Abstract: An apparatus and method for inserting prosthesis implants into a patient pocket. The apparatus has three openings including a prosthesis opening, a larger proximal opening, and a small distal opening. The apparatus prevents infection; eases insertion and placement; and reduces complications. In use, the inverse bellow is placed through the patient incision while allowing the bellow to be manipulated to force the prosthesis into a surgical pocket of a patient.

Abstract: A reduced weight implantable prosthesis, including an outer surface shell for encapsulating the prosthesis, a gel mixture comprising a mixture of cohesive gel and micro-spheres for filling the shell, one or more inner volumes internal to the shell which do not contain the gel mixture; and wherein the gel mixture contains less than 60% by volume of micro-spheres mixed into the cohesive gel.

Abstract: A reconstructive breast prosthesis suitable for implantation into a void in a breast following a lumpectomy procedure in which a body of tissue is excised from the breast, the reconstructive breast prosthesis including an implant body at least generally configured to assume an implant shape corresponding to the shape of the body of tissue excised from the breast and an implant shape retaining structure adapted to maintain the implant body in the implant shape, the reconstructive breast prosthesis having an overall density which is less than the density of the body of tissue excised from the breast.

Abstract: An adjustable implant for volumetrically altering, replacing, expanding, or augmenting tissues is provided. The implant includes an elastomeric membrane enclosed or partially enclosed about a main chamber. The implant is adapted to expand when filled with a fluid. The membrane includes an outer zone formed from at least one outer elastomeric layer; an inner zone formed from at least one inner elastomeric layer; and a middle zone formed from at least one elastomeric middle layer positioned between a least a portion of the outer zone and at least a portion of the inner zone. The implant is configured such that the middle zone is under contraction from a contracting force provided by the outer zone or the inner zone. A method of forming a fluid-filled adjustable implant for volumetrically altering, replacing, expanding, or augmenting tissues is also provided herein.

Abstract: A breast implant and process to optimize the treatment of breast cancer patients that offers more effective alternatives in breast reconstruction and simultaneously administers regional therapies in order to minimize the possibility of local recurrences. The breast implant comprises an inner porous core contained by an elastic holding layer with a system of tubes and conducts within it covered with biodegradable chemotherapeutic and attaching layers.

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: Elongated and high aspect ratio tissue treatment products are provided. Methods of making and using the tissue treatment products are also provided. The tissue treatment products can be used as implants that conform to the site of implantation and resist migration away from their implantation site in vivo.

Abstract: In various aspects, the present invention is directed to implantable neurostimulation leads and methods for their formation. In various additional aspects, the present invention is directed to medical devices having silicone-containing regions with overlying polymeric layers and to methods of forming the same.

Abstract: A method for activating silicone rubber surfaces comprising steps of: i) swelling at least the surface of the silicone rubber matrix with a silicone rubber swelling solvent; ii) treating the silicone rubber matrix during or after the swelling with a solution comprising at least a reactive silane, the reactive silane comprising: a) at least one Si—C bond and; b) at least one hydrolytically labile bond linked to at least one of the Si atoms present in the reactive silane and; c) at least one functional group F1 connected via a Si—C bond to the same or an other Si atom present in the reactive silane, the functional group comprising electrophilic and/or nucleophilic moieties, and/or at least one functional group F2 connected via a Si—C bond to the same or an other Si atom present in the reactive silane comprising moieties which become electrophilic or nucleophilic moieties by a mechanism selected from the group consisting of ring opening of a cyclic structure, hydrolysis, displacement or by a migration reaction;

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 sensor modules attached to the shell, the sensor modules oriented to detect one or more analytes in a fluid adjacent to the shell, the sensor modules positioned at a distance from each other, 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: Provided are hybrid soft tissue constructs comprising a core material, a biomaterial matrix and mammalian cells. Also provided are methods of augmenting or reconstructing a soft tissue of a mammal. Additionally, methods of forming a hybrid soft tissue construct are provided. The use of the above constructs for augmenting or reconstructing a soft tissue of a mammal are further provided. Additionally provided is the use of the above constructs for the manufacture of a medicament for augmenting or reconstructing a soft tissue of a mammal.

