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

• US 10,406,369 B2
• Filed: 01/03/2017
• Issued: 09/10/2019
• 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:
  US15/397,618
• Publication Number:
  US 20170209703A1
• Time in Patent Office: 980 Days
• Field of Search: None
• 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 system for improved positioning of an implantable lead in a patient, the system comprising:

a clinician programmer having a lead connector configured for electrically connecting to an implantable lead having a plurality of electrodes, a signal generator configured for delivery of stimulation to the lead via the lead connector, a memory, a communication module and a graphical user interface,

the clinician programmer being configured with a lead placement procedure recorded on the memory that is configured to perform steps of;

delivering a first test stimulation from the signal generator 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 plurality of electrodes of the implantable lead;

delivering another test stimulation from the signal generator at a same stimulation amplitude level for a same period of time sequentially to each remaining electrode for the plurality of electrodes of the implantable lead from the clinician programmer, wherein the other test stimulations in the sequence occur directly after the first test;

receiving, with the clinician programmer by communication with an EMG sensing electrode or by an input via the graphical user interface, EMG response information based on a recording of a stimulation-induced EMG motor response, which is detected by at least one EMG sensing electrode minimally invasively positionable on a skin surface or within the patient, for each test stimulation, the EMG response information from the plurality of electrodes at the same stimulation amplitude levels corresponding to relative distances of each electrode from the target nerve so as to provide improved lateral and/or axial resolution of the plurality of electrodes relative to a target nerve for positioning of the implantable lead at a target stimulation region along the target nerve; and

output feedback on the graphical user interface of the clinician programmer during the lead placement procedure, 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 plurality of electrodes relative the target nerve so as to facilitate improved placement of the plurality of electrodes along the target nerve.

2. The system of claim 1, wherein the clinician programmer is further configured to:

repeat steps of;

delivering a test stimulation to the principal electrode and each remaining electrode at a same stimulation and period of time, receiving EMG information based on recording a stimulation-induced 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 EMG information is indicative of multiple electrodes of the plurality of electrodes being within the target stimulation region along the target nerve.

3. The system of claim 1, wherein the clinician programmer is further configured to:

automatically adjust the stimulation amplitude level of the test stimulation for the principal electrode in pre-determined increments until a desired stimulation-induced motor response EMG recording is received by the clinician programmer;

or

receive a user input on the graphical user interface of the clinician programmer, the 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 the graphical user interface of the clinician programmer.

4. The system of claim 1, wherein the period of time is such that a sweeping cycle of test stimulations through the plurality of electrodes is completed by the clinician programmer in five seconds or less.

5. The system of claim 1, wherein the clinician programmer is further configured to:

calculate 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.

6. The system of claim 5, wherein the clinician programmer is further configured such that 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 the graphical user interface of the clinician programmer.

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

8. The system of claim 1, wherein the clinician programmer is further configured to:

display visual feedback to a user on the stimulation amplitude threshold for each electrode via the graphical user interface of the clinician programmer, wherein the visual feedback comprises color coding from at least three contrasting colors.

9. The system of claim 1 further comprising:

an implantable lead operatively coupled to the clinician programmer; and

at least one electromyography (EMG) sensing electrode minimally invasively positionable on a skin surface or within the patient, the EMG sensing electrode or an associated EMG module being communicatively coupled with the clinician programmer.

10. A system for improved positioning of an implantable lead in a patient, the system comprising:

a clinician programmer having a lead connector configured and a signal generator configured for delivery of stimulation via the lead connector, a memory and a graphical user interface;

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

at least one EMG sensing electrode minimally invasively positionable on a skin surface or within the patient, the EMG sensing electrode;

wherein the clinician programmer is configured with a lead placement procedure recorded on the memory that is configured to perform steps of;

delivering a first test stimulation at a stimulation amplitude level to a nerve tissue of the patient with a principal electrode of the implantable lead, wherein the principal electrode is selected from the plurality of electrodes of the implantable lead automatically by the clinician programmer or in response to a user input received via the graphical user interface of the clinician programmer;

delivering another test stimulation at a same stimulation amplitude level for a same period of time sequentially to each other electrode of the plurality of electrodes of the implantable lead, wherein the other test stimulations within the sequence occur directly after the first test stimulation; and

receiving EMG response information based on a recording of a stimulation-induced EMG motor response with the clinician programmer for each test stimulation on each electrode of the implantable lead as sensed via the at least one EMG sensing electrode, the EMG response information for each electrode at the same stimulation amplitude levels corresponding to relative distances of each electrode from the target nerve so as to provide improved lateral and/or axial resolution of the plurality of electrodes relative to a target nerve to facilitate positioning of the implantable lead at a target stimulation region along the target nerve.

11. The system of claim 10, wherein the clinician programmer is further configured to:

output feedback on the 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 plurality of electrodes relative the target nerve so as to facilitate improved placement of the plurality of electrodes along the target nerve.

12. The system of claim 11, wherein the clinician programmer is further configured to:

repeat steps of;

delivering a test stimulation to the principal electrode and each remaining electrode at a same stimulation and period of time, receiving EMG information based on recording a stimulation-induced 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 EMG information is indicative of multiple electrodes of the plurality of electrodes being within the target stimulation region along the target nerve.

13. The system of claim 11, wherein the clinician programmer is further configured to:

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

14. The system of claim 11, wherein the clinician programmer is further configured to:

calculate 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

calculate 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.

