Abstract: An implant includes: a sinusoidal container that includes: a plurality of projections; a plurality of troughs; and a plurality of smooth interfaces, wherein a smooth interface is interposed between a projection and an adjacent trough for the plurality of projections, troughs, and interfaces to provide a smooth continuous transition between adjacent projections and troughs. A process for making an implant includes: forming a sinusoidal container from a polymer, the sinusoidal container including: a plurality of projections; a plurality of troughs; and a plurality of smooth interfaces, wherein a smooth interface is interposed between a projection and an adjacent trough for the plurality of projections, troughs, and interfaces to provide a smooth continuous transition between adjacent projections and troughs; and providing a filling tube attached to the sinusoidal container to make the implant.

Abstract: This disclosure relates generally to a device for measuring the volume of a female breast. The disclosure is more particularly comprising of a cup-like template of variable size to embrace a breast to be measured and having an interior wall located in proximity to a breast to be measured and the cup-like template further comprises openings permit passage of excess fluid out of the space between said interior wall and the patient's breast as fluid is injected into said space, a sealing means all around periphery thereof for contact with a patient's skin of the breast to be measured, connector means in said template for passage of a fluid into the space formed between said interior wall and the breast to be measured when the template is sealed against the patient's skin by said sealing means, and a container for measuring the volume of fluid.

Abstract: An enhancer for simulating breast tissue includes a first layer of material and a second layer of material coupled to the first layer of material, where the second layer of material includes a wicking material. The enhancer also includes an third layer of material and a fourth layer of material both disposed generally between the first layer of material and the second layer of material. The third layer of material includes a plurality of monprene beads, and the fourth layer of material includes a plurality of open cell poly foam pieces. The enhancer further includes a fifth layer of material disposed at least partly between the third layer of material and the fourth layer of material, where the fifth layer of material is configured to inhibit mixing of the monprene beads of the third layer and the open cell poly foam pieces of the fourth layer.

Abstract: Methods and materials used for production of constructs having a porous open or semi-open celled structure. Constructs may include a porous matrix as a base and a biocompatible conformal coating thereon.

Abstract: A hybrid medical device that can aid in reconstructive or augmentative surgery of the breast is disclosed. The device can utilize a suitable biological collagen tissue matrix combined with a synthetic material, for example, that can impart a high initial strength to the repair site while permitting proper healing and revitalization of the implanted device.

Abstract: An interface device is structured to be connected in fluid communication with a source of breathing gas and to provide a flow of breathing gas to the airways of a patient. The interface device includes a support (24), a deformable portion (28) situated on the support, and an interface portion (32) situated on the deformable portion and being structured to be engaged with the patient in the vicinity of the airways, with the deformable portion including a plurality of deformable elements (36) that form a lattice structure and that are connected with the support at a plurality of spaced apart points of connection (44) on the support. The interface device may be formed via an additive manufacturing process.

Abstract: The invention provides method for preparing amnion tissue grafts, as well as the grafts themselves. In specific embodiments, the tissue graft comprises a single layer of dried amnion from an umbilical cord.

Abstract: The invention relates to a low molecular weight sulfate chondroitin and a preparation method thereof. A low molecular weight chondroitin sulfate with the average molecular weight of less than 1000 Dalton can be obtained by a production process of chondroitin sulfate lyase degradation, deproteinization, filtration and sterilization and drying using macromolecular sulfate chondroitin as a raw material. The low molecular weight Chondroitin sulfate has a narrow molecular weight distribution range, the ratio of chondroitin sulfate disaccharide is 43˜60% and the ratio of chondroitin sulfate tetrasaccharide is 30˜45%, the sum of chondroitin sulfate disaccharide and chondroitin sulfate tetrasaccharide is more than 87%, the total oligosaccharide content of low molecular weight chondroitin sulfate is more than 97% and the protein content is less than 0.

