Wireless nerve integrity monitoring system and device

Abstract

The present application relates to wireless neural integrity monitoring systems and devices, which can include a control module configured to generate a payload request, wherein the payload request (i) requests a data payload from a sensor in a wireless neural integrity monitoring network and (ii) indicates whether a stimulation probe device is to generate a stimulation pulse, and a 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 a 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 data payload includes data corresponding to an evoked response of a patient and wherein the evoked response is generated based on the stimulation pulse.

Description

[0001] This application is a divisional application of the invention patent application with international application number PCT / US2015 / 043844, international application date August 5, 2015, and Chinese national application number 201580053580.3, entitled "Wireless Neural Integrity Monitoring System and Device". Technical Field

[0002] The present disclosure relates to neural integrity monitoring systems and devices. Background Art

[0003] The background description provided herein is for the purpose of generally presenting the context of the present disclosure. With respect to the description in this background section, the work of the presently designated inventors and aspects of the description that may not otherwise qualify as prior art as of the filing date are not admitted, either explicitly or implicitly, as prior art that is inconsistent with the present disclosure.

[0004] A neural integrity monitoring (NIM) system may include a stimulation probe device, a sensor, an electrode connection box, and an electromyography (EMG) monitoring device. The stimulation probe device is used to stimulate nerve and / or muscle activity. As an example, the stimulation probe device may include a stimulation electrode head. The surgeon may contact a site on the patient with the electrode head to provide voltage and / or current to the site on the patient and stimulate nerve activity, thereby stimulating muscle response (or muscle activity). A reference patch may be attached to the patient away from (i) the sensor and (ii) the stimulated area. The electrodes of the reference patch may be at a reference potential. The sensor may include electrodes attached to the patient and used to monitor muscle activity. The voltage potential between the electrode head of the stimulation probe device and the reference patch and the voltage potential indicated by the output of the sensor may be provided to the electrode connection box via wires. The wires are plugged into corresponding sockets in the electrode connection box.

[0005] The electrode connection box may have channels for the following items respectively: the voltage potential of the stimulation probe device; the voltage potential of the reference patch; and the output voltage of the sensor. The electrode connection box can filter the signals received from the stimulation probe device and the sensor and provide corresponding signals to the EMG monitoring device. Depending on the surgical operation being performed, a large number of cables can be used to transmit information between (i) the stimulation probe device and the sensor and (ii) the electrode connection box. As an example, 1-32 channels can be used during a surgical operation. Each channel can correspond to a corresponding twisted pair cable (each cable having twisted pair wires). Each cable connected to the sensor is fixed to the patient via the electrodes of the sensor, extends away from the patient, and is routed to the EMG monitoring device outside the sterile area (or environment) where the patient is.

[0006] In one example, a sensor of some type can be used to monitor nerves in the patient's laryngeal musculature during a thyroid surgery. Injury to the recurrent laryngeal nerve (RLN) is one of the most serious complications of thyroid surgery. An endotracheal tube can be used during a thyroid surgery to open the airway and provide air to the patient's lungs. The endotracheal tube can include electrodes designed to contact the patient's vocal cords to facilitate EMG monitoring of the vocal cords during the surgery.

[0007] As an example, a stimulating electrode can be placed on the vagus nerve in the patient's neck to deliver a continuous low-level stimulation to the nerve endings. A baseline of the nerve function is obtained, and subsequent EMG responses are monitored via electrodes connected to the endotracheal tube. Electromyographic signals are generated and detected by the electrodes and provided to an EMG monitoring device. The EMG monitoring device monitors changes in the electromyographic signals to detect changes in the patient's laryngeal musculature. Between stimulations, the nerve can be at risk due to surgical incisions and / or "blind" trauma caused by stretching, heating, compressing, and / or manipulating the patient's tissue during a tumor / thyroidectomy. The EMG responses are plotted in real-time to provide feedback about the condition of the nerve. SUMMARY

[0008] A nerve integrity monitoring device is provided and 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 stimulating 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 stimulating probe device or (ii) transmit the payload request to a console interface module. The physical layer module is further configured to, in response to the payload request, (i) receive the data payload from the sensor and (ii) receive stimulation pulse information from the stimulating 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.

[0009] In other features, a console interface module is provided, and the console interface module includes a control module and a physical layer module. The control module is configured to: (i) receive a payload request from a neural integrity monitoring device, and (ii) generate a synchronization request including information in the payload request. The synchronization request (i) requests a data payload from a sensor in a wireless neural integrity monitoring network, and (ii) indicates whether a stimulation probe device is to generate a stimulation pulse. The physical layer module is 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. The data payload includes data corresponding to the patient's evoked response. The evoked response is generated based on the stimulation pulse.

[0010] In other features, a neural integrity monitoring system includes a first sensing module and a console interface module or a neural integrity monitoring device. 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. The first sensing module includes: 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) up-convert the first voltage signal into a first radio frequency signal, and (ii) wirelessly transmit the first radio frequency signal based on the payload request signal; the console interface module or the neural integrity monitoring device includes a second physical layer module configured to: (i) receive the first radio frequency signal from the first physical layer module, and (ii) down-convert the first radio frequency signal to a baseband signal.

[0011] Other areas of applicability of the present disclosure will become apparent from the detailed description, claims, and accompanying drawings. The detailed description and specific examples are intended for illustrative purposes only and are not intended to limit the scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is a perspective view of a wireless neural integrity monitoring (WNIM) system according to the present disclosure.

[0013] Figure 2 is a functional block diagram of a sensing module, a console interface module, and a NIM device according to the present disclosure.

[0014] Figure 3 is a functional block diagram of another sensing module and another NIM device according to the present disclosure.

[0015] Figure 4 is a functional block diagram of another sensing module according to the present disclosure.

[0016] Figure 5 is a functional block diagram of a stimulation probe device according to the present disclosure.

[0017] Figure 6 is a functional block diagram of a portion of a stimulation probe device according to the present disclosure.

[0018] Figure 7A is a perspective view of a three-gasket sensor with an electronic control module assembly according to the present disclosure.

[0019] Figure 7B There is no electronic control module assembly Figure 7A A bottom perspective view of a portion of a three-pad sensor, and showing the corresponding contact pads.

[0020] Figure 8 is a perspective view of an EMG endotracheal tube assembly according to the present disclosure.

[0021] Figure 9 yes Figure 8 Another perspective view of the EMG endotracheal tube assembly.

[0022] Figure 10 yes Figure 8 Another perspective view of the EMG endotracheal tube assembly.

[0023] Figure 11 yes Figure 8 Side view of the housing of the EMG endotracheal tube assembly.

[0024] Figure 12 yes Figure 8 Bottom view of the housing of the EMG endotracheal tube assembly.

[0025] Figure 13 yes Figure 8 Exploded view of the EMG endotracheal tube assembly housing and corresponding electronic components.

[0026] Figure 14 is a graph of stimulus pulses and corresponding evoked response signals.

[0027] Figure 15 is a timing diagram illustrating a periodic synchronization (sync) interval of two time slots per sensor according to the present disclosure.

[0028] Figure 16 is a timing diagram illustrating a periodic synchronization interval with a single time slot per sensor according to the present disclosure.

[0029] Figure 17 is a timing diagram illustrating a periodic synchronization interval with a single time slot per sensor and an increasing number of sensor time slots per frame in accordance with the present disclosure.

[0030] Figure 18 is a signal flow diagram illustrating sensors participating and communicating in a WNIM system according to the present disclosure.

[0031] Figure 19 is a signal flow diagram illustrating the integration and communication of a stimulation device in a WNIM system according to the present disclosure.

[0032] Figure 20 Methods of operating a sensor and console interface module and / or a NIM device according to the present disclosure are shown.

[0033] Figure 21 A method of powering up a sensor according to the present disclosure is shown.

[0034] Figure 22 A WNIM method of operating a stimulation probe device, one or more sensors, and a console interface module and / or NIM device according to the present disclosure is shown.

[0035] Figure 23 is a side perspective view of a portion of another EMG endotracheal tube assembly according to the present disclosure.

[0036] Figure 24 yes Figure 23 Exploded view of the EMG endotracheal tube assembly housing and corresponding electronic components.

[0037] Figure 25 is a perspective view of a sensor assembly incorporating a modular control module assembly according to the present disclosure.

[0038] Figure 26 It is connected to the patch Figure 25 Side view of the modular control module assembly.

[0039] Figure 27 is a diagram showing the pads of the patch Figure 25 Bottom perspective view of the modular control module assembly.

[0040] Figure 28 yes Figure 25 A perspective view of the modular control module assembly and the patch.

[0041] Figure 29 yes Figure 25 Bottom perspective view of the modular control module assembly and the patch.

[0042] Figure 30 is connected to a pin electrode adapter according to the present disclosure Figure 25 A perspective view of the modular control module assembly.

[0043] Figure 31 is connected to the pin electrode adapter Figure 25 Side view of the modular control module assembly.

[0044] Figure 32 is connected to the pin electrode adapter Figure 25 Bottom perspective view of the modular control module assembly.

[0045] Figure 33 yes Figure 25 A top perspective view of the modular control module assembly and the pin electrode adapter.

[0046] Figure 34 yes Figure 25 Bottom perspective view of the modular control module assembly and the pin electrode adapter.

[0047] Figure 35 is a circuit diagram of a portion of a power module according to the present disclosure.

[0048] Among the drawings, reference numbers may be reused to identify similar and / or identical elements. DETAILED DESCRIPTION

[0049] Any clutter and / or time inefficiencies that can be eliminated and / or minimized in the operating room are beneficial to both hospital personnel and patients. Neurological integrity monitoring (NIM) systems currently have extensive cabling. Most of the cabling is used to deliver evoked response signals from sensors to NIM devices due to stimulated neural activity in the patient's muscles. Various techniques are disclosed below to reduce and / or eliminate the cabling used in NIM systems, reduce and / or minimize certain time inefficiencies associated with current NIM systems, and minimize power consumption.

[0050] Figure 1 A wireless neural integrity monitoring (WNIM) system 10 is shown. As shown, the WNIM system 10 includes sensors 12, 13, a stimulation probe device 14, a wireless interface adapter (WIA) 16, and a NIM device 18. The WIA 16 includes Figure 218 and an interface 20 (e.g., a 32-pin connector) for connecting to a NIM device 18. A WIA 16 is shown inserted into the back of the NIM device 18. Although the WIA 16 is shown inserted into the NIM device 18 via the interface 20, the WIA 16 can be detached from the NIM device 18 and communicate wirelessly with the NIM device 18. The sensors 12, 13, and the stimulation probe device 14 communicate wirelessly with the CIM and / or the NIM device 18. In one embodiment, the WIA 16 is connected to the NIM device 18 and communicates wirelessly with the sensors 12, 13, and the stimulation probe device 14. Information described below as being transmitted from the NIM device 18 to the CIM can then be relayed from the CIM to the sensors 12, 13, and / or the stimulation probe device 14. Information described below as being transmitted from the sensors 12, 13, and / or the stimulation probe device 14 to the CIM can then be relayed from the CIM to the NIM device 18.

[0051] WIA 16: Passes signals between (i) the NIM device 18 and (ii) the sensors 12, 13 and stimulation probe device 14; and / or adds additional information to signals received from the NIM device 18 before forwarding the signals to the sensors 12, 13 and / or stimulation probe device 14, as described below. The WIA 16 may: operate essentially as a pass-through device; act as an intelligent device and add and / or replace information provided in a received signal; and / or generate a signal including determined information based on a received signal. For example, the WIA 16 may receive a payload request signal from the NIM device 18 and determine a delay time between when the payload request is received and when the next synchronization (sync) request signal is to be transmitted. This will refer to Figure 18 and Figure 22 The WIA 16 allows the NIM device 18 to be compatible with legacy hardware. The WIA 16 can be unplugged from the NIM device 18, and a conventional electrode connection box can be connected to the WIA 16 using the same NIM device 18 interface as the WIA 16. The WIA 16 replaces the cables that traditionally connect between (i) the NIM device 18 and (ii) the sensors 12, 13, and stimulation probe device 14. This eliminates the need for wires to traverse (extend from inside to outside) the sterile field where the patient is located.

[0052] As another example, the WIA 16 can receive signals from the sensors 12, 13 and / or the stimulation probe device 14. The signals from the sensors 12, 13 and / or the stimulation probe device 14 can indicate voltage, current level, duration, amplitude, etc., and / or the WIA device 16 can determine, for example, duration and amplitude based on the received signals. The received signals and / or the determined information can be forwarded to the NIM device 18 for evaluation and / or for display on a screen of the NIM device 18.

[0053] Although Figure 1 Two types of sensors 12, 13 are shown in FIG, but other types of sensors may be incorporated into the WNIM system 10. Figure 8-13 Another type of sensor is shown and described. The first type of sensor 12 is called a pin sensor and includes pairs of pins 21 (or needles) that are inserted into, for example, the patient's muscle tissue. The second type of sensor 13 is called a surface sensor and is adhered to the patient's skin, for example, on the muscle tissue. The pin sensor 12 can be used, for example, to detect the voltage potential between corresponding pairs of pins 21 of the pin sensor 12. The surface sensor 13 can be used, for example, to detect the voltage potential between corresponding pads of the surface sensor 13. The pin sensors 12 can each include two pins as shown or can include different numbers of pins. The pins can be called electrodes. Each surface sensor 13 can include two or more pads. The pads can be called electrodes.

[0054] One or more of the sensors 12, 13 may include a third electrode (pin or pad), as described with respect to Figures 7A-7B As further described, the sensors 12, 13 are used to digitize nerve and / or muscle activity and wirelessly transmit this information to the CIM and / or NIM device 18. The sensors 12, 13 can alert the CIM and / or NIM device 18 to bursts in nerve and / or muscle activity (e.g., increases in the voltage of evoked response signals). Evoked response signals are signals generated in the patient's tissue as a result of stimulation signals generated by the stimulation probe device 14.

[0055] The stimulation probe device 14 is used to stimulate nerves and / or muscles in the patient. The stimulation probe device 14 includes: a housing 30 having a handle 32; one or more electrodes 34 (two electrodes are shown); a switch 36; a control module (in Figure 5), an example of which is shown in FIG; and an input 38 for connecting to a reference pad (or patch) 40 via a cable 42. Although the stimulation probe device 14 is shown as having a bifurcated end with two electrodes 34, the stimulation probe device 14 can have one or more electrodes 34. The electrodes 34 are separated and insulated from each other and can extend to the housing 30 within a tube 44. A switch 36 can be used to turn on the stimulation probe device 14 and / or apply stimulation pulses to the electrodes 34. Figure 14 An example of a stimulation pulse is shown in FIG. The stimulation pulse may be generated manually by activating switch 36, or may be generated via the NIM device 18 and / or WIA 16 via the CIM. The NIM device 18 and / or CIM may signal the control module of the stimulation probe device 14 to generate one or more stimulation pulses to stimulate one or more nerves and / or muscles near the electrode 34. The reference patch 40 is used to provide a reference voltage potential. The one or more voltage potentials between the one or more electrodes 34 and the reference patch 40 may be determined by: the control module of the stimulation probe device 14; the control module of the NIM device 18 (in FIG. Figure 2-3 An example of which is shown in ); and / or a control module of the CIM (in Figure 2-3 An example of this is shown in ).

[0056] The stimulation probe device 14 can wirelessly transmit information to the CIM and / or NIM device 18. The information can include: timing information; voltage potentials between electrodes 34; voltage potentials between a reference patch 40 and one or more electrodes 34; number of stimulation pulses; pulse identifiers (IDs); voltage and current levels of the generated stimulation pulses; and amplitude, peak amplitude, and / or duration of the generated stimulation pulses. The timing information can include: start and end times of the stimulation pulses; duration of the stimulation pulses; and / or time between stimulation pulses.

[0057] In another embodiment, the WIA 16 is not included in the WNIM system 10. In this embodiment, the NIM device 18 communicates directly with the sensors 12, 13 and the stimulation probe device 14 wirelessly. This may include Figure 1 The sensors 12, 13 and stimulation probe device 14 are shown in communication with and / or other sensors (e.g., Figure 8-13 The WNIM system 10 may include any number of sensor and / or stimulation probe devices.

[0058] Now refer to Figure 1 and Figure 2, which shows a sensing module 50, a CIM 52, and a NIM device 54. The sensing module 50 communicates wirelessly with the CIM 52 and / or with the NIM device 54 via the CIM 52. The sensing module 50 may be included in any sensor disclosed herein, including Figure 1 、 Figures 7A-7B and Figure 8-13 The sensor shown in . CIM 52 may include Figure 1 WIA 16.

[0059] The sensing module 50 includes a control module 56 (e.g., a microprocessor), a memory 58, and a physical layer (PHY) module 60 (e.g., a transceiver and / or a radio). The control module 56 detects electromyographic signals generated in the patient's tissue via electrodes 62 (e.g., pins or pads). The electromyographic signals can be in the form of voltage signals having voltage potentials. The control module 56 includes a gain module 63 (e.g., an amplifier), a filtering module 64 (e.g., one or more filters), and a baseband module 66. The baseband module 66 can include an upconverter and a downconverter. The gain module 63 amplifies the electromyographic signal to generate an amplified signal. The filtering module 64 can operate as a bandpass filter and filter out (i) frequencies of the amplified signal outside a predetermined frequency range and (ii) direct current (DC) voltage. This can eliminate and / or minimize noise, such as 60 Hz noise. The filtering module 64 generates a baseband signal.

[0060] The baseband module 66 may include an analog-to-digital (A / D) conversion module 70 (e.g., an A / D converter) and converts the baseband signal (analog signal) from the filter module 64 into a digital baseband (BB) signal. The BB module 66 and / or the A / D conversion module 70 may sample the output of the filter module 64 at a predetermined rate to generate frames included in the digital BB signal. By performing the A / D conversion on the signal at the sensor rather than performing the A / D conversion at the CIM 52 or NIM device 54, the chance of signal interference is reduced.

[0061] The BB module 66 can then up-convert the digital BB signal to an intermediate frequency (IF) signal. The BB module 66 can perform direct sequence spread spectrum (DSSS) modulation during the up-conversion of the digital BB signal to the IF signal. The BB module 66 can include a mixer and an oscillator for up-conversion purposes. The BB module 66 and / or the control module 56 can compress and / or encrypt the BB signal transmitted to the PHY module 60 before up-conversion to the IF signal and / or can decompress and / or decrypt the signal received from the PHY module 60.