Abstract: An implantable device has a body that is substantially rigid and has an imageable shape. The body is further bioabsorbable and may contain permanent metallic elements to aid in its imaging. When the device is implanted in a resected cavity in soft tissue, it can cause the cavity to conform substantially to a known imageable shape. The implantable device is further imageable due to its attenuation properties being different from those of soft tissue such that the boundaries of the tissue corresponding to the predetermined shape can be determined.

Abstract: A penis erection stimulation system comprises one or more infusion needles disposed within and implanted along with one or more housings adjacent the patient's left and right corpora cavernosa. A reservoir and a pump are also implanted inside the patient's body to supply the infusion needle with infusion liquid. A drive unit also adapted for implantation inside the patient's body is arranged for advancing and retracting the tip end of the infusion needle such that it penetrates the housing at least in two different penetration areas either simultaneously or in immediate time succession, thereby injecting drugs along with the infusion liquid into the patient's body for stimulating penis erection.

Abstract: Surgical procedures of the breast where an adhesive is applied to fixate a reshaped and/or relocated portion of breast tissue.

Abstract: A graft device comprising a layer of synthetic non-metallic material having a first surface and a second surface spaced apart from the first surface. The device further includes a radiopaque marker at least partially embedded in the layer.

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; and a plurality of sensor modules attached to the shell and positioned at a distance from each other, each of the plurality of sensor modules oriented to detect one or more analytes in a fluid adjacent to the shell, 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; at least one fluid-permeable cover, the cover completely enveloping the shell; a plurality of sensor modules attached to the shell, the sensor modules oriented to detect one or more analytes in a fluid between the shell and the cover, the sensor modules positioned at a distance from each other, 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: 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: Devices and methods for non-invasive implant rupture detection are described herein. Some variations of a non-invasive implant rupture detection device comprise a single optical waveguide, such as a silicone fiber, embedded in the shell of the implantable device where one end of the optical waveguide is connected to a photo emitter and the other end of the waveguide is connected to photo detector. An optical signal successfully transmitted from the photo emitter through an intact optical waveguide to the photo detector indicates that the implant shell is intact, while an optical signal that is transmitted by the photo emitter, but not detected by the photo detector, indicates that there is a discontinuity or rupture in the shell. The status of the implant shell is wirelessly communicated to an external reader and provided to a patient and/or a practitioner.

Abstract: A medical device includes a balloon catheter having an expandable member, e.g., an inflatable balloon, at its distal end and a stent or other endoprosthesis. The stent is, for example, an apertured tubular member formed of a polymer and is assembled about the balloon. The stent has an initial diameter for delivery into the body and can be expanded to a larger diameter by inflating the balloon.

Abstract: Described herein are material compositions including various textures which when implanted in a mammal encourage an optimal biological response.

Abstract: A soft breast prosthesis is provided, the prosthesis having a surface configuration advantageous for dual plane placement of the prosthesis in a breast.

Abstract: Described herein are systems and methods for soft tissue reconstruction and augmentation using a platelet-rich fibrin matrix. In one embodiment the system of the present invention includes a blood collection apparatus capable of drawing blood from a patient, a matrix preparation container configured to hold a patient's blood while the blood is separated and coagulated to form a platelet-rich fibrin matrix therein, and a matrix delivery device configured to receive the matrix preparation container therein and compress and force the platelet-rich fibrin matrix out of the matrix preparation container and into the patient. In another embodiment the invention described herein is a method in which blood is drawn from a patient and separated and coagulated to form a platelet-rich fibrin matrix. The platelet-rich fibrin matrix is implanted into a patient at the site of a tissue defect or where tissue augmentation is desired.

Abstract: An implant comprises a structure that may be implanted into tissue and that has a first material property at normal body temperature. The first material property is variable at elevated temperatures above normal body temperature. The implant also has a plurality of particles dispersed in the structure that are adapted to convert incident radiation into heat energy when irradiated with electromagnetic radiation. The particles are in thermal contact with the structure such that exposure of the particles to incident radiation raises the temperature of the structure thereby changing the first material property relative to the first material property at normal body temperature.

