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US 11,992,579 B2Granted
Porous foams derived from extracellular matrix, porous foam ECM medical devices, and methods of use and making thereof
AssigneeACell, Inc.
InventorsChandra M. Valmikinathan, Nikhil Niraj Gheewala, Brent Donald Young, Thomas Wayne Gilbert
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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.
Claims8
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.
9 more elements
Dependencies are inferred from the claim text.