System and method for delivering modulated sub-threshold therapy to a patient

• US 9,844,674 B2
• Filed: 06/30/2016
• Issued: 12/19/2017
• Est. Priority Date: 02/05/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Parramon, Jordi, Hershey, Bradley L., Lee, Dongchul
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US15/199,080
• Publication Number:
  US 20160310742A1
• Time in Patent Office: 537 Days
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• 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
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A neuromodulation system configured for providing sub-threshold neuromodulation therapy to a patient. The neuromodulation system comprises a neuromodulation lead having at least one electrode configured for being implanted along a spinal cord of a patient, a plurality of electrical terminals configured for being respectively coupled to the at least one electrode, modulation output circuitry configured for delivering sub-threshold modulation energy to active ones of the at least one electrode, and control/processing circuitry configured for selecting a percentage from a plurality of percentages based on a known longitudinal location of the neuromodulation lead relative to the spinal cord, computing an amplitude value as a function of the selected percentage, and controlling the modulation output circuitry to deliver sub-threshold modulation energy to the patient at the computed amplitude value.

Claims

1. A system for use with a neuromodulation lead having at least one electrode configured for being implanted along a spinal cord of a patient, the system comprising:

modulation output circuitry configured to deliver sub-threshold modulation energy to the at least one electrode; and

control/processing circuitry configured to determine an amplitude value for subthreshold energy as a function of a longitudinal location of the neuromodulation lead relative to the spinal cord.

2. The neuromodulation system of claim 1, wherein the control/processing circuitry is configured to determine the longitudinal location of the implanted neuromodulation lead relative to the spinal cord.

3. The neuromodulation system of claim 1, further comprising a user interface configured to receive as user input the longitudinal location of the implanted neuromodulation lead relative to the spinal cord.

4. The neuromodulation system of claim 1, wherein the at least one electrode is more than one electrode, and the control/processing circuitry is configured to compute the amplitude value as a function of a fractionalized electrode configuration that determines a relative percentage of modulation energy assigned to each of the more than one electrode.

5. The neuromodulation system of claim 4, wherein the selected percentage is a first percentage when the longitudinal location is in a first region of the spinal cord, and the selected percentage is a second percentage when the longitudinal location is in a second region of the spinal cord, wherein the second percentage is higher than the first percentage, and the second region of the spinal cord is caudal to the first region of the spinal cord.

6. The neuromodulation system of claim 4, wherein the selected percentage is a first percentage when the longitudinal location is in a cervical region of the spinal cord, the selected percentage is a second percentage when the longitudinal location is in a thoracic region of the spinal cord, the selected percentage is a third percentage when the longitudinal location is in a lumbar region of the spinal cord, and the selected percentage is a fourth percentage when the longitudinal location is in a sacral region of the spinal cord, wherein the second percentage is greater than the first percentage, the third percentage is greater than the second percentage, and the fourth percentage is greater than the third percentage.

7. The neuromodulation system of claim 6, wherein the fourth percentage is in the range of 50%-90% of a perception threshold, the third percentage is in the range of 40%-80% of the perception threshold, the second percentage is in the range of 30% -70% of the perception threshold, and the first percentage is in the range of 20%-60% of the perception threshold.

8. The neuromodulation system of claim 1, further comprising memory storing a look-up table containing neuromodulation lead locations and a percentage associated with each of the neuromodulation lead locations, wherein the control/processing circuitry is configured to match the longitudinal location of the neuromodulation lead relative to the spinal cord with one of the neuromodulation lead locations stored in the look-up table and select the percentage associated with the matched neuromodulation lead location.

9. An external controller for use with a neuromodulation device coupled to at least one electrode, the external controller comprising:

a user interface configured to receive user input; and

control/processing circuitry configured to select a percentage of a perception threshold based on a longitudinal location of the neuromodulation lead relative to the spinal cord.

10. The external controller of claim 9, wherein the control/processing circuitry is configured to determine the longitudinal location of the implanted neuromodulation lead relative to the spinal cord.

11. The external controller of claim 9, wherein the user interface is further configured to receive as user input the longitudinal location of the implanted neuromodulation lead relative to the spinal cord.

12. The external controller of claim 9, wherein the at least one electrode is more than one electrode, and the control/processing circuitry is configured to compute an amplitude value as a function of a fractionalized electrode configuration that determines a relative percentage of modulation energy assigned to each electrode.

13. The external controller of claim 12, wherein the selected percentage is a first percentage when the longitudinal location is in a first region of the spinal cord, and the selected percentage is a second percentage when the longitudinal location is in a second region of the spinal cord, wherein the second percentage is higher than the first percentage, and the second region of the spinal cord is caudal to the first region of the spinal cord.

14. The external controller of claim 12, wherein the selected percentage is a first percentage when the longitudinal location is in a cervical region of the spinal cord, the selected percentage is a second percentage when the longitudinal location is in a thoracic region of the spinal cord, the selected percentage is a third percentage when the longitudinal location is in a lumbar region of the spinal cord, and the selected percentage is a fourth percentage when the longitudinal location is in a sacral region of the spinal cord, wherein the second percentage is greater than the first percentage, the third percentage is greater than the second percentage, and the fourth percentage is greater than the third percentage.

15. The external controller of claim 14, wherein the fourth percentage is in the range of 50%-90% of the perception threshold, the third percentage is in the range of 40%-80% of the perception threshold, the second percentage is in the range of 30% -70% of the perception threshold, and the first percentage is in the range of 20%-60% of the perception threshold.

16. The external controller of claim 9, further comprising memory storing a look-up table containing neuromodulation lead locations and a percentage associated with each of the neuromodulation lead locations, wherein the control/processing circuitry is configured to match the longitudinal location of the neuromodulation lead relative to the spinal cord with one of the neuromodulation lead locations stored in the look-up table and select the percentage associated with the matched neuromodulation lead location.

17. A method, comprising:

determining an amplitude value for subthreshold modulation energy as a function of a longitudinal location of the neuromodulation lead relative to the spinal cord; and

providing a subthreshold modulation therapy, including delivering the sub-threshold modulation energy at the determined amplitude.

18. The method of claim 17, further comprising:

determining the longitudinal location of the neuromodulation lead relative to the spinal cord.

19. The method of claim 17, further comprising:

receiving as user input the longitudinal location of the implanted neuromodulation lead relative to the spinal cord.

20. The method of claim 17, wherein delivering the sub-threshold modulation energy includes using electrodes to deliver the sub-threshold modulation energy, the method further comprising computing an amplitude value as a function of a fractionalized electrode configuration that determines a relative percentage of modulation energy assigned to each electrode.