University of Arkansas

University

Contourmed, Inc.

L Daniel Eaton

John J Miller

John L May

A method for forming the outer surface of a breast prosthesis is disclosed. A digital, three-dimensional image is formed of a patient's breast using a computerized scanner. A computer-controlled milling machine utilizes the image to form a solid model of the breast. A sheet of flexible, moldable material having a uniform, precise thickness is then vacuum-formed over the breast model. A hard, two-piece mold is cast from the flexible sheet. A soft, curable material is then either poured or injected between the two pieces of the mold to form the breast prosthesis outer surface. The breast prosthesis outer surface is then turned inside out to form a shape that is a mirror image of the patient's breast.

Method for forming a breast prothesis

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.

Methods of forming prostheses

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. By using the foam body to support the hollow prosthesis shell, it is possible to make the thickness of the shell walls thinner and thus more natural in feel and appearance. The foam body is colored with an opaque pigment and the shell is colored with a translucent pigment.

Extreme volume flexible integrity prosthesis

A flexible, seamless tissue expanding implant with predetermined memory shape to augment tissue for accurate anatomical restoration for alloplastic reconstruction. The implant is a hollow shape formed from a material that tends to resume its molded shape even when collapsed and when reinflated resumes the desired shape. A minimal incision is made in the patient. From the incision a pocket is formed under the skin of the patient. The pocket is sized to hold the implant, which is inserted, in a collapsed deflated condition. The incision is then closed and allowed to heal. The implant is provided with a one-way, self-sealing valve for periodic inflation. The one-way valve is a latex plug encapsulated with silastic and incorporated into the implant. The valve can be palpated by the surgeon so that inflation can be performed with the implant in place by inserting a hypodermic needle through the skin of the patient, through the valve and into the interior of the implant. The implant is injected with the filling material at periodic intervals so that the tissue is gradually expanded to the appropriate extent. Since the implant has previously been formed into the desired shape, the implant gradually assumes the predetermined shape as it is filled. Therefore, the tissue likewise assumes the desired shape and predetermined volume augmenting the deficient anatomy predictably.

Flexible seamless memory tissue expanding implant

An alloplastic device and process for replacement of a damaged or diseased spinal vertebral column disk. The replacement disk is hollow room temperature vulcanizable (RTV) silicone shaped to mimic the natural disk being replaced. The shape can be derived from a mold of the natural disk or an MRI scan. The replacement disk may be trabeculated (honeycombed) and may be filled with a lubricating fluid including triglyceride oil, preferably soybean oil. The replacement disk is formed by allowing RTV silicone injected into a mold to vulcanize at room temperatures until a wall of sufficient thickness is formed. The unvulcanized silicone is expressed to form the hollow interior. The replacement disk is formed with a nipple having an interior concavity. The nipple is cut from the body of the replacement disk leaving an opening into the hollow interior. The nipple is inverted and sealed into the opening so that the nipple extends from the surface of the replacement disk into the interior where it contacts the opposite wall of the disk. The inverted nipple thus provides a central support for the disk and a valve to inject the lubricating fluid into the hollow interior. The concavity of the inverted nipple is filled with RTV silicone which then vulcanizes and seals the opening. The hollow disk lubricates itself since the lubricating fluid percolates slowly through the silicone wall. Other uses include replacement for a worn out or injured miniscus, and other orthopedic applications including carpal tunnel damage or injuries.

Alloplastic vertebral disk replacement

A process and device for improved healing of large avulsed or burned tissue which prevents excessive cicatricial, keloid or fibromatoid formation, reduces fluid loss, and increases protection from infection by employing an elastomer matrix; i.e., a thin sheet of elastomer with a plurality of fenestrations, placed on the wound and a bath of oil to cover the matrix. The oil bath is provided by a flexible sealed capsule of thin silicone elastomer, preferably filled with soybean oil that percolates through the walls of the capsule. Enhanced granulation tissue formation is promoted by encapsulation of the wound with the matrix. Granulation tissue engulfs the matrix while the matrix integrity and elastic rigidity acts to reduce scarring. The barrier of the sterile soybean oil bath and the barrier of the elastomer matrix improve antisepsis and acts to reduce loss of body fluids. The matrix encourages the generation of granulation tissue since the matrix appears to the body as a foreign object that the body tries to reject.

Inherent healing accelerator

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. The fold down cup over the breast prosthesis is desirably held in position by a plurality of snap fasteners and by one or more tabs with hook and loop fastening material.

