IP Library Granted Patent US 11,426,589
Granted Patent B2
US 11,426,589 · App. 16/663,573 · Granted Aug 30, 2022

Methods and systems for controlling blood pressure

Inventors: Yuval Mika (Closter, NJ); Darren Sherman (Fort Lauderdale, FL); Robert S. Schwartz (Inver Grove Heights, MN); Robert A. Van Tassel (Excelsior, MN); Daniel Burkhoff (Manhattan, NY)
Assignee: BackBeat Medical, LLC
A61N1/36564A61N1/36578A61F2/2403A61F2/2409A61N1/3682A61N1/36117A61N1/36521A61N1/36528A61N1/36585
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Quick Facts
Patent No.
US 11,426,589
App. No.
16/663,573
Granted
Aug 30, 2022
Kind
B2
Abstract

Systems and methods for controlling blood pressure via electrical stimulation of the heart are disclosed. Embodiments may include at least two different stimulation patterns, each configured to reduce blood pressure to a different degree, and may alternate between stimulation patterns based on the need of a patient, for example, alternating between day and night or between periods of strenuous and light activity. Some embodiments may take advantage of a slow baroreflex response that occurs after treatment is stopped, suspending treatment for extended periods, and then resuming treatment before blood pressure levels reach pretreatment values. Embodiments may control blood pressure by controlling atrial pressure and atrial stretch.

Claims (64)

1. A system for reducing blood pressure in a patient having a pretreatment blood pressure, the system comprising:

a stimulation circuit configured to deliver a stimulation pulse to at least one cardiac chamber of a heart of the patient; and

at least one controller configured to execute delivery of one or more stimulation patterns of stimulation pulses to the at least one cardiac chamber over a time interval,

wherein a first stimulation pattern of the one or more stimulation patterns reduces the blood pressure of the patient by a first reduction amount,

wherein a second stimulation pattern of the one or more stimulation patterns reduces the blood pressure of the patient by a second reduction amount,

wherein the first reduction amount is greater than the second reduction amount,

wherein the second reduction amount is greater than zero, and

wherein the at least one controller switches from delivery of the first stimulation pattern to delivery of the second stimulation pattern by adjusting gradually a degree of blood pressure change of the first stimulation pattern by using transient incremental adjustment or continuous adjustment of a parameter affecting the degree of blood pressure change, such that, upon discontinuing of the delivery of the first stimulation pattern, a post-treatment blood pressure of the patient remains less than the pretreatment blood pressure.

2. The system of claim 1 , wherein the first stimulation pattern and the second stimulation pattern are delivered in correlation with a variation in the patient's blood pressure that is not a result of stimulation.

3. The system of claim 2 , further comprising a blood pressure sensor configured to sense the patient's blood pressure.

4. The system of claim 1 , wherein the time interval is a 24-hour period, and wherein the first stimulation pattern and the second stimulation pattern are delivered based on need of the patient during the 24-hour period.

5. The system of claim 4 , wherein the first stimulation pattern is delivered during at least part of day and the second stimulation pattern is delivered during at least part of night.

6. The system of claim 4 , wherein the first stimulation pattern is delivered during a period of a first level of activity by the patient and the second stimulation pattern is delivered during a period of a second level of activity by the patient, and wherein the first level is lower than the second level.

7. The system of claim 1 , wherein the first stimulation pattern provides a first atrioventricular delay and the second stimulation pattern provides a second atrioventricular delay, and wherein the first atrioventricular delay is shorter than the second atrioventricular delay.

8. The system of claim 1 , wherein at least one of the stimulation pulses stimulates the heart such that an atrial pressure resulting from atrial contraction of an atrium overlaps in time a passive pressure build-up of the atrium, such that an atrial pressure of the atrium resulting from the stimulation is a combination of the atrial pressure resulting from atrial contraction and the passive pressure build-up and is higher than an atrial pressure of the atrium would be without the stimulation, and such that the blood pressure of the patient is reduced, and

wherein the one or more stimulation patterns comprise stimulating the heart such that atrial kick is reduced or prevented.

9. The system of claim 8 , wherein the higher atrial pressure is transient and does not result in chronic increase of atrial pressure.

10. The system of claim 1 , wherein the first stimulation pattern and the second stimulation pattern reduce or prevent atrial kick.

11. The system of claim 1 , wherein the at least one controller is configured to execute delivery of a third stimulation pattern of stimulation pulses to the at least one cardiac chamber over the time interval, and wherein the third stimulation pattern is different from the first stimulation pattern and the second stimulation pattern.

12. The system of claim 1 , wherein the at least one controller delivers the first stimulation pattern for at least one week and the second stimulation pattern for at least one week.

13. The system of claim 1 , wherein the parameter is atrioventricular delay, and adjusting the degree of blood pressure change of the first stimulation pattern comprises transient 5-ms incremental adjustments.

14. The system of claim 1 , wherein the parameter is atrioventricular delay, and adjusting the degree of blood pressure change of the first stimulation pattern comprises a constant rate of change of the atrioventricular delay.

15. The system of claim 1 , wherein the at least one controller adjusts a duration of the second stimulation pattern proportionally to the first reduction amount of the first stimulation pattern.

16. The system of claim 1 , wherein the at least one controller delivers the second stimulation pattern for a duration within a range of approximately 50% to approximately 80% of a duration of the first stimulation pattern.

