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 cardiac reinforcement device for reinforcement of the heart wall at a localized area, said heart comprising an epicardial surface, and a parietal pericardium, said device comprising:
a biomedical material which can be applied to the epicardial surface of the heart at the localized area in need of reinforcement without completely surrounding a circuference of the heart;
a peripheral edge;
a means for applying at least a portion of said peripheral edae to said heart,
wherein said device is sized to cover said localized area of said heart wall in need of reinforcement; and
wherein said biomedical material has a compliance that is less than that of the heart wall.
2. The device according to claim 1 , wherein said device comprises an open mesh material.
3. The device according to claim 1 , wherein said biomedical material comprises polyester mesh.
4. The device according to claim 1 , wherein said biomedical material comprises silicon rubber.
5. The device according to claim 1 , wherein said peripheral edge is configured to enhance the strength of the device.
6. The device according to claim 1 , wherein said device is configured to be applied to the epicardial surface of the heart over the parietal pericardium of the heart.
7. The device according to claim 1 , wherein said device is configured to be applied to the epicardial surface of the heart under the parietal pericardium of the heart.
8. The device according to claim 1 , wherein said portion of the heart in need of localized support comprises a cardiac aneurysm.
9. The device according to claim 1 , wherein said portion of the heart in need of localized support comprises an area of the myocardium that has been damaged due to myocardial infarction.
10. The device of claim 1 , wherein said means for applying said peripheral edge of said device to said heart is at least one suture.
11. A cardiac reinforcement device for reinforcement of the heart wall at a localized area, said heart comprising an epicardial surface, a parietal pericardium, said device comprising:
a biomedical material which can be applied to the epicardial surface of the heart at the localized area in need of reinforcement without completely surrounding a circuference of the heart, wherein said biomedical material has a compliance that is less than that of the heart wall.
12. A method of treating a heart in need of localized reinforcement comprising the steps of:
(a) accessing a localized area of a surface of a heart in need of localized reinforcement;
(b) selecting a device comprising:
(i) a biomedical material which can be applied to the epicardeial surface of the heart at the localized area in need of reinforcement without completely surrounding a circumference of the heart;
(ii) a peripheral edge; and
(iii) a means for applying at least a portion of the peripheral edge to the heart, wherein the device is sized to cover the localized area of the heart;
(c) applying the device to the epicardial surface of the heart at the localized area; and
(d) affixing at least a portion of the peripheral edge of the device to the heart.
13. The method of claim 12 , wherein said step of accessing the heart is accomplished through a thoracotomy.
14. The method of claim 12 , wherein said step of applying at least a portion of the peripheral edge comprises forming at least on suture.
15. The method of claim 12 , wherein said step of applying at least a portion of the peripheral edge comprises suturing around the peripheral edge of the device.
16. The method of claim 12 , wherein the device is applied under the parietal pericardium.
17. The method of claim 12 , wherein the device is applied over the parietal pericardium.
18. The method of claim 12 , wherein said device is selected to comprise an open mesh material.
19. The method of claim 12 , wherein said biomedical material is selected to comprise a polyester mesh.
20. The method of claim 12 , wherein said biomedical material is selected to comprise a silicon rubber.
21. The method of claim 12 , wherein said peripheral edge is selected to be configured to enhance the strength of the device.
22. The method of claim 12 , wherein said portion of the heart in need of localized support comprises a cardiac aneurysm.
23. The method of claim 12 , wherein said portion of the heart in need of localized support comprises an area of the myocardium that has been damaged due to myocardial infarction.
24. The method of claim 12 , wherein said biomedical material is selected to have a compliance that is less than that of the heart wall.