System And Method For Omni-Directional Bipolar Stimulation Of Nerve Tissue Of A Patient Via A Bipolar Stimulation Probe

• US 20160287112A1
• Filed: 04/03/2015
• Published: 10/06/2016
• Est. Priority Date: 04/03/2015
• Status: Active Grant

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Inventors: Courtney, Bryan L., MCFARLIN, Kevin L., Hacker, David C.
• Granted Patent: US 11,980,465 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0048 Detecting, measuring or recording by applying mechanical forces or stimuli A61B5/021, A61B5/4884 and A61B9/00 take precedence
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

A bipolar stimulation probe including a first electrode, a second electrode, a control module, and switches. The control module is configured to stimulate nerve tissue of a patient by generating (i) a first output signal indicative of a first pulse to be output from the first electrode, and (ii) a second output signal indicative of a second pulse to be output from the second electrode. The first pulse and the second pulse are monophasic. The switches are configured to output from the bipolar stimulation probe (i) the first pulse on the first electrode based on the first output signal, and (ii) the second pulse on the second electrode based on the second output signal.

Claims

16. A method of operating a bipolar stimulation probe, wherein the bipolar stimulation probe includes a first electrode and a second electrode, the method comprising:

generating a first output signal indicative of a first pulse to be output from the first electrode;

generating a second output signal indicative of a second pulse to be output from the second electrode, wherein the first pulse and the second pulse are monophasic and are generated to stimulate nerve tissue of a patient; and

via a plurality of switches, outputting from the bipolar stimulation probe (i) the first pulse on the first electrode based on the first output signal, and (ii) the second pulse on the second electrode based on the second output signal.

1. A bipolar stimulation probe comprising:

a first electrode;

a second electrode;

a control module configured to stimulate nerve tissue of a patient by generating (i) a first output signal indicative of a first pulse to be output from the first electrode, and (ii) a second output signal indicative of a second pulse to be output from the second electrode, wherein the first pulse and the second pulse are monophasic; and

a plurality of switches configured to output from the bipolar stimulation probe (i) the first pulse on the first electrode based on the first output signal, and (ii) the second pulse on the second electrode based on the second output signal.

2. The bipolar stimulation probe of claim 1, wherein:

the plurality of switches include a first switch and a second switch;

the control module is configured to generate a switch control signal to (i) change an operating mode of the bipolar stimulation probe, and (ii) control states of the plurality of switches;

during a first mode, (i) the first switch is in a first state and provides the first pulse to the first electrode, and (ii) the second switch is in a first state and receives return current from the patient as a result of the first pulse; and

during a second mode, (i) the second switch is in a second state and provides the second pulse to the second electrode, and (ii) the first switch is in a second state and receives return current from the patient as a result of the second pulse.

3. The bipolar stimulation probe of claim 1, wherein the control module is configured to wait a predetermined period between generating the first output signal and the second output signal to account for a refractory period of time of the nerve tissue.

4. The bipolar stimulation probe of claim 1, further comprising an amplification module configured to:

receive a first input based on the first output signal;

amplify the first input to generate the first pulse;

receive a second input based on the second output signal; and

amplify the second input to generate the second pulse.

5. The bipolar stimulation probe of claim 1, further comprising a filter configured to:

receive a first input based on the first output signal;

filter the first input to generate a first filtered output;

receive a second input based on the second output signal; and

filter the second input to generate a second filtered output,

wherein the plurality of switches are configured to provide (i) the first pulse based on the first filtered output to the first electrode, and (ii) the second pulse based on the second filtered output to the second electrode.

6. The bipolar stimulation probe of claim 1, further comprising a digital-to-analog converter configured to convert (i) the first output signal to a first analog signal, and (ii) the second output signal to a second analog signal,

wherein the plurality of switches are configured to provide (i) the first pulse based on the first analog signal to the first electrode, and (ii) the second pulse based on the second analog signal to the second electrode.