[0062] The BB module 66 can provide a received signal strength indication (RSSI) that indicates an amount of measured power present in the RF signal received from the CIM 52. This can be used in determining with which of the plurality of CIMs the sensor is in communication. The control module 56 can select the CIM corresponding to the synchronization request signal and / or the payload request signal having the greatest power and / or signal strength. This can include (i) selecting the channel on which the synchronization request signal and / or the payload request signal is transmitted and (ii) communicating with the CIM on that channel. This allows the control module 56 to select the closest, appropriate CIM. This selection can be performed when the sensor has not previously communicated with the CIM, switched to a different WNIM network, and / or has been reset such that the sensor has no record of communicating with the CIM. In one embodiment, the sensor cannot be reset.

[0063] The memory 58 is accessed by the control module 56 and stores, for example, parameters 72. The parameters 72 can include parameters provided in the synchronization request signal and / or parameters associated with the myoelectric signals generated via the electrodes. The parameters associated with the myoelectric signals can include voltage, current level, amplitude, peak amplitude, pulse duration, etc.

[0064] The PHY module 60 includes a transmit path 74 (or transmitter) and a receiver path 76 (or receiver). The transmit path 74 includes a modulation module 78 (e.g., modulator) and an amplification module 80 (e.g., amplifier). The modulation module 78 modulates and up-converts an IF signal to generate a radio frequency (RF) signal. This can include Gaussian frequency shift keying (GFSK) modulation. The modulation module 78 can include, for example, a filter, a mixer, and an oscillator (collectively 82). The amplification module 80 can include a power amplifier 84 that amplifies the RF signal and transmits the RF signal via an antenna 86.

[0065] The receiver path 76 includes a second amplification module 90 and a demodulation module 92 (e.g., demodulator). The amplification module 90 can include a low noise amplifier (LNA) 94. The second amplification module 90 amplifies the RF signal received from the CIM 52. The demodulation module 92 demodulates the amplified RF signal to generate an IF signal. The IF signal is provided to the BB module 66, which then down-converts the IF signal to a BB signal. The demodulation module 92 can include, for example, a filter, a mixer, and an oscillator (collectively identified as 96). The A / D conversion module 70 can include a digital-to-analog (D / A) converter that converts the BB signal to an analog signal. The RF signal received from the CIM 52 can include, for example, a synchronization request signal or a partial synchronization request signal, as further described below. Examples of information included in the synchronization request signal are shown and described below with respect to Tables 1-4.

[0066] The CIM 52 includes a PHY module 100, a control module 102, a memory 104, and a NIM interface 106 (e.g., a 32-pin connector). The PHY module 100 includes a receive path (or receiver) 108 and a transmit path (or transmitter) 110. The receive path 108 includes an amplifier module 112 and a demodulator module 114. The amplifier module 112 amplifies RF signals received from the sensing module 50 and / or from other sensor modules and / or stimulation probe devices. The amplifier module 112 may include an LNA 115. The demodulator module 114 demodulates and downconverts the amplified RF signal to generate an IF signal. The demodulator module 114 may include a filter, a mixer, and an oscillator (collectively, 117). The transmit path 110 includes a modulation module 116 and an amplifier module 118. The modulation module 116 modulates and upconverts the IF signal from the control module 102 to generate an RF signal. This may include Gaussian frequency shift keying (GFSK) modulation. The modulation module 116 may include, for example, a filter, a mixer, and an oscillator (collectively designated 119 ). The amplification module 118 transmits the RF signal to the sensing module 50 and / or to other sensor modules and / or stimulation probe devices via the antenna 120 . The amplification module 118 may include a power amplifier 121 .

[0067] The control module 102 includes a BB module 124 and a filtering module 126. The BB module 124 converts the IF signal received from the PHY module 100 into a BB signal and forwards the BB signal to the filtering module 126. The BB module 124 also converts the BB signal from the filtering module 126 into an IF signal, which is forwarded to the modulation module 116. The BB module 124 may include a D / A conversion module 128. The D / A conversion module 128 may include an A / D converter for converting the analog signal from the filtering module 126 into a digital signal. The D / A conversion module 128 may include a D / A converter for converting the digital signal from the PHY module 100 into an analog signal. In one embodiment, the BB module 124 does not include the D / A conversion module 128, and the digital signal is transferred between the filtering module 126 and the PHY module 100. The BB module 124 may attenuate the signal received from the demodulation module 114 to have an amplitude similar to that of the signal received from the gain module 63 and / or the filtering module 64 of the sensing module 50. The filtering module 126 may be a bandpass filter and removes frequencies outside a predetermined range and / or DC signals. This may eliminate and / or minimize noise, such as 60 Hz noise. The BB module 124 and / or the control module 102 may compress and / or encrypt signals transmitted to the modulation module 116 and / or decompress and / or decrypt signals received from the demodulation module 114. Although the CIM 52 is shown as being connected to the NIM device 54 via the NIM interface 106, the CIM 52 may be separate from the NIM device 54 and wirelessly communicate with the NIM device 54 via the PHY module 100.

[0068] The memory 104 is accessed by the control module 102 and stores, for example, parameters 130. The parameters 130 may include parameters provided in the synchronization request signal and / or parameters associated with the electromyographic signal received via the electrodes 62. The parameters 130 associated with the electromyographic signal may include voltage, current level, amplitude, peak amplitude, pulse duration, etc., and may include or be the same as the parameters 72. The memory may also store a synchronization request 132, which is defined below.

[0069] The NIM device 54 can include a control module 140, a PHY module 142, a CIM interface 144, a display 146, and a memory 148. The control module 140: generates a payload request signal; receives data payload signals from the sensing module 50 and / or other sensing modules and stimulation probe devices via the CIM 52; and displays electromyographic signals and / or other relevant information on the display 146. The PHY module 142 can transmit and receive signals to and from the control module 140 via the interfaces 106, 144 (as shown) or wirelessly via an antenna (not shown). The memory 148 is accessed by the control module 140 and stores the parameters 130, and can store a payload request 150, which is defined as follows.

[0070] The control modules 56, 126, the BB modules 66, 128, the PHY modules 60, 100, and / or one or more modules thereof control the timing of signals transmitted between the sensing module 50 and the CIM 52. This is described in further detail below with respect to Figure 15-19 The PHY modules 60, 100 can communicate with each other within a predetermined frequency range. As an example, the PHY modules 60, 100 can communicate with each other within a 2.0-3.0 gigahertz (GHz) range. In one embodiment, the PHY modules 60, 100 transmit signals within a 2.4-2.5 GHz range. The PHY modules 60, 100 can communicate with each other via one or more channels. The PHY modules 60, 100 can transmit data at a predetermined rate (e.g., 2 megabits per second (Mbps)). The CIM 52 and / or the NIM device 54 can set the frequency range, the number of channels, and the data rate based on: the number of sensor modules located in and actively communicating in the WNIM system 10; the number of stimulation probe devices located in and actively communicating in the WNIM system 10; the types of sensors; the number of channels per sensor; the speed of each channel per sensor; the number of channels per stimulation probe device and / or the speed of each channel of the stimulation probe device.

[0071] Reference is now made to Figure 1 and Figure 3 which shows the sensing module 50 and the NIM device 162. The sensing module 50 includes the control module 56, the memory 58, and the PHY module 60. The control module 56 includes the gain module 63, the filter module 64, and the BB module 66. The control module 56 detects electromyographic signals via the electrodes 62. The control module 56 reports data associated with the electromyographic signals to the NIM device 162 via the PHY module 60. The control module 56 also receives signals (e.g., a synchronization request signal) from the NIM device 162 via the PHY module 60.

[0072] The NIM device 162 includes a control module 164 , a memory 166 , a PHY module 168 , and a display 146 . Figure 2 The functionality of the CIM 52 is included in the NIM device 162. The PHY module 168 includes a receive path 170 (or receiver) and a transmit path 172 (or transmitter). The receive path 170 includes an amplifier module 174 and a demodulator module 176. The amplifier module 174 amplifies the RF signal received from the sensing module 50 and / or from other sensor modules and / or stimulation probe devices via an LNA 175. The demodulator module 176 demodulates and downconverts the amplified RF signal to generate an IF signal. The transmit path 172 includes a modulation module 178 and an amplifier module 180. The modulation module 178 and the amplifier module 180 may operate similarly to the modulation module 116 and the amplifier module 118. The amplifier module 118 may include a power amplifier 182 and transmits the RF signal to the sensing module 50 and / or to other sensor modules and / or stimulation probe devices via an antenna 183.

[0073] Control module 164 includes a BB module 184 and a filtering module 186. BB module 184 converts the IF signal received from PHY module 168 into a BB signal and forwards the BB signal to filtering module 186. BB module 184 also converts the BB signal from filtering module 186 into an IF signal, which is forwarded to modulation module 178. BB module 184 may include a D / A converter module 188. D / A converter module 188 may include an A / D converter for converting analog signals from filtering module 186 into digital signals. D / A converter module 188 may include a D / A converter for converting digital signals from PHY module 168 into analog signals. In one embodiment, BB module 184 does not include D / A converter module 188, and digital signals are transferred between filtering module 186 and PHY module 168. BB module 184 may attenuate the signal received from demodulation module 176 to have an amplitude similar to that of the signal received from gain module 63 and / or filtering module 64 of sensing module 50. The filtering module 186 may be a bandpass filter and removes frequencies outside a predetermined range and / or DC signals. This can eliminate and / or minimize noise, such as 60 Hz noise. The BB module 184 and / or the control module 164 may compress and / or encrypt signals transmitted to the modulation module 178 and / or decompress and / or decrypt signals received from the demodulation module 176.

[0074] Now refer to Figure 2-3BB module 66 of sensing module 50 can provide a received signal strength indication (RSSI) indicating the measured amount of power present in the RF signal received from NIM device 162. This can be used when determining which of multiple NIM devices to communicate with. Control module 56 can select the NIM device corresponding to the synchronization request signal and / or payload request signal with the greatest power and / or signal strength. This can include selecting a channel on which the synchronization request signal and / or payload request signal is transmitted and communicating with CIM 52 and / or NIM device 162 on this channel. This allows control module 56 to select the closest, appropriate NIM device. This selection can be performed when the corresponding sensor has not previously communicated with NIM device 162 and / or other NIM devices and / or has been reset, such that the sensor has no record of communicating with NIM device 162 and / or other NIM devices.

[0075] The memory 166 may store the parameters 130, the payload request 150, and / or the synchronization request 132. The memory 166 may store the synchronization request but may not store the payload request because the NIM device 162 may generate the synchronization request but not the payload request.

[0076] Now refer to Figure 1 and Figure 4 , which shows a sensing module 200. The sensing module 200 can be included in any sensor disclosed herein. For example, the sensing module can be used in Figure 1-4 , 7A-13, and 23-34. The sensing module 200 includes a control module 202, a PHY module 204, a power module 206, a power supply 208, a temperature sensing module 210, an A / D converter 212, and an accelerometer 214. Although shown as separate from the control module 202, the PHY module 204, the power module 206, the temperature sensing module 210, and / or the A / D converter 212 can be included in and as part of the control module 202.

[0077] The control module 202 includes Figure 2 The PHY module 204 includes a gain module 63, a filter module 64 and a BB module 66. Figure 2 modulation module 78, demodulation module 92 and amplification modules 80, 90.

[0078] The control module 202, the PHY module 204, the temperature sensing module 210, and the A / D converter 212 operate based on power from the power module 206. The power module 206 receives power from a power source (e.g., a battery). The power module 206 may include a switch 216 (or pull tab) as shown to turn the power module 206 on and / or off, and thereby turn the sensing module 200 and / or the corresponding sensor on and / or off. The switch 216 may be manually operated or may be operated by the power module 206, the control module 202, and / or the PHY module 204. In one embodiment, the switch 216 is manually operated and at least partially exposed to the outside of the sensing module 200 and / or the corresponding sensor housing. In another embodiment, the switch 216 includes one or more transistors located in the control module 202, the PHY module 204, and / or the power module 206, as shown. If included in one of the modules 202, 204, 206, the switch 216 is not exposed to the outside of the sensing module 200 and / or the corresponding sensor housing. The state of the switch 216 can be determined by the control module 202, the PHY module 204, and / or the power module 206 based on the state of the switch 216. Figure 2-3 The switch 216 is controlled by a signal received from the electrode 62, the CIM 52, and / or the NIM device 162. The operation of switching the switch 216 from the first state to the second state to turn on at least a portion of the sensor and / or at least a portion of one or more of the modules 202, 204, 206 via one of the modules 202, 204, 206 can be referred to as "auto-start."

[0079] The sensing module 200 can operate in the following modes: high power mode (fully powered mode), low (or idle) power mode (partially powered or transmitting less frequently than when in high power mode), sleep mode, or off. Operation between these modes and transitions between these modes can be controlled by one or more of the modules 202, 204, and 206. As an example, a sensor can be turned off (or dormant) when transporting and / or not in use. The sensor can also be off if: it has not yet communicated with a CIM and / or NIM device; a connection has not yet been established between the sensing module 200 and the CIM and / or NIM device; the sensor has not yet been assigned to a CIM and / or NIM device; and / or the sensor has not yet been assigned one or more time slots for communicating with the CIM and / or NIM device.

[0080] Transitioning to low power mode, sleep mode, and / or shutdown reduces power consumption and can help minimize the size of power supply 208. While on partial power, control module 202 and / or portions of control module 202 and PHY module 204 can be disabled. The receiver path of PHY module 204 can remain active to (i) receive signals from CIM 52 and / or control module 202, and (ii) detect myoelectric signals. The transmission path 74 of PHY module 204 and / or other portions of the sensors that are not experiencing activity can be disabled. Transitioning between the modes is further described below.

[0081] When surgery is being performed, the operating room is typically kept cool. This, in turn, can lower the temperature of the patient. Studies have shown that better results are achieved if the patient remains warm (e.g., within a predetermined range of a predetermined temperature or at normal body temperature, such as 98.6°F). To keep the patient's temperature up, a heater can be used to blow warm air under the patient and / or to heat portions of the table on which the patient is lying. The patient can also be covered or wrapped with a blanket. If the heater malfunctions, is accidentally disconnected, is not set up correctly, and / or is not operated correctly, the patient's temperature can drop. Unfortunately, there is a long lag time from when the heater fails until the patient's temperature is detected to be decreasing. By the time the patient's temperature decrease is detected, for example, by the surgeon or surgical assistant, the patient's temperature can have been below the predetermined range for a long period of time.

[0082] To help detect changes in the patient's temperature early, the sensors include a temperature sensing module that can be used to detect the temperature of the place where the sensor is located. This temperature can be based on or indicative of the temperature of the portion of the patient to which the sensor is attached. While the temperature sensor can not directly contact and / or directly indicate the temperature of this portion of the patient, the temperature sensor can provide a temperature signal that is indicative of the average temperature in the vicinity of the temperature sensor.

[0083] Referring again to Figure 1 , one or more of the sensors 12, 13 can include a temperature sensing module (e.g., temperature sensing module 210) and / or an accelerometer (e.g., accelerometer 214). By including a temperature sensing module in the sensors, the temperature of various points on the patient can be monitored. This also helps detect changes in the patient's temperature early. The sensors provide an indication of a temperature problem earlier than sensors used to detect changes in the patient's core temperature because the extremities or the outside of the body tend to decrease in temperature faster than the core temperature. The core temperature can refer to the internal temperature within the torso (or chest) of the body, for example.

[0084] The temperature sensing module 210 includes a first transistor 220 and a second transistor 222. The first transistor 220 can transition between states to provide current to the second transistor 222. This turns on the temperature sensing module 210. The second transistor 222 is configured to detect temperature. As an example, the first transistor 220 can be a metal oxide semiconductor field effect transistor (MOSFET) and include a drain, a gate, and a source. The second transistor 222 can be a bipolar junction transistor (BJT) and include a collector, a base, and an emitter. Transistors 220 and 222 are shown for illustrative purposes only; one or more of transistors 220 and 222 can be replaced with other transistors or other similar operating circuits. The drain is connected to the power module 206 and receives current from the power module 206. The gate is connected to the control module 202 and receives a control signal from the control module 202. The source of the first transistor 220 is connected to the collector and the base. The collector is connected to the ground terminal 224. The collector and the emitter are also connected to the A / D converter 212.

[0085] The second transistor 222 is connected in a diode configuration. The temperature dependence of the base-emitter voltage (Vbe) is the basis of temperature measurement. The base-emitter voltage Vbe depends on the temperature, and (i) the power supply 208 and the power module 206 provide a constant level of current to the collector via the first transistor 220, and (ii) the voltage across the base and the collector is zero. The voltage across the base (or collector) and the emitter is detected by an A / D converter. The detected voltage is converted into temperature via the control module 202. The control module 202 receives a digital signal from the A / D converter and determines the temperature. The temperature can be determined using, for example, Expression 1, where A is a predetermined multiplier constant and B is a predetermined offset constant.

[0086] A·Vbe+B[1]

[0087] In addition to detecting electromyographic signals and temperature, the sensing module 200 can also detect other parameters such as heart rate, respiratory rate and / or muscle spasm. Figure 2-3 The parameters are determined by sensors in the CIM 52 and one or more control modules 202, 102, 140, 164 in the NIM device 54, 162. The NIM device 54, 162 may generate an alarm signal and / or display these parameters on the display 146. This information may also be used to provide an early indication of a patient waking up prematurely from anesthesia. The electrodes 62 may be monitored for EMG purposes as well as for heart rate, respiratory rate, and / or muscle spasms. To detect this information, the sensors may be attached to (or mounted on) the patient's torso.

[0088] Heart rate may be located in the same frequency band as the electromyographic signal. Unlike electromyographic signals, heart rate is cyclical. The voltage potential detected due to a beating heart may have an amplitude (or magnitude) greater than the amplitude (or magnitude) of the electromyographic signal. Respiratory rate is typically located in a lower frequency band than the electromyographic signal. Muscle spasms may have distinguishable frequencies and / or distinguishable frequency bands. Therefore, one or more of the control modules 202, 102, 140, 164 may distinguish signals or portions of signals corresponding to heart rate, respiratory rate, and electromyographic signals based on these differences. If the sensor control module 202 detects heart rate, respiratory rate, and / or muscle spasm, the control module 202 may wirelessly transmit this information to one of the CIM 52 and / or NIM devices 54, 162. The NIM device 54, 162 may then display this information and / or generate an alarm signal if one or more of these parameters is outside of a corresponding predetermined range and / or threshold.

