Wireless nerve integrity monitoring systems and devices

• US 9,918,669 B2
• Filed: 08/08/2014
• Issued: 03/20/2018
• Est. Priority Date: 08/08/2014
• Status: Active Grant

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Inventors: Brown, Richard L., Pollock, John G., McFarlin, Kevin L., Schulhauser, Randal C.
• Primary Examiner(s): CERIONI, DANIEL LEE
• Application Number:
  US14/455,258
• Publication Number:
  US 20160038072A1
• Time in Patent Office: 1,320 Days
• Field of Search: 600546
• CPC Class Codes: A61B 1/00004 characterised by electronic signal processing
• CPC Class Codes: A61B 1/00016 using wireless means
• CPC Class Codes: A61B 1/00036 Means for power saving, e.g. sleeping mode
• CPC Class Codes: A61B 1/2673 for monitoring movements of vocal chords
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2562/0209 Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/316 : Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/389 : Electromyography [EMG]
• CPC Class Codes: A61B 5/4041 : Evaluating nerves condition
• CPC Class Codes: A61B 5/4848 : Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/6843 : Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6848 : Needles
• CPC Class Codes: A61B 5/6852 : Catheters
• CPC Class Codes: A61B 5/7475 : User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61M 16/04 : Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0443 : Special cuff-wall materials A61M16/0481, A61M16/0422 take precedence
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/36 : related to heating or cooling
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2230/06 : Heartbeat rate only
• CPC Class Codes: A61M 2230/42 : Rate
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61M 2230/60 : Muscle strain, i.e. measured on the user
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity
• CPC Class Codes: A61N 1/36031 : using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 : specified by the stimulation parameters

Abstract

A nerve integrity monitoring device includes a control module and a physical layer module. The control module is configured to generate a payload request. The payload request (i) requests a data payload from a sensor in a wireless nerve integrity monitoring network, and (ii) indicates whether a stimulation probe device is to generate a stimulation pulse. The physical layer module is configured to (i) wirelessly transmit the payload request to the sensor and the stimulation probe device, or (ii) transmit the payload request to a console interface module. The physical layer module is also configured to, in response to the payload request, (i) receive the data payload from the sensor, and (ii) receive stimulation pulse information from the stimulation probe device. The data payload includes data corresponding to an evoked response of a patient. The evoked response is generated based on the stimulation pulse.

Claims

1. A nerve integrity monitoring system comprising:

a first sensing module including a first sensor, wherein the first sensing module is configured to receive (i) a payload request signal, and (ii) a first electromyographic signal from a patient via a first set of electrodes, wherein the first sensing module comprises;

a processing module configured to amplify and filter the first electromyographic signal to generate a first voltage signal, and

a first physical layer module configured to (i) upconvert the first voltage signal to a first radio frequency signal, and (ii) wirelessly transmit the first radio frequency signal based on the payload request signal; and

a console interface module or a nerve integrity monitoring device comprising a second physical layer module, wherein the second physical layer module is configured to (i) transmit the payload request signal to the first sensing module, (ii) receive the first radio frequency signal from the first physical layer module, and (iii) downconvert the first radio frequency signal to a baseband signal, wherein the console interface module comprises;

a control module configured to (i) receive the payload request signal from the nerve integrity monitoring device, and (ii) generate a synchronization request including information in the payload request signal, wherein the synchronization request (i) requests a data payload from the first sensor in a wireless nerve integrity monitoring network, and (ii) indicates whether a stimulation probe device is to generate a stimulation pulse; and

the second physical layer module configured to

wirelessly transmit the synchronization request to the first sensor and the stimulation probe device, and

in response to the synchronization request, (i) wirelessly receive the data payload from the first sensor, and (ii) wirelessly receive stimulation pulse information from the stimulation probe device, wherein the data payload includes data corresponding to an evoked response of the patient, and wherein the evoked response is generated based on the stimulation pulse.

2. The nerve integrity monitoring system of claim 1, wherein the first physical layer module is configured to (i) select a time slot of a synchronization interval based on the payload request signal, and (ii) transmit the first radio frequency signal to the console interface module or the nerve integrity monitoring device in the time slot.

