Systems and methods for controlling spinal cord stimulation to improve stimulation efficacy for use by implantable medical devices

• US 9,119,965 B2
• Filed: 04/09/2012
• Issued: 09/01/2015
• Est. Priority Date: 04/09/2012
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Xi, Cecilia Qin, Rosenberg, Stuart
• Primary Examiner(s): Lee, Erica
• Application Number:
  US13/442,749
• Publication Number:
  US 20130268016A1
• Time in Patent Office: 1,240 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/39624 Pain reduction therapy

Abstract

Techniques are provided for controlling spinal cord stimulation (SCS) or other forms of neurostimulation. In one example, SCS treatment is delivered to a patient and nerve impulse firing signals are sensed along the spinal cord following the SCS treatment. The nerve impulse signals are analyzed to determine whether the signals are associated with effective SCS and then the delivery of additional SCS is controlled to improve SCS efficacy. For example, the nerve impulse signals can be analyzed to determine whether the signals are consistent with a positive patient mood associated with pain mitigation and, if not, SCS control parameters are adjusted to improve the efficacy of the SCS in reducing pain. In other examples, heart rate variability (HRV) is also used to control SCS. Still further, adjustments may be made to SCS control parameters to improve antiarrhythmic or sympatholytic effects associated with SCS. Techniques employing baseline/target calibration procedures are also described.

Claims

1. A method for use with an implantable medical system for implant within a patient, the method comprising:

delivering neurostimulation to the patient using the implantable system;

sensing spinal cord nerve impulse signals in response to the neurostimulation;

measuring a power spectral density (PSD) parameter of a heart rate variability (HRV) parameter using a cardiac sensing lead implanted within the patient and assessing patient mood based on the PSD of the HRV;

analyzing the spinal cord nerve impulse signals to determine whether the signals are indicative of effective neurostimulation sufficient to improve patient mood; and

controlling the delivery of additional neurostimulation based on the spinal cord nerve impulse signals and the assessed patient mood based on the PSD of the HRV to adjust neurostimulation efficacy to improve patient mood.

2. The method of claim 1 wherein the implantable medical system includes a spinal cord stimulation (SCS) device and wherein the neurostimulation includes SCS and wherein controlling the delivery of additional neurostimulation includes adjusting SCS control parameters.

3. The method of claim 2 wherein SCS is delivered in accordance with a set of SCS control parameters including one or more of:

a neuromodulation amplitude;

a neuromodulation frequency;

a neuromodulation pulse width; and

a neuromodulation electrode configuration.

4. The method of claim 2 wherein sensing nerve impulse signals includes detecting one or more of afferent neural electrical signals and efferent neural electrical signals along at least one spinal cord fiber.

5. The method of claim 2 wherein sensing nerve impulse signals includes detecting signals within a passband in the range of 100 Hz to 2 kHz with a sampling frequency of at least 4 kHz.

6. The method of claim 2 wherein analyzing the nerve impulse signals to determine whether the impulse signals are indicative of effective neurostimulation to improve patient mood includes:

determining nerve impulse firing parameters from the nerve impulse signals sensed within the patient;

inputting one or more of baseline nerve impulse parameters and target nerve impulse parameters for the patient; and

comparing the nerve impulse parameters determined for the patient to the input nerve impulse parameters to assess the efficacy of the SCS and quantify an improvement in patient mood.

7. The method of claim 6 wherein determining nerve impulse firing parameters includes determining one or more of:

average firing rates, maximum firing rates, average firing intervals, maximum firing intervals, minimum firing intervals, firing rate variability, dominant frequency and bandwidth of dominant frequency.

8. The method of claim 6 wherein inputting nerve impulse parameters includes inputting target nerve impulse parameters known to be associated with one or the other of a positive patient mood and a negative patient mood.

9. The method of claim 6 wherein controlling the delivery of additional neurostimulation based on nerve impulse signals includes:

adjusting SCS control parameters to achieve nerve impulse parameters more closely corresponding to the target parameters associated with SCS known to be effective within the patient for improving patient mood; and

repeating the steps of delivering neurostimulation to the patient, sensing spinal cord nerve impulse signals, and analyzing the nerve impulse signals to determine whether the signals are associated with effective SCS for improving patient mood.

10. The method of claim 2 wherein adjusting the SCS control parameters includes adjusting one or more of:

an SCS amplitude;

an SCS frequency;

an SCS pulse width;

an SCS cycle time and an SCS electrode configuration.

11. The method of claim 2 further including controlling the delivery of additional SCS based, on cardiac electrical parameters measured using the cardiac sensing lead implanted within the patient.

