Systems, devices, and methods for improving hemodynamic performance through asymptomatic diaphragm stimulation

• US 10,335,592 B2
• Filed: 10/07/2016
• Issued: 07/02/2019
• Est. Priority Date: 12/19/2012
• Status: Active Grant

• Current Assignee: Viscardia, Inc.
• Original Assignee: Viscardia, Inc.
• Inventors: Bauer, Peter T., Chinchoy, Edward, Snell, Jay
• Primary Examiner(s): Fairchild, Mallika D
• Application Number:
  US15/288,130
• Publication Number:
  US 20170021166A1
• Time in Patent Office: 998 Days
• CPC Class Codes: A61B 2562/063 in a linear array
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6867 specially adapted to be attached or implanted in a specific body part A61B5/6847 takes precedence
• CPC Class Codes: A61B 5/721 using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
• CPC Class Codes: A61N 1/3601 of respiratory organs
• 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 1/36585 controlled by two or more physical parameters

Abstract

Hemodynamic performance of a heart may be improved by determining, from a location associated with a diaphragm, an occurrence of a valid cardiac event; and then delivering asymptomatic electrical stimulation therapy directly to the diaphragm at termination of a diaphragmatic stimulation delay period that is timed relative to the occurrence of the valid cardiac event. The diaphragmatic stimulation delay period may be automatically established by sensing a plurality of cardiac events directly from a diaphragm; and for each of the sensed cardia events, determining whether the sensed cardiac event represents a valid cardiac event or a non-valid cardiac event. The diaphragmatic stimulation delay period is then calculated based on a plurality of sensed cardia events that are determined to be valid.

Claims

1. A method of improving hemodynamic performance of a heart, the method comprising:

sensing a plurality of cardiac events directly from a diaphragm;

for each of the sensed cardiac events, determining whether the sensed cardiac event represents a valid cardiac event or a non-valid cardiac event;

establishing a diaphragmatic stimulation delay period based on a plurality of sensed cardiac events that are determined to be valid; and

delivering asymptomatic electrical stimulation therapy directly to the diaphragm based on the established diaphragmatic stimulation delay period.

2. The method of claim 1, wherein:

determining whether the sensed cardiac event represents a valid cardiac event or a non-valid cardiac event comprises determining a present characteristic of a waveform of the sensed cardiac event, and comparing the present characteristic of the waveform of the sensed cardiac event to a baseline characteristic of a waveform of a valid cardiac event to obtain a comparison outcome, and

a non-valid cardiac event is determined when the comparison outcome between the present characteristic and the baseline characteristic fails to satisfy a criterion.

3. The method of claim 2, wherein the present characteristic and the baseline characteristic correspond to a same characteristic, the same characteristic being one of:

an amplitude of a waveform, and an interval of a waveform.

4. The method of claim 1, wherein:

determining whether the sensed cardiac event represents a valid cardiac event or a non-valid cardiac event comprises determining a present timing between the sensed cardiac event and a prior sensed cardiac event, and comparing the present timing between the sensed cardiac event and the prior sensed cardiac event to a baseline timing between successive baseline valid cardiac events to obtain a comparison outcome, and

a non-valid cardiac event is determined when the comparison outcome between the present timing and the baseline timing fails to satisfy a criterion.

5. The method of claim 1, wherein establishing a diaphragmatic stimulation delay period comprises:

determining a plurality of measures of time, each of the plurality of measures of time corresponding to a measure of time between a pair of successive sensed cardiac events that are determined to be valid;

determining a statistical value based on the determined plurality of measures of time; and

setting the diaphragmatic stimulation delay period based on the statistical value.

6. The method of claim 5, wherein:

the pair of successive sensed cardiac events that are determined to be valid correspond to either of;

     1) a valid atrial event followed by a valid ventricular event, or

     2) a first valid ventricular event of a first type followed by a second valid ventricular event of the first type, and

the diaphragmatic stimulation delay period is set to a value less than the statistical value to provide early diaphragmatic stimulation, or greater than the statistical value to provide late diaphragmatic stimulation.

7. The method of claim 5, wherein establishing a diaphragmatic stimulation delay period further comprises:

determining a subsequent statistical value based on a plurality of subsequently determined measures of time, each of the plurality of subsequent measures of time corresponding to a measure of time between a pair of successive sensed cardiac events that are determined to be valid;

comparing the subsequent statistical value to the statistical value upon which the diaphragmatic stimulation delay period is based to obtain a comparison outcome; and

maintaining or adjusting the diaphragmatic stimulation delay period based on the comparison outcome.

