Modular NeuroNet-VII intraoperative neurophysiological monitoring system

12048,551

17/901376

September 01, 2022

The invention provides an advanced, modular, intraoperative neurophysiological monitoring (IONM) system, referred to as a “NeuroNet-VII” System, which is the first IONM system designed with a USB hub architecture comprising serially-connected functional “pods which provides multi-modality simultaneous data acquisition which supports all data types useful in operating rooms, diagnostic laboratories, intensive care units, and epilepsy monitoring units. The unique pod architecture makes the IONM system highly modular compared to current systems which typically place components in a limited number of centralized enclosures. The modular architecture of the invention also provides for real-time collection of data so that information may be communicated with a remotely-located physician; a user needs only to purchase pods that are needed; repair of a single pod may easily be replaced without disabling the entire system; and advances in hardware designs may be implemented for a specific pod without requiring replacement of the entire system.

Sclabassi, Robert Joseph (Gibsonia, PA, US); Bai, Yicheng (Sewickley, PA, US); Herrera, Rafael Eugenio (Pittsburgh, PA, US)

COMPUTATIONAL DIAGNOSTICS, INC (Pittsburgh, PA, US)

1. A modular NeuroNet-VII intraoperative neurophysiological monitoring (IONM) system for use during a surgical procedure on a patient, said system comprising: axon architecture comprising a compute module, a plurality of neuron boards, and a plurality of axon cables; and at least three data acquisition functional modules which provide signal amplification, signal filtering, and analog to digital conversion of electronic signals prior to differencing, at least one electrical stimulation functional module, and at least one audio/visual (A/V) stimulation functional module, each functional module serially interconnected together in any order, each functional module containing one of said plurality of neuron boards, each of said plurality of neuron boards comprising (a) a field programmable gate array (FPGA) chip to control functioning of the functional module, (b) a system-designed USB hub structure comprised of a system-designed USB type C hub and a USB adapter/controller, (c) a module power distribution system, (d) an isolated power module, (e) a digital isolator, (f) a multiplexer circuit, and (g) a function board, wherein said plurality of neuron boards provides bidirectional communication between the serially connected functional modules, (b) manages power distribution to the functional modules, (c) manages data transmission of the functional modules, (d) provides system synchronization of the functional modules, and (e) controls data output from the functional modules, wherein the data acquisition module includes a pin/filter board comprised of a low pass filter with more than −60 dB suppression at 300 kHz and 0 dB at less than 3 kHz, said low pass filter comprised of an inductor-capacitor (LC)-based third order active electrosurgical suppression filter which provides low thermal noise frequency bandpass properties required for continued signal acquisition without saturation during use of an electrosurgery device, wherein said compute module comprises either a core module or comprises a portable laptop with a connected adapter module, said core module further comprised of a base board, a core board, a power supply and a speaker module, said adapter module further comprised of a base board, a power supply and a speaker module, wherein said compute module is configured to be a head, or first, module in the serially connected functional modules, wherein said compute module provides signal processing and computational processing, displays and stores data, provides for data communication with the serially connected functional modules, acquires and integrates data from other devices used during a surgical procedure, and connects to the internet through an ethernet connection or wirelessly, wherein each of said plurality of axon cables has a USB type C receptacle at each end, said USB type C receptacle configured to provide a connection interface to the USB type C hub contained in each neuron board downstream from a first serially connected functional module, and to a standard USB hub contained in the laptop, and to provide a power load and data communication between the base board and a first serially connected functional module, wherein only one of said plurality of axon cables runs from the base board of the NeuroNet-VII IONM system to an operating table, wherein the functional modules may be serially connected in any order with no requirement as to which functional module is serially connected last, wherein the system is configured to allow branching of the functional modules so that up to thirty-one functional modules may be serially connected, wherein the system-designed USB hub structure in each neuron board is configured so that the plurality of serially connected functional modules are recognized by the compute module as USB type C devices and the compute module recognizes where in the serial connection each of the functional modules is located and assigns each of the functional modules a specific identification.

2. The modular NeuroNet-VII IONM system of claim 1 , wherein the core board is an artificial intelligent embedded core-enabled computer board, an embedded digital signal processing core, and an embedded micro-controller core, wherein the core board (a) receives data from the base board and the functional modules, (b) processes, displays and stores the data, (c) manages all computational processes, (d) provides an audio interface for a speaker module having an audio power amplifier (e) includes an ethernet port and (f) includes an embedded wireless module which allows for wireless communication so that the system may be controlled remotely and data may be shown to users.

3. The modular NeuroNet-VII IONM system of claim 2 , wherein the hub structure of the compute module is configured to form up to seven cascading tiers of modules comprising the core board and up to five serially connected functional modules.

