Systems and Methods for Neurostimulation Electrode Configurations Based on Neural Localization

• US 20160114167A1
• Filed: 01/08/2016
• Published: 04/28/2016
• Est. Priority Date: 08/15/2014
• Status: Active Grant

• Current Assignee: Axonics, Inc.
• Original Assignee: Axonics Modulation Technologies, Inc.
• Inventors: Jiang, Guangqiang, Woock, John, Schroeder, Dennis, Schmid, Eric
• Granted Patent: US 9,533,155 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/375 using biofeedback
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware

Abstract

Methods and systems for obtaining and analyzing electromyography responses of electrodes of an implanted neurostimulation lead for use neurostimulation programming are provided herein. System setups for neural localization and/or programming include a clinician programmer coupleable with a temporary or permanent lead implantable in a patient and at least one pair of EMG sensing electrodes minimally invasively positioned on a skin surface or within the patient. The clinician programmer is configured to determine a plurality of recommended electrode configurations based on thresholds and EMG responses of the plurality of electrodes and rank the electrode configuration according to pre-determined criteria. The clinician programmer further includes graphical user interface on which the plurality of recommended electrode configurations are displayed for modification and/or selection by a clinician in programming an IPG or EPG coupled with the lead to apply a neurostimulation treatment according to the selected electrode configuration.

Claims

1. A method of programming a neurostimulation device coupled with a plurality of electrodes of a neurostimulation lead implanted near a target nerve for treatment of overactive bladder and/or fecal incontinence, the method comprising:

obtaining a stimulation threshold for each of the plurality of electrodes with a clinician programming device via input ports connecting the plurality of electrodes to the clinician computing device, wherein the stimulation threshold is based, at least in part, on an EMG recording of at least one neuromuscular response during stimulation of a given electrode of the plurality of electrodes;

determining a plurality of electrode configurations with the clinician programming device that are suitable for delivery of neurostimulation;

identifying one or more neurostimulation programs corresponding to an electrode configuration selected from the plurality of electrode configurations, wherein identifying the one or more neurostimulation programs is based, at least in part, on the stimulation thresholds obtained by the clinician programming device;

applying the one or more identified programs and recording an EMG response with the clinician programming device; and

determining a first neurostimulation program for treatment of overactive bladder and/or fecal incontinence based on the one or more programs.

2. The method of claim 1, wherein the multiple electrode configurations are determined by selecting combinations of electrodes based on the stimulation thresholds and relative locations of the electrodes on the lead and are displayed on a user interface display of the clinician programming device in a prioritized order for selection by a clinician.

3. The method of claim 1, wherein the stimulation thresholds obtained are determined by the clinician programming device during programming via a graphical user interface housed within the clinician programming device, or are previously recorded stimulation thresholds determined by the clinician computing device during placement of the lead.

4. The method of claim 1, wherein applying the one or more identified programs and recording an EMG response comprises applying sub-threshold stimulation with the plurality of electrodes.

5. The method of claim 4, wherein determining the first neurostimulation program comprises adjusting parameters of the one or more programs based on an EMG recording of a big toe response to stimulation lower than that required to elicit an outwardly visible big toe movement.

6. The method of claim 4, wherein recording an EMG response comprises recording an EMG from a single neuromuscular response.

7. The method of claim 6, wherein the target nerve comprises a sacral nerve and the single neuromuscular response is the big toe response or the anal bellows response.

8. The method of claim 1, further comprising:

receiving an input confirming a visual observation of the neuromuscular response indicated by the EMG response, wherein determining the first program is based, at least in part, on the visual observation input.

9. The method of claim 1, wherein the clinician computing device includes a graphical user interface display, the method further comprising:

recording the EMG response with the clinician programming device; and

outputting user feedback as to an electrode configuration of the plurality of electrodes based on the determined stimulation thresholds.

