Electromyographic lead positioning and stimulation titration in a nerve stimulation system for treatment of overactive bladder

• US 9,561,372 B2
• Filed: 01/08/2016
• Issued: 02/07/2017
• 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): LEVICKY, WILLIAM J
• Application Number:
  US14/991,752
• Publication Number:
  US 20160121123A1
• Time in Patent Office: 396 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• 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 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

The present invention provides improved methods for positioning of an implantable lead in a patient with an integrated EMG and stimulation clinician programmer. The integrated clinician programmer is coupled to the implantable lead, wherein the implantable lead comprises at least four electrodes, and to at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient. The method comprises delivering a test stimulation at a stimulation amplitude level from the integrated clinician programmer to a nerve tissue of the patient with a principal electrode of the implantable lead. Test stimulations are delivered at a same stimulation amplitude level for a same period of time sequentially to each of the four electrodes of the implantable lead. A stimulation-induced EMG motor response is recorded with the integrated clinician programmer for each test stimulation on each electrode of the implantable lead via the at least one pair of EMG sensing electrodes so as to facilitate initial positioning of the implantable lead at a target stimulation region.

Claims

1. A method for improved positioning of an implantable neurostimulation lead in a patient with clinician programmer coupled to the implantable lead for treatment of bladder and/or bowel dysfunction, wherein the implantable lead comprises at least four neurostimulation electrodes, and at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient, the method comprising:

delivering a first test stimulation at a stimulation amplitude level from the clinician programmer to a nerve tissue of the patient with a principal electrode of the implantable lead, wherein the principal electrode is selected from the at least four neurostimulation electrodes of the implantable lead;

delivering another test stimulation at a same stimulation amplitude level for a same period of time sequentially to each remaining electrode for the at least four electrodes of the implantable lead from the clinician programmer;

receiving, with the clinician programmer, EMG information based on recording a stimulation-induced EMG motor response for each test stimulation on each electrode of the implantable lead via the at least one EMG sensing electrode so as to provide improved lateral and/or axial resolution of the at least four electrodes relative to a target nerve for positioning of the implantable lead at a target stimulation region along the target nerve for treatment of bladder and/or bowel dysfunction;

outputting feedback on a graphical user interface of the clinician programmer, the feedback based on the EMG information associated with the first test stimulation of the principal electrode and the other test stimulations of remaining electrodes, the feedback indicating proximity of the at least four electrodes relative the target nerve so as to facilitate improved placement of the at least four electrodes along the target nerve; and

repeating steps of;

delivering a test stimulation to the principle electrodes and each remaining electrode at a same stimulation and period of time, receiving EMG information based on recording a stimulation-induces EMG motor response for each test stimulation, and outputting feedback on the graphical user interface of the clinician programmer based on the EMG information until the EMG information is indicative of multiple electrodes of the at least four neurostimulation electrodes being within the target stimulation region along the target nerve.

2. The method of claim 1, further comprising:

selecting a principal electrode based on a user input received via the graphical user interface of the clinician programmer.

3. The method of claim 1, further comprising:

automatically adjusting the stimulation amplitude level of the test stimulation for the principal electrode until a desired stimulation-induced motor response is detected by use of EMG and received by the clinician programmer.

4. The method of claim 3, wherein automatically adjusting comprises increasing the stimulation amplitude in increments of 0.05 mA for a test stimulation less than or equal to 1 mA.

5. The method of claim 3, wherein automatically adjusting comprises any of:

increasing the stimulation amplitude in increments of 0.05 mA for a test stimulation less than or equal to 1 mA;

increasing the stimulation amplitude in increments of 0.1 mA for a test stimulation more than or equal to 1 mA and less than or equal to 2 mA;

increasing the stimulation amplitude in increments of 0.2 mA for a test stimulation more than or equal to 2 mA and less than or equal to 3 mA; and

increasing the stimulation amplitude in increments of 0.25 mA for a test stimulation more than or equal to 3 mA.

6. The method of claim 1, further comprising receiving a user input related to adjustment of the stimulation amplitude level of the test stimulation for the principal electrode in increments in a range from 0.05 mA to 0.25 mA to achieve a desired stimulation-induced motor response indicated via an EMG and shown on a graphical user interface of the clinician programmer.

7. The method of claim 1, wherein the period of time is such that a sweeping cycle of the implantable lead is completed in 5 seconds or less.

8. The method of claim 1, further comprising:

calculating an EMG response value for each test stimulation delivered at a given stimulation amplitude level to each electrode based on a maximum EMG response amplitude associated with each electrode.

9. The method of claim 1, further comprising:

calculating an EMG response value for each test stimulation delivered at a given stimulation amplitude level to each electrode based on a maximum EMG response amplitude associated with each electrode which is normalized relative to an EMG response amplitude associated with the principal electrode.

10. The method of claim 9, wherein the visual feedback is based at least in part on the EMG response value associated with each electrode and indicates to a user on how to laterally or axially position the implantable lead at the target stimulation region via a graphical user interface of the clinician programmer.

11. The method of claim 9, further comprising calculating a relative distance or position of each electrode to the target stimulation region based on the EMG response value associated with each electrode.

12. The method of claim 11, further comprising:

repeating the delivering test stimulations to each of the at least four electrodes of the implantable lead and recording steps after lead re-positioning to confirm the calculated EMG response value for each electrode are within a desired value range, or to confirm the maximum EMG response amplitude for each electrode are within a desired response range and the associated stimulation amplitude for each electrode is within a desired stimulation range.

13. The method of claim 1, wherein the lead is inserted through a foramen of a sacrum of the patient and positioned in proximity of a sacral nerve root of the patient so as to treat bladder and/or bowel related dysfunction of the patient.

