Methods and Apparatus to Increase Secretion of Endogenous Naturetic Hormones

• US 20140163600A1
• Filed: 08/06/2013
• Published: 06/12/2014
• Est. Priority Date: 03/02/2005
• Status: Active Grant

• Current Assignee: Backbeat Medical, LLC
• Original Assignee: Backbeat Medical, Inc.
• Inventors: Levin, Howard, Gelfand, Mark
• Granted Patent: US 9,687,636 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61M 2025/102 driven by a solenoid-activated pump
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10181 Means for forcing inflation fluid into the balloon
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61N 1/36117 for treating hypertension
• 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 1/37235 Aspects of the external programmer

Abstract

A method and apparatus for treatment of heart failure by increasing secretion of endogenous naturetic hormones ANP and BNP such as by stimulation of the heart atria. Heart pacing is done at an atrial contraction rate that is increased and can be higher than the ventricular contraction rate. Pacing may include mechanical distension of the right atrial appendage. An implantable device is used to periodically cyclically stretch the walls of the appendage with an implanted balloon.

Claims

1. A method for treating a patient comprising:

determining that the patient is suffering from a condition comprising at least one of hypertension, excessive fluid retention, and excessive sodium retention;

treating the condition by stressing a wall of at least one atrium of the heart beyond a natural stress condition of the wall, such that the stressed wall secretes a hormone at an elevated level above a natural secretion level occurring naturally when the wall of the at least one atrium is not stressed by the stressing; and

achieving a beneficial therapeutic effect in the patient by the hormone secreted at the elevated level, wherein the beneficial therapeutic effect includes a reduction in blood pressure.

2. The method of claim 1, wherein stressing the wall of the at least one atrium comprises expanding and contracting an expandable device implanted in an atrial appendage of the heart to temporarily stretch the wall of the at least one atrium.

3. The method of claim 2, wherein the expandable device comprises an inflatable balloon.

4. The method of claim 2, wherein expanding and contracting the expandable device comprises using an implanted pump connected to the expandable device to bidirectionally shuttle fluid in a closed system between the expandable device and the implanted pump.

5. The method of claim 2, further comprising anchoring the expandable device in an apex of a right atrial appendage of the heart.

6. The method of claim 1, wherein stressing the wall of the at least one atrium of the heart comprises stretching the wall and then restoring the wall to a substantially pre-stretched condition.

7. The method of claim 1, wherein stressing the wall of the at least one atrium comprises pacing the at least one atrium.

8. The method of claim 7, wherein pacing the at least one atrium is performed at an accelerated rate.

9. The method of claim 1, wherein stressing the wall of the at least one atrium comprises asynchronously pacing the at least one atrium and at least one ventricle of the heart such that a pacing rate of the at least one atrium exceeds a pacing rate of the at least one ventricle.

10. The method of claim 1, wherein stressing the wall of the at least one atrium comprises mechanical distension of a right atrial appendage of the heart.

11. The method of claim 1, wherein stressing the wall of the at least one atrium comprises pacing of the at least one atrium that results in increased contractions of the at least one atrium.

12. The method of claim 1, wherein stressing the wall of the at least one atrium of the heart comprises pacing of the at least on atrium that stresses the wall of the at least one atrium beyond the natural stress condition.

13. The method of claim 1, wherein the beneficial therapeutic effect includes at least one of:

limiting a degree of vasoconstriction, limiting a degree of sodium retention, increasing urine output, inhibiting a renin-angiotensin system, inhibiting endothelin secretion, inhibiting systemic and renal sympathetic activity, and counteracting effects of at least one of norepinephrine, endothelin, and angiotensin II.

14. A programmable implantable pacemaker connectable to at least one electrically conductive lead for connecting to a heart of a patient, the pacemaker being programmed to pace the heart of the patient to stress a wall of at least one atrium of the heart, such that, with the patient suffering from a condition comprising at least one of hypertension, excessive fluid retention, and excessive sodium retention:

the stressed wall secretes a hormone at an elevated level above a natural secretion level occurring naturally when the heart is not stressed by the pacing, and

a beneficial therapeutic effect is achieved in the patient by the hormone secreted at the elevated level, wherein the beneficial therapeutic effect includes a reduction in blood pressure.

