Granted Patent B2

US 12,551,510 · App. 17/341,296 · Granted Feb 17, 2026

Inventors: Scheffer Tseng (Pinecrest, FL); Lorraine Chua (Miami, FL)

Assignee: BIOTISSUE HOLDINGS INC.

A61K35/50A61K9/7007A61K35/28A61K35/51A61L15/40A61L15/44A61L27/3604A61L27/38A61L27/54

Abstract

Claims (22)

1 . A method of preparing a fetal support tissue product, the method comprising:

a) morselizing an amniotic membrane tissue to produce a morselized amniotic membrane tissue and morselizing an umbilical cord tissue to produce a morselized umbilical cord tissue,

b) mixing a therapeutically effective amount of the morselized amniotic membrane tissue and a therapeutically effective amount of the morselized umbilical cord tissue to produce a morselized umbilical cord amniotic membrane mixture;

c) homogenizing the mixture to produce a morselized homogenate;

d) sterilizing the morselized homogenate,

wherein the morselized homogenate has a water content of greater than 20% by weight percentage; and

wherein the morselized homogenate is characterized by a particle size of between about 0.1 mm to about 1.0 cm in length, width, and thickness.

2 . The method of claim 1 , wherein the morselizing is accomplished with a tool selected from the group consisting of a tissue grinder, a sonicator, a bread beater, a freezer/mill, a blender, a mortar and pestle, a ruler and a scalpel.

3 . The method of claim 1 , wherein the sterilizing comprises sterilizing by irradiation.

4 . The method of claim 1 , wherein a natural biological activity of the morselized amniotic membrane tissue and the morselized umbilical cord tissue is substantially preserved for at least 15 days after initial procurement of the source tissues.

5 . The method of claim 1 , further comprising, prior to step a), separating an amniotic membrane tissue and an umbilical cord tissue from a chorion.

6 . The method of claim 1 , further comprising freezing the morselized amniotic membrane tissue, the morselized umbilical cord tissue, or a combination thereof, before homogenization.

7 . The method of claim 6 , wherein the freezing comprises freezing in liquid nitrogen.

8 . The method of claim 1 , further comprising, prior to step a), separating an amniotic membrane tissue and an umbilical cord tissue from an umbilical vein, umbilical arteries, and at least a portion of a Wharton's jelly.

9 . The method of claim 1 , further comprising, spreading the fetal support tissue product onto at least one inert support.

10 . The method of claim 9 , wherein the inert support comprises a material selected from the group consisting of a collagen, a hydrogel, a keratin, a hydrophilic polyurethane, a polyethylene glycol, a poly(lactic-co-glycolic acids), and a hydrocolloid.

11 . The method of claim 9 , wherein the inert support comprises a gel.

12 . The method of claim 9 , wherein the inert support comprises a mesh sheet with an average pore size of about 0.2 mm to about 0.9 cm.

13 . The method of claim 9 , wherein the inert support comprises a 300 μm mesh inert support.

14 . The method of claim 1 , wherein the morselized umbilical cord tissue, the morselized amniotic membrane tissue, or a combination thereof range in size from about 0.1 mm to about 1.0 cm in length, width, or thickness.

15 . The method of claim 1 , wherein the morselized umbilical cord tissue, the morselized amniotic membrane tissue, or a combination thereof range in size from about 0.3 mm to about 1.0 cm in length, width, or thickness.

16 . The method of claim 1 , wherein water has not been substantially removed from the morselized amniotic membrane tissue or from the morselized umbilical cord tissue.

Assignments (8)

Continuity (5)

References Cited (400)