Systems and methods for delivering therapy to the dorsal horn of a patient

• US 10,420,938 B2
• Filed: 05/21/2018
• Issued: 09/24/2019
• Est. Priority Date: 12/04/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Zhu, Changfang, Moffitt, Michael A., Hershey, Bradley Lawrence
• Primary Examiner(s): Voorhees, Catherine M
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US15/985,165
• Publication Number:
  US 20180264267A1
• Time in Patent Office: 491 Days
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A method of operating an implantable neuromodulator coupled to an electrode array implanted adjacent tissue of a patient having a medical condition comprises conveying electrical modulation energy to tissue of the patient in accordance with a modulation parameter set, wherein conveying the electrical modulation energy to tissue of the patient in accordance with the modulation parameter set stimulates dorsal horn neuronal elements more than dorsal column neuronal elements.

Claims

1. A non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to deliver an electrical waveform from an implantable neuromodulator to at least some electrodes in an electrode array in accordance with a modulation parameter set to generate an electric field to stimulate dorsal horn neuronal elements more than dorsal column neuronal elements, wherein:

a first component of the electrical field generated using the electrical waveform extends along a spinal cord of the patient and a second component of the electrical field generated using the electrical waveform extends transverse to the spinal cord of the patient; and

a gradient across the first component of the electrical field renders the dorsal column neuronal elements less excitable than the dorsal horn neuronal elements are rendered by a gradient across the second component of the electrical field.

2. The non-transitory machine-readable medium of claim 1, wherein the electrical waveform delivered in accordance with the modulation parameter set parameter set is configured to generate a first driving force in dorsal horn neuronal elements that is stronger than a second driving force in dorsal column neuronal elements.

3. The non-transitory machine-readable medium of claim 1, wherein the modulation parameter set defines an electrode combination, wherein the electrode combination comprises a fractionalized electrode combination.

4. The non-transitory machine-readable medium of claim 3, wherein the fractionalized electrode combination is configured such that all electrodes on an electrical modulation lead have the same polarity.

5. The non-transitory machine-readable medium of claim 1, wherein the electrical field has an elongated shape disposed over a dorsal horn of a spinal cord of the patient, and the elongated shape has a longitudinal axis parallel to the spinal cord of the patient.

6. The non-transitory machine-readable medium of claim 1, wherein the generated electric field does not cause the patient to perceive paresthesia.

7. The non-transitory machine-readable medium of claim 1, wherein the instructions, which when executed by a machine, cause the machine to:

determine a perception threshold for electrical modulation energy conveyed through each electrode of a plurality of electrodes on an electrical modulation lead;

modify a neuronal driving force indicator for electrical modulation energy conveyed through each electrode of the plurality based on the respective determined perception threshold; and

modify the modulation parameter set based on the modified neuronal driving force indicator for electrical modulation energy conveyed through each electrode of the plurality before delivering the electrical waveform in accordance with the modulation parameter set.

8. The non-transitory machine-readable medium of claim 7, wherein the neuronal driving force indicator is an activating function.

9. The non-transitory machine-readable medium of claim 7, wherein the perception threshold is determined using patient feedback.

10. The non-transitory machine-readable medium of claim 7, wherein the perception threshold is determined by measuring local field potentials.

11. A system for use with an implantable electrode array, the system comprising:

an implantable neuromodulator configured to be coupled to the implantable electrode array, the implantable neuromodulator including a modulation output circuitry to generate an electrical waveform and a control circuitry configured to cooperate with the modulation output circuitry to deliver the electrical waveform to at least some electrodes in the electrode array in accordance with a modulation parameter set to generate an electric field to stimulate dorsal horn neuronal elements more than dorsal column neuronal element, wherein;

a first component of the electrical field generated using the electrical waveform extends along a spinal cord of the patient and a second component of the electrical field generated using the electrical waveform extends transverse to the spinal cord of the patient; and

a gradient across the first component of the electrical field renders the dorsal column neuronal elements less excitable than the dorsal horn neuronal elements are rendered by a gradient across the second component of the electrical field.

12. The system of claim 11, wherein the electrical waveform delivered in accordance with the modulation parameter set parameter set is configured to generate a first driving force in dorsal horn neuronal elements that is stronger than a second driving force in dorsal column neuronal elements.

13. The system of claim 11, wherein the modulation parameter set defines an electrode combination, wherein the electrode combination comprises a fractionalized electrode combination.

14. The system of claim 13, wherein the fractionalized electrode combination is configured such that all electrodes on an electrical modulation lead have the same polarity.

15. The system of claim 11, wherein the electrical field has an elongated shape disposed over a dorsal horn of a spinal cord of the patient, and the elongated shape has a longitudinal axis parallel to the spinal cord of the patient.

16. The system of claim 11, wherein the control circuitry configured to cooperate with the modulation output circuitry to:

determine a perception threshold for electrical modulation energy conveyed through each electrode of a plurality of electrodes on an electrical modulation lead;

modify a neuronal driving force indicator for electrical modulation energy conveyed through each electrode of the plurality based on the respective determined perception threshold; and

modify the modulation parameter set based on the modified neuronal driving force indicator for electrical modulation energy conveyed through each electrode of the plurality before delivering the electrical waveform in accordance with the modulation parameter set.

17. The system of claim 16, wherein the neuronal driving force indicator is an activating function.

18. The system of claim 16, wherein the perception threshold is determined using patient feedback.

19. The system of claim 16, wherein the perception threshold is determined by measuring local field potentials at an electrode of the plurality of electrodes.

20. A method of operating an implantable neuromodulator coupled to an implanted electrode array, comprising:

delivering an electrical waveform from the implantable neuromodulator to at least some electrodes in the implanted electrode array in accordance with a modulation parameter set to generate an electric field, wherein;

a first component of the electrical field generated using the electrical waveform extends along a spinal cord of the patient and a second component of the electrical field generated using the electrical waveform extends transverse to the spinal cord of the patient; and

a gradient across the first component of the electrical field is weaker than a gradient across the second component of the electrical field.