Abstract: A surgical device for assisting in the placement of a prosthetic implant. One or more sheets of polymer are in the form of a conical frustum such that a proximal end is sealed and a distal end is open, with an elongated slit extending from the distal end toward the proximal end. A single opening is formed by the distal opening and the elongated slit with a set of inter-lockable fastener elements disposed along opposing sides and configured to seal the elongated slit such that the distal end remains open to allow for egress of the prosthetic implant for placement into a surgical pocket. A lubricious coating is applied to the interior cavity of the frustum in addition to one or more surface active coatings. Movement of the prosthetic implant across the one or more surface active coatings causes the coatings to provide one or more offered benefits.

Abstract: A breast implant is provided which includes a filling, or core having a lower overall density relative to silicone gel-filled or saline-filled implant. The core may be a composite including flexible bodies, for example, air-containing or gas-containing bodies, and a gel medium between or around the bodies.

Abstract: A reconstruction support includes an upper half, a lower half joined to the upper half, a plurality of alignment perforations disposed on at least one of the upper half and the lower half, and a plurality of fenestrations disposed on at least one of the upper half and the lower half, the plurality of fenestrations configured to facilitate selective expansion of at least one of the upper half or the lower half, where the reconstruction support is inserted above muscle to facilitate breast reconstruction.

Abstract: A nipple implant system wherein a nipple prosthetic device is attached to a microdermal anchor without the need for invasive surgery. The microdermal anchor is inserted through a hole punched at a selected locus. The nipple prosthetic device is configured for attachment to the microdermal anchor. An areola may be tattooed around the locus or the nipple prosthetic device may include a skirt simulating an areola to make the construction complete.

Abstract: Implementations of a breast implant may include a shell including a posterior cephalic portion, a posterior caudal portion, an anterior cephalic portion, and an anterior caudal portion. Implementations of the breast implant may also include an anchor coupled within the shell and coupled directly and fixedly to the posterior caudal portion and the anterior caudal portion. The anchor may prevent rotation of the breast implant. The outer surface of the shell may be non-textured.

Abstract: Tissue expanders and methods of use. In some embodiments the tissue expanders are adapted to reduce wear on one or more components.

Abstract: A gravity sensitive silicone breast implant is provided which, in various embodiments, has a soft, natural feel and adapts shape after implantation responsive to gravity, according to movements of the patient.

Abstract: A breast cup for an undergarment, such as a brassiere, includes a cup core that has a first surface and a second surface opposite the first surface. Each of the first and second surfaces is formed with a plurality of grooves. Each groove has an elongated opening, an elongated bottom, and a sidewall on each of two longitudinal sides of the groove. The breast cup also includes a first fabric layer overlying the first surface of the cup core, and a second fabric layer overlying the second surface of the cup core. A top part of the sidewalls of one or more of the plurality of the first grooves is attached to the first fabric layer while at least a portion of the bottom of the one or more of the plurality of the first grooves is not attached to the first fabric layer.

Abstract: In a method of making a breast prosthesis for use by a wearer having a body temperature, a plurality of dissolvable beads is placed into an open back of a breast-shaped mold. The open back of the mold is sealed. A suspension of an uncured silicone rubber liquid and a plurality of phase change material pellets is injected into the mold around the beads. The uncured silicone rubber is allowed to cure, thereby forming a breast shape. The phase change material has a latent heat of fusion at a melting point so as to remove heat from the wearer when the body temperature is at least at the melting point. The breast shape is removed from the mold and the dissolvable beads are dissolved from the breast shape.

Abstract: A method for manufacturing a customized apparatus with a shape adapted to a specific user's morphology, or a mold for such an apparatus, includes obtaining a description of a generic apparatus, or of the mold for such an apparatus, the generic apparatus being adapted to a generic morphology. A description of the generic morphology and a description of the specific user's morphology is obtained. The descriptions of the generic morphology and of the specific user's morphology are processed to identify a geometric transformation mapping together the generic morphology and the specific user's morphology. The geometric transformation is applied to the description of the generic apparatus, or the description of the mold for such apparatus, in order to define the description of the customized apparatus or the mold therefor. The customized apparatus is then manufactured.

