Stimulation system

The automated facilitated MEP system addresses the challenges of costly and limited resources in MEP monitoring by optimizing MEP stimulation sequences and reducing patient movement, resulting in improved accuracy and safety during surgery.

JP2025516830AInactive Publication Date: 2025-05-30ALPHATEC SPINE INC
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Patent Information

Application Number
JP2024568596
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-05-19
Filing Date
2023-05-17
Publication Date
2025-05-30
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

Current methods for monitoring motor evoked potentials (MEPs) during surgery are hindered by the need for specialized personnel and equipment, which can be costly and limited in availability. Additionally, cranial stimulation for MEPs often causes significant patient movement, interrupting surgery and potentially leading to injury.

Method used

A system and method for detecting physiological responses using automated or semi-automated facilitated MEP, involving the transmission of stimulation pulses to peripheral or cranial nerves to optimize MEP stimulation sequences and reduce patient movement, thereby improving the accuracy and efficiency of MEP detection.

Benefits of technology

The system reduces the need for specialized personnel and equipment, minimizes surgical interruptions, and enhances the accuracy and speed of detecting physiological responses, thereby reducing the risk of patient injury during surgery.

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Abstract

A method for promoting the acquisition of motor evoked potentials (MEP) can include promoting an MEP stimulation sequence to acquire MEP. Promoting can include transmitting a first stimulation pulse to one or more peripheral nerves of a patient. The method can also include, after promotion, transmitting the MEP stimulation sequence to one or more cranial nerves of the patient to acquire MEP. The method can also include determining that a physiological response has occurred based on the MEP. The method can also include indicating that a physiological response has occurred. Promoting can reduce the intensity of the stimulation pulse train of the MEP stimulation sequence, limit the movement of the patient to the region of interest during the transmission of the MEP stimulation, and improve the accuracy of determining that a physiological response has occurred.
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Description

Technical Field

[0001] The subject matter described in this specification generally relates to patient monitoring and clinical neurophysiology, and more particularly to a stimulation system for detecting and discriminating a patient's physiological response using automated facilitated motor evoked potentials.

Background Art

[0002] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 343,941, titled "Stimulation System," filed on May 19, 2022, which is hereby incorporated by reference in its entirety.

[0003] Monitoring a patient by recording waveforms in response to stimuli transmitted to the patient during surgery enables early identification and prevention of impending injuries such as nerve or spinal cord damage. In particular, during intraoperative monitoring for spinal cord and other types of surgery, motor evoked potentials ("MEPs") can be recorded to ensure the integrity of the descending motor pathways. For example, during spinal surgery, stimulation can be applied to the patient's skull to help ensure that the patient's descending motor nerves are not damaged and that the motor function of the patient's limbs is not damaged. However, unfortunately, such responses can be affected by external factors such as the level of anesthesia or the use of paralytic agents that require subjective interpretation by an expert. Generally, a highly trained technician under the supervision of a physician monitors the patient to determine when MEPs should be obtained during the ongoing surgery and uses high-performance multi-channel amplifiers and display equipment to determine based on the results of the MEPs whether the stimulation has produced a sufficient physiological response. However, unfortunately, such specialized personnel and equipment can be costly, their availability may be limited, and / or they may require advance reservation. Such personnel may also need to manually optimize and modify the stimulation parameters and may subjectively analyze the waveforms in a stressful situation, thereby reducing the accuracy, speed, objectivity, and efficiency in detecting a physiological response or a change in the physiological response, and thus potentially increasing the risk of injury to the patient during surgery.

[0004] Cranial stimulation to obtain MEP can also interrupt the surgery and even damage the patient. For example, cranial stimulation to obtain MEP generally causes significant unwanted movements in all of the patient's limbs, body, jaw, etc. Such movements would require the surgeon to stop the execution of the surgery while the stimulation is being applied, so the surgery is interrupted and the surgery may be prolonged. As a result, the frequency of the test may decrease, and thus the effectiveness of the test may decrease. Such movements can also cause the patient's jaw to close strongly, resulting in oral injury to the patient. To obtain the desired physiological response, cranial stimulation often applies a very high voltage, which can also be harmful to the patient. Furthermore, obtaining MEP can increase the rate of false positive warnings or false negative warnings. In other words, MEP often leads to incorrect detection of changes in the physiological response to cranial stimulation or the reasons for the changes. Therefore, even when it is desirable to obtain MEP during spinal surgery, this often interrupts the surgery and may lead to insufficient utilization. In addition, the effects of anesthesia or anesthetic drugs when obtaining a consistent waveform, as well as subjective interpretation and manual implementation, can lead to errors.

Prior Art Documents

Non-Patent Documents

[0005]

Non-Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0006] A system, method, and manufactured article are provided that include a computer program product for detecting a physiological response using automated or semi-automated facilitated MEP.

Means for Solving the Problems

[0007] According to some aspects, the method includes facilitating an MEP stimulation sequence to facilitate obtaining an MEP. Facilitating includes transmitting a first stimulation pulse to one or more peripheral or cranial nerves of a patient via a first stimulation electrode. The one or more peripheral or cranial nerves can be located within the region of interest. The first stimulation electrode can be coupled to the patient within the region of interest. The method can include, after facilitating, transmitting an MEP stimulation sequence to one or more regions of the patient's scalp or skull to obtain an MEP response via a second stimulation electrode. The MEP stimulation sequence includes one or two trains of stimulation pulses. The second stimulation electrode is coupled to the patient's scalp. The method can also include determining whether a physiological response has occurred based on the MEP results. The method can also include indicating that a physiological response has occurred via a display coupled to the first and second stimulation electrodes. Facilitating is configured to perform one or more of optimizing the intensity or number of pulses of one or more trains of stimulation pulses of the MEP stimulation sequence, restricting the patient's movement to the region of interest during transmission of the MEP stimulation, and improving the accuracy of determining whether a physiological response has occurred.

[0008] In some aspects, the first stimulation pulse includes a single stimulation pulse.

[0009] In some embodiments, transmitting the first stimulus pulse to one or more peripheral nerves of a patient is configured to be transmitted by an independent stimulator or a stimulator used for somatosensory evoked potential (SSEP) stimulation.

[0010] In some embodiments, the method includes transmitting a preceding MEP stimulation sequence to the patient's skull via a second stimulation electrode prior to facilitation. The second MEP stimulation sequence includes a second train of stimulus pulses.

[0011] In some embodiments, the preceding MEP stimulation sequence is transmitted by an inter-train interval prior to the MEP stimulation sequence. Facilitation is performed during the inter-train interval.

[0012] In some embodiments, the method includes transmitting an MEP sequence during a period after facilitation of the MEP stimulation sequence.

[0013] In some embodiments, this period is pre-determined.

[0014] In some embodiments, this period is dynamically adjusted based on one or more parameters of the patient and / or the type of surgery being performed on the patient.

[0015] In some embodiments, facilitation is automatically performed during a period prior to transmitting the MEP stimulation sequence.

[0016] In some embodiments, facilitation is manually initiated prior to transmitting the MEP stimulation sequence.

[0017] In some embodiments, facilitation is automatically initiated by the system in response to one or more inputs from an SSEP monitoring system, an EMG monitoring system, a heart rate monitoring system, a blood pressure monitoring system, an anesthesia level monitoring system, and / or other patient monitoring systems.

[0018] In some embodiments, one or more of the SSEP monitoring system, the EMG monitoring system, the heart rate monitoring system, the blood pressure monitoring system, the anesthesia level monitoring system, and other patient monitoring systems are included within or are part of the stimulation system claimed herein.

[0019] In some embodiments, the MEP includes one or more waveforms.

[0020] In some embodiments, the processor stores the MEP as a baseline waveform.

[0021] In some embodiments, determining includes comparing one or more waveforms of the MEP to a baseline waveform.

[0022] In some embodiments, determining whether a physiological response has occurred includes comparing one or more features of the MEP to a threshold value and / or detecting the presence of a physiological response when one or more features are greater than or equal to the threshold value.

[0023] In some embodiments, determining whether a physiological response has occurred includes comparing one or more features of the MEP to a threshold value and / or detecting the presence of a physiological response when one or more features are less than or equal to the threshold value.

[0024] In some embodiments, the method includes an SSEP stimulation / acquisition system configured to facilitate an MEP stimulation sequence. The SSEP stimulation / acquisition system can be configured to acquire one or more SSEPs during or prior to delivery of a first MEP stimulation pulse. The MEP acquisition system can be configured to deliver an MEP stimulation sequence.

[0025] In some embodiments, the MEP acquisition system includes stimulation electrodes and recording electrodes.

[0026] In some embodiments, the second stimulation electrode includes four or more electrodes.

[0027] In some embodiments, the method can be performed by an MEP detection system for detecting and discriminating a patient's physiological response. The method can include using a first stimulation sequence to stimulate one or more regions of the patient's scalp or skull via a first stimulation electrode coupled to the patient. Stimulating can be configured to generate an MEP. The method can include recording a first plurality of resultant waveforms via a first recording electrode coupled to the patient. The first plurality of resultant waveforms can represent an adjusted MEP.

[0028] The method can also include using a second stimulation sequence to stimulate one or more peripheral or cranial nerves of the patient via a second stimulation electrode coupled to the patient. The method can also include recording a second plurality of resultant waveforms via the first recording electrode coupled to the patient. The second plurality of resultant waveforms can represent a facilitated MEP.

[0029] The method can also include using a third stimulation sequence to stimulate one or more regions of the patient's scalp or skull via the first stimulation electrode. Stimulating can be configured to generate an MEP. The method can also include recording a third plurality of resultant waveforms via the first recording electrode. The third plurality of resultant waveforms can represent an MEP.

[0030] The method can also include determining whether a physiological response has occurred based on the first, second, or third plurality of resultant waveforms. The method can also include indicating whether a physiological response has occurred via a display coupled to the first and second stimulation electrodes.

[0031] In some embodiments, the first stimulation sequence includes a first plurality of stimulation pulses. The second stimulation sequence includes a single or two stimulation pulses. The third stimulation sequence includes a second plurality of stimulation pulses.

[0032] In some embodiments, the first stimulation sequence is configured to condition or prepare one or more regions of the brain to obtain a conditioned MEP.

[0033] In some embodiments, the second stimulation sequence is configured to obtain a facilitated MEP.

[0034] In some embodiments, the third stimulation sequence is configured to obtain an MEP.

[0035] In some embodiments, the first stimulation electrode is coupled to the patient's scalp. The second stimulation electrode is coupled to the patient's peripheral region of interest or cranial nerve region. The peripheral region of interest includes one or more of the patient's limbs, hands, wrists, legs, and feet. The cranial nerve region includes one or more regions of the face.

[0036] In some embodiments, the first stimulation sequence is transmitted prior to the third stimulation sequence separated by an inter-train interval. The second stimulation sequence is performed during the inter-train interval to obtain conditioned and facilitated MEPs.

[0037] In some embodiments, the first stimulation sequence is omitted, but the second and third sequences are transmitted to obtain a facilitated MEP.

[0038] In some embodiments, the second stimulation sequence can be transmitted prior to the first and third stimulation sequences.

[0039] In some embodiments, the second stimulation sequence can be transmitted simultaneously or rapidly sequentially to two or more peripheral regions of interest or cranial nerve regions of the patient. The peripheral region of interest includes one or more of the patient's limbs, hands, wrists, legs, and feet. The cranial nerve region includes one or more regions of the face.

[0040] In some embodiments, the method includes stimulating using the third stimulation sequence during a period after stimulating using the second stimulation sequence to obtain a facilitated MEP.

[0041] In some embodiments, this period is determined in advance.

[0042] In some embodiments, this period is dynamically adjusted based on one or more parameters of the patient and / or the type of surgery being performed on the patient.

[0043] In some embodiments, stimulating using a second stimulation sequence is automatically performed at a predetermined time between stimulation using a first stimulation sequence and stimulation using a third stimulation sequence in order to obtain a facilitated MEP.

[0044] In some embodiments, determining comprises comparing a plurality of waveforms to a baseline waveform.

[0045] In some embodiments, determining whether a physiological response has occurred comprises comparing one or more features of the MEP to a threshold value and detecting the presence of a physiological response when one or more of the features are above the threshold value. The threshold value can include, but is not limited to, amplitude, morphology, reaction time, signal-to-noise ratio, or an automated waveform detection classification algorithm.

[0046] In some embodiments, determining whether a physiological response has occurred comprises comparing one or more features of the MEP to a threshold value and detecting the presence of a physiological response when one or more of the features are below the threshold value. The threshold value can include, but is not limited to, amplitude, morphology, reaction time, signal-to-noise ratio, or an automated waveform detection classification algorithm.

[0047] In some embodiments, a second stimulation electrode coupled to the patient can be utilized as the first stimulation electrode of one or more stimulation electrodes also used for SSEP to deliver a second stimulation sequence.

[0048] According to some aspects, a method of detecting and discriminating a first physiological response can include obtaining one or more first SSEPs. Obtaining can include stimulating one or more peripheral or cranial nerves of a patient in an area of interest via a first stimulating electrode. Then, by various means, it is determined whether the somatosensory evoked potential has changed from a previous acquisition. Then, automatically obtaining a motor evoked potential (MEP) can include stimulating one or more areas of a patient's scalp or skull via a second stimulating electrode. The method can include determining, based on the MEP, whether a change in the SSEP physiological response is accurate. The MEP response indicates one or both of whether the patient has motor function in the area of interest and the degree thereof. The method can include indicating that a physiological response has occurred via a display coupled to the first and second stimulating electrodes.

[0049] The method includes obtaining one or more second SSEPs. The obtaining step includes stimulating one or more peripheral nerves of the patient via the first stimulating electrode. The one or more second SSEPs indicate the continuity of the sensory nerve pathway.

[0050] Embodiments of the present subject matter can include articles comprising a tangible, machine-readable medium operable to cause a method consistent with the description provided herein and one or more machines (e.g., a computer, etc.) to perform one or more of the described features or to perform operations that cause one or more of the described features to be performed. Similarly, a computer system can be described that includes one or more processors and one or more memories coupled to the one or more processors. The memory can include a non-transitory computer-readable or machine-readable storage medium and can include, encode, store, etc., one or more programs that cause the one or more processors to perform one or more of the operations described herein. A computer-implemented method consistent with one or more embodiments of the present subject matter can be implemented by one or more data processors resident in a single computing system or multiple computing systems. Such multiple computing systems can be connected via one or more connections, including, for example, connections via a network (e.g., the Internet, a wireless wide area network, a wireless peer-to-peer network, a local area network, a wide area network, a wired network, etc.), connections via a direct connection between one or more of the multiple computing systems, etc., and can exchange data and / or commands or other instructions, etc. The present embodiments can take into account or further utilize other methods of generating an optimized MEP response, including multipolar stimulation (4-pole, 6-pole, etc.).

