Electrode selection for sub-threshold modulation therapy

• US 10,112,050 B2
• Filed: 04/06/2017
• Issued: 10/30/2018
• 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): Koharski, Christopher D
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US15/481,237
• Publication Number:
  US 20170209702A1
• Time in Patent Office: 572 Days
• Field of Search: 607 46, 607 59
• 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 of neuromodulation, the method comprising:

determining a ratio between an anodic perception threshold and a cathodic perception threshold for each of a plurality of electrode sets;

selecting an effective electrode set from the plurality of electrode sets based on the ratios; and

providing sub-threshold modulation therapy to a patient, including delivering sub-threshold electrical energy from the effective electrode set.

2. The method of claim 1, wherein the selecting the effective electrode set includes selecting an electrode set with the ratio between the anodic perception threshold and the cathodic perception threshold closest to unity.

3. The method of claim 1, wherein the patient suffers from pain in a body region, the method further comprising creating a paresthesia map comprising a body region of perceived paresthesia resulting from delivery of a super-threshold electrical energy from each of the electrode sets, wherein the selecting the effective electrode set includes selecting the effective electrode set using the paresthesia map.

4. The method of claim 3, wherein the selecting the effective electrode set includes selecting the electrode set corresponding to the body region of perceived paresthesia that matches the body region of pain.

5. The method of claim 4, further comprising determining a coverage score of a relative match between each body region of perceived paresthesia and the body region of pain, wherein the selecting the effective electrode set includes selecting the effective electrode set based on the coverage score.

6. The method of claim 5, further comprising determining a total score from the ratio and the coverage score for each of the electrode sets, wherein the selecting the effective electrode set includes selecting the one electrode set having a highest total score.

7. The method of claim 1, wherein the delivering sub-threshold electrical energy includes delivering a signal having a frequency greater than 1500 Hz.

8. The method of claim 1, wherein the delivering sub-threshold electrical energy includes delivering pulses having a pulse duration less than 200 μ

s.

9. The method of claim 1, wherein the delivering sub-threshold electrical energy includes delivering an electrical pulse train.

10. The method of claim 9, wherein the delivering the electrical pulse train includes delivering a biphasic pulse train.

11. The method of claim 10, wherein the delivering the biphasic pulse train includes providing an active anodic phase.

12. The method of claim 1, further comprising selecting another one of the electrode sets as another effective electrode set based on the ratios, wherein the providing sub-threshold modulation therapy includes delivering sub-threshold electrical energy from the other effective electrode set to the patient.

13. The method of claim 12, further comprising distributing the sub-threshold electrical energy among the effective electrode set based on the ratio.

14. The method of claim 1, further comprising determining the anodic perception threshold of super-threshold electrical energy respectively delivered from each of the plurality of electrode sets;

and

determining a cathodic perception threshold of the super-threshold electrical energy respectively delivered from each of the electrode sets.

15. The method of claim 1, further comprising delivering super-threshold anodic electrical energy and super-threshold cathodic electrical energy from each of the electrode sets, sensing evoked compound action potentials (eCAPs) in response to the delivery of the super-threshold anodic electrical energy and the super-threshold cathodic electrical energy from each of the electrode sets, and storing the anodic perception threshold and cathodic perception thresholds in response to the sensing of the eCAPs.

16. The method of claim 1, further receiving user input indicative of anodic perception thresholds and cathodic perception thresholds.

17. A non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to:

determine a ratio between an anodic perception threshold and a cathodic perception threshold for each of a plurality of electrode sets;

select an effective electrode set from the plurality of electrode sets based on the ratios; and

provide sub-threshold modulation therapy to the patient, including deliver sub-threshold electrical energy from the effective electrode set.

18. The non-transitory machine-readable medium of claim 17, further comprising instructions, which when executed by the machine, cause the machine to distribute the sub-threshold electrical energy among the effective electrode set based on the ratio.

19. A neuromodulation system for use with a plurality of electrode sets, comprising:

modulation output circuitry configured to independently deliver super-threshold anodic electrical energy and super-threshold cathodic electrical energy from each of the plurality of electrode sets, and deliver sub-threshold electrical energy from an effective one of the plurality of electrode sets; and

control circuitry configured to select the effective electrode set from the plurality of electrodes sets based on a ratio between an anodic perception threshold and a cathodic perception threshold for each of a plurality of electrode sets.

20. The system of claim 19, wherein the control circuitry is configured to distribute the sub-threshold electrical energy among the effective electrode set based on the ratio.