Short pulse width stimulation

• US 9,814,880 B2
• Filed: 09/22/2015
• Issued: 11/14/2017
• Est. Priority Date: 09/23/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Hershey, Bradley Lawrence, Moffitt, Michael A.
• Primary Examiner(s): Patton, Amanda
• Assistant Examiner(s): EDWARDS, PHILIP CHARLES
• Application Number:
  US14/861,220
• Publication Number:
  US 20160082252A1
• Time in Patent Office: 784 Days
• Field of Search: 607 46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628

Abstract

A system example may include electrodes operationally positioned for use in delivering sub-perception neural modulation, a neural modulator configured to use at least some electrodes to generate a modulation field, and a feedback system configured to receive a feedback signal that a generated modulation field provides a perceived or measurable response. A control system may implement a calibration process including controlling the neural modulator to generate the modulation field using a first and second stimulus pulse with a first and second pulse width, respectively, and using the feedback system to determine a first and second reference point that represents an intensity of the modulation field generated using the first and second pulse widths, respectively, that provides the response, and deriving sub-perception calibration data specific to sub-perception modulation delivered using a sub-perception pulse with a sub-perception pulse width.

Claims

1. A method, comprising:

generating a modulation field using a first stimulus pulse with a first pulse width and determining a first reference data point that represents a modulation intensity generated using the first pulse width that provides a known response, wherein the known response includes a response selected from the group of responses including a patient report or a measurable physiological parameter;

generating the modulation field using a second stimulus pulse with a second pulse width different from the first pulse width and determining a second reference data point that represents a modulation intensity of the modulation field generated using the second pulse width that provides the known response; and

deriving calibration data for modulation using at least two reference data points including the first and second reference data points, wherein deriving calibration data includes deriving calibration data specific to modulation delivered using a pulse with a pulse width smaller than the first pulse width and smaller than the second pulse width.

2. The method of claim 1, wherein deriving calibration data for modulation includes deriving calibration data for sub-perception modulation and the pulse width smaller than the first and second pulse widths is a sub-perception pulse width for the sub-perception modulation.

3. The method of claim 2, further comprising delivering the sub-perception modulation using a stimulation parameter set determined using the calibration data, the sub-perception modulation having an intensity level below a patient-perception threshold, the patient-perception threshold being a boundary below which a patient does not sense delivery of stimulation energy.

4. The method of claim 3, wherein the patient-perception threshold is a threshold below which the patient does not sense paresthesia.

5. The method of claim 3, wherein the patient-perceived modulation is the patient-perception threshold.

6. The method of claim 3, wherein the patient-perceived modulation is a tolerance threshold for the patient.

7. The method of claim 2, wherein deriving calibration data for sub-perception modulation includes:

estimating a data point that represents an estimated intensity of the modulation field generated using the sub-perception pulse width that is estimated to provide the patient-perceived modulation, the estimated data point being extrapolated from the at least two reference data points; and

deriving the calibration data for sub-perception using the estimated sub-perception data point.

8. The method of claim 7, wherein estimating the data point includes applying a curve fitting technique on the first and second reference data points to identify curve parameters for a model curve, and using the identified curve parameters and the model curve to estimate the data point.

9. The method of claim 8, wherein the curve parameters include chronaxie and rheobase current.

10. The method of claim 8, wherein the curve fitting technique includes a Lapique strength duration model or Weiss model charge duration model or other exponential or inverse proportionality model, and the reference data points represent a pulse width and a current amplitude of the pulse width.

11. The method of claim 8, wherein estimating the data point further includes transforming a strength duration curve to a charge duration curve, and using the charge duration to estimate the data point.

