US 11,992,579 B2
Porous foams derived from extracellular matrix, porous foam ECM medical devices, and methods of use and making thereof
Chandra M. Valmikinathan, Secaucus, NJ (US); Nikhil Niraj Gheewala, Bethesda, MD (US); Brent Donald Young, Centennial, CO (US); and Thomas Wayne Gilbert, Ellicott City, MD (US)
Assigned to ACell, Inc., Columbia, MD (US)
Filed by ACell, Inc., Columbia, MD (US)
Filed on Nov. 27, 2020, as Appl. No. 17/105,780.
Application 17/105,780 is a continuation of application No. 14/860,781, filed on Sep. 22, 2015, abandoned.
Claims priority of provisional application 62/055,056, filed on Sep. 25, 2014.
Prior Publication US 2021/0077661 A1, Mar. 18, 2021
Int. Cl. A61L 27/36 (2006.01); A61L 27/56 (2006.01); B33Y 70/00 (2020.01); B33Y 10/00 (2015.01); B33Y 80/00 (2015.01)
CPC A61L 27/3633 (2013.01) [A61L 27/3691 (2013.01); A61L 27/56 (2013.01); B33Y 70/00 (2014.12); B33Y 10/00 (2014.12); B33Y 80/00 (2014.12)] 8 Claims
 
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.