Abstract: A hybrid medical device that can aid in reconstructive or augmentative surgery of the breast is disclosed. The device can utilize a suitable biological collagen tissue matrix combined with a synthetic material, for example, that can impart a high initial strength to the repair site while permitting proper healing and revitalization of the implanted device.

Abstract: An implantable device includes a first sealed flexible shell configured for implantation within a breast of a human subject, an elastic filler material contained within the first sealed flexible shell, a second sealed flexible shell, which is disposed within the elastic filler material inside the first sealed flexible shell and a volume of gas contained within the second sealed flexible shell, such that the volume of the gas is less than a threshold inflation volume required to induce a non-zero strain in the second sealed flexible shell when the device is subject to an external pressure of one atmosphere.

Abstract: A breast implant is provided which includes a filling, or core having a lower overall density relative to silicone gel-filled or saline-filled implant. The core may be a composite including flexible, bodies, for example, air-containing, or gas-containing, bodies, and a gel medium between or around the bodies.

Abstract: A hybrid medical device that can aid in reconstructive or augmentative surgery of the breast is disclosed. The device can utilize a suitable biological collagen tissue matrix combined with a synthetic material, for example, that can impart a high initial strength to the repair site while permitting proper healing and revitalization of the implanted device.

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

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 a method of making a breast prosthesis for use by a wearer having a body temperature, a plurality of dissolvable beads is placed into an open back of a breast-shaped mold. The open back of the mold is sealed. A suspension of an uncured silicone rubber liquid and a plurality of phase change material pellets is injected into the mold around the beads. The uncured silicone rubber is allowed to cure, thereby forming a breast shape. The phase change material has a latent heat of fusion at a melting point so as to remove heat from the wearer when the body temperature is at least at the melting point. The breast shape is removed from the mold and the dissolvable beads are dissolved from the breast shape.

Abstract: Tissue expanders and methods of use. In some embodiments the tissue expanders are adapted to reduce wear on one or more components.

Abstract: A breast implant is provided which includes a filling, or core having a lower overall density relative to silicone gel-filled or saline-filled implant. The core may be a composite including flexible, bodies, for example, air-containing, or gas-containing, bodies, and a gel medium between or around the bodies.

Abstract: One aspect of the present disclosure relates to a breast implant sizer assembly for accurately sizing surgically implantable breast implants prior to implantation. The breast implant sizer assembly can include an inflatable, flexible shell containing an adjustable volume of liquid and a valve assembly, once filled with liquid, that is associated with the shell and configured like an anatomically correct nipple. The breast implant sizer assembly can have a size, shape, and weight that mimics the size, shape, and weight of a breast implant. In addition, the breast implant sizer assembly is disposable, intended for single use by a patient, allows for use in the home and everyday settings, and provides accurate, actionable information to a surgeon or other medical professional in regards to selecting actual breast implant sizes for clinical use.

Abstract: Breast implants with anatomical morphology have the problem of possibly rotating from their implantation position in the patient's body, which causes an aesthetic anomaly. With the implant of the invention, this problem is resolved, owing to the arrangement of silicone strips (5-8) fixed to the frontal face (2) and/or to the rear face (3) of silicone cover of the implant. The strips are provided at their free end with respective orifices (7, 9) for the passage of a suture point, such that these suture points enable the implant to be fixed to the corporal tissue of the user, such as for example to the breast tissue, to the pectoralis major muscle, to the fascia of the pectoralis major muscle, etc., the implant thus remaining immobilized. The implant also includes a mark (10) made of radiological material which enables the position of the implant in the patient's body to be checked by means of conventional radiology or other means.