12. The method of claim 11 for use with an implantable system also having a separate implantable cardiac rhythm management device and wherein the cardiac electrical parameters are measured by the cardiac rhythm management device for use in controlling the separate SCS device.

13. The method of claim 2 wherein the HRV PSD parameter includes one or more of a target PSD pattern indicative of a positive patient mood and a baseline PSD pattern indicative of a negative patient mood.

14. The method of claim 13 further including:

inputting one or more of a target HRV PSD pattern and a baseline HRV PSD pattern;

detecting a new HRV PSD pattern within the patient; and

comparing the new HRV PSD pattern to the input HRV PSD pattern to assess the efficacy of the SCS.

15. The method of claim 14 wherein controlling the delivery of additional SCS based, on HRV PSD includes:

adjusting SCS control parameters to achieve an HRV PSD pattern more closely corresponding to the target HRV PSD pattern indicative of positive patient mood; and

repeating the steps of delivering neurostimulation to the patient, detecting HRV PSD patterns in response to the neurostimulation and analyzing the HRV PSD patterns to determine whether the HRV PSD patterns are associated with positive patient mood.

16. The method of claim 1 for use with an implantable system also having a separate implantable cardiac rhythm management device and wherein at least one of the steps of sensing nerve impulse signals, analyzing the nerve impulse signals and controlling the delivery of additional neurostimulation are performed by the cardiac rhythm management device.

17. The method of claim 1 wherein controlling the delivery of additional neurostimulation to adjust neurostimulation efficacy is performed to improve one or more of antiarrhythmic and sympatholytic effects associated with the neurostimulation.

18. The method of claim 1 wherein assessing patient mood includes associating an increase in a peak frequency of the PSD with an improvement in patient mood.

19. An implantable medical system for implant within a patient, the system comprising:

a neurostimulation delivery system operative to deliver neurostimulation to the patient;

a spinal cord nerve impulse signal sensing system operative to sense spinal cord nerve impulse signals in response to the neurostimulation;

a detector operative to measure a power spectral density (PSD) of a heart rate variability (HRV) parameter using a cardiac sensing lead implanted within the patient and to assess patient mood based op the PSD of the HRV;

a spinal cord nerve impulse signals analysis system operative to analyze the spinal cord nerve impulse signals to determine whether the signals are indicative of effective neurostimulation sufficient to improve patient mood; and

a neurostimulation control system operative to control the delivery of additional neurostimulation based on the spinal cord nerve impulse signals and the assessed patient mood based on the PSD of the HRV to adjust neurostimulation efficacy to improve patient mood.

20. The implantable medical system of claim 19 wherein the system includes a spinal cord stimulation (SCS) system and a cardiac rhythm management device.

21. The system of claim 19 wherein the controller associates an increase in a peak frequency of the PSD with an improvement in patient mood.

22. A system for use with an implantable spinal cord stimulation (SCS) device for implant within a patient, the method comprising:

means for delivering neurostimulation to the patient using the implantable system;

means for sensing spinal cord nerve impulse signals in response to the neurostimulation;

means for measuring a power spectral density (PSD) of a heart rate variability (HRV) parameter using a cardiac sensing lead implanted within the patient and means for assessing patient mood based on the PSD of the HRV;

means for analyzing the spinal cord nerve impulse signals to determine whether the signals are indicative of effective neurostimulation sufficient to improve patient mood; and

means for controlling the delivery of additional neurostimulation based on the spinal cord nerve impulse signals and the assessment of patient mood based on the PSD of the HRV to adjust neurostimulation efficacy to improve patient mood.

23. The system of claim 22 wherein the means for assessing patient mood associates an increase in a peak frequency of the PSD with an improvement in patient mood.

24. A method for use with an implantable medical system that includes a spinal cord stimulation (SCS) device for implant within a patient, the method comprising:

delivering SCS to the patient using the implantable system;

sensing spinal cord nerve impulse signals in response to the SCS;

measuring cardiac electrical parameters using a sensing lead implanted within the patient, wherein the cardiac electrical parameters include heart rate variability (HRV) parameters including parameters representative of a power spectral density (PSD) of HRV and including one or more of a target PSD pattern indicative of a positive patient mood and a baseline PSD pattern indicative of a negative patient mood;

analyzing the spinal cord nerve impulse signals to determine whether the signals are indicative of effective SCS sufficient to improve patient mood; and

controlling the delivery of additional SCS based on the spinal cord nerve impulse signals and the target PSD pattern to adjust SCS efficacy to improve patient mood.