Methods and apparatus to stimulate heart atria

• US 10,596,380 B2
• Filed: 08/02/2016
• Issued: 03/24/2020
• Est. Priority Date: 09/25/2006
• Status: Active Grant

• Current Assignee: Backbeat Medical, LLC
• Original Assignee: Backbeat Medical, Inc.
• Inventors: Levin, Howard, Gelfand, Mark
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Ghand, Jennifer L
• Application Number:
  US15/226,056
• Publication Number:
  US 20160339244A1
• Time in Patent Office: 1,330 Days
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61N 1/3624 occurring in the atrium, i.e. atrial tachycardia
• 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 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

A method and apparatus for treatment of hypertension and heart failure by increasing vagal tone and secretion of endogenous atrial hormones by excitory pacing of the heart atria. Atrial pacing is done during the ventricular refractory period resulting in atrial contraction against closed AV valves, and atrial contraction rate that is higher than the ventricular contraction rate. Pacing results in the increased atrial wall stress. An implantable device is used to monitor ECG and pace the atria in a nonphysiologic manner.

Claims

1. A programmable implantable pacemaker for treatment of heart failure, the pacemaker connectable to at least one electrically conductive lead for connecting to a heart of a patient, and the pacemaker being programmed to generate electrical signals to be conveyed to the heart through the at least one electrically conductive lead, such that the electrical signals artificially pace an atrium of the heart;

wherein the generated electrical signals are configured to deliver excitatory stimulation to the heart; and

wherein the excitatory stimulation is configured to cause the atrium to begin contracting against a closed heart valve after the closed heart valve has stopped blood flow from the atrium to a ventricle associated with the atrium, such that the contraction distends the atrium with blood, and the distending atrium results in an increased secretion of an atrial hormone that reduces vasoconstriction and/or sodium retention.

2. The pacemaker of claim 1, wherein the pacemaker is programmed to deliver the excitatory stimulation at or after a middle of ventricular systole when the atrium is distended by passive filling with blood.

3. The pacemaker of claim 1, wherein the increased secretion of the atrial hormone overcomes detriments from reduced atrial contribution to cardiac output.

4. The pacemaker of claim 1, wherein the increased secretion of the atrial hormone offsets suboptimal performance of the heart due to reduced atrial contribution to cardiac output.

5. The pacemaker of claim 1, wherein the pacemaker is programmed to deliver the excitatory stimulation when the heart valve is closed by a ventricular pressure that exceeds a pressure of the atrium.

6. The pacemaker of claim 1, wherein the pacemaker is programmed to artificially pace the atrium by cyclically:

(a) causing artificially induced contractions of the atrium and (b) allowing naturally occurring contractions of the atrium.

7. The pacemaker of claim 1, wherein the pacemaker is programmed to pace the ventricle of the heart at a first rate and pace the atrium at a second rate that is faster than the first rate.

8. The pacemaker of claim 7, wherein the second rate is approximately two times the first rate.

9. The pacemaker of claim 1, wherein the excitatory stimulation causes the atrium to contract between a middle and an end of ventricular systole.

10. The pacemaker of claim 1, further comprising one or more electrically conductive leads connected to the pacemaker.

11. The pacemaker of claim 1, wherein the pacemaker is programmed to generate electrical signals that pace the ventricle of the heart at a normal rate.

12. The pacemaker of claim 1, wherein the excitatory stimulation causes the atrium to contract after the heart valve has been closed for a period during ventricular systole.

13. The pacemaker of claim 1, wherein the pacemaker is programmed to alternate between a first pacing period of time that comprises the atrium contracting against the closed heart valve and a second pacing period of time that is different from the first pacing period.

14. The pacemaker of claim 13, wherein the second pacing period comprises synchronous atria-ventricular pacing.

15. The pacemaker of claim 1, wherein the excitatory stimulation causes the atrium to contract during heart systole, when a ventricle of the heart is refractory to stimulation.

16. The pacemaker of claim 1, wherein the excitatory stimulation causes the atrium to contract when the heart valve is closed by a ventricular pressure that exceeds a pressure of the atrium.

17. The pacemaker of claim 1, wherein the pacemaker is programmed to deliver the excitatory stimulation to the heart following an end of an atrial refractory period and before an end of a ventricular refractory period.

18. The pacemaker of claim 17, wherein the pacemaker is programmed to sense electrical signals generated by the heart and conveyed to the programmable implantable pacemaker through the at least one electrically conductive lead, and based on the sensed electrical signals, determine the atrial refractory period and the ventricular refractory period.