8. The method of claim 7, wherein maintaining or adjusting the diaphragmatic stimulation delay period comprises one of:

maintaining the diaphragmatic stimulation delay period when the comparison outcome indicates no difference between the subsequent statistical value and the statistical value upon which the diaphragmatic stimulation delay period is based;

decreasing the diaphragmatic stimulation delay period as a function of the comparison outcome when the comparison outcome indicates the subsequent statistical value is less than the statistical value upon which the diaphragmatic stimulation delay period is based; and

increasing the diaphragmatic stimulation delay period as a function of the comparison outcome when the comparison outcome indicates the subsequent statistical value is greater than the statistical value upon which the diaphragmatic stimulation delay period is based.

9. The method of claim 1, wherein delivering asymptomatic electrical stimulation therapy directly to the diaphragm based on the established diaphragmatic stimulation delay period comprises:

detecting a cardiac event;

determine whether the cardiac event is valid or non-valid;

in response to a valid cardiac event, delivering electrical stimulation at the end of the diaphragmatic stimulation delay period timed relative to the occurrence of the valid cardiac event; and

in response to a non-valid cardiac event, withholding delivery of electrical stimulation at the end of the diaphragmatic stimulation delay period.

10. An implantable medical device comprising:

one or more electrodes configured to sense a plurality of cardiac events directly from a diaphragm; and

at least one electrical circuit structure configured to;

for each of the sensed cardiac events, determine whether the sensed cardiac event represents a valid cardiac event or a non-valid cardiac event;

establish a diaphragmatic stimulation delay period based on a plurality of sensed cardiac events that are determined to be valid; and

deliver asymptomatic electrical stimulation therapy directly to the diaphragm through the one or more electrodes based on the established diaphragmatic stimulation delay period.

11. The implantable medical device of claim 10, wherein:

the at least one electrical circuit structure is configured to determine whether the sensed cardiac event represents a valid cardiac event or a non-valid cardiac event by being further configured to determine a present characteristic of a waveform of the sensed cardiac event, and compare the present characteristic of the waveform of the sensed cardiac event to a baseline characteristic of a waveform of a valid cardiac event to obtain a comparison outcome, and

a non-valid cardiac event is determined when the comparison outcome between the present characteristic and the baseline characteristic fails to satisfy a criterion.

12. The implantable medical device of claim 11, wherein the present characteristic and the baseline characteristic correspond to a same characteristic, the same characteristic being one of:

an amplitude of a waveform, and an interval of a waveform.

13. The implantable medical device of claim 10, wherein:

the at least one electrical circuit structure is configured to determine whether the sensed cardiac event represents a valid cardiac event or a non-valid cardiac event by being further configured to determine a present timing between the sensed cardiac event and a prior sensed cardiac event, and compare the present timing between the sensed cardiac event and the prior sensed cardiac event to a baseline timing between successive baseline valid cardiac events to obtain a comparison outcome, and

a non-valid cardiac event is determined when the comparison outcome between the present timing and the baseline timing fails to satisfy a criterion.

14. The implantable medical device of claim 10, wherein the at least one electrical circuit structure is configured to establish a diaphragmatic stimulation delay period by being further configured to:

determine a plurality of measures of time, each of the plurality of measures of time corresponding to a measure of time between a pair of successive sensed cardiac events that are determined to be valid;

determine a statistical value based on the determined plurality of measures of time; and

set the diaphragmatic stimulation delay period based on the statistical value.

15. The implantable medical device of claim 14, wherein:

the pair of successive sensed cardiac events that are determined to be valid correspond to either of;

     1) a valid atrial event followed by a valid ventricular event, or

     2) a first valid ventricular event of a first type followed by a second valid ventricular event of the first type, and

the diaphragmatic stimulation delay period is set to a value less than the statistical value to provide early diaphragmatic stimulation, or greater than the statistical value to provide late diaphragmatic stimulation.

16. The implantable medical device of claim 14, wherein the at least one electrical circuit structure is configured to establish a diaphragmatic stimulation delay period by being further configured to:

determine a subsequent statistical value based on a plurality of subsequently determined measures of time, each of the plurality of subsequent measures of time corresponding to a measure of time between a pair of successive sensed cardiac events that are determined to be valid;

compare the subsequent statistical value to the statistical value upon which the diaphragmatic stimulation delay period is based to obtain a comparison outcome; and

maintain or adjust the diaphragmatic stimulation delay period based on the comparison outcome.