[0051] Details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings and from the claims. The claims that follow this disclosure are intended to define the scope of the protected subject matter.

[0052] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate specific embodiments of the subject matter disclosed herein and, together with the description, help to explain some of the principles associated with the disclosed embodiments.

Brief Description of the Drawings

[0053]

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Modes for Carrying Out the Invention

[0054] In practice, similar reference numerals indicate similar structures, features, or elements.

[0055] Monitoring a patient by recording waveforms in response to stimuli transmitted to the patient during surgery enables early identification and prevention of impending injuries such as nerve or spinal cord injuries. This can include measuring muscle responses distally while stimulating proximally at the head or spinal cord (central nervous system) (general motor nerve pathway monitoring), or stimulating peripherally and measuring responses more proximally via the central nervous system (general sensory nerve pathway monitoring).

[0056] Generally, the pyramidal tract nervous system is the motor system tested during intraoperative nerve monitoring. The pyramidal tract nervous system includes two main sets of motor neurons, upper motor neurons (UMNs) and lower motor neurons (LMNs). The excitability of UMNs and LMNs, or their likelihood of responding to stimulation, is regulated by inputs to the stimulation system from central sources (e.g., the brain, spinal cord, cerebellum, etc.) and peripheral sources (e.g., sensory sensors).

[0057] Somatosensory evoked potentials (SSEPs) can include electrical signals generated by the patient's nervous system in response to electrical stimuli applied to the patient's periphery or cranial nerves, enabling a direct and ongoing test of ascending sensory nerve pathways (e.g., the posterior columns of the spinal cord), which is effective in certain surgeries. However, the main motor nerve pathways within the spinal cord receive their blood supply from a different source, namely the anterior spinal artery. Thus, if an injury is located only in the anterior spinal artery network, SSEPs may remain unchanged while significant motor nerve pathway dysfunction occurs. Motor evoked potentials (MEPs) typically include electrical signals generated by the patient's nervous system in response to electrical or magnetic stimuli applied to the skull or brain, enabling a direct test of the somatic motor nerve pathway that indicates whether the patient has the ability to move areas of interest such as the patient's extremities (e.g., arms, legs) and / or extremities (e.g., hands, wrists, feet, etc.) or face. Therefore, monitoring MEPs during surgery can help prevent damage to the nerves that control the patient's motor function.

[0058] During intraoperative monitoring for spinal surgery, MEP can be recorded to ensure the integrity of the descending motor pathways. These can include one or more series of stimuli, each of which can include one or more stimuli. The stimulation systems described herein can provide stimulation and acquisition of facilitated MEP. For example, the stimulation systems described herein can stimulate one or more peripheral or cranial nerves of a patient before or during a series of stimuli to one or more cranial positions of the patient to obtain MEP. Such stimulation requires precise timing between peripheral stimulation followed by central stimulation or a series of stimuli. Incorrect or inappropriate intervening times can have the opposite effect and may result in suppression rather than enhancement of the resulting MEP response. In addition, this timing varies somewhat between patients and recording sites.

[0059] The intervening time between peripheral or cranial nerve stimulation and cranial stimulation or a series of stimuli can be automatically determined or optimized by calculation using one or more of the patient's height, SSEP reaction time from the same or adjacent peripheral stimulators, reaction time from un-facilitated MEP cranial stimulation, or by measuring the suppression or facilitation of movement from a specifically pre-selected intervening time.

[0060] The stimulation intensity required to obtain facilitated MEP is typically less than the stimulation intensity for un-facilitated MEP and can be induced to provide a response in a particular aspect of interest or limb. This can be used in conjunction with other methods to reduce the overall stimulation intensity, such as an additional series of cranial stimulation, multipolar cranial stimulation, or image-guided cranial stimulation. Its use can also be adjusted according to the type, dosage, and duration of anesthesia and paralytic agents being used.

[0061] For example, by first stimulating one or more peripheral nerves to promote MEP stimulation and acquisition, the need for a technician in the operating room can be reduced. This is because it can reduce interruptions during surgical procedures, reduce patient movement during MEP acquisition, reduce the voltage of the stimulus applied to the patient during MEP acquisition, direct stimulation only to anatomical regions of risk or interest, enable more frequent testing to reduce the time between change detections, reduce false positives and / or false negatives in physiological response detection, and enable a better trend of MEP responses.

[0062] MEP activates the pyramidal tract nervous system by stimulating upper motor neurons and recording the resulting electrical waveforms from the muscles. The stimuli for MEP are divided into two categories: electrical and magnetic, called transcranial electrical MEP (TSE-MEP, or sometimes TceMEP) or transcranial magnetic MEP (TSM-MEP, or sometimes TcmMEP). This stimulation causes the upper motor neurons to produce a descending volley of depolarization generated internally, which in turn activates the lower motor neurons via intervening neuron synapses, thereby activating the patient's muscles at the neuromuscular junction (NMJ). Stimulation of the brain through one or more cranial regions, etc., can induce three types of responses: (1) the D wave representing direct activation of the motor cortex and direct recording from the spinal cord, (2) the I wave recorded from the spinal cord and resulting from cortical intervening neuron responses, and (3) the M wave recorded from muscle activation. Therefore, volley suppression can occur in the descending UMN conduction pathway, the synapse from UMN to LMN or intervening neurons, the LMN conduction pathway or supplied nerves, the NMJ, or the muscle itself, etc.

[0063] Generally, the stimulating electrode is positioned on one or more parts of the patient's scalp or skull, under which the motor cortex containing the representation of the area of interest is located. The stimulating electrode transmits the stimulation to the skull. The stimulation can be a constant voltage and / or a constant current, and can include a train of stimulation pulses including a plurality of stimulation pulses. Due to this stimulation, using an electrical or myogenic sensor, the MEP response is recorded as a compound muscle action potential (CMAP). MEP is generally obtained before and / or after a risky surgical procedure to ensure that the patient maintains the motor function of the area of interest in the patient, but is most useful when recorded more frequently, enabling more timely identification of changes.

[0064] The use of MEP can present certain advantages compared to the use of SSEP. For example, MEP directly measures the corticospinal nerve pathway, provides instantaneous results without the need to average waveforms, is less susceptible to interference from peripheral neuropathy, and is less affected by electrical noise than SSEP. However, MEP can be used together with SSEP, or when SSEP is not available, MEP can be difficult to rely on because the test is inherently intermittent, is susceptible to the effects of certain anesthetics and paralytic agents, and tends to interrupt the surgical procedure. For example, to record MEP, a high-voltage stimulation is generally applied to the patient's skull or other areas of the central nervous system. This can cause significant unwanted patient movements in parts of the patient's body that are not areas of interest for monitoring, including most of the patient's body such as the patient's limbs, extremities, neck, jaw, etc. This poses a risk to the patient. The patient may experience unwanted neck flexion during a neck surgery, for example. The patient's jaw may close strongly, resulting in oral injury. Such movements can significantly interrupt the surgery. Therefore, when MEP is desired, the surgeon often pauses the surgery due to the significant unwanted patient movements associated with MEP collection. As a result, the surgeon may become negative about performing MEP collection.

[0065] Furthermore, MEP may have other drawbacks. For example, trained technicians such as those who have received training under the supervision of a physician may need to be present to monitor the patient during surgery using high-performance multi-channel amplifiers and display devices. Such personnel and equipment can be costly, their availability may be limited, or prior reservation may be required. Personnel are also prone to subjectivity when analyzing waveforms in a stressful situation, reducing the accuracy, speed, and efficiency in generating a valid MEP to detect changes in physiological responses, thus leading to undesirable interruptions or even an increase in damage to the patient during surgery. Such systems may also rely on technicians to warn the surgeon to stop the surgery before stimulating the patient to obtain MEP. Subjectively monitoring the signals in real time can lead to the possibility of false alarms and / or misidentifying the patient's physiological responses, increasing the risk of damage to the patient during surgery. MEP is also very susceptible to the effects of some anesthetic agents, which may cause unexpected changes or changes that are difficult to distinguish from tissue dysfunction due to the surgery itself. Generally, MEP may lead to detection delays or false positive detections of a number of physiological responses.

[0066] MEP also provides only snapshots of electrical waveforms rather than continuous data. Therefore, it may be difficult to obtain an accurate description of the patient's nervous system state between different MEP acquisitions.

[0067] The stimulation systems described herein can provide facilitated MEP stimulation. In other words, the stimulation system can deliver stimulation to one or more peripheral or cranial nerves of a patient before, during, or between deliveries of stimulation to one or more cranial stimulators of the patient to obtain an MEP. As described herein, such facilitated MEP stimulation can desirably induce a muscle response evoked in a region of interest of the patient's body where one or more peripheral nerves are stimulated. Such induction can be automatically applied according to the type of surgery or anatomical location and the nerve structures at risk. Such facilitated MEP stimulation described herein can, additionally and / or alternatively, reduce the overall stimulation intensity or number of stimulations delivered to the patient's scalp, brain, or skull because the stimulation is focused on the region of interest. The systems described herein can automatically calculate the relationship between the un-facilitated MEP and the facilitated MEP in order to accurately determine appropriate warning criteria for changes in the facilitated MEP. The facilitated MEP stimulation described herein can, additionally and / or alternatively, enable more frequent MEP testing to be automatically activated by a surgeon and / or after changes in SSEP or other modalities in order to affirm or negate significant new or impending injury, thereby providing the surgeon with continuous information.

[0068] The advanced MEP stimulation system described herein can, additionally and / or alternatively, reduce the interruption of surgical procedures. For example, by reducing patient movement, it becomes unnecessary to stop the surgical procedure to obtain MEP, resulting in more frequent testing and a quicker and safer surgical procedure. The advanced MEP stimulation described herein can, additionally and / or alternatively, reduce false positives and / or false negatives when detecting physiological responses. For example, by automating the facilitation of MEP stimulation and the transmission of MEP stimulation, the need for a technician to manually initiate MEP detection can be reduced or eliminated. Further, in the most difficult cases, such as when false positive or false negative results occur and the surgeon has to resort to waking the patient to determine whether the patient has motor function in the area of interest, the advanced MEP stimulation described herein can detect the physiological response more accurately and reduce or eliminate such cases.

[0069] As described herein, the stimulation system can identify one or more patient physiological responses (e.g., patient motor function or motor response) from the recorded waveforms and, using information from other EPs, determine when it is necessary to clarify, by MEP stimulation, a change in one of those modalities or the significance of the inability to obtain a response from one of those modalities. The patient physiological response can include one or more evoked potentials (EPs), particularly somatosensory evoked potentials (SSEPs), auditory evoked potentials (AERs), motor evoked potentials (MEPs), brainstem auditory evoked potentials (BAEPs), and / or visual evoked potentials (VERs). An EP can include any potential recorded from the nervous system resulting from applying a stimulus to a part of the patient's body. For example, an EP can include a voltage-versus-time signal obtained by ensemble averaging the electrophysiological responses to repetitive stimulation of the specific sensory nervous system detected using suitable electrodes. In some cases, the electrophysiological response is not ensemble averaged if the signal-to-noise ratio is better.

[0070] FIG. 1 shows a system diagram illustrating a stimulation system 100 according to some exemplary embodiments. Referring to FIG. 1, the stimulation system 100 can include a display 54, a client device 99, an identification controller 102, a database 125, a response identification device 101, an SSEP acquisition system 104, and / or an MEP acquisition system 106. In some exemplary embodiments, the display 54, the client device 99, the identification controller 102, the SSEP acquisition system 104, the MEP acquisition system 106, and / or the database 125 can form a part of the response identification device 101 and / or can be positioned within the housing of the response identification device 101.

[0071] Referring to FIG. 1, the response identification device 101, the display 54, the client device 99, the identification controller 102, the SSEP acquisition system 104, the MEP acquisition system 106, and / or the database 125 can be communicatively coupled via the network 150 and / or a direct device connection, as described herein. The link or network 150 can be a wired and / or wireless network including, for example, a public land mobile network (PLMN), a local area network (LAN), a virtual local area network (VLAN), a wide area network (WAN), the Internet, a short-range wireless connection such as Bluetooth®, a peer-to-peer mesh network, and the like.

[0072] The client device 99 can be a mobile device such as, for example, a smartphone, a laptop computer, a tablet computer, a wearable device, etc. However, it should be understood that the client device 99 can be any processor-based device including, for example, a desktop computer, a laptop or mobile computer, a workstation, etc. For example, via the client device 99, a clinician can configure specific parameters of the response identification device 101 such as a stimulation sequence or intensity, a response recording protocol, etc. In some embodiments, the client device 99 forms part of the response identification device 101. Additionally, in some examples, via the client device 99, a user can configure various stimuli or protocols, etc.

[0073] Referring to FIG. 2, the stimulation system 100 can include a response identification device 101, one or more recording electrodes 110 and / or one or more stimulation electrodes 120 coupled to the patient 10, and a display 54.

[0074] Referring to FIG. 2, the response identification device 101 of the stimulation system 100 can include an integrated portion for various modalities including, but not limited to, MEP and SSEP, and a response identification controller that enables such integration.

[0075] The stimulation electrodes 120 can be positioned over peripheral nerve structures such as the ulnar nerve, median nerve, peroneal nerve, saphenous nerve, and / or posterior tibial nerve around or near the patient's arm or leg, and on the scalp or skull to transmit central stimulation.

[0076] The stimulating electrode 120 can be intended to be placed on the skin of the patient's wrist and / or ankle, and thus these electrodes can be placed on, for example, the ulnar nerve and the posterior tibial nerve, and on or near the scalp or skull to transmit central stimulation. These configurations, such as for obtaining SSEPs, enable complete patient monitoring of the peripheral nerves and sensory conduction pathways, such as monitoring the nerves of all four limbs and the posterior columns of the spinal cord of patient 10. In some embodiments, the stimulation system 100 can be used for monitoring the upper limbs. In such embodiments, the stimulating electrode 120 can be intended to be placed on the skin of the patient's wrist, for example, on or near the ulnar or median nerve. These configurations enable complete patient monitoring of the sensory system, such as for obtaining SSEPs and detecting the sensory functions of the patient's limbs, extremities, arms, legs, feet, hands, wrists, necks, faces, etc.

[0077] In some embodiments, for obtaining MEPs, etc., the stimulating electrode 120 can be positioned over a neural structure such as the motor cortex on the patient's skull. The stimulating electrode 120 can be intended to be placed on the patient's skin on the patient's scalp or skull. These configurations enable complete patient monitoring of the pyramidal tract motor system, such as for obtaining MEPs and detecting the motor functions of the patient's limbs, extremities, arms, legs, feet, hands, wrists, necks, faces, etc.

