Methods and systems for treating cardiac malfunction

• US 10,342,982 B2
• Filed: 09/08/2016
• Issued: 07/09/2019
• Est. Priority Date: 09/11/2015
• Status: Active Grant

• Current Assignee: Backbeat Medical, LLC
• Original Assignee: Backbeat Medical, Inc.
• Inventors: Mika, Yuval, Sherman, Darren, Burkhoff, Daniel
• Primary Examiner(s): Levicky, William J
• Application Number:
  US15/259,282
• Publication Number:
  US 20170072203A1
• Time in Patent Office: 1,034 Days
• 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 1/36564 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 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence

Abstract

Methods and systems for treating cardiac malfunction are disclosed, which according to an embodiment, may involve delivering a stimulation pattern of stimulation pulses to at least one cardiac chamber of a heart, with at least one of the stimulation pulses having a first stimulation setting configured to reduce at least one of end systolic volume (ESV) and end diastolic volume (EDV) in the heart and at least one of the stimulation pulses having a second stimulation setting different from the first stimulation setting, and with the stimulation pattern being configured to reduce the at least one of end systolic volume (ESV) and end diastolic volume (EDV) by at least 5% and maintain the at least one of end systolic volume (ESV) and end diastolic volume (EDV) on average at such reduced volume for a time period of at least one hour.

Claims

1. A system for treating cardiac malfunction, comprising:

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

at least one controller configured to execute delivery of a stimulation pattern of stimulation pulses to the at least one cardiac chamber over a time period of at least three months,

wherein at least one of the stimulation pulses has a first stimulation setting configured to reduce end diastolic volume (EDV) in the heart of the patient and at least one of the stimulation pulses has a second stimulation setting different from the first stimulation setting, and

wherein the stimulation pattern is configured to;

reduce, during the time period of at least three months, the end diastolic volume (EDV) by at least 5%,

maintain, during the time period of at least three months, the end diastolic volume (EDV) in the heart of the patient on average at such reduced volume, and

maintain, during the time period of at least three months, blood pressure of the patient within an average pressure of ±

10% as compared to a pretreatment blood pressure value.

2. The system of claim 1, wherein the at least one controller is configured to receive input data relating to at least one sensed parameter indicative of cardiac strain for the time period and to adjust the stimulation pattern configuration according to the at least one sensed parameter.

3. The system of claim 2, further comprising at least one sensor configured to sense the at least one sensed parameter and to communicate the input data to the at least one controller.

4. The system of claim 3, wherein the at least one controller, the stimulation circuit, and the at least one sensor are combined in a single device.

5. A method for treating cardiac malfunction, comprising:

delivering over a time period of at least three months a stimulation pattern of stimulation pulses to at least one cardiac chamber of a heart of a patient,

wherein at least one of the stimulation pulses has a first stimulation setting configured to reduce end diastolic volume (EDV) in the heart of the patient and at least one of the stimulation pulses has a second stimulation setting different from the first stimulation setting;

reducing, by delivery of the stimulation pattern over the time period of at least three months, the end diastolic volume (EDV) by at least 5%,

maintaining, by delivery of the stimulation pattern over the time period of at least three months, the end diastolic volume (EDV) in the heart of the patient on average at such reduced volume for the time period of at least three months, and

maintaining, by delivery of the stimulation pattern over the time period of at least three months, blood pressure of the patient within an average pressure of ±

10% as compared to a pretreatment blood pressure value for the time period of at least three months.

6. The method of claim 5, wherein the time period is at least twenty-four months, and wherein the maintaining the end diastolic volume (EDV) comprises maintaining the end diastolic volume (EDV) on average at such reduced volume for the time period of at least twenty-four months.

7. The method of claim 5, wherein the stimulation pattern is configured to reduce cardiac strain, as measured by wall tension, by at least 2% and maintain the cardiac strain on average at such reduced strain for the time period.

8. The method of claim 5, wherein the stimulation pattern is configured to limit reduction in ejection fraction of the heart to a maximum of 6% reduction and a time average of 2% reduction.

9. The method of claim 5, wherein the stimulation pattern is configured to prevent cardiac remodeling in the patient.

10. The method of claim 5, further comprising:

applying the stimulation pattern at a stimulation pattern configuration for a first period;

sensing cardiac strain for the first period; and

adjusting the stimulation pattern configuration according to the sensing.

