Nerve monitoring system

Abstract

A brain-computer interface (BCI) system that provides more meaningful autonomy and independence to paralyzed individuals. The BCI system is used by individuals who require little or no assistance from caregivers or who have no caregivers, and includes a BCI system that provides an objective and functional measurement of the effectiveness of a motor nerve prosthesis in restoring motor output.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 367,592, filed on July 1, 2022; U.S. Provisional Application No. 63 / 502,831, filed on May 17, 2023; and U.S. Provisional Application No. 63 / 506,152, filed on June 5, 2023, the entire contents of each application being incorporated by reference.

Background Art

[0002] In most cases, the human brain functions as a well - tuned network composed of a collection of various brain regions, and each is now understood to function as an individual network of brain tissues and cells responsible for a specific purpose. Currently, statistical analysis of functional magnetic resonance imaging ( "fMRI") enables neuroscientists to map the regions of the brain responsible for specific tasks. Furthermore, it is understood that many cognitive tasks are carried out by the networking of several "functionally connected" individual brain regions. Thus, the brain can be regarded as a distributed neural network that coordinates a series of sub - networks associated with various regions of the brain, and each sub - network is associated with a specific purpose.

[0003] Currently, there are conventional techniques for accessing these regions of the brain. Such generally known techniques involve implanting electrodes within a specific area of the brain, where deep brain stimulation ( "DBS") in which the electrodes generate electrical impulses in an attempt to stimulate or regulate brain activity for treatment or other purposes, as well as electrocorticography ( "ECoG") which enables the neural monitoring of brain regions for diagnostic purposes.

[0004] DBS involves a surgical procedure to create small holes in the skull for implanting electrodes and to implant something like a controller or a pacemaker that is electrically coupled to the electrodes to control the stimulation. Typically, this device is placed under the skin of the chest. The amount of stimulation in deep brain stimulation can be controlled by a device such as a controller or a pacemaker, and wires / leads connect the controller device to the electrodes placed in the brain.

[0005] DBS can be used to treat several neurological disorders such as tremors, Parkinson's disease, dystonia, epilepsy, Tourette syndrome, chronic pain, and obsessive-compulsive disorder. In addition, deep brain stimulation has the potential for the treatment of major depression, stroke recovery, addiction, and dementia. Furthermore,

[0006] ECoG can provide a means to record high-fidelity brain activity, for example, during surgery (intraoperative nerve monitoring), and real-time brain activity recording can enable the treating surgeon to make immediate decisions to improve the safety of the treatment. Longer-term recordings are used both for seizure detection in epilepsy and for mapping to improve the safety of tumor resection by limiting the removal of healthy brain. However, ECoG requires directly placing an electrode array on the surface of the brain, for example, using a subdural or epidural array, after the brain has been exposed by a craniotomy. However, their use is extremely limited in applications.

[0007] FIG. 1 shows a conventional technique for accessing a region of the brain using a brain stimulation device 20 that includes electrodes 22 implanted within the brain 12 of an individual 10. As shown, the implantation requires a surgical penetration of the skull 14 by the device 20 such that the device 20 is directed towards the region of interest 30. In addition, leads 16 couple the device 20 to a controller / transceiver / generator 18.

[0008] There are several risks associated with the general surgery necessary to surgically implant the device 20 in a conventional DBS procedure. Further, considering that conventional procedures require approximate or non-invasive attempts to localize the area of interest 30, there are also risks in the DBS procedure itself. The physician then must attempt to physically place the electrodes 22 of the device 20 within or near the area of interest 30 such that the desired effect can be achieved. In some cases, the placement of the electrodes 20 may be a trial-and-error approach that requires multiple surgical attempts and multiple surgical insertion sites. Regardless of the number of attempts, inserting the device 20 to place the electrodes 22 within the area of interest 30 causes collateral damage to the brain tissue located within the path between the area of interest and the insertion point within the skull.

[0009] Currently, the surgical risks associated with such procedures can include intracerebral hemorrhage, stroke, infection, collateral damage to brain tissue, collateral damage to intracranial vascular structures, temporary pain, and inflammation at the surgical site. Apart from the surgical risks, DBS carries the risk of side effects of DBS if the electrodes stimulate or affect areas outside the area of interest 30. Such risks can include respiratory disorders, nausea, cardiac disorders, seizures, headache, confusion, etc. However, considering that the tissue around the device and the implantation site may heal, attempting to remove the DBS device after a certain period of time can introduce additional risks.

[0010] However, conventional approaches that are intended to access many of the brain's sub-networks are insufficient in that they cannot maximize the advantages of accessing and directly communicating / stimulating many of the brain's sub-networks.

[0011] Conventional invasive approaches involving direct brain penetration result in progressive scarring due to gliosis. Due to the invasive nature of the craniotomy and the progressive nature of the increased scarring due to gliosis, it is not feasible to remove and replace conventional DBS electrodes within the brain.

[0012] In addition to the problems discussed above, the advancement of brain-computer interface (“BCI”) technology is currently focused on both safety and enabling paralyzed individuals to use a BCI system to control electronic devices, including prosthetic hands and computers, to complete various daily tasks. The need to restore continuous and independent movement output that enables computer control in people with complete or partial paralysis. BCI systems hold promise for restoring lost nerve functions, including motor neuroprostheses (“MNPs”), to recover an individual's motor ability. Implanted MNPs can directly infer movement intent by detecting local brain signals and transmitting motor control signals from the brain to generate movement output and then control computer actions or other electronic devices. In one variant, this physiological function can be performed by motor neurons in an individual.

[0013] However, while conventional BCI systems provide some degree of autonomy to paralyzed individuals through device control, existing BCI systems today provide very limited overall autonomy to individuals with paralysis. For example, paralyzed individuals using a BCI system typically require assistance with setting up or turning on the BCI system (including charging / recharging), calibrating the system for personal use, which includes learning how an individual must think to enable useful electronic commands to be generated, and setting up the individual (as opposed to setting up the system itself, adjusting the individual's screen, antenna, and / or posture to enable use of the system).

