Abstract: Surgical implants for human breasts have small, 5-10 cc flat disc-shaped pouches containing saline material. About 20-50 pouches are held within an outer membrane. The encapsulation of the saline solution within the pouches provides an apparent increase of viscosity of saline, and the flat disc shapes provide protection against rupture.

Abstract: Areola and nipple prosthesis device for application to the surface of a human breast comprising an areola portion having an inner concave surface which conforms to the shape of a human breast to which it is applied and an outer convex surface. The inner concave surface includes an adhesive for removably positioning the prosthesis to the human breast. The nipple portion of the device is disposed proximate to the center of areola portion and extends outwardly from the outer surface of the areola portion.

Abstract: A mammary prosthesis for augmentation mammoplasty is comprised of a shell containing an insoluble, fibrous material which when the shell is inflated with inflating fluid adjusts the feel and appearance of the inflated shell to approximate natural mammary tissue. The shell is sealed except for a valve which can be used to inflate the shell.

Abstract: The tissue expander includes a shell with a base layer and an expansion layer that define an expansion chamber therebetween. A conduit or fill tube extends from the shell and is the sole source of communication with the expansion chamber. The base and expansion layers are thermoplastically joined together by a major seam and a minor seam. The major seam is substantially concealed within the expansion chamber whereas the minor seam defines a border portion of the expansion chamber and is not concealed. The tissue expander can be of any selected size and shape. The base layer can be made expandable along with the expansion layer or nonexpandable as desired.

Abstract: A transition layer for an implant to be placed in the human body. The implant has a core, and the transition surface surrounds the core. The transition layer is an open celled foam with cut surfaces. An adhesive adheres one surface to the core, and penetrates the transition layer a limited distance so as to leave over the entire surface, microstructures of cell fragments providing for tissue attachment without formation of a firm encapsulation.

Abstract: The self-sealing tissue expander includes inner and outer layers of relatively nonflowable material and a median layer of flowable material. The median layer of flowable material which can include one or more sublayers of flowable material is under a predetermined compression imposed by the inner and outer layers due to a prestressing of the tissue expander shell during formation of the tissue expander. The self-sealing shell seals an opening in the shell wall following removal of an infusion needle. In all embodiments of the invention a needle stop member is provided to prevent the needle that accesses the fluid chamber from passing outwardly of the tissue expander. The need for a septum, a fluid conduit or a special fluid entry opening in the tissue expander shell is thus optional. The shell can also be made relatively more stretchable in some areas than in other areas.

Abstract: A launderable prosthetic device for camouflaging missing or deformed human body mass or parts comprises a plurality of layers which are sized, shaped and interconnected to form a composite structure that, when partially compressed, assimilates the size, shape and resiliency of the camouflaged body mass. A soft inner liner provides an interface between the composite structure and the human body surface and a smooth outer shield liner provides an interface between the composite structure and an abutting outer garment. The liners are joined to enclose the composite structure and cooperate to maintain the composite structure in a partially compressed state. Randomly spaced openings in the layers provide ventilation for the body surface abutting the prosthetic device.

Abstract: The strength and integrity of hydrophilic polyurethane resins prepared by reacting a diol component, an organic chain extender and an organic diisocyanate are improved by critical selection of the diol component, the amount of water in the reaction mixture and the mole rations of the reactants. The diol component is at least one of (1) a long chain poly(oxyethylene) glycol of molecular weight above 2500 and (2) a medium chain poly(oxyethylene) glycol or polyester glycol of 250-2500 molecular weight. The chain extender is a difunctional compound having a molecular weight of less than 250. The amount of water in the reaction mixture is 0.5 to 2.5 weight % and the urea content of the resins is from about 13.6 to 33.7 weight %.

Abstract: A breast prosthesis aggregate consisting of (a) a flexible resilient breast prosthesis (10) imitating a female left or right breast; and (b) one or more flexible fastening slabs (12; 40,42) sealable to the skin of the wearer by a skin-friendly adhesive. The prosthesis can be releasably secured to the slab or slabs by complementary, interacting attachment members, preferably of the hook-and-loop type with the hooks on the prosthesis, placed on a backward ledge (18) on the prosthesis and the front side of the slabs. On the ledge the attachment members are arranged in separate areas (20) disposed at a mutual distance in an arched, upward convex pattern. Loop members of the closure may be placed in an analogous pattern or may cover the entire front side of the slab. Single slab (12) may be replaced by a number of small slabs (40,42) each corresponding to one area (20) of attachment members on the ledge.