3. The nerve integrity monitoring system of claim 1, further comprising a plurality of sensors, wherein:

the plurality of sensors comprise the first sensor and are attached to the patient;

the plurality of sensors are configured to generate a plurality of radio frequency signals;

the plurality of radio frequency signals comprise the first radio frequency signal; and

the second physical layer module is configured to (i) receive the plurality of radio frequency signals from the first physical layer module, and (ii) downconvert the plurality of radio frequency signals to baseband signals.

4. The nerve integrity monitoring system of claim 3, wherein the nerve integrity monitoring device is configured to display versions of the baseband signals.

5. The nerve integrity monitoring system of claim 3, further comprising a plurality of sensing modules, wherein the plurality of sensing modules comprise:

the first sensing module, wherein the first sensing module is configured to generate the first radio frequency signal, wherein the first set of electrodes include pin electrodes; and

a second sensing module receives a second electromyographic signal via a second set of electrodes, wherein the second sensing module is configured to generate a second radio frequency signal, wherein the plurality of radio frequency signals comprises the second radio frequency signal, and wherein the second set of electrodes include pad electrodes.

6. The nerve integrity monitoring system of claim 1, wherein first set of contacts includes at least one contact on an endotracheal tube.

7. The nerve integrity monitoring system of claim 1, further comprising the stimulation probe device in wireless communication with the console interface module or the nerve integrity monitoring device, wherein the stimulation probe device is configured to (i) wirelessly receive the payload request signal, (ii) in response to the payload request signal, generate a stimulation pulse, and (iii) wirelessly transmit information pertaining to the stimulation pulse to the console interface module or the nerve integrity monitoring device.

8. The nerve integrity monitoring system of claim 1, comprising the console interface module and the nerve integrity monitoring device, wherein:

the console interface module is configured to (i) receive the first radio frequency signal from the first physical layer module, and (ii) based on the first radio frequency signal, generate a first digital signal or a first analog signal; and

the nerve integrity monitoring device is configured to receive from the console interface module the first digital signal or the first analog signal.

9. The nerve integrity monitoring system of claim 1, comprising the nerve integrity monitoring device, wherein the nerve integrity monitoring device is configured to (i) receive the first radio frequency signal from the first physical layer module, and (ii) based on the first radio frequency signal, generate either a first digital signal or a first analog signal.

10. The nerve integrity monitoring system of claim 1, wherein:

the first sensing module comprises a temperature sensor;

the temperature sensor is configured to generate a temperature signal; and

the first sensing module is configured to wirelessly transmit the temperature signal to the console interface module or the nerve integrity monitoring device.

11. The nerve integrity monitoring system of claim 1, wherein the console interface module or the nerve integrity monitoring device is configured to, based on the first radio frequency signal, (i) determine a heart rate or a respiration rate, or (ii) detect a muscle spasm.

12. The nerve integrity monitoring system of claim 1, wherein:

the first sensing module comprises an accelerometer;

the accelerometer is configured to generate an acceleration signal;

the first sensing module is configured to wirelessly transmit the acceleration signal to the console interface module or the nerve integrity monitoring device; and

the console interface module or the nerve integrity monitoring device is configured to, based on the acceleration signal, (i) determine a heart rate or a respiration rate, or (ii) detect a muscle spasm.

13. The nerve integrity monitoring system of claim 1, comprising the nerve integrity monitoring device, wherein the nerve integrity monitoring device comprises:

a control module configured to generate the payload request signal, wherein the payload request signal (i) requests a data payload from the first sensing module in the wireless nerve integrity monitoring network, and (ii) indicates whether the stimulation probe device is to generate the stimulation pulse; and

the second physical layer module configured to

(i) wirelessly transmit the payload request signal to the first sensor and the stimulation probe device, or (ii) transmit the payload request signal to the console interface module, and

in response to the payload request signal, (i) receive the data payload from the first sensor, and (ii) receive stimulation pulse information from the stimulation probe device, wherein the data payload includes data corresponding to an evoked response of the patient, and wherein the evoked response is generated based on the stimulation pulse.

14. The nerve integrity monitoring system of claim 13, wherein the second physical layer module is connected to the console interface module or is separate from and remotely located away from the console interface module.

