Abstract: A method of enhancing the third stage of breast reconstruction involves sampling an artificial nipple prosthetic device attachable to a female human breast by trying on and wearing different sized and colored devices at different locations of the breast. This allows the female patient to advise her surgeon where, what size and what color nipple she wants the surgeon to reconstruct. The nipple prosthetic devices have a substantially cylindrical solid nipple portion made of a breathable water-resistant natural or microporous polymeric material and an areola portion surrounding the nipple portion made of the same material. The inside of the device, at both the nipple and areola portions, has a concave shape that conforms to an outer contour of a female human breast and the device is attached by means of a water resistant adhesive layer. The shades of color of the nipple and areola portions conform to the female anatomy.

Abstract: A method of breast reconstruction utilizes a breast prosthesis having a plurality of chambers or compartments distributed through a body member or shell in the form of a breast. The chambers are disposed along the superior, lateral and inferior surfaces, as well as in the interior, of the body member. The chambers are differentially pressurized or filled in order to control the shape of the prosthesis upon implantation thereof. Valves are provided for regulating the flow of fluid into and from the chambers. The prosthesis and the fill levels of the respective chambers may be selected by computer.

Abstract: A breast prosthesis has an adhesive element which forms a continuous surface conforming to the back section of the prosthesis which faces the user. One side of the adhesive element is detachably secured to the back section of the prosthesis and the other side of the adhesive element is detachably adhered to the user. The adhesive element is formed from an inner body which is lined with material. The breast prosthesis has a flat annular region on its back section and an elevated edge along the perimeter of the flat annular region. A gap is provided in the elevated edge at an upper region of the prosthesis. The adhesive element extends to the inner surface of the elevated edge and has a projection conforming to the gap.

Abstract: The present invention concerns methods for joining flexible polymer workpieces using light energy. These methods, referred to as laser welding, can be used to join thermoplastic or thermoset polymers. The laser welding method of the invention is applicable to the creation or repair of any article requiring the bonding of two flexible polymer components or a flexible polymer component and an inflexible polymer component.

Abstract: Disclosed is a breast prosthesis comprised of at least one layer and formed to imitate the shape of a breast, the at least one layer being welded in a plastic film, comprised of a phase change material having a phase change temperature approximate the user's body temperature.

Abstract: The present invention provides an integrated prosthetic nipple and areola suitable for use with a breast prosthesis, wherein the prosthetic nipple and areola comprises a first curable gel zone configured to define a nipple region, and a second curable gel zone integrally connected to the first curable gel zone and configured to define an areola region.

Abstract: A breast prosthesis may be formed by forming an outer layer on a mold, and filling the mold with a polymerizable foaming composition. The mold may be formed by forming a computer model of the prosthesis based on scanning a patient. The computer model may be used to form a solid model. A prosthesis may be coupled to the patient by coupling at least one metallic insert to the prosthesis and at least one magnet to the patient. Alternately, the prosthesis may be formed with a retaining harness integral to the prosthesis. In still another method, the prosthesis may be coupled to a retaining device surgically implanted in the patient.

Abstract: The present invention provides a novel apparatus for measuring the shape of various parts of anatomy, and alternatively capturing and digitizing an image of the part for the purpose of creating prosthetic or orthotic devices. Also provided are methods of measuring anatomical profiles involving physical contact with the body parts, and methods of manufacturing internal or external prosthetic and orthotic articles which mimic natural body parts in texture and motion characteristics, and in some cases, appearance.

Abstract: A symmetrical, heart-shaped breast prosthesis has two identical notches which are arranged symmetrically with respect to a plane of symmetry dividing the prosthesis body into two equal halves and at an angle in the range between 30° and 90° between them, in such a way that, when the prosthesis is worn, only one of the two notches is essentially perpendicular to the longitudinal axis of the wearer's body. The notches have the effect that the prosthesis collapses slightly when the wearer is in the upright position and becomes flatter when the wearer is in the prostrate position. In the state when worn, the heart-shaped prosthesis which is symmetrical in the unshaped state becomes an asymmetrical prosthesis having a lateral branch and an upper branch which moves downwards when the wearer is in the upright position and slips upwards when the wearer is prostrate.

