Tissue repair fabric
AssigneeOrganogenesis, Inc.
InventorsRobert M. Carr JR., Kimberlie D. Condon, Paul L. Termin, Janet Hardin Young
Life of this patent
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Abstract
This invention is directed to prosthesis, which, when implanted into a mammalian patient, serves as a functioning replacement for a body part, or tissue structure, and will undergo controlled biodegradation occurring concomitantly with bioremodeling by the patient's living cells. The prosthesis is treated so that it is rendered non-antigenic so as not to elicit a significant humoral immune response. The prosthesis of this invention, in its various embodiments, thus has dual properties. First, it functions as a substitute body part, and second, it functions as bioremodeling template for the ingrowth of host cells.
Claims33
A prosthesis comprising two or more superimposed, bonded layers of collagenous tissue which have been crosslinked with a crosslinking agent that permits bioremodeling and sterilized, wherein all of the layers of the prosthesis are completely bioremodelable, and which, when implanted into a mammalian patient, undergoes controlled biodegradation occurring with adequate living cell replacement such that the original implanted prosthesis is remodeled by the patient's living cells.
The prosthesis of claim 10 wherein said prosthesis is non-antigenic.
A method of preparing a prosthesis having two or more superimposed, bonded layers of collagen material, comprising:
- (a) bonding the two or more collagen layers together using heat welding by heating said collagenous tissue layers for a time and under conditions sufficient to effect the bonding of the collagen layers and to form a prosthesis;
- (b) cooling said heated prosthesis;
- and,
- (c) crosslinking said prosthesis with a crosslinking agent that permits bioremodeling, wherein said thus formed prosthesis when implanted into a mammalian patient, undergoes controlled biodegradation occurring with adequate living cell replacement such that the original implanted prosthesis is remodeled by the patient's living cells;
- wherein the collagenous tissue layers are sterilized with peracetic acid before bonding in step (a) or the prosthesis is sterilized after crosslinking in step (c).
A method of repairing or replacing a damaged tissue comprising implanting a prosthesis in a patient comprising two or more superimposed, bonded layers of collagenous tissue which have been sterilized with peracetic acid and crosslinked with a crosslinking agent that permits bioremodeling, wherein all of the layers of the prosthesis are completely bioremodelable, and which, when implanted into a mammalian patient, undergoes controlled biodegradation occurring with adequate living cell replacement such that the original implanted prosthesis is remodeled by the patient's living cells.
A sterile, non-pyrogenic, and non-antigenic prosthesis formed from mammalian derived collagenous tissue for engraftment to a recipient patient, whereby said engrafted prosthesis does not elicit a humoral immune response to components in said collagenous tissue and wherein said prosthesis concomitantly undergoes bioremodeling occurring with adequate living cell replacement such that the original implanted prosthesis is remodeled by the patient's living cells.
A method of preparing a non-antigenic prosthesis prepared from collagenous tissue derived from a mammalian source selected from the group consisting of intestinal material, fascia lata, dura mater, and pericardium, comprising:
- (a) disinfecting the collagen material with peracetic acid at a concentration between about 0.01 and 0.3% v/v in water;
- and,
- (b) crosslinking said sterilized collagenous tissue with a crosslinking agent that permits bioremodeling;
- wherein the prosthesis isformed from two or more superimposed, bonded layers of collagenous tissue, wherein all of the layers of the prosthesis are bioremodelable, and wherein the prosthesis when implanted into a marmnalian patient, undergoes controlled bioremodeling occurring with adequate living cell replacement such that the original implanted prosthesis is remodeled by the patient's living cells without eliciting a significant humoral immune response.
Dependencies are inferred from the claim text.