Abstract: A method for implanting a breast implant into a subject, the method includes: providing a sterile, flexible, elastic biodegradable bag sized to contain the breast implant; providing a sterile breast implant; inserting, using sterile handling, the sterile breast implant into the sterile bag to form a sterile breast implant assembly; closing the bag to fully enclose the implant within the bag; and implanting in a sterile manner the sterile breast implant assembly into the subject. A sterile bag, which may be provided in a kit, preferably for use with the method includes first and second chambers connected by a channel for moving a breast implant from the first chamber through the channel to the second chamber without directly touching the implant. An incision dilator may also be included with the kit or separately provided for use in a preferred embodiment of the method.

Abstract: The present invention relates to a breast prosthesis having at least one contact surface which is intended for contact on a body surface, with the contact surface having at least one means by means of which air circulation and/or an exchange of air can be achieved between the contact surface and the body surface.

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: A breast implant system is provided comprising a plurality of chambers including one or more first fluid chambers (1) and one or more second fluid chambers (2). The first fluid chamber (1) forms part of a breast implant (10), whereas the second fluid chamber (2) may also form part of the breast implant or may be implanted remote from the breast implant. The first and second fluid chambers are interconnected so as to allow exchange of fluid between the first and second chambers, thereby causing the shape and, depending upon the specific embodiment, also the volume to change accordingly.

Abstract: Embodiments of apparatus and methods for tissue lifting, or for correcting a ptosis condition caused by tissue stretching, are described. In some embodiments a tissue is supported by a support member. In some embodiments, tension is applied to a support member through at least one suspension member. The described embodiments provide examples of methods and apparatus effective for use in lifting or otherwise applying tension to various tissues, including tissues of the breast, buttock, thigh, arm, abdomen, neck and face.

Abstract: A method of texturing a soft prosthetic implant shell, such as a silicone breast implant shell. A soft prosthetic implant with a textured external surface layer of silicone elastomer and having an open-cell structure is made by adhering and then dissolving round salt crystals. The resulting roughened surface has enhanced physical properties relative to surfaces formed with angular salt crystals. An implant having such a textured external surface layer is expected to help prevent capsular contraction, to help prevent scar formation, and to help in anchoring the implant within the body.

Abstract: The invention relates to a soft-tissue implant for use in the medical field which has an antibacterial effect. The soft-tissue implant, which may for example be a breast implant, has at least one antibiotic substance bound to the implant surface in first and second configurations that release the antibiotic substance, after implanting in an animal body, at short term and long term release rates. The first and second configurations are each present at one or more common surface locations. The soft-tissue implant has an antibacterial effect that prevents or reduces the deposition of bacteria and the formation of bacteria-containing biofilms.

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 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 elastomeric fluid-filled prosthetic implant having a shell and a patch providing a reinforced access region on the shell for introduction of manufacturing implements, such as a gel-filling tool. The shell may cover the entire inner face of the patch, or a substantial part thereof, and a peripheral edge of the patch and the shell cooperate to form a flush interface with no sudden surface steps on both interior and exterior surfaces of the implant. The removal of any surface steps eliminates undesirable tactile discontinuities and stress points that may cause the shell wall to wear or may irritate the surrounding tissues. The prosthetic implant may be a breast implant formed of a silicone elastomer. The patch may be the same material or a liquid silicone rubber, but at least has similar material properties such as elastic modulus, durometer and elongation.

Abstract: A fluid-filled prosthetic implant having the properties of a gel-filled implant. The prosthetic implant includes a soft flexible shell defining an inner chamber and having a predetermined volume when the shell is filled or inflated. A quantity of dry nanoparticles is introduced into the inner chamber during manufacture. A surgeon inserts the flexible implant shell into a body cavity, and then utilizes a syringe or other means to deliver a fluid to the inner chamber of the shell. The fluid mixes with the quantity of dry nanoparticles to form a gel, for example, a hydrogel. The hydrated nanoparticles provide to the implant the desirable properties of a gel-filled implant. In this way, the incision used can be smaller than that for a filled implant, but the resulting prosthesis is more natural than a typical saline-filled implant.

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

Abstract: Various embodiments provide methods and systems for ultrasound treatment of tissue are provided. Accordingly, a method can include locating an implant in a site in a body, directing a medicant to at least one of the implant and the site, directing ultrasound energy to the site, and accelerating healing of the implant and/or native tissue at the site.

Abstract: A breast implant includes an implant shell having an outer surface and defining a first fluid reservoir, and a porous membrane overlying the outer surface of the implant shell and defining a second fluid reservoir. The breast implant includes a filling tube having a first conduit in communication with the first reservoir and a second conduit in communication with the second reservoir. The breast implant includes an injection dome coupled with the filling tube and having a first fluid chamber in communication with the first conduit and a second fluid chamber in communication with the second conduit. The injection dome includes an upper end having an injection cover, a lower end including a support base, the first fluid chamber located adjacent the injection cover, the second fluid chamber located adjacent the support base, and a diaphragm dividing the first and second fluid chambers from one another.