Abstract: An breast form having a plurality of independent and detachable/separable chambers, where each of the chambers is formed from a thermoplastic film material. A volume of deformable substance is sealably disposed within each of the chambers; and a pressure-sensitive adhesive is permanently grown to an interior surface of each of the chambers, such that the pressure-sensitive adhesive detachably adjoins to either an exterior surface of an adjacent chamber or a user's skin.

Abstract: A symmetrical, heart-shaped breast prosthesis has two identical notches which are arranged symmetrically with respect to a plane of symmetry dividing the prosthesis body into two equal halves and at an angle in the range between 30° and 90° between them, in such a way that, when the prosthesis is worn, only one of the two notches is essentially perpendicular to the longitudinal axis of the wearer's body. The notches have the effect that the prosthesis collapses slightly when the wearer is in the upright position and becomes flatter when the wearer is in the prostrate position. In the state when worn, the heart-shaped prosthesis which is symmetrical in the unshaped state becomes an asymmetrical prosthesis having a lateral branch and an upper branch which moves downwards when the wearer is in the upright position and slips upwards when the wearer is prostrate.

Abstract: A symmetrical, heart-shaped breast prosthesis has two identical notches which are arranged symmetrically with respect to a plane of symmetry dividing the prosthesis body into two equal halves and at an angle in the range between 30° and 90° between them, in such a way that, when the prosthesis is worn, only one of the two notches is essentially perpendicular to the longitudinal axis of the wearer's body. The notches have the effect that the prosthesis collapses slightly when the wearer is in the upright position and becomes flatter when the wearer is in the prostrate position. In the state when worn, the heart-shaped prosthesis which is symmetrical in the unshaped state becomes an asymmetrical prosthesis having a lateral branch and an upper branch which moves downwards when the wearer is in the upright position and slips upwards when the wearer is prostrate.

Abstract: A container for a tissue implantable solid filler material is disclosed. The filler material can be directly inserted into a cavity within the tissue or into a shell can be inserted into the cavity which either already contains the filler or has the filler added thereto during implantation. Methods for packaging the filler material are also disclosed.

Abstract: A push-up bra has an envelope between the front panel and the rear panel of the bra cups, that receives a flexible pouch containing a mixture of water and a hygroscopic agent such as 70% glycerine-30% water. The hygroscopic agent will draw moisture into the envelope preventing the volume of liquid from decreasing.

Abstract: The breast saver comfort band is a band worn around the chest and between the breast to prevent lateral gravitational breast shifting while in the side lying positions for prolonged periods or night time. It does not support the breast while in the upright position as the traditional brassiere. Its construction is of a stretchable band which on one end holds a bolster that is placed over the sternum while the balance of the band is encircled around the body and fastened in the front. It's main objective is to provide relief and comfort from lateral breast shifting in women experiencing mastitis as well as preventing skin breakdown in the female geriatric population who have flaccid breast and lay in the side lying position for prolonged periods due to immobility and paralysis.

Abstract: A system is provided for application of a layer permanently adhering to the inside of a breast prosthesis formed as a shell-shaped body made from a soft-elastic material, in which a two-component silicone rubber forming the adhesive layer is injected into a mold prior to curing of the body and then cured together with the body. Alternatively, the two-component silicone rubber forming the adhesive layer is first cured in a shell, with the shell then being applied to the body in a mold and then cured again with the body. In a third alternative, the adhesive layer is cured while being joined to a carrier film, with the carrier film then being adhered to the prosthesis sheath which is then filled with addition-vulcanizing two-component silicone rubber and cured in a mold.