7. The bipolar stimulation probe of claim 1, further comprising a feedback module configured to (i) detect a first voltage across the first electrode and the second electrode during generation of the first pulse, (ii) detect a second voltage across the first electrode and the second electrode during generation of the second pulse, and (iii) generate a feedback signal based on the first voltage or the second voltage,

wherein the control module is configured to generate a third pulse based on the first voltage or the second voltage.

8. The bipolar stimulation probe of claim 7, wherein:

the feedback module comprises a transconductance amplifier;

the transconductance amplifier is configured to (i) convert the first voltage to a first current, and (ii) the second voltage to a second current; and

the control module is configured to generate the third pulse based on the first current or the second current.

9. The bipolar stimulation probe of claim 1, wherein:

the control module is configured to stimulate the nerve tissue of the patient by generating (i) a first plurality of output signals indicative of a first plurality of pulses to be output from the first electrode, and (ii) a second plurality of output signals indicative of a second plurality of pulses to be output from the second electrode, wherein the first plurality of pulses and the second plurality of pulses are monophasic, wherein the first plurality of pulses includes the first pulse, and the second plurality of pulses includes the second pulse; and

the plurality of switches are configured to output from the bipolar stimulation probe (i) the first plurality of pulses on the first electrode based on the first plurality of output signals, and then (ii) the second plurality of pulses on the second electrode based on the second plurality of output signals.

10. A system comprising:

the bipolar stimulation probe of claim 1;

a sensor configured to detect signal activity in an area of the patient; and

a nerve integrity monitoring device configured to (i) based on the first pulse and the second pulse, monitor the signal activity in an area of the patient, (ii) determine when the first pulse and the second pulse are generated, and (ii) based on when the first pulse and the second pulse are generated, filter out portions of the signal activity.

11. The system of claim 10, wherein:

the signal activity includes the first pulse, the second pulse and at least one artifact of the first pulse and the second pulse; and

the nerve integrity monitoring device is configured to filter out the at least one artifact during a rejection period and monitor electromyography signals during a first monitoring period,

the first monitoring period is subsequent to the rejection period.

12. The system of claim 11, wherein the nerve integrity monitoring device is configured to:

filter out a first artifact of the first pulse or a second artifact of the second pulse during a rejection period; and

the first monitoring period is subsequent to the rejection period and corresponds to both the first pulse and the second pulse.

13. The system of claim 11, wherein the nerve integrity monitoring device is configured to:

filter out a first artifact of the first pulse during a first rejection period;

filter out a second artifact of the second pulse during a second rejection period;

monitor a first electromyography signal during the first monitoring period;

monitor a second electromyography signal during a second monitoring period;

the first monitoring period is based on the first pulse; and

the second monitoring period is based on the second pulse.

14. A system comprising:

the bipolar stimulation probe of claim 1; and

a nerve integrity monitoring device configured to generate a first request signal,

wherein the control module is configured to, based on the first request signal, generate the first output signal or the second output signal.

15. The system of claim 14, wherein:

the bipolar stimulation probe comprises

a feedback module configured to (i) monitor a voltage across the first electrode and the second electrode, and (ii) generate a feedback signal based on the voltage, and

a physical layer module configured to wirelessly communicate with the nerve integrity monitoring device;

the control module is configured to (i) determine a parameter of the feedback signal, and (ii) wirelessly transmit the parameter via the physical layer module to the nerve integrity monitoring device;

the nerve integrity monitoring device is configured to (i) generate a second request signal based on the parameter, and (ii) wirelessly transmit the second request signal back to the physical layer module; and

the control module is configured to generate a third pulse based on the second request signal.

17. The method of claim 16, further comprising:

generating a switch control signal to (i) change an operating mode of the bipolar stimulation probe, and (ii) control states of the plurality of switches, wherein the plurality of switches include a first switch and a second switch;

during a first mode and while the first switch is in a first state and the second switch is in a first state, (i) providing the first pulse to the first electrode via the first switch, and (ii) receiving return current from the patient as a result of the first pulse via the second switch; and

during a second mode and while the second switch is in a second state and the first switch is in a second state, (i) providing the second pulse to the second electrode via the second switch, and (ii) receiving return current from the patient as a result of the second pulse via the first switch.