12. The method of claim 8, wherein the data point represents a current amplitude for the smaller pulse width.

13. A method, comprising:

generating a modulation field using a first current pulse with a first pulse width and determining a first reference amplitude for the first current pulse that provides patient-perceived modulation at a patient-perception threshold, the patient-perception threshold being a boundary below which a patient does not sense paresthesia;

generating the modulation field using a second current pulse with a second pulse width different from the first pulse width and determining a second reference amplitude for the first current pulse that provides the patient-perceived modulation at the patient-perception threshold;

deriving, using at least the first and second reference amplitudes, calibration data for sub-perception modulation that includes a sub-perception pulse, wherein deriving calibration data includes deriving first sub-perception calibration data specific for a first sub-perception pulse width, the first sub-perception pulse width being smaller than the first pulse width and smaller than the second pulse width; and

delivering the sub-perception modulation using a stimulation parameter set determined using the calibration data, the sub-perception modulation having an intensity level below the patient-perception threshold.

14. The method of claim 13, wherein the calibration data further includes second sub-perception calibration data specific for a second sub-perception pulse width.

15. The method of claim 13, wherein deriving calibration data for sub-perception modulation includes:

estimating a sub-perception amplitude for the sub-perception pulse width that is estimated to provide the patient-perceived level of stimulation, the estimated sub-perception amplitude being extrapolated at least from the first and second reference amplitudes; and

deriving the first calibration data using the estimated sub-perception amplitude.

16. The method of claim 15, wherein estimating the sub-perception amplitude for the sub-perception pulse width includes applying a curve fitting technique on the first and second reference amplitudes to identify curve parameters for a charge duration model curve, and using the first and second reference amplitudes and the charge duration model curve to estimate the sub-perception amplitude for the sub-perception pulse width that provides the patient-perception threshold.

17. A system, comprising:

electrodes on at least one lead configured to be operationally positioned for use in delivering neural modulation;

a neural modulator configured to use active electrodes in the array of the stimulation electrodes to generate a modulation field;

a feedback module configured to receive a signal that a generated modulation field provides a perceived or measurable response; and

a controller operably connected to the neural modulator and the feedback module and configured to implement a calibration process including;

controlling the neural modulator to generate the modulation field using a first stimulus pulse with a first pulse width and using the feedback module to determine a first reference point that represents an intensity of the modulation field generated using the first pulse width that provides the response;

controlling the neural modulator to generate the modulation field using a second stimulus pulse with a second pulse width different from the first pulse width and using the feedback module to determine a second reference point that represents an intensity of the modulation field generated using the second pulse width that provides the response; and

deriving sub-perception calibration data for sub-perception neural modulation using at least the first and second reference data points, wherein deriving sub-perception calibration data includes deriving sub-perception calibration data specific to sub-perception delivered using a sub-perception pulse with a sub-perception pulse width, the sub-perception pulse width being smaller than the first pulse width and smaller than the second pulse width.

18. The system of claim 17, wherein the sub-perception modulation includes preferential modulation of dorsal horn neural tissue or dorsal root neural tissue over dorsal column neural tissue, and the controller is configured to control the neural modulator to deliver the sub-perception modulation using a modulation parameter set determined using the sub-perception calibration data, the sub-perception modulation having an intensity level below a patient-perception threshold, the patient-perception threshold being a boundary below which a patient does not sense paresthesia.

19. The system of claim 17, wherein:

the first reference point includes a first reference current amplitude for the first stimulation pulse with the first pulse width;

the second reference point includes a second reference current amplitude for the second stimulation pulse with the second pulse width; and

in the calibration process implemented by the controller, deriving sub-perception calibration data using at least the first and second reference data points includes;

estimating an amplitude for the sub-perception pulse width that is estimated to provide the response, the estimated sub-perception amplitude being extrapolated at least from the first and second reference current amplitudes; and

deriving the calibration data using the estimated amplitude.

20. The system of claim 17, wherein in the calibration process implemented by the controller, estimating the amplitude for the sub-perception pulse width includes applying a curve fitting technique on the first and second reference amplitudes to identify curve parameters for a charge duration model curve, and using the first and second reference amplitudes and the charge duration model curve to estimate the amplitude for the sub-perception pulse width that provides the response.