Prosthetic Valve Delivery and Mounting Apparatus and System

• US 20140330370A1
• Filed: 04/29/2014
• Published: 11/06/2014
• Est. Priority Date: 05/03/2013
• Status: Abandoned Application

• Current Assignee: Cormatrix Cardiovascular, Inc.
• Original Assignee: Cormatrix Cardiovascular, Inc.
• Inventors: Matheny, Robert G., Fallon, Anna, Cox, James
• Application Number:
  US14/264,746
• Publication Number:
  US 20140330370A1
• Time in Patent Office: Days
• US Class Current: 623/2.14
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A valve mounting apparatus having an elongated tubular mesh structure with proximal and distal ends, a cardiovascular structure engagement region disposed between the proximal and distal ends, and a lumen therethrough, the distal end of the structure including a valve engagement region that is configured to engage a first end of a prosthetic valve, the mesh structure being configured to transition from a pre-deployment configuration, wherein the structure is capable of being disposed at a cardiovascular valve region, such as a valve annulus region, to a post-deployment expanded configuration, wherein the cardiovascular structure engagement region is anchored to the cardiovascular valve region.

Claims

1. A valve mounting apparatus, comprising:

an elongated tubular mesh structure having proximal and distal ends and a lumen therethrough, said mesh structure being configured to receive a proximal end of a prosthetic valve therein,

said proximal end of said mesh structure including a first valve engagement region that is configured to engage a first region of a first end of said prosthetic valve, said distal end of said mesh structure including a second valve engagement region that is configured to engage a second region of said first end of said prosthetic valve,

said mesh structure further including a cardiovascular structure engagement region disposed between said mesh structure proximal and distal ends,

said mesh structure being configured to transition from a pre-deployment configuration, wherein said mesh structure is capable of being disposed at a first cardiovascular valve region, to a post-deployment compressed configuration, wherein said cardiovascular structure engagement region is disposed adjacent cardiovascular tissue disposed proximate said first cardiovascular valve region.

2. The valve mounting apparatus of claim 1, wherein said first cardiovascular valve region comprises a valve annulus having ventricular and atrial regions, and wherein, when said mesh structure is in said post-deployment configuration, said cardiovascular structure engagement region is anchored to said ventricular and atrial regions.

3. The valve mounting apparatus of claim 2, wherein said first cardiovascular valve region comprises a mitral valve region.

4. The valve mounting apparatus of claim 2, wherein said first cardiovascular valve region comprises a tricusped valve region.

5. The valve mounting apparatus of claim 1, wherein said mesh structure has a pre-deployment length extending from said mesh structure proximal end to said mesh structure distal end in the range of 3 mm-5 cm.

6. The valve mounting apparatus of claim 1, wherein said mesh structure has a pre-deployment diameter in the range of 8 mm-6 cm.

7. The valve mounting apparatus of claim 1, wherein said mesh structure comprises a biocompatible polymeric material.

8. The valve mounting apparatus of claim 7, wherein said polymeric material comprises a polymeric material selected from the group consisting of Dacron®

and Artelon®

.

9. The valve mounting apparatus of claim 7, wherein said polymeric material further includes first biologically active agent.

10. The valve mounting apparatus of claim 9, wherein said first biologically active agent is dispersed in said polymeric material.

11. The valve mounting apparatus of claim 9, wherein said first biologically active agent comprises an active agent coating.

12. The valve mounting apparatus of claim 9, wherein said first biologically active agent comprises a growth factor selected from the group consisting of a platelet derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor alpha (TGF-alpha), transforming growth factor beta (TGF-beta), fibroblast growth factor-2 (FGF-2), basic fibroblast growth factor (bFGF), vascular epithelial growth factor (VEGF), hepatocyte growth factor (HGF), insulin-like growth factor (IGF), nerve growth factor (NGF), platlet derived growth factor (PDGF), tumor necrosis factor alpha (TNA-alpha), and placental growth factor (PLGF).

13. The valve mounting apparatus of claim 9, wherein said first biologically active agent comprises a cell selected from the group consisting of a human embryonic stem cell, fetal cardiomyocyte, myofibroblast, mesenchymal stem cell, autotransplated expanded cardiomyocyte, adipocyte, totipotent cell, pluripotent cell, blood stem cell, myoblast, adult stem cell, bone marrow cell, parenchymal cell, epithelial cell, endothelial cell, mesothelial cell, fibroblast, osteoblast, chondrocyte, exogenous cell, endogenous cell, hematopoietic stem cell, myocardial cell, skeletal cell, multi-potent progenitor cell, unipotent progenitor cell, macrophage, xenogenic cell and allogenic cell.

