Implantable prosthetic or tissue expanding device

Abstract

A keratin hydrogel-filled implantable prosthetic device. One device is a breast implant for augmenting or reconstructing a human breast including an envelope containing a keratin hydrogel. One keratin hydrogel is formed from a solid precursor which forms a keratin hydrogel upon addition of water. One source of keratin is human hair. In one method, an envelope suitable for implantation and a solid keratin hydrogel precursor are provided. The solid can be in fibrous or powder form. The solid precursor can be inserted into the envelope interior. A small incision near the breast can be made and the envelope inserted into the incision. After insertion, water can be injected into the envelope interior, preferably through the incision and through a self-sealing port in the envelope. In one method, the implant is provided as a kit, with the envelope and keratin hydrogel provided. The hydrogel can be injected into the envelope either before or after insertion into the breast area. One kit has a powdered, keratin hydrogel precursor disposed within the envelope interior, awaiting the addition of water, preferably after insertion of the implant into the body.

Description

PRIORITY AND CROSS REFERENCE TO CO-PENDING APPLICATIONS [0001] The present application is a continuation of U.S. patent application Ser. No. 09 / 394,783 filed Sep. 13, 1999. This present application is also related to U.S. patent application Ser. No. 09 / 330,550, filed Jun. 11, 1999, entitled SOLUBLE KERATIN PEPTIDE, and U.S. patent application Ser. No. 09 / 394,782, filed Sep. 13, 1999, entitled WATER ABSORBENT KERATIN AND GEL FORMED THEREFROM.FIELD OF THE INVENTION [0002] The present invention is generally related to medical prostheses or implants for augmentation, tissue expansion or replacement of soft tissue, including breast implants. In particular, the present invention is related to implants filled with a keratin hydrogel. BACKGROUND OF THE INVENTION [0003] Breast augmentation and reconstruction through medical procedures has been performed by physicians for decades. Early attempts using filler materials alone, without an enclosing envelope, had less than optimal long-term effec...

AI Technical Summary

Benefits of technology

"The present invention provides a safer, more natural-looking implant for augmenting or reconstructing the human breast or other tissue. The implant is made of a keratin hydrogel that is more absorbable and has a reduced antigenicity in the human body. The keratin material used in the implant is preferably human hair or other fibrous or powdered animal or plant material. The implant is formed by adding water to a hydratable keratin material that has been oxidized to break disulfide bonds and create sulfonic acid groups. The resulting solid is then suspended in a non-aqueous solvent and the pH is adjusted upward with a base to at least neutral pH. The invention provides a safer and more natural-looking implant that can be used in subdermal or other tissue augmentation procedures."

Problems solved by technology

Early attempts using filler materials alone, without an enclosing envelope, had less than optimal long-term effects on appearance and health.

The use of silicone gel-filled silicone envelopes gave improved long-term appearance but has created concerns for manufacturers, surgeons and patients due to possible leakage of the silicone gel from the envelopes into the body.

Another issue in the field of breast reconstruction and in the healing of open wounds is the use of tissue expanders.

Unfortunately, in order to change the volume of the tissue expander a needle must be inserted into the envelope, thus requiring penetration of the tissue and causing pain and an increased possibility of infection.