Abstract: A one-piece prosthesis for use by a woman who has undergone a mastectomy, the prosthesis comprising the form of a complete breast, without voids therein, and with a supplement extending toward the axilla, and a supplement extending toward the clavicle, each supplement designed to fill a void left by surgery, and further having a band below the breast to underlie the lower band of brassiere, said supplements and band being tapered to a fine edge of avoid the appearance of demarcation lines. The prosthesis is molded of silicone which may contain dye to match skin coloration, and approximates the size, shape, density, resilience and pliability of the natural breast in various chest and cup sizes.

Abstract: A portable support for a breast prosthesis includes in two disclosed embodiments an inflatable bladder of a closed loop configuration with the bladder being made of a flexible material and including valve means whereby the bladder can be selectively inflated and deflated. The bladder in its inflated condition serves to circumferentially and substantially uniformly engage and support the prosthesis without substantially deforming the prosthesis.

Abstract: A process for producing a breast prosthesis with a concave recess facing the human body. A synthetic resin composition curable to a gelatinous state is enclosed between two thermoplastic films and is shaped in a heated mold defined by a male die and female die. A first film which will face away from the human body is stretched over the female die and heated to permanently conform it to the contour of the die by deep drawing. The deep-drawn film is removed from the female die and an insert having a volume and a free area which correspond to the volume and free area of the concave recess facing the body is then positioned in the female die. The deep-drawn film is placed over the insert in the die and the die is filled with the synthetic resin composition up to its edge. The synthetic resin composition is covered with a second film (cover film) which is welded to the first film over these entire overlapping edges.

Abstract: A surgical prosthesis is disclosed having a textured exterior surface formed of non-absorbent material substantially free of pores and interstices. The invented device is usable for mammary and other implants. Various methods of manufacturing the device are also disclosed.

Abstract: Prosthesis for the correction of myodystrophies; the prosthesis comprises a shaped body in an elastomeric material, having the form and consistency of the tissues of the area of the limb to be corrected. The body of the prosthesis has at least one elastically dilatable part defining a cavity which can be expanded by filling with a pressurized liquid; a filling tube is connected to said expandable cavity by a check valve.

Abstract: An external breast prosthesis is disclosed including two shell shaped chambers containing silicone rubber material of different softness. The silicone rubber material is confined by outer front and back polyurethane films, and the chambers are divided by an intersitial film. The films are welded together along their common peripheral edge. The silicone rubber in the back chamber which is placed next to the chest wall is softer than that in the front chamber, and conforms to the shape of the chest wall following surgery.

Abstract: An areola/nipple surfical wound protector including a sterile pad having an upper surface, a lower non-stick surface and a centrally-located pad opening extending through it. A transparent cone-shaped nipple protector member having an outwardly-disposed flange at its base portion is secured via the flange to generally the upper pad surface and over the pad opening. The nipple protector member has an opening in its base portion, a dome with holes therethrough at its radially opposite end and an interior configured to receive the patient's nipple up through the opening and into the protector member. Spaced adhesive tape strips extend radially out from the pad for securing the pad and protector member to the patient's breast and over her nipple. Alternatively, the dome can be configured to be flatter on its upper surface and have a large medication opening through the center thereof and a surrounding rasied annular rim having a plurality of suture holes therethrough.

Abstract: The present invention provides a breast form that is adapted to be located within a pocket formed by a cover flap connected to the cup of a brassiere. In a preferred embodiment the breast form includes a body member having an outer protruding surface that terminates in a base edge that is configured to fit against the juncture of the cup and the cover flap. The body member has a chamber that is spaced from the base edge. A weighted member, located within this chamber, is thus also spaced from the base edge to produce a moment in the brassiere cup that is resolved as a tensile force in a strap of the brassiere. The wearer experiences this tensile force as that produced by a breast form, located within the cup of the brassiere, that weighs more than the combined weight of the body member and the weighted member.

Abstract: The breast prosthesis consists of an elastically deformable envelope filled at least partly with an inert flowable mass. The shape of said envelope imitates that of the breast and its sidewall, facing the thorax, has a concave form. The prosthesis is provided with at least one transverse through-duct open at its ends, in which is located a non-return valve allowing air to flow only from the inside outwards.

Abstract: A breast-feeding trainer is provided to be worn over clothing in the teaching of nursing techniques. The trainer includes a simulated breast and is worn on the chest of a student in overlying relationship to the natural breasts. The trainer is constructed of lightweight material to be comfortably worn and easily removed after the completion of training. A shroud is draped over the simulated breasts to simulate clothing that may be manipulated during actual breast-feeding.