14. The valve mounting apparatus of claim 7, wherein said polymeric material further comprises a pharmacological agent selected from the group consisting of antibiotics, anti-viral agents, analgesics, steroidal anti-inflammatories, non-steroidal anti-inflammatories, anti-neoplastics, anti-spasmodics, modulators of cell-extracellular matrix interactions, proteins, hormones, enzymes and enzyme inhibitors, anticoagulants and/or antithrombic agents, DNA, RNA, modified DNA and RNA, NSAIDs, inhibitors of DNA, RNA or protein synthesis, polypeptides, oligonucleotides, polynucleotides, nucleoproteins, compounds modulating cell migration, compounds modulating proliferation and growth of tissue, and vasodilating agents.

15. The valve mounting apparatus of claim 1, wherein said mesh structure further comprises an impermeable liner, said liner being disposed in said mesh structure lumen.

16. The valve mounting apparatus of claim 15, wherein said liner comprises a first extracellular matrix (ECM) material.

17. The valve mounting apparatus of claim 16, wherein said first ECM material is derived from a mammalian tissue source selected from the group consisting of small intestine submucosa, urinary bladder submucosa, stomach submucosa, central nervous system tissue, epithelium of mesodermal origin, dermal extracellular matrix, subcutaneous extracellular matrix, gastrointestinal extracellular matrix, placental extracellular matrix, ornomentum extracellular matrix, cardiac extracellular matrix, kidney extracellular matrix, pancreas extracellular matrix, lung extracellular matrix, and combinations thereof.

18. The valve mounting apparatus of claim 17, wherein said first ECM material further comprises an exogenously added second biologically active agent.

19. The valve mounting apparatus of claim 18, wherein said second biologically active agent comprises a growth factor selected from the group consisting of a platelet derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor alpha (TGF-alpha), transforming growth factor beta (TGF-beta), fibroblast growth factor-2 (FGF-2), basic fibroblast growth factor (bFGF), vascular epithelial growth factor (VEGF), hepatocyte growth factor (HGF), insulin-like growth factor (IGF), nerve growth factor (NGF), platlet derived growth factor (PDGF), tumor necrosis factor alpha (TNA-alpha), and placental growth factor (PLGF).

20. The valve mounting apparatus of claim 18, wherein said second biologically active agent comprises a cell selected from the group consisting of a human embryonic stem cell, fetal cardiomyocyte, myofibroblast, mesenchymal stem cell, autotransplated expanded cardiomyocyte, adipocyte, totipotent cell, pluripotent cell, blood stem cell, myoblast, adult stem cell, bone marrow cell, parenchymal cell, epithelial cell, endothelial cell, mesothelial cell, fibroblast, osteoblast, chondrocyte, exogenous cell, endogenous cell, hematopoietic stem cell, myocardial cell, skeletal cell, multi-potent progenitor cell, unipotent progenitor cell, macrophage, xenogenic cell and allogenic cell.

21. The valve mounting apparatus of claim 16, wherein said first ECM material further comprises a pharmacological agent selected from the group consisting of antibiotics, anti-viral agents, analgesics, steroidal anti-inflammatories, non-steroidal anti-inflammatories, anti-neoplastics, anti-spasmodics, modulators of cell-extracellular matrix interactions, proteins, hormones, enzymes and enzyme inhibitors, anticoagulants and/or antithrombic agents, DNA, RNA, modified DNA and RNA, NSAIDs, inhibitors of DNA, RNA or protein synthesis, polypeptides, oligonucleotides, polynucleotides, nucleoproteins, compounds modulating cell migration, compounds modulating proliferation and growth of tissue, and vasodilating agents.

22. A prosthetic atrioventricular tissue valve, comprising:

a continuous tubular member formed from a first biocompatible material, said tubular member having first proximal and distal ends and a first lumen therethrough, and at least one valve leaflet formed therein,

said first distal end of said tubular member including cardiovascular structure engagement means for connecting said tubular member to a cardiovascular structure, said cardiovascular structure engagement means comprising first and second elongated members that extend distally from said first distal end of said tubular member,

said first elongated member comprising a looped member having first and second ends, said first end of said first elongated member being attached to a first point on said first distal end of said tubular member and said second end of said first elongated member being attached to a second point on said first distal end of said tubular member,

said second elongated member comprising a looped member having third and fourth ends, said third end of said second elongated member being attached to a third point on said first distal end of said tubular member and said fourth end of said second elongated member being attached to a fourth point on said first distal end of said tubular member; and

a valve mounting apparatus comprising an elongated tubular mesh structure having proximal and distal ends and a lumen therethrough, said mesh structure lumen being configured to receive said first proximal end of said tubular member in said mesh structure lumen,

said proximal end of said mesh structure including a first valve engagement region that is configured to engage a first region of said first proximal end of said tubular member, said distal end of said mesh structure including a second valve engagement region that is configured to engage a second region of said first end of said tubular member,

said mesh structure further including a cardiovascular structure engagement region disposed between said mesh structure proximal and distal ends,

said mesh structure being configured to transition from a pre-deployment configuration with said tubular member disposed in said mesh structure lumen, wherein said mesh structure and tubular member are capable of being disposed at a first cardiovascular valve region, to a post-deployment compressed configuration, wherein said cardiovascular structure engagement region is disposed adjacent cardiovascular tissue disposed proximate said first cardiovascular valve region.