Abstract: Described herein are devices for placement in surgically created soft tissue spaces, potential spaces, or cavities. The implantable devices generally include a bioabsorbable body having an open framework that facilitates attachment of tissue thereto in a manner that helps avoid post-surgical deformities. Methods for using the implantable devices in oncoplastic surgery are further described.

Abstract: The disclosed embodiments are for a method and apparatus for textured bra insert/s. The insert may be constructed with an outer layer (or outer side) that faces the garment. The texture may comprise a raised pattern of geometrical shapes of silicone or equivalent functioning material.

Abstract: Tissue expanders and methods of use. In some embodiments the tissue expanders are adapted to reduce wear on one or more components.

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 breast implant is provided which includes a filling, or core having a lower overall density relative to silicone gel-filled or saline-filled implant. The core may be a composite including flexible, bodies, for example, air-containing, or gas-containing, bodies, and a gel medium between or around the bodies.

Abstract: An external breast prosthesis having a thin-walled outer shell and an air-filled interior cavity. The prosthesis is fabricated using a method and die set to form the two-part shell without internal supporting structure. The method provides a repeatable process which yields a prosthesis having durable air-tight seal between the anterior and posterior shell and a Class-A exterior surface which accurately replicates the visual and tactile characteristics of a human breast.

Abstract: An implantable prosthesis is provided having a membrane which holds a flowable substance. The membrane is separated into a first chamber and a second chamber with the first and second chambers being fluidly coupled via an orifice. The orifice has a size which may be adjusted by the user after implanting the prosthesis into the patient.

Abstract: A healable gel putty may comprise an elastomeric polymer and a plasticizer. The elastomeric polymer may have a melt mass-flow rate in a range extending from about 2 g/10 min to about 100 g/10 min. A weight ratio of the plasticizer to the elastomeric polymer may be from about 1-to-1 to about 50-to-1. An article of manufacture may comprise gel putty disposed in a flexible container. A method of forming gel putty may comprise forming a mixture comprising an elastomeric polymer and a plasticizer. An article of manufacture may be formed by disposing gel putty within a flexible container.

Abstract: According to the improved systems and methods described herein, a patient may be immobilized so that one or both breasts are returned to a known position. Additionally, the improved systems and methods reduce respiratory movement of the breasts. Thus, the immobilization devices and techniques described herein provide accurate and reproducible breast positioning while simultaneously reducing respiratory motion.

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: 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: 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: Implantable prosthesis, components of prosthesis, and methods of making same are provided. The methods generally include the steps of providing an implant shell, applying a curable fluid composition to the shell to form a coating thereon and applying a particulate component to the composition. The composition is a mixture, for example, an emulsion, containing a silicone-based elastomer dispersion and droplets of a suspended leachable agent. After the elastomer is stabilized and cured, the particulate component and leachable agent are removed, resulting in an implantable member having a porous, open-cell surface texture designed to be effective in reducing incidence of capsular formation or contraction.

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: A breast prosthesis for wearing against a chest of a user includes a bag, a first silicone rubber and a silicone agglomerate putty. The bag includes at least three films that are sealed together around a periphery so as to define at least a front chamber and a back chamber. The first silicone rubber is disposed in the front chamber and is cured in an outer shape of a breast. The silicone agglomerate putty is disposed in the back chamber and is configured as a shear thinning fluid that conforms in shape to surface features of the chest of the user when placed against the chest of the user.

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: 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: 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: 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: Filamentous bodies which are longitudinally extended and other film-like constructions are made by combining liquid siliceous precursors with air and extruding them. Distinct types or grades of fibers, strands, and other film-like constructions are produced which have a multiplicity of useful applications and indications for use owing to their inherent memory, compactability, tensile strength and density. A prosthetic device for a mastectomy bra is constructed with filamentous bodies. It can be sewn permanently into the bra cup. The device can be refilled to counteract volume loss.

Abstract: Described herein are foam-like materials having substantially the same physical structure of polyurethane foams but with properties that can be tailored for a particular application. Methods of forming these foam-like materials are also described.