4. The modular NeuroNet-VII IONM system of claim 3 , wherein the hub structure comprises seven tiers of modules comprised of Tier 1 through Tier 7, wherein the core board contains Tier 1 and Tier 2, said Tier 1 comprised of a USB root hub directly attached to a USB host controller in a CPU chip in the core module, said Tier 2 comprised of one USB type C hub which connects to the USB root hub in Tier 1, said USB type C hub in Tier 2 providing a port which connects to a second USB type C hub in an adjacent Tier 3 functional module I via an axon cable, said second USB type C hub connecting to a USB adapter contained in Tier 3 and providing a port which connects to a third USB type C hub in an adjacent Tier 4 functional module II via an axon cable, said third USB connecting to a USB adapter contained in Tier 4 and providing a port which connects to a fourth USB type C hub contained in an adjacent Tier 5 functional module III via an axon cable, said fourth USB type C hub connecting to a USB adapter container in Tier 5 and providing a port which connects to a fifth USB type C hub contained in an adjacent Tier 6 functional module IV via an axon cable, said fifth USB type C hub connecting to a USB adapter contained in Tier 6 and providing a port which connects to a USB adapter contained in an adjacent Tier 7 functional module V via an axon cable.

5. The modular NeuroNet-VII IONM system of claim 3 , wherein the hub structure comprised of the portable laptop and the base board of the adapter module also is configured to form up to seven cascading tiers of modules, wherein Tier I comprises the laptop containing a USB root hub attached to a USB host controller in a CPU chip and Tier 2 comprises the base board, wherein because the serially connected functional modules cannot connect directly to a standard USB type C port of a conventional computer, the base board provides a connection interface, said interface comprised of a USB type C port to connect to the Tier 3 through Tier 7 serially connected functional modules via an axon cable and a standard USB type B port to connect to the standard USB type C port of the laptop.

6. The modular NeuroNet-VII IONM system of claim 5 , wherein a switching circuit contained in each of the plurality of neuron boards in each of the functional modules is configured to detect whether an adjacent downstream functional module is plugged in to an adjacent functional module or is the last functional module in the serial connection, wherein when a functional module is determined not to be last in the serial connection, the switching circuit includes both the USB type C hub and the USB adapter in a circuit in that functional module, wherein when the switching circuit detects that a functional module is last in the serial connection, the USB type C hub in the functional module is switched out of the circuit so that only the USB adapter in the last functional module is active which ensures that only five functional modules are serially connected.

7. The modular NeuroNet-VII IONM system of claim 6 , wherein the switching circuit in each neuron board is configured to detect power load and load current on a ground wire in each of the plurality of USB type C axon cables, wherein when one or more functional modules are serially connected downstream to a particular functional module, the power load and the load current of the axon cable and the ground wire is detected by the switching circuit and a detection signal is generated which is used to drive a selection signal on the multiplexer circuit on the neuron board, wherein the multiplexer circuit switches on a connection channel between the USB type C hub and the USB adapter, wherein the switching unit detects no power load or load current in a USB type C axon cable downstream from a functional module that is the last Tier 7 Functional Module V in the serial connection, which has no power load or load current going downstream, so that no detection signal is generated which ensures that only five functional modules are serially connected.

8. The modular NeuroNet-VII IONM system of claim 7 , wherein the system further comprises application software which issues a warning to a user when a sixth serial module is serially connected, said warning alerting the user that the sixth serial module will not function, said application software also issuing a control signal to the switching circuit which functionally disconnects the sixth serial module from the serially connected Tiers 1 through 7.

9. The modular NeuroNet-VII IONM system of claim 1 , wherein the base board provides data concatenation and provides system synchronization to each of the plurality of neuron boards contained in the functional modules, wherein the base board is an FPGA-based multimedia data acquisition board which is configured to acquire data from multiple sources in an operating room, said data comprising video, images, and data from an anesthesia monitor, wherein the data are encapsulated by the FPGA, sent to the core board, and then broadcast for viewing.

10. The modular NeuroNet-VII IONM system of claim 9 , wherein the system synchronization comprises a synchronization protocol which synchronizes, within 63 μsecs, data acquired from a data acquisition functional module from each data sample and stimulus in order to provide near real-time operation and to ensure that all data are aligned for processing, said system synchronization protocol comprising a synchronization clock on the base board which provides a common synchronization signal to each of the plurality of neuron boards in the functional modules so that the base board and the functional modules are running under the same clock, wherein the system synchronization protocol comprises: (a) an Acquire Data command issued by a user, (b) the base board sends a USB system synchronization signal to each of the plurality of neuron boards in the functional modules, (c) each of the plurality of neuron boards in the functional modules receives the synchronization signal and sends a response back to the base board to indicate that the functional modules are ready for system synchronization, (d) the base board sends a digital logic pulse to each of the plurality of neuron boards in the functional modules, (e) each of the plurality of neuron boards in the functional modules detects the digital logic pulse, and (f) each of the plurality of neuron boards in the functional modules resets its internal counter and register so that that all of the functional modules start with a same initial time.

