# US 12,758,590 B2 · Micronized placental tissue compositions and methods of making and using the same

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- Number: US 12,758,590 B2
- Document ID: US12758590B2
- Status: Granted
- Kind: B2
- Application number: 17/647,505
- Filed: 2022-01-10
- Published: 2022-04-28
- Granted: 2026-10-13
- Earliest claimed: 2011-02-14
- Assignees: MiMedx Group, Inc.
- Applicants: MiMedx Group, Inc.
- Inventors: Brenda S. Morse; Somaly Sith; Randall Spencer; Steven Ray; John Daniel; Robert Tofe
- Web page: https://patentgrep.com/patent/US12758590B2

## CPC

- A61K 35/50: Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
- A61K 8/982: {Reproductive organs; Embryos, Eggs}
- A61K 35/12: Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells (vaccines or medicinal preparations containing antigens or antibodies A61K39/00)
- 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}
- 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 27/3695: {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)}
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61Q 19/00: Preparations for care of the skin
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2430/34: for soft tissue reconstruction
- 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)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS

## 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.

## Claims

### Claim 1

A method of preparing micronized human placental tissue particles, said method comprising the steps of:
i) providing a human amniotic sac collected during a Cesarean section birth, said amniotic sac comprising an amnion and a chorion;
ii) removing clotted blood from said amnion and chorion;
iii) chemically decontaminating said amnion and chorion using an antibiotic solution, thereby forming amnion and chorion comprising an antibiotic;
iv) removing said antibiotic from said amnion and chorion comprising an antibiotic formed in step iii);
v) dehydrating said amnion and chorion formed in step iv);
vi) micronizing said dehydrated amnion and chorion, thereby forming micronized human placental tissue particles; and
vii) separating a portion of the micronized human placental tissue particles by size,
wherein the micronized human placental tissue particles obtained in step vii) have a particle size that is either between 20 and 100 μm or between 150 and 350 μm.

### Claim 2 (depends on 1)

The method of claim 1, wherein the micronized human placental tissue particles obtained in step vii) have a particle size between 150 and 350 μm.

### Claim 3 (depends on 1)

The method of claim 1, wherein the micronized human placental tissue particles obtained in step vii) have a particle size of between 20 and 100 μm.

### Claim 4 (depends on 1)

The method of claim 1, further comprising adding a filler to the amnion and chorion.

### Claim 5 (depends on 4)

The method of claim 4, wherein the filler comprises allograft pericardium, allograft acellular dermis, Wharton's jelly, purified xenograft Type-1 collagen, biocellulose polymers or copolymers, biocompatible synthetic polymer or copolymer films, purified small intestinal submucosa, bladder acellular matrix, cadaveric fascia, or any combination thereof.

### Claim 6 (depends on 1)

The method of claim 1, further comprising adding a bioactive agent to the amnion and chorion.

### Claim 7 (depends on 6)

The method of claim 6, wherein the bioactive agent comprises a hemostatic agent, a fibrin glue, an allograft, or an autogenous material.

### Claim 8 (depends on 1)

The method of claim 1, wherein the amnion in the micronized human placental tissue particles comprises an epithelial layer.

### Claim 9 (depends on 1)

The method of claim 1, wherein the amnion in the micronized human placental tissue particles has had its epithelial layer substantially removed.

### Claim 10 (depends on 1)

The method of claim 1, further comprising cross-linking the amnion and chorion.

### Claim 11 (depends on 1)

The method of claim 1, wherein the amnion and chorion are dehydrated by chemical dehydration.

### Claim 12 (depends on 1)

The method of claim 1, wherein the amnion and chorion are dehydrated by freeze-drying.

### Claim 13 (depends on 1)

The method of claim 1, wherein the amnion and chorion are dehydrated by application of heat.

### Claim 14 (depends on 1)

The method of claim 1, wherein the micronization is performed by mechanical grinding or shredding.

### Claim 15 (depends on 1)

The method of claim 1, wherein the micronization is performed by cryogenic grinding.

### Claim 16 (depends on 10)

The method of claim 10, wherein the cross-linking is performed using oxidized dextran as a cross-linker.