18. The method of claim 16, further comprising waiting a predetermined period between generating the first output signal and the second output signal to account for a refractory period of time of the nerve tissue.

19. The method of claim 16, further comprising:

receiving a first input at an amplification module based on the first output signal;

amplifying the first input to generate the first pulse;

receiving a second input at the amplification module based on the second output signal; and

amplifying the second input to generate the second pulse.

20. The method of claim 16, further comprising:

receiving at a filter a first input based on the first output signal;

filtering the first input to generate a first filtered output;

receiving at the filter a second input based on the second output signal;

filtering the second input to generate a second filtered output; and

via the plurality of switches, providing (i) the first pulse based on the first filtered output to the first electrode, and (ii) the second pulse based on the second filtered output to the second electrode.

21. The method of claim 16, further comprising:

converting (i) the first output signal to a first analog signal, and (ii) the second output signal to a second analog signal; and

via the plurality of switches, providing (i) the first pulse based on the first analog signal to the first electrode, and (ii) the second pulse based on the second analog signal to the second electrode.

22. The method of claim 16, further comprising:

detecting a first voltage across the first electrode and the second electrode during generation of the first pulse;

detecting a second voltage across the first electrode and the second electrode during generation of the second pulse;

generating a feedback signal based on the first voltage or the second voltage; and

generating a third pulse based on the first voltage or the second voltage.

23. The method of claim 22, further comprising:

converting the first voltage to a first current;

converting the second voltage to a second current; and

generating the third pulse based on the first current or the second current.

24. The method of claim 16, further comprising:

stimulating the nerve tissue of the patient by generating (i) a first plurality of output signals indicative of a first plurality of pulses to be output from the first electrode, and (ii) a second plurality of output signals indicative of a second plurality of pulses to be output from the second electrode, wherein the first plurality of pulses and the second plurality of pulses are monophasic, wherein the first plurality of pulses includes the first pulse, and the second plurality of pulses includes the second pulse; and

outputting from the bipolar stimulation probe (i) the first plurality of pulses on the first electrode based on the first plurality of output signals, and then (ii) the second plurality of pulses on the second electrode based on the second plurality of output signals.

25. The method of claim 16, further comprising:

detecting signal activity at a sensor in an area of the patient;

based on the first pulse and the second pulse, monitoring the signal activity in an area of the patient;

determining when the first pulse and the second pulse are generated; and

based on when the first pulse and the second pulse are generated, filtering out portions of the signal activity.

26. The method of claim 25, further comprising:

during a rejection period, filtering out at least one artifact of the first pulse and the second pulse, wherein the signal activity includes the first pulse, the second pulse and the at least one artifact; and

monitoring electromyography signals during a first monitoring period, wherein the first monitoring period is subsequent to the rejection period.

27. The method of claim 26, further comprising during a rejection period, filtering out a first artifact of the first pulse or a second artifact of the second pulse, wherein the first monitoring period is subsequent to the rejection period and corresponds to both the first pulse and the second pulse.

28. The method of claim 26, further comprising:

filtering out a first artifact of the first pulse during a first rejection period;

filtering out a second artifact of the second pulse during a second rejection period;

monitoring a first electromyography signal during the first monitoring period; and

monitoring a second electromyography signal during a second monitoring period;

wherein the first monitoring period is based on the first pulse, and

wherein the second monitoring period is based on the second pulse.

29. The method of claim 28, further comprising:

monitoring a voltage across the first electrode and the second electrode;

generating a feedback signal based on the voltage;

determining a parameter of the feedback signal;

wirelessly transmitting the parameter from the bipolar stimulation probe to the nerve integrity monitoring device;

generating a second request signal based on the parameter;

wirelessly transmitting the second request signal back to the bipolar stimulation probe; and

generating a third pulse based on the second request signal via the bipolar stimulation probe.

28-1. The method of claim 16, further comprising:

generating a first request signal at a nerve integrity monitoring device;

transmitting the first request signal to the bipolar stimulation probe; and

based on the first request signal, generating the first output signal or the second output signal.