Method and system to select a neurostimulation system configuration based on cardiac rhythm feedback

• US 9,037,236 B2
• Filed: 06/29/2012
• Issued: 05/19/2015
• Est. Priority Date: 06/29/2012
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Xi, Cecilia Qin, Ness, Lanitia, Rosenberg, Stuart
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US13/537,757
• Publication Number:
  US 20140005739A1
• Time in Patent Office: 1,054 Days
• Field of Search: None
• US Class Current: 607/14
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability

Abstract

Methods and systems are provided to control a configuration of a neural stimulation (NS) system having an NS device coupled to an NS lead. The methods and systems change between configurations of the NS system and collect cardiac signals from a patient that are representative of cardiac rhythms experienced by the patient over a period of time and in connection with multiple NS configurations. The methods and systems derive, from the cardiac signals, characteristic values for at least one physiologic characteristic indicative of at least one of normal and abnormal cardiac rhythms in connection with the multiple NS configurations; and select, from the multiple NS configurations, an NS operating configuration to be used by the NS system based on the characteristic values.

Claims

1. A method to control a configuration of a neural stimulation (NS) system having an NS device coupled to an NS lead, the method comprising:

cycling through multiple predetermined potential NS configurations of the NS system;

setting a timer associated with an amount of time for an arrhythmia related electrophysiology change to occur in response to at least one of the predetermined potential NS configurations;

after the timer expires, collecting cardiac signals from a patient that are representative of cardiac rhythms experienced by the patient, the collecting operation in connection with each of the multiple predetermined potential NS configurations for a corresponding period of time;

deriving, from the cardiac signals collected after the timer expires, characteristic values (CVs) for at least one physiologic characteristic indicative of at least one of normal and abnormal cardiac rhythms in connection with each of the corresponding multiple predetermined potential NS configurations; and

then selecting, from the multiple predetermined potential NS configurations, an NS operating configuration to be used by the NS system based on the CVs.

2. The method of claim 1, wherein the collecting is performed over an extended period of time to obtain long-term diagnostic trends, the selecting operation further comprising assessing whether a long-term improvement is achieved when utilizing one or more of the NS operating configurations.

3. The method of claim 1, wherein the collecting is performed over an extended period of time sufficient to obtain a trend for AT/AF burden, the method further comprising identifying the trend for AT/AF burden, the selecting operation selecting the NS operating configuration based on the trend for AT/AF burden that is identified.

4. The method of claim 1, wherein the cycling through the predetermined potential NS configurations is performed automatically at predetermined time periods of interest.

5. The method of claim 1, wherein the selecting includes identifying a select characteristic value that satisfies a predetermined condition and determining a one of the predetermined potential NS configurations that is associated with the select characteristic value.

6. The method of claim 1, further comprises maintaining a one to one relation between the characteristic values that are derived and one of the predetermined potential NS configurations that was operative at the time when the cardiac signals associated with the characteristic values were collected.

7. The method of claim 1, further comprising determining that the cardiac rhythm exhibits an arrhythmia, and directing the NS device to begin operation with one of the predetermined potential NS configurations in response to the determination that the cardiac rhythm exhibits an arrhythmia.

8. The method of claim 1, wherein the deriving includes determining a characteristic value for at least one of an acute cardiac rhythm characteristic and a chronic cardiac rhythm characteristic.

9. The method of claim 1, wherein the deriving includes determining a characteristic value for at least one of the following physiologic characteristics:

restoration time, R-R interval, P-P interval, R-wave regularity, P-wave regularity, dominate frequency of atrial fibrillation (AF), AF rate, AF regularity, Peak atrial rate, and a ratio of a number of ventricular events per set of atrial events.

10. The method of claim 1, wherein the cycling includes switching, after a predetermined time period of interest, between at least one of i) first and second electrode combinations, ii) first and second stimulus patterns, and iii) first and second active electrode placements, utilized to deliver an NS therapy from the NS lead.

11. The method of claim 1, wherein the cycling includes switching, after a predetermined time period of interest, between first and second stimulus patterns utilized to deliver an NS therapy from the NS lead.

12. The method of claim 1, wherein the cycling includes changing, after a predetermined time period of interest, a configuration value of at least one configuration parameter from the set of configuration parameters that includes stimulus phase, frequency, pulse width, pulse amplitude, number of active electrodes, active electrode pattern, active electrode position within electrode array, active electrode placement with respect to a reference anatomy.

13. The method of claim 1, further comprising sensing the cardiac signals, the cardiac signals representing one of intra-thoracic electrogram signals, electrocardiogram signals, heart sound signals, blood pressure signals, and blood oxygen content signals.

14. The method of claim 1, wherein the timer is associated with a predetermined time period representing at least one time constant associated with the arrhythmia related electrophysiology change that occurs while the NS device operates in accordance with the current one of the predetermined potential NS configurations.

15. The method of claim 1, wherein the setting operation includes setting at least two different timers in connection with at least two different arrhythmia related electrophysiology changes that occur in response to the predetermined potential NS configurations.

16. The method of claim 1, wherein the timer corresponds to a first time constant related to an amount of time needed after delivery of an NS therapy with a current one of the predetermined potential NS configurations before stabilization of local circuit neurons of an intrinsic cardiac nervous system (ICN).

17. The method of claim 16, wherein the timer corresponds to a second time constant related to an amount of time before triggering centrally-mediated reflexes (TMR) occurs.

18. The method of claim 1, wherein the cycling, setting, waiting, and deriving operations are performed during a first iteration while the timer is set to a first time constant, and then the cycling, setting, waiting and deriving operations are repeated during a second iteration while the timer is set to a second time constant.

