# US 11,992,579 B2 · Porous foams derived from extracellular matrix, porous foam ECM medical devices, and methods of use and making thereof

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- Number: US 11,992,579 B2
- Document ID: US11992579B2
- Status: Granted
- Kind: B2
- Application number: 17/105,780
- Filed: 2020-11-27
- Published: 2021-03-18
- Granted: 2024-05-28
- Earliest claimed: 2014-09-25
- Assignees: ACell, Inc.
- Applicants: ACell, Inc.
- Inventors: Chandra M. Valmikinathan; Nikhil Niraj Gheewala; Brent Donald Young; Thomas Wayne Gilbert
- Web page: https://patentgrep.com/patent/US11992579B2

## CPC

- A61L 27/3633: {Extracellular matrix [ECM]}
- 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 27/56: Porous materials, {e.g. foams or sponges}
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- B33Y 70/00: Materials specially adapted for additive manufacturing
- B33Y 10/00: Processes of additive manufacturing
- B33Y 80/00: Products made by additive manufacturing
- 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
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING

## Abstract

The invention disclosed herein is directed to a porous wound healing foam composition that is made from an extracellular matrix of a mammal, method of making, and method of using.

## Claims

### Claim 1

A method for making a medical foam device, comprising:
(a) solubilizing dehydrated extracellular matrix material obtained from a mammalian tissue in a solution comprising a pH less than 4.0 or a pH greater than 9.0;
(b) foaming said acidified (pH<4) or basic (pH>9) solubilized extracellular matrix material in an industrial blender at speeds in the range of about 500 RPM to 2500 RPM to form a foamy extracellular matrix material;
(c) neutralizing said foamy extracellular matrix material in a solution to about pH 7; and
(d) mixing said foamy extracellular matrix material in the solution in step (c) to aid in neutralization of said foaming extracellular matrix material to a pH of about 7;
(e) introducing said foamy extracellular matrix material of step (d) into a mold;
(f) lyophilizing said neutralized molded foamy extracellular matrix material by pre-cooled lyophilizer shelves at a temperature range between 25° C. to −40° C.; followed by
(g) stabilizing said material in step (f) by introducing ice crystals into said molded extracellular matrix material of step (f) at a temperature range between 0° C. to −40° C. at a rate of 0.01° C./min. to 1° C./min. change in temperature for periods of time ranging between 0 minutes to 240 minutes; followed by
(h) sublimating said ice crystals introduced in step (g) at a vacuum pressure in the range of 100-120 mmHg to produce a porous extracellular matrix medical foam device;
wherein said porous extracellular matrix material medical foam device comprises a plurality of pores in the interior of the device and a plurality of pores on the exterior of the device, the diameter of the plurality of pores in the interior of the device being different than the diameter of the pores on the exterior of the device.

### Claim 2 (depends on 1)

The method of claim 1 wherein said extracellular matrix material is selected from the group consisting of submucosa, epithelial basement membrane, epithelial basement membrane and tunica propria, dermis, and liver basement membrane.

### Claim 3 (depends on 1)

The method of claim 1 further comprising particularizing the molded foamy extracellular matrix material after step (h).

### Claim 4 (depends on 1)

The method of claim 1 wherein said neutralizing solution is an acid selected from the group consisting of HCl, phosphoric acid, and acetic acid, or a base selected from the group consisting of sodium hydroxide and ammonium hydroxide.

### Claim 5 (depends on 1)

The method of claim 1 wherein said neutralizing solution comprises a base selected from the group consisting of NaOH, NaHCO3 and KCl or an acid selected from the group consisting of acetic acid and hydrochloric acid.

### Claim 6 (depends on 1)

The method of claim 1 wherein said mold comprises a sheet-like shape.

### Claim 7 (depends on 1)

A method for making a medical gel comprising:
providing the molded foamy extracellular matrix material of claim 1;
milling said molded foamy extracellular matrix material to form a powder; and
mixing said powder with an aqueous solution to form said medical gel.

### Claim 8 (depends on 1)

The method of claim 1 wherein said plurality of pores in the interior of the porous extracellular matrix material medical foam device has a diameter in the range of about 1 micron to about 500 microns.