177 results about "Prosthesis breast" patented technology

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.

A medical implant assembly and method having a medical implant, e.g. a breast prostheses, affixed 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.

An elastomeric gel-filled prosthetic implant having a shell made of a single gel barrier layer. The barrier layer is formed of a homogeneous silicone elastomer capable of sterically retarding permeation of the silicone gel through the shell and having a bleed rate that is less than about 40% of the bleed rate of current shells which use a sandwiched construction with an internal barrier layer. Further, the barrier layer shell is made of a material that exhibits a wet strength that is comparable to or greater than current shells. The silicone elastomer may be a polydimethyl siloxane, and the substituted chemical group is a diphenyl group with a minimum mole percent of at least 13%. The implant may be designed for breast reconstruction or augmentation such that the shell is accordingly shaped. The shell wall thickness is at least 0.254 mm (0.010 inches), and desirably about 0.456 mm (0.018 inches). The implant shell may be made by dip-forming, spray-forming, or rotational molding. The exterior may be smooth or textured.

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.

A dual lumen gravity oriented breast prosthesis or implant for surgical implantation includes inner and outer lumens which are defined by inner and outer closed envelopes of a medical grade elastomer. The outer closed envelope or lumen defines a generally oval or tear-shape with upper and lower portions. The outer envelope also contains a quantity of fluid material as for example a silicone gel having a first density. The prosthesis also includes a second or inner lumen defined by a second closed envelope of medical grade elastomer which is disposed in and fixed in the lower portion of the outer closed envelope. The inner lumen may be of various shapes such as generally spherical or preferably crescent shape. The second lumen is filled with a saline solution which has a density which is greater than the density in the outer lumen. The inner lumen with its greater density maintains or returns the prosthesis to its predetermined orientation when an individual in whom the prosthesis is implanted is in a standing or sitting position.

A breast prosthesis has a flexible shell surrounding an interior compartment. An inner surface of the shell has a plurality of flexible protuberances or struts integral therewith that extend inwardly into the interior compartment. The opposing outer surface of the shell of the breast prosthesis is preferably textured to promote tissue ingrowth. A hole in the flexible shell allows the breast prosthesis to be made in an everted configuration, then everted to provide the prosthesis. In a preferred embodiment, the prosthesis does not contain a fluid filler material and is leak and rupture-proof. The breast prosthesis may be encased in a biocompatible elastomeric shell for implantation or be made from a suitable and inexpensive elastomer and worn as an explant. The prosthesis can be made in a variety of shapes for other types of soft tissue implants.

Thermoplastic elastomers may be manufactured by mixing together plasticizing oil, a triblock copolymer and one or more additives, e.g., an antioxidant, an antimicrobial agent, and / or other additives, to form a mixture which is melted then cooled into the thermoplastic elastomer. During cooling the thermoplastic elastomer may be molded or otherwise formed into any number of articles including, but not limited to, prosthetic liners, prosthetic sleeves, external breast prostheses, breast enhancement bladders, wound dressing sheets, wound dressing pads, socks, gloves, malleolus pads, metatarsal pads, shoe insoles, urinary catheters, vascular catheters and balloons for medical catheters both vascular as well as urinary.

The invention concerns an implantable breast prosthesis comprising a soft pouch capable of a containing filler substance such as a physiological serum or a silicone gel and which is made side-specific, so as to satisfy aesthetic requirements and for better matching the convexity of the thorax.

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.

The invention discloses a breast prosthesis manufacturing method based on the three-dimensional printing technology. The method comprises the steps that a tumor to be excised is analyzed and positioned according to breast medical image data of a patient before an operation, the shape, size and position of the excision part are determined, a three-dimensional digitalization tumor model is established, the radical treatment of the tumor and the demand for individualization overall beauty of the patient in the breast reestablishing process are comprehensively taken into consideration, a breast prosthesis three-dimensional model is optimized and designed according to the established tumor model and the breast shaping golden method, biologically-compatible materials conforming to the hand touch texture of the breast are selected, and the breast prosthesis is printed and formed through the biological three-dimensional printing technology. According to the breast prosthesis manufacturing method, the relation between the breast tumor and the peripheral tissue can be clearly displayed by analyzing and establishing the three-dimensional digitalization tumor model, and thus a doctor can conveniently determine the tumor excision range before the operation; the individualized accurate breast prosthesis can be provided for the patient quickly through the biological three-dimensional printing technology to improve the tumor radical treatment effect and the plastic surgery treatment effect, the living quality is improved, and the medical cost is lowered.

