External cardiac stress reduction method

• US 8,579,798 B2
• Filed: 06/05/2008
• Issued: 11/12/2013
• Est. Priority Date: 09/21/1998
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Inventors: Mortier, Todd J., Schweich, Cyril J. Jr., Vidlund, Robert M., Keith, Peter T., Paulson, Thomas M., Kusz, David A.
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): ALTER MORSCHAUSER, ALYSSA MARGO
• Application Number:
  US12/155,535
• Publication Number:
  US 20080312493A1
• Time in Patent Office: 1,986 Days
• Field of Search: 600/18, 600/16, 600/17, 600/37, 607/129
• US Class Current: 600/37
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: Y10S 623/904 Heart

Abstract

An external heart wall stress reduction apparatus is provided to create a heart wall shape change. The device is generally disposed to the exterior of a heart chamber to reshape the chamber into a lower stress configuration.

Claims

1. A method for treating a heart, comprising:

providing an external heart device sized to completely encircle the heart generally horizontally around the ventricles thereof, the external heart device further having a plurality of inflatable chambers spaced apart from each other;

securing the external heart device to an external surface and generally horizontally around the ventricles of a patient'"'"'s heart such that the inflatable chambers face the external surface and are spaced apart from each other around the heart, the external heart device having a width such that none of the external heart device covers an apex of the heart; and

adjusting a size of one of the plurality of inflatable chambers to change a configuration of the patient'"'"'s heart, throughout a cardiac cycle.

2. The method of claim 1, wherein the method includes maintaining the one of the plurality of inflatable chambers in a static size so as to maintain the changed configuration of the patient'"'"'s heart.

3. The method of claim 2, wherein the inflatable chambers are generally ellipsoidal in shape.

4. The method of claim 1, wherein the step of adjusting includes pre-inflating the one of the plurality of inflatable chambers prior to placement around the heart.

5. The method of claim 1, wherein a porous portion of each inflatable chamber that faces toward the heart is configured to promote tissue ingrowth.

6. The method of claim 5, wherein the porous portion has a pore size between about 10 and about 100 microns.

7. The method of claim 5, wherein the porous portion comprises an expanded PTFE.

8. The method of claim 5, wherein a second portion of each inflatable chamber that faces away from the heart does not promote tissue ingrowth.

9. The method of claim 1, wherein adjusting a size of one of the plurality of inflatable chambers to change a configuration of the patient'"'"'s heart reduces a dimension of the patient'"'"'s heart.

10. The method of claim 9, wherein the dimension is a cross-sectional dimension of a ventricle.

11. The method of claim 1, wherein no portion of the external heart device is placed within a chamber of the heart.

12. The method of claim 1, wherein the step of adjusting includes inflating the one of the plurality of inflatable chambers after placement of the external heart device onto the external surface of the patient'"'"'s heart.

13. The method of claim 1, wherein there are two inflatable chambers spaced around the external heart device so as to be positioned on opposite sides of the left ventricle and deform the left ventricle from a generally circular cross sectional configuration to a bi-lobe configuration.

14. The method of claim 1, wherein there are two inflatable chambers spaced around the external heart device so as to be positioned on opposite sides of the left ventricle and deform the left ventricle from a generally circular cross sectional configuration to a substantially bifurcated configuration by bringing the oppositely disposed heart walls into contact with each other.

15. The method of claim 1, wherein the inflatable chambers are filled with a curable polymer.

16. The method of claim 1, wherein the inflatable chambers are filled and sealed.

17. A method for treating a heart, comprising:

providing an external heart device sized to completely encircle the heart generally horizontally around the ventricles thereof, the external heart device further having at least two inflatable chambers spaced apart from each other;

positioning the two inflatable chambers on opposite sides of and in contact with the left ventricle;

securing the external heart device to an external surface and generally horizontally around the ventricles of a patient'"'"'s heart such that the inflatable chambers face the external surface and are spaced apart from each other around the heart;

inflating the two inflatable chambers to a static size to deform the left ventricle from a generally circular cross sectional configuration to a bi-lobe configuration.

18. The method of claim 17, wherein the external heart device includes an elongate band having a length that is greater than a width of the band.

19. The method of claim 17, wherein the external heart device has a width such that none of the entire external heart device covers an apex of the heart.

20. The method of claim 17, wherein a porous portion of each inflatable chamber that faces toward the heart is configured to promote tissue ingrowth.

21. The method of claim 20, wherein the porous portion has a pore size between about 10 and about 100 microns.

22. The method of claim 21, wherein the pore size is between about 20 and about 40 microns.

23. The method of claim 20, wherein the porous portion comprises an expanded PTFE.

24. The method of claim 20, a second portion of each inflatable chamber that faces away from the heart does not promote tissue ingrowth.

25. The method of claim 17, wherein the step of inflating includes pre-inflating the inflatable chambers prior to positioning on opposite sides of the left ventricle.

26. The method of claim 17, wherein the step of inflating includes pre-inflating the inflatable chambers after positioning on opposite sides of the left ventricle.

27. The method of claim 17, wherein the inflatable chambers are filled with a curable polymer.

28. The method of claim 17, wherein the inflatable chambers are filled and sealed.