19. A programmable implantable pacemaker for treatment of heart failure, the pacemaker connectable to at least one electrically conductive lead for connecting to a heart of a patient, and the pacemaker being programmed to generate electrical signals to be conveyed to the heart through the at least one electrically conductive lead, such that the electrical signals artificially pace an atrium of the heart;

wherein the generated electrical signals are configured to deliver excitatory stimulation to the heart;

wherein the excitatory stimulation is configured to cause the atrium to contract against a closed heart valve associated with the atrium such that the contraction distends the atrium with blood, and the distending atrium results in an increased secretion of an atrial hormone that reduces vasoconstriction and/or sodium retention; and

wherein the distending atrium results in a therapeutic increase in secretion of atrial natriuretic peptide and/or brain natriuretic peptide.

20. The pacemaker of claim 19, wherein the therapeutic increase in secretion reduces heart failure symptoms of the patient.

21. The pacemaker of claim 19, wherein the therapeutic increase in secretion reduces collagen accumulation and a pathologic remodeling that contributes to progressive congestive heart failure.

22. The pacemaker of claim 19, wherein the therapeutic increase in secretion provides beneficial physiological and clinical sequelae in the patient.

23. A programmable implantable pacemaker for treatment of heart failure, the pacemaker connectable to at least one electrically conductive lead for connecting to a heart of a patient, and the pacemaker being programmed to generate electrical signals to be conveyed to the heart through the at least one electrically conductive lead, such that the electrical signals artificially pace an atrium of the heart;

wherein the generated electrical signals are configured to deliver excitatory stimulation to the heart;

wherein the excitatory stimulation is configured to cause the atrium to contract against a closed heart valve associated with the atrium such that the contraction distends the atrium with blood, and the distending atrium results in an increased secretion of an atrial hormone that reduces vasoconstriction and/or sodium retention; and

wherein the closed heart valve associated with the atrium is a normally-functioning heart valve.

24. The pacemaker of claim 23, wherein the pacemaker is programmed to alternate between a first pacing period of time that comprises the atrium contracting against the closed heart valve and a second pacing period of time that is different from the first pacing period.

25. The pacemaker of claim 24, wherein the second pacing period comprises synchronous atria-ventricular pacing.

26. The pacemaker of claim 23, wherein the excitatory stimulation causes the atrium to contract during heart systole, when a ventricle of the heart is refractory to stimulation.

27. The pacemaker of claim 23, wherein the excitatory stimulation causes the atrium to contract when the heart valve is closed by a ventricular pressure that exceeds a pressure of the atrium.

28. The pacemaker of claim 23, wherein the pacemaker is programmed to deliver the excitatory stimulation to the heart following an end of an atrial refractory period and before an end of a ventricular refractory period.

29. The pacemaker of claim 28, wherein the pacemaker is programmed to sense electrical signals generated by the heart and conveyed to the programmable implantable pacemaker through the at least one electrically conductive lead, and based on the sensed electrical signals, determine the atrial refractory period and the ventricular refractory period.

30. The pacemaker of claim 23, wherein the pacemaker is programmed to deliver the excitatory stimulation at or after a middle of ventricular systole when the atrium is distended by passive filling with blood.

31. The pacemaker of claim 23, wherein the increased secretion of the atrial hormone overcomes detriments from reduced atrial contribution to cardiac output.

32. The pacemaker of claim 23, wherein the increased secretion of the atrial hormone offsets suboptimal performance of the heart due to reduced atrial contribution to cardiac output.

33. The pacemaker of claim 23, wherein the pacemaker is programmed to deliver the excitatory stimulation when the heart valve is closed by a ventricular pressure that exceeds a pressure of the atrium.

34. The pacemaker of claim 23, wherein the pacemaker is programmed to artificially pace the atrium by cyclically:

(a) causing artificially induced contractions of the atrium and (b) allowing naturally occurring contractions of the atrium.

35. The pacemaker of claim 23, wherein the pacemaker is programmed to pace a ventricle of the heart at a first rate and pace the atrium at a second rate that is faster than the first rate.

36. The pacemaker of claim 35, wherein the second rate is approximately two times the first rate.

37. The pacemaker of claim 23, wherein the excitatory stimulation causes the atrium to contract between a middle and an end of ventricular systole.

38. The pacemaker of claim 23, further comprising one or more electrically conductive leads connected to the pacemaker.

39. The pacemaker of claim 23, wherein the pacemaker is programmed to generate electrical signals that pace a ventricle of the heart at a normal rate.

40. The pacemaker of claim 23, wherein the excitatory stimulation causes the atrium to contract after the heart valve has been closed for a period during ventricular systole.