A lightweight breast prosthesis is formed as an enclosed body having therein at least two compartments chamber, wherein one of the compartments chamber is filled with silicone gel, and the other compartment chamber or compartments chamber are filled with a substance lighter than silicone gel. Thus, the breast prosthesis, which is soft and tender like silicone gel but lighter than a breast prosthesis made entirely of silicone gel, can serve either as a complete prosthetic breast or as a breast shape-supplementing pad for locally supplementing the breast shape or making up a partially removed breast.

An elastomeric gel-filled prosthetic implant having a shell made of a single gel barrier layer. The barrier layer is formed of a homogeneous silicone elastomer capable of sterically retarding permeation of the silicone gel through the shell and having a bleed rate that is less than about 40% of the bleed rate of current shells which use a sandwiched construction with an internal barrier layer. Further, the barrier layer shell is made of a material that exhibits a wet strength that is comparable to or greater than current shells. The silicone elastomer may be a polydimethyl siloxane, and the substituted chemical group is a diphenyl group with a minimum mole percent of at least 13%. The implant may be designed for breast reconstruction or augmentation such that the shell is accordingly shaped. The shell wall thickness is at least 0.254 mm (0.010 inches), and desirably about 0.456 mm (0.018 inches). The implant shell may be made by dip-forming, spray-forming, or rotational molding. The exterior may be smooth or textured.

A leak-proof implantable breast prosthesis and a method for making the prosthesis. The breast prosthesis comprises an elastically deformable body or core which is encased within a flexible biocompatible elastomeric shell. In one embodiment, the deformable body is attached, in segments, to the inner surface of the shell by adhesive means and has shape-memory. In another embodiment, the shell encases the core but is not attached to the core. When the outer shell of the prosthesis is subjected to a deforming force, the prosthesis deforms then returns to an original shape when the deforming force is removed. In the event that the shell is ruptured, the prosthesis cannot leak exogenous filler fluid into the surrounding tissue because the prosthesis is substantially void of exogenous filler fluid.

The present disclosure relates to a method of manufacturing a breast prosthesis, wherein a film pouch of at least three film layers is welded for the production of at least two chambers. First, the film pouch is inserted into a prosthetic mold and the outwardly disposed chamber is filled with a mass; the mold is closed with a rear mold part having a specially defined contour and the transparent mass is cross-linked so much that it remains stable in shape in the further production steps. Subsequently, the inner chamber is filled with a second, largely light impermeable mass comprising light fillers and a mold half comprising a shallow cavity is inserted to completely cross-link the masses located in the chamber at a raised temperature.

The present invention relates to a support device for breast prosthesis based on an acellular matrix material of a biological tissue. The support device for breast prosthesis is formed by tailoring a membranaceous material into a petal-shaped planar biological matrix blank and by connecting adjacent edges thereof. The support device can match with the breast prosthesis; and provide a support, fixation and coverage for the breast prosthesis in various surgical operations such as mammoplasty and breast orthopedics, to avoid the ptosis and translocation of the breast prosthesis, thereby achieving desirable effects of plastic surgery. Once being implanted, the matrix material of a biological tissue can be integrated into the surrounding breast tissue of the subject, and thus transformed into new tissues in human body without the retention of foreign bodies. The present invention further relates to a method for manufacturing a support device, and a membranaceous biological matrix material.

The present invention is directed toward a lightweight, external breast prosthesis. In particular, the present invention provides a breast prosthesis comprised of three material layers which allow the production of an extremely light prosthesis while maintaining the look, shape, feel, and behavior of a natural human breast. The outermost layer is comprised of reduced density gel formed in the shape of a human breast. The second layer is a thin layer of standard density gel comprised to provide support and firmness to the outer layer. The innermost layer is a removable foam insert with a sticky coating enabling the innermost layer to “grab” the second layer allowing the three layers of the prosthesis to move as a single unit while maintaining the look, feel, and behavior of a natural human breast at a fraction of the weight of a standard silicone breast prosthesis.

