POROUS FOAMS DERIVED FROM EXTRACELLULAR MATRIX, POROUS FOAM ECM MEDICAL DEVICES, AND METHODS OF USE AND MAKING THEREOF
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.
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) blending said acidified (pH<4) or basic (pH>9) solubilized extracellular matrix material to form a foamy extracellular matrix material slurry;
(c) neutralizing said blended foamy extracellular matrix material slurry in a solution to about pH 7;
(d) mixing said extracellular matrix material in the solution in step (c) to aid in neutralization of said foamy extracellular matrix material slurry; and,
(e) dehydrating said foamy extracellular matrix material slurry in step (d).
2 . The method of claim 1 further comprising,
introducing said foamy extracellular matrix material slurry from step (d) into a mold before step (e).
3 . The method of claim 1 wherein step (b) comprises blending said extracellular matrix material in an industrial blender at speeds of about 500 RPM to 2500 RPM.
4 . 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.
5 . The method of claim 1 further comprising particularizing said foamy porous extracellular matrix material after step (e).
6 . The method of claim 1 wherein said acid is selected from the group consisting of HCl, phosphoric acid, acetic acid or said base is selected from the group consisting of sodium hydroxide and ammonium hydroxide.
7 . The method of claim 1 wherein said neutralizing solution of step (c) comprises a base selected from the group consisting of NaOH, NaHCO 3 and KCl or if a base is used to blend, an acid selected from the group consisting of acetic acid and hydrochloric acid.
8 . The method of claim 2 wherein said mold comprises a sheet-like shape.
9 . The method of claim 1 further comprising, before step (e).
(g) introducing said extracellular matrix material slurry in step (d) into a three-dimensional (3D) printer; and
(h) printing said medical foam device by said 3-D printer.
10 . A method for making a medical gel comprising,
providing the molded dehydrated porous extracellular matrix material of step of claim 2 ;
milling said molded porous extracellular matrix material to form a powder; and
mixing said powder with an aqueous solution to form said medical gel.
11 . The method of claim 1 wherein said porous extracellular matrix material comprises a pore size in the range of about 1 micron to about 500 microns.
12 . A medical device, comprising:
a devitalized, solidified, porous extracellular matrix foam material derived from a mammal comprising a plurality of pores having a diameter in the range of about 1 micron to 500 microns.
13 . The medical device of claim 12 wherein said device further comprises a mineral selected from the group consisting of calcium, phosphate, calcium and phosphate salts, calcium nitrate, calcium hydroxide, calcium carbonate, calcium oxide, sodium phosphate, sodium dehydrogen phosphate, phosphoric acid, demineralized or decellularized bone matrix, powdered allogenic bone, hydroxyapatite and tricalcium phosphates.
14 . The medical device of claim 12 wherein said device comprises a shape configured for implanting at a sight of tissue injury in a patient.
15 . The medical device of claim 12 wherein said device is manufactured by three-dimensional (3-D) printing.