WIRELESS SENSORS AND CORRESPONDING SYSTEMS AND METHODS FOR INTRA-OPERATIVE NERVE ROOT DECOMPRESSION MONITORING

• US 20170007146A1
• Filed: 07/08/2015
• Published: 01/12/2017
• Est. Priority Date: 08/08/2014
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Schulhauser, Randal, Brown, Richard L., Kallmyer, Todd A.
• Application Number:
  US14/794,504
• Publication Number:
  US 20170007146A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 sensor including an array of pins, a sensing element, a control module, and a physical layer module. The array of pins or needles is configured to be inserted in tissue of a patient. The sensing element is separate from the array of pins or needles and is configured to (i) detect a first parameter of the tissue, and (ii) generate a first signal indicative of the first parameter. The control module is configured to (i) receive the first signal, (ii) monitor a second parameter of the tissue based on a second signal received from the array of pins or needles, and (ii) generate a third signal based on the first signal and the second parameter, where the third signal is indicative of a level of decompression of a nerve of the patient. The physical layer module is configured to wirelessly transmit the third signal from the sensor to a console interface module or a nerve integrity monitoring device.

Claims

1. A sensor comprising:

an array of pins or needles configured to be inserted in tissue of a patient;

a first sensing element separate from the array of pins or needles and configured to (i) detect a first parameter of the tissue, and (ii) generate a first signal indicative of the first parameter;

a control module configured to (i) receive the first signal, (ii) monitor a second parameter of the tissue based on a second signal received from the array of pins or needles, and (ii) generate a third signal based on the first signal and the second parameter, wherein the third signal is indicative of a level of decompression of a nerve of the patient; and

a physical layer module configured to wirelessly transmit the third signal from the sensor to a console interface module or a nerve integrity monitoring device.

2. The sensor of claim 1, wherein:

the control module is configured to determine the level of decompression based on the first signal and the second signal; and

the third signal indicates the level of decompression.

3. The sensor of claim 1, further comprising:

a power source; and

a front end module configured to (i) receive power from the power source, and (ii) generate a stimulation signal to be applied to the tissue via the array of pins or needles,

wherein the second signal is an evoked response to the stimulation signal.

4. The sensor of claim 1, wherein:

the first signal is indicative of a temperature of the tissue, an oxygen level of the tissue, or a pH level of the tissue; and

the second signal is an electromyography signal.

5. The sensor of claim 1, further comprising:

a motion sensing element configured to generate a motion signal; and

a pH sensing element configured to generate a pH signal indicative of a pH level of the tissue,

wherein

the first signal is indicative of a temperature of the tissue, and

the control module is configured to

determine a perfusion level based on the first signal or the second signal,

determine a conduction speed based on the second signal and a time when a stimulation signal was previously generated,

receive the motion signal, and

generate the third signal based on the motion signal, the pH level, the perfusion level, and the conduction speed.

6. The sensor of claim 1, further comprising:

a light emitting device configured to emit light at the tissue; and

a photodiode configured to (i) detect portions of the light reflected off of the tissue, and (ii) generate a fourth signal indicative of a wavelength and corresponding intensity of the light reflected off of the tissue,

wherein the control module is configured to generate the third signal based on the fourth signal.

7. The sensor of claim 1, comprising a sensing array, wherein:

the sensing array comprises

a first substrate, wherein at least a portion of the first substrate is transparent,

the array of pins or needles attached to the first substrate,

a second substrate connected to the first substrate by conductive elements,

an illuminating device configured to emit light through the at least a portion of the first substrate and at the tissue, and

a photodiode configured to (i) detect a reflected portion of the light reflected back through the first substrate, and (ii) generate a fourth signal; and

the control module is configured to generate the third signal based on the fourth signal.

8. The sensor of claim 7, further comprising a base, wherein:

the conductive elements include a first set of conductive balls; and

the second substrate is connected to the base via a second set of conductive balls.

