CARDIAC WALL TENSION RELIEF WITH CELL LOSS MANAGEMENT

• US 20080125622A1
• Filed: 02/06/2008
• Published: 05/29/2008
• Est. Priority Date: 06/12/2000
• Status: Abandoned Application

• Current Assignee: Acorn Cardiovascular, Inc.
• Original Assignee: Acorn Cardiovascular, Inc.
• Inventors: Walsh, Robert G., Pignato, Paul Andrew, Thomas, Ann Margaret
• Application Number:
  US12/027,093
• Publication Number:
  US 20080125622A1
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells

Abstract

Methods and apparatus are disclosed for treating congestive heart failure. The method includes relieving wall stress on a diseased heart by an amount to decrease a rate of myocardial cell loss. Further, the method includes pharmacologically encouraging a myocardial cell gain. Cell gain may be encouraged by cell replication, cell recruitment or inhibition of cell death. Further embodiments of the method include a passive cardiac constraint selected to reduce wall stress on the heart. An apparatus of the present invention includes a passive cardiac constraint and a pharmacological agent to encourage cell gain.

Claims

1. An apparatus for treating a condition of a heart comprising:

a passive constraint sized to be placed on at least a portion of the heart of a patient and left in situ on the heart following placement; and

a scaffold or matrix placed between at least a portion of the heart and the constraint to promote reverse remodeling of the heart.

2. An apparatus according to claim 1 wherein the scaffold or matrix is fabricated from polyester, polytetrafluoroethylene, polypropylene, piezoelectric materials, or metals.

3. An apparatus according to claim 2 wherein the piezoelectric materials are metals or polymers.

4. An apparatus according to claim 2 wherein the metals are stainless steel, titanium or nitinol.

5. An apparatus according to claim 1 wherein the scaffold or matrix is a resorbable or bioresorbable material.

6. An apparatus according to claim 1 wherein the scaffold or matrix is a biodegradable or nonbiodegradable material including polymer materials selected from polyesters, polyanhydrides or blends thereof;

polymer materials selected from ethylene vinyl acetate copolymers;

or natural materials selected from collagen or gelatin.

7. An apparatus according to claim 1 wherein the passive constraint is a jacket with the scaffold or matrix incorporated into a material of the jacket.

8. An apparatus according to claim 1 wherein the scaffold or matrix incorporates a therapeutic agent.

9. An apparatus according to claim 8 wherein the therapeutic agent incorporated into the scaffold or matrix comprises one or more pharmacological agents, cellular materials, or combinations thereof.

10. An apparatus according to claim 9 wherein the cellular materials comprise differentiated cells with a cardiac cell phenotype or cells with a different phenotype, or non-differentiated cells.

11. An apparatus according to claim 9 wherein the cellular materials comprise smooth muscle cells, endothelial cells, fibroblasts, myocardial cells, or mesenchymal stem cells.

12. An apparatus according to claim 9 wherein the therapeutic agent incorporated into the scaffold or matrix comprises cytokines, growth factors or transcription factors.

13. An apparatus according to claim 12 wherein the growth factors include one or more of vascular endothelial growth factor, basic fibroblast growth factor, or hepatocyte growth factor.

14. An apparatus according to claim 1 wherein the scaffold or matrix incorporates a hydrogel.

15. An apparatus according to claim 14 wherein the hydrogel comprises polycarboxylic acids, water-swollen cellulose derivatives, gelatin, polyvinylpyrrolidone, maleic anhydride polymers, polyamides, poly(vinyl alcohol), polyethylene oxides, poly(2-hydroxyethyl methacrylate), poly(ethylene oxide), or copolymers thereof.

16. An apparatus according to claim 8 wherein the passive constraint is a jacket with the scaffold or matrix and therapeutic agent incorporated into a material of the jacket.

17. An apparatus for treating a condition of a heart comprising:

a passive constraint sized to be placed on at least a portion of the heart of a patient and left in situ on the heart following placement;

wherein the passive constraint is a jacket with an internal surface facing an epicardial surface of the heart and external surface;

a first scaffold or matrix on the internal surface of the jacket; and

a second scaffold or membrane on the external surface of the jacket.

18. An apparatus according to claim 17 wherein the scaffold or matrix is fabricated from polyester, polytetrafluoroethylene, polypropylene, piezoelectric materials, or metals.

19. An apparatus according to claim 17 where in the scaffold or matrix is resorbable or bioresorbable.

20. An apparatus according to claim 17 wherein the scaffold or matrix is a biodegradable or nonbiodegradable material including polymer materials selected from polyesters, polyanhydrides or blends thereof;

polymer materials selected from ethylene vinyl acetate copolymers;

or natural materials selected from collagen or gelatin.

21. An apparatus according to claim 17 wherein the scaffold or matrix incorporates a therapeutic agent.

22. An apparatus according to claim 21 wherein the therapeutic agent incorporated into the scaffold or matrix comprises one or more pharmacological agents, cellular materials, or combinations thereof.

23. An apparatus according to claim 22 wherein the cellular materials comprise differentiated cells with a cardiac cell phenotype or cells with a different phenotype, or non-differentiated cells.

24. An apparatus according to claim 22 wherein the cellular materials comprise smooth muscle cells, endothelial cells, fibroblasts, myocardial cells, or mesenchymal stem cells.

25. An apparatus according to claim 21 wherein the therapeutic agent incorporated into the scaffold or matrix comprises cytokines, growth factors or transcription factors.

26. An apparatus according to claim 25 wherein the growth factors include one or more of vascular endothelial growth factor, basic fibroblast growth factor, or hepatocyte growth factor.

27. An apparatus according to claim 17 wherein the scaffold or matrix incorporates a hydrogel.

28. An apparatus according to claim 27 wherein the hydrogel comprises polycarboxylic acids, water-swollen cellulose derivatives, gelatin, polyvinylpyrrolidone, maleic anhydride polymers, polyamides, poly(vinyl alcohol), polyethylene oxides, poly(2-hydroxyethyl methacrylate), poly(ethylene oxide), or copolymers thereof.

29. An apparatus for treating a condition of a heart comprising:

a passive constraint sized to be placed on at least a portion of the heart of a patient and left in situ on the heart following placement;

wherein the passive constraint is a jacket incorporating a scaffold or matrix; and

cellular materials associated with the jacket via a spacer arm.

30. An apparatus according to claim 29 wherein the spacer arm comprises a string of methylene groups, natural peptides, or synthetic peptides.

31. An apparatus according to claim 30 wherein the spacer arm terminates with an arginine-glycine-aspartic acid amino acid sequence.

32. An apparatus according to claim 29 wherein the jacket has a surface facing an epicardial surface the of the heart and the cellular materials are attached to the surface of the jacket by the spacer arm.