Abstract: A flexible external prosthesis formed by first creating a thin walled hollow elastomeric shell of the shape required for anatomical augmentation. The interior of the hollow shell is filled with a flexible foam body formed into the same shape. The foam is formed by either of two methods. In one method the same mold used to form the thin walled hollow shell is used again to shape the foam into the same shape as the hollow shell. The hollow prosthesis may then be opened, the foam body inserted and the shell resealed. In another method, the foam is injected into the hollow shell while it is contained in the mold. The foam is desirably a two-part material which chemically generates a foaming agent when the two parts are mixed together. The foam then expands into the interior of the hollow shell and assumes the shape imposed by the mold. The foam body is lubricated to ensure free movement of the shell with respect to the foam body, desirably using a triglyceride oil, such as soy bean oil.

Abstract: A non-surgical device used to duplicate a protruding or non-protruding nipple and areola containing sebaceous glands (Montgomery follicles) and sweat glands, creating the most natural looking nipple and areola possible. The device will function as a nipple prosthesis, nipple enhancer or a nipple protector. At the user's discretion, the vertex can be shaped in several polyhedral angles, such as rounded, squared and pointed. The nipple portion may be custom sized by cutting for either erect, non-erect, rounded, squared or have a pointed look or it may be left in its original size. The nipple portion of the device can be eliminated to give the user a smooth appear and provide a nipple protector from nipple friction that causes chaffing, sun damage and protect sensitive nipples. The areola will be thin and flexible and may be custom sized by cutting to fit the users personal size preference or it may be left in it's original size if preferred by the user.

Abstract: An external breast prosthesis support means comprising a support member attached or attachable at one end to the prosthesis and remotely applicable to the body surface such as to laterally support the weight of the prosthesis. In a preferred embodiment the applicable portion of the support member has a flat undersurface with a high coefficient of static friction against human skin such as to laterally support the weight of the prosthesis and may be overlain on a flat outer surface by a bra shoulder strap such as to transmit load from the shoulder strap downwardly onto the support means, thereby enhancing its load supporting capacity and compensating for sudden increases in load associated with physical activity. The outer surface of the support member has a relatively low coefficient of static friction so as to inhibit the bra shoulder strap from transferring its load laterally to the support means.

Abstract: A two-layer external breast prosthesis comprising a first inner layer comprised of a self-shaping dispersion and a second outer layer comprised of an elastic material, wherein the second outer layer is relatively stiffer than the first inner layer.

Abstract: A system is provided for application of a layer permanently adhering to the inside of a breast prosthesis formed as a shell-shaped body made from a soft-elastic material, in which a two-component silicone rubber forming the adhesive layer is injected into a mold prior to curing of the body and then cured together with the body. Alternatively, the two-component silicone rubber forming the adhesive layer is first cured in a shell, with the shell then being applied to the body in a mold and then cured again with the body. In a third alternative, the adhesive layer is cured while being joined to a carrier film, with the carrier film then being adhered to the prosthesis sheath which is then filled with addition-vulcanizing two-component silicone rubber and cured in a mold.

Abstract: The invention relates to a breast prosthesis for breast-amputated women with a flexible plastic body comprising two plastic sheets connected to each other along their common edge and a plastic mass enclosed between the two plastic sheets, wherein the plastic body has a front side formed to resemble the contour of the natural breast and a back side capable of facing the torso of the person, and an elastically deformeable thin part secured with its edge to the back side of the plastic body. In order to improve the wear comfort of the breast prosthesis, the thin part is secured to the plastic body inside the common edge of the connected plastic sheets.

Abstract: The invention relates to a method for manufacturing an epithesis, including the following steps: making a plastic shell using a two-piece mould realized based on a body impression, said shell being provided with apertures to be filled; possibly hardening of the shell in the mould; filling the shell with material in the mould; closing the shell and demoulding.

Abstract: The present invention is directed to a self-forming prosthetic device. The present invention is further directed to a method of making the self-forming prosthetic device. In addition, the present invention is directed to a new bra for use with a prosthetic device in the form of a breast prosthesis.

