Biological filler and use of same

#The present invention relates to the treatment of soft tissue in the body and more particularly relates to the replacement of soft tissue. In greater particularity, the present invention is a soft tissue replacement material and the method for use of the same. In still greater particularity, the present invention relates to the use of a biological replenishable material as the replacement material. Specifically, the present invention relates to the use of hair as the material for soft tissue replacement surgery.

#Restorative surgery has long had the difficult task of finding replacement materials for use as fillers, grafts and connectors in the practice of the specialty. In this practice, as well as in many other aspects of medicine, the body's superbly designed defense mechanisms present a challenge to the physician's task of intervening and manipulating the body tissue to achieve a functional or an aesthetically pleasing result. To date, different methods of replacement of tissue and different replacement materials have been widely used, however, they have been, to a certain extent, unsatisfactory. Evidence of the unsatisfactory result is shown by the history of the use of silicon in breast implants. In addition to the variety of medical problems reported by the implantees of such devices, silicones are known to be problematic due to capsular contraction.

#Another form of replacement has been the use of dermal fat grafts; however, such grafts have a tendency for resorption, leaving the graftee in little better condition than before the procedure. The use of bovine collagen has been attempted, but such attempts bring their own peculiar set of worries.

#The accompanying drawings depict our invention in use and form a portion of this disclosure as follows:

#FIG. 1 is a partial sectional view of a mass of hair encapsulated for use as an implant;

#FIG. 2 is a perspective view of a connective strand made from harvested hair and a physiologically degradable substance;

#Referring to the Drawings for a clearer understanding of the invention, it should be understood that the current invention is not to hair or autologous hair as it appears, for example, on the human head. The hair on one's head, although routinely shampooed and neatly combed, is far from being an acceptable filler material, inasmuch as the hair is a repository for numerous micro-organisms which may adversely affect the use of the hair as a medical implant. Likewise, one's hair may be subject to remnants of numerous cosmetic preparations placed thereon and is generally a repository of minute airborne contaminants of various descriptions. Consequently, the present disclosure is not directed to "hair" which has not been harvested and appropriately treated.

#Our invention contemplates the use of hair as a replacement filler or structure substitute in situations wherein the subject patient has had a loss of tissue mass or was born with a defect of insufficient mass, or in some instance, simply finds that increased soft tissue in certain areas of the anatomy would be physiologically and psychologically beneficial. Accordingly, the patient will normally be prepared for the surgery, and, at some point in advance thereof, a quantity of hair can be harvested from the patient's head or the head of another person. Harvesting requires cutting the hair shaft to sever the hair follicle from the root, which remains intact. Accordingly, the harvesting may be less traumatic to the patient than a bad haircut.

#Subsequent to harvesting, the hair must be ridden of all the potential contaminants: accordingly, the harvested hair should be sterilized, such as by boiling or steam treatment to raise the temperature and separate all undesirable oils, greases, and residues, and to remove any minute organic or inorganic contaminants. After sterilization, the hair is washed in a non-ionic detergent to further remove any contamination left by the sterilization process. Finally, the harvested hair is washed carefully with an isotonic salt solution to eliminate possible microorganism bacteria and other substances that could be the cause of infection or antigenic activity.