[0014] There is a need for a BCI system that provides more meaningful autonomy and independence to paralyzed individuals. Such meaningful autonomy and independence can be provided by a BCI system that requires little caregiver support or is used by individuals without a caregiver. There remains a need for an objective and functional measurement of the effectiveness of MNP in restoring motor output. One such method relies on the concept of digitized motor output (DMO), which is the motor output directly decoded from neural recordings when an individual attempts limb movement, and a BCIU converts this neural intent into commands to control an electronic device. DMO can be classified as a discrete and continuous representation of motor control and has various degrees of freedom.

[0015] The need for at least intermittent independence of the patient can also benefit the patient in cases where the caregiver does not understand the patient's needs or to communicate to a third party the patient's dissatisfaction or fear of the caregiver.

Prior Art Documents

Patent Documents

[0016]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

Patent Document 9

[0017] [Non-Patent Document 1] Classen, J. (2019). Detection of Brain Activation in Unresponsive Patients with Acute Brain Injury. The New England Journal of Medicine, 380(26), 2497-2505

Summary of the Invention

Means for Solving the Problems

[0018] The ability to access the functionally distributed networks of the brain, which enables direct access to, monitoring of, and / or communication with specific regions of the brain, can enable technological improvements in several fields, including but not limited to improvements in healthcare, quality of life, use of technology by individuals, and communication within groups of networked individuals. For example, this direct access to the neural distributed network can enable improvements in conventional healthcare treatments for individuals and / or improvements in machine control by individuals. In additional variations, the ability to directly access, monitor, and / or communicate with an individual's neural distributed network enables improved communication with individuals and / or improved communication between individuals configured such that their respective neural distributed networks are directly networked.

[0019] The present disclosure includes one or more methods for adjusting a neural interface by monitoring an individual's neural activity, the neural interface comprising a neural monitoring device operably connected to a control unit, the control unit being configured to generate an output control signal for interacting with an external electronic device, the method including the following. For example, such a method may include providing a signal from a neural monitoring device embedded within an individual to the control unit, the signal representing the individual's neural activity, detection of a predetermined neural activity causing the control unit to generate an output control signal, and determining an activity level of the individual by monitoring the individual's neural activity. The control unit is configured to adjust the neural interface from a first operating configuration to a second operating configuration when it determines that the activity level meets a first predetermined condition, and the power consumption of the neural interface in the first operating configuration is different from the power consumption of the neural interface in the second operating configuration.

[0020] A variation of the method includes a first predetermined condition including the individual's sleep state, and the step of determining the activity level includes determining the individual's sleep state by evaluating neural activity for a neural sleep metric. The first predetermined condition can include the inability to generate an output control signal within a predefined period.

[0021] In an additional variation, the control unit can be further configured to adjust the neural interface from a first operating configuration to a second operating configuration when the output control signal is associated with an idle command instruction.

[0022] The neural interface can be configured to provide a perceptible feedback to an individual to indicate whether it is in a first operating configuration or a second operating configuration. The neural interface can be configured to enable the individual to keep the neural interface in the first operating configuration. A variant of the control unit can be further configured to send an idle signal to an external electronic device when adjusting to, or before adjusting to, the second operating configuration.

[0023] Another variant of the method includes the step of determining the activity level of an individual by monitoring the neural activity of the individual while the neural interface is in the second operating configuration, and the control unit is further configured to adjust the neural interface from the second operating configuration to the first operating configuration when it is determined that the activity level meets a second predetermined condition.

[0024] The control unit can be further configured to adjust the neural interface from the second operating configuration to the first operating configuration when the output control signal is associated with an active command instruction. The control unit can be further configured to adjust the neural interface from the second operating configuration to the first operating configuration when the individual generates at least one output control signal.

[0025] Another variant of the method described herein includes a method of changing the frequency of communication within the neural interface by monitoring the neural activity of an individual, the neural interface comprising a neural monitoring device operably configured to communicate with the control unit at a communication speed, and the control unit being configured to generate an output control signal for interacting with an external electronic device.

[0026] An example of such a method can include the step of providing a signal from a nerve monitoring device embedded within an individual to a control unit, where the signal represents the individual's nerve activity and detection of a predetermined nerve activity causes the control unit to generate an output control signal, and the step of determining the individual's activity level by monitoring the individual's nerve activity. The control unit is configured to change a nerve interface from a first operating configuration to a second operating configuration when it determines that the activity level meets a first predetermined condition, and the communication speed in the first operating configuration is different from the communication speed in the second operating configuration.

[0027] Another example of a method according to the present disclosure is to provide a brain-computer interface configured to monitor the nerve activity of a paralyzed individual, where the brain-computer interface includes a nerve monitoring device operably connected to a control unit, the control unit is configured to generate an output signal for interacting with an external electronic device, and the brain-computer interface is configured to enter an idle mode in which the brain-computer interface consumes less power than in the active mode, and to receive an activation signal from the paralyzed individual to switch the brain-computer interface from the idle mode to the active mode, thereby enhancing the autonomy of the paralyzed individual in operating the external electronic device.

[0028] In such a method, the step of coupling the control unit and the external electronic device can include the step of shortening the calibration time of the brain-computer interface when entering the active mode. The control unit and the external electronic device can be wirelessly coupled.

[0029] Variations of the method include a brain-computer interface configured to couple to a recharge power source by a paralyzed individual or to transmit operational data from the brain-computer interface to a remote electronic dashboard, the remote electronic dashboard enabling the individual to monitor the activity of the brain-computer interface. The brain-computer interface can be configured to wirelessly transmit operational data from the brain-computer interface to the remote electronic dashboard. The brain-computer interface can be configured to have a latency of 5 seconds or less (however, any longer duration is also within the scope of the present disclosure).