Natural fixation of breast prosthesis

An alloplastic device and process for replacement of a damaged or diseased spinal vertebral column disk. The replacement disk is hollow room temperature vulcanizable (RTV) silicone shaped to mimic the natural disk being replaced. The shape can be derived from a mold of the natural disk or an MRI scan. The replacement disk may be trabeculated (honeycombed) and may be filled with a lubricating fluid including triglyceride oil, preferably soybean oil. The replacement disk is formed by allowing RTV silicone injected into a mold to vulcanize at room temperatures until a wall of sufficient thickness is formed. The unvulcanized silicone is expressed to form the hollow interior. The replacement disk is formed with a nipple having an interior concavity. The nipple is cut from the body of the replacement disk leaving an opening into the hollow interior. The nipple is inverted and sealed into the opening so that the nipple extends from the surface of the replacement disk into the interior where it contacts the opposite wall of the disk. The inverted nipple thus provides a central support for the disk and a valve structure to inject the lubricating fluid into the hollow interior. The concavity of the inverted nipple is filled with RTV silicone which then vulcanizes and seals the opening. The hollow disk lubricates itself since the lubricating fluid percolates slowly through the silicone wall. Other uses include replacement for a worn out or injured miniscus, and other orthopedic applications including carpal tunnel damage or injuries.

Method for forming a hollow prosthesis

A process for non-surgical repositioning of craniofacial bones following surgery for severe disease or trauma. At least two osseointegrated, i.e. bone implanted, fixtures are implanted in the patient. A malleable bar, preferably of a gold, platinum and nickel alloy, is fastened between the two fixtures. The gold bar initially has a flexed shape that could include loops, curves or other nonlinear segments. The flexed gold bar is periodically bent to a more straightened position which thus applies a force between the two bone implanted fixtures. The force between the two fixtures tends to reposition the facial bones over a period of time to restore function and/or form to the injured area.

Bone anchored fixation for displacement of facial bones

Method for forming a breast prosthesis

An external prosthesis and a method for affixing the prosthesis to the user by means compliantly housed magnets interacting with surgical steel implants inserted beneath the skin of the user. The implants are surgical steel buttons coated with methylmethacrylate to avoid the release of corrosion products and silastic, a biocompatible material. The implant is inserted beneath the patient's skin along with a biocompatible mesh material to provide additional strength. A flexible carrier is formed with a hollow cylindrical shape to allow a magnet to move freely within the carrier. The opening of the flexible carrier is covered with a mesh. The flexible carrier/magnet/mesh combination is formed into the prosthesis so that the prosthesis aligns with the surgical steel implants and allows freedom of movement within the flexible carrier. The mesh material allows for breathability and also avoids skin strangulation from excess pressure of the magnet on the surgical steel implant.

Flexible exint retention fixation for external breast prosthesis

A combination prosthesis and osseointegrated fixture for the attachment of the prosthesis. A percutaneous osseointegrated fixture is provided with a bar of biocompatible material. The bar is formed into a plurality of loops and the prosthesis is molded to form a plurality of complementary mushroom-headed protuberances that fit snapwise into the loops.

Internal fixation retention for osseointegration

A breast prosthesis and an underwire adapted to retain the breast prosthesis. The breast prosthesis is affixed to the underwire by an attachment fixture molded into the posterior (or chest side) of the prosthesis. The attachment fixture, a female plug, is complementary to a retention fixture, a male plug, molded into a loop on the underwire. The loop of the underwire is adapted to provide a spring bias of the male plug against the chest wall of the wearer for a secure and comfortable fit and to provide sensory feedback as to the correct positioning of the prosthesis. The attachment fixture and the retention fixture are preferably essentially spherical in outline so as to form a ball and socket connection. The underwire is carried by a bandeau which may be removably attached to an unmodified bra.

Breast prosthesis

A breast prosthesis and an underwire bra adapted to retain the breast prosthesis. The breast prosthesis is affixed to the underwire bra by an attachment fixture molded into the posterior (or chest side) of the prosthesis. The attachment fixture, a female plug, is complementary to a retention fixture, a male plug, molded into a loop on the underwire of the bra. The loop of the underwire is adapted to provide a spring bias of the male plug against the chest wall of the wearer for a secure and comfortable fit and to provide sensory feedback as to the correct positioning of the prosthesis.

The method of the present invention creates a hollow plastic prosthesis using the following steps. First, a mold of the prosthetic article is created and the mold is injected with room temperature vulcanizable plastic. The mold containing the RTV plastic is maintained at a fixed temperature for a sufficient period of time for the outer most portions of the RTV plastic to form a vulcanized layer in proximity to the inner surface of the mold. The RTV plastic article is then removed from the mold and the remaining unvulcanized plastic is expressed from the interior. The opening is then sealed and the entire article is allowed to completely cure. The prosthetic article thus created is a one piece seamless article conforming substantially to the shape of the mold. The article is hollow and contains no openings communicating with the exterior so that the article retains flexibility and furthermore has the property of being compressible while retaining the ability to return to its original shape once pressure has been moved.

Growing community of inventors

Little Rock, AR, United States of America

L Daniel Eaton