11. The method of claim 5, wherein the first stimulation setting is configured to reduce the end diastolic volume (EDV) by at least 5% and the second stimulation setting is configured to reduce a baroreflex response or adaptation to the reduction in the end diastolic volume (EDV).

12. The method of claim 5, wherein the stimulation pattern is configured to reduce a baroreflex response or adaptation to the reduction in the end diastolic volume (EDV).

13. The method of claim 5, wherein the first stimulation setting is configured to reduce the end diastolic volume (EDV) by at least 5% and the second stimulation setting is configured to reduce a neuronal response or adaptation to the reduction in the end diastolic volume (EDV).

14. The method of claim 5, wherein the stimulation pattern is configured to reduce a neuronal response or adaptation to the reduction in the end diastolic volume (EDV).

15. The method of claim 5, wherein the first stimulation setting is configured to reduce the end diastolic volume (EDV) by at least 5% and the second stimulation setting is configured to increase hormonal secretion.

16. The method of claim 5, wherein the stimulation pattern is configured to increase hormonal secretion.

17. The method of claim 5, wherein the first stimulation setting comprises stimulating a ventricle of the heart 40-90 milliseconds after atrial activation.

18. The method of claim 17, wherein the second stimulation setting comprises stimulating an atrium of the heart to thereby produce atrial stimulation.

19. The method of claim 5, wherein the second stimulation setting comprises stimulating a ventricle of the heart 100-180 milliseconds after atrial activation.

20. The method of claim 5, wherein the second stimulation setting comprises allowing a natural AV delay to occur.

21. The method of claim 5, wherein the stimulation pattern includes at least 4 consecutive heartbeats having the first stimulation setting for every 1 consecutive heartbeat having the second stimulation setting.

22. The method of claim 21, wherein the stimulation pattern includes at least 8 consecutive heartbeats having the first stimulation setting for every 1 consecutive heartbeat having the second stimulation setting.

23. The method of claim 5, wherein the stimulation pattern comprises at least one stimulation pulse having a third stimulation setting different from the first and second stimulation settings.

24. The method of claim 5, wherein the cardiac malfunction is associated with an increase in at least one of end systolic volume (ESV) or end diastolic volume (EDV).

25. The method of claim 5, wherein the cardiac malfunction is congestive heart failure.

26. The method of claim 5, further comprising:

applying the stimulation pattern at a stimulation pattern configuration for a first period;

sensing at least one parameter indicative of at least one of end systolic volume (ESV), end diastolic volume (EDV), cardiac strain, or blood pressure for the first period; and

adjusting the stimulation pattern configuration according to the sensing.

27. The method of claim 26, wherein the adjusting the stimulation pattern includes adjusting at least one of the first stimulation setting or the second stimulation setting.

28. The method of claim 26, wherein the adjusting the stimulation pattern configuration includes adjusting at least one of the number or proportion of at least one of stimulation pulses having the first stimulation setting or stimulation pulses having the second stimulation setting within the stimulation pattern.

29. The method of claim 5, wherein the stimulation pattern limits, during the time period, reduction in ejection fraction of the heart to a maximum of 6% reduction.

30. A method for treating cardiac malfunction, comprising:

delivering over a time period of at least twenty-four months a stimulation pattern of stimulation pulses to at least one cardiac chamber of a heart of a patient,

wherein at least one of the stimulation pulses has a first stimulation setting that stimulates a ventricle of the heart 40-90 milliseconds after atrial activation and reduces end diastolic volume (EDV) in the heart of the patient,

wherein at least one of the stimulation pulses has a second stimulation setting that stimulates the ventricle 100-180 milliseconds after atrial activation, and

wherein the stimulation pattern includes at least 4 consecutive heartbeats having the first stimulation setting for every 1 consecutive heartbeat having the second stimulation setting,

such that the stimulation pattern;

reduces, during the time period, the end diastolic volume (EDV) by an average of at least 5%,

maintains, during the time period, the end diastolic volume (EDV) in the heart of the patient on average at such reduced volume, and

maintains, during the time period, blood pressure of the patient within an average pressure of ±

10% as compared to a pretreatment blood pressure value.