Methods and systems for lowering blood pressure through reduction of ventricle filling

• US 10,610,689 B2
• Filed: 03/05/2018
• Issued: 04/07/2020
• Est. Priority Date: 12/21/2012
• Status: Active Grant

• Current Assignee: Backbeat Medical, LLC
• Original Assignee: Backbeat Medical, Inc.
• Inventors: Mika, Yuval, Sherman, Darren, Schwartz, Robert S., Van Tassel, Robert A., Burkhoff, Daniel
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US15/911,249
• Publication Number:
  US 20180256899A1
• Time in Patent Office: 764 Days
• Field of Search: 607 9, 607 17, 607 23
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2424 Ball valves
• CPC Class Codes: A61F 2250/0013 for adjusting fluid pressure
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36528 the parameter being measured by means of ultrasound
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/36571 controlled by blood flow rate, e.g. blood velocity or cardiac output
• CPC Class Codes: A61N 1/36578 controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3682 with a variable atrioventricular delay
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation

Abstract

Systems and methods for reducing ventricle filling volume are disclosed. In some embodiments, a stimulation circuit may be used to stimulate a patient'"'"'s heart to reduce ventricle filling volume or even blood pressure. When the heart is stimulated at a consistent rate to reduce blood pressure, the cardiovascular system may over time adapt to the stimulation and revert back to the higher blood pressure. In some embodiments, the stimulation pattern may be configured to be inconsistent such that the adaptation response of the heart is reduced or even prevented. In some embodiments, a stimulation circuit may be used to stimulate a patient'"'"'s heart to cause at least a portion of an atrial contraction to occur while the atrioventricular valve is closed. Such an atrial contraction may deposit less blood into the corresponding ventricle than when the atrioventricular valve is opened throughout an atrial contraction.

Claims

1. A system for reducing blood pressure comprising:

at least one stimulation electrode for stimulating at least one chamber of a heart of a patient with a stimulation pattern comprising at least one stimulation pulse; and

at least one controller configured to;

receive input relating to blood pressure of the patient; and

adjust the stimulation pattern based on the blood pressure,

wherein the stimulation pattern is configured to cause a reduction in blood pressure of the patient by at least a predetermined amount within about 3 seconds from an application of electricity to the heart, and to maintain the reduction in blood pressure for a time interval of at least 1 minute.

2. The system of claim 1, wherein the at least one controller is configured to adjust the stimulation pattern by performing an adjustment process that includes adjusting a parameter of a first stimulation setting of at least one of the at least one stimulation pulse.

3. The system of claim 2, wherein the first stimulation setting is configured to reduce or prevent atrial kick in at least one ventricle.

4. The system of claim 3, wherein the parameter is adjustment of AV delay.

5. The system of claim 1, wherein the time interval is at least 5 minutes.

6. The system of claim 1, wherein the predetermined amount of blood pressure reduction is 8 mmHg or more.

7. The system of claim 1, wherein the predetermined amount of blood pressure reduction is at least 4% of a pretreatment blood pressure of the patient.

8. The system of claim 1, wherein the patient'"'"'s blood pressure does not exceed a predetermined average value during the time interval by more than a predetermined degree.

9. The system of claim 8, wherein the predetermined degree is a difference of about 8 mmHg or less.

10. The system of claim 8, wherein the predetermined degree is a percentage of the predetermined amount within a range of about 26% to 100%.

11. The system of claim 1, wherein the at least one controller is configured to:

execute a plurality of stimulation patterns and receive for each of the stimulation patterns a corresponding input data set relating to the patient'"'"'s blood pressure during the stimulation;

calculate for each of the plurality of stimulation patterns at least one blood pressure variation parameter relating to the input data set; and

adjust the stimulation pattern according to the at least one blood pressure variation parameter.

12. The system of claim 11, wherein the at least one controller is configured to adjust the stimulation pattern to be the one with the best blood pressure variation parameter.