[0078] The recording electrode 110 can be positioned on the patient 10's torso, spine, neck, and / or head to record signals from the peripheral nerves or the brain. In some embodiments, the recording electrode 110 is intended to be placed on the skin over the patient 10's trunk muscles or facial muscles. In some embodiments, the recording electrode 110 can be positioned over the muscles, particularly those muscles related to the nerve level near where the surgical procedure is performed.

[0079] In some embodiments, the stimulating electrodes can be placed on both the skull and near it, but only one set of recording electrodes is placed on or near the muscle of interest.

[0080] As shown in FIG. 2, the reaction identification device 101 can be coupled to the recording electrode 110 and the stimulating electrode 120 via a plurality of cables 130 and the like. The reaction identification device 101 can also be electrically, electronically, and / or mechanically coupled to the display 54 via a link 150 and the like. The link 150 can include internal wiring and / or external cables. In some embodiments, the link 150 is a wireless communication link. For example, the reaction identification device 101 can be wirelessly coupled to the display 54 via Bluetooth® or other radio frequency signals, or via short-range communication or cellular signals.

[0081] The SSEP acquisition system 104 of the reaction identification device 101 can apply an electrical stimulus to the patient's peripheral nerves by transmitting an electrical signal to the stimulating electrode 120 located on some or all of the patient's limbs or cranial nerves. By repeating the stimulation, a response of the patient's nervous system can be elicited in the form of a physiological response such as an EP, and this response travels from the peripheral or cranial nerves to the brain, for example, through the spinal column of the spinal cord. The EP can be detected, and changes in the monitored EP can indicate changes in nerve function. For example, the recording electrode 110 can receive one or more resultant electrical waveforms in response to a stimulus being provided to the patient 10 via the stimulating electrode 120. The reaction identification device 101 can detect changes (such as changes in reaction time, amplitude, or morphology) within the EP (e.g., via the SSEP acquisition system 104). Based on the observed changes, the reaction identification device 101 can identify potential damage caused by, for example, the physical position of the patient's body, the action of the procedure being performed, the stimulus transmitted to the patient, etc. (e.g., via the SSEP acquisition system 104). In some embodiments, the reaction identification device 101 can identify a specific nerve structure or body region affected by a positioning action or stimulus based on the EP (e.g., via the SSEP acquisition system 104). The reaction identification device 101 can recommend measures for reducing damage (e.g., via the SSEP acquisition system 104) by recommending a change in position, as an additional and / or alternative method, via the display 54 and the like.

[0082] The MEP acquisition system 106 of the reaction identification device 101 can apply electrical stimulation to a patient by transmitting an electrical signal to a stimulation electrode 120 positioned on the patient's skull or scalp. By repeating the stimulation, a response of the patient's nervous system can be elicited in the form of a physiological response such as an EP, which travels through the nervous system to at least the area of interest or where there is a risk of patient injury. The EP can be detected, and changes in the monitored EP can indicate changes in nervous system function. For example, the recording electrode 110 can receive one or more resultant electrical waveforms in response to a stimulation being provided to the patient 10 via the stimulation electrode 120. The reaction identification device 101 can detect changes (such as changes in reaction time, amplitude, or morphology in the EP) (e.g., via the MEP acquisition system 106). Based on the observed changes, the reaction identification device 101 can identify (e.g., via the MEP acquisition system 106) potential damage to the patient's nervous system and / or potential decline in motor function in the patient's area of interest. The reaction identification device 101 can recommend (e.g., via the MEP acquisition system 106) and / or as an additional or alternative method, measures for reducing or alleviating these damages via a display 54 or the like.

[0083] As described above, the stimulation system 100 can include one or more stimulation electrodes 120. The stimulation system 100 can include one or more stimulation systems that are temporally linked. The response discrimination device 101 can record the EP through the recording electrode 110 while sequentially stimulating the peripheral nerves of the patient 10 through the stimulation electrode 120. Cranial stimulation stimulates the peripheral nerves of the patient 10, and the response discrimination device 101 can also record the EP through the recording electrode 110 while stimulating the cranium of the patient 10 through the stimulation electrode. Thus, the stimulation of the peripheral nerves before cranial stimulation can facilitate cranial stimulation when obtaining the MEP. Such peripheral stimulation can also be performed between two or more series of cranial stimulations. Thus, in some embodiments, the stimulation electrode 120 is coupled to the response discrimination device 101 as an output, and the recording electrode 110 is coupled to the response discrimination device 101 as an input.

[0084] The response discrimination device 101 can include various circuit components such as an electrical stimulator, a preamplifier, an amplifier, and / or other components to control the stimulation and process the feedback signal. In some embodiments, the response discrimination device 101 can average the responses to several stimulations together to reduce the noise in the signal.

[0085] As described herein, the response discrimination device 101 can analyze the signal and determine when alarms and warnings are appropriate through a response discrimination controller portion or the like. For example, the response discrimination device 101 can send a signal to the display 54 to display an alarm and / or a warning when the stimulation is approaching the patient's nerve, when the patient has motor function in the area of interest, and / or when the patient has lost or impaired motor function in the area of interest.

[0086] The display 54 can form part of the reaction identification device 101 and / or the client device 99, and / or can be separately coupled to the reaction identification device 101 and / or the client device 99. The display 54 can also include a user interface. The user interface can form part of the display screen of the display 54 that presents information to a user (e.g., a clinician, a patient, a technician, etc.), and / or the user interface can be separate from the display screen. For example, the user interface can include one or more buttons, or a portion of the display screen for receiving input from the user.

[0087] The display 54 can display various information such as a patient's medical history, the location where the electrodes are proposed, stimulation parameters, the stimulated and recorded areas, the baseline and current signal traces, the historical trend of the signal, the associated changes in the signal, the location of the signal change, the quality of the recorded signal, the electrode position, a warning due to a significant change in the signal, a proposed movement to mitigate a harmful signal change, the recorded resultant electrical waveform, etc. The display 54 can enable an operator to set an initial monitoring layout or plan, interact with the display 54 during monitoring to add additional information, view the information in different formats, and / or respond to warnings. In some embodiments, the display 54 can enable a user to invalidate a change in the signal, such as when the signal change is related to a change in the dosage of an anesthetic or some other event not related to the stimulation of the patient's nerves or skull.

[0088] FIG. 3 shows an example of a display 54 consistent with an embodiment of the present subject matter. In some embodiments, the stimulation system 100 facilitates the setting of stimulation protocols by clinicians and / or non-professional personnel by providing visual cues and instructions during the setting process. For example, as shown in FIG. 3, the display can show the MEP response as a physiological waveform of a muscle response or as an interpreted emoji. The display 54 can also display pictorial instructions regarding the location of placing stimulation and / or recording electrodes, such as stimulation electrode 120 and / or recording electrode 110, on the patient's body. Such images can be displayed when starting the response identification device 101, when starting the monitoring of a new patient, or when receiving a signal indicating that the cable is connected to the response identification device 101.

[0089] Generally, the display 54 (e.g., a dynamic display) also improves the way the client device 99 and / or the response identification device 101 display information and interact with the user. By dynamically generating values based on input, the client device 99 and / or the response identification device 101 can reduce the need to draw additional complex data input elements to complete programming. For example, the graphical user interface presented by the display 54 can include graphical elements for increasing or decreasing the value of the displayed parameter, rather than presenting a full keypad for data input. The client device 99 and / or the response identification device 101 can process and authenticate these input signals more efficiently, and these input signals can be more than inputs from free-form text or numeric data input fields. Also, by using smaller input elements, the display area on the client device 99 and / or the response identification device 101 is saved. This enables more programming parameters to be presented during data input, thereby further reducing the likelihood of programming errors.

[0090] Referring back to FIG. 1, the database 125 can include one or more databases, which can provide physical data storage within a dedicated function and / or be stored locally in the response identification device 101 and / or the client device 99. Additionally and / or alternatively, the database 125 can include a cloud-based system, which can provide remote storage of data, for example, in a multi-tenant computing environment. The database 125 can also include a non-transitory computer-readable medium. The database 125 can store data recorded from the waveforms recorded by the recording electrodes 110 and / or the waveforms received by the response identification device 101, and / or data calculated based on such waveforms.

[0091] The database 125 can include and / or be coupled to a server 126, which can be a server coupled to a network, a cloud server, etc. The response identification device 101 and / or the client device 99 can communicate wirelessly with the server 126. The server 126 can include a cloud-based server and, consistent with embodiments of the present subject matter, can provide and / or receive data and / or instructions from the data system 125 to the response identification device 101 and / or the client device 99 to implement one or more features of the stimulation system 100. Additionally and / or alternatively, the server 126 can receive data (e.g., one or more waveform signals, patient information, information characterizing one or more waveform signals, etc.) from the response identification device 101 and / or the client device 99.

[0092] The identification controller portion can be at least partially embedded and / or implemented within the response identification device 101 and / or the client device 99. The controller 102 can detect and identify the patient's physiological response based on the recorded waveforms to help prevent or reduce the risk of damage to the patient's nerves during surgery.

[0093] Consistent with embodiments of the present subject matter, prior to the central stimulation for obtaining MEP, the adjustment and / or facilitation of the central stimulation can be performed by transmitting a prior stimulus to the patient's one or more peripheral nerves at the skull (skull adjustment stimulus) or peripherally (facilitation). FIG. 4 shows an exemplary stimulus sequence 400 consistent with embodiments of the present subject matter, which can be automatically implemented by the system 100 or implemented by the system 100 in response to a request by a user. The stimulus sequence 400 can include one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more) stimulus sequences or trains. In other words, the plurality of stimulus trains 402 of the stimulus sequence 400 can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more stimulus trains. As shown in FIG. 4, the stimulus sequence 400 can include a first stimulus sequence 406, a second stimulus sequence 407, and a third stimulus sequence 408. In some embodiments, before, during, or after the stimulus sequence 400, the system 100 can obtain one or more SSEPs by stimulating one or more peripheral nerves of the patient via, for example, the SSEP acquisition system 104. The stimulus sequence 400 generally shows the acquisition of MEP via, for example, the MEP acquisition system 106, but the sequence 400 can be used to obtain SSEP before the acquisition of MEP. By using an SSEP stimulating electrode or a separate stimulating electrode via a peripheral or cranial nerve, a facilitation stimulus 422 can be transmitted as part of the second stimulus sequence 407.

[0094] The first stimulus sequence 406 can be transmitted to the patient via one or more first stimulating electrodes (e.g., stimulating electrode 120) positioned on the patient's skull and / or scalp. The one or more first stimulating electrodes can include 1, 2, 3, 4, 5, or more stimulating electrodes. One or more (e.g., 1, 2, 3, 4, 5, or more) recording electrodes, such as the recording electrode 110, can record one or more electrical waveforms in response to the transmission of the first stimulus sequence 406.

[0095] Using the first stimulation sequence 406, MEP can be obtained and / or one or more regions of the patient's scalp or brain can be adjusted or prepared to obtain MEP. The first stimulation sequence 406 can include one or more (e.g., multiple, one, two, three, four, five, or more) first stimulation pulses 430. One or more first stimulation pulses 430 can be transmitted to one or more regions of the patient's scalp or brain, for example, on the patient's skull or scalp. In some embodiments, one or more first stimulation pulses 430 define a first stimulation train. Thus, the length 404 of the train of the first stimulation sequence 406 can be one, two, three, four, five, or more pulses.

[0096] Referring to FIG. 4, the second MEP can be obtained using the third stimulation sequence 408. The third stimulation sequence 408 can include one or more (e.g., multiple, one, two, three, four, five, or more) third stimulation pulses 434. One or more third stimulation pulses 434 can be transmitted to one or more regions of the patient, for example, on the patient's skull or scalp. In some embodiments, one or more third stimulation pulses 434 define a third stimulation train. Thus, the length of the train of the third stimulation sequence 408 can be one, two, three, four, five, or more pulses.

[0097] In some embodiments, each pulse of the one or more first stimulus pulses 430 and the one or more third stimulus pulses 434 can include one or more pulse characteristics such as amplitude or pulse intensity 410, duration 412 or pulse width, inter-stimulus interval (ISI) 414, frequency, pulse train duration 418 (e.g., the sum of the ISI 414 and the stimulus duration 412). In some embodiments, each pulse of the one or more first stimulus pulses 430 has the same pulse characteristics. In some embodiments, one or more of the one or more first stimulus pulses 430 and the one or more third stimulus pulses 434 have one or more different characteristics. In some embodiments, one or more of the pulse characteristics are skewed compared to previous pulses in the first stimulus train and / or the third stimulus train. For example, in some embodiments, the pulse intensity 410, duration 412, ISI 414, and / or frequency of the next pulse can increase compared to the previous pulse in the first stimulus train and / or the third stimulus train. Additionally or alternatively, in some embodiments, the pulse intensity 410, duration 412, ISI 414, and / or frequency of the next pulse can decrease compared to the previous pulse in the first stimulus train and / or the third stimulus train. One or more pulse characteristics of the stimulus pulses of the first stimulus train and / or the third stimulus train can be determined in advance and / or adjusted dynamically by the system 100 automatically or by the user operating the system 100. One or more pulse characteristics of the stimulus pulses of the first stimulus train and / or the third stimulus train, whether determined in advance or adjusted dynamically, may be affected or influenced by available patient data such as SSEP data, most recently acquired MEP data (facilitated or non-facilitated).

[0098] In some embodiments, the pulse intensity 410 of the stimulation pulses of the first stimulation sequence 406 can be about 25 - 1000 volts, 1 - 25 volts, 25 - 50 volts, 50 - 100 volts, 100 - 250 volts, 250 - 500 volts, 500 - 750 volts, 750 - 1000 volts, 1000 - 1250 volts, or more, or other ranges therebetween. In some embodiments, the stimulation duration 412 is about 50 - 500 μs, 1 - 50 μs, 50 - 100 μs, 100 - 200 μs, 200 - 300 μs, 300 - 400 μs, 400 - 500 μs, 500 - 600 μs, or more, or other ranges therebetween. In some embodiments, the ISI 414 is about 1 - 5 ms, 0.25 - 1 ms, 1 - 2 ms, 2 - 3 ms, 3 - 4 ms, 4 - 5 ms, 5 - 6 ms, 6 - 7 ms, or more, or other ranges therebetween. The ISI 414 can be adjusted in increments of 0.25 ms.

[0099] The third stimulation sequence 408 can be delivered to the patient after the first stimulation sequence 406 and / or the second stimulation sequence 407. The third stimulation sequence 408 can be delivered to the patient after the first stimulation sequence 406 and can be temporally spaced from the first stimulation sequence 406 by an inter-train interval (「ITI」) 416. The ITI 416 can be about 10 - 500 ms. In some embodiments, the ITI 416 is about 15 - 40 ms or 200 - 500 ms. In some embodiments, the ITI 416 is 10 - 50 ms, 50 - 100 ms, 100 - 200 ms, 200 - 300 ms, 300 - 400 ms, 400 - 500 ms, 500 - 600 ms, 600 - 700 ms, or more, or other ranges therebetween. The ITI 416 can be pre-determined and / or can be dynamically adjusted, for example, in increments of 1 ms, 2 ms, 5 ms, 10 ms, 15 ms, 20 ms, or 50 ms.

