Methods and apparatus to increase secretion of endogenous naturetic hormones

• US 9,687,636 B2
• Filed: 08/06/2013
• Issued: 06/27/2017
• Est. Priority Date: 03/02/2005
• Status: Active Grant

• Current Assignee: Backbeat Medical, LLC
• Original Assignee: Backbeat Medical, Inc.
• Inventors: Gelfand, Mark, Levin, Howard
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US13/960,015
• Publication Number:
  US 20140163600A1
• Time in Patent Office: 1,421 Days
• Field of Search: 607 9, 607 23, 607 44
• 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 suffering from a condition comprising at least one of hypertension, excessive fluid retention, and excessive sodium retention, the method comprising:

treating the condition by stressing a wall of at least one atrium of a heart of the patient 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,

wherein stressing the wall of the at least one atrium of the heart comprises;

synchronously pacing the heart of the patient during a first pacing period,

pacing, during a second pacing period lasting at least long enough to cause secretion of the hormone at the elevated level, the heart of the patient to cyclically contract and stretch the at least one atrium, stress the wall of the at least one atrium due to the stretch, and restore the wall of the at least one atrium to substantially the natural stress condition, and

alternating in a preset pattern between repetitions of the synchronous pacing of the first pacing period and the pacing of the second pacing period,

wherein the second pacing period is applied at least two preset times per day at durations each lasting at least ten minutes,

such that the stressed wall secretes the hormone at an elevated level above a natural secretion level occurring naturally when the heart is not stressed by the pacing of the repetitions of the second pacing period.

2. The method of claim 1, wherein the pacing of the second pacing period comprises pacing the at least one atrium.

3. The method of claim 2, wherein pacing the at least one atrium is performed at an accelerated rate.

4. The method of claim 1, wherein the pacing of the second pacing period 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.

5. The method of claim 1, wherein the pacing of the second pacing period comprises pacing of the at least one atrium that results in an increased contraction rate of the at least one atrium.

6. 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.

7. The method of claim 1, wherein synchronously pacing the heart comprises pacing the at least one atrium and at least one ventricle of the heart.

8. The method of claim 1, wherein the second pacing period comprises accelerated atrial pacing.

9. The method of claim 1, wherein stressing the wall of the at least one atrium of the heart comprises applying the pacing of the second pacing period at three separate times per day.

10. The method of claim 1, wherein synchronously pacing the heart comprises pacing at least one ventricle of the heart.

11. The method of claim 1, wherein the pacing of the second pacing period 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.

12. The method of claim 11, 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.

13. The method of claim 1, wherein the pacing of the second pacing period produces extra contractions of the at least one atrium.

14. The method of claim 1, wherein the second pacing period lasts up to thirty minutes.

15. The method of claim 1, wherein the second pacing period is applied at least three times per day at varying durations each lasting within a range of about 10 minutes to about 60 minutes.

16. A programmable implantable pacemaker connectable to at least one electrically conductive lead for connecting to a heart of a patient suffering from a condition comprising at least one of hypertension, excessive fluid retention, and excessive sodium retention,

wherein the pacemaker is programmed to treat the condition by stressing a wall of at least one atrium of the heart of the patient 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,

wherein the pacemaker is programmed to achieve 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, and

wherein to stress the wall of the at least one atrium of the heart, the pacemaker is programmed to:

synchronously pace the heart of the patient during a first pacing period,

pace, during a second pacing period lasting at least long enough to cause secretion of the hormone at the elevated level, the heart of the patient to cyclically contract and stretch the at least one atrium, stress the wall of the at least one atrium due to the stretch, and restore the wall of the at least one atrium to substantially the natural stress condition, and

alternate in a preset pattern between repetitions of the synchronous pacing of the first pacing period and the pacing of the second pacing period,

wherein the second pacing period is applied at least two preset times per day at durations each lasting at least ten minutes,

such that the stressed wall secretes the hormone at an elevated level above a natural secretion level occurring naturally when the heart is not stressed by the pacing of the repetitions of the second pacing period.

17. The pacemaker of claim 16, 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.

18. The pacemaker of claim 16, wherein the pacemaker is programmed to pace the at least one atrium so as to cause an increased contraction rate of the at least one atrium.

19. The pacemaker of claim 16, wherein the pacemaker is programmed to pace the at least one atrium of the heart in the first pacing period and the second pacing period.

20. The pacemaker of claim 16, wherein the pacemaker is programmed to synchronously pace the at least one atrium and at least one ventricle of the heart during the first pacing period.

21. The pacemaker of claim 16, further comprising one or more electrically conductive leads connected to the pacemaker.

22. The pacemaker of claim 16, 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.

23. The pacemaker of claim 16, wherein the second pacing period is applied at three separate times per day.

24. The pacemaker of claim 16, wherein the second pacing period lasts up to thirty minutes.

25. The pacemaker of claim 16, wherein the second pacing period is applied at least three times per day at varying durations each lasting within a range of about 10 minutes to about 60 minutes.