Extracellular matrix (ECM) structures for tissue regeneration

• US 10,293,084 B2
• Filed: 04/14/2015
• Issued: 05/21/2019
• Est. Priority Date: 05/10/2007
• Status: Active Grant

• Current Assignee: Elutia Med LLC
• Original Assignee: Aziyo Med, LLC (Elutia, Inc.)
• Inventors: Matheny, Robert G.
• Primary Examiner(s): Chen, Shin Lin
• Application Number:
  US14/685,714
• Publication Number:
  US 20150217026A1
• Time in Patent Office: 1,498 Days
• Field of Search: 424423, 424551, 424572, 435325, 530350, 536 168
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: A61K 35/22 Urine; Urinary tract, e.g. kidney or bladder; Intraglomerular mesangial cells; Renal mesenchymal cells; Adrenal gland
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: A61K 35/38 Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
• CPC Class Codes: A61K 38/005 Enzyme inhibitors protease inhibitors A61K38/55
• CPC Class Codes: A61K 38/18 Growth factors; Growth regulators
• CPC Class Codes: A61K 38/1825 Fibroblast growth factor [FGF]
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3679 Hollow organs, e.g. bladder, esophagus, urether, uterus, intestine
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3839 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: C07K 14/435 from animals; from humans
• CPC Class Codes: C12N 5/068 Stem cells; Progenitors

Abstract

An extracellular matrix (ECM) structure for tissue regeneration, the ECM structure having a a sheet member comprising small intestine submucosa (SIS), the SIS sheet member being folded and laminated proximate the sheet member edge, wherein a folded laminated ECM structure having a cavity therein is formed, the ECM structure further including an ECM composition that is disposed in the ECM structure cavity, the ECM composition including liver basement membrane, urinary bladder submucosa, a mesenchymal stem cell and a growth factor.

Claims

1. An implantable medical product, comprising:

a bioremodelable pouch structure comprising an extracellular matrix (ECM) structure in sheet form, said ECM structure comprising acellular ECM from a decellularized mammalian tissue source, said decellularized mammalian tissue source being small intestine submucosa, liver basement membrane, stomach submucosa, urinary bladder submucosa, placental basement membrane, pancreatic basement membrane, large intestine submucosa, lung interstitial membrane, respiratory tract submucosa, heart extracellular matrix, or dermal matrix;

said pouch structure comprising an internal cavity having an opening, wherein the pouch structure is configured to contain an additional component or composition in the internal cavity;

wherein the ECM structure provides tensile strength to support newly forming tissue and includes first and second ECM sheets or sheet portions, each ECM sheet or sheet portion having single or plural layers and edges, wherein only the edges of the ECM sheets or sheet portions are joined together by laminating, suturing or gluing except for the edges that form the opening to provide the internal cavity that is located between the sheets or sheet portions;

wherein the composition provided in the internal cavity of the pouch structure comprises an antibiotic or a drug or a biologically active agent,

wherein the pouch structure effectively improves biological functions by promoting tissue regeneration, modulated healing of adjacent tissue or growth of new tissue when implanted in a body of a warm blooded mammal.

2. The product of claim 1, wherein the edges are joined together by suturing.

3. The product of claim 1, wherein the pouch structure has a rectangular configuration with one closed end and only the edges of both sides of the ECM sheet portions adjacent the closed end are joined together.

4. The product of claim 1, wherein the composition contained in the internal cavity comprises cells or a protein as the biologically active agent.

5. The product of claim 1, wherein the composition contained in the internal cavity is a biologically active agent.

6. The product of claim 1, wherein the composition contained in the internal cavity is a gelatinous semi-solid or powder material.

7. The product of claim 6, wherein the edges are partially joined so that the composition can ooze out from the internal cavity.

8. The product of claim 1, wherein the pouch has a periphery that is round.

9. The product of claim 1, wherein the pouch has a periphery that is generally rectangular.

10. The product of claim 1, wherein each ECM sheet includes 2 or 3 layers of SIS material.

11. The product of claim 1, wherein the edges are completely laminated or joined together.

12. The product of claim 1, wherein the pouch structure has a rectangular configuration with one closed end and only the edges of both sides adjacent the closed end are joined together, and with the composition contained in the internal cavity of the pouch structure comprising an antibiotic or a drug or a biologically active agent.

13. The product of claim 1, wherein the pouch structure has a round configuration and the composition contained in the internal cavity comprises an antibiotic or a drug or a biologically active agent.

14. The product of claim 13, wherein the additional composition in the internal cavity of the pouch structure is in the form of a gelatinous semi-solid or powder material, wherein the edges are partially joined so that the material can ooze out from the internal cavity.

15. An implantable medical product, comprising:

a bioremodelable pouch structure comprising an extracellular matrix (ECM) structure in sheet form, said ECM structure comprising acellular ECM from a decellularized mammalian tissue source, said decellularized mammalian tissue source being small intestine submucosa, liver basement membrane, stomach submucosa, urinary bladder submucosa, placental basement membrane, pancreatic basement membrane, large intestine submucosa, lung interstitial membrane, respiratory tract submucosa, heart extracellular matrix, or dermal matrix;

said pouch structure comprising an internal cavity and an opening, wherein the pouch structure is configured to receive and contain an additional component or composition in the internal cavity;

wherein the ECM structure provides tensile strength to support newly forming tissue and includes first and second ECM sheets or sheet portions, each ECM sheet or sheet portion having single or plural layers and edges, wherein only the edges of the ECM sheets or sheet portions are joined together by laminating, suturing or gluing except for the edges that form the opening to provide the internal cavity that is located between the sheets or sheet portions;

wherein the composition provided in the internal cavity of the pouch structure effectively improves biological functions by promoting tissue regeneration, modulated healing of adjacent tissue or growth of new tissue when implanted in a body of a warm blooded mammal.

16. The product of claim 15, wherein the edges are joined together by suturing.

17. The product of claim 15, wherein each ECM sheet is made of 2 or 3 layers of ECM material and the pouch structure has a periphery that is round.

18. The product of claim 15, wherein each ECM sheet is made of 2 or 3 layers of ECM material and the pouch structure is generally rectangular.