[0089] In addition to or as an alternative to monitoring the electrodes 62 to detect heart rate, respiratory rate, and / or muscle spasms, the sensor may include an accelerometer. As described above, one or more of the control modules 202, 102, 140, and 164 may monitor the acceleration signal generated by the accelerometer 214 to detect heart rate, respiratory rate, and / or muscle spasms. This acceleration signal and / or heart rate, respiratory rate, and / or muscle spasm information determined based on the acceleration signal may be wirelessly transmitted from the sensor and / or the PHY module 204 to one of the CIM 52 and / or NIM devices 54 and 162.

[0090] As shown below Figure 21 As further described, the sensor can "self-wake up". In other words, when attached to a patient, the sensor can automatically switch from being off or in low power (or sleep) mode to being powered on and in high power mode. For example, although not attached to a patient, there is an "open" circuit between the electrodes 62. Therefore, the impedance between the electrodes 62 is high (e.g., greater than 10 kilo-ohms (kOhms)). After the sensor is attached to the patient, the impedance between the electrodes 62 is low (e.g., less than 1 kOhms) and / or significantly less than the impedance when the sensor is not attached. This difference in impedance can be detected and the power module 206 and / or control module 202 can be caused to switch operating modes.

[0091] In another embodiment, the electrodes 62 and the patient's impedance operate as a switch for activating the power module 206. When activated, the power module 206 may provide power to the control module 202 and / or the PHY module 204.

[0092] In another embodiment, the power module 206 (or analog front end) is configured to generate a DC voltage when the sensor is not attached to the patient. The generation of the DC voltage can be based on the impedance between the electrodes 62. This DC voltage is detected by the control module 202. The control module 202 remains in a low power (or sleep) mode while receiving the DC voltage. When the electrodes are attached to the patient, the power module 206 stops providing the DC voltage. This causes the control module to be switched from (i) disconnected to being in a low power mode or a high power mode, or (ii) switched from being in a sleep mode to being in a low power mode or a high power mode.

[0093] The control module 202 and / or the power module 206 can periodically switch between a low power (or sleep) mode and a high power mode to check the impedance between the electrodes 62 and whether to provide a DC voltage. This can occur every predetermined period (e.g., 30-60 seconds). In another embodiment, in response to the electrodes 62 being attached to the patient, the power module 206 can switch from (i) not providing power to the control module 202, the PHY module 204, and / or portions thereof to (ii) providing power to the control module 202, the PHY module 204, and / or portions thereof.

[0094] Although modules 204, 206, 210 and A / D converter 212 are shown as being separate from control module 202, one or more of modules 204, 206, 210 and A / D converter 212 or portions thereof may be incorporated into control module 202. In addition, electrode 62 may include two or more electrodes. Signal lines 221 for two electrodes are shown. A third signal line 222 may be included for noise feedback cancellation. This will be referred to as Figures 7A-7B Further description.

[0095] Now refer to Figure 1-3 and Figure 5, shows a stimulation probe device 230 that can communicate with the CIM 52 and / or one of the NIM devices 54, 162. The stimulation probe device 230 includes a control module 232, a memory 234, a PHY module 236, a stimulation module 238, electrodes 240, a power module 242, and a power supply 244. The stimulation module 238 receives power from the power module 242 and generates stimulation signals that are provided to the patient's tissue via the electrodes 240. Although the modules 236, 238, 242 are shown as separate from the control module 232, one or more of the modules 236, 238, 242, or portions thereof, may be incorporated into the control module 232. The stimulation module 238 can detect the voltage provided to the electrodes 240 and / or the voltage potential applied to the two electrodes 240 and generate stimulation information signals indicative thereof. The stimulation module 238 can include a current-to-voltage conversion module 246 for measuring the current provided to one or more electrodes 240 and generating stimulation information signals indicative thereof. The stimulation information signal may be provided to the control module 232 .

[0096] The control module 232 wirelessly communicates with one or more of the CIM 52 and / or NIM devices 54, 162 via the PHY module 236 and antenna 248. The control module 232 includes a filtering module 250 and a BB module 252. The filtering module 250 can operate as a bandpass filter and filter out frequencies and direct current (DC) voltages of the amplified signal outside a predetermined frequency range. This can eliminate and / or minimize noise, such as 60 Hz noise. The filtering module 250 can receive a stimulation information signal from the stimulation module 238 and convert the stimulation information signal and / or a signal generated based on the stimulation information signal into a BB signal. The stimulation module 238 can monitor the actual voltage, current level, amplitude, and duration of the stimulation pulses via the stimulation information signal and indicate to the control module 232 the actual voltage, current level, amplitude, and duration of the stimulation pulses. The control module 232 can then transmit this information to the CIM 52 and / or one of the NIM devices 54, 162 via the PHY module 236.

[0097] The BB module 252 may include an analog-to-digital (A / D) conversion module 254 and convert the BB signal from the filter module 250 into a digital BB signal. The BB module 252 and / or the A / D conversion module 254 may sample the output of the filter module 250 at a predetermined rate to generate a frame included in the digital BB signal. By performing the A / D conversion on the signal at the sensor rather than performing the A / D conversion at one of the CIM 52 or NIM devices 54, 162, the chance of signal interference is reduced.

[0098] The BB module 252 can then up-convert the digital BB signal to an intermediate frequency (IF) signal. The BB module 252 can perform DSSS modulation during the up-conversion of the digital BB signal to the IF signal. The BB module 252 can include a mixer and an oscillator for up-conversion. The BB module 252 and / or the control module 232 can compress and / or encrypt the BB signal transmitted to the PHY module 236 before up-conversion to the IF signal and / or can decompress and / or decrypt the signal received from the PHY module 236.

[0099] The BB module 252 can provide a received signal strength indicator (RSSI) that indicates the measured amount of power present in the received RF signal. This can be used when determining which of multiple CIM and / or NIM devices to communicate with. The control module 232 can select the CIM and / or NIM device corresponding to the synchronization request signal and / or payload request signal with the greatest power and / or signal strength. This can include selecting a channel on which the synchronization request signal and / or payload request signal is transmitted and communicating with the CIM or NIM device on this channel. This allows the control module 232 to select the closest, appropriate CIM and / or NIM device. This selection can be performed when the stimulation probe device has not previously communicated with a CIM and / or NIM device and / or has been reset, such that the stimulation probe device has no record of communicating with the CIM and / or NIM.

[0100] Memory 234 is accessed by control module 232 and stores, for example, parameters 260. Parameters 260 may include parameters provided in the synchronization request signal and / or parameters associated with stimulation pulses generated via electrodes 240. Parameters associated with stimulation pulses may include voltage, wavelength, current level, amplitude, peak amplitude, pulse duration, etc.

[0101] The PHY module 236 includes a transmission path 262 (or transmitter) and a receiver path 264 (or receiver). The transmission path 262 includes a modulation module 266 and an amplifier module 268. The modulation module 266 modulates the IF signal to up-convert the IF signal to an RF signal. This may include GFSK modulation. The modulation module 266 may include, for example, a filter, a mixer, and an oscillator. The amplifier module 268 may include a power amplifier 269, which amplifies the RF signal and transmits it via the antenna 248.

[0102] Receiver path 262 includes a second amplification module 270 and a demodulation module 272. Second amplification module 270 may include an LNA 274. Second amplification module 270 amplifies the RF signal received from the CIM. Demodulation module 272 demodulates the amplified RF signal to generate an IF signal. The IF signal is provided to BB module 252, which then downconverts the IF signal into a BB signal. A / D conversion module 254 may include a D / A converter that converts the BB signal into an analog signal. The RF signal received from CIM 52 may include, for example, a synchronization request signal or a portion of a synchronization request signal, as further described below. Examples of information included in the synchronization request signal are shown and described below with respect to Tables 1-4.

[0103] The power module 242 receives power from the power supply 244 and provides the power to the stimulation module 238, the control module 232, and the PHY module 236. The power module 242 may include a switch 276. The switch 276 may be actuated to generate stimulation pulses. When the switch 276 is closed or switched and / or when the control module 232 generates a control signal commanding the generation of one or more stimulation pulses, the power module 242 and / or the control module 232 signals the stimulation module 238 to generate one or more stimulation pulses. The timing, amplitude, and / or duration of each stimulation pulse may be based on information received from the CIM 52 and / or one of the NIM devices 54, 162. The frequency of the stimulation pulses and / or the time between stimulation pulses may also be controlled and based on corresponding information received from the CIM 52 and / or one of the NIM devices 54, 162.

[0104] Also refer to Figure 6 , which shows a portion 279 of the stimulation probe device 230. The stimulation probe device 230 includes a control module 232, a stimulation module 238, an electrode 240, a power module 242 having a switch 276, and a power supply 244. The control module 232 can be connected to the reference patch 40. In one embodiment, the stimulation module 238 is connected to the reference patch 40. The stimulation module 238 can include a current-to-voltage conversion module 246, a boost module 280, and a D / A converter 282. The current-to-voltage conversion module 246 converts the current provided to the electrode 240 into a voltage detected by the control module 232. The control module 232 can include an A / D converter for converting the voltage signal received from the current-to-voltage conversion module 246 into a digital signal.

[0105] The D / A converter 282 can convert the analog control signal from the control module 232 into a digital control signal. The digital control signal is provided to the boost module 280 and sets the current level, voltage, and duration of one or more stimulation pulses to be generated by the boost module 280 via the electrode 240. The boost module 280 generates a stimulation signal having stimulation pulses to be provided to the electrode 240. The stimulation signal has an increased voltage, current, and / or power compared to other signals transmitted in the WNIM system 10 (e.g., signals transmitted between other modules and / or RF signals). The increased voltage, current, and / or power generates stimulation pulses to stimulate the patient's tissue (nerve or muscle tissue). The boost module 280 receives power from the power module 242. The control module 232 can control the power module 242 to provide a selected amount of current to the boost module 280 for generating the stimulation signal.

[0106] Although not shown, the reference patch 40 may be replaced and / or configured as a "smart" reference patch that is configured to communicate wirelessly with the stimulation probe device 230. The smart reference patch may, for example, be configured to be similar to a Figure 2-3 The sensing module 50 of the reference patch 40 may include one or more electrodes, a control module, and a PHY module with a transmitter path. The control module and transmitter path of the reference patch 40 may be configured to be similar to Figure 2 or Figure 3 The control module 56 and transmission path 74 of the sensing module 50 of the reference patch 40 are similar in operation to the reference patch 40. The control module of the reference patch 40 can be connected to the one or more electrodes and detect the reference voltage at the one or more electrodes and wirelessly transmit it to the stimulation probe device 230. The reference voltage can be transmitted via the transmitter path of the reference patch 40. The control module of the reference patch 40 can generate a reference voltage signal indicating the reference voltage. The reference voltage can be a constant voltage or can vary depending on the patient's state in the area where the reference patch 40 is attached.

[0107] Now refer to Figure 1 and Figures 7A-7B , which shows a three-pad sensor 300. The sensor 300 can replace any of the sensors disclosed herein. As shown, the sensor 300 includes a base 302 (which can be referred to as a patch) having electrodes 304 and an electronic control module assembly 305. The electronic control module assembly 305 is modular and includes a control (or sensing) module 306 mounted on a substrate 307, a power supply support member 308, a power supply 310, and a housing 312. Figure 7B , the base 302 is shown without the electronic control module assembly 305 .

[0108] The base 302 may include a flexible substrate 314 and an adhesive layer 316 attached to the bottom surface of the substrate 314. The adhesive layer 316 may be attached to, for example, the patient's skin. The control module 306 may include a PHY module (e.g., Figure 4 PHY module 204) and power module (e.g., Figure 4 The control module 306, the PHY module and the power module may be similar to Figure 4 The control module 202 , the PHY module 204 , and the power module 206 may operate and may communicate wirelessly with the CIM 52 and / or one of the NIM devices 54 , 162 .

[0109] The power supply support member 308 can be attached to the base plate 307 and hold the power supply 310 to the control module 306. The power supply support member 308 can be, for example, a clip. The power supply 310 can be held between the control module 306 and the power supply support member 308. The electronic control module assembly 305 can be attached to the top of the electrode 304 via a receiving connector 317. The receiving connector 317 can snap on and off the electrode 304. This allows the electronic control module assembly 305 to be modular, so that the electronic control module assembly 305 can be removed from the patch and used on another patch, for example. The electronic control module assembly 305 can be reusable, and the patch 302 can be non-reusable. For example, the electronic control module assembly 305 and the patch 302 can be applied to one location on the patient during a first time period. Then, the electronic control module assembly 305 can be removed from the patch 302 and snapped onto a different patch, applied to a second location on the patient for use during a second time period. As another example, the electronic control module assembly 305 and patch 302 can be applied to a first patient during a first period of time. The electronic control module assembly 305 can then be removed from the patch 302 and snapped onto a different patch and applied to a second patient for use during a second period of time.

[0110] Although sensor 300 is shown as having three electrodes 304, sensor 300 can have two or more electrodes. Electrodes 304 extend upward from base 302 and connect to conductive pads 318 on the bottom of adhesive layer 316. When attached to a patient, pads 318 can come into contact with the patient's skin.

[0111] The third electrode in electrodes 304 can be used as a feedback terminal to provide an inverted common-mode noise signal to the patient. The inverted common-node noise signal is provided to the patient to cancel or attenuate the common-node nasal signal detected at the other two electrodes. The common-node nasal signal can be detected, for example, at a node between resistors in a voltage divider of the sensor. The control module 306 can monitor the voltage signals at the two electrodes and at the node to detect the common-node noise signal; invert the common-node noise signal; filter the inverted common-node noise signal; and feed the inverted and filtered common-node noise signal back to the patient. The control module 306 can feed back the inverted and filtered common-node noise signal (referred to as the feedback signal) to eliminate low-frequency noise. This "cleans up" the voltage signals detected at the two electrodes and can be used to monitor induced tissue response signals, heart rate, respiratory rate, muscle spasm, etc. The feedback signal can be, for example, a 50-60 Hz signal. As an example, the control module can include four amplifiers and the voltage divider. The signal received at each of the other two electrodes can be amplified by a corresponding first amplifier and second amplifier. The outputs of the first and second amplifiers can be provided to respective ends of the voltage divider. The voltage at the ends of the voltage divider can be provided to the input of the third amplifier as a differential signal. The output of the third amplifier can be wirelessly transmitted to a CIM and / or NIM device. The node can be connected between the resistors of the voltage divider. The signal at the node can be amplified by a fourth amplifier and fed back to a third electrode in the electrode 304.

[0112] The control module disclosed above may include digital signal processing algorithms that further suppress the noise provided by the filters disclosed above.The control module disclosed above may also include algorithms for processing and distinguishing between signals detected via the sensors disclosed herein.

[0113] Figure 8-13 An EMG endotracheal tube assembly 330 and corresponding housing 332 are shown. Figure 11-13 Shown Figure 8-10 3. The EMG endotracheal tube assembly 330 includes a housing 332 and corresponding electronics assembly 334. The EMG endotracheal tube assembly 330 includes an EMG tube 336 having a distal (first) end 338 and a proximal (second) end 340. The distal end 338 is connected to a connector 342, which can be connected to a pump for providing air and / or fluid to the patient via the EMG tube 336. The EMG tube 336 can be inserted into the patient's throat and can provide air and / or fluid to, for example, the patient's lungs. The proximal end 340 includes an inflatable portion 344 (shown in an inflated state) that can be used to seal, for example, the trachea to prevent any other fluid or substance from bypassing the inflatable portion 344 and entering the lungs.

[0114] The EMG endotracheal tube assembly 330 also includes a housing 332 having an electronics assembly 334, electrodes 346, a spring-loaded pin element 347, a first set of contacts 348, and a second set of contacts 350. The electronics assembly 334, electrodes 346, spring-loaded pin element 347, and contacts 348, 350 can be collectively referred to as a sensor. The electrodes 346, contacts 348, and / or contacts 350 can be applied to the EMG tube 336. In another embodiment, the electrodes 346, contacts 348, and / or contacts 350 are printed on the EMG tube and / or implemented as part of a flexible printed circuit board (PCB).

[0115] The electrodes 346 may extend from the first set of contacts 348 to the second set of contacts 350. The electrodes 346 extend parallel to the EMG tube 336 and are separated so as not to contact each other. One or more insulating layers 352 may be applied to the electrodes 346 to prevent external electrical contact with the electrodes 346. Each insulating layer 352 may cover one or more electrodes 346 and may not completely surround the EMG tube 336. The first set of contacts 348 is in electrical contact with a spring-loaded pin element 347 connected to a substrate 354 (or printed circuit board). Each of the electrodes 346, the first set of contacts 348, and the second set of contacts 350 may include conductive ink. The insulating layer 352 may be a non-conductive mold formed from a non-conductive material (e.g., rubber).

[0116] The sensor may further include a housing 332, a substrate 354, a control module 355, a power supply 356, a power supply support bracket 358, an antenna 360, a spring-loaded pin element 347, and a sealing gasket 362. The housing 332 may include a first upper portion 364, a second lower portion 366, and a flange 368. The housing 332 is formed of a non-conductive material (e.g., plastic). The housing 332 may be shaped to enclose the substrate 354, the power supply 356, and the control module 355 while minimizing the size of the housing 332. The housing 332 is snapped onto the EMG tube 336 via the flange 368. The flanges 368 are opposed to each other and fastened to the EMG tube 336. The EMG tube 336 may include guide marks 370 for placing and attaching the housing 332 to the EMG tube 336. Guide markings 370 may be applied to the EMG tube 336 and may be visible below the housing 332 and on the side of the EMG tube 336 opposite the housing 332. The EMG tube 336 is compressed between the flanges 368 and against the spring-loaded pin element 347 and the sealing gasket 362. The first portion 364 and the second portion 366 may be sealed to each other via an adhesive, such as an ultraviolet (UV) light-cured adhesive. The first portion 364 may be ultrasonically welded to the second portion 366.