[0030] Another method of enhancing the autonomy of a paralyzed individual in operating an external electronic device is to provide a brain-computer interface configured to monitor the neural activity of the paralyzed individual, the brain-computer interface comprising a nerve monitoring device operably connected to a control unit, the control unit being configured to generate an output control signal for interacting with the external electronic device in response to the neural activity of the paralyzed individual associated with a cue signal generated by the brain-computer interface, and calibrating the brain-computer interface within a minimum period, enabling the paralyzed individual to activate the output control signal after a certain period of non-use of the brain-computer interface by the paralyzed individual.

[0031] Yet another variation of a method for enhancing the autonomy of a paralyzed individual to operate an external electronic device can include the step of providing a brain-computer interface configured to monitor the neural activity of the paralyzed individual. The brain-computer interface includes a neural monitoring device operably connected to a control unit. The control unit is configured to generate an output control signal for interacting with the external electronic device when the paralyzed individual generates neural activity in response to a cue generated by the brain-computer interface. The brain-computer interface includes a high-precision interface ratio, which is a measurement of intentional neural activity associated with a cue relative to neural activity not associated with the cue. The high-precision interface ratio includes 95%.

[0032] The present disclosure also includes a brain-computer interface for enhancing the autonomy of a paralyzed individual when operating an external electronic device. An example of such a brain-computer interface can include a neural monitoring device configured to detect neural activity from the paralyzed individual and a control unit operably connected to the neural monitoring device. The control unit is configured to generate a cue on a display, where the cue is associated with one or more commands, and when the paralyzed individual generates neural activity associated with the intention to select the cue, the control unit generates an output control signal for interacting with the external electronic device. The control unit is configured to generate the cue and the output control signal within the shortest possible time.

[0033] Another example of a brain-computer interface system for enhancing the autonomy of an individual interacting with an electronic device when the individual is completely or partially paralyzed, the brain-computer interface system includes a nerve monitoring device coupled to the individual and configured to detect nerve activity from the individual, and a control unit operably coupled to the nerve monitoring device and removably coupled to the individual, the control unit being configured to interact with the electronic device when the individual generates nerve activity, and the nerve monitoring device is further configured to electronically communicate with an electronic network such that when the control unit is detached from the individual, the individual can maintain a state of being able to communicate with the electronic network using nerve activity. Examples of nerve monitoring devices include an implant configured to be disposed adjacent to or within nerve tissue, and an internal unit that communicates electrically with the implant. Alternatively, the device can be an external device, a transcutaneously disposed device, an intravascularly disposed device, or any combination of the foregoing.

[0034] In one variation, the brain-computer interface system includes a nerve monitoring device configured to electronically communicate with an electronic network independently of the control unit. Alternatively, or in combination, the nerve monitoring device is configured to electronically communicate with the electronic network using the control unit.

[0035] In the case where an individual is completely or partially paralyzed, another variant of a brain-computer interface system for enhancing the autonomy of an individual interacting with an electronic device includes a nerve monitoring device coupled to the individual and configured to detect nerve activity from the individual, and a control unit operably coupled to the nerve monitoring device and removably coupled to the individual, the control unit being configured to interact with the electronic device when the individual generates nerve activity, and the control unit is further configured to communicate electronically with an electronic network so as to maintain a state in which the individual can communicate with the electronic network using nerve activity when the electronic device is detached from the individual.

[0036] The present disclosure also includes a method for enhancing the autonomy of an individual using a brain-computer interface in the case where the individual is completely or partially paralyzed, the method including the steps of disposing a nerve monitoring device inside or on the body of the individual, the nerve monitoring device being configured to detect nerve activity from the individual; detaching a control unit from the individual, the control unit being configured to be operably coupled to the nerve monitoring device and configured to interact with one or more electronic devices when the individual generates nerve activity; and coupling the nerve monitoring device to an electronic network so as to maintain the ability of the individual to communicate with the electronic network using nerve activity.

[0037] The method can further include the step of coupling the nerve monitoring device to the electronic network by using the control unit to couple the nerve monitoring device to the electronic network when the control unit is detached from one or more electronic devices.

[0038] In another variant, the method can include coupling the nerve monitoring device to the electronic network by coupling the nerve monitoring device to the electronic network without using a control unit. Another variant includes that the step of coupling the nerve monitoring device to the electronic network includes the step of disconnecting the control unit from the individual.

[0039] In any of the above methods, the nerve monitoring device can include an implant configured to be placed adjacent to or within nerve tissue, and an internal unit that communicates electrically with the implant.

Brief Description of the Drawings

[0040]

Figure 1

Figure 2A

Figure 2B

Figure 3

Figure 4A

Figure 4B

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Best Mode for Carrying Out the Invention

[0041] The method and device are related to electrodes configured to directly access, monitor, and / or communicate with specific regions or sub-networks of the brain via a vascular approach for the purpose of using direct access to transmit and receive data between an individual's brain and various sub-networks of the associated nerves. As discussed below, the use of such data directly communicated between these nerve sub-networks can improve any number of areas, including but not limited to medical applications, control of machines and electronic devices, real-time feedback for goal-directed activities, and communication and consumer goods.

[0042] Figure 2A shows a diagram of the cerebral cortex of the brain 12 having a network of blood vessels 40 supplying various regions of the cerebral cortex of the brain 12. The methods and devices described herein use the blood vessels 40 to place one or more electrodes adjacent to a particular region of the brain. Various methods can include steps of using veins and / or arteries for placement of the device. In certain variations, the electrodes are placed within a vein to reduce the likelihood of inadvertently reducing or stopping blood flow to the brain tissue. Further, as discussed below, the device can be placed entirely within the blood vessel. However, variations can include the use of a device or structure that penetrates the wall of the blood vessel.