10. A method of programming a neurostimulation device for treatment of overactive bladder and/or fecal incontinence, the neurostimulation device being coupled with a plurality of electrodes of a neurostimulation lead implanted near a target nerve, the method comprising:

determining a plurality of electrode configurations with a clinician programming device that are suitable for delivery of the neurostimulation treatment by automatically selecting combinations of electrodes with the clinician programming device based on a characterization of each of the electrodes performed in situ and selecting an electrode configuration from the plurality based on a clinician input received with the clinician programming device;

applying one or more neurostimulation programs identified for a selected electrode configuration and verifying electrode position and/or electrode selection by obtaining an EMG recording of a big toe response to stimulation of an electrode of the plurality at a given amplitude; and

determining a first neurostimulation program for treatment of overactive bladder and/or fecal incontinence from the one or more programs based in part on the EMG recording of the big toe response such that the first neurostimulation program delivers stimulation at an amplitude sufficiently lower than the given amplitude so as to avoid an outwardly visible big toe response to stimulation delivered during long term therapy.

11. A method of programming a neurostimulation device for treatment of overactive bladder and/or fecal incontinence, the neurostimulation device having an implanted neurostimulation lead with a plurality of electrodes that is operatively coupled with a clinician programmer, the method comprising:

obtaining a stimulation threshold for each of the plurality of electrodes with the clinician programming device, wherein the stimulation threshold is based, at least in part, on an EMG recording of at least one neuromuscular response during stimulation of each electrode of the plurality of electrodes;

determining, with the clinician programming device, a plurality of recommended electrode configurations for a plurality of electrodes of the implanted neurostimulation lead by;

obtaining a stimulation threshold value for each electrode of the plurality of electrodes,

identifying cathode configurations of the plurality of electrode configurations,

identifying anode configurations of the plurality of electrode configurations, and

outputting the plurality of electrode configurations to a clinician on a graphical user interface display of the clinician programming device for selection by the clinician; and

determining one or more neurostimulation programs for a selected electrode configuration with the clinician programmer for treatment of overactive bladder and/or fecal incontinence.

12. The method of claim 11, wherein identifying the cathode configurations comprises:

categorizing the plurality of electrodes in one of at least three different tiers based on the stimulation threshold values, the at least three different tiers including a first tier, a second tier and a third tier, the first tier denoting good electrodes for therapy delivery, the second tier denoting marginal electrodes for delivering therapy, and the third tier denoting electrodes unacceptable for delivering therapy;

ranking electrodes within each tier as to suitability for delivering neurostimulation therapy; and

assigning the cathode configurations of the plurality of electrode configurations with the clinician programming device based on the ranking of electrodes and tiers and a pre-determined criteria.

13. The method of claim 12, wherein the pre-determined criteria comprises:

(i) assigning single cathode configurations for each electrode in the first tier, prioritized from farthest pair to closest pair.

14. The method of claim 12, wherein the pre-determined criteria comprises:

(i) assigning single cathode configurations for each electrode in the first tier, prioritized from lowest to highest threshold.

15. The method of claim 13, the pre-determined criteria further comprising:

(ii) assigning double cathode configurations for each pair of adjacent electrodes in the first tier, prioritized by lowest combined threshold.

16. The method of claim 15, the pre-determined criteria further comprising:

(iii) assigning single cathode configurations for each electrode in the second tier, prioritized from lowest to highest threshold.

17. The method of claim 16, the pre-determined criteria further comprising:

(iv) assigning double cathode configurations for each pair of adjacent electrodes of the plurality of electrodes from the first and second tiers, prioritized by lowest combined threshold.

18. The method of claim 17, wherein the pre-determined criteria is applied in the order recited in the respective claims.

19. The method of claim 12, wherein identifying anode configurations comprises assigning as an anode for each cathode configuration an electrode of the plurality of electrodes furthest from the assigned cathode when the respective configuration corresponds to bipolar operation.

20. The method of claim 13, further comprising:

obtaining, with the clinician programming device, an impedance measurement for each electrode of the plurality and excluding any electrode with an unacceptable impedance from being assigned as a cathode or anode in the identified cathode and anode configurations.