15. The system of claim 14, wherein the clinician programmer is configured such that 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 the graphical user interface of the clinician programmer.

16. The system of claim 14, wherein the clinician programmer is further configured to calculate a relative distance or position of each electrode to the target stimulation region based on the EMG response value associated with each electrode.

17. The system of claim 14, wherein the clinician programmer is further configured to:

repeat the delivering test stimulations to each of the plurality of 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

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.

18. The system of claim 11, wherein the clinician programmer is configured such that the feedback of the proximity of the plurality of 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 plurality of electrodes.

19. The system of claim 10, wherein the clinician programmer is further configured to:

automatically adjust the stimulation amplitude level of the test stimulation for the principal electrode until the clinician programmer receives an input via the graphical user interface or communication from the at least one EMG sensing electrode that a desired stimulation-induced motor response is detected by use of EMG.

20. The system of claim 19, 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.

21. The system of claim 19, 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.

22. The system of claim 10, wherein the clinician programmer is further configured to:

receive a user input via the graphical user interface of the clinician programmer, the 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 the graphical user interface of the clinician programmer.

23. The system of claim 10, wherein the period of time is such that performing a sweeping cycle of test stimulations through the plurality of electrodes is completed by the clinician programmer in five seconds or less.

24. The system of claim 10, wherein the clinician programmer is further configured to:

display a visual image of the recorded stimulation-induced EMG motor response during each test stimulation on the graphical user interface of the clinician programmer, wherein the visual image includes a waveform comprising a compound muscle action potential (CMAP).

25. The system of claim 10, wherein the least one EMG sensing electrode comprises one or more EMG sensing electrode patches configured for minimally invasively positioning on the skin surface of the patient.

26. A system for improved positioning of an implantable lead in a patient, the system comprising:

a clinician programmer having a lead connector configured for electrically connecting to an implantable lead having a plurality of electrodes, a signal generator configured for delivery of stimulation to the lead via the lead connector, a communication module, a memory and a graphical user interface, the clinician programmer being configured to receive electromyography (EMG) information obtained from at least first and second EMG sensing electrodes coupled with the patient, wherein the clinician programmer is further configured with a lead placement procedure recorded on the memory that is configured to;

perform a sweeping cycle during the lead placement procedure, the sweeping cycle comprising;

delivering a test stimulation at a plurality of stimulation amplitude levels from the clinician programmer to the sacral nerve tissue of the patient with a principal electrode of the implantable lead when connected to the lead connector until the clinician programmer receives an indication that a desired stimulation-induced EMG motor response indicated by the EMG information corresponds to the principal electrode being positioned in a target stimulation region adjacent the sacral nerve, wherein the principal electrode is selected from the plurality of electrodes of the implantable lead;

recording on the memory of the clinician programmer the stimulation amplitude level at which the desired stimulation-induced EMG motor response is indicated when stimulating with the principal electrode;

delivering test stimulations at a same stimulation amplitude level as the recorded stimulation amplitude level for a same period of time sequentially to each remaining electrode of the plurality of electrodes of the implantable lead via the lead connector, wherein the test stimulations to the remaining electrodes are delivered in sequential order without any intervening stimulations at other stimulation amplitude levels, and

receive EMG response information, by communication with the first and second EMG sensing electrodes or by an input via the graphical user interface, the EMG information based on a first stimulation-induced EMG motor response associated with a big toe of the patient obtained from the first EMG electrode and a second stimulation-induced EMG motor response associated with an anal bellows of the patient obtained from the second EMG electrode that are simultaneously recorded for the same level test stimulation on each electrode of the implantable lead via the lead connector during the sweeping cycle, the EMG response information from the plurality of electrodes at the same stimulation amplitude levels corresponding to relative distances of each electrode from the target nerve so as to facilitate positioning of the implantable lead at the target stimulation region along the sacral nerve.

27. The system of claim 26, wherein the clinician programmer is further configured to:

perform one or more subsequent sweeping cycles after lateral and/or axial adjustment of a position of the implantable lead based on the first and second stimulation-induced EMG motor responses simultaneously recorded during the last performed sweeping cycle until stimulation-induced EMG motor response recordings received are indicative of multiple electrodes of the plurality of electrodes being in the target region along the sacral nerve.

28. The system of claim 26, wherein the clinician programmer is further configured to:

automatically store on the memory or display data on the graphical user interface for each test stimulation delivered at incremental or proportional stimulation amplitude levels for each individual electrode of the plurality of electrodes of the implantable lead and the associated EMG recording of the big toe and the anal bellows of the patient for each test stimulation.

29. The system of claim 26, wherein the clinician programmer is further configured to:

repeat the sweeping cycle after lateral and/or axial adjustment of a position of the implantable lead based on the simultaneous recording of the first and second stimulation-induced EMG motor responses during the last previously performed sweeping cycle until multiple electrodes of the plurality of electrodes are positioned in the target stimulation region.

30. The system of claim 26, further comprising:

an implantable lead operatively coupled to the clinician programmer; and

at least one electromyography (EMG) sensing electrode minimally invasively positionable on a skin surface or within the patient, the EMG sensing electrode or an associated EMG module being communicatively coupled with the clinician programmer.

31. The system of claim 26 wherein the lead placement procedure is configured to display on the graphical user interface steps associated with the lead placement procedure.

32. The system of claim 26 wherein the test stimulations of the sweeping cycle are performed in rapid succession such that the sweeping cycle is completed within less than 5 seconds.