[0100] In some embodiments, the second stimulus sequence 407 is the first stimulus sequence transmitted as part of an MEP acquisition procedure. In such a procedure, the ITI 416 is then irrelevant or essentially non-existent. In some embodiments, the second stimulus sequence 407 is the first stimulus sequence transmitted as part of an MEP acquisition procedure performed after a previous MEP acquisition procedure. Thus, in such a situation, the ITI 416 can be from about 1 minute to 240 minutes, from about 2 minutes to 20 minutes, from about 3 minutes to 15 minutes, and / or any time range therebetween.

[0101] As described above, the first stimulus sequence 406 can prepare or condition one or more neural pathways of a patient for MEP acquisition by transmitting a third stimulus sequence 408. Thus, when the first stimulus sequence 406 is paired with the third stimulus sequence 408, the first stimulus sequence 406 can define a conditioning stimulus train. Since the first stimulus sequence 406 can define a conditioning train, the first stimulus sequence 406 can include fewer pulses (e.g., 2 to 3 pulses) and / or a lower intensity (e.g., 150 to 250 volts) compared to the stimulus pulses of the third stimulus sequence 408. In such embodiments, the third stimulus sequence 408 can define a stimulus train. Thus, the third stimulus sequence 408 can include a greater number of stimulus pulses (e.g., 4 to 6 pulses) and / or a higher intensity (e.g., 200 to 300 volts) compared to the first stimulus sequence 406. In some embodiments, a fourth stimulus sequence can be transmitted, such as when the third stimulus sequence 408 does not produce an MEP or a suitable MEP.

[0102] Referring again to FIG. 4, the stimulation sequence 400 can include a second stimulation sequence 407. As described above, the second stimulation sequence 407 can be transmitted to one or more peripheral nerves of the patient simultaneously or in rapid succession. The second stimulation sequence 407 can be transmitted from electrodes commonly used to acquire SSEPs and / or from separate stimulation electrodes used only to facilitate the acquisition of MEPs. In other words, the transmission of the second stimulation sequence 407 can improve the acquisition of MEPs via the third stimulation sequence 408. The second stimulation sequence 407 can include one or more (e.g., a plurality, one, two, three, four, five, or more) second stimulation pulses 422. In some embodiments, the second stimulation sequence 407 includes a single stimulation pulse 422, such as a single peripheral facilitation pulse. The one or more second stimulation pulses 422 can be transmitted to one or more peripheral nerves of the patient simultaneously or sequentially, for example, at one or more of the patient's limbs, neck, and / or extremities.

[0103] The stimulation pulse 422 can have a stimulation duration of about 300 μs. The stimulation pulse 422 can include one, two, three, or more stimulations and can have a stimulation duration in the range of about 50 - 100 μs, 100 - 150 μs, 150 - 200 μs, 200 - 250 μs, 250 - 300 μs, 300 - 350 μs, 350 - 400 μs, 400 - 450 μs, more, and / or other ranges therebetween. The second stimulation sequence 407 including the stimulation pulse 422 can be transmitted to the patient during the ITI 416 (e.g., automatically, manually initiated, etc.). For example, the second stimulation sequence 407 can be transmitted between the first stimulation sequence 406 and the third stimulation sequence 408.

[0104] The second stimulation sequence 407 can be transmitted to the patient (e.g., automatically, manually initiated, etc.) just before the third stimulation sequence 408 by a stimulation interval from the periphery to the center (the "PCISI") 420. The PCISI 420 can be about 56 - 64 ms. The PCISI 420 can be about 10 - 30 ms. The PCISI 420 can be about 90 - 150 ms. The PCISI 420 can be about 10 - 50 ms, 50 - 100 ms, 100 - 150 ms, 150 - 200 ms, less than, more than, or other ranges in between. Thus, the second stimulation sequence 407 can promote the acquisition of MEP by transmitting a stimulation to one or more peripheral nerves of the patient before transmitting a stimulation to one or more cranial nerves of the patient.

[0105] In particular, the second stimulation sequence 407 can be transmitted to the region of interest of the patient. The region of interest can be a part of the patient's body, such as the patient's limbs, arms, legs, feet, hands, face, etc. The region of interest can be the region of the patient at risk during a surgery such as a spinal surgery. Thus, during the surgery, it may be beneficial to determine whether the patient has motor function in the region of interest. The region of interest can be the peripheral region of the patient. In some embodiments, by transmitting the second stimulation sequence 407 to the region of interest before transmitting the third stimulation sequence 408 to the patient's skull, it can help to limit movement in response to the transmission of the third stimulation sequence 408 of the patient to the region of interest of the patient, thereby reducing the interruption of the surgical procedure and enabling more continuous collection of data during the surgical procedure.

[0106] Additionally and / or alternatively, by delivering a second stimulation sequence 407 to the region of interest before delivering a third stimulation sequence 408 to the patient's skull, it is possible to reduce the voltage or pulse intensity of at least one (e.g., one, two, three, four, five, six, or more, or all) of the pulses of the third stimulation sequence 408. Additionally and / or alternatively, by delivering a second stimulation sequence 407 to the region of interest before delivering a third stimulation sequence 408 to the patient's skull, the possibility of false positive and / or false negative detection of motor or physiological responses can be reduced.

[0107] FIG. 5 shows an example of a stimulation sequence 400 consistent with an embodiment of the present subject matter. For example, as shown in FIG. 5, the stimulation sequence may not include a first stimulation sequence 406. In other words, the stimulation sequence 400 may include only a second stimulation sequence 407 (in this case, the first stimulation sequence of the stimulation sequence 400) and a third stimulation sequence 408 (in this case, the second stimulation sequence of the stimulation sequence 400). Additionally and / or alternatively, the stimulation sequence 400 shows an exemplary stimulation sequence that includes the second stimulation sequence 407 being delivered to one or more peripheral or cranial nerves of the patient, such as in the region of interest, before the third stimulation sequence 408 is delivered to one or more regions of the patient's scalp or skull.

[0108] In some embodiments, the methods of performing the surgeries or other procedures described herein include performing robot-assisted surgeries, such as, for example, robotic-assisted hysterectomy, other gynecological surgeries, prostatectomy, urological surgeries, general laparoscopic surgeries, thoracoscopic surgeries, valve replacement surgeries, other cardiac surgeries, bariatric surgeries, other gastrointestinal surgeries, or oncological surgeries. The methods of some embodiments further include transmitting electrical stimulation to peripheral or cranial nerves within the body, recording the resultant electrical waveforms generated by the body's nervous system in response to the electrical stimulation, and monitoring the resultant electrical waveforms to detect changes indicative of potential nerve damage. The methods of some embodiments further include transmitting electrical stimulation to the scalp or skull or brain, recording the resultant electrical waveforms generated by the body's nervous system in response to the electrical stimulation, and monitoring the resultant electrical waveforms to detect changes indicative of potential nerve damage or motor function. Additionally or alternatively, in some embodiments, the method of performing a surgery can include any of the methods of detecting the function of one or more nerves or neural pathways described elsewhere herein. The methods of detecting the function of one or more nerves or using the response discrimination device 101 can be incorporated at any point during the robotic surgery. For example, such methods can be performed at multiple times, continuously, at preselected situations such as when a particular type of procedure is initiated or terminated (including any of the above). The methods of various embodiments further include adjusting the patient's position when potential nerve damage or abnormalities are detected.

[0109] Figures 6-8 illustrate methods 600, 700, and 800, respectively, implemented by the stimulation system 100 described herein. One or more of the steps of method 600 can be implemented by method 700 and / or method 800. One or more of the steps of method 700 can be implemented by method 600 and / or method 800. One or more of the steps of method 800 can be implemented by method 700 and / or method 600.

[0110] FIG. 6 shows a method 600 for facilitating an MEP stimulation sequence to obtain an MEP that is consistent with an embodiment of the present subject matter.

[0111] At 602, the system can facilitate an MEP stimulation sequence (e.g., via the identification controller 102) used to obtain an MEP. Facilitating the MEP stimulation sequence can include transmitting a first stimulation pulse to one or more peripheral nerves of a patient via a first stimulation electrode. One or more peripheral nerves of the patient can include the brachial plexus, peroneal nerve, femoral nerve, lateral femoral cutaneous nerve, sciatic nerve, spinal accessory nerve, tibial nerve, one or more nerves of the somatic nervous system, one or more nerves of the autonomic nervous system, and the like. The one or more peripheral nerves can be positioned at least partially within the region of interest. In some embodiments, the first stimulation electrode is coupled to the patient within the region of interest. The region of interest can be a part of the patient's body such as the patient's limbs, arms, legs, feet, hands, ankles, wrists, fingers, face, and the like.

[0112] In some embodiments, the first stimulation pulse includes a single stimulation pulse. In some embodiments, the first stimulation pulse includes a plurality of stimulation pulses. In some embodiments, the first stimulation pulse can be transmitted to one or more peripheral nerves of the patient by the same electrodes used to obtain an SSEP. When collected, the SSEP can indicate that a surgeon is approaching a nerve or nerve structure during a surgical procedure such as a spinal surgery. The one or more peripheral nerves can include the tibial nerve (e.g., posterior tibial nerve), saphenous nerve, ulnar nerve, and the like.

[0113] In some embodiments, the SSEP stimulation system described herein facilitates the MEP stimulation sequence by sharing one or more SSEP stimulation sites or stimulation pulses and correlating changes in the two stimulation techniques.

[0114] At 604, the system can transmit an MEP stimulation sequence to one or more peripheral or cranial nerves of the patient to obtain an MEP (e.g., via the identification controller 102) through the second stimulation electrode after facilitation. The MEP stimulation sequence can include a train of stimulation pulses. In some embodiments, the second stimulation electrode is coupled to the patient's scalp or skull. In some embodiments, the MEP acquisition system described herein can transmit an MEP stimulation sequence.

[0115] In some embodiments, prior to facilitation, through the second stimulation electrode, the system can transmit a second MEP stimulation sequence to one or more cranial or scalp regions of the patient (e.g., via the identification controller 102). The second MEP stimulation sequence can include a second train of stimulation pulses. The second MEP stimulation sequence can be transmitted prior to the MEP stimulation sequence. For example, the second MEP stimulation sequence can be transmitted prior to the MEP stimulation sequence and can be spaced from the MEP stimulation sequence by an inter-train time interval. The inter-train time interval can be about 10 - 500 ms. In some embodiments, the inter-train time interval 416 is about 15 - 40 ms or 200 - 500 ms. In some embodiments, the inter-train time interval 416 is about 10 - 50 ms, 50 - 100 ms, 100 - 200 ms, 200 - 300 ms, 300 - 400 ms, 400 - 500 ms, 500 - 600 ms, 600 - 700 ms, or more, or other ranges therebetween.

[0116] In some embodiments, facilitation is performed during the inter-train time interval. For example, facilitation can be performed during the period before the MEP stimulation sequence and / or after the first MEP stimulation sequence. In other words, the MEP stimulation sequence can be transmitted during the period after adjustment of the MEP stimulation sequence.

[0117] In some embodiments, this period is determined in advance. In some embodiments, this period is dynamically adjusted based on one or more parameters of the patient and / or the type of surgery being performed on the patient. For example, one or more parameters of the patient can include the patient's age, height, weight, gender, health status, etc. Additional parameters that can be used to adjust one or more parameters of the MEP stimulation / acquisition procedure include the results of the patient's SSEP monitoring, the results of the patient's EMG monitoring, and the results of the patient's previous MEP monitoring.

[0118] In some embodiments, facilitation is automatically performed at a specific time after the first or second MEP adjustment stimulation sequence and / or before transmitting the MEP stimulation sequence. For example, after the second MEP adjustment stimulation sequence has been transmitted to the patient, the first stimulation pulse can be transmitted to the patient at a specific time (or within a period) after the second MEP adjustment stimulation sequence. Additionally and / or alternatively, the first stimulation pulse can be automatically transmitted to the patient at a specific time (or within a period) before the transmission of the MEP stimulation sequence. Additionally and / or alternatively, the MEP stimulation sequence can be automatically transmitted at a specific time (or within a period) after transmitting the stimulation pulse as part of the facilitation. By automatically facilitating the MEP stimulation sequence and / or transmitting the MEP stimulation sequence, it is possible to assist the surgeon during the surgery by reducing the need for technicians in the operating room, reducing interruptions during the surgical procedure, reducing patient movement, reducing the length of the surgical procedure, etc. In some embodiments, the facilitation (e.g., transmission of the stimulation pulse to the peripheral or cranial nerve), the entire MEP stimulation sequence, and / or the second MEP stimulation sequence are manually initiated in a response discrimination device 101 or the like.

[0119] At 606, the system can determine whether a physiological response has occurred based on the MEP (e.g., via the identification controller 102). For example, the system can compare the expected baseline waveform with the initial waveform in one or more of shape, size, or morphology, by algorithm classification or other means, or when comparing one or more waveform baseline waveforms of the MEP collected after the baseline was collected, to determine that a physiological response has occurred. In some embodiments, the system determines that a physiological response has occurred by comparing one or more characteristics such as, but not limited to, the amplitude, waveform shape, frequency, reaction time, etc. of the MEP with a threshold value. In such embodiments, the system can detect the presence of a physiological response when one or more characteristics are above the threshold value. As an addition or alternative, the system can detect the presence of a physiological response when one or more characteristics are below the threshold value.

[0120] At 608, the system can indicate that a physiological response has occurred via a display (e.g., display 54) coupled to the first and second stimulation electrodes (e.g., via the identification controller 102). The display can be coupled to the reaction identification device 101, the SSEP acquisition system 104, the MEP acquisition system 106, and / or other components of the stimulation system 100. This indication can include one or more warnings, such as one or more audible, visual, and / or tactile warnings or signals. This indication can show that the surgeon is approaching or interfering with the patient's nerve or nerve conduction pathway. This indication can show that the patient has motor function in the area of interest. In some embodiments, this indication shows that no physiological response has occurred or that the response has changed. In such cases, the surgeon may need to pause the surgery, wake up the patient, and / or change the surgical procedure.

[0121] Accordingly, the stimulation system can reduce the intensity of the pulses, the number of pulses per train, or the number of trains of stimulation pulses of the MEP stimulation sequence, such as by facilitating the MEP stimulation sequence, restrict the patient's movement to the region of interest during the transmission of the MEP stimulation, and / or improve the accuracy of determining that a physiological response has occurred or changed.

[0122] FIG. 7 shows a method 700 for facilitating an MEP stimulation sequence to obtain an MEP, consistent with an embodiment of the present subject matter.