Abstract: A breast prosthesis is disclosed. The breast prosthesis is comprised of at least one body formed to imitate the shape of a breast, the body being welded in at least one plastic film and comprised of a silicone rubber. That portion of the prosthesis adapted to face toward or to be received against the body of the user is comprised at least in part of a phase change material having a phase change temperature approximate that of the user's body temperature.

Abstract: It is sought to provide a body part substitute, which can be held mounted without feel of uncomfortability and be held mounted continuously for long time without possibility of occasional detachment, and a method of mounting the same. A thin film having breathable property, flexibility and extensible-contractible property is attached to the corresponding portion of the body part substitute to be held in close contact with the human body. Alternatively, the thin film is bonded to the human body, and then the corresponding portion of the body part substitute is bonded to the thin film. By preparing the thin film as a transparent film, the skin of the human body can be seen through the thin film, and more natural feel is thus obtainable.

Abstract: A prosthetic implant for use in augmentation of the shape of a human body or replacement of animal or human body tissue includes an expandable body member having a first predetermined shape and a first volume in an expanded condition and a second predetermined shape in a second volume smaller than the first volume in a compressed condition. An endoscopic prosthetic implant instrument inserts the prosthetic implant through an anatomical wall of a body and includes a hollow sleeve member, a pusher member and a clam shell mechanism. A combination endoscope and prosthetic implant instrument includes an endoscope having an operating channel that slidably receives the endoscopic prosthetic implant instrument. A method using the prosthetic implant augments the shape or appearance of a human body or replacement of animal or human body tissue.

Abstract: A symmetrical, heart-shaped breast prosthesis has two identical notches which are arranged symmetrically with respect to a plane of symmetry dividing the prosthesis body into two equal halves and at an angle in the range between 30° and 90° between them, in such a way that, when the prosthesis is worn, only one of the two notches is essentially perpendicular to the longitudinal axis of the wearer's body. The notches have the effect that the prosthesis collapses slightly when the wearer is in the upright position and becomes flatter when the wearer is in the prostrate position. In the state when worn, the heart-shaped prosthesis which is symmetrical in the unshaped state becomes an asymmetrical prosthesis having a lateral branch and an upper branch which moves downwards when the wearer is in the upright position and slips upwards when the wearer is prostrate.

Abstract: A breast form receivable in the cup of a brassiere includes a breathable padded casing selectively filled with a flowable aggregate so as to substantially and comfortably conform to the chest cavity of a wearer, thereby being responsive to the movements of the wearer. The breathable padded casing includes a plurality of soft and supple composite panels joined together so as to loosely confine the flowable aggregate and thereby provide a soft but firm appearance for the breast form.

Abstract: A system is provided for application of a layer permanently adhering to the inside of a breast prosthesis formed as a shell-shaped body made from a soft-elastic material, in which a two-component silicone rubber forming the adhesive layer is injected into a mold prior to curing of the body and then cured together with the body. Alternatively, the two-component silicone rubber forming the adhesive layer is first cured in a shell, with the shell then being applied to the body in a mold and then cured again with the body. In a third alternative, the adhesive layer is cured while being joined to a carrier film, with the carrier film then being adhered to the prosthesis sheath which is then filled with addition-vulcanizing two-component silicone rubber and cured in a mold.

Abstract: The present invention proposes a modified falsie structure, which comprises a container made of waterproof and flexible material. Fluid and a plurality of hollow microspheres are filled in the container. Cloth is joined on the outer surface of the container by glue, heat melting, or sewing. The container and the cloth are of circular arc shape with concave arc edges. The concave arc edges can be bent to get close to form a three-dimensional bust form. The center of the falsie can form a projecting shape and its rigidity can be enhanced so that it will not be easily deformed. Thereby the falsie of the present invention can enhance the appearance of the breasts of the user for a long time when directly placed in the brassiere. Moreover, the breasts of the user can be uniformly pressured to achieve better feeling and comfort.