An external breast prosthesis includes an elastomeric skin in the form of a human breast surrounding an inner material such as a silicone gel or hydrogel. The inner material may be of a defined shape or may be amorphous and conform to the shape of the elastomeric skin. The elastomeric skin can be formed from a front skin and a rear skin, and the skins can be made of a soft styrenic elastomer having attributes similar to a gel. The elastomeric skin can be substantially soft to the touch and have an elastic memory that tends to maintain the skin in a pliable yet pre-defined shape.

A breast prosthesis device and method for making same are disclosed. The prosthesis has an inner wall mesh having a first density. The inner wall mesh is configured to align with a chest wall of the user. The prosthesis has an outer wall mesh having a second density. The outer wall mesh configured to have an ideal shape for the user. The prosthesis may also have a band with a density greater or equal to the inner and outer wall meshes. The prosthesis has a central portion disposed in between the inner and outer wall meshes. The prosthesis can be generated using 3D scans of the user manipulated such that the resulting structure mimics human tissue.

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

A breast prosthesis that includes an outer first layer, a middle second layer and an inner third layer. The outer first layer includes a first material that has a first firmness. The first firmness allows for a 20 mm to a 25 mm penetration by a cone penetrometer. The first layer has a shape corresponding to a shape of a breast form. The middle second layer is disposed adjacent to the first layer and includes a second material that has a second firmness that is greater than the first firmness. The inner third layer is disposed adjacent to the second layer opposite from the first layer and includes a third material that has a third firmness that is less than the second firmness.

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

An external lightweight breast prosthesis comprising an elastomeric polyurethane skin filled with copolymer gel filler comprising a mixture of mineral oil, thermoplastic copolymer and glass microspheres and initially configured to approximate the shape of a natural breast wherein the breast prosthesis can be reconfigured to be customized to the individual wearer by subjecting the prosthesis to heating, reshaping, and followed by cooling until the prosthesis retains its new shape.

The invention discloses chest filler and a manufacturing method thereof. The chest filler is of a three-dimensional mesh-shaped structure formed by mutually communicating a plurality of porous units,and the porous units are communicated with one another in a penetrating mode; the overall porosity of the chest filler is 20-80%, and the chest filler is made of an implantable-level silicone rubber material and is integrally formed by using a 3D printing technology. The chest filler is free of a silica gel material, and the problems of surrounding tissue lesions and the like caused by leakage ofsilica gel contained in breast filler, such as breast prostheses, in the existing market are avoided; the shape and size distribution of the porous units can achieve gradient design and manufacture ofthree-dimensional space distribution, and the hardness and mechanical properties of all the areas of the filler can be conveniently adjusted, so that the chest filler has the softness, hand feeling and mechanical strength similar to those of the traditional prostheses containing the silica gel material; the chest filler can be customized according to personal requirements, and the problem that the existing prostheses are easy to move is reduced.

Abreast prosthesis / enhancement cover (1) having a perimeter (6), a first rear section (7) secured to a portion of the front section perimeter (6) and a second rear section (8) secured to a portion of the front section perimeter (6) in such a manner so as the second rear section (8) overlaps a portion of the first rear section (7) to form a pocket (11) for the acceptance of a breast prosthesis / enhancement (3). A securing means (4) is located on the front section (2), which is preferably an adhesive strip of a predetermined size. The sections (2), (7) and (8) of the cover (1) are preferably made of a soft, non-irritating material so as to be comfortable to the user. An optional faux nipple (5) may also be located on the front section (2) so as to provide a natural appearance when the cover (1) is used.

A fluid-filled surgically-implantable prosthetic device encloses one or more non-enclosing fitted shells arranged adjacent to and in a graduated relation to each other. The invention relates specifically to implantable breast prostheses with a low coefficient of friction between two or more interacting elastomeric shells in an aqueous fluid environment, without the addition of a lubricating agent to the fluid.

Article of clothing for post mastectomy surgery that has, one or two breast prosthesis pockets with breast prosthesis, and one or more removable drain pocket portions, and adapted to be easily removable from a patient's body and reduce or otherwise prevent irritation.