[0123] At 706, a system, such as system 100, can stimulate one or more peripheral nerves of a patient via a first stimulation electrode coupled to the patient using a second stimulation sequence (e.g., via identification controller 102). The first stimulation electrode can include one, two, three, four, five, six, seven, eight, or more stimulation electrodes. The first stimulation electrode can be positioned in the region of interest of the patient. For example, during various types of surgeries, it may be desirable to determine whether the patient has movement in the extremities, feet, legs, hands, wrists, etc. The region of interest can include regions of the patient such as the extremities, feet, legs, hands, wrists, face, etc. The region of interest can be a region of the patient at risk during surgery if the health of the nerves is a priority or at risk, or if the health of the patient's nerves can be related to the treatment, regardless of whether the surgery is a spinal surgery or any other surgery. For example, it can be beneficial to determine whether the patient has motor function in the region of interest during surgery. The region of interest can be a peripheral region of the patient.

[0124] At 702, a system such as system 100 can stimulate one or more regions of a patient's scalp, skull, or brain via a second stimulation electrode coupled to the patient using a first stimulation sequence (e.g., via identification controller 102). The second stimulation electrode can include one, two, three, four, five, six, seven, eight, or more stimulation electrodes. The second stimulation electrode can be positioned over one or more regions of the patient's scalp, skull, or brain. In some embodiments, the stimulation sequence includes a first plurality of stimulation pulses as part of a first stimulation pulse train as described herein. One or more of the stimulation pulses of the first plurality of stimulation pulses can include the same amplitude, the same pulse width, and / or the same frequency. Additionally and / or alternatively, one or more of the stimulation pulses of the first plurality of stimulation pulses can include different amplitudes, pulse widths, and / or frequencies. The first plurality of stimulation pulses can include one, two, three, four, five, six, or more stimulation pulses. The first stimulation pulse can prepare the brain to obtain an MEP. By combining preparing or conditioning the brain with facilitating an MEP stimulation sequence, it can help produce more accurate results, reduce the likelihood of injury to the patient, and / or help reduce the likelihood that the surgery will be significantly interrupted. Additionally and / or alternatively, preparing or conditioning can be done at 706, before or simultaneously with facilitating. Additionally and / or alternatively, the first stimulation sequence may not be transmitted.

[0125] At 704, system 100 can record a first plurality of resultant electrical waveforms via a first recording electrode coupled to a patient, such as via identification controller 102. The first plurality of resultant electrical waveforms can include one, two, three, four, five, or more resultant electrical waveforms. The first plurality of resultant electrical waveforms can be received by a response identification device. The resultant electrical waveforms can be generated by the patient's reaction to a transmitted electrical stimulus, such as a first stimulus sequence. In some embodiments, the first stimulating electrode and / or the first recording electrode can form part of MEP acquisition system 106.

[0126] In some embodiments, a second stimulus sequence follows or occurs during the first stimulus sequence and facilitates a third stimulus sequence. In other words, the second stimulus sequence can be applied to the patient's region of interest prior to transmitting the third stimulus sequence in order to condition the patient's physiological response to the third stimulus sequence in the region of interest. In some embodiments, the second stimulating electrode and / or the second recording electrode (described in more detail below) can form part of SSEP acquisition system 104.

[0127] In some embodiments, the second stimulus sequence includes a single stimulus pulse. In some embodiments, the second stimulus sequence includes a plurality of stimulus pulses as part of a second stimulus train, as described herein. In some embodiments, such as when the second stimulus sequence includes a second plurality of stimulus pulses, one or more of the stimulus pulses of the second plurality of stimulus pulses can include pulses of the same amplitude, the same pulse width, and / or the same frequency. Additionally and / or alternatively, one or more of the stimulus pulses of the second plurality of stimulus pulses can include different amplitudes, pulse widths, and / or frequencies.

[0128] At 710, a system such as system 100 can stimulate one or more cranial nerves of a patient via a first stimulation electrode coupled to the patient using a third stimulation sequence (e.g., via identification controller 102). In some embodiments, the third stimulation sequence is the same as the first stimulation sequence. In some embodiments, the third stimulation sequence is different from the first stimulation sequence. In some embodiments, the third stimulation sequence includes a plurality of third stimulation pulses as part of a third stimulation pulse train as described herein. One or more of the stimulation pulses among the plurality of third stimulation pulses can have the same amplitude, the same pulse width, and / or the same frequency. Additionally and / or alternatively, one or more of the stimulation pulses among the plurality of third stimulation pulses can have different amplitudes, pulse widths, and / or frequencies. The plurality of third stimulation pulses can include one, two, three, four, five, six, or more stimulation pulses. The plurality of third stimulation pulses acquire an MEP.

[0129] At 712, system 100 can record a plurality of second resultant electrical waveforms via a second recording electrode coupled to the patient, such as via identification controller 102. The plurality of second resultant electrical waveforms can include one, two, three, four, five, or more resultant electrical waveforms. The plurality of second resultant electrical waveforms can be received by a response identification device. The plurality of second resultant electrical waveforms can be generated by the patient's response to a transmitted electrical stimulation such as a second stimulation sequence.

[0130] In some embodiments, stimulating using the second stimulation sequence is performed during an inter-column time interval between the stimulation using the first stimulation sequence and the stimulation using the third stimulation sequence. For example, the second stimulation sequence can be performed within a period such as PCISI 420 before the third stimulation sequence and / or after the first stimulation sequence. In other words, the third stimulation sequence can be transmitted within a period after the transmission of the second stimulation sequence.

[0131] In some embodiments, stimulating using the second stimulation sequence is performed before or during stimulation using the first stimulation sequence and stimulation using the third stimulation sequence. For example, the second stimulation sequence can be performed within a period such as PCISI420 before the third stimulation sequence and / or before or after the first stimulation sequence. In other words, the third stimulation sequence can be transmitted within a period after the transmission of the second stimulation sequence.

[0132] In some embodiments, this period is determined in advance. In some embodiments, this period is dynamically adjusted based on one or more parameters of the patient and / or the type of surgery being performed on the patient. For example, one or more parameters of the patient can include the patient's age, height, weight, gender, health status, and the like. The one or more parameters can also include current or past SSEP, MEP, or EMG data.

[0133] In some embodiments, the second stimulation sequence is automatically delivered at a specific time after the first stimulation sequence and / or before delivering the third stimulation sequence. For example, after the first stimulation sequence has been delivered to the patient, the second stimulation sequence can be delivered to the patient at a specific time (or within a period) after the first stimulation sequence. Additionally and / or alternatively, the second stimulation sequence can be automatically delivered to the patient at a specific time (or within a period) before the delivery of the third stimulation sequence. Additionally and / or alternatively, the third stimulation sequence can be automatically delivered at a specific time (or within a period) after the delivery of the second stimulation sequence. Automatically delivering the second stimulation sequence and / or delivering the third stimulation sequence can assist the surgeon during the surgery by reducing the need for a technician in the operating room, reducing interruptions during the surgical procedure, reducing patient movement, reducing the length of the surgical procedure, etc. In some embodiments, promoting the third stimulation sequence and / or the first stimulation sequence (e.g., delivering the second stimulation sequence) is manually initiated in a response identification device 101 or the like. In some embodiments, the first stimulation sequence is not delivered.

[0134] In 712, system 100 can record a second plurality of resultant electrical waveforms via a first recording electrode coupled to a patient, such as via an identification controller 102. The second plurality of resultant electrical waveforms can include one, two, three, four, five, or more resultant electrical waveforms. The second plurality of resultant electrical waveforms can be received by a response identification device. The second plurality of resultant electrical waveforms can be generated by the patient's response to a delivered electrical stimulation, such as a third stimulation sequence. In some embodiments, one or more of the resultant electrical or mechanical waveforms among the second plurality of resultant electrical or mechanical waveforms represent MEP.

[0135] At 714, the system can determine whether a physiological reaction has occurred based on the MEP (e.g., via the identification controller 102). For example, the system can determine that a physiological reaction has occurred by comparing one or more resulting electrical waveforms of the MEP with a baseline waveform. In some embodiments, the system determines that a physiological reaction has occurred by comparing one or more characteristics of the MEP, such as amplitude, waveform shape, frequency, waveform shape, etc., with a threshold. In such embodiments, the system can detect the presence of a physiological reaction when one or more characteristics are above the threshold. Additionally or alternatively, the system can detect the presence of a physiological reaction when one or more characteristics are below the threshold. Such maximum or minimum thresholds can be reaction time, duration, magnitude, frequency, waveform shape, etc.

[0136] At 716, the system can indicate (e.g., via the identification controller 102) that a physiological reaction has occurred via a display (e.g., display 54) coupled to the first and second stimulation electrodes. The display can be coupled to the reaction identification device 101, the SSEP acquisition system 104, the MEP acquisition system 106, and / or other components of the stimulation system 100. This indication can include one or more warnings, such as one or more audible, visual, and / or tactile warnings or signals. This indication can show that the surgeon is approaching or interfering with the patient's nerve or nerve pathway. This indication can show that the patient has motor function and / or sensation in the area of interest. In some embodiments, this indication shows that no physiological reaction has occurred. In such cases, the surgeon may need to pause the surgery, wake up the patient, and / or change the surgical procedure.

[0137] Thus, the stimulation system can reduce the intensity and / or duration of the stimulation pulse train of the third stimulation sequence, such as by promoting the third stimulation sequence by the second stimulation sequence, restrict the patient's movement to the region of interest during the transmission of the third stimulation sequence to obtain MEP, and / or improve the accuracy of determining that a physiological response has occurred.

[0138] FIG. 8 shows a method 800 for obtaining MEP and SSEP in accordance with an embodiment of the present subject matter.

[0139] At 802, the system can obtain one or more first SSEPs (e.g., via the identification controller 102). Obtaining one or more first SSEPs can include stimulating one or more peripheral nerves of the patient via a first stimulation electrode. One or more of the peripheral nerves can be positioned at least partially within the region of interest. In some embodiments, the first stimulation electrode is coupled to the patient in the region of interest. The region of interest can be a part of the patient's body, such as the patient's limbs, arms, legs, feet, hands, etc.

[0140] In some embodiments, stimulating via the first stimulation electrode can include transmitting a stimulation pulse. In some embodiments, the stimulation pulse is a single stimulation pulse. In some embodiments, the stimulation pulse includes a plurality of stimulation pulses. In some embodiments, the stimulation pulse can be transmitted to one or more peripheral nerves of the patient to obtain one or more first SSEPs. The first SSEP can indicate that a surgeon is approaching or interfering with a nerve or nerve conduction pathway during a surgical procedure such as spinal surgery. One or more of the peripheral nerves can include the tibial nerve (e.g., the posterior tibial nerve), the superficial peroneal nerve, the ulnar nerve, etc.

[0141] In some embodiments, as described herein, stimulating one or more peripheral nerves of a patient promotes the acquisition of MEPs. In doing so, prior to acquiring the MEP, by transmitting the stimulation of one or more peripheral nerves of the patient to the area of interest of the patient, the physiological response of the patient to the stimulation of one or more cranial nerves of the patient can be focused on the area of interest.

[0142] At 804, the system can then acquire the MEP (e.g., via the identification controller 102). Acquiring the MEP can include stimulating one or more scalp or cranial regions of the patient to acquire the MEP via a second stimulation electrode. Stimulating can include transmitting a train of stimulation pulses. In some embodiments, the second stimulation electrode is coupled to the patient's scalp.

[0143] In some embodiments, the acquisition of one or more first SSEPs is automatically performed at a specific time prior to acquiring the MEP, and / or the MEP can be automatically acquired at a specific time after one or more first SSEP stimulations are transmitted. The first stimulation electrode used to acquire the first SSEP can also be used to facilitate the acquisition of the MEP.

[0144] In some embodiments, the acquisition of one or more first SSEPs and the delivery of SSEP stimulation pulses are automatically performed upon the occurrence of a pre-established event, such as the results of ongoing SSEP monitoring of the patient, the results of EMG monitoring of the patient, and / or the results of previous MEP monitoring of the patient. By automatically acquiring the MEP, the need for a technician in the operating room can be reduced, thereby assisting the surgeon during the surgery. By using the SSEP stimulation electrodes to facilitate the MEP, the number of electrodes that need to be coupled to the patient can be reduced. By using one or more of the SSEP stimulation electrodes to facilitate the MEP, the surgeon can be further assisted by reducing interruptions during the surgical procedure, reducing patient movement, reducing the length of the surgical procedure, and the like. In some embodiments, facilitating prior to MEP acquisition (in this example, by delivering a second stimulation sequence using the SSEP electrodes prior to MEP) is manually initiated in a response discrimination device 101 or the like. In some embodiments, facilitating prior to MEP acquisition is automatically triggered based on one or more parameters, such as the elapsed time since a previous MEP, SSEP, or EMG acquisition, the elapsed time of the surgical procedure, the results of the most recently performed MEP, SSEP, or EMG, one or more of the results of MEP, SSEP, or EMG performed prior to the surgical procedure, or some results of another monitoring system such as heart rate monitoring.

[0145] At 806, the system can determine (e.g., via the identification controller 102) whether a first physiological reaction has occurred based on the MEP. For example, the system can determine that a first physiological reaction has occurred by comparing one or more waveforms of the MEP with an expected reaction or a baseline waveform. In some embodiments, the system determines that a physiological reaction has occurred by comparing one or more characteristics of the MEP, such as amplitude, waveform shape, reaction time, frequency, etc., with a threshold. In such embodiments, the system can detect the presence of a physiological reaction when one or more characteristics are above the threshold. Additionally or alternatively, the system can detect the presence of a physiological reaction when one or more characteristics are below the threshold. The first physiological reaction can indicate that the patient has motor function in the area of interest, such as the patient's arm, leg, foot, hand, wrist, limb, face, etc.

[0146] At 808, the system can indicate (e.g., via the identification controller 102) that a physiological reaction has occurred via a display (e.g., display 54) coupled to the first and second stimulation electrodes. The display can be coupled to the reaction identification device 101, the SSEP acquisition system 104, the MEP acquisition system 106, and / or other components of the stimulation system 100. This indication can include one or more warnings, such as one or more audible, visual, and / or tactile warnings or signals. This indication can show that the surgeon is approaching or interfering with the patient's nerve or nerve conduction pathway. This indication can show that the patient has motor function and / or sensation in the area of interest. In some embodiments, this indication shows that no physiological reaction has occurred. In such cases, the surgeon may need to pause the surgery, wake up the patient, and / or change the surgical procedure and / or the patient's position. In some embodiments, the system can provide the surgeon with an indication regarding which solutions are available and / or recommended based on the results of the MEP acquisition.