[0117] The gasket 362 can be adhesively attached to the second portion of the housing 332 and the EMG tube 336. The gasket 362 is disposed between the second portion 366 of the housing 332 and the EMG tube 336. The gasket 362 can have a layer of adhesive (or adhesive) on a first side 372 facing the second portion 366 of the housing 332 and on a second side 374 facing the EMG tube 336. The adhesive can be a UV light cured adhesive. The gasket 362 can be ultrasonically welded to the second portion 366 and / or the EMG tube 336. The gasket 362 provides a fluid seal to prevent contaminants from contacting the first set of contacts 348 and / or the spring-loaded pin elements 347.

[0118] The spring-loaded pin elements 347 include respective spring members 376 and pins 378. The spring-loaded pin elements 347 are disposed in the gasket 362 and between the substrate 354 and the first set of contacts 348. The pins 378 are spring loaded to maintain contact with the first set of contacts 348. Each spring member 376 and / or pin 378 is in direct or indirect contact with the control module 355. These connections between the spring members 376 and the control module 355 can be provided, for example, through vias and / or traces in the substrate 354. The sensor can include any number of spring-loaded pin elements 347 and respective contacts. More than one spring-loaded pin element can be provided for each contact in the first set of contacts 348.

[0119] The power source 356 is disposed on the substrate 354 and held by a power support bracket 358 connected to the substrate 354. The antenna 360 can be a printed and / or trace disposed on the substrate 354 and connected to the control module 355. The control module 355 can be similarly configured and operated as any of the control modules of the sensors disclosed herein. As shown, the control module 355 has two channels. Each channel is connected to a respective pair of first set of contacts 348. Dual channels can be provided for redundancy to ensure that the signals provided at the second set of contacts 350 are detected by the control module 355. The second channel can be used to back up the first channel. As disclosed below, when communicating with CIM and / or NIM devices, a respective one or more time slots can be assigned to each of these channels.

[0120] Figure 14 A graph showing a stimulation pulse 390 and a corresponding evoked response signal 392 is shown. The stimulation pulse 390 can be generated by, for example, one of the stimulation probe devices disclosed herein (e.g., the stimulation probe device 230 of Figure 5 The evoked response signal 392 can represent neural and / or muscle activity detected by one of the sensors disclosed herein.

[0121] Stimulation is a function provided for nerve and / or muscle monitoring. The reaction time between stimulation and muscle response is used for nerve position sensing and nerve health monitoring. This can be achieved by measuring the time between stimulation and response (e.g., the time between stimulation pulse and evoked response). The wireless RF protocol disclosed herein can include determining the amount of time between stimulation and evoked response. The time between stimulation and evoked response can be determined by the NIM device disclosed herein.

[0122] Now refer to Figure 1-13 , the CIMs (e.g., CIM 52), NIM devices (e.g., NIM devices 54, 162), sensors (e.g., sensors 12, 13, and / or Figure 7A-13 The sensors of the embodiments of the present invention), stimulation probe devices (e.g., stimulation probe devices 14, 230), and reference patches (e.g., the smart reference patches described above) communicate with each other via the wireless protocol disclosed herein. The wireless protocol is designed to wirelessly transmit high-rate data from multiple sensors (which may be referred to as remote body sensors), stimulation probe devices, and / or reference patches to CIM and / or NIM devices. The sensors, stimulation probe devices, and reference patches digitize the signals and send them over the air (OTA) when requested by the CIM and / or NIM devices. The digitized data is received by the CIM and / or NIM devices and can be converted into analog data and / or displayed at the NIM devices.

[0123] The wireless protocol is designed to process large amounts of data received at one or more high data rates (e.g., 2.5kHz, 5kHz, or 10kHz). The sensor, stimulation probe device, and reference patch can transmit at the same speed or at different speeds. The sensor, stimulation probe device, and reference patch can each transmit data on one or more channels. Each channel can have the same corresponding data rate or can have different corresponding data rates. In order to transmit and process multiple channels from multiple devices at the same or different transmission speeds, the wireless protocol includes a sensor and stimulation probe synchronization protocol and a low-power consumption protocol, some of which have been described above, and other parts will be described below. The wireless protocol allows different types of sensors (with different transmission speeds, number of channels, etc.) and different types of stimulation probe devices (with different transmission speeds, number of channels, etc.) to be connected to the CIM and NIM devices. This allows modular upgrades (e.g., replacing sensors and / or stimulation probe devices with increased transmission speeds and / or number of channels).

[0124] The wireless protocol begins with a payload request generated by a NIM device. The payload request is transmitted to the CIM and / or converted into a synchronization request. The synchronization request is a payload request and is provided as a synchronization signal. The CIM or NIM device can search for idle channels (channel hopping) and select an unused channel with the least amount of noise. The selected channel can then be used as a broadcast channel to transmit the synchronization request to the sensors and stimulation probe devices in the corresponding WNIM system. The CIM can update the synchronization request and periodically transmit the updated synchronization request. As an example, the CIM can wait a predetermined amount of time (referred to as a predetermined interval) between each transmission of the synchronization signal. The predetermined interval can be, for example, 4 milliseconds (ms).

[0125] Therefore, the synchronization signal can be transmitted every predetermined interval or 4ms on the selected RF channel. The RF channel can be in a predetermined frequency range (e.g., 2.4-2.484GHz). Any sensor and / or stimulation probe device that is within range and 'listens' on the broadcast channel can receive and interpret the synchronization request. The payload request and synchronization request can include a predetermined number of words (e.g., 16), wherein each word has 16 bits of information. Examples of the content included in the synchronization request and the corresponding words are shown in Tables 1-4 provided below.

[0126] In the following sections and elsewhere, NIM devices, CIMs, sensors, and stimulation probe devices are described as communicating with each other and transmitting various signals and requests between each other. Each of these transmissions can be generated and / or transmitted by the corresponding control modules and PHY modules of these devices, as described above.

[0127] Table 1 shows an example of a synchronization request payload. A synchronization request includes 16 words, designated as words 0-15. Word 0 is the CIM or NIM device status word, the contents of which are shown in Table 2. Word 1 and words 11-12 are unused. Word 2 is the stimulation probe device status word, the contents of which are shown in Table 4. Words 3-10 are time slot status words. Table 3 shows an example of the contents of each of the time slot status words. Word 13 indicates the delay period between the time when the NIM device generates a payload request and the time when the NIM device or CIM transmits the next synchronization request. The stimulation probe device can adjust the timing of data (or data payload) transmitted from the stimulation probe device based on the delay period. Word 14 indicates the stimulation pulse amplitude. Word 15 indicates the stimulation pulse width (or duration). The stimulation probe device can generate stimulation pulses based on words 13-15. Although a certain number of stimulation probe device status words, time slot status words, and stimulation information words are shown, the synchronization request payload can include any number of individual words. For example, if more than one stimulation probe device is used, additional stimulation probe device status words and / or stimulation information words may be included. Similarly, if more than 8 channels and / or more than 8 sensors are communicating with the CIM and / or NIM device, additional time slot status words may be included.

[0128] Character Synchronous Request 0 Console interface module or NIM device status 1 Idle 2 Stimulation probe device status 3 Slot 1 status 4 Slot 2 status 5 Slot 3 status 6 Slot 4 status 7 Slot 5 status 8 Slot 6 status 9 Slot 7 status 10 Slot 8 status 11 Idle 12 Idle 13 STIM delay 14 STIM amplitude 15 STIM duration and / or pulse width

[0129] Table 1 - Synchronization request signals

[0130] The CIM or NIM device status word shown in Table 2 includes 16 global bits identified as 0-15. Because these are global bits, all sensors and / or stimulation probe devices communicating with the CIM and / or NIM device can communicate according to these bits, unless indicated in one or more corresponding time slot status words or stimulation probe device status words. Positions 0-7 (7:0) provide a CIM unique identifier (or NIM device unique identifier). When selecting a channel for a CIM and / or NIM device, the unique identifier can be used by the sensor and / or stimulation probe device to identify the CIM and / or NIM device. This ensures that the sensor and / or stimulation probe device communicates with the same CIM and / or NIM device that the sensor and / or stimulation probe device previously communicated with.

[0131] Bits 9:8 of the CIM or NIM device status word are request sequencer bits that indicate in which interval the sensor and / or stimulation device is to communicate. For example, the sensor and stimulation probe device may communicate in corresponding time slots of each interval, or may communicate in time slots of different intervals. The sensor and / or stimulation probe device may communicate in one or more of a series of intervals based on these bits. This will be referred to below. Figure 15-17 Further description.

[0132] Bits 11:10 of the CIM or NIM device status word indicate the speed (i.e., data rate) at which the sensor and / or stimulation probe device transmits information and / or data to the CIM and / or NIM device. In the example shown, the data rate can be 0, 2.5 kHz, 5 kHz, or 10 kHz, depending on the value of bits 11:10. The data rate can be set to be less than or equal to the maximum data rate of one or more of the sensor and / or stimulation probe devices. In one embodiment, the data rate of bits 11:10 of the CIM or NIM device status word can be set to the lowest maximum data rate of the sensor to accommodate all sensors and / or stimulation probe devices.

[0133] In another embodiment, the data rate of bits 11:10 of the CIM or NIM device status word is set to the highest maximum data rate of the sensor. The data rate provided in the time slot status word and the stimulation probe device status word is used to accommodate sensors and / or stimulation probe devices that cannot communicate at the highest maximum data rate. When the stimulation probe device is OFF, in sleep mode, and / or in low power mode, the data rate of bits 11:10 of the CIM or NIM device status word can be reduced. This reduces the power consumption of the sensor and / or stimulation probe device when no data is collected and / or monitored due to stimulation pulses.

[0134] Bits 14:12 are unused. Bit 15 indicates whether the stimulation probe device should be turned on to generate the stimulation probe signal. If bit 15 is OFF (or low), the stimulation probe device can be OFF or in a corresponding low power mode. The sensor and / or the stimulation probe device can switch between OFF, sleep, low power and / or high power modes based on bits 15 and 11:10. For example, the sensor can be in high power mode when bit 11:10 indicates a first data rate, and can be in low power mode when bit 11:10 indicates a second data rate, wherein the second data rate is less than the first data rate.

[0135]

[0136]

[0137] Table 2 - Console Interface Module or NIM Device Status Word

[0138] The time slot status word shown in Table 3 includes 16 bits, designated as bits 0-15. These bits can be referred to as local bits because they are associated with the sensor assigned to that time slot. Bits 7:0 indicate whether the corresponding time slot (referred to as "the time slot") is paired or unpaired. If paired, the time slot is assigned to the sensor, and bits 7:0 represent the sensor's unique identifier (SUID). If unpaired, the time slot is not assigned to the sensor, and bits 7:0 represent the pipe address through which the sensor communicates with the CIM or NIM device. Bits 9:8 indicate whether the corresponding time slot is available or allocated during the allocation process. A sensor can examine these bits when determining whether to select a time slot. Bits 11:10 indicate the speed at which the sensor assigned to the time slot can transmit information and / or data to the CIM and / or NIM device. Bits 13:12 indicate the type of sensor assigned to the time slot. Bit 14 is unused. Bit 15 indicates whether the stimulation probe device corresponding to the sensor assigned to the time slot is ON. The sensor assigned to the time slot can switch between OFF, sleep, low power and / or high power modes based on bit 15 and / or bits 11: 10. As an example, when bits 11: 10 indicate a data rate of zero, the sensor can be OFF or in sleep mode and / or low power mode.

[0139]

[0140] Table 3 - Time Slot Status Word

[0141] The time slot status word shown in Table 4 includes 16 bits identified as bits 0-15. These bits can be referred to as local bits because they are related to the stimulation probe device assigned to this time slot. Bits 0:7 indicate whether the corresponding time slot (referred to as "the time slot") is paired or unpaired. If paired, the time slot is assigned to the stimulation probe device, and bits 0:7 represent the unique identifier (STIMUID) of the stimulation probe device. If unpaired, the time slot is not assigned to the stimulation probe device, and bits 0:7 represent the pipe address to be communicated by the stimulation probe device when communicating with the CIM or NIM device. Bits 9:8 indicate whether the corresponding time slot is available or allocated during the allocation process. The stimulation probe device can check these bits when determining whether to select this time slot. Bits 10:11 indicate the speed at which the stimulation probe device assigned to this time slot transmits information and / or data to the CIM and / or NIM device. Bits 13:12 indicate the type of stimulation probe device assigned to the time slot. Bit 14 is unused. Bit 15 indicates whether the stimulation probe device assigned to the time slot is ON. The stimulation probe device assigned to the time slot can switch between OFF, sleep, low power and / or high power modes based on Bit 15 and / or Bits 11:10. As an example, when Bits 11:10 indicate a data rate of zero, the stimulation probe device can be OFF or in sleep mode and / or low power mode.

[0142]

[0143] Table 4 - Stimulus probe status word

[0144] When joining a WNIM network, sensors and stimulation probe devices can frequency hop (or broadcast) channels to detect synchronization requests. A WNIM network can include one or more sensors, one or more stimulation probe devices, CIM and / or NIM devices. The sensors and stimulation probe devices can select the channel with the strongest synchronization request, at which point they check the slot bit status word and the stimulation probe device status word in the synchronization request. The sensors and stimulation probe devices then select the corresponding available time slots on which to communicate with the CIM and / or NIM devices.

[0145] To select an available time slot, the sensor or stimulation probe device transmits a data payload during the selected time slot. Figure 15An exemplary periodic synchronization interval is shown in FIG. 3. The periodic synchronization interval includes a time slot 396 to transmit a synchronization request, eight sensor time slots 397, and a stimulation probe device time slot 398. The periodic synchronization interval is set up for two time slots for each sensor S1-S4. Thus, each sensor S1-S4 has one or more unique (or designated) time slots to transmit a data payload in response to the synchronization request. The periodic synchronization interval has a predetermined length (e.g., 4 ms). The predetermined length is the time between successive synchronization requests. The periodic synchronization interval can be referred to as an "RF frame."

[0146] Figure 15 The periodic synchronization interval of FIG. 3 can support, for example, four 10 kHz sensors and a stimulation probe device. Each of the four sensors sends a data payload during its designated time slot. Each data payload can include a respective SUID and a predetermined number (e.g., 15) of data words. The data from the sensors can include the information disclosed above, such as voltage potential, current level, amplitude, peak voltage (or amplitude), etc. The data from the stimulation probe device can include the information disclosed above, such as amplitude and duration of stimulation pulses. The synchronization timing in the respective time slots of the data payloads prevents the data payload response signals from being transmitted during the same time period and colliding with each other.

[0147] Figure 16 Another example of a periodic synchronization interval setup is provided for one time slot for each sensor and another for the stimulation probe device. In this example, Figure 16 The data rates of the sensors and the stimulation probe device of the example of FIG. 3 can be Figure 15 Half the speed of the example of FIG. 3. For example, Figure 16 The sensors and the stimulation probe device of the example of FIG. 3 can each have an output data rate of 5 kHz. Figure 17 Yet another example of a periodic synchronization interval setup is provided for eight sensors S1-S8. As an example, each of the sensors S1-S8 can have a single respective time slot, and the output data rate of each of the sensors can be 5 kHz.

[0148] While a certain number of sensor time slots and stimulation probe time slots are shown in each periodic synchronization interval in Figure 15-17 different numbers of sensor time slots and stimulation probe time slots can be included in a periodic synchronization interval. Further, while the examples of FIGS. 3-5 are described with respect to a single stimulation probe device, multiple stimulation probe devices can be included in a periodic synchronization interval. Figure 15-17Each of the sensor and stimulation probe devices described in FIG. 6 has the same output data rate (e.g., 10 kHz or 5 kHz), but the sensor and / or stimulation probe devices associated with one or more periodic synchronization intervals can have different output data rates. These different data rates can be indicated in the time slot status word of the synchronization request and the stimulation probe status word. In addition, each sensor and / or stimulation probe device of a periodic synchronization interval can be designated to a different number of time slots in that periodic synchronization interval than another sensor and / or stimulation probe device.

[0149] The time slots of a periodic synchronization interval designated to a single sensor or stimulation probe device can all be associated with a single channel of the sensor or stimulation probe device. As another example, one or more time slots of a periodic synchronization interval designated to a single sensor or stimulation probe device can be associated with each channel of the sensor or stimulation probe device. In other words, each channel can correspond to a respective group of time slots, with each group having one or more time slots. As another example, a sensor and / or stimulation probe device can select and / or be designated to the same or different time slots of consecutive synchronization intervals.

[0150] Additional details of the wireless protocol are described below with reference to Figure 18 and Figure 19 Figure 18 A signal flow diagram illustrating a sensor 400 joining a WNIM network and communicating with a CIM and / or NIM device (collectively 402) in a WNIM system is shown. The sensor 400 can refer to any of the sensors disclosed herein. Similarly, the CIM and / or NIM device 402 can refer to any of the CIM and / or NIM devices disclosed herein. The joining procedure is performed before the sensor responds to a synchronization request with a data payload. The joining establishes a link between the sensor and the CIM and / or NIM device, and the sensor and the CIM and / or NIM device (and / or other sensors and / or stimulation probe devices linked to the CIM and / or NIM device) together provide a WNIM network. Figure 18 An example sequence of events performed for a sensor 400 to join a WNIM network is shown, as well as how different modes of operation are obtained.

[0151] ​A synchronization request signal 404 is transmitted from the CIM and / or NIM device 402 and includes a word for each time slot in the corresponding synchronization interval. The synchronization request signal 404 is periodically and / or continuously updated and transmitted to indicate the status of the time slot. To join the WNIM network, the sensor 400 checks all available time slots and selects a time slot in which to transmit a data payload signal to the CIM and / or NIM device 402. Before transmitting the data payload, the sensor 400 sends a join request 406 to join the WNIM network and communicate in the selected time slot. The join request 406 may be transmitted in the selected time slot and may indicate the sensor's SUID, the selected time slot, the sensor type, and the sensor's minimum and / or maximum data rate. In one embodiment, the sensor 400 transmits the SUID in the selected time slot, and the CIM and / or NIM device 402 maintains a record of the sensor's type and data rate.

[0152] Based on the join request 406, the CIM and / or NIM device 402 populates the appropriate timeslot status word with the SUID from the sensor 400. The CIM and / or NIM device 402 may then send an updated synchronization request 408 to the sensor 400 with the designated updated timeslot status word indicating the selected timeslot. The sensor 400 receives the updated synchronization request with the SUID in the corresponding timeslot status word and responds by sending a data payload 410 to the CIM and / or NIM device 402 in the selected timeslot. If more than one timeslot is selected and / or designated for the sensor 400, the sensor 400 may transmit one or more data payloads 410 in the selected and / or designated timeslots to the sensor 400. The timeslots may be associated with one or more channels of the sensor 400. The synchronization request and the transmission of the data payload may be periodically transmitted over a series of periodic synchronization intervals (or RF frames).