[0043] Figure 2B is a diagram of the brain 12 with the blood vessels to various cytoarchitectonic regions (C1 - C46) of the cerebral cortex omitted. These regions correspond to Brodmann areas based on the organization of neurons observed within the cerebral cortex corresponding to various cortical functions of the cerebral cortex. C1, C2, and C3 represent the primary somatosensory cortex within the postcentral gyrus, C4 is the primary motor cortex, C5 is the superior parietal lobule, C6 is the premotor cortex and supplementary motor cortex, C7 is the visual motor cortex, C8 includes the frontal eye fields, C9 is the dorsolateral prefrontal cortex, C10 is the anterior prefrontal cortex (the most rostral part of the superior and middle frontal gyri), C11 is the orbital prefrontal cortex (the orbital and straight gyri, plus a part of the rostral part of the superior frontal gyrus), C17 is the primary visual cortex (V1), C18 is the secondary visual cortex (V2), C19 is the visual association cortex (V3, V4, V5), C20 is the inferior temporal gyrus, C21 is the middle temporal gyrus, C22 is a part of the superior temporal gyrus included within Wernicke's area, C37 is the fusiform gyrus, C38 is the temporal pole region (the most rostral part of the superior and middle temporal gyri), C39 is the angular gyrus which some consider to be part of Wernicke's area, C40 is the supramarginal gyrus which some consider to be part of Wernicke's area, C41 and C42 are the auditory cortex, C44 and C45 are Broca's area including the opercular and triangular parts of the inferior frontal gyrus, and C46 is the dorsolateral prefrontal cortex.

[0044] The devices, methods, and systems described herein can claim the benefits of, or be combined with, intravascular carriers, and electrode arrays, and systems / methods using nerve signals, disclosed in U.S. Patent No. 10,575,783, issued March 3, 2020, U.S. Patent No. 10,485,968, issued November 26, 2019, U.S. Patent No. 10,729,530, issued August 4, 2020, U.S. Patent No. 10,512,555, issued December 24, 2019, U.S. Publication No. 2019 / 0358445, published November 28, 2019, U.S. Publication No. 2018 / 0303595, published October 25, 2018, U.S. Publication No. 2020 / 0352697, published November 12, 2020, U.S. Publication No. 2019 / 0038438, published February 7, 2019, U.S. Publication No. 2020 / 0078195, published March 12, 2020, U.S. Publication No. 2019 / 0336748, published November 7, 2019, U.S. Publication No. 2020 / 0016396, published January 16, 2020, U.S. Publication No. 2020 / 0363869, published November 19, 2020, U.S. Application No. 17 / 093,196, filed November 9, 2020, PCT Applications PCT / US2020 / 060780 and PCT / US2020 / 059509, both filed November 6, 2020, U.S. Provisional Application No. 63 / 003,480, filed April 1, 2020, U.S. Provisional Application No. 63 / 057,379, filed July 28, 2020, and U.S. Provisional Application No. 63 / 062,633, filed August 7, 2020. The entire content of each of these is hereby incorporated by reference in its entirety.

[0045] FIG. 3 shows an additional variant of the intravascular electrode array as part of the micro wire monitoring / stimulation probe 100. As shown, the probe 100 includes one or more distal electrodes 108 disposed on a helical or sinusoidal portion 106 of the micro wire 102. As discussed below, the non-linear distal portion 106 comprises a non-invasive tip 104 that enables the temporary fixation of the electrodes 108 and the distal portion 106 within the blood vessels of the brain without causing trauma to the blood vessels or the brain. The non-linear shape 106 provides juxtaposition of the wire against the blood vessel wall and can function to place the electrodes 108 in contact with the blood vessel wall. The non-linear distal portion 106 can include a nitinol material or core that enables the device to assume a non-linear shape when not restrained or when activated with a current. Examples of micro wires can be found in U.S. Pat. No. 6,260,458, U.S. Pat. No. 6,428,489, U.S. Pat. No. 6,431,039, U.S. Pat. No. 6,440,088, U.S. Pat. No. 6,553,880, U.S. Pat. No. 6,579,246, and U.S. Pat. No. 6,766,720, the entireties of each of which are incorporated by reference.

[0046] In an additional variant, the entire micro wire 102 can comprise a shape memory alloy. In most variants, the device 100 is configured to be removable from the blood vessel, for example, by pulling on the proximal end of the micro wire 102. Additional variants of the device 100 include a non-linear shape 106 in the electrode region, which can range from a helical shape to a simple bent shape or any shape that enables fixation to the delicate blood vessels of the brain. Alternatively, the series of electrodes 108 can be disposed on any structure that provides fixation but does not restrict blood flow within the blood vessel.

[0047] The micro wire 102 is typically sized in terms of length and diameter so as to be advanced into the remote vasculature within the brain. For example, the diameter of the micro wire 102 can range from 0.010 to 0.018 inches. However, the size of the micro wire should be selected to enable advancement of the electrode portion into remote regions of the brain. Alternatively, the proximal portion of the micro wire 102 can have a larger diameter than the intermediate and distal regions to enable improved extrudability of the wire 102. The proximal end 112 of the micro wire 102 is coupled to a connector base 110 that communicates with monitoring software or other electronic / computing device 120 using either a wireless connection or a wired connection.

[0048] In addition to being non-invasive, variations of the monitoring probe 100 described herein are configured to be removable when used for short periods of time. Alternatively, variations of the monitoring probe can be left implanted for months and / or years. In any case, the device 100 can have an anti-thrombotic coating (e.g., heparin) that inhibits blood clotting.