Abstract: A breast prosthesis is provided having a support shell which is accommodated in a fabric cover, wherein one or more filling chambers for accommodating a filler material is/are located at the rear side of the breast prosthesis, wherein the breast prosthesis has a silicone shell which is arranged in front of the support shell and which is accommodated in the fabric cover in removable manner.

Abstract: Disclosed herein is a sizer for use in cosmetic surgery augmentation procedures, along with methods for using same.

Abstract: A breast implant system comprises at least one first element (1) and at least one second element (2) for implantation in the patient's body so as to form part of a breast implant (10). The first element is displaceable relative to the second element, when implanted in the patient's breast, so as to change the outer shape of the breast implant. Preferably, the elements are contained in a casing (12, 13) with a flexible outer shape. More preferably, a reservoir (R) comprising a lubricating fluid is connected to the casing so as to allow lubricating fluid to be supplied to, and removed from, the casing, in order to reduce surface friction between adjacent elements, and/or between the casing and the elements, before the shape of the breast implant is changed by relative displacement of the first and second elements.

Abstract: Absorbable implants for breast surgery that conform to the breast parenchyma and surrounding chest wall have been developed. These implants support newly lifted breast parenchyma, and/or a breast implant. The implants have mechanical properties sufficient to support a reconstructed breast, and allow the in-growth of tissue into the implant as it degrades. The implants have a strength retention profile allowing the support of the breast to be transitioned from the implant to regenerated host tissue, without significant loss of support. Three-dimensional implants for use in minimally invasive mastopexy/breast reconstruction procedures are also described, that confer shape to a patient's breast. These implants are self-reinforced, can be temporarily deformed, implanted in a suitably dissected tissue plane, and resume their preformed three-dimensional shape. The implants are preferably made from poly-4-hydroxybutyrate (P4HB) and copolymers thereof.

Abstract: A mammary prosthesis built from a sack of elastic material or biocompatible material having a sealed interior cavity with the sack having an anterior surface forming a dome and a posterior surface forming a base, with a sealed and seamless interior cavity filled with microspheres of foamed or expanded polymers or a combination of both. The sack may also be permeable to establish equilibrium between body fluids and interstitial volume of the microspheres.

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

Abstract: Graft materials and devices for surgical breast procedures, as well as methods of making graft devices are described.

Abstract: This novel solid silicone device is designed to let women have more and better choices in breast implant technology for both cosmetic and reconstructive purposes, include shape filling and solid devices overcoming longstanding needs.

Abstract: A self-sealing shell useful as a component of a soft fluid-filled prosthetic implant is provided. The shell is at least partly constructed of a wall made of a colloid of an elastomeric polymer matrix and particles of a water-soluble material distributed therein.

Abstract: An implantable device includes at least one solid structure having an external surface and a volume beneath the surface. One or more of a first conductor or set of conductors is disposed externally and/or internally on or within the structure and an array of elongate electrically conductive elements are disposed radially outwardly within the volume. A breach is detected when a conductive fluid intrudes into the volume through the surface.

Abstract: Surgical procedures of the breast where an adhesive is applied to fixate a reshaped and/or relocated portion of breast tissue.

Abstract: Bio-implantable textured tubular and sheet structures of un-sintered ePTFE are described. Such micro-textured structures stimulate robust development of beneficial bio-integative scar attachment to adnexal soft tissues. Methods for texturing one side of an un-sintered extruded ePTFE tube or sheet are also described. A select length of tubing of any thickness or diameter is applied over a matching mandrel and adhesively stabilized thereon by applying intense suction. The texture is made by “RIGDA tooling” into the wall thickness of the material and by removing undesired material by distraction and avulsion tooling and methods assisted by vibration, leaving intact the finished product. Disclosed is an implantable, non-attached, enveloping, conforming and supportive drainage cover for breast and other soft implants.

Abstract: A telepresence device allows a remote meeting participant to establish a telepresence at a remote meeting location. The telepresence device provides a video image of the remote meeting participant on a video display screen at a meeting location To enhance the visual sensation that the remote person is present at the meeting location, the telepresence device may display the silhouette image of the remote meeting participant without the image of the background scene of the remote participant's location (e.g., office, home or home office). Further, the telepresence device may be equipped with a rear-facing camera that captures a video image of the background scene behind the telepresence device at the meeting location. The silhouette image of the remote meeting participant may be superimposed on the video image of the background scene at the meeting location, which is captured by the rear-facing camera.

