one of the plurality of compartments, wherein each of the plurality of sensor modules includes a unique identifier and is configured to utilize energy transmitted from an external source.

Abstract: The present invention generally relates to an implant insertion device, and particularly, to a breast implant insertion device and method of using thereof. The present invention is related to surgical delivery of an implant. In particular, the invention describes a device for the delivery of a breast implant that avoids contact with the skin reducing potential sources of incidental infection.

Abstract: Breast reconstruction or augmentation methods are provided which generally include implanting a mammary prosthesis comprising a shell having a self sealing wall and defining an inflatable cavity, inflating the prosthesis by introducing a fluid into the cavity using a cannula inserted percutaneously into the self sealing wall, imaging the procedure to assist with guiding the needle, and repeating the steps of inflating, imaging and allowing tissue and skin to expand, until a desired aesthetic outcome is achieved.

Abstract: Methods for breast reconstruction and augmentation are provided which may reduce the incidence of capsular contracture. Methods for treating an encapsulated breast and reducing potential for capsular contracture in the breast are also provided.

Abstract: A mastopexy implant for maintaining the breast in an elevated and aesthetically pleasing position includes a lower pole support comprising end portions which may be affixed to the chest wall or to a previously installed upper suspension strut. The implant is loaded in an insertion device. The insertion device is inserted through a small incision and into a subcutaneous pocket created in an inferior half of the breast. The lower pole support may have various constructs and in one embodiment includes a unitary conformable mesh having a plurality of arm or band members which are attached across the breast parenchyma and to the chest wall.

Abstract: Methods for optimal breast reconstruction are disclosed. The methods include steps for performing a mastectomy that preserves a breast skin envelope. A prosthesis may be inserted into the breast and may be inflated to preserve the shape of the breast skin envelope. The prosthesis may include, a base, a balloon coupled to the base, where the balloon may be inflated to preserve the shape of the breast skin envelope. The prosthesis may also include tube coupled to port for filling the balloon to a predetermined volume. A needle-lock system, coupled to the port may be used to inject, for example, fluids into the balloon. If a patient requires post-mastectomy radiation, breast reconstruction may be delayed and the prosthesis may remain in the breast cavity during the treatment. The treatment may be external beam radiation. Alternatively, the treatment may include brachytherapy technique for treating the internal breast cavity.

Abstract: Breast implants including sensor modules and related methods are described herein. Breast implants include those with: a shell configured to be substantially filled with a viscous material; a plurality of projections extending from an external surface of the shell, the projections forming a plurality of compartments adjacent to the external surface of the shell; at least one fluid-permeable cover attached to the projections, the cover completely enveloping the shell and the plurality of projections; a plurality of sensor modules attached to the shell, each of the sensor modules oriented to detect one or more analytes in a fluid within one of the plurality of compartments, wherein each of the plurality of sensor modules includes a unique identifier; and at least one power source operably attached to the plurality of sensor modules.

Abstract: Breast implants including sensor modules and related methods are described herein. Breast implants include those with: a shell configured to be substantially filled with a viscous material; at least one fluid-permeable cover, the cover completely enveloping the shell; and a plurality of sensor modules attached to the shell and positioned at a distance from each other, each of the sensor modules oriented to detect one or more analytes in a fluid between the shell and the cover, wherein each of the plurality of sensor modules includes a unique identifier and is configured to utilize energy transmitted from an external source.

Abstract: Elastomeric fluid-filled prosthetic implants having an elastomeric shell and a flush patch are provided as well as methods for making and using such implants.

Abstract: The present specification provides for methods for purifying fibroins, purified fibroins, methods of conjugating biological and synthetic molecules to fibroins, fibroins conjugated to such molecules, methods of making fibroin hydrogels, fibroin hydrogels and fibroin hydrogel formulations useful for a variety of medical uses, including, without limitation uses as bulking agents, tissue space fillers, templates for tissue reconstruction or regeneration, cell culture scaffolds for tissue engineering and for disease models, surface coating to improve medical device function, or drug delivery devices.

Abstract: An implantable mammary prosthesis includes an urchin buttress fill port structure. The fill port structure preferably comprises a shell, the shell including an opening, a compartment interior to the shell adapted to contain a filler. The urchin buttress is generally cup-shaped, and is disposed within the shell. The urchin buttress is preferably attached to the shell adjacent the opening to form a fluidic seal, optionally via a sealing flange. The urchin buttress may include one or more ribs, such as to provide structural support to the urchin buttress. Preferably, a reservoir is disposed external to the shell.

Abstract: An implantable mammary prosthesis includes a limpet buttress fill port structure. The fill port structure preferably comprises a shell, the shell including an opening, a compartment interior to the shell adapted to contain a filler. The limpet buttress is generally cup-shaped, and is disposed within the shell. The limpet buttress is preferably attached to the shell adjacent the opening to form a fluidic seal, optionally via a sealing flange. The limpet buttress may include one or more ribs, such as to provide structural support to the limpet buttress. Preferably, a reservoir is disposed external to the shell.