11. The modular NeuroNet-VII intraoperative neurophysiological monitoring system of claim 1 , wherein each data acquisition functional module contains 24 electrodes and the system assigns electrodes of the data acquisition functional module that is first in the serial connection numbers 1 through 24; assigns electrodes of the data acquisition functional module that is second in the serial connection numbers 25 through 48; and assigns electrodes of the data acquisition functional module that is third in the serial connection numbers 49 through 72, wherein one of the at least three data acquisition functional modules need not be the first functional module in the serial connection and the three data acquisition functional modules need not be adjacent to one another.

12. The modular NeuroNet-VII IONM system of claim 1 , wherein each of the at least three data acquisition modules further comprises a pin/filter board, twenty-four channels of amplification with DC drift suppression which supports acquiring data from its twenty-four electrodes, feedback common mode noise suppression signals, differencing between pairs of electrode signals after analog to digital (A/D) conversion, said A/D conversion referred to as digitization, and an organic light-emitting diode (OLED) display board, said data acquisition module capable of acquiring neurophysiological data ranging from 0.1 μvolt to 1000 μvolts in amplitude.

13. The modular NeuroNet-VII IONM system of claim 12 , wherein the digitization is implemented by an analog-to-digital convertor, said analog-to-digital convertor configured to difference different pairs of electrodes from any one of the data acquisition modules to increase ways of presenting data.

14. The modular NeuroNet-VII intraoperative neurophysiological monitoring system of claim 13 , wherein each of the data acquisition modules provides a stimulus artifact blanking and trace restore function controlled by the FPGA chip on its neuron board comprised of an N-channel MOSFET controllable switch which is used to provide a path for a signal to an analog ground, wherein a logic 1 control closes the MOSFET switch and an input terminal of an amplifier is pulled to analog ground, wherein the stimulus artifact blanking and trace restore function allows for data to be acquired without containing contaminating stimulus artifacts and allows for electrical stimulation to be applied adjacent to recording electrodes so that signals are capable of being recorded through the recording electrodes immediately after completion of the electrical stimulation.

15. The modular NeuroNet-VII IONM system of claim 12 , wherein the feedback common mode noise suppression signals comprises utilizing a feedback signal to a patient of a noise component of signals that are being measured, said feedback signal capable of balancing out common mode noise of the twenty-four electrodes.

16. The modular NeuroNet-VII IONM system of claim 12 , wherein three color OLED display screens are utilized in each of the at least three data acquisition modules to display data from each of the at least three data acquisition modules, module number, and identification of the twenty-four electrodes.

17. The modular NeuroNet-VII IONM system of claim 1 , wherein the at least one electrical stimulator module further comprises a stimulator pin board, an extender module board, and three color OLED display screens to display identification of the electrical stimulator module.

18. The modular NeuroNet-VII intraoperative neurophysiological monitoring system of claim 17 , wherein the at least one electrical stimulation module includes a plurality of electrical stimulators to produce a variety of train patterns for stimuli, said variety of train patterns capable of being synchronized to provide simultaneous acquisition of multi-modality electrical evoked potentials, wherein control of the variety of train pattern stimuli is provided by the FPGA chip on the neuron board contained in the electrical stimulation module, wherein the electrical stimulation module provides both constant current mode stimulation and constant voltage mode stimulation, both capable of being used interchangeably for electrical stimulation, wherein the constant current mode stimulation and constant voltage mode stimulation support uniphasic and biphasic electrical stimulation, said uniphasic and biphasic electrical stimulation capable of being used interchangeably for electrical stimulation.

19. The modular NeuroNet-VII IONM system of claim 1 , wherein the at least one audio/visual stimulator module further comprises an audio/visual stimulation board, three color OLED display screens to display identification of the audio/visual stimulator module, output to ear buds for auditory stimulation, and output to a video graphic array (VGA) monitor or goggles for visual stimulation, wherein visual stimulation by the VGA monitor is driven through a VGA full color range encoder chip, wherein patterns are predefined with different colors, textures, intensities, and flashing frequencies to produce a variety of patterns and frequencies, wherein the full color range visual stimulation with the variety of patterns and frequencies allows the IONM system to produce complicated visual-related evoked potential signal monitoring, wherein control of the variety of patterns and frequencies is provided by the FPGA chip on each of the plurality of neuron boards.

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