Methods of preparing lyophilized human tissues
OwnerTerry W. Broussardinventor
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Abstract
Described herein are methods of preparing human amniotic membrane tissue grafts derived from the placenta. The grafts are composed of three layers as seen in the amniotic membrane in utero. These grafts are processed using physiologic solutions, lyophilized and terminal sterilized (via gamma irradiation in a frozen state) that thereby preserves the graft in such a manner as to retain the naturally occurring biological properties of the amniotic membrane and offer a sterile graft for transplantation. By dehydration via lyophilization and terminal sterilization in a frozen state, the graft has the advantage of storage at ambient temperatures for prolonged periods of time prior to transplantation.
Claims15
A method of preparing a tissue to be a biological dressing or a tissue graft, said method comprising, in listed order:
- processing and cleaning, consisting of using only a physiologic saline solution and physical manipulation, an amniotic membrane maintaining the following layers in the following order:
- a) an epithelium layer;
- b) a basement membrane layer;
- and
- c) a stroma layer comprising an upper compact layer, a middle fibroblast layer, and a lower spongy layer;
- freezing and dehydrating while lyophilizing, without heat or chemicals, the amniotic membrane after said cleaning to create a frozen, dehydrated amniotic membrane;
- and
- in a frozen state, sterilizing the frozen, dehydrated amniotic membrane using gamma irradiation.
A method of preparing a tissue to be a biological dressing or a tissue graft, said method comprising:
- step for processing an amniotic membrane consisting of using only physiologic saline solution and physical manipulation;
- step for cleaning, consisting of using only physiologic saline solution and physical manipulation, an amniotic membrane maintaining the following layers in the following order:
- a) an epithelium layer;
- b) a basement membrane layer;
- and
- c) a stroma layer comprising an upper compact layer, a middle fibroblast layer, and a lower spongy layer;
- step for freezing and dehydrating while lyophilizing, without heat or chemicals, the amniotic membrane to create a frozen, dehydrated amniotic membrane, after said step for cleaning;
- and
- step for sterilizing the frozen, dehydrated amniotic membrane in a frozen state using gamma irradiation, after said step for freezing and dehydrating while lyophilizing.
Dependencies are inferred from the claim text.