Abstract: The present invention provides a novel apparatus for measuring the shape of various parts of anatomy, and alternatively capturing and digitizing an image of the part for the purpose of creating prosthetic or orthotic devices. Also provided are methods of measuring anatomical profiles involving physical contact with the body parts, and methods of manufacturing internal or external prosthetic and orthotic articles which mimic natural body parts in texture and motion characteristics, and in some cases, appearance.

Abstract: A breast form prosthesis has hook material attached to both front and back surfaces. A bust cup has loop material attached to the inside edges of the bust cup. A comfort pad is constructed of moisture absorbing material and is placed on the back of the prosthesis to absorb perspiration and reduce skin irritation.

Abstract: A method is provided for application of a layer permanently adhering to the inside of a breast prosthesis formed as a shell-shaped body made from a soft-elastic material, in which a two-component silicone rubber forming the adhesive layer is injected into a mold prior to curing of the body and then cured together with the body. Alternatively, the two-component silicone rubber forming the adhesive layer is first cured in a shell, with the shell then being applied to the body in a mold and then cured again with the body. In a third alternative, the adhesive layer is cured while being joined to a carrier film, with the carrier film then being adhered to the prosthesis sheath which is then filled with addition-vulcanizing two-component silicone rubber and cured in a mold.

Abstract: It is characterized in that at least one cohesive and elastic pressure-sensitive adhesive patch which can be repositioned on the skin is used, and said patch can be detached from the prosthesis by pulling parallel to the surface of the prosthesis.

Abstract: There is disclosed medical prostheses filled with an aqueous solution of polyethylene glycol. The aqueous solution can be a saline solution. There is also disclosed a method of making such medical prostheses. The novel prostheses are useful, for example, as breast implants.

Abstract: The present invention relates to a temporary tattoo used for aesthetic and reconstructive purposes to match one member of a paired body part that has been lost or to cover a portion of the body that is aesthetic unappealing or undesirable. The present invention also includes the method of making a customized temporary tattoo used for either reconstructive or aesthetic purposes such as scar coverage.

Abstract: A filler material for a surgically implantable prosthesis comprised of a synthetic triglyceride having a viscosity substantially greater than that of naturally occurring triglycerides is provided. The triglyceride composition is formed of saturated alkyl chains to reduce or limit the potential for oxidation of the alkyl chains to form peroxide groups which adversely affect the biocompatibility of the filler material and the implant. Preferably, the filler material has a viscosity substantially the equivalent of a normal human breast. The synthetic triglyceride filler material may also have a lower viscosity which is a liquid at room temperature for use in inflatable devices. Prostheses containing filler material having the desired viscosity and antioxidation characteristics are also provided as well as a method for preparing the filler material.

Abstract: A filler material for a surgically implantable prosthesis comprised of a synthetic triglyceride having a viscosity substantially greater than that of naturally occurring triglycerides is provided. The triglyceride composition is formed of saturated alkyl chains to reduce or limit the potential for oxidation of the alkyl chains to form peroxide groups which adversely affect the biocompatibility of the filler material and the implant. Preferably, the filler material has a viscosity substantially the equivalent of a normal human breast. The synthetic triglyceride filler material may also have a lower viscosity which is a liquid at room temperature for use in inflatable devices. Prostheses containing filler material having the desired viscosity and antioxidation characteristics are also provided as well as a method for preparing the filler material.

Abstract: An improved breast implant prosthesis provides fastening components to anchor the implant to retroglandular or retromuscular tissue and secure the implant in place. Location markers are also provided to ensure correct orientation of the prosthesis during the augmentation mammaplasty procedure and provide postoperative orientation information without the use of invasive procedures.

Abstract: The present invention is directed to a self-forming partial breast prosthesis suitable for use with partial mastectomies. The present invention is further directed to a method of making the self-forming partial breast prosthesis.

