Methods and apparatus to stimulate heart atria

• US 9,370,661 B2
• Filed: 11/29/2012
• Issued: 06/21/2016
• Est. Priority Date: 09/08/2008
• 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): Morales, Jon Eric C
• Application Number:
  US13/688,978
• Publication Number:
  US 20130331901A1
• Time in Patent Office: 1,300 Days
• Field of Search: 607/9, 607 17- 19, 607/23
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• 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 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• 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

Abstract

A method and apparatus for treatment of hypertension and heart failure by increasing secretion of endogenous atrial hormones by pacing of the heart atria. Atrial pacing is done during the ventricular refractory period resulting in premature atrial contraction that does not result in ventricular contraction. Pacing results in the atrial wall stress, peripheral vasodilation, ANP secretion. Concomitant reduction of the heart rate is monitored and controlled as needed with backup pacing.

Claims

1. A method for controllably reducing heart rate by pacing a heart of a patient having an atrium and a ventricle, the method comprising:

pacing, after a first ventricular contraction of the heart, an atrium of the heart, wherein the atrial pacing occurs after expiration of an atrial refractory period of the heart and during a ventricular refractory period of the heart; and

causing an atrial contraction as a result of the atrial pacing,

wherein the atrial contraction does not elicit a second ventricular contraction, and

wherein the atrial contraction causes a vasodilation and a release of a natriuretic hormone in the heart.

2. The method of claim 1, further comprising monitoring a ventricular contraction rate resulting from the atrial pacing to determine whether the atrial pacing conducts to the ventricle, and adjusting the atrial pacing based on the monitoring.

3. The method of claim 1, further comprising pacing the atrium upon expiration of a predetermined delay after the first ventricular contraction.

4. The method of claim 3, further comprising adjusting the predetermined delay based on a detected propagation of the atrial pacing to the ventricle.

5. The method of claim 3, wherein the predetermined delay is between approximately 150 milliseconds and 300 milliseconds after the first ventricular contraction.

6. The method of claim 1, further comprising monitoring a spontaneous heart beat after application of an atrial pacing pulse, and delivering another atrial pacing pulse if a predetermined delay after the first ventricular contraction is longer than a predetermined period corresponding to a lowest selected heart rate, wherein the another atrial pacing pulse generates ventricular contraction.

7. The method of claim 6, wherein the lowest selected heart rate is less than approximately 50 beats per minute.

8. The method of claim 1, wherein causing the atrial contraction as a result of the atrial pacing comprises causing the atrium to contract in approximately a middle of ventricular systole.

9. The method of claim 1, wherein causing the atrial contraction as a result of the atrial pacing comprises causing the atrium to contract when an atrioventricular valve between the atrium and the ventricle is closed.

10. The method of claim 1, wherein pacing the atrium comprises one of pacing the right atrium, pacing the left atrium, and pacing both the left and right atria.

11. The method of claim 1, wherein during a given cardiac cycle a first atrial contraction occurs followed by the first ventricular contraction, and wherein causing the atrial contraction as a result of the atrial pacing comprises causing a second atrial contraction after the first atrial contraction and the first ventricular contraction.

12. A method, carried out with an implanted heart muscle stimulator associated with a heart of a patient, for treating a blood pressure disorder in the patient, the patient having a pretreatment blood pressure, the method comprising:

pacing at least one chamber of the heart of the patient so as to cause an atrium of the heart to contract while a heart valve associated with the atrium is closed;

causing increased atrial wall stress as a result of the atrial contraction against the closed heart valve;

reducing the patient'"'"'s blood pressure from the pretreatment blood pressure as a result of the increased atrial wall stress; and

causing release of a natriuretic hormone as a result of the increased atrial wall stress, wherein the released natriuretic hormone contributes to the reduction in the blood pressure.

13. The method of claim 12, wherein the natriuretic hormone comprises atrial natriuretic peptide.

14. The method of claim 12, wherein pacing the at least one chamber comprises applying a pacing pulse timed relative to sensing or pacing of electrical activity of the at least one chamber.

15. The method of claim 12, wherein pacing the at least one chamber comprises applying a pacing pulse timed relative to sensing or pacing of electrical activity of at least one other chamber of the heart other than the paced at least one chamber of the heart.

16. The method of claim 12, further comprising monitoring a heart rate of the patient and pacing the heart such that the heart rate remains above a threshold minimum heart rate.

17. The method of claim 16, wherein the threshold minimum heart rate is 50 beats per minute.

18. The method of claim 12, wherein the pacing of the at least one chamber is performed only when a blood pressure of the patient exceeds a given blood pressure.

19. The method of claim 12, further comprising:

determining an exercise activity of the patient; and

suspending the pacing of the at least one chamber when a determined exercise activity of the patient is above a predetermined threshold level.

20. The method of claim 19, wherein determining the exercise activity comprises using one or more activity sensors to sense at least one of motion, respiration, and heart rhythm.

21. The method of claim 12, wherein the pacing of the at least one chamber is performed for part of a day.

22. The method of claim 12, wherein the pacing of the at least one chamber is performed intermittently.

23. The method of claim 12, wherein the pacing of the at least one chamber comprises pacing the at least one chamber above an intrinsic rate of the at least one chamber.

24. The method of claim 12, further comprising causing vasodilation as a result of the increased atrial wall stress.

25. The method of claim 24, wherein the vasodilation contributes to the reduction in the blood pressure.

26. The method of claim 12, further comprising causing neurological activation as a result of the increased atrial wall stress, wherein the neurological activation contributes to the reduction in the blood pressure.