[0153] Once linked to the CIM and / or NIM device 402, the sensor 400 can now be controlled by the CIM and / or NIM device 402 via the transmission of an updated synchronization request. The CIM and / or NIM device 402 can control, for example, the output data rate and the transitions between power modes of the sensor 400. As an example, the CIM and / or NIM device 402 can update the output data rate for the sensor 400's time slot from 10 kHz to 5 kHz by transmitting the updated synchronization request 412. The sensor linked to the CIM and / or NIM device 402 checks the control bits in the synchronization request (e.g., bits of the time slot status word) to determine the corresponding operation and / or power mode. The sensor then transitions to the indicated operation and / or power mode.

[0154] Figure 19 A signal flow diagram illustrating a stimulation probe device 420 participating in a WNIM network and communicating with CIM and / or NIM devices (collectively, 422) within the WNIM system is shown. Stimulation probe device 420 may refer to any stimulation probe device disclosed herein. CIM and / or NIM device 422 may refer to any CIM and / or NIM device disclosed herein. Stimulation pulse generation may be initiated at the NIM device and / or CIM 422. The NIM device may issue a payload request having bit 15 of a status word indicating the generation of a stimulation pulse. The status word may include: a CIM and / or NIM status word; a time slot status word; and a stimulation probe status word. Based on the payload request, the CIM may generate a synchronization request 424, which also has bit 15 of the status word set to ON to indicate the generation of a stimulation pulse. Both the payload request and the synchronization request may indicate a delay, the amplitude of the stimulation pulse, and / or the duration of the stimulation pulse via corresponding words 13-15. In response to bit 15 indicating that a stimulation pulse is to be generated, the stimulation pulse device 420 and / or one or more sensors for monitoring the stimulation pulse to be generated may be switched to a high power mode. When switched to the high power mode, the sensors may generate and transmit data payloads at a predetermined default frequency and / or at a frequency indicated by bits 11:10 of the status word of the synchronization request.

[0155] In response to the synchronization request 424, the stimulation probe device 420 generates stimulation pulses that are provided to the patient. To achieve precise timing and measurement of the stimulation pulses relative to the evoked response, the delay period provided in the synchronization request 424 is monitored by the stimulation probe device 420. The stimulation probe device 420 generates a response signal 426 that is indicative of the amplitude and duration of the stimulation pulses when applied to the patient.

[0156] Following the response signal 426 from the stimulation pulse device 420, the NIM device and / or CIM 422 generates a payload request (or synchronization request) 428 with the stimulation bit 15 low (or OFF). In response to the received payload request (or synchronization request), the stimulation probe device 420 sends an acknowledgement (ACK) signal 430 to the CIM and / or NIM device 422. The generation of the payload request (or synchronization request) and ACK signal can be repeated until the next stimulation pulse is generated, in which case the stimulation process can be repeated.

[0157] As described above, the CIM, NIM devices, sensors, reference patches, and stimulation probe devices disclosed herein can communicate with each other using bits within payload requests, synchronization H requests, data payloads, and response signals. The CIM and / or NIM device can initiate communication by sending a payload request (synchronization request). The data payload can include a 16-bit word for payload verification. The 16-bit word can include a SUID or STIMUID. When a CIM and / or NIM device receives a data payload, it compares the SUID or STIMUID with an expected SUID or STIMUID stored in memory of the CIM and / or NIM device. The SUID or STIMUID may have been stored in memory when the sensor or stimulation probe device joined the corresponding WNIM network. If the comparison indicates a match, the data in the data payload can be displayed at the NIM device.

[0158] Similarly, when the sensor receives a synchronization request, the sensor compares the CUID of the CIM and / or NIM device provided in the synchronization request with the expected CUID stored in the sensor's memory. The CUID may have already been stored in the memory when the sensor joined the corresponding WNIM network. If the CUID comparison indicates a match, the sensor may respond with one or more data payloads in the appropriate time slot following the synchronization request based on a mode status bit within the slot status word of the synchronization request. The mode status bit may be a bit of the slot status word that indicates the data rate and / or whether stimulation pulses are to be generated.

[0159] The systems, devices, and modules disclosed herein may be operated in a number of ways, in addition to the methods described above. Figure 20-22 Some additional example methods are shown in . Figure 20 In the present invention, a method of operating a sensor and a CIM and / or NIM device is shown. Although mainly related to Figure 1-4 and Figure 7A-13 The following tasks are described in an implementation of FIG, but can be easily modified to apply to other implementations of the present disclosure. The tasks can be performed iteratively.

[0160] The method can begin at 500. At 502, an electromyographic signal is generated, for example, by generating a stimulation pulse. The electromyographic signal is detected by a control module (e.g., one of control modules 56 and 202) via electrodes. At 504, a gain module (e.g., gain module 63) adjusts the gain of the electromyographic signal. At 506, a filtering module (e.g., filtering module 64) filters the output of the gain module. The filtering module can perform bandpass filtering on the amplified electromyographic signal received from the gain module.

[0161] At 508, a BB module (e.g., BB module 66) generates a BB signal based on the filtered and amplified myoelectric signal. At 510, a modulation module (e.g., modulation module 78) modulates and upconverts the BB signal to generate an RF signal. At 514, a PHY module (e.g., one of PHY modules 60, 204) and / or an amplification module (e.g., amplification module 80) transmits the RF signal from the sensing module to the CIM and / or NIM device.

[0162] At 516, the CIM and / or NIM device receives the RF signal from the sensing module and amplifies the RF signal. At 518, a demodulation module (e.g., one of demodulation modules 114, 176) downconverts the RF signal to generate a second BB signal. At 522, a BB module (e.g., one of BB modules 128, 184) at the CIM and / or NIM device can attenuate the second BB signal, as described above. At 524, a filtering module (e.g., one of filtering modules 126, 186) filters the attenuated second BB signal to generate a second filtered signal. This can include bandpass or lowpass filtering.

[0163] At 526, the second filtered signal can be provided from the CIM to the NIM device. At 528, the NIM device can display the second filtered signal. Similar methods can be performed for data requested and received from the stimulation probe device as described with respect to Figure 20 The method can end at 530.

[0164] At Figure 21 a method of powering up a sensor is shown. While the following tasks are described primarily with respect to Figure 1-4 and Figure 7A-13 implementations, the tasks can be easily modified to apply to other implementations of the present disclosure. The tasks of Figure 21 may be performed iteratively. The method can begin at 550.

[0165] At 552, due to the attachment of the sensor to the patient, the impedance between the myoelectric signal and / or electrodes is reduced. At 554, a power module (e.g., power module 206) determines whether the impedance is less than a predetermined impedance (or threshold). If the impedance is less than the predetermined impedance, task 560 can be performed as shown, or alternatively, task 556 can be performed. If the impedance is greater than or equal to the predetermined impedance, one or more of tasks 560, 561, 562, 564 can be performed. While tasks 560, 561, 562, 564 are shown, any of the tasks can not be performed and / or can be skipped. Furthermore, tasks 560, 561, 562, 564 can be performed in a different order.

[0166] At 560, a control module (e.g., one of control modules 56 and 202) determines whether a DC voltage (which may be referred to as an output voltage or output voltage signal) has been received from a power module (e.g., power module 206), as described above. If a DC voltage has not been received, task 556 may be performed. If a DC voltage has been received, task 561 may be performed.

[0167] At 556, the sensing module of the sensor switches to a low power mode or a high power mode, which may include powering on a portion, all, or the remainder of the control module and / or the PHY module. As an example, if a stimulation pulse is to be generated, the power module may switch to a high power mode and power on all or the remainder of the control module and / or the PHY module that are not already powered. After task 556, the method may end at 558. After task 556, the control module may proceed to, for example, Figure 20 Task 504.

[0168] At 561, the power module can determine whether the voltage potential across the electrodes is greater than a predetermined voltage and / or has a magnitude greater than a predetermined magnitude. If the voltage potential is greater than the predetermined voltage and / or the magnitude is greater than the predetermined magnitude, task 556 can be performed, otherwise task 562 can be performed. In one embodiment, a stimulation probe device is used to activate a sensor. The stimulation probe device generates an initial stimulation pulse to activate the sensor. Additional stimulation pulses can be generated after activating the sensor. The power module can detect the initial stimulation pulse by monitoring the voltage at the electrodes and / or an amplified signal generated based on the voltage detected at the electrodes.

[0169] At 562, the power module can determine whether the amount of current received from one of the electrodes is greater than a predetermined current level. If the amount of current is greater than the predetermined current level, task 556 can be performed, otherwise task 564 can be performed. As described above, the stimulation probe device can generate an initial stimulation pulse to activate the sensor. The power module can detect the initial stimulation pulse by monitoring the current received from one or more electrodes and / or an amplified signal generated based on the current received from the one or more electrodes. In one embodiment, tasks 561 and / or 562 are performed, and tasks 554 and / or 560 are not performed.

[0170] At 564, the power module inhibits generating an output voltage (or output signal), and the sensing module inhibits transitioning to a low power mode or a high power mode and remains in a sleep mode and / or a low power mode. After task 564, task 552 may be performed as shown, or the method may end at 558.

[0171] exist Figure 22 In the present invention, a WNIM method of operating a stimulation probe device, one or more sensors, and a console interface module and / or NIM device is shown. Figure 1-19 The following tasks are described in the implementation of , but can be easily modified to apply to other implementations of the present disclosure. Figure 21 The following tasks provide examples of initial power-up and continuous initial generation of periodic synchronization requests. The method can begin at 600.

[0172] At 602, a sensor and one or more stimulation probe devices receive one or more synchronization requests from one or more CIM and / or NIM devices. A control module of the NIM device may generate a payload request signal to request data payloads from the sensor and stimulation probe devices. The control modules of the CIMs may each generate a synchronization request signal, which may be transmitted periodically (e.g., once per a predetermined period or synchronization period).

[0173] At 604, the stimulation probe device selects a broadcast channel for one of the synchronization requests based on the signal strength of the synchronization request received by the stimulation probe device. The stimulation probe device may skip channels in the table to receive the synchronization request. The broadcast channel for the synchronization request with the greatest signal strength is selected. The stimulation probe device may determine whether there is more than one stimulation probe device in the WNIM network for the selected synchronization request. If there is more than one stimulation probe device, an available time slot is selected by the stimulation probe device that joins the WNIM network. This may be implemented similarly to how a sensor selects a time slot, as described above.

[0174] At 605, the stimulation probe device joining the WNIM network determines not to generate stimulation pulses based on the corresponding status bit of the synchronization request of the selected broadcast channel. At 606, the stimulation probe device sends an ACK signal to the CIM and / or NIM device of the selected broadcast channel.

[0175] At 607, the stimulation probe device receives an updated synchronization request from the CIM and / or NIM device of the selected broadcast channel.

[0176] At 608, the stimulation probe device that has joined the WNIM network determines whether to generate a stimulation pulse based on the corresponding status bit of the updated synchronization request of the selected broadcast channel. If the stimulation pulse is requested to be generated, task 610 is performed; otherwise, task 609 is performed. At 609, the stimulation pulse device sends an ACK signal to the CIM and / or NIM device of the selected broadcast channel.

[0177] At 610, the stimulation pulse device generates a stimulation pulse signal based on the stimulation information word in the synchronization request. The stimulation pulse signal can be generated based on the delay period, amplitude and / or duration provided in the synchronization request. At 612, the stimulation probe device reports the measured (or detected) amplitude and duration of the generated stimulation pulse to the CIM and / or NIM device in a specified time slot of the periodic synchronization interval. This may occur in the same periodic synchronization interval as the synchronization request. Task 607 can be performed after task 612, or the method can end at 630, as shown.

[0178] At 620, each of the sensing modules selects the broadcast channel with the synchronization request having the greatest signal strength. The sensing modules may skip channels in a table stored in the sensing modules to find and select a broadcast channel. At 622, each sensing module of the sensor selects one or more time slots and / or checks the status of the time slots indicated in the synchronization request for the selected broadcast channel. If the sensing module was not previously connected to the CIM and / or NIM device transmitting the selected broadcast channel, the sensing module selects an available time slot. If the sensing module was previously connected to the CIM and / or NIM device, the sensing module checks the status of the previously selected time slot to ensure that it is still assigned to the sensing module. If the time slot is no longer assigned to the sensing module, the sensing module may select another available time slot.

[0179] Based on the type of corresponding sensor, multiple time slots can be assigned to a sensing module without requiring the sensing module to previously request multiple time slots. For example, if the sensor has multiple channels and / or is to be assigned multiple time slots, the CIM and / or NIM device can update the time slot status word accordingly based on a single time slot request. The sensing module can then detect that multiple time slots have been assigned during an inspection of the time slot status word in a subsequent synchronization request.

[0180] At 624, the sensing module may transmit a data payload in the respectively selected time slot. This serves a dual purpose. In addition to providing data corresponding to the signals detected at the sensor electrodes, the transmitted data payload serves as a request for the selected time slot. At 626, the sensing module may receive a next update synchronization request from the CIM and / or NIM device. The next update synchronization request may indicate the sensing module's SUID in the time slot status word. Task 626 may be performed while executing task 607. Tasks 626 and 607 may refer to the same update synchronization request.

[0181] At 628, the sensing module sends a data payload to the CIM and / or NIM device in the designated time slot in accordance with the updated synchronization request. Task 628 may be performed after task 610. Task 626 may be performed after task 628, or the method may end at 630, as shown. Figure 22 Not shown, but some tasks may be performed iteratively for the generation of subsequent synchronization request signals and / or additional stimulation pulses.

[0182] Figure 20-22 The above tasks are intended to be illustrative examples; the tasks may be performed sequentially, synchronously, simultaneously, continuously, or in a different order during overlapping time periods depending on the application. In addition, any task may not be performed or may be skipped depending on the implementation and / or sequence of events.

[0183] Figure 23-24 A portion 700 of another EMG endotracheal tube assembly is shown, including a housing 702 and corresponding electronics assembly 704. The EMG tube assembly may replace or substitute Figure 8-13 706. The EMG tube assembly of FIG. 706 is used with an EMG tube assembly and may include any of the modules described above with respect to any of the sensors disclosed herein. Housing 702 is connected to endotracheal tube 706 via flange 707. Housing 702 includes a top portion (or cover) 708 and a bottom portion 709. The EMG endotracheal tube assembly includes housing 702 having an electronics assembly 704, electrodes 710, a spring-loaded pin element 712, and contacts 714. The electronics assembly 704, electrodes 710, spring-loaded pin element 712, and contacts 714 may be collectively referred to as a sensor. The sensor may also include housing 702, substrate 716, control (or sensing) module 718, power supply 720, antenna 722, spring-loaded pin element 712, and sealing gasket 724.

[0184] Figure 23-24 The EMG Endotracheal Tube Assembly provides Figure 8-13 The power source (or battery) 720 has a "flat" or low profile, which allows the housing 702 to have a lower profile than the housing 332. The power source 720 can be a "flat pack" battery, a lithium-ion polymer (LiPON) battery, a wafer-scale battery, or other flat-pack power source.

[0185] Figure 25-34 As shown, the sensor assembly 750 incorporates a modular control (or sensing) module assembly 752 and includes one or more of the following: (i) a patch 754 having an electrode 755; and (ii) a pin electrode adapter 756 having a pin electrode 760 having an electrode 758. The patch 754 may include a base (similar to a base) having a flexible substrate and an adhesive layer with a spacer sheet 762. Figures 7A-7B The patch 754 provides electrical connection between the electrode 755 and the spacer 762. The pin electrode adapter 756 provides electrical connection between the electrode 758 and the pin electrode 760. The patch 754 and the pin electrode adapter 756 may include passive components and may not include active (or smart) components. The sensor assembly 750 or a portion thereof may be used to replace Figure 1 Any sensor shown, and may include any modules described above with respect to any sensor disclosed herein.

[0186] The modular control module assembly 752 can be snapped onto the electrode 755 of the patch 754 or can be snapped onto the electrode 758 of the pin electrode adapter 756. The modular control module assembly 752 and the pin electrode adapter 756 can replace Figure 1 One of the sensors 12. The modular control module assembly 752 and the patch 754 can be replaced Figure 1 One of the sensors 13.

[0187] Figure 29 and Figure 34 766 is shown connected to the electrode 755 of the patch 754 and the electrode 758 of the pin electrode adapter 756. The electrodes 755, 758 can be inserted or plugged into the receiving connector 766. The electrodes 755, 758 can have one or more ribs (e.g., rib 768) and recesses (e.g., recess 770) that mate with corresponding portions of the receiving connector 766, as shown. Figure 25 、 28 and 33. The modular control module assembly 752 may be reusable, and the patch 754 and pin electrode adapter 756 may not be reusable, as described above with respect to Figures 7A-7B This minimizes system cost by allowing the modular control module assembly 752 to be reused multiple times, as opposed to being discarded after a single use and / or for a single surgical procedure. In one embodiment, the modular control module assembly 752: is non-reusable; may be connected to or include the patch 754 and / or the pin electrode adapter 756; and may not snap onto the patch 754 or the pin electrode adapter 756.

[0188] Now refer to Figure 4 and Figure 35 , which shows a power module (e.g., Figure 4A portion 800 (referred to as a front-end circuit) of the power module 206 of FIG. Portion 800 includes resistors R1 and R2 connected to electrodes 62. Resistor R1 is connected between one of electrodes 62 and a voltage source providing a voltage V+. Resistor R2 is connected between the other of electrodes 62 and a voltage source or reference voltage V− (e.g., a ground reference voltage).

[0189] Portion 800 further includes capacitors C1 and C2, resistors R3, R4, R5, and R6, capacitors C3, C4, and C5, an amplifier module 801, and a detection module 802. Capacitors C1 and C2 are connected in series with two electrodes 62, respectively, and are connected between resistors R1 and R2 and resistors R3 and R4, respectively. Resistors R3 and R4 are connected in series (i) between capacitors C1 and C2, and (ii) between resistors R5 and R6. Capacitor C1 and resistors R3 and R5 are each connected to each other at terminal 803. Capacitor C2 and resistors R4 and R6 are each connected to each other at terminal 805.

