Placental tissue grafts and methods of preparing and using the same

Patent metadata

Field	Value
Publication number	US-11504449-B2
Application number	US-201715436914-A
Country	US
Kind code	B2
Filing date	Feb 20, 2017
Priority date	Aug 17, 2006
Publication date	Nov 22, 2022
Grant date	Nov 22, 2022

Abstract

A method for preparing placenta membrane tissue grafts for medical use, includes obtaining a placenta from a subject, cleaning the placenta, separating the chorion tissue from the amniotic membrane, mounting a selected layer of either the chorion tissue or the amniotic membrane onto a drying fixture, dehydrating the selected layer on the drying fixture, and cutting the selected layer into a plurality of tissue grafts. Preferably, the drying fixture includes grooves or raised edges that define the outer contours of each desired tissue graft, after they are cut, and further includes raised or indented logos that emboss the middle area of the tissue grafts during dehydration and that enables an end user to distinguish the top from the bottom side of the graft. The grafts are comprised of single layers of amnion or chorion, multiple layers of amnion or chorion, or multiple layers of a combination of amnion and chorion.

First claim

What is claimed is:

1. A package comprising a sealed, deoxygenated container, said sealed, deoxygenated container comprising a dehydrated, laminated placental tissue graft comprising a first chorion tissue layer and a second chorion tissue layer which is laminated to said first chorion tissue layer, wherein at least one of the chorion tissue layers is not decellularized, wherein said laminated placental tissue graft has been contacted with an antibiotic prior to being dehydrated; and wherein said graft has a shelf-life of at least 5 years when stored in said container at room temperature.

2. The package of claim 1 , said dehydrated, laminated placental tissue graft further comprising at least one additional tissue layer, wherein the at least one additional tissue layer is amnion, chorion, or a combination thereof.

3. The package of claim 1 , wherein the first chorion tissue layer and the second chorion tissue layer are not decellularized.

4. The package of claim 1 , said dehydrated, laminated placental tissue graft further comprising a texture or design embossed within the graft, and wherein the texture or design distinguishes one side of the graft from the other side.

5. The package of claim 1 , wherein said container is a pouch.

6. The package of claim 1 , wherein said pouch is an inner pouch.

7. The package of claim 1 , wherein said sealed, deoxygenated container is heat sealed.

8. The package of claim 1 , further comprising an outer container.

9. The package of claim 8 , wherein said sealed, deoxygenated container is disposed within said outer container.

10. The package of claim 8 , wherein said outer container is a pouch.

11. The package of claim 1 , wherein the dehydrated, laminated placental tissue graft has been contacted with streptomycin sulfate and gentamicin sulfate prior to being dehydrated.

Assignees

• Mimedx Group Inc

Inventors

• Daniel John

Classifications

• A61L2430/40

  Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking · CPC title

• A61L27/58

  Materials at least partially resorbable by the body · CPC title

• A61L27/3691

  characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation · CPC title

• A61K35/50

  Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells · CPC title

• A61L27/3604 Primary

  characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel · CPC title