27. The method of claim 12, wherein prior to pacing the at least one chamber of the heart, the method comprises one of sensing and pacing a first ventricular contraction of the heart.

28. The method of claim 12, further comprising timing the pacing of the at least one chamber so as to avoid propagation thereof to another chamber of the heart.

29. The method of claim 12, further comprising causing the atrium to distend as a result of the atrial contraction.

30. The method of claim 12, wherein the at least one chamber is the atrium.

31. The method of claim 12, further comprising causing a response in neurological activation as a result of the increased atrial wall stress, wherein the response in neurological activation contributes to the reduction in the blood pressure.

32. A device for treating a blood pressure disorder in a patient, the patient having a pretreatment blood pressure, the device comprising:

at least one electrically conductive lead configured to connect to a heart of the patient;

an electrical pulse generator connectable to the at least one electrically conductive lead and configured to;

generate electrical pulses to excitable heart tissue of the heart through the at least one electrically conductive lead,

wherein the electrical pulses pace at least one chamber of the heart so as to cause an atrium of the heart to contract while a heart valve associated with the atrium is closed such that the atrial contraction against the closed heart valve causes increased atrial wall stress, and

wherein the electrical pulse generator monitors a ventricular contraction rate resulting from the atrial pacing to determine whether the atrial pacing conducts to a ventricle, and adjusts the atrial pacing based on the monitoring.

33. The device of claim 32, wherein the at least one electrically conductive lead comprises a plurality of electrically conductive leads that are connectable to multiple chambers of the heart, and wherein the electrical pulse generator is configured to apply the electrical pulses to the multiple chambers through the plurality of electrically conductive leads.

34. The device of claim 32, wherein the electrical pulse generator monitors a spontaneous heart beat after application of an electrical pulse, and delivers another electrical pulse if a predetermined delay after a first ventricular contraction is longer than a predetermined period corresponding to a lowest selected heart rate, wherein the another electrical pulse generates ventricular contraction.

35. The device of claim 32, wherein the electrical pulse generator causes the atrium to contract in approximately a middle of ventricular systole.

36. The device of claim 32, wherein the electrical pulse generator is configured to sense or pace electrical activity of the at least one chamber and to apply the electrical pulses timed relative to the sensed or paced electrical activity.

37. The device of claim 32, wherein the electrical pulse generator is configured to sense or pace electrical activity of at least one other chamber of the heart other than the paced at least one chamber of the heart and to apply the electrical pulses timed relative to the sensed or paced electrical activity.

38. The device of claim 32, wherein the electrical pulse generator is configured to monitor a heart rate of the patient and pace the heart such that the heart rate remains above a threshold minimum heart rate.

39. The device of claim 32, further comprising one or more activity sensors that sense at least one of motion, respiration, and heart rhythm, and wherein the electrical pulse generator is further configured to receive electrical signals from the one or more activity sensors, determine an exercise activity of the patient, and suspend the pacing of the at least one chamber when a determined exercise activity of the patient is above a predetermined threshold level.

40. The device of claim 32, wherein the electrical pulse generator is further configured to:

sense electrical signals from the heart through the at least one electrically conductive lead;

determine, based on the electrical signals, an atrial refractory period and a ventricular refractory period of the heart; and

generate the electrical pulses to artificially pace the at least one chamber of the heart during a period between an end of the atrial refractory period and an end of the ventricular refractory period.

41. The device of claim 32, wherein the electrical pulse generator is programmed to generate the electrical pulses to the at least one chamber of the heart solely during a period between an end of an atrial refractory period and an end of a ventricular refractory period.

42. The device of claim 32, further comprising a blood pressure sensor that senses a blood pressure of the patient, wherein the electrical pulse generator is configured to pace the at least one chamber of the heart when the blood pressure sensed by the blood pressure sensor exceeds a given blood pressure.

43. The device of claim 32, wherein the electrical pulse generator is configured to pace the at least one chamber of the heart at discrete times during a day separated by periods during which pacing of the at least one chamber is not performed.

44. The device of claim 32, wherein the electrical pulse generator is configured to pace the at least one chamber intermittently.

45. The device of claim 32, wherein the electrical pulse generator is configured to pace the at least one chamber above an intrinsic rate of the at least one chamber.

46. A device for treating a blood pressure disorder in a patient, the patient having a pretreatment blood pressure, the device comprising:

at least one electrically conductive lead configured to connect to a heart of the patient;

an electrical pulse generator connectable to the at least one electrically conductive lead and configured to;

generate electrical pulses to excitable heart tissue of the heart through the at least one electrically conductive lead,

wherein the electrical pulses pace at least one chamber of the heart so as to;

cause an atrium of the heart to contract while a heart valve associated with the atrium is closed,

cause increased atrial wall stress as a result of the atrial contraction against the closed heart valve,

reduce the patient'"'"'s blood pressure from the pretreatment blood pressure as a result of the increased atrial wall stress, and

cause release of a natriuretic hormone as a result of the increased atrial wall stress, wherein the released natriuretic hormone contributes to the reduction in the blood pressure.

47. A method for controllably reducing heart rate by pacing a heart of a patient having an atrium and a ventricle, the method comprising:

pacing, after a first ventricular contraction of the heart, an atrium of the heart, wherein the atrial pacing occurs after expiration of an atrial refractory period of the heart and during a ventricular refractory period of the heart; and

causing an atrial contraction as a result of the atrial pacing,

wherein the atrial contraction does not elicit a second ventricular contraction, and

wherein causing the atrial contraction as a result of the atrial pacing comprises causing the atrium to contract when the atrium is distended with blood.