15. The pacemaker of claim 14, wherein the pacemaker is programmed to stress the wall of the at least one atrium of the heart beyond a natural stress condition of the wall.

16. The pacemaker of claim 14, wherein the pacemaker is programmed to asynchronously pace the at least one atrium and at least one ventricle of the heart such that a pacing rate of the at least one atrium exceeds a pacing rate of the at least one ventricle.

17. The pacemaker of claim 14, wherein the pacemaker is programmed to pace the at least one atrium so as to cause increased contractions of the at least one atrium.

18. The pacemaker of claim 14, wherein the pacemaker is programmed to alternate pacing of the heart between a first pacing period that asynchronously paces the at least one atrium and a second pacing period that paces the at least one atrium normally.

19. The pacemaker of claim 14, wherein the pacemaker is programmed to alternate pacing of the heart between a first asynchronous pacing period and a second normal pacing period that synchronously paces the at least one atrium and at least one ventricle of the heart.

20. The pacemaker of claim 14, further comprising one or more electrically conductive leads connected to the pacemaker.

21. The pacemaker of claim 14, wherein the beneficial therapeutic effect includes at least one of:

limiting a degree of vasoconstriction, limiting a degree of sodium retention, increasing urine output, inhibiting a renin-angiotensin system, inhibiting endothelin secretion, inhibiting systemic and renal sympathetic activity, and counteracting effects of at least one of norepinephrine, endothelin, and angiotensin II.

22. A method for treating a patient comprising:

determining that the patient is suffering from a condition comprising at least one of hypertension, excessive fluid retention, and excessive sodium retention;

treating the condition by pacing a heart of the patient to stress a wall of at least one atrium of the heart, such that the stressed wall secretes a hormone at an elevated level above a natural secretion level occurring naturally when the heart is not stressed by the pacing; and

achieving a beneficial therapeutic effect in the patient by the hormone secreted at the elevated level, wherein the beneficial therapeutic effect includes a reduction in blood pressure.

23. The method of claim 22, wherein pacing the heart to stress the wall of the at least one atrium comprises alternating between a first pacing period that asynchronously paces the at least one atrium and a second pacing period that paces the at least one atrium normally.

24. The method of claim 22, wherein pacing the heart to stress the wall of the at least one atrium comprises a first asynchronous pacing period, and wherein the method further comprises alternating between the first asynchronous pacing period and a second normal pacing period that synchronously paces the at least one atrium and at least one ventricle of the heart.

25. The method of claim 24, wherein the first asynchronous pacing period comprises accelerated atrial pacing.

26. The method of claim 24, wherein pacing the heart comprises applying the first asynchronous pacing period three times per day.

27. The method of claim 22, wherein pacing the heart comprises pacing at least one ventricle of the heart.

28. The method of claim 22, wherein pacing the heart comprises pacing a ventricle of the heart at a first rate and pacing the at least one atrium at a second rate that is faster than the first rate.

29. The method of claim 28, wherein the first rate is within a range of about 50 to about 110 bpm and the second rate is within a range of about 120 to about 240 bpm.

30. The method of claim 22, wherein pacing the heart comprises pacing the heart to cyclically contract the at least one atrium, stress the wall of the at least one atrium, and restore the wall of the at least one atrium to a substantially pre-stressed condition.

31. The method of claim 22, wherein pacing the heart produces extra contractions of the at least one atrium.

32. The method of claim 22, wherein the beneficial therapeutic effect includes at least one of:

limiting a degree of vasoconstriction, limiting a degree of sodium retention, increasing urine output, inhibiting a renin-angiotensin system, inhibiting endothelin secretion, inhibiting systemic and renal sympathetic activity, and counteracting effects of at least one of norepinephrine, endothelin, and angiotensin II.