Fibrous tissue dressing or implant

Claim 2

A fibrous tissue preparation of mammalian dermal origin which is suitable for homo or heterotransplantation for the permanent repair of or as temporary dressing for cutaneous wounds and soft tissue injuries, which preparation is substantially free of nonfibrous tissue proteins and antigenic polysaccharides, mucopolysaccharides, and glycoproteins.

Claim 3

A fibrous tissue preparation according to claim 1, wherein the mammal is a human or pig.

Claim 4

A process for the preparation of a fibrous tissue according to claim 1, which comprises treating below 20° C. a fibrous tissue of mammalian origin with a proteolytic enzyme selected from the group consisting of pepsin, trypsin, chymotrypsin, ficin, and papain, which will, under the conditions of the process, remove non-fibrous tissue proteins, and further treating said fibrous tissue with a carbohydrate-splitting enzyme, selected from the group consisting of amylase, hyaluronidase, and neuramidinase, which will, under the conditions of the process, remove antigenic polysaccharides, mucopolysaccharides and glycoproteins from said fibrous tissue.

Claim 5

A process according to claim 3 in which the fibrous tissue is treated with both the proteolytic and carbohydrate-splitting enzymes, wherein substantially all of the proteolytic enzyme is removed from said fibrous tissue before treating said fibrous tissue with the carbohydrate-splitting enzyme.

Claim 6

A process according to claim 3, wherein the proteolytic enzyme is trypsin.

Claim 7

A process according to claim 3, wherein prior to the first enzyme treatment the fibrous tissue is contacted with a cold aqueous sodium chloride solution.

Claim 8

A process according to claim 3 which further comprises the step of treating the fibrous tissue with a cross-linking agent, selected from the group consisting of glutaraldehyde, formaldehyde, or nitrous acid, which forms a link between the terminal amino groups of the lysine groups in the fibrous tissue, and under the conditions of the process removes any antigenicity from the tissue.

Claim 9

A process according to claim 7 wherein the further treatment with the cross-linking agent comprises: (1) treating the tissue with a formaldehyde or glutaraldehyde solution having a strength of more than 0.01% by weight; and (2) washing the tissue to remove therefrom free formaldehyde, any reversibly bound formaldehyde, and free glutaraldehyde; such that the resulting fibrous tissue preparation, after its sterilization, will not invoke foreign body reactions and will become vascularized in a recipient.

Claim 10

A process as claimed in claim 8, in which the fibrous tissue is treated with said proteolytic enzyme, and, before the fibrous tissue is treated with said carbohydrate-splitting enzyme, all or substantially all, of said proteolytic enzyme is removed therefrom.

Claim 11

A process as claimed in claim 9, in which the fibrous tissue is treated in the presence of both enzymes, the process conditions being so chosen that when one of said enzymes is active, the other is inactive.

Claim 12

A process as claimed in claim 8, in which said formaldehyde solution has a strength of more than 0.01% and not more than 10%.

Claim 13

A process as claimed in claim 8, in which said glutaraldehyde solution has a strength of from 0.1% to 1.0%.

Claim 14

A fibrous tissue preparation which has been provided by the process of claim 7.

Claim 15

A fibrous tissue preparation which has been prepared by the process of claim 8.

Claim 16

A tissue preparation which is suitable as a cleansing agent for cutaneous wounds and soft tissue injuries and which has been provided by sterilizing, lyophilizing and powdering a fibrous tissue preparation as claimed in claim 14.