[0147] At 810, the system can acquire one or more second SSEPs (e.g., via the identification controller 102). Acquiring one or more second SSEPs can include stimulating one or more peripheral nerves of the patient via the first stimulation electrode. Thus, the systems described herein can acquire (e.g., automatically acquire) SSEPs and MEPs during a surgical procedure.

[0148] Thus, the stimulation system can reduce the intensity of the stimulation transmitted to one or more scalp or cranial regions during MEP acquisition, limit the patient's movement to the region of interest during MEP acquisition, and / or improve the accuracy of determining that a physiological response has occurred, such as by facilitating MEP acquisition.

[0149] FIG. 9 shows a block diagram illustrating a computing system 900 consistent with an embodiment of the present subject matter. Referring to FIGS. 1 and 9, the computing system 900 can be used to implement the stimulation system 100 and / or any of the components described herein.

[0150] As shown in FIG. 9, the computing system 900 can include a processor 910, a memory 920, a storage device 930, and an input / output device 940. The processor 910, the memory 920, the storage device 930, and the input / output device 940 can be interconnected via a system bus 950. The processor 910 is capable of processing instructions for execution within the computing system 900. Such executed instructions can implement, for example, one or more components of the identification controller 102. In some exemplary embodiments, the processor 910 can be a single-threaded processor. Alternatively, the processor 910 can be a multi-threaded processor. The processor 910 is capable of processing instructions stored in the memory 920 and / or on the storage device 930 to present graphical information for a user interface provided via the input / output device 940.

[0151] Memory 920 is a computer-readable medium such as volatile or non-volatile that stores information within computing system 900. Memory 920 can store, for example, a data structure representing a configuration object database. Storage device 930 can provide persistent storage for computing system 900. Storage device 930 can be a floppy disk device, a hard disk device, a solid state drive, an optical disk device, or a tape device, or other suitable persistent storage means. Input / output device 940 provides input / output operations for computing system 900. In some exemplary embodiments, input / output device 940 includes a keyboard and / or a pointing device and / or a touch-sensitive screen. In various embodiments, input / output device 940 includes a display unit for displaying a graphical user interface.

[0152] According to some exemplary embodiments, input / output device 940 can provide input / output operations for network devices. For example, input / output device 940 can include an Ethernet port or other networking port to communicate with one or more wired and / or wireless networks (e.g., local area network (LAN), wide area network (WAN), Internet).

[0153] In some exemplary embodiments, computing system 900 can be used to execute various interactive computer software applications that can be used for the compilation, analysis, and / or storage of various forms of data. Alternatively, computing system 900 can be used to execute software applications. These applications can be used to perform various functions, such as planning functions (e.g., generation, management, editing of spreadsheet documents, word processing documents, and / or any other objects), computing functions, communication functions, and the like. The applications can include various add-in functions or can be stand-alone computing products and / or functions. When launched within an application, these functions can be used to generate a user interface provided via input / output device 940. The user interface can be generated and presented to the user by computing system 900 (e.g., on a computer screen monitor, etc.).

[0154] One or more aspects or features of the subject matter described in this specification can be realized in digital electronic circuitry, integrated circuitry, specially designed ASICs, field programmable gate array (FPGA) computer hardware, firmware, software, and / or combinations thereof. These various aspects or features can include implementation in one or more computer programs executable and / or analyzable on a programmable system including at least one programmable processor, which programmable system may be special purpose or general purpose and is coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device. A programmable system or computing system can include clients and servers. Clients and servers are remote from each other and typically interact via a communication network. The relationship of client and server arises by virtue of computer programs running on respective computers and having a client-server relationship to each other.

[0155] These computer programs, which may also be referred to as programs, software, software applications, applications, components, or code, include machine instructions for a programmable processor and can be implemented in high-level procedural and / or object-oriented programming languages and / or assembly language / machine language. As used herein, the term "machine-readable medium" refers to any computer program product, apparatus, and / or device used to provide machine instructions and / or data to a programmable processor, including a machine-readable medium that receives the machine instructions as a machine-readable signal, such as, for example, a magnetic disk, an optical disk, a memory, and a programmable logic device (PLD). The term "machine-readable signal" refers to any signal used to provide machine instructions and / or data to a programmable processor. The machine-readable medium can store such machine instructions non-transitorily, such as, for example, in the case of a non-transitory solid-state memory or a magnetic hard drive or any equivalent storage medium. The machine-readable medium can alternatively or additionally store such machine instructions temporarily, such as, for example, in the case of a processor cache or other random access memory associated with one or more physical processor cores.

[0156] To provide interaction with a user, one or more aspects or features described herein can be implemented on a computer having a display device such as a cathode ray tube (CRT), liquid crystal display (LCD), or light emitting diode (LED) monitor for displaying information to the user, and one or more hardware buttons, a keyboard, and / or a pointing device such as a mouse or trackball by which the user can provide input to the computer. Other types of devices can be used to provide interaction with the user as well. For example, the feedback provided to the user can be any form of sensory feedback such as, for example, visual feedback, auditory feedback, or tactile feedback, and the input from the user can be received in any form including acoustic, speech, or tactile input. Other possible input devices include touch screens or other touch-sensitive devices such as single or multi-point resistive or capacitive track pads, speech recognition hardware and software, optical scanners, optical pointers, digital image capture devices, hardware buttons, and associated analysis software.