14. The method of claim 1, further comprising displaying a visual image of the recorded stimulation-induced motor response during each test stimulation on a graphical user interface of the clinician programmer, wherein the visual image includes a waveform comprising a compound muscle action potential (CMAP).

15. The method of claim 1, further comprising:

validating lead placement by testing for a stimulation amplitude threshold for each electrode.

16. The method of claim 15, further comprising:

receiving a user input related to an adjustment of the stimulation amplitude threshold of the test stimulation for each electrode in increments in a range from 0.05 mA to 0.25 mA to achieve a desired stimulation-induced motor response at a minimum stimulation amplitude threshold via a graphical user interface of the clinician programmer.

17. The method of claim 16, further comprising displaying visual feedback to a user on the stimulation amplitude threshold for each electrode via a graphical user interface of the clinician programmer, wherein the visual feedback comprises color coding from at least three contrasting colors.

18. A method for improved positioning of an implantable neurostimulation lead in a patient with an integrated electromyography (EMG) and stimulation clinician programmer coupled to the implantable lead for treatment of bladder and/or bowel dysfunction, wherein the implantable lead comprises at least four neurostimulation electrodes, and the integrated clinician programmer is further coupled to at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient, the method comprising:

delivering a first test stimulation at a stimulation amplitude level from the integrated clinician programmer to a nerve tissue of the patient with a principal electrode of the implantable lead, wherein the principal electrode is selected from the at least four neurostimulation electrodes of the implantable lead;

delivering another test stimulation at a same stimulation amplitude level for a same period of time sequentially to each remaining electrode of the at least four electrodes of the implantable lead from the integrated clinician programmer;

recording via EMG a stimulation-induced motor response with the integrated clinician programmer for each test stimulation on each electrode of the implantable lead via the at least one EMG sensing electrode so as to provide improved lateral and/or axial resolution of the at least four electrodes relative a target nerve for positioning of the implantable lead at a target stimulation region along the target nerve for treatment of bladder and/or bowel dysfunction;

outputting feedback on a graphical user interface of the integrated clinician programmer, the feedback based on the EMG information associated with the first test stimulation of the principal electrode and the other test stimulations of remaining electrodes, the feedback indicating proximity of the at least four electrodes relative the target nerve so as to facilitate improved placement of the at least four electrodes along the target nerve; and

repeating steps of;

delivering a test stimulation to the principle electrode and each remaining electrode at a same stimulation and period of time, recoding via EMG a stimulation-induces motor response for each test stimulation, and outputting feedback on the graphical user interface of the clinician programmer based on the EMG recordings until the EMG recording are indicative of multiple electrodes of the at least four neurostimulation electrodes being in the target stimulation region along the target nerve the second occurrence of.

19. The method of claim 18, further comprising:

selecting a principal electrode based on a user input received via the graphical user interface of the integrated clinician programmer.

20. The method of claim 18, further comprising:

automatically adjusting the stimulation amplitude level of the test stimulation for the principal electrode until a desired stimulation-induced motor response is detected.

21. The method of claim 20, wherein automatically adjusting comprises any of:

increasing the stimulation amplitude in increments of 0.05 mA for a test stimulation less than or equal to 1 mA;

increasing the stimulation amplitude in increments of 0.1 mA for a test stimulation more than or equal to 1 mA and less than or equal to 2 mA;

increasing the stimulation amplitude in increments of 0.2 mA for a test stimulation more than or equal to 2 mA and less than or equal to 3 mA;

increasing the stimulation amplitude in increments of 0.25 mA for a test stimulation more than or equal to 3 mA;

or any combination thereof.

22. The method of claim 18, further comprising receiving a user input related to adjustment of the stimulation amplitude level of the test stimulation for the principal electrode in increments in a range from 0.05 mA to 0.25 mA to achieve a desired stimulation-induced EMG motor response via a graphical user interface of the integrated clinician programmer.

23. The method of claim 18, wherein the period of time is such that a sweeping cycle of the implantable lead is completed in 5 seconds or less.

24. The method of claim 18, further comprising:

calculating an EMG response value for each test stimulation delivered at a given stimulation amplitude level to each electrode based on a maximum EMG response amplitude associated with each electrode, or

calculating an EMG response value for each test stimulation delivered at a given stimulation amplitude level to each electrode based on a maximum EMG response amplitude associated with each electrode which is normalized relative to an EMG response amplitude associated with the principal electrode.

25. The method of claim 24, wherein the visual feedback is based at least in part on the EMG response value associated with each electrode and indicates to a user on how to laterally or axially position the implantable lead at the target stimulation region via a graphical user interface of the integrated clinician programmer.

26. The method of claim 25, further comprising calculating a relative distance or position of each electrode to the target stimulation region based on the EMG response value associated with each electrode.

27. The method of claim 26, further comprising:

repeating the delivering test stimulations to each of the at least four electrodes of the implantable lead and recording steps after lead re-positioning to confirm the calculated EMG response value for each electrode are within a desired value range, or to confirm the maximum EMG response amplitude for each electrode are within a desired response range and the associated stimulation amplitude for each electrode is within a desired stimulation range.

28. The method of claim 27, further comprising displaying a visual image of the recorded stimulation-induced EMG motor response during each test stimulation on a graphical user interface of the integrated clinician programmer, wherein the visual image includes a waveform comprising a compound muscle action potential (CMAP).

29. The method of claim 18, wherein the least one EMG sensing electrode comprises one or more EMG sensing electrode patches that are minimally invasively positioned on a skin surface of the patient.

30. The method of claim 18, wherein the feedback of the proximity of the at least four electrodes relative the target nerve is based on a single sweep of the single test stimulation at the same stimulation amplitude level through each of the at least four neurostimulation electrodes.