Abstract: The present invention is an atherectomy catheter with a hollow head. The head has a window with at least one internal bladed edge, a plunger, and an adjustable angle nose. The angle of the nose can be manipulated by the operator to apply pressure to an artery wall, thereby forcing the window and the window cutting edge up against a plaque target on the opposite side of the artery wall. The position of the plunger can be manipulated by the operator to open or close the window, thereby exposing or not exposing the bladed window edge, and optionally also pinching off dangling plaque fragments. Cut plaque enters the hollow catheter head through the open window, and is stored inside the catheter for removal from the body and subsequent analysis. In some embodiments, the catheter head may have optional sensors, or the plunger may also serve as a rotary cutter.

Abstract: An elastomeric prosthetic breast implant is provided having a shell and a patch forming a flush interface with the shell and no sudden surface steps on both interior and exterior surfaces of the shell.

Abstract: Biodegradable polymer-coated surgical meshes formed into pouches are described for use with cardiac rhythm management devices (CRMs) and other implantable medical devices. Such meshes are formed into a receptacle, e.g., a pouch or other covering, capable of encasing, surrounding and/or holding the cardiac rhythm management device or other implantable medical device and preventing or retarding the formation of a biofilm.

Abstract: A method of texturing a soft prosthetic implant shell, such as a silicone breast implant shell. A soft prosthetic implant with a textured external surface layer of silicone elastomer and having an open-cell structure is made by adhering and then dissolving round salt crystals. The resulting roughened surface has enhanced physical properties relative to surfaces formed with angular salt crystals. An implant having such a textured external surface layer is expected to help prevent capsular contraction, to help prevent scar formation, and to help in anchoring the implant within the body.

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: An implant for insertion into a breast lumpectomy cavity to serve as a guide for orienting a radiation source relative to the breast lumpectomy cavity, includes a body formed of a bioabsorbable material comprised of chitosan having a porosity sufficient to ensure tissue in-growth before significant bio-absorption of the implant, the body having exterior margins. An interior orientation marker is spaced inwardly from the exterior margins of the body to facilitate relative orientation between the implant and the radiation source.

Abstract: An implant for anatomically reconstructing, or increasing the positive displacement of, a soft portion of a living body is formed of a casing made of a flexible biocompatible material and filled with a gel. The inner surface of the cover that is in contact with the gel is texturized, comprising microscopic open cells.

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: A novel method of partial breast radiation utilizing a breast implant which can provide a stable and improved target for stereotactic radiation treatment.

Abstract: Provided are devices, compositions and methods utilizing EP4 and EP2 receptor agonists for preventing, reducing, or treating capsular contracture occurring in response to the implantation of breast prostheses.

Abstract: The present invention relates to a breast prosthesis 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 removal form.

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: 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: Disclosed are an artificial breast implant in which the surface thereof is formed or modified with a silicone open cell (open pore) foam layer, and a method for producing the same. More specifically, disclosed are an artificial breast implant that has a surface including an open cell foam layer made of silicone and thus minimizes side effects such as in vivo rejection, which may occur after implantation of the implant into the body, in particular, the occurrence of capsular contracture to achieve superior biocompatibility and safety, and a method for producing the same.

Abstract: An implantable soft tissue prosthesis device comprising a silicone elastomer-shell filled with silicone gel or liquid, which among the layers that constitute its shell includes a barrier layer formed of a low permeability silicone, which impedes the bleeding or diffusion of the silicone gel from the inside of the implant to its surroundings through the shell. This barrier layer is given a coloration different to the other layers of the shell, making it visible in the finished product. The coloration of the barrier layer gives the fabricator of the implant as well as to medical personnel, the possibility to identify the presence of the barrier layer and its homogeneity, improving the safety of the device.

Abstract: Described are methods and apparatus for use in supporting tissue in a patient's body. In some embodiments, the patient's breast is supported. In some embodiments, the methods provide ways of supporting and adjusting tissue, and the apparatus includes components and embodiments for supporting and adjusting the tissue. Some embodiments include a supporting device, having a first portion, a second portion, and a support member positioned between the first portion and second portion. Some embodiments include advancing the first portion of the supporting device into the body to a first location in the body; advancing the second portion of the supporting device into the body to a second location in the body; securing the first portion of the supporting device at the first location; and shifting soft tissue in the body with the support member.

Abstract: Devices with internal flexibility sipes, such as slits, provide improved flexibility, improved cushioning to absorb shock and/or shear forces, and improved stability of support. Siped devices can be used in any existing product that provides or utilizes cushioning and stability. These products include human and other footwear, both soles and uppers, as well as orthotics; athletic, occupational and medical equipment and apparel; padding or cushioning, such as for equipment or tool handles, as well as furniture; balls; tires; and any other structural or support elements in a mechanical, architectural, or any other product.