[0049] Figure 4A shows a first variant of a system for directly accessing and monitoring a specific region or subnetwork of the brain 12 via a vascular approach. In this variant, the micro-wire monitoring probe device 100 is advanced through the vasculature into the blood vessel 40 within the brain 12. The illustrated variant is shown to be implanted for a surgical procedure that provides monitoring of the brain during the procedure. In this variant, the device 100 can be removed after the procedure or left implanted during a post-procedure monitoring period. Thus, the proximal portion of the micro-wire 102 extends through one or more incisions 8 within the individual 10 for coupling to the controller 110 or another connector base. The system shown in Figure 4A includes a single device 100 for illustrative purposes. In practice, any number of micro-wire monitoring probe devices can be used. Further, the device 100 can be positioned using a micro-catheter (not shown) that constrains the electrode portion 106 until it is deployed. Alternatively, a caregiver can advance the device 100 directly in a linear configuration. Once positioned within the desired region, the caregiver can apply a current to the device to convert the electrode portion 106 from a linear configuration to a non-linear configuration so that the device remains fixed in the desired location.

[0050] As shown, the distal portion of device 106 is configured to detect neural activity and remain temporarily fixed within a blood vessel. Device 100 is deployed within a blood vessel adjacent to region of interest 50. In this example, region of interest 50 represents an area of brain tissue intended to be removed or inactivated. Such procedures can include removal of tumors, removal of brain tissue to reduce epileptic seizures, treatment of arteriovenous malformations in the brain, and the like. In conventional techniques, dyes are used to identify target region 50. Placing one or more devices 100 within a blood vessel adjacent to or surrounding target region 50 enables monitoring of neural signals at the site of device deployment. Neural signals can be monitored before, during, and after injection of the dye to confirm the effect of the dye or treatment.

[0051] As shown in FIG. 4B, in an additional variant, the device described herein can replace or enhance the Wada test, which is performed on epileptic patients under consideration for surgery. The Wada test, also known as the intracarotid sodium amobarbital procedure (ISAP), establishes the language and memory representation of the brain in each hemisphere. In the test, which is performed with the patient awake, a physician introduces a barbiturate (e.g., sodium amobarbital) into one of the internal carotid arteries via a cannula or an intra-arterial catheter. The physician injects the drug into the right or left internal carotid artery of one hemisphere at a time to suppress each side of the brain. For example, when the drug is injected into the right carotid artery, the right side of the brain is suppressed and cannot communicate with the left side of the brain. This allows the physician to observe the impact on any language or memory functions in that hemisphere in order to evaluate the other hemisphere. The test can also involve EEG recording to confirm that the affected side of the brain is inactive. The physician can then involve the patient in language- and memory-related tests. The device can enable the physician to place the device 100 within a specific cytoarchitectonic region of the brain (see FIG. 2B) to record activity while providing various memory, language, or psychomotor tasks that activate the brain. Detecting neural activity during the test can enable mapping where in the brain that task is occurring. Once mapped, the physician can determine whether to perform treatment / removal of the area of interest 50 and the potential consequences of doing so. In addition, the device 100 can be used to monitor various regions of the brain during and after the procedure.

[0052] In another variant, such as shown in FIGS. 4A and 4B, the device 100 can be placed within a specific cytoarchitectonic area of the brain (see FIG. 2B) to assist in the safe endovascular embolization of arteriovenous malformations or malignant tumors, either intra-arterially or intravenously. The use of nerve monitoring during endovascular embolization involves recording evoked potentials from the brain using scalp-based EEG techniques. Somatosensory evoked potentials are triggered by electrical impulses transmitted via electrical stimulation of the lower limbs and are recorded from the sensory cortex via EEG. To confirm that the artery targeted for embolization does not supply normal brain, an anesthetic such as lidocaine is injected into the artery. Any decrease in the evoked potentials recorded during or immediately after the injection of lidocaine may indicate potential brain damage that could occur if the embolic agent is subsequently injected into the target artery. Intracranial intravascular ECoG recording is significantly more sensitive than scalp-based EEG and may present an opportunity to improve the safety of intraoperative nerve monitoring during arterial embolization.

[0053] The system described in FIGS. 4A and 4B is well-suited for intraoperative and postoperative monitoring of a patient with little patient movement, such that the micro-wires 102 can extend from one or more incisions 8 of the individual 10. FIG. 5 shows a variant of a system comprising a plurality of micro-wire monitoring probes 100 coupled to one or more monitoring devices 130. The monitoring device 130 can be fully or partially implanted within the patient 10. Alternatively, the monitoring device 130 can be placed extracorporeally, but is capable of aseptically coupling to the probe 100. One purpose of the system shown in FIG. 5 is to provide inpatient or outpatient monitoring of the individual 10. In such cases, the probe 100 remains within a specific area of the brain 12 for several days or months.

[0054] One use of the system shown in FIG. 5 involves monitoring epileptic patients, particularly those who do not respond positively to drug therapy. In such cases, any number of probes 100 are placed within various regions of the brain 12. The probes 100 are coupled to a monitoring device that communicates 150 with any number of electronic interface devices (e.g., personal electronic device 140 or computer system 120) via either a wired or wireless connection. The patient 10 then discontinues the seizure medication for a period of time, during which the system monitors the brain activity via the probes 100. The activity is then analyzed to determine the regions of the brain associated with the seizure, including the regions that were active prior to the seizure and / or the regions that caused the seizure. The implanted system allows for monitoring over a period of days or months. Current methods for determining the brain regions associated with seizures involve craniotomy, which involves removing the skull or a portion of the skull to access the regions of the brain. The system shown in FIG. 5 performs brain region seizure mapping using vascular techniques. In additional variations, the systems described herein can be used in addition to conventional treatments.

[0055] The implanted unit 130 can include an amplifier, a filter, a controller, data storage, a power source, and wireless communication equipment (e.g., RF, Bluetooth, etc.). Such equipment allows for the capture of data over a relatively long period of time in order to provide the individual with mobility while being evaluated.