Abstract: The present specification discloses porous materials, methods of forming such porous materials, biocompatible implantable devices comprising such porous materials, and methods of making such biocompatible implantable devices.

Abstract: Disclosed herein are polyurethane polymer matrices with a porosity of from about 20 microns to about 90 microns that are useful in promoting closure and protection of incision sites; supporting the lower pole position of breast implants; and providing a partial or complete covering of breast implants to provide a beneficial interface with host tissue and to reduce the potential for malpositioning or capsular contracture. The disclosed matrices can be seeded with mammalian cells.

Abstract: Devices and methods are provided for making a variable textured breast implant when used in conjunction with a breast implant mandrel having a molding surface and a stem depending therefrom.

Abstract: Methods and systems are provided for facilitating a breast augmentation or reconstruction procedure. The methods generally include performing an incision in a breast of a patient and forming a surgical pocket in the breast, introducing, into the pocket, a mock breast implant, introducing an injectable composition adjacent the mock breast implant in the breast, and replacing the mock implant with a permanent breast implant. Kits useful to perform these methods are also provided.

Abstract: An expandable implant includes an implant shell having an opening and a valve assembly closing the opening. The valve assembly has a first elastic patch, and a second elastic patch juxtaposed with the first elastic patch. A major face of the first elastic patch opposes a major face of the second elastic patch, and the opposing major faces have a bonded area in which the opposing faces are joined together and an unbonded area in which the opposing faces are not joined together and are free to move away from one another. A plug is disposed between the opposing major faces. A first opening extends through the first elastic patch and a second opening extends through the second elastic patch. The first and second openings are offset from one another and the unbonded area defines an elongated channel extending between the first and second openings.

Abstract: Methods for creating a foam-like texture on an implantable material are provided. More particularly, methods for creating foam-like texture on implantable silicone materials are provided.

Abstract: A method for utilizing an implant in a breast cavity in a human breast, comprising forming a substantially radio-opaque implant constructed of biodegradable material, the biodegradable material being elastic, compressible, expandable, and allowing for in-growth of fibrous tissue into the biodegradable material, the substantially radio-opaque implant being compressed during implantation in the breast cavity; and the substantially radio-opaque implant configured to expand in the breast cavity when implanted within the breast cavity for supporting the tissue surrounding the breast cavity.

Abstract: A valve assembly for an implant has an inner shell, a self-sealing material disposed within the inner shell, and an insertion pathway extending through the self-sealing material. At least one gap is formed in the self-sealing material that intersects with the insertion pathway to define a proximal pathway section and a distal pathway section. A filling tube is passed through the valve assembly for filling the outer shell of the implant with a fluid. After the implant is filled, the filling tube is removed. As the filling tube is removed, if the self-sealing material within the distal section of the pathway is unable to self-seal before the fluid reaches its proximal end, the fluid is diverted into the gap. The time that elapses before the gap is completely filled by the fluid provides sufficient time for the self-sealing material within the proximal section of the pathway to self-seal.

Abstract: The specification discloses compositions and methods for treating a soft tissue defect of an individual.

Abstract: The apparatus includes a funnel member, a coupling member and retractors. The funnel member is flexible and is frusto-conical in shape. The funnel member proximal end opening is larger than the distal end opening. The funnel member couples to a distal or coupling member that is located at the funnel member distal end portion. The distal or coupling member is rigid and has catches for removably coupling to the retractors. In use, the retractors anchor the apparatus to the patient while allowing the funnel member to be manipulated to force the prosthesis into a surgical cavity of a patient.

Abstract: An implant for marking an area within a living body includes a matrix material and a marking material. The implant is formable to fit the shape and size of a cavity in the human body. The implant is configured to support tissue surrounding the cavity and to allow in-growth of fibrous tissue into and replace at least a portion of the matrix material.

Abstract: Disclosed is a mammary prosthetic implant with an expandable mammary prosthesis that expands to an enlarged state after implantation. A prosthetic device supports, and conforms to the shape of, the mammary prosthesis before, during, and after the mammary prosthesis is expanding within the implantation site. The prosthetic device has an absorbable main body formed of other than biological tissue, and is penetrable for the in-growth of dermal or subcutaneous tissue. The main body has an anterior end portion, an opposite posterior end portion, and a size relative to the mammary prosthesis upon implantation so that the anterior end portion engages an incised portion of a pectoralis major extending anteriorly of the mammary prosthesis while the opposite posterior end portion engages tissue inferiorly spaced from the incised portion of the pectoralis major and near the inframammary fold. Methods of preparing and using a prosthetic device as described herein also are disclosed.