13. The system of claim 11, wherein at least two stimulation patterns of the plurality of stimulation patterns each comprise at least one stimulation pulse having a stimulation setting configured to reduce or prevent atrial kick in at least one ventricle, and wherein the at least two stimulation patterns differ one from another by the number of times or the length of time the at least one stimulation pulse is provided in sequence.

14. The system of claim 11, wherein the plurality of stimulation patterns differs by the number of times or the length of time that the system is configured to elicit a predetermined AV delay in sequence.

15. The system of claim 11, wherein at least two stimulation patterns of the plurality of stimulation patterns differ one from another by one or more stimulation settings included within each of the at least two stimulation patterns.

16. The system of claim 11, wherein the plurality of stimulation patterns includes a first stimulation pattern and a second stimulation pattern executed after the first stimulation pattern, the second stimulation pattern having at least one stimulation setting that was set based on an algorithm using blood pressure variation parameters relating to the input data set of the first stimulation pattern.

17. The system of claim 11, comprising a blood pressure sensor for providing the input data set relating to the patient'"'"'s blood pressure.

18. The system of claim 17, wherein the blood pressure sensor is implantable.

19. The system of claim 17, wherein the blood pressure sensor and the at least one controller are configured to operate at least partially as a closed loop.

20. A system for reducing blood pressure comprising:

at least one stimulation electrode for stimulating at least one chamber of a heart of a patient with a stimulation pulse; and

a controller configured to;

provide a first stimulation pattern comprising at least one stimulation setting configured to reduce or prevent atrial kick in at least one ventricle for a first time interval and to receive a first input data set relating to a patient'"'"'s blood pressure during said first time interval,

wherein the first stimulation pattern is configured to cause a reduction in blood pressure of the patient by at least a predetermined amount within about 3 seconds from an application of electricity to the heart, and to maintain the reduction in blood pressure for a time interval of at least 1 minute;

calculate at least one blood pressure variation parameter relating to the first input data set;

adjust at least one parameter of a second stimulation pattern comprising a second stimulation setting configured to reduce or prevent atrial kick in at least one ventricle, the second stimulation setting being based upon the at least one blood pressure variation parameter; and

provide the second stimulation pattern for a second time interval.

21. The system of claim 20, wherein the controller is configured to adjust the at least one parameter of the second stimulation pattern to provide a lowest degree of baroreflex response, or a lowest degree or a lowest rate of adaptation.

22. A system for reducing blood pressure comprising:

at least one stimulation electrode for stimulating at least one chamber of a heart of a patient with a stimulation pattern comprising at least one stimulation pulse; and

at least one controller configured to;

receive input relating to blood pressure of the patient,

adjust the stimulation pattern based on the blood pressure,

execute a plurality of stimulation patterns and receive for each of the stimulation patterns a corresponding input data set relating to the patient'"'"'s blood pressure during the stimulation,

calculate for each of the plurality of stimulation patterns at least one blood pressure variation parameter relating to the input data set,

adjust the stimulation pattern according to the at least one blood pressure variation parameter, to be the one with the best blood pressure variation parameter, and

wherein the best blood pressure variation parameter is one that displays a lowest degree of baroreflex response, or a lowest degree or a lowest rate of adaptation.

23. A system for reducing blood pressure comprising:

at least one stimulation electrode for stimulating at least one chamber of a heart of a patient with a stimulation pattern comprising at least one stimulation pulse; and

at least one controller configured to;

receive input relating to blood pressure of the patient,

adjust the stimulation pattern based on the blood pressure,

execute a plurality of stimulation patterns and receive for each of the stimulation patterns a corresponding input data set relating to the patient'"'"'s blood pressure during the stimulation,

calculate for each of the plurality of stimulation patterns at least one blood pressure variation parameter relating to the input data set,

adjust the stimulation pattern according to the at least one blood pressure variation parameter, to be the one with the best blood pressure variation parameter, and

wherein the best blood pressure variation parameter is one that displays a baroreflex response within a predetermined range or a degree of adaptation within a predetermined range.