[0056] In addition to brain mapping, by being implanted over a longer duration, the systems described herein can provide a warning system for patients prone to seizures. For example, the implant 100 can monitor various regions of the brain 12 and, if the system detects that an individual has a high risk of having a seizure, can provide a notification via an external device (e.g., 140) or the monitoring device 130. In such cases, the individual can take precautions and avoid environments that pose an additional risk of a seizure (e.g., driving, bathing, exercising, etc.). The system can also provide various levels of warnings, such as low-risk, medium-risk, and high-risk seizures, which can enable the affected individual to be more free from sudden unexpected seizures.

[0057] In another variation, the systems described herein can also function as a neuromonitoring diagnostic system that detects electrophysiological biomarkers in patients suffering from brain contusions who do not respond in other ways. Detection of the biomarker can be an indicator of the patient's recovery. An example of such a response is discussed in Classen, J. (2019). Detection of Brain Activation in Unresponsive Patients with Acute Brain Injury. The New England Journal of Medicine, 380(26)2497-2505.

[0058] For example, when coma, stroke, hypoxic brain injury, or any brain injury renders a patient clinically unresponsive. The use of the system described herein can evaluate an unresponsive patient for evidence of brain activation using ECoG in response to external stimuli including auditory stimuli (e.g., voice commands, familiar voices, etc.) and / or physical stimuli. In one variation, the purpose of the stimuli is to elicit a change in the brain state by interacting with the unresponsive patient. The nerve monitoring system can then provide a user interface / user exchange to the caregiver to provide various information regarding the patient's state. For example, the user interface can provide a prediction of the outcome, degree of recovery, and / or measurement of improvement in the unresponsive patient over time. The measured response to the external stimuli can be compared to a dataset to predict the patient's recovery pattern. The dataset is cloud-based and can be updated based on machine learning algorithms that provide normalization of the data to provide an assessment of the patient's state, such as highly likely to improve or unlikely to improve.

[0059] The nerve monitoring system can also be combined with an evoked test, in which the patient is monitored at rest to determine activity and then monitored again after anesthesia is applied to the patient or a specific area of the patient's brain. The difference in the measured signals can be an indicator of brain function.

[0060] The use of the system described herein as a neural monitoring system, for example, enables the placement of one or more intravascular electrode arrays in the motor regions of the brain. However, the arrays can be placed in any number of regions of the brain. The implantation of the electrodes can be temporary, and the arrays are removed after patient monitoring. Alternatively, the arrays can be implanted for a longer period of time for enhanced patient monitoring. In either case, the proximal end of the array may desirably be directly coupled to a controller / transceiver / generator that is not implanted in the patient (see, e.g., FIG. 3).

[0061] FIG. 6 shows another use of the system described herein that uses a distributed neural network of the brain for improved technical control, movement control, sensory feedback, and communication with an individual. For example, FIG. 6 shows an enlarged view of the brain 12 of an individual 10 having any number of micro-wire probes 100 disposed within blood vessels 40 associated with specific individual cell architecture regions of the brain 12 (e.g., C1, C19, and C42). Placing implants within individual regions or networks of the brain enables sensory stimulation or neural signal measurement in different regions of the brain to improve communication of data with an individual. In the illustrated example, the cell architecture regions are associated with the auditory, sensory, and visual regions of the brain 12. However, these regions are selected for illustrative purposes only. Additional variations of the systems and methods disclosed herein include any number of probes 100 arranged to be associated with any number of cell architecture regions of the brain.

[0062] As shown in FIG. 6, the probe 100 is coupled to the control unit 130 via a micro wire 102 that extends through the additional blood vessel 40. As will be described below, the probe 100 enables data transfer between various regions of the brain 12 to provide improved communication of information with the individual 10 and improved control of the probe 100 and the networked electronic devices with the control unit 130. The regions shown in FIG. 6 are useful for the data supplied to the individual. In additional variations, the regions of the brain useful for the data supplied from the individual can include the same or different regions of the brain. For example, such regions can include regions of the brain responsible for language, decision prediction, motor control, emotion, and the like.

[0063] FIG. 7 shows an example of a system described herein that uses the distributed neural network of the individual 10 for improved communication of data with the individual 10 and for improved interaction with any type of external device or machine 70. FIG. 7 shows an airplane or drone 72, and an automobile 74 for purposes of illustrating improved communication or data transfer. Clearly, the present disclosure can include any machine or device configured for interaction with the individual 10.

[0064] In a conventional system, an operator uses a remote control device with an electronic interface that includes a screen for providing various data on the operating parameters of a drone (e.g., speed, altitude, fuel, direction, etc.). The operator must observe these parameters in order to respond to any changing situation of the operating parameters. Next, the operator must formulate thoughts about any subsequent actions, and then, in order to execute any corrective measures, the operator must perform a physical act of providing the corrective measures to the drone. The operator can perform these actions quickly, but there is a time delay between a change in the state of the drone, observing the change in state, and then performing a physical corrective action to control the drone. The reaction speed of a vehicle operator requires that thought be carried from the origin in the cortex through the spinal cord and peripheral nerves and ultimately trigger muscle activity to execute a conscious command. The device (Figure 5) enables information transfer at a speed superior to that of an unmodified human body.

[0065] In a system such as that shown in Figure 7, data 64 regarding the operating parameters of the drone can be transmitted directly to the network 62 or to an electronic device 140 that interfaces with the control unit 130 of the system described herein. (As discussed above, the use of a separate electronic unit 140 is optional for all examples discussed herein.) As described above (see Figure 6), various probes can be placed within different cytoarchitectonic regions so that the information 62 transmitted to an individual can trigger the stimulation of a particular cytoarchitectonic region. For example, if the drone is ascending in altitude, the system can stimulate a first region of the brain, and if the drone is losing airspeed, the system can stimulate a second region of the brain. The operator is trained to recognize the various stimulations in order to react accordingly. This direct transmission of data from the machine 70 to the system and the individual 10 enables high-fidelity control of the drone.

