Integrated electromyographic clinician programmer for use with an implantable neurostimulator

• US 10,092,762 B2
• Filed: 08/14/2015
• Issued: 10/09/2018
• 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): CERIONI, DANIEL LEE
• Application Number:
  US14/827,095
• Publication Number:
  US 20160045746A1
• Time in Patent Office: 1,152 Days
• Field of Search: 600546
• 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 1/3603 Control systems
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• 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

An integrated electromyography (EMG) and signal/stimulation generation clinician programmer may be coupled with an implantable temporary or permanent lead in a patient and at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient. Generally, the integrated clinician programmer may comprise a portable housing, a signal/stimulation generator, and EMG signal processor, and a graphical user interface. The signal/stimulation generator may be disposed within the housing and configured to deliver test stimulation to a nerve tissue of the patient via the implantable lead. The EMG signal processor may be disposed within the housing and configured to record a stimulation-induced EMG motor response for each test stimulation via the at least one EMG sensing electrode. The graphical user interface at least partially comprises the external surface of the housing and has a touch screen display for direct user interaction or a keyboard, mouse, or the like.

Claims

1. An integrated electromyography (EMG) and signal generation clinician programmer coupleable with an implantable temporary or permanent lead in a patient and at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient, the integrated clinician programmer comprising:

a portable housing having an external surface and enclosing circuitry at least partially disposed within the housing;

a lead connector disposed on the housing for electrical connection with the implantable lead;

a signal generator disposed within the housing and configured to deliver test stimulation to a nerve tissue of the patient via the implantable lead;

an EMG signal processor disposed within the housing and configured to record a stimulation-induced EMG motor response for each test stimulation via the at least one EMG sensing electrode;

a graphical user interface at least partially comprising the external surface of the housing and configured to facilitate positioning and programming of the implantable lead based at least on the EMG recording; and

a memory having recorded thereon instructions for effecting each of;

a lead placement procedure, and

a programming procedure,

wherein the lead placement procedure includes;

a foramen needle placement procedure that detects connection with the foramen needle via a foramen needle stimulation connector on the housing and delivers stimulation to the foramen needle in response to a stimulation input received via the graphical user interface, and

an implantable lead placement procedure that detects connection with the implantable lead via the lead connector and delivers stimulation to the lead through the lead connector in response to the stimulation input received via the graphical user interface.

2. The integrated clinician programmer of claim 1, wherein the graphical user interface includes a touch screen and an EMG display comprising a visual image of the EMG record, wherein the visual image includes a waveform comprising a compound muscle action potential (CMAP) or a visual indicator of a maximum, integral average, or root mean square CMAP response.

3. The integrated clinician programmer of claim 2, wherein the EMG display includes a motor response graphical element which is configured for user input of the EMG motor response associated with each test stimulation.

4. The integrated clinician programmer of claim 1, wherein the graphical user interface includes a sensory response graphical element which is configured for user input of a sensory response from the patient associated with each test stimulation.

5. The integrated clinician programmer of claim 1, wherein the graphical user interface includes a stimulation amplitude adjustment graphical element which is configured for user adjustment of a stimulation amplitude of the test stimulation from the signal generator in increments in a range from about 0.05 mA to about 0.25 mA, wherein the test stimulation amplitude is less than 10 mA.

6. The integrated clinician programmer of claim 1, wherein the graphical user interface includes at least one parameter graphical element which is configured for user adjustment of a pulse width of the test simulation, a pulse frequency of the test stimulation, a cycling or continuous mode of the test stimulation, a bipolar or monopolar mode of the test stimulation, or an electrode configuration of the implantable lead.

7. The integrated clinician programmer of claim 1, further comprising a foramen needle connector disposed on the housing for electrically coupling the signal generator to a foramen needle, wherein the circuitry is configured to identify or locate a target nerve prior to an initial lead placement in response to signals from the foramen needle, and to guide positioning of the permanent lead or to facilitate programming of the permanent lead or both in response to signals from the permanent lead.

8. The integrated clinician programmer of claim 1, wherein the implantable lead comprises at least four stimulation electrodes arranged in a linear array along a length of the lead, wherein the lead is configured to be inserted through a foramen of a sacrum and positioned in proximity of a sacral nerve root so at to treat overactive bladder, or bladder related dysfunction, or fecal dysfunction.

