# US 10,441,680 B2 · Placental tissue grafts produced by chemical dehydration/freeze-drying and methods for making and using the same

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- Number: US 10,441,680 B2
- Document ID: US10441680B2
- Status: Granted
- Kind: B2
- Application number: 15/596,476
- Filed: 2017-05-16
- Published: 2017-08-31
- Granted: 2019-10-15
- Earliest claimed: 2011-12-02
- Assignees: MiMedx Group, Inc.
- Applicants: MiMedx Group, Inc.
- Inventors: John Daniel; Randall Spencer; Steven Ray
- Web page: https://patentgrep.com/patent/US10441680B2

## CPC

- 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}
- A61K 35/50: Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
- 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}
- A61L 27/3687: {characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents}
- 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}
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- A61L 2430/12: for dental implants or prostheses
- A61L 2430/16: for reconstruction of eye parts, e.g. intraocular lens, cornea
- A61L 2430/20: for reconstruction of the heart, e.g. heart valves
- A61L 2430/34: for soft tissue reconstruction
- A61L 2430/38: for reconstruction of the spine, vertebrae or intervertebral discs
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

Described herein are placental tissue grafts produced by chemical dehydration followed by freeze-drying the placental tissue to produce the tissue graft. The tissue grafts retain their biological properties preferably at the same level as the placental tissues before they are processed. The placental tissue grafts have numerous medical applications. Methods for making the tissue graft compositions are also described herein.

## Claims

### Claim 1

A laminated tissue graft comprising:
a first membrane comprising modified decellularized amnion wherein the modified amnion comprises a first side and a second side, wherein the first side comprises an exposed basement membrane, and, and the second side is a decellularized fibroblast layer;
a second membrane comprising a chorion membrane layered directly adjacent to the first membrane, wherein said chorion membrane is not decellularized; and
optionally one or more additional membranes layered adjacent to the first or second membrane, wherein the one or more additional membranes is selected from the group consisting of amnion, chorion, Wharton's jelly, and combinations thereof.

### Claim 2 (depends on 1)

The laminated tissue graft of claim 1, further comprising at least one component selected from the group consisting of a naturally occurring growth factor, a platelet concentrate, a bone marrow aspirate, stem cells, and an antibiotic.

### Claim 3 (depends on 1)

The laminated tissue graft of claim 1, wherein the laminated tissue graft is dehydrated.