Systems and Methods for Neurostimulation Electrode Configurations Based on Neural Localization

• US 20160045751A1
• Filed: 08/14/2015
• Published: 02/18/2016
• Est. Priority Date: 08/15/2014
• Status: Active Grant

• Current Assignee: Axonics, Inc.
• Original Assignee: Axonics Modulation Technologies, Inc.
• Inventors: Schroeder, Dennis, Schmid, Eric, Jiang, Guangqiang, Woock, John
• Granted Patent: US 9,855,423 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 analyzing electrode response of a plurality of electrodes implanted near a targeted nerve for use in neurostimulation programming, the method comprising:

determining a stimulation threshold for each of the plurality of electrodes with a clinician computing device by individually stimulating each electrode and increasing stimulation of the respective electrode until at least one desired neuromuscular response corresponding to stimulation of the target nerve is indicated by an EMG response obtained by the clinician computing device via input ports connecting the plurality of electrodes to the clinician computing device, and recording the stimulation at which the response is evoked, wherein the stimulation threshold is below a muscle activation threshold,

recording the EMG response with the clinician computing device; and

outputting, with a graphical user interface display housed within the clinician computing device, user feedback based on the determined stimulation thresholds, the user feedback being indicative of one or more neurostimulation programs corresponding to one or more electrode configurations of the plurality of electrodes.

2. The method of claim 1, wherein the EMG response is recorded by an EMG module of the clinician computing device.

3. The method of claim 1, wherein the desired neuromuscular response is a maximum CMAP at lowest stimulation threshold.

4. The method of claim 1, wherein determining the stimulation threshold further comprises receiving an input, with the clinician computing device, confirming a visual observation of the neuromuscular response indicated by the EMG response.

5. The method of claim 1, wherein the target nerve comprises a sacral nerve and the at least one neuromuscular response comprises one or both of a big toe response and an anal bellows response to stimulation of a given electrode of the plurality of electrodes.

6. A method of programming a neurostimulation device coupled with a plurality of electrodes of a neurostimulation lead implanted near a target nerve, 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;

identifying one or more neurostimulation programs corresponding to one or more electrode configurations of the plurality of electrodes of the lead 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 based on the one or more programs and selecting the first program to the neurostimulation device for application as a current therapy.

7. The method of claim 6, wherein the stimulation thresholds are determined by the clinician programming device during programming via a graphical user interface housed within the clinician programming device.

8. The method of claim 6, wherein the stimulation thresholds obtained are previously recorded stimulation thresholds determined by the clinician computing device during placement of the lead.

9. The method of claim 6, wherein the applying the one or more identified programs and recording an EMG response comprises applying sub-threshold stimulation with the plurality of electrodes.

10. The method of claim 9, wherein determining the first therapy 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.

11. The method of claim 9, wherein recording an EMG response comprises recording an EMG from a single neuromuscular response.

12. The method of claim 11, wherein the target nerve comprises a sacral nerve and the single neuromuscular response is the big toe response or the anal bellows response.

13. The method of claim 6, 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.

14. The method of claim 6, wherein the clinician computing device includes a graphical user interface display, the method further comprising:

recording the EMG response with the clinician programing device; and

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

15. A method of programming a neurostimulation device coupled with a plurality of electrodes of a neurostimulation lead implanted near a target nerve, the method comprising:

applying one or more neurostimulation programs identified for the plurality of electrodes 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 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.

16. A system setup for programming a neurostimulation system, the system setup comprising:

a clinician programmer operatively coupled with an IPG or EPG of the neurostimulation system;

an implantable lead coupleable to the clinician programmer, wherein the implantable lead comprises a plurality of electrodes; and

at least one set of EMG sensing electrodes minimally invasively positionable on a skin surface or within the patient, the EMG sensing electrodes coupleable with an EMG unit associated with and/or integrated with the clinician programmer via input ports connecting the plurality of electrodes to the clinician programmer;

wherein the clinician programmer is configured for;

obtaining a stimulation threshold for each of the plurality of electrodes 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;

identifying one or more neurostimulation programs corresponding to one or more electrode configurations of the plurality of electrodes of the lead based, at least in part, on the stimulation thresholds obtained by the clinician programming device and indicated by a graphical user interface housed within the clinician programmer;

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

determining a first neurostimulation program based on the one or more programs and selecting the first program for application as a current therapy delivered with the neurostimulation system.