9. The integrated clinician programmer of claim 8, further comprising first and second EMG connectors on the housing for coupling the EMG signal processor to first and second EMG sensing electrodes, wherein the first and second EMG sensing electrodes are positionable on a big toe of the patient.

10. The integrated clinician programmer of claim 9, wherein the first and second EMG sensing electrodes are positionable on a flexor hallucis brevis or tendon of a flexor hallucis longus of a plantar flexion region of the big toe.

11. The integrated clinician programmer of claim 9, further comprising third and fourth EMG connectors on the housing for coupling the EMG signal processor to third and fourth EMG sensing electrodes, wherein the third and fourth EMG sensing electrodes are positionable within an anal bellows of the patient.

12. The integrated clinician programmer of claim 11, wherein the third and fourth EMG sensing electrodes are positionable on each side or same side of levator ani muscles of perineal musculature of the anal bellows.

13. The integrated clinician programmer of claim 11, wherein the EMG signal processor simultaneously records a first stimulation-induced EMG motor response associated with the big toe and a second stimulation-induced EMG motor response associated with the anal bellows for each test stimulation.

14. The integrated clinician programmer of claim 8, wherein the graphical user interface includes an implantable lead graphical element which is configured for user selection of an individual stimulation electrode from the at least four stimulation electrodes and an amplitude adjustment graphical element which is configured for user adjustment of an amplitude of the test stimulation associated with the selected stimulation electrode.

15. The integrated clinician programmer of claim 14, wherein the graphical user interface further includes a visual indicator associated with each stimulation electrode and configured to indicate a status of the stimulation electrode, an amplitude threshold value of the stimulation electrode based on EMG record, an EMG value or status associated with the stimulation amplitude threshold value, a sensory response status associated with the stimulation amplitude threshold value, or an impedance status of the stimulation electrode.

16. The integrated clinician programmer of claim 1, wherein the test stimulation delivered by the signal generator comprises at least one electrical pulse below a muscle activation threshold and the EMG sensing electrode detects stimulation of the nerve tissue.

17. The integrated clinician programmer of claim 1, wherein the implantable lead comprises a plurality of electrodes, and

wherein the instructions are further configured so that when the lead placement procedure is selected, the clinician programmer effects automated sequential stimulation of each electrode of the plurality to facilitate determination of proximity of the plurality of electrodes from a target nerve based on stimulation responses received by the clinician programmer.

18. The integrated clinician programmer of claim 17, wherein the programming procedure includes an electrode contact characterization procedure for determining a stimulation amplitude threshold for each electrode from stimulation responses during which the clinician programmer is connected to the implantable lead.

19. The integrated clinician programmer of claim 1, wherein the instructions further include an automated threshold determination based on stimulation-induced EMG responses received with the clinician programmer to provide rapid feedback during the lead placement method and programming procedure.

20. An integrated electromyography (EMG) and signal generation clinician programmer coupleable with an implantable temporary or permanent lead in a patient and at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient, the integrated clinician programmer comprising:

a portable housing having an external surface and enclosing circuitry at least partially disposed within the housing;

a lead connector disposed on the housing for electrical connection with the implantable lead;

a signal generator disposed within the housing and configured to deliver test stimulation to a nerve tissue of the patient via the implantable lead;

an EMG signal processor disposed within the housing and configured to record a stimulation-induced EMG motor response for each test stimulation via the at least one EMG sensing electrode; and

a graphical user interface at least partially comprising the external surface of the housing and configured to facilitate positioning and programming of the implantable lead based at least on the EMG recording;

wherein the clinician programmer includes at least one EMG connector on the housing for connection with the at least one EMG sensing electrodes, and a memory having recorded thereon instructions for effecting each of;

a lead placement procedure, and

a programming procedure,

wherein the instructions are further configured such that;

absent detection of EMG electrodes connected to the at least one EMG connector, the graphical user interface performs the lead placement and programming procedures based on responses input by the clinician via the graphical user interface; and

upon detection of EMG electrodes connected to the at least one EMG connector, the graphical user interface performs the lead placement and programming procedures based on EMG responses received via the at least one EMG connector and displayed on the graphical user interface.