Systems and methods for neurostimulation electrode configurations based on neural localization

• US 9,855,423 B2
• Filed: 08/14/2015
• Issued: 01/02/2018
• 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
• Primary Examiner(s): Wu, Eugene T
• Application Number:
  US14/827,067
• Publication Number:
  US 20160045751A1
• Time in Patent Office: 872 Days
• 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 coupleable 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, wherein the stimulation threshold is based, at least in part, on a first electromyographic (EMG) recording of at least one neuromuscular response during stimulation of a given electrode of the plurality of electrodes;

generating a plurality of electrode configurations of the plurality of electrodes for use in therapy based, at least in part, on the stimulation thresholds obtained by the clinician programming device;

identifying a plurality of neurostimulation programs corresponding to the plurality of 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 plurality of identified neurostimulation programs with the clinician programming device and recording at least a second EMG response of at least one neuromuscular response during applying each of the plurality of identified neurostimulation programs with the clinician programming device;

determining a first neurostimulation program based on the plurality of identified neurostimulation programs applied with the clinician programming device based, at least in part, on the second EMG response and selecting the first neurostimulation program for application as a current therapy with the neurostimulation device; and

programming the neurostimulation device with the clinician programming device with the first neurostimulation program as a current therapy.

2. The method of claim 1, wherein the applying the plurality of identified neurostimulation programs and recording at least a second EMG response comprises applying sub-threshold stimulation with the plurality of electrodes.

3. The method of claim 2,

wherein determining the first neurostimulation therapy program from the plurality of neurostimulation programs comprises adjusting parameters of one neurostimulation program of the plurality of neurostimulation programs based on the at least a second EMG recording of a big toe response to stimulation lower than that required to elicit an outwardly visible big toe movement.

4. The method of claim 2, wherein recording the at least a second EMG response comprises recording an EMG of only a single neuromuscular response.

5. The method of claim 4, wherein the target nerve comprises a sacral nerve and the single neuromuscular response is a big toe response or an anal bellows response.

6. The method of claim 5, wherein the single neuromuscular response is the big toe response.

7. The method of claim 1, further comprising:

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

8. The method of claim 1, wherein the stimulation thresholds obtained are previously recorded stimulation thresholds determined by the clinician programming device during placement of the lead.

9. The method of claim 1, wherein the stimulation thresholds are determined by the clinician programming device after placement of the lead.

10. The method of claim 1, wherein the clinician programming device is directly electrically coupled to the plurality of electrodes of the lead during programming via input ports of the clinician programming device.

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

recording the at least a second 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.

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

a clinician programmer operatively coupled with an implantable pulse generator (IPG) or an external pulse generator (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 electromyographic (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;

wherein the clinician programmer is configured for;

obtaining a stimulation threshold for each of the plurality of electrodes based, at least in part, on a first EMG recording of at least one neuromuscular response during stimulation of a given electrode of the plurality of electrodes;

generating a plurality of electrode configurations of the plurality of electrodes for use in therapy based, at least in part, on the stimulation thresholds obtained by the clinician programmer;

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

applying the plurality of identified neurostimulation programs and recording at least a second EMG response with the clinician programmer;

determining a first neurostimulation program based on the plurality of identified neurostimulation programs applied with the clinician programmer and selecting the first neurostimulation program for application as a current therapy delivered with the neurostimulation system; and

programming, with the clinician programmer, the IPG or EPG with the first neurostimulation program as a current therapy.

13. The system setup of claim 12, wherein the at least one set of EMG sensing electrodes comprises at least one set of EMG patches minimally invasively positionable on a skin surface and adapted for obtaining an EMG recording of a neuromuscular response.

14. The system setup of claim 13, wherein the at least one set of EMG patches comprises a single set of electrodes adapted for obtaining an EMG recording of only a single neuromuscular response, the single neuromuscular response being a big toe response or an anal bellows response.

15. The system setup of claim 12, wherein the clinician programmer is directly electrically coupled to the plurality of electrodes of the lead during the obtaining a stimulation threshold for each of the plurality of electrodes and the applying the plurality of identified neuro stimulation programs via input ports of the clinician programmer.