17. The implantable medical device of claim 16, wherein the at least one electrical circuit structure is configured to maintain or adjust the diaphragmatic stimulation delay period by being further configured to:

maintain the diaphragmatic stimulation delay period when the comparison outcome indicates no difference between the subsequent statistical value and the statistical value upon which the diaphragmatic stimulation delay period is based;

decrease the diaphragmatic stimulation delay period as a function of the comparison outcome when the comparison outcome indicates the subsequent statistical value is less than the statistical value upon which the diaphragmatic stimulation delay period is based; and

increase the diaphragmatic stimulation delay period as a function of the comparison outcome when the comparison outcome indicates the subsequent statistical value is greater than the statistical value upon which the diaphragmatic stimulation delay period is based.

18. The implantable medical device of claim 10, wherein the at least one electrical circuit structure is configured to deliver asymptomatic electrical stimulation therapy directly to the diaphragm based on the established diaphragmatic stimulation delay period by being further configured to:

detect a cardiac event;

determine whether the cardiac event is valid or non-valid;

in response to a valid cardiac event, deliver electrical stimulation at the end of the diaphragmatic stimulation delay period timed relative to the occurrence of the valid cardiac event; and

in response to a non-valid cardiac event, withhold delivery of electrical stimulation at the end of the diaphragmatic stimulation delay period.

19. A method for improving hemodynamic performance of a heart, the method comprising:

determining, from a location associated with a diaphragm, an occurrence of a valid cardiac event;

determining a termination of a delay period that is timed relative to the occurrence of the valid cardiac event; and

delivering asymptomatic electrical stimulation therapy directly to the diaphragm at the termination of the delay period.

20. The method of claim 19, wherein:

determining an occurrence of a valid cardiac event comprises one of;

     1) detecting a valid intrinsic atrial event at the location associated with the diaphragm, or

     2) receiving, at the location associated with the diaphragm, a signal from an implanted cardiac rhythm management device, which signal indicates that a valid intrinsic atrial event has been detected by the implanted cardiac rhythm management device; and

further comprising determining a time between an occurrence of an intrinsic atrial event and an occurrence of a following intrinsic ventricular event, wherein the delay period is based on the time.

21. The method of claim 19, wherein:

determining an occurrence of a valid cardiac event comprises one of

     1) detecting an atrial pacing stimulus at the location associated with the diaphragm, or

     2) receiving, at the location associated with the diaphragm, a signal from an implanted cardiac rhythm management device, which signal indicates that an atrial pacing stimulus has been delivered by the implanted cardiac rhythm management device; and

further comprising determining a time between an occurrence of an atrial pacing stimulus and an occurrence of a following intrinsic ventricular event, wherein the delay period is based on the time.

22. The method of claim 19, wherein:

determining an occurrence of a valid cardiac event comprises one of

     1) detecting an evoked atrial event at the location associated with the diaphragm, or

     2) receiving, at the location associated with the diaphragm, a signal from an implanted cardiac rhythm management device, which signal indicates that an evoked atrial event has been sensed by the implanted cardiac rhythm management device; and

further comprising determining a time between an occurrence of an evoked atrial event and an occurrence of a following intrinsic ventricular event wherein the delay period is based on the time.

23. The method of claim 19, wherein:

determining an occurrence of a valid cardiac event comprises one of;

     1) detecting a valid intrinsic ventricular event at the location associated with the diaphragm, or

     2) receiving, at the location associated with the diaphragm, a signal from an implanted cardiac rhythm management device, which signal indicates that a valid intrinsic ventricular event has been detected by the implanted cardiac rhythm management device; and

further comprising determining a time between an occurrence of an intrinsic ventricular event of a first type and an occurrence of a following intrinsic ventricular event of the first type, wherein the delay period is based on the time.

24. The method of claim 19, wherein:

determining an occurrence of a valid cardiac event comprises one of

     1) detecting a ventricular pacing stimulus at the location associated with the diaphragm, or

     2) receiving, at the location associated with the diaphragm, a signal from an implanted cardiac rhythm management device, which signal indicates that a ventricular pacing stimulus has been delivered by the implanted cardiac rhythm management device; and

further comprising determining a time between an occurrence of a ventricular pacing stimulus and an occurrence of a following ventricular pacing stimulus, wherein the delay period is based on the time.