[0157] Embodiment The following embodiments are included in the present disclosure as non-limiting examples of various combinations of features contemplated by the authors of the present disclosure. Embodiment 1: An automated MEP device configured to optimize one or more of the stimulation, acquisition, and analysis parameters for the collection of both facilitated and unfacilitated MEP, at least one first pair of stimulation electrodes disposed on or near the patient's peripheral or cranial nerve, at least one first pair of recording electrodes disposed on or near the patient's skull, at least one second pair of stimulation electrodes disposed on or near the patient's skull, at least one second pair of recording electrodes disposed on or near the patient's area of interest, at least one processor, At least one memory for storing instructions that, when executed by at least one processor, cause operations, and these operations include Transmitting a first stimulation sequence including one or more electrical pulses via a second pair of stimulation electrodes, Transmitting a second stimulation sequence including one or more electrical pulses via a first pair of stimulation electrodes before, during, or after the first stimulation sequence, Transmitting a third stimulation sequence including one or more electrical pulses via the second pair of stimulation electrodes, Recording an evoked potential via a second pair of recording electrodes Including at least two or more of the above, and these operations are executed one or more times, A device in which the processor automatically executes instructions based on at least one of a predetermined interval, a predetermined delay, the occurrence of a monitored event, the result of a previous execution of an instruction, and the personal characteristics of the patient. Embodiment 2: An automated device according to Embodiment 1, wherein the processor analyzes the evoked potential to optimize one or more of the first and / or second and / or third stimulation sequences, the number of pulses, the frequency of the pulses, the pulse amplitude, the pulse duration, and the duration between the first stimulation sequence and the second stimulation sequence, the duration between the second stimulation sequence and the third stimulation sequence, and stores the result of the analysis in the memory. Embodiment 3: An automated device according to Embodiment 2, wherein the processor outputs the analysis on a display. Embodiment 4: An automated device according to Embodiment 2 or 3, wherein the processor automatically adjusts one or more parameters of the next transmission of the first and / or second and / or third stimulation sequences based on the analysis. Embodiment 5: An automated device according to Embodiment 1, 2, 3, or 4, wherein At least one third stimulation sequence not associated with the second stimulation sequence (“unfacilitated MEP”), as well as at least one first, second, and third stimulation sequence (“adjusted facilitated MEP”), and at least one second stimulation sequence immediately following the third stimulation sequence (“facilitated MEP”) are transmitted, Compare one or more evoked potentials resulting from the unfacilitated MEP with one or more evoked potentials resulting from the facilitated MEP, Compare one or more evoked potentials resulting from the facilitated MEP with the evoked potentials resulting from the adjusted facilitated MEP, Compare one or more evoked potentials resulting from the unfacilitated MEP with the adjusted facilitated MEP, Compare one or more first evoked potentials resulting from unfacilitated, facilitated, or adjusted facilitated evoked potentials with one or more second evoked potentials of the same type, Analyze this comparison to determine at least one of the optimal stimulation pattern, the health status of the patient's nerve or nerve conduction pathway, one or more optimized parameters of the first and / or second and / or third stimulation sequences, recommendations for adjusting one or more parameters of the first and / or second stimulation sequences, recommendations for changing the patient's position, and recommendations for changes in the surgical procedures being performed on the patient, A device configured to store the recommendations in memory and / or output the recommendations to a display. Embodiment 6: An automated device according to Embodiment 1, 2, 3, 4, or 5, wherein the processor determines an optimal amplitude for the first stimulation sequence that maximizes a desired aspect of the second evoked potential based on the recorded first and second evoked potentials. Embodiment 7: An automated device according to Embodiment 6, wherein the desired aspect of the second evoked potential is at least one of a response from the muscle of interest or muscle segment, a response from the muscle of interest or muscle segment above a threshold, a response above a threshold. Embodiment 8: An automated device according to Embodiment 1, 2, 3, 4, 5, 6, or 7, wherein a processor determines optimal parameters for a second stimulation sequence that maximizes the evoked potential based on the recorded first and / or second evoked potential. Embodiment 9: An automated device according to Embodiment 1, 2, 3, 4, 5, 6, 7, or 8, wherein the processor determines an optimal period between a first stimulation sequence and a second stimulation sequence that maximizes the amplitude of the second evoked potential based on the recorded first and second evoked potentials. Embodiment 10: The automated device according to Embodiment 9, wherein the maximized amplitude is within the target muscle or muscle segment for the user. Embodiment 11: An automated device according to Embodiment 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10, wherein a processor determines optimized parameters for the first, second, and third stimulation sequences based on the recorded first and second evoked potentials and stores one of the corresponding second evoked potentials in memory as a baseline. Embodiment 12: The automated device according to Embodiment 10, wherein the device transmits the next first and / or second stimulation sequence, followed by a third stimulation sequence, and the processor compares the resulting evoked potential to the baseline, the comparison being based on, but not limited to, one or more of reaction time, amplitude, morphology, area under the curve, and waveform shape. Embodiment 13: The automated device according to Embodiment 12, wherein when the comparison of the resulting evoked potential and the baseline exceeds a threshold, the device generates a warning, the threshold being pre-determined by the user or established by the processor based on published standards or stored data of previous evoked potentials. Embodiment 14: An automated device according to Embodiment 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or 13, wherein the occurrence of a monitored event is derived from at least one of SSEP data and EMG data acquired in real time from a patient, facilitated MEP, and unfacilitated MEP. Embodiment 15: An automated device according to Embodiment 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or 14, wherein the personal characteristics of the patient are at least one of the patient's height, age, gender, SSEP reaction time, and facilitated, adjusted and facilitated, or unfacilitated MEP reaction time. Embodiment 16: An automated device according to Embodiment 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15, wherein the processor calculates warning criteria for facilitated MEP according to one or more factors including, but not limited to, MEP amplitude, morphology, area under the curve, stimulus intensity of the first and / or third stimulus sequences, stimulus sequence, and stimulus pulse duration of the first and / or third stimulus sequences, and trends of one or more of these factors. Embodiment 17: An automated device according to Embodiment 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or 16, wherein the processor determines the optimal location on the patient for the placement of at least one first pair of stimulating electrodes based on the type of treatment being performed on the patient and is configured to notify the user. Embodiment 18: An automated device according to Embodiment 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or 17, wherein the processor determines when to refrain from operating during a specified period so that a stimulus sequence is not transmitted to the patient during the specified period, and the determination to refrain is notified by the execution of an evoked EMG test in progress on the patient during at least a portion of the specified period. Embodiment 19: A method for providing neurological monitoring of a patient, Providing an automated device according to Embodiments 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, or 18, Attaching at least one first pair of stimulating electrodes near a patient's peripheral or cranial nerve, wherein the peripheral or cranial nerve is located within the patient's region of interest, Attaching at least one first pair of recording electrodes to or near the patient's skull, Attaching at least one second pair of stimulating electrodes to or near the patient's skull, A method comprising attaching at least one second pair of recording electrodes near the patient's region of interest. Embodiment 20: A stimulation system for detecting and discriminating a patient's physiological response, At least one processor, At least one memory storing instructions that, when executed by the at least one processor, cause an operation, the operation being Promoting a motor evoked potential (MEP) stimulation sequence to obtain an MEP, the promoting including transmitting a first stimulation pulse to one or more of the patient's peripherals or cranial nerves via a first stimulating electrode, the one or more peripherals or cranial nerves being located within the region of interest, and the first stimulating electrode being coupled to the patient within the region of interest, After promoting, transmitting the MEP stimulation sequence to one or more regions of the patient via a second stimulating electrode to obtain an MEP response, the MEP stimulation sequence including a train of stimulation pulses, and the second stimulating electrode being coupled to the patient's scalp, Determining whether a physiological response has occurred based on the MEP, Indicating that a physiological response has occurred via a display coupled to the first and second stimulating electrodes. A stimulating system configured to perform one or more of optimizing the intensity or pulse duration or number of pulses of the pulse train of the MEP stimulation sequence, restricting to a region of interest of patient movement during transmission of the MEP stimulation, and improving the accuracy of determining whether a physiological response has occurred. Embodiment 21: The system according to embodiment 20, wherein the first stimulation pulse comprises a single stimulation pulse. Embodiment 22: The system according to embodiment 20 or 21, wherein transmitting the first stimulation pulse to one or more peripheral nerves of a patient is configured to be transmitted by an independent stimulator or a stimulator used for SSEP stimulation. Embodiment 23: The system according to any one of embodiments 20, 21, or 22, wherein the operation further comprises transmitting a second MEP stimulation sequence to one or more regions of the patient's scalp or skull via a second stimulation electrode before, during, or after facilitation, and the second MEP stimulation sequence comprises a second pulse train. Embodiment 24: The system according to embodiment 23, wherein the second MEP stimulation sequence is transmitted before the MEP stimulation sequence by an inter-train time interval, and facilitation is performed before, during, or after the inter-train time interval. Embodiment 25: The system according to any one of embodiments 21, 21, 23, or 24, wherein the operation further comprises transmitting an MEP sequence during a period after facilitation of the MEP stimulation sequence. Embodiment 26: The system according to embodiment 25, wherein the period is a pre-determined period. Embodiment 27: The system according to embodiment 25, wherein the period is dynamically adjusted based on one or more parameters of the patient and / or the type of surgery being performed on the patient. Embodiment 28: The system according to any one of embodiments 25, 26, or 27, wherein facilitation is automatically performed during a period before transmission of the MEP stimulation sequence. Embodiment 29: A system according to any one of Embodiments 20, 21, 22, 23, 24, 25, 26, 27, or 28, wherein the facilitation is manually initiated before transmitting the MEP stimulation sequence. Embodiment 30: A system according to any one of Embodiments 20, 21, 22, 23, 24, 25, 26, 27, 28, or 29, wherein the facilitation is automatically initiated by the system in response to one or more inputs from an SSEP monitoring system, an EMG monitoring system, a heart rate monitoring system, a blood pressure monitoring system, or other patient monitoring system. Embodiment 31: The system according to Embodiment 30, wherein one or more of the SSEP monitoring system, the EMG monitoring system, the heart rate monitoring system, the blood pressure monitoring system, and other patient monitoring systems are included within or are part of the claimed stimulation system. Embodiment 32: A system according to any one of Embodiments 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, or 31, wherein the MEP includes one or more waveforms. Embodiment 33: A system according to any one of Embodiments 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, or 32, wherein the processor stores the MEP as a baseline waveform. Embodiment 34: The system according to Embodiment 33, wherein the determination includes comparing one or more waveforms of the MEP with the baseline waveform. Embodiment 35: A system according to any one of Embodiments 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, or 34, wherein determining whether a physiological response has occurred includes comparing one or more characteristics of the MEP with a threshold value, and / or detecting the presence of a physiological response when one or more characteristics are greater than or equal to the threshold value. Embodiment 36: A system according to any one of Embodiments 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, or 34, wherein determining whether a physiological reaction has occurred comprises comparing one or more characteristics of the MEP to a threshold value, and / or detecting the presence of a physiological reaction when one or more characteristics are below the threshold value. Embodiment 37: A system according to any one of Embodiments 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, or 36, comprising a somatosensory evoked potential (SSEP) stimulation / acquisition system configured to use one or more identical facilitating electrodes as an MEP stimulation sequence, the SSEP stimulation / acquisition system configured to acquire one or more SSEPs during or prior to transmission of a first stimulation pulse, and an MEP acquisition system configured to transmit the MEP stimulation sequence. Embodiment 38: A system according to Embodiment 20, further comprising a stimulating electrode, and a recording electrode. Embodiment 39: A system according to any one of Embodiments 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, or 38, wherein the second stimulating electrode comprises four or more electrodes. Embodiment 40: A facilitated motor evoked potential (MEP) detection system for detecting and discriminating a patient's physiological reaction, comprising at least one data processor, and at least one memory storing instructions that, when executed by the at least one data processor, cause an operation, the operation comprising stimulating one or more regions of the patient's scalp or skull via a first stimulating electrode coupled to the patient using a first stimulation sequence, the stimulation being configured to generate an MEP, and Recording a first plurality of result waveforms via a first recording electrode coupled to a patient, wherein the first plurality of result waveforms represent un-facilitated MEPs; Using a second stimulation sequence to stimulate one or more peripheral nerves or cranial nerves of the patient via a second stimulation electrode coupled to the patient; Using a third stimulation sequence to stimulate one or more regions of the patient's scalp or skull via the first stimulation electrode, wherein the stimulation is configured to generate an MEP; Recording a third plurality of result waveforms via the first recording electrode, wherein the third plurality of result waveforms represent facilitated MEPs; Determining whether a physiological response has occurred based on the third plurality of result waveforms; A stimulation system comprising indicating whether a physiological response has occurred via a display coupled to the first stimulation electrode and the second stimulation electrode. Embodiment 41: The system according to embodiment 40, wherein the first stimulation sequence comprises a first plurality of stimulation pulses, the second stimulation sequence comprises a single stimulation pulse, and the third stimulation sequence comprises a second plurality of stimulation pulses. Embodiment 42: The system according to embodiment 40 or 41, wherein the first stimulation sequence is configured to prepare one or more regions of the brain to obtain facilitated MEPs. Embodiment 43: The system according to any one of embodiments 40, 41, or 42, wherein the first stimulation electrode is coupled to the patient's scalp, the second stimulation electrode is coupled to a peripheral nerve or cranial region of interest of the patient, and the peripheral nerve or cranial region of interest comprises one or more of the patient's limbs, hands, wrists, feet, face, and toes. Embodiment 44: The system according to any one of embodiments 40, 41, 42, or 43, wherein the first stimulation sequence is transmitted prior to the third stimulation sequence by an inter-train time interval, and the second stimulation sequence is performed before, during, or after the inter-train time interval. Embodiment 45: A system according to any one of Embodiments 40, 41, 42, 43, or 44, wherein the operation further includes stimulating using a third stimulation sequence within a period after stimulating using a second stimulation sequence. Embodiment 46: A system according to Embodiment 45, wherein the period is a pre-determined period. Embodiment 47: A system according to Embodiment 45, wherein the period is dynamically adjusted based on one or more parameters of the patient and / or the type of surgery being performed on the patient. Embodiment 48: A system according to Embodiment 45, wherein stimulating using the second stimulation sequence is automatically performed before, during, or at a predetermined time between the stimulation using the first stimulation sequence and the stimulation using the third stimulation sequence. Embodiment 49: A system according to any one of Embodiments 40, 41, 42, 43, 44, 45, 46, 47, or 48, wherein determining includes comparing a plurality of waveforms with a baseline waveform. Embodiment 50: A system according to any one of Embodiments 40, 41, 42, 43, 44, 45, 46, 47, 48, or 49, wherein determining whether a physiological reaction has occurred includes comparing one or more characteristics of the MEP with a threshold, and detecting the presence of a physiological reaction when one or more characteristics are greater than or equal to the threshold. Embodiment 51: A system according to any one of Embodiments 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50, wherein determining that a physiological reaction has occurred includes comparing one or more characteristics of the MEP with a threshold, and detecting the presence of a physiological reaction when one or more characteristics are less than or equal to the threshold. Embodiment 52: A system for detecting and discriminating a physiological reaction of a patient, comprising at least one processor, and At least one memory storing instructions that, when executed by at least one processor, cause an operation, and the operation is acquiring one or more first somatosensory evoked potentials (SSEPs), wherein acquiring includes stimulating one or more peripheral or cranial nerves of a patient in a region of interest via a first stimulation electrode acquiring a motor evoked potential (MEP), wherein acquiring includes stimulating one or more regions of the patient's scalp or skull at the patient's scalp via a second stimulation electrode determining whether a first physiological response has occurred based on the MEP, wherein the first physiological response indicates one or both of whether the patient has motor function in the region of interest and the degree thereof indicating that a physiological response has occurred via a display coupled to the first and second stimulation electrodes acquiring one or more second SSEPs, wherein acquiring includes stimulating one or more peripheral nerves of the patient via the first stimulation electrode, and the one or more second SSEPs indicate the continuity of the sensory nerve pathway, and a stimulation system comprising the acquiring Embodiment 53: A method for facilitating the detection of a motor evoked potential (MEP), comprising facilitating a motor evoked potential (MEP) stimulation sequence to acquire an MEP, wherein facilitating includes transmitting a first stimulation pulse to one or more peripheral or cranial nerves of the patient via a first stimulation electrode, the one or more peripheral or cranial nerves being located within a region of interest, and the first stimulation electrode being coupled to the patient within the region of interest after facilitating, transmitting the MEP stimulation sequence to one or more regions of the patient's scalp or skull to acquire an MEP response via a second stimulation electrode, wherein the MEP stimulation sequence includes a train of stimulation pulses, and the second stimulation electrode is coupled to the patient's scalp determining whether a physiological response has occurred based on the MEP including indicating that a physiological reaction has occurred via a display coupled to a first stimulation electrode and a second stimulation electrode facilitating is configured to perform one or more of optimizing the intensity or number of pulses of the pulse train of the MEP stimulation sequence, restricting the patient's movement to the region of interest during transmission of the MEP stimulation, and improving the accuracy of determining whether a physiological reaction has occurred, a method Embodiment 54: A non-transitory computer-readable storage medium including program code that causes an operation when executed by at least one data processor, the operation being facilitating a motor evoked potential (MEP) stimulation sequence to obtain an MEP, the facilitating including transmitting a first stimulation pulse to one or more peripheral or cranial nerves of a patient via a first stimulation electrode, the one or more peripheral or cranial nerves being located within a region of interest, the first stimulation electrode being coupled to the patient within the region of interest after facilitating, transmitting, via a second stimulation electrode, the MEP stimulation sequence to one or more regions of the patient's scalp or skull to obtain an MEP response, the MEP stimulation sequence including a pulse train, the second stimulation electrode being coupled to the patient's scalp determining whether a physiological reaction has occurred based on the MEP including indicating that a physiological reaction has occurred via a display coupled to the first stimulation electrode and the second stimulation electrode facilitating is configured to perform one or more of optimizing the intensity, pulse duration, or number of pulses of the pulse train of the MEP stimulation sequence, restricting the patient's movement to the region of interest during transmission of the MEP stimulation, and improving the accuracy of determining whether a physiological reaction has occurred, a non-transitory computer-readable storage medium Embodiment 55: An apparatus Means for promoting a motor evoked potential (MEP) stimulation sequence to obtain an MEP, wherein promoting includes transmitting a first stimulation pulse to one or more peripheral nerves or cranial nerves of a patient via a first stimulation electrode, the one or more peripheral nerves or cranial nerves being located within a region of interest, and the first stimulation electrode being coupled to the patient within the region of interest. After promotion, means for transmitting an MEP stimulation sequence to one or more regions of the patient's scalp or skull to obtain an MEP response via a second stimulation electrode, wherein the MEP stimulation sequence includes a train of stimulation pulses, and the second stimulation electrode is coupled to the patient's scalp. Means for determining whether a physiological response has occurred based on the MEP. Means for indicating that a physiological response has occurred via a display coupled to the first stimulation electrode and the second stimulation electrode. The promotion is configured to perform one or more of optimizing the intensity, pulse duration, or number of pulses of the train of stimulation pulses of the MEP stimulation sequence, restricting the patient's movement to the region of interest during transmission of the MEP stimulation, and improving the accuracy of determining whether a physiological response has occurred. Embodiment 56: The apparatus according to Embodiment 55, comprising means for performing any one of the functions described in any one of Embodiments 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, or 52. Embodiment 57: A method for performing a spinal cord treatment, Promoting a motor evoked potential (MEP) stimulation sequence to obtain an MEP, wherein promoting includes transmitting a first stimulation pulse to one or more peripheral nerves of a patient via a first stimulation electrode, the one or more peripheral nerves being located within a region of interest, and the first stimulation electrode being coupled to the patient within the region of interest. After facilitation, transmitting, via a second stimulation electrode, a motor evoked potential (MEP) stimulation sequence to one or more regions of the patient's scalp or skull to obtain an MEP response, the MEP stimulation sequence including a train of stimulation pulses and the second stimulation electrode being coupled to the patient's scalp; Determining, based on the MEP, whether a physiological response has occurred; Indicating, via a display coupled to the first and second stimulation electrodes, that a physiological response has occurred; and Facilitating being configured to perform one or more of optimizing the intensity or number of pulses of the train of stimulation pulses of the MEP stimulation sequence, restricting movement of the patient to the region of interest during transmission of the MEP stimulation, and improving the accuracy of determining whether a physiological response has occurred. Embodiment 58: A method of reducing movement of a patient during spinal surgery, facilitating a motor evoked potential (MEP) stimulation sequence to obtain an MEP, facilitating including transmitting, via a first stimulation electrode, a first stimulation pulse to one or more peripheral nerves or cranial nerves of the patient, the one or more peripheral nerves or cranial nerves being located within the region of interest and the first stimulation electrode being coupled to the patient within the region of interest; After facilitation, transmitting, via a second stimulation electrode, an MEP stimulation sequence to one or more regions of the patient's scalp or skull to obtain an MEP response, the MEP stimulation sequence including a train of stimulation pulses and the second stimulation electrode being coupled to the patient's scalp; Determining, based on the MEP, whether a physiological response has occurred; Indicating, via a display coupled to the first and second stimulation electrodes, that a physiological response has occurred; and facilitating being configured to perform one or more of optimizing the intensity or number of pulses of the train of stimulation pulses of the MEP stimulation sequence, restricting movement of the patient to the region of interest during transmission of the MEP stimulation, and improving the accuracy of determining whether a physiological response has occurred. Embodiment 59: A method for automatically facilitating the acquisition of motor evoked potentials (MEPs) in a patient undergoing a surgical procedure, comprising: providing a facilitating stimulus via an electrode positioned on a first extremity; providing a stimulus via an electrode positioned on a second skull; recording the MEP resulting from the stimulus via a second recording electrode; automatically determining, via a processor, whether the MEP is acceptable; analyzing the MEP using the processor to determine the health status of the patient's nerve; and displaying, via a display, at least one of the nerve health status and the MEP. Embodiment 60: The method according to Embodiment 59, further comprising recording a somatosensory evoked potential (SEP) resulting from the facilitating stimulus. Embodiment 61: The method according to Embodiment 60, further comprising automatically determining, via a processor, whether the SEP is acceptable. Embodiment 62: The method according to Embodiment 61, further comprising analyzing the SEP using the processor to determine the health status of the patient's nerve. Embodiment 63: The method according to Embodiment 62, further comprising displaying, via a display, at least one of the nerve health status and the SEP. Embodiment 64: The method according to any one of Embodiments 59, 60, 61, 62, or 63, further comprising providing an adjustment stimulus via an electrode positioned on a second skull before providing the facilitating stimulus. Embodiment 65: The method according to Embodiment 64, further comprising recording an adjusted MEP resulting from the adjustment stimulus. Embodiment 66: The method according to Embodiment 65, further comprising automatically determining, via a processor, whether the adjusted MEP is acceptable. Embodiment 67: The method according to Embodiment 66, further comprising analyzing the adjusted MEP using a processor and determining the health state of the patient's nerves. Embodiment 68: The method according to Embodiment 67, further comprising displaying at least one of the nerve health state and the adjusted MEP via a display. Embodiment 69: The method according to any one of Embodiments 59, 60, 61, 62, 63, 64, 65, 66, 67, or 68, further comprising automatically establishing a baseline MEP that is an MEP or an adjusted MEP via a processor. Embodiment 70: The method according to Embodiment 69, providing a next stimulus via an electrode positioned on a second skull, recording a next MEP resulting from the next stimulus, further comprising analyzing the next MEP using a processor and determining the health state of the patient's nerves by comparing the pattern of the next MEP with the pattern of the baseline MEP. Embodiment 71: The method according to Embodiment 70, wherein the pattern includes at least one of amplitude, morphology, reaction time, and signal-to-noise ratio. Embodiment 72: The method according to Embodiment 70 or 71, wherein based on the health state of the patient's nerves determined by comparing the next MEP with the baseline MEP, the processor generates a warning indicating a problem with the health state of the nerves, modifies the baseline MEP based on the next MEP, or generates an updated indication of the health state of the nerves to be displayed by a display. Embodiment 73: The method according to any one of Embodiments 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, or 72, wherein the facilitating stimulus is provided to the region of interest of the patient via an electrode positioned on a first periphery. Embodiment 74: The method according to Embodiment 73, wherein the region of interest is one or more of the patient's limbs, hands, wrists, or legs. Embodiment 75: The method according to Embodiment 73 or 74, wherein the facilitating stimulus is provided via an electrode positioned on a second peripheral nerve located within a region of interest separate from the region of interest where the electrode positioned on the first peripheral nerve is located. Embodiment 76: The method according to any one of Embodiments 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75, wherein for the facilitating stimulus, the MEP is preferentially induced to the region of interest. Embodiment 77: The method according to any one of Embodiments 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, or 76, wherein for the facilitating stimulus, the MEP is more certain than in the absence of the facilitating stimulus. Embodiment 78: The method according to any one of Embodiments 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, or 77, wherein for the facilitating stimulus, the stimulation via the electrode positioned on the second skull has a lower intensity than would normally be required to obtain a suitable MEP.