19. The method of claim 1, wherein the timer is set to different first and second time constants associated with stabilization of local circuit neurons of an intrinsic cardiac nervous system (ICN) and triggering centrally-mediated reflexes (TMR), respectively.

20. A neural stimulation (NS) system, comprising:

an NS device coupled to an NS lead;

memory configured to save multiple predetermined potential NS configurations;

a controller configured to direct the NS device to cycle through each of the multiple predetermined potential NS configurations, the controller configured to set a timer associated with an amount of time for an arrhythmia related electrophysiology change to occur in response to at least one of the predetermined potential NS configurations and to collect cardiac signals after the timer expires;

inputs configured to receive the cardiac signals that are collected from a patient over a period of time during which each of the multiple predetermined potential NS configurations is utilized, the cardiac signals being representative of cardiac rhythms experienced by the patient;

a cardiac signal analysis (CSA) module configured to derive, from the cardiac signals collected after the time expires, characteristic values (CVs) for at least one physiologic characteristic indicative of at least one of normal and abnormal cardiac rhythms that occur while the NS device operates in each of the corresponding multiple predetermined potential NS configurations; and

a CV analysis module configured to analyze the multiple CVs and then select, from the multiple predetermined potential NS configurations, an NS operating configuration to be used by the NS system based on the CVs.

21. The system of claim 20, wherein the inputs receive cardiac signals over an extended period of time and the CV analysis module analyzes the CVs to obtain long-term diagnostic trends, the CV analysis module configured to assess whether a long-term improvement is achieved when utilizing one or more of the NS operating configurations.

22. The system of claim 20, wherein the CV analysis module analyzes AT/AF burden experienced by the heart and obtains a trend for AT/AF burden, the CV analysis module selects the NS operating configuration based on the trend for AT/AF burden.

23. The system of claim 20, wherein the controller cycles from one of the multiple predetermined potential NS configurations to another of the multiple predetermined potential NS configurations based on at least one of i) automatically after a predetermined time period of interest and ii) the physiologic characteristic of the cardiac signals, the physiologic characteristic representing AT/AF burden, the memory recording the characteristic values for AT/AF burden exhibited during each of the predetermined time periods of interest.

24. The system of claim 20, wherein the CV analysis module identifies a select characteristic value that satisfies a predetermined condition and determines one of the predetermined potential NS configurations that is associated with the select characteristic value.

25. The system of claim 20, wherein the memory maintains a one to one relation between the characteristic values that are derived and a one of the predetermined potential NS configurations that was operative at the time when the cardiac signals associated with the characteristic values were collected.

26. The system of claim 20, wherein the controller is configured to direct the NS device to begin operation with one of the multiple predetermined potential NS configurations in response to a determination that the cardiac rhythm exhibits an arrhythmia.

27. The system of claim 20, wherein the CSA module determines a characteristic value for at least one of an acute cardiac rhythm characteristic and a chronic cardiac rhythm characteristic.

28. The system of claim 20, wherein the CSA module determines a characteristic value for at least one of the following physiologic characteristics:

restoration time, R-R interval, P-P interval, R-wave regularity, P-wave regularity, dominate frequency of atrial fibrillation (AF), AF rate, AF regularity, Peak atrial rate, and a ratio of a number of ventricular events per set of atrial events.

29. The system of claim 20, wherein the controller changes the predetermined potential NS configuration by switching, after a predetermined time period of interest, between at least one of i) first and second electrode combinations, ii) first and second stimulus patterns, and iii) first and second active electrode placements, utilized to deliver an NS therapy from the NS lead.

30. The system of claim 20, wherein the controller changes the predetermined potential NS configuration by switching, after a predetermined time period of interest, between first and second stimulus patterns utilized to deliver an NS therapy from the NS lead.

31. The system of claim 20, wherein the controller changes the predetermined potential NS configuration, after a predetermined time period of interest, by changing a configuration value of at least one configuration parameter from the set of configuration parameters that includes stimulus phase, frequency, pulse width, pulse amplitude, number of active electrodes, active electrode pattern, active electrode position within electrode array, active electrode placement with respect to a reference anatomy.

32. The system of claim 20, further comprising a sensor coupled to the input, the sensor configured to collect cardiac signals that represent one of intra-thoracic electrogram signals, electrocardiogram signals, heart sound signals, blood pressure signals, and blood oxygen content signals.

33. The system of claim 20, wherein the timer is associated with a predetermined time period representing at least one time constant associated with the arrhythmia related electrophysiology change that occurs while the NS device operates in accordance with the current one of the predetermined potential NS configurations.

34. The system of claim 20, wherein the controller sets at least two different timers in connection with at least two different arrhythmia related electrophysiology changes that occur in response to the predetermined potential NS configurations.

35. The system of claim 20, wherein the timer corresponds to a first time constant related to an amount of time needed after delivery of an NS therapy with a current one of the predetermined potential NS configurations before stabilization of local circuit neurons of an intrinsic cardiac nervous system (ICN).

36. The system of claim 35, wherein the timer corresponds to a second time constant related to an amount of time before triggering centrally-mediated reflexes (TMR) occurs.

37. The system of claim 20, wherein the controller and CAS module perform the cycling, setting, waiting, and deriving operations during a first iteration while the timer is set to a first time constant, and then repeat the cycling, setting, waiting and deriving operations during a second iteration while the timer is set to a second time constant.

38. The system of claim 20, wherein the timer is set to different first and second time constants associated with stabilization of local circuit neurons of an intrinsic cardiac nervous system (ICN) and triggering centrally-mediated reflexes (TMR), respectively.