Electrode selection for sub-threshold modulation therapy

• US 10,398,900 B2
• Filed: 08/31/2018
• Issued: 09/03/2019
• Est. Priority Date: 06/28/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Lee, Dongchul, Zhu, Changfang
• Primary Examiner(s): Voorhees, Catherine M
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US16/119,560
• Publication Number:
  US 20180369591A1
• Time in Patent Office: 368 Days
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• 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 neuromodulation system and method of providing sub-threshold therapy to a patient. An anodic perception threshold of super-threshold electrical energy and a cathodic perception threshold of super-threshold electrical energy are determined for a plurality of electrode sets. A ratio between the anodic perception threshold and the cathodic perception threshold is calculated for each of the electrode sets. An effective electrode set is selected based on the ratio between the anodic perception threshold and the cathodic perception threshold.

Claims

1. A method performed using a plurality of electrodes implanted in a patient, the method comprising:

delivering anodic stimulation to each of a plurality of electrode sets from the plurality of electrodes and sensing a corresponding evoked compound action potential (eCAP) response to the anodic stimulation, and delivering cathodic stimulation to each of the plurality of electrodes sets and sensing a corresponding eCAP response to the cathodic stimulation;

determining an electrode set for use in delivering a neuromodulation therapy from the plurality of electrodes based on the eCAP response to the anodic stimulation and the eCAP response to the cathodic stimulation; and

providing a neuromodulation therapy, including delivering electrical energy from the selected electrode set.

2. The method of claim 1, wherein the determining the electrode set includes automatically selecting the electrode set based on the eCAP response to the anodic stimulation and the eCAP response to the cathodic stimulation.

3. The method of claim 1, wherein the determining the electrode set includes displaying, on a user interface, information indicative of the eCAP response to the anodic stimulation and the eCAP responses to the cathodic stimulation, and receiving via the user interface a user selection of the electrode set.

4. The method of claim 1, further comprising determining at least one characteristic of the eCAP response to the anodic stimulation and at least one characteristic of the eCAP response to the cathodic stimulation, wherein the determining the electrode set includes selecting the electrode set based on the determined characteristics of the eCAP responses.

5. The method of claim 4, wherein the determining the electrode set for use in delivering the neuromodulation therapy includes selecting the electrode set based on a computed function based on the characteristics of the eCAP responses.

6. The method of claim 1, wherein the neuromodulation therapy includes a subthreshold neuromodulation therapy.

7. The method of claim 1, wherein the eCAP response to the anodic stimulation is indicative of an anodic perception threshold and the eCAP response to the cathodic stimulation is indicative of a cathodic stimulation threshold.

8. The method of claim 7, wherein the determining the electrode set for use in delivering the neuromodulation therapy includes selecting the electrode set with a ratio between the anodic perception threshold and the cathode perception threshold closest to unity.

9. The method of claim 1, wherein the delivering the anodic stimulation to each of a plurality of electrode sets from the plurality of electrodes includes delivering monopolar anodic stimulation to each of the plurality of electrodes, and the delivering cathodic stimulation includes delivering monopolar cathodic stimulation to each of the plurality of electrodes.

10. The method of claim 1, wherein the delivering the anodic stimulation includes delivering multipolar anodic stimulation and the delivering the cathodic stimulation includes delivering multipolar cathodic stimulation.

11. The method of claim 1, wherein the determining the electrode set for use in delivering the neuromodulation therapy includes selecting the electrode set based on a combination of the eCAP responses and one or more paresthesia maps for each of the plurality of electrode sets.

12. The method of claim 11, wherein the one or more paresthesia maps include one or more anodic paresthesia maps.

13. The method of claim 1, wherein the neural stimulation therapy is delivered using fractionalized values defining energy distribution among the selected electrode set.

14. A neuromodulation system for use with a plurality of electrodes implanted in the patient, comprising:

modulation output circuitry configured to deliver neurostimulation therapy and deliver both anodic stimulation and cathodic stimulation to each of a plurality of electrode sets from the plurality of electrodes;

evoked compound action potential (eCAP) sensing circuitry configured to sense corresponding eCAP responses to the anodic stimulation delivered to each of the plurality of electrode sets and sense corresponding eCAP responses to the cathodic stimulation delivered to each of the plurality of electrode sets; and

control circuitry configured to control the modulation output circuitry to deliver both the anodic stimulation and the cathodic stimulation to each of the plurality of electrode sets and process the sensed eCAP responses to the anodic stimulation and the sensed eCAP responses to the cathodic stimulation for determining an electrode set for use in delivering the neurostimulation therapy, and control the modulation output circuitry to deliver the neurostimulation therapy using the determined electrode set.

15. The neuromodulation system of claim 14, wherein the control circuitry is configured to automatically select the determined electrode set based on the eCAP responses to the anodic stimulation and the eCAP responses to the cathodic stimulation.

16. The neuromodulation system of claim 14, further comprising a user interface, wherein the system is configured to display information indicative the eCAP responses to the anodic stimulation and the eCAP responses to the cathodic stimulation on the user interface, and receive via the user interface a user selection indicative of the determined electrode set.

17. The neuromodulation system of claim 14, wherein the control circuitry is configured to determine at least one characteristic of the eCAP response to anodic stimulation and at least one characteristic of the eCAP response to the cathodic stimulation, and automatically select the determined electrode set based on the determined characteristic of the eCAP response to the anodic stimulation and the eCAP response to the cathodic stimulation.

18. The neuromodulation system of claim 14, wherein the eCAP response to the anodic stimulation is indicative of an anodic perception threshold and the eCAP response to the cathodic stimulation is indicative of a cathodic stimulation threshold.

19. A non-transitory computer-readable storage medium including instructions, which when executed by a system, cause the system to perform a method for, the method comprising:

delivering anodic stimulation to each of a plurality of electrode sets from a plurality of electrodes and sensing a corresponding evoked compound action potential (eCAP) response to the anodic stimulation, and delivering cathodic stimulation to each of the plurality of electrodes sets and sensing a corresponding eCAP response to the cathodic stimulation;

determining an electrode set for use in delivering a neuromodulation therapy from the plurality of electrodes based on the eCAP response to the anodic stimulation and the eCAP response to the cathodic stimulation; and

providing a neuromodulation therapy, including delivering electrical energy from the selected electrode set.

20. The non-transitory computer-readable storage medium of claim 19, wherein the eCAP response to the anodic stimulation is indicative of an anodic perception threshold and the eCAP response to the cathodic stimulation is indicative of a cathodic stimulation threshold.