Prosthetic Tissue Valves

• US 20160317292A1
• Filed: 07/11/2016
• Published: 11/03/2016
• Est. Priority Date: 05/03/2013
• Status: Active Grant

• Current Assignee: Cormatrix Cardiovascular, Inc.
• Original Assignee: Cormatrix Cardiovascular, Inc.
• Inventors: Vo, Minh X., Chang, Carlos C., Natarajan, Selvamuthu K., Matheny, Robert G.
• Granted Patent: US 10,188,509 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/64 Animal cells
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/04 Metals or alloys
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3826 Muscle cells, e.g. smooth muscle cells
• CPC Class Codes: A61L 27/3834 Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells
• CPC Class Codes: A61L 27/3873 Muscle tissue, e.g. sphincter
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

A prosthetic valve comprising a conical shaped sheet member comprising an extracellular matrix (ECM) composition, the sheet member having a plurality of open slit regions that are disposed uniformly on linear planes that are parallel to the sheet member longitudinal axis, and a proximal annulus engagement end diameter and length ratio in the range of 5:1 to 2:1.

Claims

1. A prosthetic valve, comprising:

a conical shaped sheet member comprising a first extracellular matrix (ECM) composition, said first ECM composition comprising first acellular ECM from a first mammalian tissue source,

said sheet member further comprising a longitudinal axis, inner and outer surfaces, a proximal annulus engagement end,

said sheet member further comprising a plurality of open slit regions that are disposed uniformly on linear planes that are parallel to said sheet member longitudinal axis,

said sheet member further comprising a proximal annulus engagement end diameter and length ratio in the range of 5;

1 to 2;

1,

said sheet member being configured to induce host cell and tissue proliferation, remodeling of damaged cardiovascular tissue and regeneration of new cardiovascular tissue and tissue structures with site-specific structural and functional properties, when said sheet member is disposed proximate a valve annulus.

2. The prosthetic valve of claim 1 wherein said sheet member has a length from said proximal annulus engagement end to said distal end in the range of 5 mm to 150 mm.

3. The prosthetic valve of claim 2, wherein said slit regions comprise in the range of 10% to 98% of said sheet member length.

4. The prosthetic valve of claim 1, wherein said first mammalian tissue source is selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS), urinary basement membrane (UBM), liver basement membrane (LBM), stomach submucosa (SS), mesothelial tissue, subcutaneous extracellular matrix, large intestine extracellular matrix, placental extracellular matrix, omentum extracellular matrix, heart extracellular matrix and lung extracellular matrix.

5. The prosthetic valve of claim 1, wherein said first ECM composition further comprises at least one exogenously added first biologically active agent.

6. The prosthetic valve of claim 5, wherein said first biologically active agent comprises a cell selected from the group consisting of a human embryonic stem cell, fetal cardiomyocyte, myofibroblast, and mesenchymal stem cell.

7. The prosthetic valve of claim 5, wherein said first biologically active agent comprises a first growth factor selected from the group consisting of a transforming growth factor-alpha (TGF-α

), transforming growth factor-beta (TGF-β

), fibroblast growth factor-2 (FGF-2), and vascular epithelial growth factor (VEGF).

8. The prosthetic valve of claim 1, wherein said first ECM composition further comprises at least a first pharmacological agent.

9. The prosthetic valve of claim 8, wherein said first pharmacological agent comprises a first agent selected from the group consisting of an antibiotic, anti-viral agent, analgesic, anti-inflammatory, anti-neoplastic, anti-spasmodic, and anticoagulant and antithrombic agent.

10. The prosthetic valve of claim 8, wherein said first pharmacological agent comprises a first statin selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin.

11. The prosthetic valve of claim 1, wherein said sheet member further comprises an annulus ring, said annulus ring being disposed on said proximal annulus engagement end of said sheet member.

12. The prosthetic valve of claim 11, wherein said annulus ring comprises a second ECM composition, said second ECM composition comprising second acellular ECM from a second mammalian tissue source selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS), urinary basement membrane (UBM), liver basement membrane (LBM), stomach submucosa (SS), mesothelial tissue, subcutaneous extracellular matrix, large intestine extracellular matrix, placental extracellular matrix, ornomentum extracellular matrix, heart extracellular matrix and lung extracellular matrix.

13. The prosthetic valve of claim 12, wherein said second ECM composition further comprises at least one exogenously added second biologically active agent.

14. The prosthetic valve of claim 13, wherein said second biologically active agent comprises a growth factor selected from the group consisting of TGF-α

, TGF-β

, FGF-2, and VEGF.

15. The prosthetic valve of claim 11, wherein said annulus ring comprises poly(urethane urea).

16. The prosthetic valve of claim 11, wherein said annulus ring comprises poly(glycerol sebacate).

17. The prosthetic valve of claim 1, wherein said sheet member further comprises a structural ring that is disposed on said distal end of said sheet member, said structural ring being configured to receive said distal end of said sheet member therein.

18. The prosthetic valve of claim 17, wherein said structural ring comprises a shape memory alloy.

19. The prosthetic valve of claim 17, wherein said structural ring comprises poly(urethane urea).

20. The prosthetic valve of claim 17, wherein said structural ring comprises poly(glycerol sebacate).

21. The prosthetic valve of claim 1, wherein said sheet member further comprises an outer coating comprising a pharmacological composition.