9. The sensor of claim 8, further comprising:

a control layer comprising the control module; and

an interposer layer disposed between the control layer and the base, wherein the control module is connected to the sensor and the second set of conductive balls via interconnections within the interposer layer.

10. The sensor of claim 1, further comprising a second array of pins or needles, wherein the control module is configured to (i) monitor the second parameter or a third parameter of the tissue based on a fourth signal received from the second array of pins or needles, and (ii) generate the third signal based on the second parameter or the third parameter.

11. The sensor of claim 10, wherein the control module is configured to (i) monitor the second parameter and the third parameter of the tissue based on the fourth signal, and (ii) generate the third signal based on the second parameter and the third parameter.

12. A system comprising:

the sensor of claim 1; and

the console interface module or the nerve integrity monitoring device.

13. The system of claim 12, comprising the nerve integrity monitoring device, wherein the nerve integrity monitoring device comprises:

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

a second physical layer module configured to

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

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, wherein the third signal includes the data payload, 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 system of claim 12, comprising the console interface module, wherein the console interface module comprises:

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

a second physical layer module configured to

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

in response to the synchronization request, (i) wirelessly receive the data payload from the sensor, and (ii) wirelessly receive stimulation pulse information from the stimulation probe device, wherein the third signal includes the data payload, 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.

15. The system of claim 12, wherein the console interface module or the nerve integrity monitoring device is configured to:

determine baseline values for the first parameter and the second parameter;

during or subsequent to a surgery, compare the baseline values respectively to the first parameter and the second parameter; and

based on the comparisons, generating the third signal or indicating whether positive results exist for tasks performed during the surgery.

16. A method of operating a sensor, the method comprising:

detecting a first parameter of a tissue of a patient via a first sensing element of the sensor;

generating a first signal indicative of the first parameter;

monitoring a second parameter of the tissue based on a second signal received from an array of pins or needles, wherein the array of pins or needles is configured to be inserted in the tissue, and wherein the array of pins or needles are separate from the first sensing element;

generating a third signal based on the first signal and the second parameter, wherein the third signal is indicative of a level of decompression of a nerve of the patient; and

wirelessly transmitting the third signal from the sensor to a console interface module or a nerve integrity monitoring device.

17. The method of claim 16, further comprising:

receiving power from a power source within the sensor and at a front end module; and

generating a stimulation signal to be applied to the tissue via the array of pins or needles,

wherein

the first signal is indicative of a temperature of the tissue, an oxygen level of the tissue, or a pH level of the tissue,

the second signal is an evoked response to the stimulation signal and is an electromyography signal.

18. The method of claim 16, further comprising:

generating a motion signal indicative of muscle activity;

generating a pH signal indicative of a pH level of the tissue,

wherein the first signal is indicative of a temperature of the tissue;

determining a perfusion level based on the first signal or the second signal;

determining a conduction speed based on the second signal and a time when a stimulation signal was previously generated;

receiving the motion signal;

emitting light via a light emitting device at the tissue;

detecting portions of the light reflected off of the tissue;

generating a fourth signal indicative of a wavelength and corresponding intensity of the light reflected off of the tissue; and

generating the third signal based on the motion signal, the pH level, the perfusion level, the conduction speed and the fourth signal.

19. The method of claim 16, further comprising:

emitting light through the at least a portion of a first substrate and at the tissue,

wherein the array of pins or needles are included in a sensing array, and

wherein the sensing array comprises

the first substrate attached to the array of pins or needles, wherein at least a portion of the first substrate is transparent, and

a second substrate connected to the first substrate by conductive elements;

detecting a reflected portion of the light reflected back through the first substrate;

generating a fourth signal based on the detected reflected portion of the light reflected back through the first substrate; and

generating the third signal based on the fourth signal.

20. The method of claim 16, further comprising:

monitoring the second parameter and a third parameter of the tissue based on a fourth signal received from a second array of pins or needles; and

generating the third signal based on the second parameter and the third parameter.