Multi-electrode apparatus and method for treatment of congestive heart failure

• US 6,643,546 B2
• Filed: 02/13/2002
• Issued: 11/04/2003
• Est. Priority Date: 02/13/2001
• Status: Expired due to Fees

• Current Assignee: Quetzal Biomedical, Inc.
• Original Assignee: Quetzal Biomedical, Inc.
• Inventors: Rottenberg, William B., Mathis, Scott, Prentice, John K., Schmidt, John A.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US10/075,808
• Publication Number:
  US 20020169484A1
• Time in Patent Office: 629 Days
• Field of Search: 607/9, 607/119, 607/123, 607/148
• US Class Current: 607/9
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/3686 configured for selecting the electrode configuration on a lead A61N1/3688 takes precedence

Abstract

An apparatus and method for treatment of congestive heart failure from the right side of the heart. An implantable cardiac stimulation system with a multi-electrode lead having three or more selectable electrodes, together with apparatus for identifying an optimal subset of electrodes, apparatus for shaping a propagating wave front, and apparatus for modifying the intrinsic ventricular cardiac activation sequence, or generating simultaneous or near simultaneous pacing pulses to the septum or right ventricular outflow tract during ventricular systole in order to improve left ventricular cardiac efficiency and reduce mitral regurgitation in patients with dilated cardiomyopathy. A three dimensional map of electrode placement may be calculated. A sub set of the available electrodes in the right side of the heart is selected for stimulation such that septal motion during systole is reduced or the mitral valve area is stiffened to reduce mitral regurgitation.

Claims

1. A method for treating congestive heart failure comprising

implanting a multi-electrode lead in at least the right ventricle of the heart of a patient, said multi-electrode lead having at least three selectable electrodes,

implanting a cardiac stimulator in the body of said patient, said cardiac stimulator being connected to said multi-electrode lead,

selecting a subset of said electrodes lying on the right septal wall for stimulating the heart such that stimulation through said set of electrodes improves cardiac performance, and

stimulating the heart through said set of electrodes.

2. The method of claim 1 further comprising developing a plurality of template patterns of wave fronts passing said electrodes and distinguishing between intrinsic and ectopic wave fronts by comparing sensed wave fronts to said template patterns.

3. The method of claim 1 wherein the step of selecting said set of electrodes further comprises selecting a set of electrodes to stiffen the septum during systole.

4. The method of claim 1 wherein the step of selecting said set of electrodes comprises selecting a set of electrodes to reduce motion of the septum during systole.

5. The method of claim 4 wherein the motion of the septum is imaged.

6. The method of claim 3 wherein the septum is stimulated within at least the first 10 per cent of ventricular contraction time.

7. The method of claim 3 wherein the step of stimulating the heart comprises stimulating at said set of electrodes to stiffen the septum substantially simultaneously.

8. The method of claim 3 wherein the step of stimulating the heart comprises stimulating at said set of electrodes to stiffen the septum in a sequence such that substantially all of the septum stiffens substantially simultaneously.

9. The method of claim 1 wherein said multi-electrode lead is implanted from the right ventricular outflow tract along the right ventricular septal wall to the right ventricular apex.

10. The method of claim 1 wherein the set of electrodes lying on the septal wall is selected by identifying a set of electrodes close to a line connecting two electrodes that are known to lie on the septal wall.

11. The method of claim 1 wherein the step of selecting a set of electrodes further comprises selecting a set of electrodes near the right ventricular outflow tract.

12. The method of claim 11 wherein the step selecting said set of electrodes further comprises selecting a set of electrodes to stiffen the heart around the mitral valve during systole.

13. The method of claim 12 wherein the mitral regurgitation is minimized by stimulation from the right side of the heart.

14. The method of claim 13 wherein mitral regurgitation is imaged by an echo cardiogram.

15. The method of claim 1 wherein the step of implanting said multi-electrode lead comprises distributing sufficient electrodes on the right ventricular septal wall such that at least fifty per cent of the right ventricular wall could be stimulated within the first ten percent of the ventricular contraction time.