23. The prosthetic valve of claim 22, wherein said first cardiovascular valve region comprises a valve annulus having ventricular and atrial regions, and wherein, when said mesh structure is in said post-deployment configuration, said cardiovascular structure engagement region is anchored to said ventricular and atrial regions.

24. The prosthetic valve of claim 23, wherein said first cardiovascular valve region comprises a mitral valve region.

25. The prosthetic valve of claim 23, wherein said first cardiovascular valve region comprises a tricusped valve region.

26. The prosthetic valve of claim 22, wherein said cardiovascular structure comprises at least one papillary muscle.

27. The prosthetic valve of claim 22, wherein said mesh structure comprises a biocompatible polymeric material.

28. The prosthetic valve of claim 27, wherein said biocompatible polymeric material comprises a polymeric material selected from the group consisting of Dacron®

and Artelon®

.

29. The prosthetic valve of claim 22, wherein said tubular member comprises a first extracellular matrix (ECM) material.

30. The prosthetic valve of claim 29, wherein said first ECM material is derived from a mammalian tissue source selected from the group consisting of small intestine submucosa, urinary bladder submucosa, stomach submucosa, central nervous system tissue, epithelium of mesodermal origin, dermal extracellular matrix, subcutaneous extracellular matrix, gastrointestinal extracellular matrix, placental extracellular matrix, ornomentum extracellular matrix, cardiac extracellular matrix, kidney extracellular matrix, pancreas extracellular matrix, lung extracellular matrix, and combinations thereof.

31. The prosthetic valve of claim 30, wherein said first ECM material further comprises an exogenously added first biologically active agent.

32. The prosthetic valve of claim 31, wherein said first biologically active agent comprises a growth factor selected from the group consisting of a platelet derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor alpha (TGF-alpha), transforming growth factor beta (TGF-beta), fibroblast growth factor-2 (FGF-2), basic fibroblast growth factor (bFGF), vascular epithelial growth factor (VEGF), hepatocyte growth factor (HGF), insulin-like growth factor (IGF), nerve growth factor (NGF), platlet derived growth factor (PDGF), tumor necrosis factor alpha (TNA-alpha), and placental growth factor (PLGF).

33. The prosthetic valve of claim 31, wherein said first biologically active agent comprises a cell selected from the group consisting of a human embryonic stem cell, fetal cardiomyocyte, myofibroblast, mesenchymal stem cell, autotransplated expanded cardiomyocyte, adipocyte, totipotent cell, pluripotent cell, blood stem cell, myoblast, adult stem cell, bone marrow cell, parenchymal cell, epithelial cell, endothelial cell, mesothelial cell, fibroblast, osteoblast, chondrocyte, exogenous cell, endogenous cell, hematopoietic stem cell, myocardial cell, skeletal cell, multi-potent progenitor cell, unipotent progenitor cell, macrophage, xenogenic cell and allogenic cell.

34. The prosthetic valve of claim 30, wherein said first ECM material further comprises a pharmacological agent selected from the group consisting of antibiotics, anti-viral agents, analgesics, steroidal anti-inflammatories, non-steroidal anti-inflammatories, anti-neoplastics, anti-spasmodics, modulators of cell-extracellular matrix interactions, proteins, hormones, enzymes and enzyme inhibitors, anticoagulants and/or antithrombic agents, DNA, RNA, modified DNA and RNA, NSAIDs, inhibitors of DNA, RNA or protein synthesis, polypeptides, oligonucleotides, polynucleotides, nucleoproteins, compounds modulating cell migration, compounds modulating proliferation and growth of tissue, and vasodilating agents.

35. The prosthetic valve of claim 22, wherein said mesh structure further includes an impermeable liner, said liner being disposed in said mesh structure lumen.

36. The prosthetic valve of claim 35, wherein said liner comprises a first biocompatible material.

37. The prosthetic valve of claim 36, wherein said first biocompatible material comprises a second ECM material, said second ECM material being derived from a mammalian tissue source selected from the group consisting of small intestine submucosa, urinary bladder submucosa, stomach submucosa, central nervous system tissue, epithelium of mesodermal origin, dermal extracellular matrix, subcutaneous extracellular matrix, gastrointestinal extracellular matrix, placental extracellular matrix, ornomentum extracellular matrix, cardiac extracellular matrix, kidney extracellular matrix, pancreas extracellular matrix, lung extracellular matrix, and combinations thereof.