17. The system of claim 1 , wherein the at least one controller delivers the second stimulation pattern for a duration approximately two-thirds of a duration of the first stimulation pattern.

18. The system of claim 1 , further comprising at least one sensor configured to sense excitation of the heart,

wherein the at least one controller delivers the first stimulation pattern by:

pacing a first cardiac chamber of the heart and, after a first delay, pacing a second cardiac chamber of the heart to obtain a desired blood pressure change;

receiving from the at least one sensor a first signal indicating intrinsic excitation of the first cardiac chamber and, after a second delay, pacing the second cardiac chamber;

determining a first blood pressure change resulting from the second delay;

comparing the first blood pressure change to the desired blood pressure change;

adjusting the second delay to a third delay intended to adjust the first blood pressure change closer to the desired blood pressure change;

receiving from the at least one sensor a second signal indicating intrinsic excitation of the first cardiac chamber and, after the third delay, pacing the second chamber;

determining a second blood pressure change resulting from the third delay;

determining that the second blood pressure change is substantially equal to the desired blood pressure change; and

delivering stimulation patterns to the heart that comprise pulses having the third delay between sensing intrinsic excitation of the first cardiac chamber and delivering a stimulation pulse to the second cardiac chamber.

19. A system for reducing blood pressure in a patient, the system comprising:

a stimulation circuit configured to deliver a stimulation pulse to at least one cardiac chamber of a heart of the patient;

at least one controller configured to execute delivery of one or more stimulation patterns of stimulation pulses to the at least one cardiac chamber over a time interval; and

at least one sensor configured to sense excitation of the heart,

wherein a first stimulation pattern of the one or more stimulation patterns reduces the blood pressure of the patient by a first reduction amount,

wherein a second stimulation pattern of the one or more stimulation patterns reduces the blood pressure of the patient by a second reduction amount,

wherein the first reduction amount is greater than the second reduction amount,

wherein the second reduction amount is greater than zero, and

wherein the at least one controller delivers the first stimulation pattern by:

pacing a first cardiac chamber of the heart and, after a first delay, pacing a second cardiac chamber of the heart to obtain a desired blood pressure change,

receiving from the at least one sensor a first signal indicating intrinsic excitation of the first cardiac chamber and, after a second delay, pacing the second cardiac chamber,

determining a first blood pressure change resulting from the second delay,

comparing the first blood pressure change to the desired blood pressure change,

adjusting the second delay to a third delay intended to adjust the first blood pressure change closer to the desired blood pressure change,

receiving from the at least one sensor a second signal indicating intrinsic excitation of the first cardiac chamber and, after the third delay, pacing the second chamber,

determining a second blood pressure change resulting from the third delay,

determining that the second blood pressure change is substantially equal to the desired blood pressure change, and

delivering stimulation patterns to the heart that comprise pulses having the third delay between sensing intrinsic excitation of the first cardiac chamber and delivering a stimulation pulse to the second cardiac chamber.

20. A method for delivering a blood pressure reducing electrical stimulation to a heart of a patient, the method comprising:

pacing a first chamber of the heart and, after a first delay, pacing a second chamber of the heart to obtain a desired blood pressure change;

sensing a first intrinsic excitation of the first chamber and, after a second delay, pacing the second chamber;

determining a first blood pressure change resulting from the second delay;

comparing the first blood pressure change to the desired blood pressure change;

adjusting the second delay to a third delay intended to adjust the first blood pressure change closer to the desired blood pressure change;

sensing a second intrinsic excitation of the first chamber and, after the third delay, pacing the second chamber;

determining a second blood pressure change resulting from the third delay;

determining that the second blood pressure change is substantially equal to the desired blood pressure change; and

delivering stimulation patterns to the heart that comprise pulses having the third delay between sensing intrinsic excitation of the first chamber and delivering a stimulation pulse to the second chamber.

Assignments (5)
SECURITY INTEREST Recorded Aug 7, 2025
From: ORCHESTRA BIOMED HOLDINGS, INC.; ORCHESTRA BIOMED, INC.; BACKBEAT MEDICAL, LLC; CALIBER THERAPEUTICS, LLC
To: MEDTRONIC, INC.
Reel/Frame 072341/0075 →
SECURITY INTEREST Recorded Aug 4, 2025
From: ORCHESTRA BIOMED HOLDINGS, INC.; ORCHESTRA BIOMED, INC.; BACKBEAT MEDICAL, LLC; CALIBER THERAPEUTICS, LLC
To: LIGAND PHARMACEUTICALS, INC.
Reel/Frame 072359/0219 →
SECURITY INTEREST Recorded Nov 6, 2024
From: ORCHESTRA BIOMED HOLDINGS, INC.; ORCHESTRA BIOMED, INC.; CALIBER THERAPEUTICS, LLC; BACKBEAT MEDICAL, LLC; FREEHOLD SURGICAL, LLC
To: HERCULES CAPITAL, INC.
Reel/Frame 069312/0758 →
ENTITY CONVERSION Recorded Aug 10, 2020
From: BACKBEAT MEDICAL, INC.
To: BACKBEAT MEDICAL, LLC
Reel/Frame 053449/0445 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 13, 2020
From: MIKA, YUVAL; SHERMAN, DARREN; SCHWARTZ, ROBERT S.; VAN TASSEL, ROBERT A.; BURKHOFF, DANIEL
To: BACKBEAT MEDICAL, INC.
Reel/Frame 052379/0386 →