Placental tissue grafts and improved methods of preparing and using the same

Patent metadata

Field	Value
Publication number	US-10406259-B2
Application number	US-201715655020-A
Country	US
Kind code	B2
Filing date	Jul 20, 2017
Priority date	Aug 17, 2006
Publication date	Sep 10, 2019
Grant date	Sep 10, 2019

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 placental tissue graft, wherein said graft has a shelf-life of at least 5 years when stored in said container at room temperature;
wherein said graft comprises a first layer which is a separated and washed amnion layer which comprises an epithelial cell layer, and a second layer which is a separated and washed amnion or chorion layer, and
wherein the first and second layers are directly laminated to each other.

2. The package of claim 1 , wherein said graft is embossed.

3. The package of claim 1 , wherein said graft comprises a groove.

4. The package of claim 1 , wherein said graft has been chemically decontaminated prior to placement in the container.

5. The package of claim 1 , wherein the second layer of said graft is a chorion layer.

6. The package of claim 1 , wherein said graft consists essentially of said first layer which is a separated and washed amnion layer which comprises an epithelial cell layer, and a second layer which is a chorion layer.

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

8. The package of claim 7 , wherein said pouch is an inner pouch.

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

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

11. The package of claim 10 , wherein said sealed, deoxygenated container is disposed within said outer container.

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

Assignees

• Mimedx Group Inc

Inventors

• Daniel John

Classifications

• 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

• 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

• A61L27/54

  Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} · CPC title

• A61K35/50

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

• A61L2300/412

  Tissue-regenerating or healing or proliferative agents · CPC title