[0190] Resistors R1, R2, R3, and R4 provide a voltage divider between voltage terminals 804 and 806 that receive voltages V+ and V-. Resistors R5 and R6 are connected in series with capacitors C1 and C2, respectively, and in series with capacitor C5. Capacitor C5 is connected between resistors R5 and R6. Capacitors C3 and C4 are connected in series with each other and between resistors R5 and R6. Capacitor C5 is connected across capacitors C3 and C4. Terminal 808 between resistors R3 and R4 is connected to terminal 810 between capacitors C3 and C4. Each of resistors R3 and R4 is connected to each of capacitors C3 and C4 via terminals 808 and 810. Amplifier module 801 includes: (i) two inputs connected to the ends of capacitor C5, respectively; and (ii) an output connected to detection module 802.

[0191] Capacitor C1 and resistor R3 operate as a first high-pass filter. Capacitor C2 and resistor R4 operate as a second high-pass filter. Resistor R5 and capacitor C3 operate as a first low-pass filter. Resistor R6 and capacitor C4 operate as a second low-pass filter.

[0192] During operation, if a patient is not connected to electrode 62, an imbalance exists across terminals 803, 805, causing the voltage at terminal 803 to be pulled up to voltage V+ via resistor R1 and capacitor C1, and the voltage at terminal 805 to be pulled down to voltage V- via resistor R2 and capacitor C2. Capacitors C1, C2 provide DC voltage blocking, but may exhibit leakage, which may be detected and amplified by amplifier module 801. The voltage output of amplifier module 801 is detected by detection module 802. When the patient is not connected to electrode 62, the detection module may generate a DC voltage. The DC voltage may then be provided to control module 202 for detecting that the patient is not connected to electrode 62. This is referred to as "disconnected wire" detection. As an example, the voltage difference between V+ and V- is between 2-5V.

[0193] If the patient is connected to the electrodes 62, the imbalance between the terminals 803 and 805 decreases because the voltage potential difference between the terminals 803 and 805 decreases. The change in voltage after filtering is amplified by the amplifier module 802 and detected by the control module 202. The amplifier module 801 may include an amplifier for amplifying the voltage across the capacitor C5. When the voltage potential difference between the terminals 803 and 805 decreases, the detection module may not generate a DC voltage and / or may not provide a DC voltage to the control module 202.

[0194] There is a subtle effect, particularly due to the DC blocking capacitors C1 and C2. Resistors R1, R2, R3, R4, capacitors C1 and C2, and voltages V+ and V- are configured to allow for both line break detection and line up detection while minimizing the current that may be delivered to the patient via electrode 62. Current may follow a current path from terminal 804 through resistor R1, capacitor C1, resistors R3 and R4, capacitor C2, and then through resistor R2 to terminal 806. For example, if 5 nanoamperes (nA) of current flow along this path, there may be 100 microvolts (μV) across resistors R3 and R4. If amplifier module 801 provides a gain of 150, the output of amplifier module 801 may be 15 millivolts (mV) DC, which may be detected by detection module 802.

[0195] Figure 35 The circuit shown in FIG can be used to alert a user that a sensor is disconnected from a patient and / or to wake up the sensor. In one embodiment, portion 800, power module 206, control module 202, and / or a portion thereof periodically wake up and check whether the patient is attached to electrode 62. As an example, power module 206 can periodically wake up and detect whether the patient is attached and notify control module 202. As another example, control module 202 can periodically wake up power module 206 to perform this detection.

[0196] As another example, portion 800 can include a timing module 810 that receives power from power supply 208. Power supply 208 can also provide voltages V+, V-, or the power module can generate voltages V+, V- based on power from power supply 208. Timing module 810 can periodically wake up and supply power to resistors R1, R2, amplifier module 801, and / or detection module 802. Detection module 802 can then detect whether a patient is attached to electrodes 62. If electrodes 62 are attached to a patient, the detection module can notify control module 202 and / or power on control module 202 and / or PHY module 204.

[0197] The wireless communication and corresponding systems and devices disclosed herein offer several advantages. For example, they provide an improved signal-to-noise ratio, at least in part due to the elimination of large coils associated with conventional systems. They also electrically isolate the patient from the monitoring device. This provides improved safety by minimizing the amount of current that may be supplied to the patient.

[0198] The wireless communications described in this disclosure may be conducted in whole or in part in accordance with IEEE Standard 802.11-2012, IEEE Standard 802.16-2009, and / or IEEE Standard 802.20-2008. In various implementations, IEEE 802.11-2012 may be supplemented by Draft IEEE Standard 802.11ac, Draft IEEE Standard 802.11ad, and / or Draft IEEE Standard 802.11ah.

[0199] The foregoing description is merely illustrative in nature and is not intended to limit the present disclosure, its application or use in any way. The broad teachings of the present disclosure can be implemented in various forms. Therefore, although the present disclosure includes specific examples, the true scope of the present disclosure should not be so limited, because other modifications will become apparent after studying the drawings, the specification and the appended claims. As used herein, the phrase at least one of A, B and C should be interpreted as meaning a logical (A or B or C) using a non-exclusive logical OR, and should not be interpreted as meaning "at least one of A, at least one of B and at least one of C". It should be understood that one or more steps in the method can be performed in a different order (or simultaneously) without changing the principles of the present disclosure.

[0200] In this application, including the following definitions, the term 'module' or the term 'controller' may be replaced by the term 'circuit'. The term 'module' may refer to a portion of or include the following: an application-specific integrated circuit (ASIC); a digital, analog, or mixed analog / digital discrete circuit; a digital, analog, or mixed analog / digital integrated circuit; a combinational logic circuit; a field-programmable gate array (FPGA); a processor circuit (shared, dedicated, or group) that executes code; a memory circuit (shared, dedicated, or group) that stores code executed by the processor circuit; other suitable hardware components that provide the described functionality; or a combination of some or all of the above, such as in a system-on-a-chip.

[0201] The module may include one or more interface circuits. In some examples, the interface circuit may include a wired or wireless interface connected to a local area network (LAN), the Internet, a wide area network (WAN), or a combination thereof. The functionality of any given module of the present disclosure may be distributed among multiple modules connected via the interface circuits. For example, multiple modules may allow for load balancing. In another example, a server (also referred to as a remote or cloud) module may implement some functionality on behalf of a client module.

[0202] The term code, as used above, may include software, firmware, and / or microcode, and may refer to programs, routines, functions, classes, data structures, and / or objects. The term shared processor circuit includes a single processor circuit that executes some or all code from multiple modules. The term group processor circuit includes a processor circuit that is combined with additional processor circuits to execute some or all code from one or more modules. References to multiple processor circuits include multiple processor circuits on discrete dies, multiple processor circuits on a single die, multiple cores of a single processor circuit, multiple threads of a single processor circuit, or a combination of the above. The term shared memory circuit includes a single memory circuit that stores some or all code from multiple modules. The term group memory circuit includes a memory circuit that is combined with additional memory to store some or all code from one or more modules.

[0203] The term memory circuit is a subset of the term computer-readable medium. As used herein, the term computer-readable medium does not include transient electrical or electromagnetic signals propagating through a medium (e.g., on a carrier wave); the term computer-readable medium may therefore be considered to be tangible and non-transient. Non-limiting examples of non-transient tangible computer-readable media include non-volatile memory circuits (e.g., flash memory circuits or mask read-only memory circuits), volatile memory circuits (e.g., static random access memory circuits and dynamic random access memory circuits), and secondary storage devices such as magnetic storage devices (e.g., magnetic tape or hard drives) and optical storage devices.

[0204] The devices and methods described herein may be implemented in part or in whole by a special-purpose computer created by configuring a general-purpose computer to perform one or more specific functions implemented in a computer program. The computer program includes processor-executable instructions stored on at least one non-transitory tangible computer-readable medium. The computer program may also include or rely on stored data. The computer program may include a basic input / output system (BIOS) that interacts with the hardware of the special-purpose computer, device drivers that interact with specific devices of the special-purpose computer, one or more operating systems, user applications, background services and applications, and the like.

[0205] The computer program may include: (i) assembly code; (ii) object code generated by a compiler from the source code; (iii) source code for execution by an interpreter; (iv) source code for compilation and execution by a just-in-time compiler; (v) descriptive text for parsing, such as HTML (Hypertext Markup Language) or XML (Extensible Markup Language). By way of example only, the source code may be in C, C++, C#, Objective-C, Haskell, Go, SQL, Lisp, ASP, Perl, HTML5, Ada, ASP (Active Server Pages), Perl, Scala, Erlang, Ruby, Visual Lua or

[0206] Unless an element is expressly recited using the phrase "means for..." or a method claim uses the phrase "operation of..." or "step for...", no element recited in a claim is intended to be a means-plus-function element within the meaning of 35 U.S.C. §112(f).

[0207] This application should cover the implementation methods described in the following clauses.

[0208] 1. A neural integrity monitoring device comprising:

[0209] a control module configured to generate a payload request, wherein the payload request (i) requests a data payload from a sensor in the wireless neural integrity monitoring network and (ii) instructs the stimulation probe device whether to generate a stimulation pulse; and

[0210] A physical layer module, the physical layer module being configured to:

[0211] (i) wirelessly transmitting the payload request to the sensor and the stimulation probe device, or (ii) transmitting the payload request to a console interface module, and

[0212] In response to the payload request, (i) the data payload is received from the sensor, and (ii) stimulation pulse information is received 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.

[0213] 2. The neural integrity monitoring device of clause 1, wherein the physical layer module is connected to the console interface module or is separate from and located remote from the console interface module.

[0214] 3. The nerve integrity monitoring device according to clause 1, wherein the stimulation pulse information includes the amplitude of the stimulation pulse and the duration of the stimulation pulse.

[0215] 4. The neural integrity monitoring device of clause 1 , wherein the payload request includes a data rate at which the sensor transmits the data payload to the physical layer module or the console interface module.

[0216] 5. The neural integrity monitoring device of clause 1, wherein the payload request includes a second data rate, and the stimulation probe device transmits the stimulation pulse information to the physical module or the console interface module at the second data rate.

[0217] 6. The neural integrity monitoring device of clause 1, wherein the payload request includes slot status words, wherein each of the slot status words indicates whether a slot is allocated to the sensor or another sensor.

[0218] 7. The neural integrity monitoring device of clause 1, wherein the payload request includes a request sequencer bit that indicates at which synchronization interval in a series of synchronization intervals the sensor is to transmit data to the physical module or the console interface module.

[0219] 8. The neural integrity monitoring device of clause 1, wherein the payload request includes a unique identifier of the sensor or indicates a type of the sensor.

[0220] 9. The neural integrity monitoring device of clause 1, wherein the payload request indicates whether each of a plurality of time slots in each of a plurality of synchronization intervals is: available; in the process of being allocated; or designated for the sensor or another sensor.

[0221] 10. A console interface module, comprising:

[0222] a control module configured to: (i) receive a payload request from a neural 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 a sensor in a wireless neural integrity monitoring network, and (ii) instructs a stimulation probe device whether to generate a stimulation pulse; and

[0223] A physical layer module, the physical layer module being configured to:

[0224] wirelessly transmitting the synchronization request to the sensor and the stimulation probe device, and

[0225] In response to the synchronization request, (i) the data payload is wirelessly received from the sensor, and (ii) stimulation pulse information is wirelessly received from the stimulation probe device, wherein the data payload includes data corresponding to the patient's evoked response and wherein the evoked response is generated based on the stimulation pulse.

[0226] 11. The console interface module of clause 10, wherein the physical layer module is configured to transmit the data payload and the stimulation pulse information to the nerve integrity monitoring device.

[0227] 12. The console interface module of clause 10, wherein the physical layer module is connected to the neural integrity monitoring device or is separate from and located remotely from the neural integrity monitoring device.

[0228] 13. The console interface module of clause 10, wherein the stimulation pulse information comprises an amplitude of the stimulation pulse and a duration of the stimulation pulse.

[0229] 14. The console interface module of clause 10, wherein the synchronization request includes time slot status words, wherein each of the time slot status words indicates whether a time slot is allocated to the sensor or another sensor.

[0230] 15. The console interface module of clause 10, wherein the synchronization request includes a request sequencer bit that indicates at which synchronization interval in a series of synchronization intervals the sensor is to transmit data to the physical module.

[0231] 16. The console interface module of clause 10, wherein the synchronization request includes a unique identifier of the sensor or indicates a type of the sensor.

[0232] 17. The console interface module of clause 10, wherein the synchronization request indicates whether each of a plurality of time slots in each of a plurality of synchronization intervals is: available; in the process of being allocated; or assigned to the sensor or another sensor.

[0233] 18. A neural integrity monitoring system comprising:

[0234] A first sensing module 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:

[0235] a processing module configured to amplify and filter the first electromyographic signal to generate a first voltage signal, and

[0236] a first physical layer module configured to: (i) up-convert the first voltage signal into a first radio frequency signal, and (ii) wirelessly transmit the first radio frequency signal based on the payload request signal; and

[0237] A console interface module or a neural integrity monitoring device includes a second physical layer module configured to: (i) receive the first radio frequency signal from the first physical layer module, and (ii) down-convert the first radio frequency signal to a baseband signal.

[0238] 19. The neural integrity monitoring system of clause 18, 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 neural integrity monitoring device in the time slot.

[0239] 20. The neural integrity monitoring system of clause 18, further comprising a plurality of sensors, wherein:

[0240] the plurality of sensing modules including the first sensing module and being attached to the patient;

[0241] The plurality of sensing modules are configured to generate a plurality of radio frequency signals;

[0242] The plurality of radio frequency signals include the first radio frequency signal; and

[0243] The second physical layer module is configured to: (i) receive the plurality of radio frequency signals from the first physical layer module, and (ii) down-convert the plurality of radio frequency signals into baseband signals.

[0244] 21. The neural integrity monitoring system of clause 20, wherein the neural integrity monitoring device is configured to display versions of the baseband signal.

[0245] 22. The neural integrity monitoring system of clause 20, wherein the plurality of sensing modules comprises:

[0246] the first sensing module, wherein the first sensing module is configured to generate the first radio frequency signal, wherein the first set of electrodes includes pin electrodes; and

[0247] 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 includes the second radio frequency signal, and wherein the second set of electrodes includes pad electrodes.

[0248] 23. The nerve integrity monitoring system of clause 18, wherein the first sensing module is configured to contact a contact on an endotracheal tube.

[0249] 24. The neurological integrity monitoring system of clause 18, further comprising an endotracheal tube assembly, wherein the endotracheal tube assembly comprises:

[0250] an endotracheal tube for insertion into the airway of the patient, wherein the endotracheal tube comprises a proximal end, a distal end, a contact, and a trace, wherein the contact is located on the endotracheal tube closer to the proximal end than to the distal end, and wherein the trace extends between the contact and the distal end and is configured to receive a second myoelectric signal from the patient via the contact; and

[0251] a second sensing module configured to connect to the trace and receive the second myoelectric signal, wherein the second sensing module is configured to: (i) detect the second myoelectric signal and generate a second voltage signal, (ii) up-convert the second voltage signal into 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 neural integrity monitoring device.

[0252] 25. The neural integrity monitoring system of clause 18, further comprising a stimulation probe device in wireless communication with the console interface module or the neural integrity monitoring device, wherein:

[0253] The console interface module or the neural integrity monitoring device is configured to generate a payload request signal; and

[0254] The stimulation probe device is configured to: (i) wirelessly receive the payload request signal, (ii) generate stimulation pulses in response to the payload request signal, and (iii) wirelessly transmit information related to the stimulation pulses to the console interface module or the neural integrity monitoring device.

[0255] 26. A neural integrity monitoring system according to clause 18, wherein:

[0256] The console interface module is configured to: (i) receive the first radio frequency signal from the first physical layer module, and (ii) generate a first digital signal or a first analog signal based on the first radio frequency signal; and

[0257] The neural integrity monitoring device is configured to receive the first digital signal or the first analog signal from the console interface module.

[0258] 27. The neural integrity monitoring system of clause 18, wherein the neural integrity monitoring device is configured to: (i) receive the first radio frequency signal from the first physical layer module, and (ii) generate a first digital signal or a first analog signal based on the first radio frequency signal.

[0259] 28. The neural integrity monitoring system of clause 18, wherein:

[0260] The first sensing module includes a temperature sensor;

[0261] The temperature sensor is configured to generate a temperature signal; and

[0262] The first sensing module is configured to wirelessly transmit the temperature signal to the console interface module or the nerve integrity monitoring device.

[0263] 29. The neural integrity monitoring system of clause 18, wherein the console interface module or the neural integrity monitoring device is configured to: based on the first radio frequency signal, (i) determine heart rate or respiratory rate, or (ii) detect muscle spasm.

[0264] 30. The neural integrity monitoring system of clause 18, wherein:

[0265] The first sensing module includes an accelerometer;

[0266] The accelerometer is configured to generate an acceleration signal;

[0267] The first sensing module is configured to wirelessly transmit the acceleration signal to the console interface module or the neural integrity monitoring device; and

[0268] The console interface module or the nerve integrity monitoring device is configured to: based on the acceleration signal, (i) determine heart rate or respiratory rate, or (ii) detect muscle spasm.

[0269] 31. A sensor comprising:

[0270] a plurality of electrodes configured to (i) attach to a patient and (ii) receive a first myoelectric signal from the patient;

[0271] a control module connected to the plurality of electrodes, wherein the control module is configured to: (i) detect the first electromyographic signal, and (ii) generate a first voltage signal; and

[0272] A physical layer module, the physical layer module being configured to:

[0273] Receives a payload request from a console interface module or neural integrity monitoring device, and

[0274] Based on the payload request, (i) the first voltage signal is up-converted into a first radio frequency signal, and (ii) the first radio frequency signal is wirelessly transmitted from the sensor to the console interface module or the neural integrity monitoring device.

[0275] 32. The sensor of clause 31, wherein:

[0276] The payload request includes a data rate;

[0277] The physical layer module is configured to transmit a data payload at the data rate to the console interface module or the neural integrity monitoring device; and

[0278] The data payload includes data generated based on the first electromyographic signal.

[0279] 33. The sensor of clause 31, wherein:

[0280] The payload request includes a plurality of time slot status words;

[0281] The control module is configured to: (i) determine a status of a plurality of time slots based on the plurality of time slot status words, and (ii) select one or more of the time slots; and

[0282] The physical layer module is configured to transmit one or more data payloads in selected one or more of the time slots.

