# US 11,026,980 B1 · Flowable birth tissue composition and related methods

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- Number: US 11,026,980 B1
- Document ID: US11026980B1
- Status: Granted
- Kind: B1
- Application number: 16/284,443
- Filed: 2019-02-25
- Granted: 2021-06-08
- Earliest claimed: 2018-02-26
- Assignees: Triad Life Sciences, Inc.
- Applicants: Triad Life Sciences, Inc.
- Inventors: Kurt Klitzke; Jon G. Hargis
- Web page: https://patentgrep.com/patent/US11026980B1

## CPC

- A61K 35/50: Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
- A61K 35/51: Umbilical cord; Umbilical cord blood; Umbilical stem cells
- A61K 38/39: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
- A61L 26/0057: {Ingredients of undetermined constitution or reaction products thereof}
- A61L 26/008: {Hydrogels or hydrocolloids}
- A61L 26/009: {Materials resorbable by the body}
- A61L 26/0095: {Composite materials, i.e. containing one material dispersed in a matrix of the same or different material}
- 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 27/3687: {characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents}
- A61L 27/44: having a macromolecular matrix
- A61L 27/52: Hydrogels or hydrocolloids
- A61L 27/58: Materials at least partially resorbable by the body
- C12N 5/0605: {Cells from extra-embryonic tissues, e.g. placenta, amnion, yolk sac, Wharton's jelly}
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2400/12: Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
- A61L 2430/34: for soft tissue reconstruction
- A61L 2430/40: Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- C12N 2539/00: Supports and/or coatings for cell culture characterised by properties
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A flowable birth tissue composition fabricated from birth tissue is provided. Methods of processing a mammal's placental tissue to form a flowable birth tissue composition are provided. Various methods of treatment and uses are also provided.

## Claims

### Claim 1

A flowable porcine birth tissue composition comprising
detergent-treated, milled porcine placental tissue; and
at least one carrier,
wherein the placental tissue is mixed with the at least one carrier to form the flowable porcine birth tissue composition, and
wherein the detergent includes at least one anionic detergent and at least one protease enzyme.

### Claim 2 (depends on 1)

The flowable porcine birth tissue composition of claim 1, wherein the porcine placental tissue includes at least one placental membrane, at least one amnion membrane, at least one chorion membrane, at least one intermediate layer, at least one placental globe, at least one umbilical cord, at least one amniotic fluid, or any combination thereof.

### Claim 3 (depends on 1)

The flowable birth tissue composition of claim 1, further comprising at least one bioresorbable bead.

### Claim 4 (depends on 1)

The flowable porcine birth tissue composition of claim 1, wherein the porcine placental tissue exhibits a pH of between about 6.8 and about 7.2.

### Claim 5 (depends on 1)

The flowable porcine birth tissue composition of claim 1, wherein the porcine placental tissue includes a dehydrated porcine placental membrane comprising collagen I, collagen IV, elastin, laminin, fibronectin and hyaluronic acid.

### Claim 6 (depends on 1)

The flowable porcine birth tissue composition of claim 1, wherein the porcine placental tissue is derived from a female pig that is not genetically modified to halt or reduce expression of a functional alpha-1,3 galactosyltransferase gene.

### Claim 7 (depends on 1)

The flowable porcine birth tissue composition of claim 1, wherein the flowable porcine birth tissue composition is formulated as a gel.

### Claim 8 (depends on 1)

The flowable porcine birth tissue composition of claim 1, wherein the at least one carrier comprises water, saline, 0.9% sodium chloride injection, aqueous hyaluronic acid, dextrose solution, amniotic fluid, Hank's solution, Ringer's solution, or any combination thereof.

### Claim 9 (depends on 1)

The flowable porcine birth tissue composition of claim 1, wherein the milled porcine placental tissue is present in an amount of from about 0.01 g/mL to about 2.0 g/mL of flowable porcine birth tissue composition.

### Claim 10 (depends on 5)

The flowable porcine birth tissue composition of claim 5, wherein the collagen I, collagen IV, elastin, laminin, fibronectin and hyaluronic acid are present in the dehydrated porcine placental membrane in an amount that is different from native porcine placental membrane.