Micronized placental tissue compositions and methods of making and using the same

Patent metadata

Field	Value
Publication number	US-11219647-B2
Application number	US-201816164191-A
Country	US
Kind code	B2
Filing date	Oct 18, 2018
Priority date	Feb 14, 2011
Publication date	Jan 11, 2022
Grant date	Jan 11, 2022

Abstract

Described herein are compositions composed of micronized placental components and pharmaceutical compositions thereof. The compositions have numerous medical applications. Methods for making and using the micronized compositions are also described herein.

First claim

What is claimed:

1. A micronized composition comprising micronized particles, said micronized particles comprising an amnion layer and a chorion layer; wherein the chorion layer is layered directly over the amnion layer; wherein the amnion layer has an epithelial layer; and wherein an intermediate layer of said amnion layer has been substantially removed.

2. The micronized composition of claim 1 , further comprising micronized amnion.

3. The micronized composition of claim 1 , further comprising one or more additional layers selected from the group consisting of amnion, chorion, intermediate tissue layer, allograft pericardium, allograft acellular dermis, Wharton's jelly, purified xenograft Type-I collagen, biocellulose polymers or copolymers, biocompatible synthetic polymer or copolymer films, purified small intestinal submucosa, bladder acellular matrix, cadaveric fascia, and any combination thereof.

4. The micronized composition of claim 1 , wherein the micronized particles are dehydrated.

5. The micronized composition of claim 1 , wherein the micronized particles are less than 500 μm.

6. The micronized composition of claim 1 , wherein the micronized particles are from 150 μm to 350 μm.

7. The micronized composition of claim 1 , wherein the micronized particles are from 25 μm to 150 μm.

8. The micronized composition of claim 1 , wherein the micronized particles are from 25 μm to 75 μm.

9. A sterile pharmaceutical composition comprising a pharmaceutically acceptable fluid carrier and micronized particles, said micronized particles comprising an amnion layer and a chorion layer; wherein the chorion layer is layered directly over the amnion layer; wherein the amnion layer has an epithelial layer; and wherein an intermediate layer of said amnion layer has been substantially removed.

10. The sterile pharmaceutical composition of claim 9 , wherein the pharmaceutically acceptable fluid carrier comprises water, aqueous hyaluronic acid, saline, Ringer's solution, dextrose solution, Hank's solution, a buffer, or an nonaqueous vehicle.

11. The sterile pharmaceutical composition of claim 10 , wherein the buffer comprises a phosphate buffer, bicarbonate buffer, or Tris buffer.

12. The sterile pharmaceutical composition of claim 9 , wherein the composition is injectable.

13. The sterile pharmaceutical composition of claim 9 , wherein the composition is a liquid, gel or paste.

14. The sterile pharmaceutical composition of claim 9 , wherein the micronized particles are dehydrated.

15. The sterile pharmaceutical composition of claim 9 , wherein the micronized particles are less than 500 μm.

16. The sterile pharmaceutical composition of claim 9 , wherein the micronized particles are from 150 μm to 350 μm.

17. The sterile pharmaceutical composition of claim 9 , wherein the micronized particles are from 25 μm to 150 μm.

18. The sterile pharmaceutical composition of claim 9 , wherein the micronized particles are from 25 μm to 75 μm.

Assignees

• Mimedx Group Inc

Inventors

• Morse Brenda S
• Sith Somaly
• Spencer Randall
• Ray Steven
• Daniel John
• Tofe Robert

Classifications

• A61L27/3604

  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 title

• A61L2400/06

  Flowable or injectable implant compositions · CPC title

• A61L2430/34

  for soft tissue reconstruction · CPC title

• A61L27/3695

  characterised by the function or physical properties of the final product, where no specific conditions are defined to achieve this (A61L27/3687, A61L27/3691 take precedence) · CPC title

• A61P17/02

  for treating wounds, ulcers, burns, scars, keloids, or the like · CPC title