Cardiac reinforcement device
The present disclosure is directed to a cardiac reinforcement device (CRD) and method for the treatment of cardiomyopathy. The CRD provides for reinforcement of the walls of the heart by constraining cardiac expansion, beyond a predetermined limit, during diastolic expansion of the heart. A CRD of the invention can be applied to the epicardium of the heart to locally constrain expansion of the cardiac wall or to circumferentially constrain the cardiac wall during cardiac expansion.
1. A passive cardiac reinforcement device for constraining outward expansion of a heart wall of a patient's heart during diastole, said device comprising:
(a) a jacket constructed from a biomedical material, said jacket having an apical end and a base end and a predetermined size selected to surround an external surface of said heart; and
(b) a marker for evaluating cardiac performance.
2. The cardiac reinforcement device according to claim 1 wherein said marker for evaluating cardiac performance comprises a radiopaque marker.
3. The cardiac reinforcement device according to claim 2 wherein said radiopaque marker is selected from the group consisting of platinum wire, titanium wire and stainless steel wire.
4. The cardiac reinforcement device according to claim 2 wherein said biomedical material comprises a continuous mesh construction, said continuous mesh construction defining a plurality of open cells.
5. The cardiac reinforcement device according to claim 4 wherein said biomedical material is sized to constrain cardiac expansion during diastole beyond a predetermined limit without substantially assisting cardiac contraction during systole.
6. The cardiac reinforcement device according to claim 1 wherein said marker for evaluating cardiac performance comprises a radioluscent marker.
7. The cardiac reinforcement device according to claim 1 wherein said biomedical material comprises a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent open cell.
8. The cardiac reinforcement device according to claim 1 wherein said apical end of said device is open.
9. The cardiac reinforcement device according to claim 1 wherein said biomedical material is a polyester mesh.
10. The cardiac reinforcement device according to claim 1 wherein said biomedical material is elastic.
11. The cardiac reinforcement device according to claim 1 wherein said biomedical material is substantially non-elastic.
12. The cardiac reinforcement device according to claim 1 wherein said jacket further comprises a lateral slot for providing selective adjustment of a circumference of said jacket to a predetermined size.
13. The cardiac reinforcement device according to claim 12 wherein said slot has opposing lateral edges which decrease said predetermined size of said circumference of said biomedical material by moving said opposing lateral edges together.
14. The cardiac reinforcement device according to claim 12 wherein the radiopaque marker is included proximate the lateral slot.
15. The cardiac reinforcement device of claim 1 further comprising an inflatable member sized for selectively adjusting said predetermined size of said biomedical material, said inflatable member sized for positioning between said device and said patient's heart and an inflation port.
16. The cardiac reinforcement device of claim 15 wherein the radiopaque marker is included proximate the inflation port.
17. A method for monitoring cardiac performance of a heart, said method comprising:
(a) selecting a passive cardiac reinforcement device, said cardiac reinforcement device comprising:
(i) a jacket constructed from a biomedical material, said jacket having an apical end and a base end and a predetermined size selected to surround an external surface of said heart; and
(ii) at least one radiopaque or radioluscent marker; and
(b) applying said cardiac reinforcement device to said heart;
(c) securing said cardiac reinforcement device to said heart; and
(d) determining the position of the marker.
18. The method according to claim 17 wherein said step of determining the position of the marker comprises viewing the cardiac reinforcement device with an x-ray or fluoroscope.
19. The method according to claim 18 wherein the step of selecting includes selecting a cardiac reinforcement device comprising more than one marker.
20. The method according to claim 19 wherein the step of selecting includes selecting a jacket constructed from a biomedical material that constrains cardiac expansion during diastole beyond a predetermined limit without substantially assisting cardiac contraction during systole.
21. The method according to claim 19 wherein said step of determining the position of the marker comprises evaluating the position of the markers relative to one another.