Abstract: A breast implant includes an elastomer shell; a dermal matrix disposed on the implant shell; and a support interposed between the elastomer shell and dermal matrix to separate the elastomer shell and dermal matrix. A process for making a breast implant includes disposing an elastomer shell in a support; and disposing a dermal matrix on an outer surface of the support. A method of using the breast implant include disposing the breast implant in a subject and attaching the support to tissue of the subject.

Abstract: An implantable device for use in tissue and ligament repair comprising at least one knitted section and at least one single continuous fiber traversing the at least one knitted section, the at least one single continuous fiber forming a plurality of traverses extending through the at least one knitted section. The implantable device may comprise at least one single continuous silk fiber. The implantable device is suitable for use in a variety or reconstructive or support applications such as breast reconstruction, mastopexy, breast augmentation revision, breast augmentation support, standard breast augmentation, chest wall repair, organ support, body contouring, abdominoplasty, facial reconstruction, hernia repair, and pelvic floor repair.

Abstract: An implantable device for use in tissue and ligament repair comprising at least one knitted section and at least one single continuous fiber traversing the at least one knitted section, the at least one single continuous fiber forming a plurality of traverses extending through the at least one knitted section. The implantable device may comprise at least one single continuous silk fiber. The implantable device is suitable for use in a variety or reconstructive or support applications such as breast reconstruction, mastopexy, breast augmentation revision, breast augmentation support, standard breast augmentation, chest wall repair, organ support, body contouring, abdominoplasty, facial reconstruction, hernia repair, and pelvic floor repair.

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: An implantable soft tissue prosthesis comprising a hollow shell formed of a flexible elastomeric envelope, the shell having an inner volume and an exterior surface, when the inner volume is filled with an elastomeric silicone tubing that is preshaped conforming to the inner volume of the shell, the prosthesis being adapted to be surgically implanted in a human breast.

Abstract: The present invention relates to an artificial breast prosthesis which minimizes stress concentration and to a production method therefor, and more specifically relates to an artificial breast prosthesis which has excellent mechanical properties, superior tactile texture, and excellent safety and efficacy as a breast prosthesis, and also relates to a production method therefor. The artificial breast prosthesis made with the production method of the present invention, comprises a silicone shell which is of the same thickness as the connecting portion and has the same or similar physical properties thereof, and which minimizes the concentration of the stresses sustained after insertion into the body and maximizes resistance to fatigue failure such that durability is improved while at the same time the thinness of the connecting portion provides an outstanding texture to the prosthesis as a whole, and safety and efficiency are improved as stress concentration is minimized.

Abstract: A method of using a silk derived medical device in a breast augmentation or in a breast reconstruction cosmetic or surgical procedure such as single-stage or two-stage breast reconstruction or augmentation. The device can be a silk scaffold with a knit pattern that substantially prevents unraveling and preserves the stability of the scaffold especially when cut. An example device can have a knitted mesh which includes at least two yarns laid in a knit direction and engaging each other to define a plurality of node.

Abstract: A tapered sleeve is provided for implant delivery. An implant (e.g., a pre-filled silicone 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. Sized appropriately to the implant, the sleeve remains intact during implant run-through of the sleeve.

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: A system for cosmetic augmentation includes a plurality of microballoons. An injector can be provided for injecting microballoons into a subcutaneous pocket at a cosmetic site through an incision. A method for performing cosmetic augmentation surgery and microballoons for use in the method are also disclosed.

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: A tapered sleeve is provided that includes a lubricating coating on an inner surface. 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 apparatus.

Abstract: Provided is a flexible, collapsible, implantable breast prosthesis which is form stable such that it can be inserted through a relatively small incision and then will regain its configuration and maintain its shape within the breast. The prosthesis may include an anterior portion including a closed-cell silicone foam.

Abstract: Injectable compositions are provided which include both a living cellular component and a filler component conducive to cell growth. The compositions are capable of providing both immediate tissue filling and long term tissue regeneration.

Abstract: A tapered sleeve is provided for implant delivery. An implant (e.g., a pre-filled silicone 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. Sized appropriately to the implant, the sleeve remains intact during implant run-through of the sleeve.

Abstract: Mastopexy and breast reconstruction prostheses and implantation method that allow for radiographic imaging of the breast tissue. The prostheses are arcuate and elongate optionally meshed to conform with breast tissue when implanted. Prostheses are made from naturally occurring extracellular matrix, primarily collagen, that, allows for mammographic imaging without interference as is expected from synthetic materials.

Abstract: A saline-filled breast prosthesis has enhanced performance by virtue of having tactile characteristics approximating those of gel-filled implants. The invention retains all the benefits of the recognized safety profile, straight-forward construction, and broad clinical indications for saline implants. An enhanced implantable mammary prosthesis comprises a shell, a slurry filler compartment interior to the shell containing slurry filler, a fluid compartment, the fluid compartment being deformable from a neutral profile under pressure from the slurry filler and which recoils to the neutral profile when not under pressure, a reservoir, the reservoir being disposed external to the shell, the reservoir and fluid compartment being fluidically coupled by a port, and a limiting membrane region disposed between the fluid compartment and the reservoir.