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.

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: 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: 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: The present invention comprises, when adjusting a breast substitute (10) for the preparation of breast reconstruction; abreast female mold creating step (101) of transcribing the existing breast or the breast to be removed and creating a breast female mold (1); a receiving step (102) of receiving the breast substitute (10) in the concave portion (1a) of the breast female mold (1) so as to include excess part of the concave portion (1a); a size adjusting step or an indicating step of removing the excess part of the concave portion (1a) of the breast substitute (10) as an unwanted part (301) of the breast substitute (10), or indicating the boundary for removal, or folding back the excess part to make it smaller so that an excess part does not form, or indicating a base line for making the excess part smaller; and a substitute preparing step (104) of unloading the breast female mold (1) and preparing as the breast substitute (10) after the size adjusting step or the indicating step.

Abstract: An inflatable tissue expander or more permanent prosthesis, suitable for implantation in a breast, is provided. The tissue expander includes a puncturable, self-sealing anterior portion forming a fillable cavity, and posterior portion that is puncture resistant. The anterior portion includes a silicone-based elastomer material having a mesh embedded therein. The posterior portion includes a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed in a spaced apart fashion.

Abstract: Systems and methods for molding shells for fluid-filled prosthetic implants, including spinning and rotating dip- or spray-mandrels during a devolatilization step to ensure an even covering. The mandrels may be spun during the dipping or spraying step, and/or afterward while a solvent evaporates until a gum state is formed. The techniques are particularly useful for forming hollow shells from silicone dispersions for soft implants, such as breast implants.

Abstract: The present invention relates to a silicon breast implant which minimizes stress concentration applied thereto after being inserted into the human body to maximize the resistance of same to fatigue-induced rupture, thereby improving the durability of the implant. The breast implant may include an elegant patch-adhesion portion having a thin thickness so as to provide superior overall feel and improve the appearance of the product. Further, the breast implant has a silicon shell defining an outer wall thereof and the patch adhesion portion for closing, from the outside, a hole formed in a bottom surface of the silicon shell so that the patch adhesion portion is increased in strength to maximize adhesion durability, safety of use, and effectiveness. The silicon shell has a uniform overall thickness, and the patch adhesion portion comprises a patch hole through which a patch adheres to a lower end of the silicon shell using an adhesive material.

Abstract: The present specification discloses compositions and methods for use in breast augmentation procedures. The compositions include adipose tissue and compounds that upregulate both FGF-2 and VEGF, promote new blood vessel formation thereby reducing tissue volume loss and increasing survival rate of the adipose tissue when the composition is introduced into breast tissue.

Abstract: Described herein are methods of making open celled foams including a matrix of interconnected spheres. The open celled foams are silicone based materials and can be used to coat implants, such as breast implants, and function to encourage tissue ingrowth and reduce capsular formation.

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

Abstract: The present specification discloses compositions and methods of transplanting tissue useful for treating a soft tissue condition of an individual.

Abstract: Provided is a restorative breast implant device that can be used to replace lumpectomy tissue and prevent the late aesthetic deformities which may occur following lumpectomy or partial mastectomy. The disclosed implant is an inflatable device comprising an outer shell composed of a biological material and an inner chamber. The device may be inflated/filled with a biological filler material to conform the implant to a lumpectomy cavity's dimensions. In addition, the disclosed implant is able to attain a blood supply thereby insuring incorporation into the breast while resisting resorption. The restorative breast implant is also optionally radiolucent so as not to interfere with future surveillance imaging. Further, in contrast to synthetic radiopaque implants, the disclosed implant resists fibrosis and infection.

Abstract: The present disclosure provides devices and methods relating to surgical breast procedures. The devices can include a holder and backing to assist in positioning a biological material adjacent to a tissue expander or implant.

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-swellable material distributed therein.

Abstract: The present disclosure provides tissue products produced from adipose-containing tissues, as well as methods for producing such tissue products. The tissue products can comprise decellularized and partially de-fatted tissues. In addition, the present disclosure provides systems and methods for using such products.

Abstract: A soft prosthetic implant, for example, a breast implant, having a shell filled with a fluid. One or more components of the soft prosthetic implant receive a unique identifier for traceability during the manufacturing process. The unique identifier is placed on one component, such as a patch molded-in-place with a shell to form a soft prosthetic implant. Information about the respective components, as well as process parameters, can be stored on the unique identifier for later reference. The unique identifier may be a two-dimensional printed label or laser-etched characters, or may be a three-dimensional embossed or indented region. The unique identifier may be a separate label attached to the respective component, or may be formed in the component, such as with embossing.

Abstract: A tissue expander includes an elastomeric shell having an anterior inside surface and a posterior inside surface with a self-healing layer abutting only a portion of the anterior inside surface. The layer is spaced apart from the posterior inside surface while facilitating folding of the shell prior to insertion into a tissue pocket and also enabling inflation of the shell subsequent to insertion by a fluid injected between the self healing layer and posterior surface.

Abstract: A method of using a silk derived medical device in a two stage breast reconstruction procedure.

