HUMAN PLACENTAL TISSUE GRAFT PRODUCTS, METHODS, AND APPARATUSES
Provided herein are tissue grafts, and in particular human placenta-derived tissue grafts and methods and articles for the manufacture and use thereof.
1 - 15 . (canceled)
16 . A tissue graft comprising:
a processed human fetal amniotic membrane comprising an amnion layer and a chorion layer wherein processing the human fetal amniotic membrane comprises:
removing maternal decidua cells from the membrane;
compressing the membrane; and
dehydrating the membrane,
wherein processing the membrane provides a dense matrix having a compact structure and a reduced amount of maternal decidua cells without a step of delaminating the amnion layer from the chorion layer.
17 - 22 . (canceled)
23 . The tissue graft of claim 16 , wherein the dense matrix allows the releases bioactives in a controlled or extended manner.
24 . (canceled)
25 . The tissue graft of claim 16 , wherein the dense matrix is resistant to degradative enzymes.
26 - 31 . (canceled)
32 . The tissue graft of claim 16 , wherein removing maternal decidua cells is carried out by mechanical, chemical, osmotic, and/or enzymatic treatment.
33 - 42 . (canceled)
43 . The tissue graft of claim 16 , wherein processing the membrane further comprises folding the membrane.
44 - 52 . (canceled)
53 . The tissue graft of claim 16 , wherein processing the membrane further comprises removing cells of a trophoblast layer from the membrane.
54 . The tissue graft of claim 53 , wherein removing the cells of a trophoblast layer is carried out by mechanical, chemical, osmotic, or enzymatic treatment.
55 - 57 . (canceled)
58 . The tissue graft of claim 16 , wherein processing the membrane further comprises decontaminating the membrane to reduce its bioburden.
59 . (canceled)
60 . The tissue graft of claim 58 , wherein the membrane is decontaminated with ethanol.
61 - 74 . (canceled)
75 . The tissue graft of claim 17 , wherein the compressing the membrane step and the dehydrating the membrane step produces visibly distinguishable surfaces of the membrane.
76 - 77 . (canceled)
78 . The tissue graft of claim 16 , wherein the membrane is dehydrated to equal to or less than 10% by weight moisture content.
79 - 85 . (canceled)
86 . The tissue graft of claim 16 , wherein the process further comprises terminally sterilizing the membrane.
87 - 97 . (canceled)
98 . The tissue graft of claim 16 , wherein the membrane is secured onto a backing.
99 - 104 . (canceled)
105 . The tissue graft of claim 98 , wherein the backing comprises multiple tabs configured to secure different sizes of the tissue graft.
106 - 131 . (canceled)
132 . A method of treating a wound on a patient comprising:
applying to the wound, a tissue graft comprising a human fetal amniotic membrane comprising an amnion layer and a chorion layer wherein the two layers have not been delaminated,
wherein the membrane is prepared by a process comprising
maintaining the membrane so that the amnion and chorion layers are not delaminated;
removing maternal decidua cells from the membrane; and
compressing and dehydrating the membrane to result in a dense and compact matrix.
133 - 135 . (canceled)
136 . An apparatus for compressing and dehydrating a tissue, comprising:
a chamber defining an opening at one end, the chamber being in fluid connection with a vacuum source;
a support platform covering the opening of the chamber; and
a sealing sheet positioned adjacent the perforated support platform opposite the chamber, the sealing sheet being configured to seal the chamber upon depressurization of the chamber by the vacuum source,
wherein the apparatus is configured to receive the tissue between the support platform and the sealing sheet, such that the tissue is dehydrated upon depressurization of the chamber.
137 . The apparatus of claim 136 , wherein the support platform comprises a perforated rigid support layer and a moisture, liquid and vapor permeable material layer, the moisture, liquid and vapor permeable material layer being positioned opposite the chamber.
138 - 140 . (canceled)
141 . The apparatus of claim 136 , wherein the sealing sheet comprises a gas impermeable, compliant or conformable polymer sheet.
142 . (canceled)
143 . The apparatus of claim 136 , further comprising an air source in fluid connection with the chamber and configured to deliver air to the sealed chamber, to augment the dehydration of the tissue.
144 - 145 . (canceled)
146 . The apparatus of claim 136 , wherein the chamber contains a desiccant material.
147 - 148 . (canceled)