Abstract: A sterile body implant is derived from a body structure having as its major protein component collagens in the form of extracellular matrix. The body structure is treated to remove cellular membranes, nucleic acids, lipids and cytoplasmic components. Such structures are implanted internally in the body or externally on the body in a variety of medical uses.

Abstract: The invention relates to a method of producing a new and novel gel composition suitable for use in breast prostheses, including a mixture of hydroxyl terminated polybutadiene resin, diundecyl phthalate, polymethylene polyphenyl isocyanate, and dibutyltin dilaurate catalyst, allowing the mixture to stand, and curing the mixture.

Abstract: A surgically implantable areola and nipple prosthesis comprising a base and a nipple forming protrusion, wherein said base is concave on one surface, and convex on the other surface and wherein the nipple forming protrusion is integrally formed onto the convex surface, and wherein the concave surface of the implantable nipple prosthesis may be affixed to a usual breast implantable sac in a location and manner so that the nipple forming prosthesis is oriented in as nearly normal position as possible, or wherein the invention may be implanted in a pocket in tissue as a separate item; and wherein the skin and tissue of the patient is closed about the areola and nipple forming prosthesis, and wherein the patient's skin will naturally assume the shape of the areola and nipple forming prosthesis, and wherein the exterior skin now shaped as an areola and nipple can be colored to resemble an areola and nipple, and wherein the coloring may be of the removable type, such as make-up, or of the more permanent type, such

Abstract: A surgically implantable, multi-lumen, high profile mammary implant includes a first, flexible, lumen at least partly and filled with a soft gel material and having a front wall approximating the shape of a human breast and a second, firmer flexible lumen elastic within the first lumen and connected thereto solely at the rear wall of the first lumen. The second lumen has a volume which is less than the volume of the first lumen and at least partly filled with a second soft gel material. A third lumen preferably inflatably surrounds the first lumen and is inflated with saline solution.

Abstract: A method for fabricating breast prostheses in accordance with the invention includes the steps of forming an outer sheet to a concave configuration; forming an inner sheet to a concave configuration; bonding an intermediate sheet to a form member having a concave inner surface and a convex outer surface; sealing the inner sheet, intermediate sheet, and outer sheet together along their peripheries, thereby forming an outer chamber defined by the outer sheet and the intermediate sheet and an inner chamber defined by the intermediate sheet and the inner sheet, the inner chamber containing the form member; filling the outer chamber with uncured silicone gel; compressing the chamber to remove the air therefrom; placing the compressed chamber in a vacuum chamber to further remove any remaining air therefrom; sealing the chamber; and curing the liquid silicone into a gel.

Abstract: A mastoprosthesis consists of a soft synthetic material member (1) formed after the shape of a natural breast, which member is provided on its back side with a cavity (2), into which a pad member (3) is inserted, which may consist of foam material or of fibers. The pad member (3) is held within cavity (2) for example by means of a rebound (or back salient) means (5) on the synthetic material member (1).

Abstract: A tissue expander, of the type containing within the interior of its expandable shell an injection reservoir self-sealing to punctures by a hypodermic needle, is disclosed. The tissue expander includes a reinforcing member or insert which is substantially more rigid than the expandable shell, is larger than the injection reservoir, and is mounted to the expandable shell with its center substantially at the apex of the shell and substantially superimposed with the center of injection reservoir. The reinforcing member substantially prevents folding of the expandable shell over the injection reservoir and thereby substantially prevents inadvertent puncture of the expandable shell by a needle which is directed into the injection reservoir. Magnetically detectable material is mounted into the injection reservoir to enable an externally applied magnet locator to find the injection reservoir when the entire tissue expander assembly is temporarily implanted in a patient.

Abstract: A surgical instrument and method for use in inserting and positioning prosthesis, including a body portion having an elongate hollow handle defining a feed trough for supplying normal saline solution to the body portion to aid in the insertion and positioning of a prosthetic implant.

Abstract: A method for producing an external breast prosthesis or support by forming a mold directly from the subject for whom the prosthesis is being prepared. After a molding material is applied to the subject's breast, the breast is immersed in an isodensity liquid to present the breast to a zero-gravity condition while the molding material cures.

Abstract: A prosthetic implant for human breasts, comprising a fluid or gel filled body, the surface of which has waves arranged in a concentric pattern rather than a smooth configuration. The amplitude of the waves reduces under the pressure of capsular contracture, thereby relieving said pressure without reducing the volume or firmness of the implant.