[0283] 34. The sensor of clause 33, wherein:

[0284] The physical layer module is configured to periodically receive a synchronization request signal from the console interface module or the neural integrity monitoring device;

[0285] There is a synchronization gap between transmissions of consecutive pairs of synchronization request signals of the synchronization request signal; and

[0286] The physical layer module is configured to transmit a plurality of data payloads in selected one or more of the time slots of the synchronization request signal.

[0287] 35. The sensor of clause 31, further comprising a power module, wherein the power module is configured to: (i) detect impedance between the plurality of electrodes, and (ii) power on a portion of the control module or a portion of the physical layer module based on the impedance.

[0288] 36. The sensor of clause 31, further comprising a power module, wherein the power module is configured to: (i) detect impedance between the plurality of electrodes, and (ii) power on the control module and the physical layer module based on the impedance.

[0289] 37. The sensor of clause 36, further comprising a power supply,

[0290] The power module is configured to enable power to be provided from the power supply to the control module or the physical layer module based on the impedance.

[0291] 38. The sensor of clause 37, wherein the power module is configured to power on the control module or the physical layer module if the impedance is less than a predetermined impedance.

[0292] 39. The sensor of clause 31 further comprising a power module configured to: (i) detect a voltage across the plurality of electrodes, and (i) power on a portion of the control module or a portion of the physical layer module based on the voltage.

[0293] 40. The sensor of clause 31 further comprising a power module configured to: (i) detect an amount of current received at one of the plurality of electrodes, and (i) power on a portion of the control module or a portion of the physical layer module based on the amount of current.

[0294] 41. The sensor of clause 31, further comprising a power module configured to provide voltage to the control module.

[0295] Wherein, based on whether the control module is receiving voltage from the power module, the power module is configured to (i) switch from being off to being in a low power mode or a high power mode, or (ii) switch from being in the low power mode to being in the high power mode.

[0296] 42. The sensor of clause 31, wherein the plurality of electrodes comprises pin electrodes.

[0297] 43. The sensor of clause 31 , wherein the plurality of electrodes comprises pad electrodes.

[0298] 44. The sensor of clause 31 , wherein the control module is configured for connection to contacts on an endotracheal tube.

[0299] 45. The sensor of clause 31, wherein:

[0300] The control module includes a temperature sensor;

[0301] The temperature sensor is configured to detect temperature and generate a temperature signal; and

[0302] The physical layer module is configured to wirelessly transmit the temperature signal to the console interface module or the nerve integrity monitoring device.

[0303] 46. ​​The sensor of clause 31, further comprising an accelerometer configured to generate an acceleration signal,

[0304] The physical layer module is configured to wirelessly transmit the acceleration signal to the console interface module or the neural integrity monitoring device.

[0305] 47. The sensor of clause 31, wherein:

[0306] The plurality of electrodes are attached to patches or pin electrodes;

[0307] The control module is snapped onto the plurality of electrodes via a connector;

[0308] the control module is reusable and configured to be disconnected from the first plurality of electrodes and connected to a second plurality of electrodes; and

[0309] the patch and the pin electrodes are non-reusable.

[0310] 48. The sensor of clause 31, further comprising:

[0311] a front-end circuit connected to the plurality of electrodes;

[0312] an amplifier module configured to amplify an output of the front-end circuit;

[0313] a detection module configured to: based on an output of the amplifier module, (i) detect whether the plurality of electrodes is attached to the patient, and (ii) generate an output signal indicative of whether the plurality of electrodes is attached to the patient,

[0314] wherein the control module is configured to generate the first voltage signal based on the output signal.

[0315] 49. The sensor of clause 48, further comprising a timing module configured to periodically wake up and power on the amplifier module and the detection module to check whether the plurality of electrodes is attached to the patient.

[0316] 50. A method comprising:

[0317] receiving a payload request from a console interface module or a neural integrity monitoring device;

[0318] receiving, at a sensing module, a first electromyographic signal via a plurality of electrodes, wherein the sensing module is directly connected to the plurality of electrodes;

[0319] generating a first voltage signal based on the electromyographic signal;

[0320] upconverting the first voltage signal into a first radio frequency signal; and

[0321] wirelessly transmitting the first radio frequency signal from the sensing module to the console interface module or the neural integrity monitoring device based on the payload request.

[0322] 51. The method of clause 50, further comprising transmitting a data payload to the console interface module or the neural integrity monitoring device at a data rate, wherein:

[0323] the payload request comprises the data rate; and

[0324] The data payload includes data generated based on the first electromyographic signal.

[0325] 52. The method of clause 50, further comprising:

[0326] determining a status of a plurality of time slots based on a plurality of time slot status words, and (ii) selecting one or more of the time slots, wherein the payload request includes the plurality of time slot status words; and

[0327] One or more data payloads are transmitted in selected one or more of the time slots.

[0328] 53. The method of clause 52, further comprising:

[0329] periodically receiving a synchronization request signal from the console interface module or the neural integrity monitoring device, wherein a synchronization interval exists between transmissions of consecutive pairs of synchronization request signals of the synchronization request signal; and

[0330] A plurality of data payloads are transmitted in selected one or more of the time slots of the synchronization request signal.

[0331] 54. The method of clause 50, further comprising:

[0332] detecting impedance between the plurality of electrodes; and

[0333] Based on the impedance, a portion of a control module of the sensing module or a portion of a physical layer module of the sensing module is powered on.

[0334] 55. The method of clause 50, further comprising:

[0335] detecting impedance between the plurality of electrodes; and

[0336] Based on the impedance, power on the control module and the physical layer module,

[0337] The sensing module includes the control module and the physical layer module.

[0338] 56. The method of clause 55, further comprising: enabling power to be provided from a power source to the control module or the physical layer module based on the impedance,

[0339] The sensing module includes the control module and the physical layer module.

[0340] 57. The method of clause 56, comprising powering on the control module or the physical layer module if the impedance is less than a predetermined impedance.

[0341] 58. The method of clause 50, further comprising:

[0342] detecting voltages across the plurality of electrodes; and

[0343] Based on the voltage, power on a portion of the control module or a portion of the physical layer module;

[0344] The sensing module includes the control module and the physical layer module.

[0345] 59. The method of clause 50, further comprising:

[0346] detecting an amount of current received at one of the plurality of electrodes; and

[0347] Based on the current amount, a portion of a control module or a portion of a physical layer module is powered on, wherein the sensing module includes the control module and the physical layer module.

[0348] 60. The method of clause 50, further comprising:

[0349] providing voltage to the control module of the sensing module via the power module; and

[0350] Based on whether the control module is receiving voltage, the power module is switched (i) from off to a low power mode or a high power mode, or (ii) from the low power mode to the high power mode.

[0351] 61. The method of clause 50, wherein the electrode is located on an endotracheal tube.

[0352] 62. The method of clause 50, further comprising:

[0353] detecting temperature and generating a temperature signal; and

[0354] The temperature signal is wirelessly transmitted to the console interface module or the nerve integrity monitoring device.

[0355] 63. The method of clause 50, further comprising:

[0356] generating an acceleration signal via an accelerometer; and

[0357] The acceleration signal is wirelessly transmitted to the console interface module or the nerve integrity monitoring device.

[0358] 64. A stimulation probe device comprising:

[0359] a first electrode;

[0360] a stimulation module configured to: (i) wirelessly receive a payload signal from a console interface module or a nerve integrity monitoring device, and (ii) provide a voltage or current to the first electrode to stimulate a nerve or muscle in the patient;

[0361] a control module configured to generate a parameter signal indicative of the voltage or the amount of current provided to the electrode; and

[0362] A physical layer module is configured to: (i) up-convert the parameter signal into a first radio frequency signal, and (ii) wirelessly transmit the first radio frequency signal from the stimulation probe to the console interface module or the nerve integrity monitoring device.

[0363] 65. The stimulation probe device of clause 64, wherein:

[0364] The physical layer module is configured to: (i) receive a second radio frequency signal from the console interface module or the neural integrity monitoring device, and (ii) down-convert the second radio frequency signal into a control signal; and

[0365] The stimulation module is configured to provide the voltage or the current to the first electrode based on the control signal.

[0366] 66. The stimulation probe device of clause 65, wherein:

[0367] The second radio frequency signal includes parameters;

[0368] The parameter is a predetermined voltage, a predetermined current, or a predetermined wavelength; and

[0369] The stimulation module is configured to provide the predetermined voltage, the predetermined current, or the signal having the predetermined wavelength to the first electrode.

[0370] 67. The stimulation probe device of clause 64, further comprising a power supply,

[0371] Wherein, the stimulation module is configured to provide the voltage or the current to the first electrode based on power received from the power source.

[0372] 68. The stimulation probe device of clause 64, further comprising a manually operated switch having a first state and a second state, wherein:

[0373] The stimulation module is configured to provide the voltage or the current to the first electrode when the switch is in the first state; and

[0374] The switch is configured to disable providing the voltage or the amount of current to the first electrode when the switch is in the second state.

[0375] 69. The stimulation probe device of clause 64, wherein:

[0376] The physical layer module is configured to wirelessly receive a payload request from the console interface module or the neural integrity monitoring device;

[0377] The stimulation module is configured to: provide the voltage or the current amount as a stimulation pulse to the first electrode based on the payload request; and

[0378] The control module is configured to wirelessly transmit information related to the stimulation pulse to the console interface module or the nerve integrity monitoring device in response to the payload request.

[0379] 70. The stimulation probe device of clause 69, wherein:

[0380] The payload request indicates a data rate; and

[0381] The physical layer module transmits the information related to the stimulation pulses to the console interface module or the nerve integrity monitoring device at the data rate.

[0382] 71. The stimulation probe device of clause 69, wherein:

[0383] The physical layer module is configured to periodically receive a synchronization request from the console interface module or the neural integrity monitoring device; and

[0384] The control module is configured to: (i) select a time slot based on a first one of the synchronization requests, and (ii) transmit a data payload to the console interface module or the neural integrity monitoring device in the selected time slot.

[0385] 72. A neural integrity monitoring system comprising:

[0386] A stimulation probe device as described in clause 64, and

[0387] The console interface module or the neural integrity monitoring device.

[0388] 73. The neural integrity monitoring system of clause 72 further comprises a sensor, wherein the sensor comprises a plurality of electrodes configured to: (i) attach to the patient's muscles, and (ii) receive electromyographic signals from the patient's muscles based on the voltage or the current supplied to the electrodes.

[0389] 74. The neural integrity monitoring system of clause 73, wherein the sensor comprises:

[0390] a second control module connected to the plurality of electrodes, wherein the second control module is configured to: (i) detect the electromyographic signal, and (ii) generate a voltage signal; and

[0391] A second physical layer module is configured to: (i) up-convert the voltage signal into a second radio frequency signal, and (ii) wirelessly transmit the second radio frequency signal from the sensor to the console interface module or the neural integrity monitoring device.

[0392] 75. The neural integrity monitoring system of clause 72 further comprises an endotracheal tube for opening the patient's airway, wherein the endotracheal tube comprises an electrical element, wherein the electrical element is configured to receive electromyographic signals from the patient's muscles based on the voltage or the amount of current supplied to the electrode.

[0393] 76. The neurological integrity monitoring system of clause 72, further comprising an endotracheal tube assembly, the endotracheal tube assembly comprising:

[0394] an endotracheal tube for opening 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 located on the endotracheal tube closer to the proximal end than to the distal end, and wherein the trace extends between the proximal end and the distal end and is configured to receive an electromyographic signal from the patient via the contact based on the voltage or the amount of current supplied to the electrode; and

[0395] A sensing module configured to:

[0396] connecting to the trace and receiving the electromyographic signal via the contact,

[0397] generating a voltage signal based on the electromyographic signal,

[0398] Up-converting the voltage signal into a second radio frequency signal, and

[0399] The second radio frequency signal is wirelessly transmitted from the sensing module to the console interface module or the nerve integrity monitoring device.

[0400] 77. A method of operating a stimulation probe device, the method comprising:

[0401] wirelessly receives payload signals from a console interface module or neural integrity monitoring device;

[0402] providing a voltage or a current to the first electrode;

[0403] generating a parameter signal indicative of the voltage or the amount of current supplied to the electrode;

[0404] Up-converting the parameter signal into a first radio frequency signal; and

[0405] The first radio frequency signal is wirelessly transmitted from the stimulation probe to the console interface module or the nerve integrity monitoring device.

[0406] 78. The method of clause 77, further comprising:

[0407] receiving a second radio frequency signal from the console interface module or the neural integrity monitoring device;

[0408] down-converting the second radio frequency signal into a control signal; and

[0409] Based on the control signal, the voltage or the current is provided to the first electrode.

[0410] 79. The method of clause 78, further comprising providing a predetermined voltage, a predetermined current, or a signal having a predetermined wavelength to the first electrode, wherein:

[0411] The second radio frequency signal includes parameters; and

[0412] The parameter is the predetermined voltage, the predetermined current amount, or the predetermined wavelength.

[0413] 80. The method of clause 77, further comprising providing the voltage or the amount of current to the first electrode based on power received from a power source at a control module.

[0414] 81. The method of clause 77, further comprising:

[0415] providing the voltage or the current to the first electrode when a switch is in a first state, wherein the switch is manually operated and has the first state and a second state; and

[0416] When the switch is in the second state, supply of the voltage or the amount of current to the first electrode is disabled.

[0417] 82. The method of clause 77, further comprising:

[0418] wirelessly receiving a payload request from the console interface module or the neural integrity monitoring device;

[0419] providing the voltage or the amount of current as a pulse to the first electrode based on the payload request; and

[0420] In response to the payload request, information related to the pulse is wirelessly transmitted to the console interface module or the neural integrity monitoring device.

[0421] 83. The method of clause 82, further comprising transmitting the information related to the pulse to the console interface module or the neural integrity monitoring device at a data rate,

[0422] The payload request indicates the data rate.

[0423] 84. The method of clause 82, further comprising:

[0424] periodically receiving a synchronization request from the console interface module or the neural integrity monitoring device;

[0425] selecting a time slot based on a first one of the synchronization requests; and

[0426] A data payload is transmitted to the console interface module or the neural integrity monitoring device in the selected time slot.

[0427] 85. The method of clause 77, further comprising:

[0428] receiving an electromyographic signal at a sensor based on the voltage or the amount of current supplied to the electrode;

[0429] generating a first voltage signal based on the electromyographic signal;

[0430] Up-converting the first voltage signal into a second radio frequency signal; and

[0431] The second radio frequency signal is wirelessly transmitted from the sensor to the console interface module or the nerve integrity monitoring device.

[0432] 86. The method of clause 85, further comprising receiving the electromyographic signal at an electrical element of an endotracheal tube based on the voltage or the amount of current provided to the electrode.

[0433] 87. The method of clause 85, further comprising:

[0434] The myoelectric signal is received via a contact on an endotracheal tube based on the voltage or the amount of current provided to the electrode, wherein the endotracheal tube comprises a proximal end, a distal end, the contact, and a trace, wherein the contact is located on the endotracheal tube closer to the proximal end than to the distal end, and wherein the trace extends between the proximal end and the distal end and is configured to:

[0435] receiving the electromyographic signal from the trace via the contact;

[0436] generating a second voltage signal based on the electromyographic signal;

[0437] up-converting the second voltage signal to generate a third radio frequency signal; and

[0438] The third radio frequency signal is wirelessly transmitted from the sensing module to the console interface module or the nerve integrity monitoring device.

Claims

1. A neural integrity monitoring system comprising: Neural Integrity Monitoring (NIM) equipment; as well as Console Interface Module CIM device; The neural integrity monitoring (NIM) device includes: a NIM control module configured to generate a payload request, wherein the payload request (i) requests a data payload from a sensor in the wireless neural integrity monitoring network and (ii) indicates whether a stimulation probe device is to generate stimulation pulses for nerve and / or muscle monitoring, the stimulation probe device having a housing configured to be movably positioned relative to a patient by a user; and NIM physical layer module, the physical layer module is configured to: transmitting the payload request to the CIM device, and in response to the payload request, (i) receiving the data payload from the CIM device, and (ii) receiving stimulation pulse information from the CIM 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 for nerve and / or muscle monitoring, The CIM equipment includes: a console control module configured to generate a synchronization request including the information in the payload request, wherein the synchronization request (i) requests a data payload from a sensor in the wireless neural integrity monitoring network and (ii) indicates whether a stimulation probe device is to generate stimulation pulses for neural and / or muscle monitoring; and A console physical layer module, the console physical layer module being configured to: wirelessly transmitting the synchronization request to the sensor and the stimulation probe device, and In response to the synchronization request, (i) wirelessly receiving the data payload from the sensor, and (ii) wirelessly receiving stimulation pulse information from the stimulation probe device, The CIM device is separated from the NIM device, and wireless communication is performed between the CIM device and the NIM device via the console physical layer module of the CIM device.

2. The neural integrity monitoring system according to claim 1, wherein: The NIM physical layer module is located away from the CIM device.

3. The neural integrity monitoring system according to claim 1, wherein: The stimulation pulse information includes the amplitude of the stimulation pulse and the duration of the stimulation pulse.

4. The neural integrity monitoring system according to claim 1, wherein: The payload request includes a data rate at which the sensor transmits the data payload to the NIM physical layer module or the CIM device.

5. The neural integrity monitoring system according to claim 1, wherein: The payload request includes a second data rate, and the stimulation probe device transmits the stimulation pulse information to the NIM physical layer module or the CIM device at the second data rate.

6. The neural integrity monitoring system according to claim 1, wherein: The payload request includes slot status words, wherein each of the slot status words indicates whether a slot is allocated to the sensor or another sensor.

7. The neural integrity monitoring system according to claim 1, wherein: The payload request includes a request sequencer bit that indicates at which synchronization interval in a series of synchronization intervals the sensor is to transmit data to the NIM physical layer module or the CIM device.

8. The neural integrity monitoring system of claim 1, wherein: The payload request includes a unique identifier of the sensor or indicates a type of the sensor.

9. The neural integrity monitoring system of claim 1, wherein: The payload request indicates whether each of a plurality of time slots in each of a plurality of synchronization intervals is: available; in the process of being allocated; or designated for the sensor or another sensor.