17. The system setup of claim 16, wherein the at least one set of EMG patches comprises one or more electrodes adapted for obtaining an EMG recording of a neuromuscular response.

18. The system setup of claim 17, wherein the at least one set of EMG patches comprises a single set of one or more electrodes adapted for obtaining an EMG recording of a single neuromuscular response, the single neuromuscular response being a big toe response or an anal bellows response.

19. A method of determining a plurality of recommended electrode configurations for a plurality of electrodes of an implanted neurostimulation lead, the method comprising:

obtaining a stimulation threshold value for each electrode of the plurality of electrodes with a clinician programming device via input ports connecting the plurality of electrodes to the clinician programming device;

identifying cathode configurations of the plurality of electrode configurations with the clinician programming device;

identifying anode configurations of the plurality of electrode configurations with the clinician programming device; and

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

20. The method of claim 19, 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;

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.

21. The method of claim 20, 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.

22. The method of claim 21, wherein the pre-determined criteria comprises:

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

23. The method of claim 21 or 22, 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.

24. The method of claim 23, the pre-determined criteria further comprising:

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

25. The method of claim 24, 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.

26. The method of claim 25, wherein the pre-determined criteria is applied in the order recited in the respective claims.

27. The method of claim 25, wherein the pre-determined criteria is applied until the plurality of recommended electrode configurations comprises at least four recommended electrode configurations.

28. The method of claim 25, 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.

29. The method of claim 25, wherein identifying anode configurations comprises assigning as an anode a can of an IPG of the neurostimulation device when the respective configuration corresponds to monopolar operation.

30. The method of claim 21 or 22, 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.

31. The method of claim 30, wherein an unacceptable impedance is less than 50 Ohms or greater than 3,000 Ohms.

32. The method of claim 21 or 22, further comprising:

receiving, with the clinician programming device, subjective patient data as to any negative sensations felt by the patient upon stimulation of each electrode of the plurality; and

excluding from the plurality of electrode configurations any electrode associated with negative sensations in the received subjective patient data.

33. A system for determining a plurality of recommended electrode configurations for a plurality of electrodes of an implanted neurostimulation lead, the system comprising:

an implantable neurostimulation lead having a plurality of electrodes operatively coupled with an IPG or EPG; and

a clinician programmer coupleable with the neurostimulation lead and the associated IPG or EPG so as to save a first neurostimulation program selected from a plurality of recommended electrode configurations on the IPG or EPG for application as a current therapy,

wherein the clinician programmer is configured to;

obtain a stimulation threshold value for each electrode of the plurality of electrodes with a clinician programming device via input ports connecting the plurality of electrodes to the clinician programming device;

identify cathode configurations of the plurality of electrode configurations with the clinician programming device;

identify anode configurations of the plurality of electrode configurations with the clinician programming device; and

output the plurality of recommended electrode configurations to a clinician on a graphical user interface display of the clinician programming device for modification and/or selection by the clinician.

34. A method of re-programming a neurostimulation device coupled with a plurality of electrodes of a neurostimulation lead implanted near a target nerve, the method comprising:

establishing communication with the neurostimulation device using a clinician programming device;

obtaining, with the clinician programing device, a first therapy program stored on a memory of the neurostimulation device, the first therapy program being selected as a current therapy delivered by the neurostimulation device;

determining a second therapy program with the clinician programming device; and

storing the second therapy program on the neurostimulation device with the clinician programming device, the second therapy program being selected as the current therapy delivered by the neurostimulation device.

35. The method of claim 34, wherein determining the second therapy program comprises adjusting one or more parameters of the first therapy program with the clinician programming device.

36. The method of claim 34, further comprising:

obtaining, with the clinician programing device, a plurality of therapy programs last applied by and stored on the neurostimulation device, wherein the plurality of therapy programs includes the first therapy program,

wherein determining the second therapy program is based on one or more of the plurality of therapy programs last applied by and stored on the neurostimulation device.

37. The method of claim 34, further comprising:

measuring a threshold for each of the plurality of electrodes with the clinician programing device during re-programming.

38. The method of claim 37, wherein determining the second therapy program comprises adjusting parameters of the first therapy program based on the measured thresholds.

39. The method of claim 37, further comprising:

generating a plurality of recommended electrode configuration based on the thresholds measured during re-programming; and

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