[0066] Additionally, the system can enable an individual 10 to use brain activity generated in a specific cytoarchitectonic region to issue control commands to a drone. For example, if the individual 10 determines that the drone needs a course correction (e.g., move to the right), an implant placed in the individual's motor region picks up the individual's brain activity that can generate thoughts of motor activity on the right side (e.g., push down with the right foot or activate the muscles on the right side). This neural activity is then transmitted via data 62, through network 60 or directly to drone 72, such that the drone receives data 64 to automatically correct its course. In both examples described herein, the system enables direct communication between individual regions of the brain and an external machine 70 that requires control. The system enables improved control of machine 70, as well as improved perception of the operating state of the machine. The above description discusses the use of cytoarchitectonic regions that control motor activity, but is not limited to, any number of cytoarchitectonic regions can be used, including regions that control emotional broadcast, language, decision-making prediction, visuospatial perception, auditory perception, and sensory perception (e.g., touch, smell, taste, etc.).

[0067] In yet a further variant, the system shown in FIG. 7 can use artificial intelligence or external data generated by network 60, independently of or indirectly from machine 70. For example, if an implant is placed within the sensory area of the brain, triggering the implant can generate a perception of a smell, taste, or similar sensory feed associated with a warning of some predetermined condition. As an example, if individual 10 is in enemy territory and either drone 72 or a satellite has identified an area of actual or potential danger, the implant can be triggered to generate a specific perception associated with the area of actual or potential danger. The perception can be triggered to increase as the individual moves towards the area and decrease as they move away. Alternatively, or in addition, this additional data can be used to feed the position of the enemy through the visual cortex and can be represented in a geospatial representation through the brain of individual 10 to generate a direct visual feed to the brain from a control station.

[0068] FIG. 8 shows another variant that uses a distributed neural network for improved communication of data with individual 10. In this variant, the embedded micro-wire sensors can be embedded in the area of the brain corresponding to the prefrontal cortex responsible for decision-making. Thus, the embedded probe can generate signals that predict a decision. Such a function can be used when individual 10 is in a situation where they are faced with making a difficult decision (e.g., a soldier, law enforcement, firefighter, etc.). The system can transmit data 66, 68 to a monitoring site 80, which can attempt to actually predict how the individual will make a decision and then interact with the individual to assist, aid, or prevent an action.

[0069] In a further variant, a tactical subject during a mission with restricted communication with a base command, such as an astronaut, uses the system for better communication (e.g., with another astronaut or mission control). The device (FIG. 5) enables monitoring of the real-time cognitive activities of the astronaut across the distributed cognitive area (FIG. 2B) that supports decision-making. For example, it can monitor emotional arousal broadcasts, decision-making predictions, and motor functions. Mission control or an additional individual can further provide information to the cognitive area of the subject that can be received in various forms of perception, including sensation, hearing, vision, and smell. For example, geospatial information that supports decision-making during the mission can be directly supplied to the visual cortex, and an auditory feed can be directly supplied to the auditory cortex. The astronaut can then perform the mission with higher accuracy by utilizing the flow of information that directly enters and exits the cortex.

[0070] Figure 9 shows another variant of using a distributed neural network by creating an inter-brain network between at least two individuals 10, 11, each having a micro-wire monitoring / stimulation probe 100 disposed within a respective specific cytoarchitectonic region of their brain. Figure 9 shows two individuals 10, 11 for purposes of illustration. However, the present disclosure can include any number of individuals. As described herein, data transfers 66 and 68 between individuals can be dependent on network 60 or can occur directly via a local network or a private network. Also, as discussed, the system can include one or more electronic devices 140, 142 that communicate with control units 130, 132 that couple the probes, or the electronic devices 140, 142 can be integrated into the control units 130, 132, respectively. The example shown in Figure 9 enables linking two individuals 10, 11 via any number of means, depending on the placement of the devices, particularly the cytoarchitectonic regions of the brain. In one example, the implant can be placed within a region of the brain responsible for emotional responses such that each individual can recognize the emotional components of other individuals. Such networking is not limited to emotions and can include connecting any region of the brain to directly provide data communication between individuals for sensations, movement, language, hearing, vision, taste, smell, etc.

[0071] In a variant, the tactical cohort of subjects utilizes networked brain functions to achieve an excellent level of information flow between groups. The ability to cooperate as one connected organism enables excellent group capabilities to achieve a common goal. In one example, a bright flash from an explosive can be seen not only by the direct witnesses of the explosion but also by the entire group. The injury of one member of the group can be felt by the entire group. The shared awareness across cognitive regions enables the group to perform at a higher function.

[0072] Although FIGS. 7-9 above are illustrated for separate uses, it should be noted that combining each use or a part of each use is within the scope of the present disclosure.

[0073] In addition to the uses described above, the neural interface system described herein can provide an implantable brain-computer interface (BCI) for people with severe paralysis, enhancing people's autonomy by restoring the ability to perform daily life functions and activities with minimal intervention from caregivers compared to current standard care. Thus, the BCI system described herein may require an "always-on" function. For battery-powered systems, charging requires caregiver support, so minimizing power consumption is prioritized. Additionally, the BCI system may require continuous streamed data to provide the user with low-latency control of the target device.

[0074] Conventionally, achieving an "always-on" function in battery-powered systems has been difficult due to the high power consumption of BCI recording hardware and decoding algorithms.

[0075] Since the system described herein already has access to the user's neural data, it can alleviate concerns related to an "always-on" system. Thus, a variant of the system described herein can provide different operational configurations depending on the user's activity. For example, the operational configurations can include various energy consumption states such that one operational configuration is a low-power usage configuration. The BCI can enter this low-power usage state either by the user selecting this configuration using a control interface or automatically if the system is already monitoring the user's neural activity.