Abstract: A method for utilizing an implant in a human breast includes forming a breast cavity within the breast at a lumpectomy site, the breast cavity having surrounding tissue; forming a substantially radio-opaque implant constructed of biocompatible and biodegradable material configured to allow for in-growth of fibrous tissue into and replacing the biocompatible and biodegradable material, the biocompatible and biodegradable material being elastically compressible; sizing the substantially radio-opaque implant to occupy the breast cavity; and implanting within the breast cavity the substantially radio-opaque implant to support the tissue surrounding the breast cavity, the step of implanting including compressing the biocompatible and biodegradable material.

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.

Abstract: Surgical tools, kits, and methods for breast implants are provided. One surgical tool is a rigid or semi-rigid form that matches the size and shape of a corresponding breast implant. The form may be employed to determine skin tension when inserted into a breast. The form may also be employed to mark a fixation suture line for attachment between an acellular dermal matrix and the chest wall of a patient in some instances. However, in other instances a breast implant template surgical tool may be employed to mark one or more fixation suture lines. The breast implant template may be thin and flexible, and define a perimeter matching the size and shape of a footprint of a corresponding breast implant. Marking around the perimeter of the form or the breast implant template allows for convenient selection of fixation suture lines which may result in desirable overall breast symmetry.

Abstract: The present invention provides, in various embodiments, a breast implant with an RFID transponder embedded therein, so that the implant can be conveniently identified while inside the human body, and methods of making the same.

Abstract: A device for improving the early detection of a malignant breast cancer tumor in the breast of a human being includes a foreign body implant which is shaped and dimensioned to imitate a breast tumor. The foreign body implant is implanted in the breast of a human being and provides a tactile standard with which to compare a possible actual breast cancer tumor. During periodic breast self examination, the human being feels the foreign body implant to reinforce a tactile memory of what breast tumors feel like.

Abstract: A fluid-filled prosthetic implant having a shell comprising a matrix material and an additive distributed in the matrix material.

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

Abstract: An implant includes a first container and a plurality of members disposed in the first container. The implant can be made by attaching a member to a second container disposed in the first container and inserting the second container in the first container. The implant can be used by disposing the implant into a subject and adjusting a volume of a fluid in the implant. Additionally, a tissue expander includes an outer container; and an inner container disposed in the outer container and comprising: a reticulated frame comprising a plurality of struts which interconnect; a void disposed between the struts in the reticulated frame; and a projection connected to the struts to cover the void.

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: 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: 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: An inflatable tissue expander or more permanent prosthesis, suitable for implantation in a breast, is provided. The tissue expander includes a puncturable, self-sealing anterior portion forming a fillable cavity, and posterior portion that is puncture resistant. The anterior portion includes a silicone-based elastomer material having a mesh embedded therein. The posterior portion includes a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed in a spaced apart fashion.

Abstract: A method for utilizing an implant in a human breast includes forming a breast cavity within the breast at a lumpectomy site, the breast cavity having surrounding tissue; forming a substantially radio-opaque implant constructed of biocompatible and biodegradable material configured to allow for in-growth of fibrous tissue into and replacing the biocompatible and biodegradable material, the biocompatible and biodegradable material being elastically compressible; sizing the substantially radio-opaque implant to occupy the breast cavity; and implanting within the breast cavity the substantially radio-opaque implant to support the tissue surrounding the breast cavity, the step of implanting including compressing the biocompatible and biodegradable material.

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: Biocompatible materials are provided which include various textured surfaces, which when such materials are implanted in a human being, for example, as a component of a breast prosthesis, provide for tissue integration, reduce the linear alignment of collagen fibers around the implant and reduce or eliminate the potential for capsular contracture.

Abstract: A method of augmenting or reconstructing a breast of a patient, the method comprising the step of implanting into the patient, a breast prosthesis, having surface characteristics directed at reducing collagen alignment in periprosthetic tissue.

Abstract: Tissue expanders and their methods of use.

Abstract: A medical system (10) is provided having a pulling device (20) and an active substance chain (50). The active substance chain (50) has at least two storage units (51) arranged like a chain, and at least one of the storage units (51) is loaded with a medicinal active substance. The pulling device (20) has a grip element (30) and a coupling element (40), and the coupling element (40) has at least one recess (41, 41?). In a free position (100) the active substance chain (50) is arranged separated from the pulling device (20), while in an inserted position (110) at least one of the storage units (51) is arranged form-fitting in a recess (41, 41?). The active substance chain (50) can be moved reversibly from the free position (100) into the inserted position (110).

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 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: 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; 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; 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: 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 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: The invention provides systems and methods for tissue expansion. A tissue expander may have an implant portion which may be used to expand the tissue. A delivery/drainage system may be also be provided, which may be in fluid communication with a pocket surrounding the tissue expander. Various port configurations may be provided that may provide access to the implant portion and/or the delivery/drainage system. The tissue expander may advantageously help prevent or treat infection, or check the state of the pocket surrounding the tissue expander.

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: 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 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-swellable material distributed therein.