Placental tissue grafts

• US 9,265,800 B2
• Filed: 02/11/2015
• Issued: 02/23/2016
• Est. Priority Date: 08/17/2006
• Status: Active Grant

• Current Assignee: Mimedx Group Incorporated
• Original Assignee: Mimedx Group Incorporated
• Inventors: Daniel, John
• Primary Examiner(s): FOX, ALLISON M
• Application Number:
  US14/619,987
• Publication Number:
  US 20150209475A1
• Time in Patent Office: 377 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 35/50 Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/60 characterised by a special physical form
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/3604 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 Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3691 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 Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body

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.

Claims

1. A sealed package comprising:

a sterile dehydrated placental tissue graft, wherein the placental tissue graft has one or more asymmetric labels on a portion thereof and wherein the one or more asymmetric labels are visually distinguishable and wherein said one or more asymmetric labels are formed or configured by the dehydrated placental tissue; and

a sealable packaging element,

wherein the sealable packaging element is sealed to contain the sterile dehydrated placental tissue graft.

2. The package of claim 1, wherein the tissue graft comprises amnion.

3. The package of claim 1, wherein the tissue graft comprises chorion.

4. The package of claim 1, wherein the tissue graft comprises amnion and chorion.

5. The package of claim 1, wherein the asymmetric label is an embossment.

6. The package of claim 1, wherein the asymmetric label is a logo, a design, a name, or text.

7. A sealed package comprising:

a sterile dehydrated placental tissue graft, wherein the placental tissue graft has one or more asymmetric labels on a portion thereof and wherein said one or more asymmetric labels are visually distinguishable and wherein said one or more asymmetric labels are formed or configured by the dehydrated placental tissue, and further wherein said tissue graft is a dehydrated, laminated graft containing two or more layers wherein said layers are selected from amnion and chorion provided that at least one of said layers is an amnion layer which retains its fibroblast layer and further provided that the layers are laminated to each other; and

a sealable packaging element,

wherein the sealable packaging element is sealed to contain the sterile dehydrated placental tissue graft.

8. The package of claim 7, wherein the fibroblast layer of said amnion layer is laminated to an amnion or chorion layer.