16. The method of claim 15 wherein said electrodes are within 8 mm of each other.

17. The method of claim 16 wherein the electrodes are within 4 mm of each other.

18. The method of claim 1 wherein the step of selecting a set of said electrodes comprises stimulating said heart to locate an electrode lying near a sweet spot in the heart.

19. The method of claim 18 further comprising stimulating at at least one electrode, sensing a physiologic parameter correlated to cardiac output, and selecting an electrode or electrodes such that said cardiac output is maximized.

20. The method of claim 1 wherein the step of selecting a set of electrodes comprises determining a three dimensional position for each electrode.

21. The method of claim 1 wherein the step of selecting a set of electrodes comprises mapping the progress of a wave front through at least a portion of the heart past at least some of said electrodes.

22. The method of claim 21 wherein said step of mapping a wave front comprises mapping an intrinsic contraction wave front.

23. The method of claim 21 wherein the step of mapping a wave front comprises stimulating the heart at at least one electrode and sensing a resulting wave front propagating through the heart.

24. The method of claim 1 wherein the step of stimulating the heart comprises sequentially stimulating at a plurality of electrodes.

25. The method of claim 24 wherein sequentially stimulating comprises stimulating at said electrodes to cause the contraction wave form to conform to a selected normal wave form.

26. A method for treating congestive heart failure comprising

implanting a multi-electrode lead in at least the right ventricle of the heart of a patient, said multi-electrode lead having at least three selectable electrodes,

implanting a cardiac stimulator in the body of said patient, said cardiac stimulator being connected to said multi-electrode lead,

developing a plurality of template patterns of wave fronts passing said electrodes;

distinguishing between intrinsic and ectopic wave fronts by comparing sensed wave fronts to said template patterns;

selecting a subset of said electrodes for stimulating the heart such that stimulation through said set of electrodes improves cardiac performance, and

stimulating the heart through said set of electrodes.

27. A method for treating congestive heart failure comprising

implanting a multi-electrode lead in at least the right ventricle of the heart of a patient, said multi-electrode lead having at least three selectable electrodes,

implanting a cardiac stimulator in the body of said patient, said cardiac stimulator being connected to said multi-electrode lead,

selecting a first subset of said electrodes near the right ventricular outflow tract;

stimulating the heart through said first subset of said electrodes;

determining a first regurgitation through the mitral valve;

selecting a second subset of said electrodes near the right ventricular outflow tract,

stimulating the heart through said second set of electrodes,

determining a second regurgitation through the mitral valve, and

choosing the subset of electrodes such that regurgitation through the mitral valve is minimized.

28. The method of claim 27 further comprising selecting additional subsets of said electrodes, determining regurgitation for each of said subsets and choosing an optimum subset from all of said subsets of electrodes.

29. A method for treating congestive heart failure comprising

implanting a multi-electrode lead in at least the right ventricle of the heart of a patient, said multi-electrode lead having at least three selectable electrodes,

implanting a cardiac stimulator in the body of said patient, said cardiac stimulator being connected to said multi-electrode lead,

selecting a subset of said electrodes lying on the right septal wall by

selecting a first electrode near the right ventricular outflow tract,

selecting a second electrode near the apex of the right ventricular chamber, and

identifying electrodes on the septal wall adjacent a shortest path connecting said first and second electrodes, and

stimulating the heart through said set of electrodes.

30. A method for treating congestive heart failure comprising

implanting a multi-electrode lead in at least the right ventricle of the heart of a patient, said multi-electrode lead having at least three selectable electrodes,

implanting a cardiac stimulator in the body of said patient, said cardiac stimulator being connected to said multi-electrode lead,

mapping the progress of a wave front past said electrodes;

selecting a subset of said electrodes for stimulating the heart in a sequence such that recreates the progress of said mapped wave front, and

stimulating the heart through said set of electrodes in said sequence.

31. The method of claim 30 wherein said step of stimulating the heart through said set of electrodes further comprises inhibiting stimulation at any individual electrode whenever an advancing wave front recreates said mapped wave front at said individual electrode.

32. The method of claim 30 wherein said step of mapping the progress of said wave front comprises mapping an intrinsic contraction wave front.