US2017007146A1PendingUtilityA1

Wireless sensors and corresponding systems and methods for intra-operative nerve root decompression monitoring

Assignee: WARSAW ORTHOPEDIC INCPriority: Aug 8, 2014Filed: Jul 8, 2015Published: Jan 12, 2017
Est. expiryAug 8, 2034(~8 yrs left)· nominal 20-yr term from priority
A61N 1/36031A61N 1/36034A61B 5/0024A61M 2230/50A61B 5/6843A61B 5/02055A61B 5/6852A61B 5/1107A61M 2230/42A61B 5/0002A61B 1/00036A61M 2205/8206A61B 5/11A61M 16/0443A61M 2205/36A61M 2230/63A61B 1/00004A61B 1/2673A61M 2205/52A61M 2230/06A61B 5/01A61B 5/7475A61B 5/4848A61B 5/6848A61M 2230/60A61B 5/024A61M 2205/3569A61B 5/14539A61B 2560/0209A61B 1/00016A61B 5/0816A61M 2205/502A61M 2205/3592A61B 5/0004A61B 5/6833A61B 5/0008A61B 5/1473A61B 5/0084A61M 16/04A61B 2562/0209A61B 5/4041A61B 5/397A61B 5/389A61B 5/0492A61B 5/04012A61B 5/4836A61N 1/36014A61B 5/296A61B 5/316
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Claims

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

exact text as granted — not AI-modified
What is claimed is: 
     
         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.

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