Prosthetic tissue valves

• US 10,188,509 B2
• Filed: 07/11/2016
• Issued: 01/29/2019
• Est. Priority Date: 05/03/2013
• Status: Active Grant

• Current Assignee: Cormatrix Cardiovascular, Inc.
• Original Assignee: Cormatrix Cardiovascular, Inc.
• Inventors: Matheny, Robert G, Vo, Minh X, Chang, Carlos C, Natarajan, Selvamuthu K
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Wolf, Megan
• Application Number:
  US15/206,814
• Publication Number:
  US 20160317292A1
• Time in Patent Office: 932 Days
• 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 for modulating fluid flow through a cardiovascular structure during cardiac cycles of a heart, said fluid flow exhibiting a plurality of positive and negative flow pressures during said cardiac cycles, said prosthetic valve comprising:

a remodelable biological tissue structure comprising a conical shaped sheet member, said sheet member comprising an extracellular matrix (ECM) composition, said ECM composition comprising acellular ECM from a mammalian tissue source,

said sheet member further comprising an open proximal annulus engagement end configured to engage said cardiovascular structure and receive said fluid flow therein and a closed distal end,

said sheet member further comprising a plurality of linear interstices disposed between said sheet member open proximal annulus engagement end and said closed distal end, wherein said plurality of linear interstices do not extend to said closed distal end,

said sheet member being configured to transition from an expanded position when said proximal annulus engagement end of said sheet member is engaged to said cardiovascular structure and receives said fluid flow therein, and said fluid flow exhibits a first positive flow pressure of said plurality of positive flow pressures, to a collapsed position when said fluid flow exhibits a first negative flow pressure of said plurality of negative flow pressures,

said plurality of linear interstices being configured to transition from an open position, when said sheet member is in said expanded position, to a closed position, when said sheet member is in said collapsed position,

said closed distal end of said sheet member being configured to block said fluid flow therethrough when said plurality of linear interstices are in said open and closed positions, wherein when said plurality of linear interstices are in said open position, said plurality of linear interstices allow said fluid flow to be transmitted through said plurality of linear interstices and said sheet member, and wherein when said plurality of linear interstices are in said closed position, said plurality of linear interstices and said distal end of said sheet member jointly block said fluid flow through said sheet member,

said sheet member being further configured to remodel, and 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 proximal annulus engagement end of said sheet member is engaged to said cardiovascular structure, wherein said proximal annulus engagement end of said sheet member is disposed proximate damaged tissue of said cardiovascular structure.

2. The prosthetic valve of claim 1, wherein said sheet member has a length from said proximal annulus engagement end to said distal end less than 25 mm.

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

4. The prosthetic valve of claim 1, wherein said 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, placental tissue, and cardiac tissue.

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

6. The prosthetic valve of claim 5, wherein said at least one exogenously added 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 at least one exogenously added 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 ECM composition further comprises a pharmacological agent.

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

10. The prosthetic valve of claim 8, wherein said pharmacological agent comprises a 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 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.