IP Library Granted Patent US 10,973,856
Granted Patent B2
US 10,973,856 · App. 14/211,234 · Granted Apr 13, 2021

ECM implant compositions and methods

Inventors: Michelle Chutka (West Lafayette, IN); Michael C. Hiles (West Lafayette, IN)
Assignee: Cook Biotech Incorporated
A61K35/38A61K35/22A61L27/3633A61L27/56C08J3/00
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Quick Facts
Patent No.
US 10,973,856
App. No.
14/211,234
Granted
Apr 13, 2021
Kind
B2
Abstract

Described our medical compositions and methods including a particulate extracellular matrix tissue in admixture with sugar. Such medical compositions, in dried forms, can demonstrate enhanced rehydration properties. Medical compositions and products as described herein find particular use in treating diseased and/or damaged tissue, such as wound repair. Related methods of manufacture and use are also described.

Claims (36)

1. A medical composition comprising:

an admixture comprising a particulate extracellular matrix (ECM) tissue and fructose wherein said particulate extracellular matrix tissue comprises comminuted extracellular matrix material, wherein the weight ratio of particulate ECM tissue to said fructose is about 3:1 to about 1:1, and wherein said comminuted extracellular matrix material includes native bioactive factors retained from a source tissue for the comminuted extracellular matrix material, the native bioactive factors comprising native non-collagenous solids, and wherein the native non-collagenous solids constitute at least 1% of the total dry weight of the particulate extracellular matrix material, and wherein the native bioactive factors comprise native growth factors, proteins, glycoproteins, proteoglycans, and glycosaminoglycans, wherein:

said admixture is in the form of a dried porous body wettable with an aqueous medium to form a shape retaining but formable putty, and wherein said particulate extracellular matrix tissue and said fructose comprise at least 70% by weight of said dried composition; or

said admixture is in the form of a shape-retaining but formable putty also comprising an aqueous medium, and wherein said particulate extracellular matrix tissue, said fructose, and said aqueous medium comprise at least 70% by weight of said putty.

2. The medical composition of claim 1 , wherein:

said admixture is present in a dried, porous body, and wherein said dried porous body has a mass of about 0.5 g to about 5 g.

3. The medical composition of claim 1 , wherein said aqueous medium comprises a blood fraction.

4. The medical composition of claim 1 , wherein said aqueous medium comprises cells.

5. The medical composition of claim 1 , wherein said admixture is in the form of a dried porous body, and wherein said particulate extracellular matrix tissue and said fructose comprise at least 70% by weight of said dried composition.

6. The medical composition of claim 1 , wherein said admixture and said aqueous medium is in the form of a putty, and wherein said particulate extracellular matrix tissue, said fructose, and said aqueous medium comprise at least 70% by weight of said putty.

7. The medical composition of claim 1 , wherein said growth factors comprise basic fibroblast growth factor, transforming growth factor beta, epidermal growth factor, cartilage derived growth factor, and/or platelet derived growth factor.

8. The medical composition of claim 5 , wherein said particulate extracellular matrix tissue and said fructose comprise at least 90% by weight of said dried composition.

9. The medical composition of claim 8 , wherein said particulate extracellular matrix tissue and said fructose comprise at least 95% by weight of said dried composition.

10. The medical composition of claim 6 , wherein said particulate extracellular matrix tissue, said fructose, and said aqueous medium comprise at least 90% by weight of said putty.

11. The medical composition of claim 10 , wherein said particulate extracellular matrix tissue, said fructose, and said aqueous medium comprise at least 95% by weight of said putty.

12. A medical product comprising:

a dried porous body comprising an admixture of a particulate extracellular matrix tissue and fructose, wherein the weight ratio of particulate extracellular matrix tissue to said fructose is about 3:1 to 1:1, said particulate extracellular matrix tissue including native bioactive factors retained from a source tissue for the particulate extracellular matrix tissue, the native bioactive factors comprising native non-collagenous solids and constituting at least 1% of the total dry weight of the particulate extracellular matrix tissue, wherein the native bioactive factors comprise native growth factors, proteins, glycoproteins, proteoglycans, and/or glycosaminoglycans, and wherein said particulate extracellular matrix tissue and said fructose comprise at least 90% by weight of said dried porous body.

13. The medical composition of claim 12 , wherein said particulate extracellular matrix tissue and said fructose comprise at least 95% by weight of said dried porous body.

14. The medical composition of claim 12 , further comprising a tray and wherein said dried porous body is sterilely packaged on said tray.

15. A medical product comprising:

a dried porous body comprising an admixture of a particulate extracellular matrix tissue and a sugar component comprising fructose, wherein the weight ratio of particulate extracellular matrix tissue to said fructose is about 3:1 to 1:1, said particulate extracellular matrix tissue including native bioactive factors retained from a source tissue for the particulate extracellular matrix tissue, the native bioactive factors comprising native non-collagenous solids and constituting at least 3% of the total dry weight of the particulate extracellular matrix tissue, wherein the native bioactive factors comprise native growth factors, proteins, glycoproteins, proteoglycans, and glycosaminoglycans, wherein said native growth factors comprise: basic fibroblast growth factor, transforming growth factor beta, and platelet derived growth factor, and wherein said particulate extracellular matrix tissue and said sugar component comprise at least 90% by weight of said dried porous body.

16. A method of preparing a medical composition as described in claim 1 , the method comprising:

drying an admixture of materials including a particulate extracellular matrix tissue, fructose, and a liquid, so as to form said dried porous body of claim 1 .

17. The method of claim 16 , wherein:

said drying comprises lyophilizing.

18. The method of claim 16 further comprising locating the admixture in a mold, and wherein said drying is conducted with the admixture in the mold.

19. The method of claim 16 , wherein:

said particulate extracellular matrix tissue comprises submucosa.

20. A method of preparing a material for treating a patient, comprising:

wetting said dried porous body of claim 1 with an aqueous medium to form a shape retaining but formable putty.

21. The method of claim 20 , wherein:

said rehydrating is conducted sufficiently to form a shape-retaining but formable putty.

22. The method of claim 20 , wherein:

said rehydrating includes combining an aqueous medium with the dried body.

23. The method of claim 22 , wherein:

said aqueous medium is or includes blood, blood serum or a blood fraction, and wherein said blood, blood serum or blood fraction is autologous to a subject that is to be treated with the material.

Assignments (4)
SECURITY INTEREST Recorded Sep 25, 2025
From: RTI SURGICAL, INC.; COOK BIOTECH INCORPORATED; TISSX, LLC
To: GOLUB CAPITAL MARKETS LLC, AS COLLATERAL AGENT
Reel/Frame 072924/0721 →
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENTS AND TRADEMARKS Recorded Sep 25, 2025
From: ARES CAPITAL CORPORATION
To: COOK BIOTECH INCORPORATED
Reel/Frame 072938/0231 →
SECURITY INTEREST Recorded Apr 3, 2024
From: COOK BIOTECH INCORPORATED
To: ARES CAPITAL CORPORATION, AS SECURITY AGENT
Reel/Frame 067001/0541 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 14, 2014
From: CHUTKA, MICHELLE; HILES, MICHAEL C.
To: COOK BIOTECH INCORPORATED
Reel/Frame 032442/0149 →
Continuity (2)
Provisional Application 61802113 · Mar 15, 2013
Related Publication 20140275290A1 · Sep 18, 2014