# US 8,784,890 B2 · Methods for producing ECM-based biomaterials

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- Number: US 8,784,890 B2
- Document ID: US8784890B2
- Status: Granted
- Kind: B2
- Application number: 13/675,688
- Filed: 2012-11-13
- Published: 2013-03-21
- Granted: 2014-07-22
- Earliest claimed: 2009-12-22
- Assignees: Cook Medical Technologies LLC; Cook Biotech Incorporated
- Applicants: Cook Medical Technologies LLC; Cook Biotech Incorporated
- Inventors: Laura-Lee Farrell; Chad E. Johnson
- Web page: https://patentgrep.com/patent/US8784890B2

## CPC

- A61K 9/0087: {Galenical forms not covered by A61K9/02 - A61K9/7023}
- A61K 38/39: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
- A61L 27/3633: {Extracellular matrix [ECM]}
- A61L 31/005: {Ingredients of undetermined constitution or reaction products thereof}
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- B29C 39/08: Introducing the material into the mould by centrifugal force
- B29C 67/20: for porous or cellular articles, e.g. of foam plastics, coarse-pored {(chemical aspects of working up macro-molecular substances to porous or cellular articles C08J9/00)}
- 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
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)

## Abstract

A method for forming an extracellular matrix material (ECM) material includes providing at least an ECM composition containing ECM particles varying in their capacity for migration through a fluid medium, including at least one population of expanded ECM particles. The ECM composition is combined in a fluid medium to form a flowable ECM composition. The flowable ECM composition is subjected to a centrifugal force in a mold for a period of time sufficient to distribute the ECM particles according to differences in their physical characteristics. The ECM composition is dried to form a dried ECM material having a density gradient extending from a less dense region to a more dense region. The dried ECM material may formed as a porous, substantially acellular ECM material expandable in an aqueous fluid environment by at least 100% in volume.

## Claims

### Claim 1

An extracellular matrix (ECM) material comprising:
first and second populations of ECM particles centrifugally cast in a mold and dried to form the ECM material, the ECM material expandable in an aqueous fluid environment by at least 100% in volume,
wherein the first population is characterized by a first average particle size or first average particle density, and the second population is characterized by a second average particle size or second average particle density, wherein the corresponding average particle sizes or average particle densities differ from one another in the first and second populations; and
wherein the ECM material has a shape defined by the mold and is characterized by a density gradient extending from a less dense region to a more dense region.

### Claim 2 (depends on 1)

The ECM material of claim 1, wherein the less dense region is a central region and the more dense region is an outer region.

### Claim 3 (depends on 2)

The ECM material of claim 2, wherein the first population comprises expanded ECM particles and the second population comprises non-expanded ECM particles, and wherein the outer region comprises more non-expanded ECM particles than the inner region.

### Claim 4 (depends on 3)

The ECM material of claim 3, wherein the non-expanded ECM particles include FGF-2 native to a source tissue, and wherein the ECM material further comprises an FGF-2 gradient extending from a lower-FGF-2 content central region to a higher FGF-2 content outer region.

### Claim 5 (depends on 1)

The ECM material of claim 1, wherein the ECM material is formed into a solid plug, hollow plug or sleeve.

### Claim 6 (depends on 1)

The ECM material of claim 1, wherein the ECM material is a porous, decellularized ECM material.

### Claim 7 (depends on 1)

The ECM material of claim 1, wherein the first and second populations of ECM particles have different bioactivity relative to one another, such that the ECM material is characterized by a bioactivity gradient.

### Claim 8 (depends on 1)

The ECM material of claim 1, wherein the first and second populations of ECM particles have different levels of growth factors relative to one another.

### Claim 9 (depends on 1)

The ECM material of claim 1, wherein the first and second populations of ECM particles have different levels of glycosaminoglycans relative to one another.

### Claim 10 (depends on 1)

The ECM material of claim 1, wherein the first and second populations of ECM particles have different levels of proteoglycans relative to one another.
