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

• US 10,010,715 B2
• Filed: 12/01/2014
• Issued: 07/03/2018
• 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): KOHARSKI, CHRISTOPHER
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US14/556,742
• Publication Number:
  US 20150151125A1
• Time in Patent Office: 1,310 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 method of operating an implantable neuromodulator coupled to an electrode array implanted adjacent tissue of a patient having a medical condition, comprising:

delivering an electrical waveform from the implantable modulator 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 of the patient more than dorsal column neuronal elements of the patient, 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 method of claim 1, wherein the electrical field has a locus disposed adjacent a dorsal horn of the spinal cord of the patient.

3. The method of claim 2, wherein the locus is disposed closer to the dorsal horn of the spinal cord of the patient than an ipsilateral dorsal column of the spinal cord of the patient, wherein the dorsal column is adjacent the dorsal horn.

4. The method of claim 1, wherein the at least some electrodes are on an implanted electrical modulation lead, and the electric field generated using the electrical waveform stimulates dorsal horn neuronal elements along a substantial portion of the implanted electrical modulation lead.

5. The method of claim 1, wherein delivering the electrical waveform in accordance with the modulation parameter set generates a first driving force in dorsal horn neuronal elements that is stronger than a second driving force in dorsal column neuronal elements.

6. The method of claim 1, wherein the modulation parameter set defines an electrode combination, wherein the electrode combination comprises a fractionalized electrode combination.

7. The method of claim 6, wherein the fractionalized electrode combination is configured such that all electrodes on an electrical modulation lead have the same polarity.

8. The method of claim 7, wherein the fractionalized electrode combination is further configured such that all electrodes on the electrical modulation lead are anodes.

9. The method of claim 6, wherein the fractionalized electrode combination is further configured such that:

the same amount of current is directed to each electrode of the plurality;

or

the same neuronal driving force is directed to each electrode of the plurality.

10. The method 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.

11. The method of claim 1, wherein the generated electric field does not cause the patient to perceive paresthesia.

12. The method of claim 1, further comprising:

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

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

modifying 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.

13. The method of claim 12, wherein the neuronal driving force indicator is an activating function.

14. The method of claim 12, wherein the neuronal driving force indicator is a total driving force function.

15. The method of claim 12, wherein the perception threshold is determined using patient feedback or is determined by measuring local field potentials at an electrode of the plurality.

16. The method of claim 12, wherein delivering an electrical waveform from the implantable modulator to at least some electrodes in the electrode array in accordance with the modified modulation parameter set generates a modified electrical field, wherein delivering an electrical waveform from the implantable modulator to at least some electrodes in the electrode array in accordance with the modulation parameter set before modification generates a non-modified electrical field, and wherein a first gradient across a component of the modified electrical field extending a spinal cord of the patient is weaker than a second gradient across a component of the non-modified electrical field extending along the spinal cord of the patient.

17. A method of operating an implantable neuromodulator coupled to an electrode array implanted adjacent tissue of a patient having a medical condition, comprising:

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

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

modifying a modulation parameter set based on the modified neuronal driving force indicator for electrical modulation energy conveyed through each electrode of the plurality of electrodes, wherein the modified neuronal driving force indicator is an activating function;

delivering an electrical waveform from the implantable modulator to at least some electrodes in the electrode array in accordance with the modified modulation parameter set to dorsal horn neuronal elements more than dorsal column neuronal elements;

wherein the activating function is a continuous activating function determined by calculating the second-order spatial derivative of the extracellular potential along an axon or the activating function is a discrete activating function estimating by the formula AF(n)=G_a/(π

×

d×

l)×

[V_e(n−

1)−

2 V_e(n)+V_e(n+1)], wherein Ga is the axonal intermodal conductance,

d is the axonal diameter, l is the length of the node of Ranvier, V_e(n) is the strength of the electric field at the node for which the activating function is determined, V_e(n−

1) is the strength of the electric field at the node preceding the node for which the activating function is determined, and V_e(n+1) is the strength of the electric field at the node following the node for which the activating function is determined.

18. The method of claim 17, further comprising:

estimating the current fractionalization by minimizing the integral of the square of the discrete activating function over a longitudinal axis of the electrical modulation lead while maximizing the electric field over the dorsal horn of the spinal cord of the patient, to thereby minimize the discrete activating function of the dorsal column neuronal elements;

or

estimating the current fractionalization by minimizing the sum of the square of the discrete activating function divided by the determined perception threshold at each electrode on an electrical modulation lead.

19. A method of operating an implantable neuromodulator coupled to an electrode array implanted adjacent tissue of a patient having a medical condition, comprising:

implanting a first electrical modulation lead adjacent a dorsal horn of a spinal cord of the patient and a second electrical modulation lead adjacent a dorsal column of the spinal cord of the patient; and

delivering an electrical waveform from the implantable neuromodulator to at least some electrodes in the implanted first and second electrical modulation leads to tissue of the patient in accordance with a modulation parameter set to provide an electric field over the spinal cord, wherein the electric field provided by the electrical waveform in accordance with the modulation parameter set stimulates dorsal horn neuronal elements more than dorsal column neuronal elements, wherein delivering the electrical waveform in accordance with the modulation parameter set generates a first driving force in dorsal horn neuronal elements that is stronger than a second driving force in dorsal column neuronal elements, and wherein the modulation parameter set defines a fractionalized electrode combination.