15. The nerve integrity monitoring system of claim 13, wherein the stimulation pulse information comprises an amplitude of the stimulation pulse and a duration of the stimulation pulse.

16. The nerve integrity monitoring system of claim 13, wherein the payload request signal comprises a data rate at which the first sensor is to communicate the data payload to the second physical layer module or the console interface module.

17. The nerve integrity monitoring system of claim 13, wherein the payload request signal comprises a second data rate at which the stimulation probe device is to communicate the stimulation pulse information to the second physical module or the console interface module.

18. The nerve integrity monitoring system of claim 13, wherein:

the payload request signal comprises slot status words; and

each of the slot status words indicates whether a time slot is allocated to the first sensor or another sensor.

19. The nerve integrity monitoring system of claim 13, wherein the payload request signal comprises request sequencer bits indicating which of a series of synchronization intervals the first sensor is to transmit data to the second physical module or the console interface module.

20. The nerve integrity monitoring system of claim 13, wherein the payload request signal comprises a unique identifier of the first sensor or indicates a type of the first sensor.

21. The nerve integrity monitoring system of claim 13, wherein the payload request signal indicates whether each of a plurality of time slots, in each of a plurality of synchronization intervals is available, is in a process of being assigned, or is designated to the first sensor or to another sensor.

22. The nerve integrity monitoring system of claim 1, wherein the second physical layer module is configured to transmit the data payload and the stimulation pulse information to the nerve integrity monitoring device.

23. The nerve integrity monitoring system of claim 1, wherein the second physical layer module is connected to the nerve integrity monitoring device or is separate from and remotely located away from the nerve integrity monitoring device.

24. The nerve integrity monitoring system of claim 1, wherein the stimulation pulse information comprises an amplitude of the stimulation pulse and a duration of the stimulation pulse.

25. The nerve integrity monitoring system of claim 1, wherein:

the synchronization request comprises slot status words; and

each of the slot status words indicates whether a time slot is allocated to the sensor or another sensor.

26. The nerve integrity monitoring system of claim 1, wherein the synchronization request comprises request sequencer bits indicating which of a series of synchronization intervals the first sensor is to transmit data to the second physical module.

27. The nerve integrity monitoring system of claim 1, wherein the synchronization request comprises a unique identifier of the first sensor or indicates a type of the first sensor.

28. The nerve integrity monitoring system of claim 1, wherein the synchronization request indicates whether each of a plurality of time slots, in each of a plurality of synchronization intervals is available, is in a process of being assigned, or is designated to the first sensor or to another sensor.

29. A nerve integrity monitoring system comprising:

a first sensing module including a first sensor, wherein the first sensing module is configured to receive (i) a payload request signal, and (ii) a first electromyographic signal from a patient via a first set of electrodes, wherein the first sensing module comprises;

a processing module configured to amplify and filter the first electromyographic signal to generate a first voltage signal, and

a first physical layer module configured to (i) upconvert the first voltage signal to a first radio frequency signal, and (ii) wirelessly transmit the first radio frequency signal based on the payload request signal; and

a console interface module or a nerve integrity monitoring device comprising a second physical layer module, wherein the second physical layer module is configured to (i) transmit the payload request signal to the first sensing module, (ii) receive the first radio frequency signal from the first physical layer module, and (iii) downconvert the first radio frequency signal to a baseband signal;

an endotracheal tube assembly, wherein the endotracheal tube assembly comprises;

an endotracheal tube for insertion in an airway of the patient, wherein the endotracheal tube comprises a proximal end, a distal end, a contact, and a trace, wherein the contact is on the endotracheal tube and is closer to the proximal end than the distal end, and wherein the trace extends between the contact and the distal end and is configured to receive a second electromyographic signal from the patient via the contact; and

a second sensing module configured to connect to the trace and receive the second electromyographic signal, wherein the second sensing module is configured to (i) detect the second electromyographic signal and generate a second voltage signal, (ii) upconvert the second voltage signal to a second radio frequency signal, and (iii) wirelessly transmit the second radio frequency signal from the second sensing module to the console interface module or the nerve integrity monitoring device.