Abstract: A mastectomy garment for retaining a breast prosthesis in place on the anterior chest wall of a mastectomy patient. A combination bandeau/bra includes a normal bra cup for the natural breast (unless the patient has undergone a double mastectomy, in which case no normal bra cup is required), and a fold down cup for the prosthesis. Beneath the fold down cup a bandeau conforms to the anatomy of the patient's chest and presents a surface of hook and loop fastening material for the attachment of the breast prosthesis which carries mating hook and loop material on the posterior side. In one embodiment, the bandeau over the mastectomy site is provided with fenestration to improve the breathability of the site. The hook and loop fastening material on the bandeau covers substantially the entire portion of the bandeau over the mastectomy site allowing flexibility in the placement of the breast prosthesis on the bandeau.

Abstract: A breast prosthesis envelope formed from flexible, non-absorbable material containing a filler material which is substantially shortening. Shortening composition is mainly any or a mixture of any of the following modified oils or fats such as derivatives of vegetable oil, soy bean oil, peanut oil, olive oil, cannula oil, and animal and human fat and approximately 10 percent laird have been found suitable for use.

Abstract: A human body implant has a separate bladder made from a bio-compatible flexible polymer into which a mobile device or prosthesis is placed after the bladder has been introduced into a subcutaneous body pocket. The bladder completely forms an artificial scar by ingrowth of body tissue into pores in the bladder to form an artificial scar. In the case of a breast implant, a breast prosthesis of many different types can be used. The prosthesis is isolated from but is mobile in the bladder. Fluids can be withdrawn from the prosthesis without contaminating the body.

Abstract: A breast prosthesis worn in a brassiere or the like. It has a prosthesis y having a front side in the shape of a natural breast, a back side with a recess and a prosthesis edge which follows a closed line on which the front side and the back side both end. The prosthesis body has a soft elastic silicone rubber compound which is enclosed without any voids in a bag consisting of two elastically expandable plastic films joined tightly together along the edge of the prosthesis. When the wearer is lying down, the prosthesis should assume a stretched form, where the front side is flattened slightly. When the wearer stands upright, the upper part should sag downward slightly, with the lower and middle areas of the front side having a somewhat greater bulge.

Abstract: An external custom prosthetic device is created and positioned upon a patient such that an area to be covered is matingly engaged with a product that is a simulacrum of the part desired to be replaced due to reversed imaging, by laser photography or laser mapping. A method for creating a silicone based prosthetic, process for generating same with or without an air pocket disposed therein, and products by these processes are likewise taught.

Abstract: A brassiere pad is used in a cup of a brassiere, with the brassiere pad retaining a non-flammable liquid and positioned within the cup for enhancing the appearance of the breast. The non-flammable liquid includes a humectant and a glycerine-based fluid, and the brassiere pad may include a main chamber for retaining the non-flammable liquid, and a tapered chamber connected to the main chamber by a canal to allow the liquid to pass between the tapered chamber and the main chamber. The brassiere pad may be composed of polyurethane.

Abstract: The invention relates to a breast prosthesis for breast-amputated women with a flexible plastic body (1) comprising two plastic sheets (2, 3) connected to each other along their common edge (23) and a plastic mass (4) enclosed between the two plastic sheets (2, 3), wherein the plastic body (1) has a front side (21) formed to resemble the contour of the natural breast and a back side (31) capable of facing the torso of the person, and an elastically deformeable thin part (6) secured with its edge (611) to the back side (31) of the plastic body (1). In order to improve the wear comfort of the breast prosthesis, the thin part (6) is secured to the plastic body (1) inside the common edge (23) of the connected plastic sheets (2, 3).

Abstract: The invention relates to an epithesis consisting of a sheath adapted to a body part on the back and simulating the desired body surface on the front, and a filling inside the sheath, wherein the filling consists of an elastic material with a density of d<0.25 g/cm.sup.3.

Abstract: A functional bra with a silicone gum cup padding in a design consistent with human body engineering. The silicone gum cup padding includes a silicone gum body, a polyurethane (PU) film, and a seaming cloth. The silicone gum body is thin in an upper part and thick toward the lower part. The silicone gum cup padding is made by covering the silicone gum body with said PU film, evacuating the inside of the PU film, sealing said PU film, and securing the seaming cloth on the sealed silicone gum body.