25. The method of claim 19, wherein:

determining an occurrence of a valid cardiac event comprises one of

     1) detecting an evoked ventricular event at the location associated with the diaphragm, or

     2) receiving, at the location associated with the diaphragm, a signal from an implanted cardiac rhythm management device, which signal indicates that an evoked ventricular event has been sensed by the implanted cardiac rhythm management device; and

further comprising determining a time between an occurrence of an evoked ventricular event and an occurrence of a following evoked ventricular event, wherein the delay period is based on the time.

26. An implantable medical system for improving hemodynamic performance of a heart, the system comprising:

one or more electrical stimulation therapy elements configured for placement on or near a diaphragm; and

at least one electrical circuit structure coupled to the one or more electrical stimulation therapy elements and configured to;

determine, from a location associated with the diaphragm, an occurrence of a valid cardiac event; and

deliver asymptomatic electrical stimulation therapy directly to the diaphragm at termination of a delay period that is timed relative to the occurrence of the valid cardiac event.

27. The implantable medical system of claim 26, wherein:

the at least one electrical circuit structure is configured to determine an occurrence of a valid cardiac event by being further configured to at least one of;

     1) detect a valid intrinsic atrial event at the location associated with the diaphragm, or

     2) receive, at the location associated with the diaphragm, a signal from an implanted cardiac rhythm management device, which signal indicates that a valid intrinsic atrial event has been detected by the implanted cardiac rhythm management device; and

the delay period is based on a time between an occurrence of an intrinsic atrial event and an occurrence of a following intrinsic ventricular event.

28. The implantable medical system of claim 26, wherein:

the at least one electrical circuit structure is configured to determine an occurrence of a valid cardiac event by being further configured to at least one of

     1) detect an atrial pacing stimulus at the location associated with the diaphragm, or

     2) receive, at the location associated with the diaphragm, a signal from an implanted cardiac rhythm management device, which signal indicates that an atrial pacing stimulus has been delivered by the implanted cardiac rhythm management device; and

the delay period is based on a time between an occurrence of an atrial pacing stimulus and an occurrence of a following intrinsic ventricular event.

29. The implantable medical system of claim 26, wherein:

the at least one electrical circuit structure is configured to determining an occurrence of a valid cardiac event by being further configured to at least one of

     1) detect an evoked atrial event at the location associated with the diaphragm, or

     2) receive, at the location associated with the diaphragm, a signal from an implanted cardiac rhythm management device, which signal indicates that an evoked atrial event has been sensed by the implanted cardiac rhythm management device; and

the delay period is based on a time between an occurrence of an evoked atrial event and an occurrence of a following intrinsic ventricular event.

30. The implantable medical system of claim 26, wherein:

the at least one electrical circuit structure is configured to determining an occurrence of a valid cardiac event by being further configured to at least one of;

     1) detect a valid intrinsic ventricular event at the location associated with the diaphragm, or

     2) receive, at the location associated with the diaphragm, a signal from an implanted cardiac rhythm management device, which signal indicates that a valid intrinsic ventricular event has been detected by the implanted cardiac rhythm management device; and

the delay time is based on a time between an occurrence of an intrinsic ventricular event of a first type and an occurrence of a following intrinsic ventricular event of the first type.

31. The implantable medical system of claim 26, wherein:

the at least one electrical circuit structure is configured to determining an occurrence of a valid cardiac event by being further configured to at least one of

     1) detect a ventricular pacing stimulus at the location associated with the diaphragm, or

     2) receive, at the location associated with the diaphragm, a signal from an implanted cardiac rhythm management device, which signal indicates that a ventricular pacing stimulus has been delivered by the implanted cardiac rhythm management device; and

the delay time is based on a time between an occurrence of a ventricular pacing stimulus and an occurrence of a following ventricular pacing stimulus.

32. The implantable medical system of claim 26, wherein:

the at least one electrical circuit structure is configured to determining an occurrence of a valid cardiac event by being further configured to at least one of

     1) detect an evoked ventricular event at the location associated with the diaphragm, or

     2) receive, at the location associated with the diaphragm, a signal from an implanted cardiac rhythm management device, which signal indicates that an evoked ventricular event has been sensed by the implanted cardiac rhythm management device; and

the delay time is based on a time between an occurrence of an evoked ventricular event and an occurrence of a following evoked ventricular event.