Abstract: A tapered sleeve (4) is provided for implant delivery (2). An implant (e.g., a pre-filled silicon breast implant) is introduced into a large proximal end of the sleeve and extruded into a surgical pocket of minimal access incision size through a small-sized distal end of the device. Features of the delivery system are provided to assist in sterile preparation, ensure one time use, improve the delivery of high-friction implants and/or achieve a combination of the above.

Abstract: An apparatus and method are disclosed for realistically simulating the appearance of a nipple-areolar complex. The apparatus may include a first flat surface having a non-toxic self-adhesive material and a second flat surface comprising a photographic image of a female human nipple complex. The photographic image may be a realistic depiction of a human nipple-areolar complex, having a first colored area resembling a human areola, and a second colored area formed within the first area, resembling a human teat.

Abstract: Implantable medical prosthesis, in particular a breast implant, comprising gel-type filling materials having different rigidities in a specific geometrical arrangement. For example, a breast implant comprises an outer shell and at least one first gel-type filling and at least one second gel-type filling, wherein at least one first gel-type filling has a softer consistency than at least one second gel-type filling, wherein said at least one first gel-type filling extends predominantly along the posterior part of the prosthesis, and wherein said at least one second gel-type filling extends predominantly along the superior portion of the anterior surface of the prosthesis without extending along the entirety of such anterior surface of the prosthesis.

Abstract: Disclosed are methods and devices for minimally invasive mastopexy, or other soft tissue suspension, which may be accomplished with our without augmentation.

Abstract: The present invention relates to a customizable prosthesis, for instance a breast prosthesis, comprised of an outer shell, removable micro-compartments and flexible filling tubes formulated out of soft Poly (methyl 2-methylpropenoate) gel, wherein the removable micro-compartments of the prosthesis are arranged in a hierarchical layering scheme to create a prosthesis capable of undergoing modifications quickly, easily and with minimal invasiveness, while retaining a prosthesis with low specific gravity.

Abstract: A mammary prosthesis built from a sack of elastic material or biocompatible material having a sealed interior cavity with the sack having an anterior surface forming a dome and a posterior surface forming a base, with a sealed and seamless interior cavity filled with microspheres of foamed or expanded polymers or a combination of both. The sack may also be permeable to establish equilibrium between body fluids and interstitial volume of the microspheres.

Abstract: Improved breast prostheses, methods of making breast prostheses, and methods of treatment using such breast prostheses are described.

Abstract: At least one embodiment is directed to an insert for measuring a parameter of the muscular-skeletal system. The insert can be temporary or permanent. In one embodiment, the insert is prosthetic component for a single compartment of the knee. The insert comprises a support structure and a support structure respectively having an articular surface and a load bearing surface. The height of the insert is less than 10 millimeters. At least one internal cavity is formed when support structures are coupled together for housing electronic circuitry, sensors, and the power source. The cavity is sterilized through a port. A membrane is between the port and the cavity. A sterilization gas permeates the membrane for sterilizing cavity. The membrane prevents ingress of solids and liquids to the cavity.

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

Abstract: A biodegradable, flexible covering for a breast implant is provided which comprises one or more biodegradable polymer layers dimensioned and shaped to cover at least a portion of the breast implant. The implant can be inserted into an opening of the covering immediately prior to surgery, but alternate configurations and times of insertion are contemplated as well as open or sheet type devices. The coverings can optionally contain one or more drugs for delivery at the surgical site, particularly for treating or preventing infection, pain, inflammation, capsular contracture, scarring or other complications associated with breast augmentation or breast reconstruction.

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

Abstract: The invention relates to compositions comprising a silk fibroin material, 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 silk fibroin material can be in the form of a silk hydrogel, a silk film, a silk scaffold, a silk sheet, a silk porous material or a silk fiber. The silk fibroin material can be substantially sericin free.

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.