[0158] The present disclosure described herein may be described and / or illustrated separately for different variants, including figures, but it should be understood that all or some of those variants, or combinations of their components, can be combined.

[0159] Although various exemplary embodiments have been described above, any of a plurality of modifications can be added to the various embodiments. For example, the order in which the various described method steps are performed can often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps can be completely omitted. In some embodiments, optional features of various device and system embodiments can be included, and in other embodiments, they may not be included. Therefore, the above description is provided mainly for purposes of illustration and should not be construed as limiting the claims.

[0160] As used herein, when a feature or element is referred to as being "above" another feature or element, this feature or element may be directly positioned above the other feature or element, or intervening features and / or elements may be present. In contrast, when a feature or element is referred to as being "directly above" another feature or element, there are no intervening features or elements. When a feature or element is referred to as being "connected to", "attached to", or "coupled to" another feature or element, it will be understood that this feature or element may be directly connected, attached, or coupled to the other feature or element, or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected to", "directly attached to", or "directly coupled to" another feature or element, there are no intervening features or elements. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated can also be applied to other embodiments. References to a structure or feature being "adjacent" to another feature can include portions that are located above or below the adjacent feature.

[0161] The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting. For example, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. The terms "comprises" and / or "comprising", as used herein, specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / " where appropriate.

[0162] Spatially relative terms such as "under", "below", "lower", "over", "upper", etc. may be used herein for ease of explanation to describe the relationship of one element or one feature shown in the figures to another element or feature. It will be understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if the device in the figures is inverted, an element described as "under" or "beneath" another element or feature should be in an orientation "over" the other element or feature. Thus, the exemplary term "under" can encompass both upward and downward orientations. The device may be in a different orientation (rotated 90 degrees or otherwise), and the spatially relative descriptors used herein are to be interpreted accordingly. Similarly, terms such as "upwardly", "downwardly", "vertical", "horizontal", etc. are used herein for purposes of explanation only unless specifically indicated otherwise.

[0163] The terms "first" and "second" may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless specifically indicated otherwise in the context. These terms may be used to distinguish one feature / element from another. Thus, without departing from the teachings provided herein, the first feature / element discussed below could be referred to as the second feature / element, and similarly, the second feature / element discussed below could be referred to as the first feature / element.

[0164] Throughout this specification and the following claims, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", are to be interpreted as including various components in methods and articles (e.g., compositions and apparatuses including devices and methods) together. For example, it will be understood that the term "comprising" implies the inclusion of any recited element or step, without the exclusion of any other element or step.

[0165] In this specification and the claims, unless specifically designated otherwise, including when used in examples, all numbers may be read as if the word "about" or "approximately" preceded them, even if the term is not explicitly stated. The phrases "about" or "approximately" may be used to indicate that the recited value and / or position is within a reasonable predictive range of values and / or positions when describing magnitude and / or position. For example, a numerical value can have a value of ±0.1% of the recited value (or range of values), ±1% of the recited value (or range of values), ±2% of the recited value (or range of values), ±5% of the recited value (or range of values), ±10% of the recited value (or range of values), etc. Any numerical value recited herein should also be understood to include about or approximately that value, unless the context indicates otherwise.

[0166] The examples and illustrations contained in this specification are illustrative, not limiting, and show specific embodiments in which the subject matter can be practiced. As noted above, other embodiments can be utilized and derived therefrom, and thus structural and logical substitutions and changes can be made without departing from the scope of this disclosure. Specific embodiments are illustrated and described herein, but any arrangement calculated to achieve the same purpose can be substituted for the specific embodiments shown. This disclosure is intended to embrace any adaptations or variations of various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein are possible.

[0167] In the foregoing description and claims, for example, a list of elements or features may follow phrases such as "at least one of" or "one or more of". The term "and / or" may also be present within a list of two or more elements or features. Such phrases are intended to mean any one of the recited elements or features individually, or any one of the recited elements or features in combination with any one of the other recited elements or features, unless otherwise implicitly or explicitly disclaimed by the context in which they are used. For example, the phrases "at least one of A and B", "one or more of A and B", and "A and / or B" are each intended to mean "only A, only B, or both A and B". Similar interpretations are intended for lists containing three or more items. For example, each of the phrases "at least one of A, B, and C", "one or more of A, B, and C", and "A, B, and / or C" is intended to mean "only A, only B, only C, both A and B, both A and C, both B and C, or all of A, B, and C". The use of the term "based on" in the foregoing and claims is intended to mean "based at least in part on", and thus features or elements not recited are also admissible.

[0168] As used herein, a "user interface" (also referred to as an interactive user interface, graphical user interface, or UI) can refer to a network-based interface that receives input signals or provides electronic information and / or provides information to a user in response to any received input signal, including data fields and / or other control elements. Control elements can include dials, buttons, icons, selectable areas, or other perceptible marks presented via the UI that initiate the exchange of data with the device presenting the UI when interacted with (e.g., clicked, touched, selected, etc.). The UI can be implemented in whole or in part using technologies such as Hypertext Markup Language (HTML), FLASH (trademark), JAVA (trademark), NET (trademark), C, C++, web services, or Rich Site Summary (RSS). In some embodiments, the UI can be included within a stand-alone client (e.g., a thick client, a fat client) configured to communicate (e.g., send or receive data) according to one or more of the described manners. The communication can occur between the medical device or server with which it communicates.

[0169] As used herein, the term "determine" or "determining" encompasses a wide variety of actions. For example, "determining" can include calculations, computing, processing, deriving, generating, obtaining, searching (e.g., searching a table, database, or other data structure), ascertaining, etc. via hardware elements without user intervention. Also, "determining" can include receiving (e.g., receiving information), accessing (e.g., accessing data in memory), etc. via hardware elements without user intervention. "Determining" can include resolving, selecting, choosing, establishing, etc. via hardware elements without user intervention.

[0170] As used herein, the terms "provide" or "providing" encompass a wide variety of actions. For example, "providing" can include storing a value at a location in a memory device for a subsequent search, directly transmitting a value to a recipient via at least one wired or wireless communication medium, transmitting or storing a reference to the value, and the like. "Providing" can also include encoding, decoding, encrypting, decrypting, authenticating, verifying, etc. via hardware elements.

[0171] As used herein, the term "message" encompasses a wide variety of forms for communicating information (e.g., transmitting or receiving). A message can include a machine-readable aggregation of information such as an XML document, a fixed-field message, a comma-separated message, JSON, a custom protocol, etc. In some embodiments, a message can include a signal utilized to transmit one or more representations of information. Although shown in the singular, it will be understood that a message can be composed of, transmitted, stored, received, etc. in multiple parts.

[0172] As used herein, the terms "selectively" or "selective" can encompass a wide variety of actions. For example, a "selective" process can include determining one option from a plurality of options. A "selective" process can include one or more of dynamically determined inputs, pre-configured inputs, or inputs initiated by a user for making the determination. In some embodiments, an n-input switch can be included to provide a selective function, where n is the number of inputs used for making the selection.

[0173] As used herein, the terms "correspond" or "corresponding" encompass a structural, functional, quantitative, and / or qualitative correlation or relationship between two or more objects, datasets, information, etc., and preferably, this correspondence or relationship can be used to interpret one or more of the two or more objects, datasets, information, etc. as being the same or equal. Correspondence can be evaluated using one or more of a threshold, a range of values, fuzzy logic, pattern matching, a machine learning evaluation model, or a combination thereof.

[0174] In any embodiment, the generated or detected data can be transferred to a "remote" device or location, where "remote" means a location or device other than the location or device where the program is executed. For example, a remote location can be another location within the same city (e.g., an office, a research institute, etc.), another location in a different city, another location in a different state, another location in a different country, etc. Thus, when one article is indicated as being "remote" from another article, this means that the two articles can be located apart even within the same room, or at least in different rooms or different buildings, and can be at least 1 mile, 10 miles, or at least 100 miles apart. "Communicating" information refers to transmitting the data representing that information as an electrical signal via a suitable communication channel (e.g., a private or public network). "Forwarding" an article refers to any means of moving the article from one location to another, whether physically transporting the article or transporting it in another way (if possible), and in the case of at least data, includes physically transporting the medium that conveys the data or communicates the data. Examples of communication media include wireless or infrared transmission channels, as well as network connections to another computer or network device and the Internet, or include information such as email transmissions and information recorded on a website.

[0175] The examples and illustrations contained in this specification are illustrative, not limiting, and show specific embodiments in which the subject matter can be practiced. As noted above, other embodiments can be utilized and derived therefrom, and thus structural and logical substitutions and changes can be made without departing from the scope of the present disclosure. Such embodiments of the subject matter of the present invention can be referred to herein, for convenience only, by the term "the present invention," individually or collectively, and are not intended to arbitrarily limit the scope of the application to any single invention or inventive concept, in fact, when more than two are disclosed. Accordingly, specific embodiments are illustrated and described herein, but any arrangement calculated to achieve the same purpose can also be substituted for the specific embodiments shown. The present disclosure is intended to embrace any adaptations or variations of various embodiments. Upon consideration of the above description, combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art.

Claims

1. A stimulation system for detecting and discriminating a patient's physiological response, comprising: at least one processor; and at least one memory storing instructions that, when executed by the at least one processor, cause an operation, wherein the operation comprises: facilitating a motor evoked potential (MEP) stimulation sequence to obtain an MEP, the facilitating including transmitting a first stimulation pulse to one or more peripheral or cranial nerves of the patient via a first stimulation electrode, the one or more peripheral or cranial nerves being located within a region of interest, and the first stimulation electrode being coupled to the patient within the region of interest; after the facilitating, transmitting the MEP stimulation sequence to one or more regions of the patient via a second stimulation electrode to obtain an MEP response, the MEP stimulation sequence including a train of stimulation pulses, and the second stimulation electrode being coupled to the patient's scalp; determining whether a physiological response has occurred based on the MEP; and indicating that the physiological response has occurred via a display coupled to the first and second stimulation electrodes; wherein the facilitating is configured to perform one or more of optimizing the intensity or duration or number of pulses of the train of stimulation pulses of the MEP stimulation sequence, restricting movement of the patient to the region of interest during transmission of the MEP stimulation, and improving the accuracy of determining whether the physiological response has occurred. A stimulation system, characterized in that.

2. The system according to claim 1, wherein the first stimulation pulse includes a single stimulation pulse. A system, characterized in that.

3. The system according to claim 1 or 2, wherein transmitting the first stimulation pulse to the one or more peripheral nerves of the patient is configured to be transmitted by an independent stimulator or a stimulator used for SSEP stimulation. A system, characterized in that.

4. The system according to any one of claims 1, 2, or 3, wherein the operation further includes transmitting a second MEP stimulation sequence to the one or more regions of the patient's scalp or skull via the second stimulation electrode before, during, or after the facilitating, and the second MEP stimulation sequence includes a second train of stimulation pulses. A system, characterized in that. ​ **Claim 5** The system according to claim 4, wherein the second MEP stimulation sequence is transmitted before the MEP stimulation sequence by an inter-train time interval, and the promoting is performed before, during, or after the inter-train time interval, characterized in that the system is a system. **Claim 6** The system according to any one of claims 1, 2, 3, 4, or 5, wherein the operation further includes transmitting the MEP sequence within a period after the promotion of the MEP stimulation sequence, characterized in that the system is a system. **Claim 7** The system according to claim 6, wherein the period is a pre-determined period, characterized in that the system is a system. **Claim 8** The system according to claim 6, wherein the period is dynamically adjusted based on one or more parameters of the patient and / or the type of surgery being performed on the patient, characterized in that the system is a system. **Claim 9** The system according to any one of claims 6, 7, or 8, wherein the promoting is automatically performed within the period before the transmission of the MEP stimulation sequence, characterized in that the system is a system. **Claim 10** The system according to any one of claims 1, 2, 3, 4, 5, 6, 7, 8, or 9, wherein the promoting is manually initiated before the transmission of the MEP stimulation sequence, characterized in that the system is a system. **Claim 11** The system according to any one of claims 1, 2, 3, 4, 5, 6, 7, 8, or 9, wherein the promoting is automatically initiated by the system in response to one or more inputs from an SSEP monitoring system, an EMG monitoring system, a heart rate monitoring system, a blood pressure monitoring system, or another patient monitoring system, characterized in that the system is a system. **Claim 12** The system according to claim 11, wherein one or more of the SSEP monitoring system, the EMG monitoring system, the heart rate monitoring system, the blood pressure monitoring system, and the other patient monitoring system are included within the claimed stimulation system or are part of the claimed stimulation system, characterized in that the system is a system. **Claim 13** The system according to any one of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12, wherein the MEP includes one or more waveforms, characterized in that the system is a system. **Claim 14** The system according to any one of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or 13, wherein the processor stores the MEP as a baseline waveform, characterized by the system.

15. The system according to claim 14, wherein the determining includes comparing one or more waveforms of the MEP with the baseline waveform, characterized by the system.

16. The system according to any one of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15, wherein the determining whether the physiological reaction has occurred includes comparing one or more characteristics of the MEP with a threshold value, and / or detecting the presence of the physiological reaction when the one or more characteristics are equal to or greater than the threshold value, characterized by the system.

17. The system according to any one of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15, wherein the determining whether the physiological reaction has occurred includes comparing one or more characteristics of the MEP with a threshold value, and / or detecting the presence of the physiological reaction when the one or more characteristics are equal to or less than the threshold value, characterized by the system.

18. The system according to any one of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or 17, a somatosensory evoked potential (SSEP) stimulation / acquisition system configured to use one or more identical facilitating electrodes as the MEP stimulation sequence, the SSEP stimulation / acquisition system being configured to acquire one or more SSEPs during or before transmission of the first stimulation pulse, an MEP acquisition system configured to transmit the MEP stimulation sequence, further comprising, characterized by the system.

19. The system according to claim 1, further comprising the stimulating electrode, and the recording electrode, characterized by the system.

20. The system according to any one of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, or 19, wherein the second stimulating electrode includes four or more electrodes, characterized by the system.

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