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

11. The neural integrity monitoring system of claim 1 , wherein: The console physical layer module is separate from and located remotely from the neural integrity monitoring device.

12. The neural integrity monitoring system of claim 10, wherein: The stimulation pulse information includes the amplitude of the stimulation pulse and the duration of the stimulation pulse.

13. The neural integrity monitoring system of claim 1, wherein: The synchronization request includes a time slot status word, wherein each of the time slot status words indicates whether a time slot is allocated to the sensor or another sensor.

14. The neural integrity monitoring system of claim 1, wherein: The synchronization request includes a request sequencer bit that indicates at which synchronization interval in a series of synchronization intervals the sensor is to transmit data to the console physical layer module or the NIM physical layer module.

15. The neural integrity monitoring system of claim 1, wherein: The synchronization request includes a unique identifier of the sensor or indicates a type of the sensor.

16. The neural integrity monitoring system of claim 1 , further comprising: A first sensing module 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) up-convert the first voltage signal into a first radio frequency signal, and (ii) wirelessly transmit the first radio frequency signal based on the payload request signal; wherein the console physical layer module of the CIM device or the NIM physical layer module of the neural integrity monitoring device is further configured to: (i) receive the first radio frequency signal from the first physical layer module, and (ii) down-convert the first radio frequency signal to a baseband signal; and An endotracheal tube assembly, wherein the endotracheal tube assembly comprises: an endotracheal tube for insertion into the airway of the patient, wherein the endotracheal tube comprises a proximal end, a distal end, a contact, and a trace, wherein the contact is located on the endotracheal tube closer to the proximal end than to the distal end, and wherein the trace extends between the contact and the distal end and is configured to receive a second myoelectric 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) up-convert the second voltage signal into a second radio frequency signal, and (iii) wirelessly transmit the second radio frequency signal from the second sensing module to the CIM device or the neural integrity monitoring device.

17. The neural integrity monitoring system of claim 16, 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 CIM device or the neural integrity monitoring device in the time slot.

18. The neural integrity monitoring system of claim 16, further comprising an additional sensing module, wherein: The additional sensing module is attached to the patient with the first sensing module and is configured to generate a plurality of radio frequency signals; The plurality of radio frequency signals include the first radio frequency signal; and The console physical layer module of the CIM device or the NIM physical layer module of the neural integrity monitoring device is further configured to: (i) receive the multiple radio frequency signals from the first physical layer module, and (ii) down-convert the multiple radio frequency signals into baseband signals.

19. The neural integrity monitoring system of claim 18, wherein: The neural integrity monitoring device is configured to display versions of the baseband signal.

20. The nerve integrity monitoring system of claim 16, wherein the stimulation probe device has the housing configured to be movably positioned relative to the patient by a user, the stimulation probe device wirelessly communicating with the CIM device or the nerve integrity monitoring device, wherein: The CIM device or the neural integrity monitoring device is configured to generate a payload request signal; and The stimulation probe device is configured to: (i) wirelessly receive the payload request signal, (ii) generate a stimulation pulse in response to the payload request signal, and (iii) wirelessly transmit information related to the stimulation pulse to the CIM device or the neural integrity monitoring device.

21. The neural integrity monitoring system of claim 16, wherein: The CIM device is configured to: (i) receive the first radio frequency signal from the first physical layer module, and (ii) generate a first digital signal or a first analog signal based on the first radio frequency signal; and The neural integrity monitoring device is configured to receive the first digital signal or the first analog signal from the CIM device.

22. The neural integrity monitoring system of claim 16, wherein: The neural integrity monitoring device is configured to: (i) receive the first radio frequency signal from the first physical layer module, and (ii) generate a first digital signal or a first analog signal based on the first radio frequency signal.

23. The neural integrity monitoring system of claim 16, wherein: The first sensing module includes 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 CIM device or the nerve integrity monitoring device.

24. The neural integrity monitoring system of claim 16, wherein: The CIM device or the nerve integrity monitoring device is configured to: based on the first radio frequency signal, (i) determine heart rate or respiratory rate, or (ii) detect muscle spasm.

25. The neural integrity monitoring system of claim 16, wherein: The first sensing module includes 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 CIM device or the neural integrity monitoring device; and The CIM device or the nerve integrity monitoring device is configured to: based on the acceleration signal, (i) determine heart rate or respiratory rate, or (ii) detect muscle spasm.

26. The neural integrity monitoring system of claim 1, further comprising the sensor comprising: a plurality of electrodes configured to (i) attach to a patient and (ii) receive a first myoelectric signal from the patient to confirm the integrity of a selected nerve in the patient based on the received first myoelectric signal; a sensor control module connected to the plurality of electrodes, wherein the control module is configured to: (i) detect the first electromyographic signal, and (ii) generate a first voltage signal; A sensor physical layer module, the physical layer module being configured to: receiving the payload request from the CIM device or the neural integrity monitoring device, and Based on the payload request, (i) up-converting the first voltage signal into a first radio frequency signal, and (ii) wirelessly transmitting the first radio frequency signal from the sensor to the CIM device or the neural integrity monitoring device; a power module, wherein the power module is configured to: (i) detect a predetermined impedance between the plurality of electrodes, or a predetermined voltage across the plurality of electrodes, and (ii) power on a portion of the sensor control module or a portion of the sensor physical layer module based on the detected predetermined impedance or predetermined voltage; a power supply configured to enable power to be supplied from the power supply to a portion of the sensor control module or a portion of the sensor physical layer module based on the detected predetermined impedance or predetermined voltage; a housing configured to house at least the sensor physical layer module, the power supply, and the power module, and for positioning the plurality of electrodes for removable attachment to a patient; The CIM device or the nerve integrity monitoring device is configured to receive the transmitted first radio frequency signal for monitoring the integrity of the selected nerve.

27. The neural integrity monitoring system of claim 26, wherein: The payload request includes a data rate; The sensor physical layer module is configured to transmit a data payload to the CIM device or the neural integrity monitoring device at the data rate; and The data payload includes data generated based on the first electromyographic signal.

28. The neural integrity monitoring system of claim 26, wherein: The payload request includes a plurality of time slot status words; The sensor control module is configured to: (i) determine a status of a plurality of time slots based on the plurality of time slot status words, and (ii) select one or more of the time slots; and The sensor physical layer module is configured to transmit one or more data payloads in selected one or more of the time slots.

29. The neural integrity monitoring system of claim 28, wherein: The sensor physical layer module is configured to periodically receive a synchronization request signal from the CIM device; There is a synchronization gap between transmissions of consecutive pairs of synchronization request signals of the synchronization request signal; and The sensor physical layer module is configured to transmit a plurality of data payloads in selected one or more of the time slots of the synchronization request signal.

30. The neural integrity monitoring system of claim 26, wherein: The power module is configured to: (i) detect impedance between the plurality of electrodes, and (ii) power on the sensor control module and the sensor physical layer module based on the impedance.

31. The neural integrity monitoring system of claim 30, in, The power module is configured to enable power to be provided from the power supply to the sensor control module or the sensor physical layer module based on the impedance.

32. The neural integrity monitoring system of claim 31, wherein: The power module is configured to power on the sensor control module or the sensor physical layer module if the impedance is less than a predetermined impedance.

33. The neural integrity monitoring system of claim 26, wherein the power module is configured to: (i) detect a voltage across the plurality of electrodes, and (ii) power on a portion of the sensor control module or a portion of the sensor physical layer module based on the voltage.

34. The neural integrity monitoring system of claim 26, wherein the power module is configured to: (i) detect an amount of current received at one of the plurality of electrodes, and (ii) power on a portion of the sensor control module or a portion of the sensor physical layer module based on the amount of current.

35. The neural integrity monitoring system of claim 26, wherein the power module is configured to provide voltage to the control module. in, Based on whether the sensor control module is receiving voltage from the power module, the power module is configured to (i) transition from being off to being in a low power mode or a high power mode, or (ii) transition from being in the low power mode to being in the high power mode.

36. The neural integrity monitoring system of claim 26, wherein: The plurality of electrodes include pin electrodes.

37. The neural integrity monitoring system of claim 26, wherein: The plurality of electrodes include pad electrodes.

38. The neural integrity monitoring system of claim 26, wherein: The sensor control module is configured for connection to contacts on an endotracheal tube.

39. The neural integrity monitoring system of claim 26, wherein: The sensor control module includes a temperature sensor; The temperature sensor is configured to detect temperature and generate a temperature signal; and The sensor physical layer module is configured to wirelessly transmit the temperature signal to the CIM device or the neural integrity monitoring device.

40. The neural integrity monitoring system of claim 26, further comprising an accelerometer configured to generate an acceleration signal. in, The sensor physical layer module is configured to wirelessly transmit the acceleration signal to the CIM device or the neural integrity monitoring device.

41. The neural integrity monitoring system of claim 26, wherein: The plurality of electrodes are attached to patches or pin electrodes; The sensor control module is snapped onto the plurality of electrodes via a connector; The sensor control module is reusable and configured to disconnect from the plurality of electrodes and connect to a second plurality of electrodes; and The patch and the pin electrodes are not reusable.

42. The neural integrity monitoring system of claim 26, further comprising: a front-end circuit connected to the plurality of electrodes; an amplifier module configured to amplify an output of the front-end circuit; a detection module configured to: based on the output of the amplifier module, (i) detect whether the plurality of electrodes are attached to the patient, and (ii) generate an output signal indicating whether the plurality of electrodes are attached to the patient, The sensor control module is configured to generate the first voltage signal based on the output signal.

43. The nerve integrity monitoring system of claim 42, further comprising a timing module configured to periodically wake up and power on the amplifier module and the detection module to check whether the plurality of electrodes are attached to the patient.

44. The neural integrity monitoring system of claim 1, wherein: The NIM physical layer module is further 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.

45. A neural integrity monitoring system comprising: An in vitro stimulation probe device, comprising: an external housing configured for movement relative to a patient and for housing at least: a first electrode; a stimulation module configured to: (i) wirelessly receive a payload signal from a console interface module (CIM) device, wherein the CIM device is separate from a nerve integrity monitoring device, and wirelessly communicate with the nerve integrity monitoring device via a physical layer module of the CIM device, and (ii) provide a voltage or current to the first electrode to stimulate a nerve or muscle in a patient for nerve and / or muscle monitoring; a stimulation probe control module configured to generate a parameter signal indicative of the voltage or the amount of current provided to the electrode; and a stimulation probe physical layer module configured to: (i) up-convert the parameter signal into a first radio frequency signal, and (ii) wirelessly transmit the first radio frequency signal from the stimulation probe device to the CIM device; The neural integrity monitoring system further comprises a sensor, wherein the sensor comprises: a plurality of electrodes configured to: (i) be attached to a muscle of the patient, and (ii) receive an electromyographic signal from the muscle of the patient based on the voltage or the amount of current supplied to the electrodes; a sensor control module connected to the plurality of electrodes, wherein the sensor control module is configured to: (i) detect the electromyographic signal, and (ii) generate a voltage signal; and a sensor physical layer module configured to: (i) up-convert the voltage signal into a second radio frequency signal, and (ii) wirelessly transmit the second radio frequency signal from the sensor to the CIM device, in, The stimulus probe physical layer module is configured to wirelessly receive a payload request from the CIM device; The stimulation module is configured to: provide the voltage or the current amount as a stimulation pulse to the first electrode based on the payload request; The stimulation probe control module is configured to: wirelessly transmit information related to the stimulation pulse to the CIM device in response to the payload request; The payload request indicates a data rate; the stimulation probe physical layer module transmitting the information related to the stimulation pulse to the CIM device at the data rate; The stimulus probe physical layer module is configured to periodically receive a synchronization request from the CIM device; and The stimulation probe control module is configured to: (i) select a time slot based on a first one of the synchronization requests, and (ii) transmit a data payload to the CIM device in the selected time slot.

46. ​​The neural integrity monitoring system of claim 45, wherein: The stimulation probe physical layer module is configured to: (i) receive a second radio frequency signal from the CIM device or the neural integrity monitoring device, and (ii) down-convert the second radio frequency signal into a control signal; and The stimulation module is configured to provide the voltage or the current to the first electrode based on the control signal.

47. The neural integrity monitoring system of claim 46, wherein: The second radio frequency signal includes parameters; The parameter is a predetermined voltage, a predetermined current, or a predetermined wavelength; and The stimulation module is configured to provide the predetermined voltage, the predetermined current, or the signal having the predetermined wavelength to the first electrode.

48. The neural integrity monitoring system of claim 45, further comprising a power source, in, The stimulation module is configured to provide the voltage or the amount of current to the first electrode based on power received from the power source.

49. The nerve integrity monitoring system of claim 45, further comprising a manually operable switch having a first state and a second state, wherein: The stimulation module is configured to provide the voltage or the current to the first electrode when the switch is in the first state; and The switch is configured to disable providing the voltage or the amount of current to the first electrode when the switch is in the second state.

50. The neural integrity monitoring system of claim 45, further comprising: The CIM device and the neural integrity monitoring device.

51. The nerve integrity monitoring system of claim 50, further comprising an endotracheal tube for opening the patient's airway, wherein The endotracheal tube includes an electrical element, wherein the electrical element is configured to receive a myoelectric signal from a muscle of the patient based on the voltage or the amount of current provided to the electrode.

52. A neural integrity monitoring system comprising: a console interface module (CIM) device, the CIM device being separate from the neural integrity monitoring device and communicating wirelessly with the neural integrity monitoring device via a physical layer module of the CIM device; An in vitro stimulation probe device having an in vitro housing configured to be movably positioned relative to a patient by a user, the stimulation probe device comprising: a first electrode; a stimulation module configured to: (i) wirelessly receive a payload signal from the CIM device, and (ii) provide a voltage or current to the first electrode to stimulate a nerve or muscle in the patient for nerve and / or muscle monitoring; a stimulation probe control module configured to generate a parameter signal indicative of the voltage or the amount of current provided to the electrode; and a stimulation probe physical layer module configured to: (i) up-convert the parameter signal into a first radio frequency signal, and (ii) wirelessly transmit the first radio frequency signal from the stimulation probe device to the CIM device; The neural integrity monitoring system further comprises an endotracheal tube assembly, wherein the endotracheal tube assembly comprises: an endotracheal tube for opening 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 located on the endotracheal tube closer to the proximal end than to the distal end, and wherein the trace extends between the proximal end and the distal end and is configured to receive an electromyographic signal from the patient via the contact based on the voltage or the amount of current supplied to the electrode; and A sensing module configured to: connecting to the trace and receiving the electromyographic signal via the contact, generating a voltage signal based on the electromyographic signal, Up-converting the voltage signal into a second radio frequency signal, and wirelessly transmitting the second radio frequency signal from the sensing module to the CIM device, in, The stimulus probe physical layer module is configured to wirelessly receive a payload request from the CIM device; The stimulation module is configured to: provide the voltage or the current amount as a stimulation pulse to the first electrode based on the payload request; The stimulation probe control module is configured to: wirelessly transmit information related to the stimulation pulse to the CIM device in response to the payload request; The payload request indicates a data rate; the stimulation probe physical layer module transmitting the information related to the stimulation pulse to the CIM device at the data rate; The stimulus probe physical layer module is configured to periodically receive a synchronization request from the CIM device; and The stimulation probe control module is configured to: (i) select a time slot based on a first one of the synchronization requests, and (ii) transmit a data payload to the CIM device in the selected time slot.

53. A method of operating an in vitro wireless stimulation probe device having an in vitro housing configured to be movably positioned by a user relative to a patient for nerve and / or muscle monitoring, the method comprising: wirelessly receiving a payload signal from a console interface module (CIM) device, the CIM device being separate from the neural integrity monitoring device and wirelessly communicating with the neural integrity monitoring device via a physical layer module of the CIM device; providing a voltage or a current to the first electrode; generating a parameter signal indicative of the voltage or the amount of current supplied to the electrode; Up-converting the parameter signal into a first radio frequency signal; wirelessly transmitting the first radio frequency signal from the wireless stimulation probe device to the CIM device, receiving an electromyographic signal at a wireless sensor based on the voltage or the amount of current provided to the electrode for nerve and / or muscle monitoring; generating a first voltage signal based on the electromyographic signal; Up-converting the first voltage signal into a second radio frequency signal; wirelessly transmitting the second radio frequency signal from the wireless sensor to the CIM device, wirelessly receiving a payload request from the CIM device; providing the voltage or the current as a pulse to the first electrode based on the payload request; wirelessly transmitting information related to the pulse to the CIM device in response to the payload request; transmitting the information related to the pulse to the CIM device at a data rate, wherein the payload request indicates the data rate; Periodically receiving a synchronization request from the CIM device; selecting a time slot based on a first one of the synchronization requests; and A data payload is transmitted to the CIM device in the selected time slot.

54. The method of claim 53, further comprising: receiving a third radio frequency signal from the CIM device; down-converting the third radio frequency signal into a control signal; as well as Based on the control signal, the voltage or the current is provided to the first electrode for nerve and / or muscle monitoring.

55. The method of claim 54, further comprising providing a predetermined voltage, a predetermined current, or a signal having a predetermined wavelength to the first electrode, wherein: The third radio frequency signal includes parameters; and The parameter is the predetermined voltage, the predetermined current amount, or the predetermined wavelength.

56. The method of claim 53, further comprising providing the voltage or the amount of current to the first electrode based on power received from a power source at a control module.

57. The method of claim 53, further comprising: providing the voltage or the current to the first electrode when a switch is in a first state, wherein the switch is manually operated and has the first state and a second state; and When the switch is in the second state, supply of the voltage or the amount of current to the first electrode is disabled.

58. The method of claim 53, further comprising: The myoelectric signal is received at an electrical component of an endotracheal tube based on the voltage or the amount of current supplied to the electrode.

59. The method of claim 53, further comprising: The myoelectric signal is received via a contact on an endotracheal tube based on the voltage or the amount of current provided to the electrode, wherein the endotracheal tube comprises a proximal end, a distal end, the contact, and a trace, wherein the contact is located on the endotracheal tube closer to the proximal end than to the distal end, and wherein the trace extends between the proximal end and the distal end and is configured to: receiving the electromyographic signal from the trace via the contact; generating a second voltage signal based on the electromyographic signal; up-converting the second voltage signal to generate a third radio frequency signal; and The third radio frequency signal is wirelessly transmitted from the sensing module to the CIM device.

Images