[0076] For example, the systems described herein can adjust a neural interface by monitoring an individual's neural activity. The neural interface can comprise a neural monitoring device (such as an implant described herein) operably connected to a control unit. The operable connection can include a wired connection, a wireless connection, infrared, sound, and / or vibration. The control unit can be configured to generate an output control signal for interacting with an external electronic device. Variations of the control signal include an implanted control unit or an external telemetry unit. One variation of the system and / or method is to provide a signal from a neural monitoring device implanted within an individual to a control unit, the signal representing the individual's neural activity, and the detection of a predetermined neural activity causing the control unit to generate an output control signal, and to determine the individual's activity level by monitoring the individual's neural activity, wherein the control unit is configured to adjust the neural interface from a first operating configuration to a second operating configuration when it determines that the activity level meets a first predetermined condition, and the power consumption of the neural interface in the first operating configuration is different from the power consumption of the neural interface in the second operating configuration.

[0077] In one variation, the first predetermined condition includes the individual's sleep state, and determining the activity level includes determining the individual's sleep state by evaluating neural activity for a neural sleep metric. Since the BCI system already has access to the individual's neural signals, the system can monitor neural data that does not exist when the user is awake. For example, neurophysiological phenomena such as K-complexes and sleep spindles occur during the initial stages of sleep. Thus, using neural data to detect that the user is asleep can be used to switch any device to a low-energy usage state.

[0078] Alternatively, or in combination, the first predetermined condition includes the inability to generate an output control signal within a predefined period.

[0079] The control unit can be further configured to adjust the neural interface from a first operating configuration to a second operating configuration when the output control signal is associated with an idle command instruction.

[0080] Variations of the system and / or method include a neural interface configured to provide a perceptible feedback to an individual to indicate whether the individual is in the first operating configuration or the second operating configuration. The system and / or method can provide a neural interface configured to allow the individual to keep the neural interface in the first operating configuration.

[0081] In an additional variation, the control unit can be further configured to transmit an idle signal to an external electronic device when adjusting to, or prior to adjusting to, the second operating configuration.

[0082] Further variations of the method and / or system include determining an individual's activity level by monitoring the individual's neural activity while the neural interface is in the second operating configuration, and the control unit is further configured to adjust the neural interface from the second operating configuration to the first operating configuration when it determines that the activity level meets a second predetermined condition.

[0083] The control unit can be further configured to adjust the neural interface from a second operating configuration to a first operating configuration when the output control signal is associated with an active command instruction. In addition, the control unit can be configured to adjust the neural interface from the second operating configuration to the first operating configuration when the individual generates at least one output control signal.

[0084] Another variation of the method and / or system includes changing the frequency of communication within the neural interface by monitoring an individual's neural activity. The method and / or system is to provide a signal from a neural monitoring device embedded within the individual to a control unit, the signal representing the individual's neural activity, and the detection of a predetermined neural activity causes the control unit to generate an output control signal, and may include determining the activity level of the individual by monitoring the individual's neural activity. The control unit is configured to change the neural interface from a first operating configuration to a second operating configuration when it determines that the activity level meets a first predetermined condition, and the communication speed in the first operating configuration is different from the communication speed in the second operating configuration.

[0085] While in the "idle" state, the BCI can perform the minimum amount of recording and calculation necessary to provide a single switch output, which may be much slower than the normal switch output generated in the "active" state. For example, in the "active" state, the BCI can sample all electrode channels and stream all recorded data to a decoding algorithm. While in the "idle" state, the BCI can sample a smaller subset of electrode channels and stream data only at a lower duty cycle (e.g., 10%).

[0086] To indicate the BCI state, visual feedback and / or auditory feedback can also be provided to the user, and this visual feedback can be synchronized with the data transmission duty cycle to facilitate the user's wake-up. For example, a visual indicator can show the user that the device is currently in the "idle" mode and can display a countdown timer or a timed radial to show the user the appropriate moment when the wake-up switch becomes available to the user. In the absence of visual feedback, the user can repeatedly generate the switch output until they confirm that the "active" function has been restored.

[0087] The wake-up switch function can be implemented by software only and may be configurable by the user. Thus, the user can determine whether a lower operating state is desirable. If not, the function can be disabled and the BCI will always be in the "active" mode.

[0088] Identification of the user's activity level can also enable the system to control external devices that are not part of the neural interface or BCI. For example, in a smart home, the neural interface can interface with the home control system to control various items such as turning off all the lighting in the house, ensuring that the doors are locked, and controlling any desired soundscape to improve the user's sleep quality.

[0089] The BCI system can be configured for a person to be continuously connected over a long period of time. This eliminates the need for a caregiver to disconnect or connect the person to the BCI system. For example, the BCI system can include a charging mechanism that supplies power to the BCI system for a long period (e.g., 6 hours). In another variant, the BCI system is configured in an "idle mode" to reduce the current drain from the battery. In the "idle mode", the person can activate the system or end the "idle mode" without the assistance of a caregiver. Additionally, enabling easy recharging or automatic recharging of the BCI system increases the duration of continuous connection. In such cases, the BCI can enable one or more components of the system to be placed in a position that allows recharging of the components.

[0090] Another advantage of continuous connection and rechargeability is that it allows for minimal caregiver intervention. In such cases, the caregiver only needs to be present up to once a day to assist with charging or perform a BCI check. This can be achieved by leaving the charger in place and incorporating firmware updates into the charger from a mobile app. The firmware should be able to turn the energy on and off without the need to press a physical button.

[0091] All of the aspects of the system described above can support the patient's (at least intermittent) communication autonomy.

[0092] In an additional variant, the BCI system can include one or more dashboards that provide details regarding the BCI's operation history. Such dashboards can comprise a monitor that communicates electrically with the BCI, or can include data transmitted by the BCI to a server or network such that the BCI's operation history can be accessed via a portable electronic device or other website. This enables not only the individual and caregiver to observe the BCI operation, but also stakeholders (e.g., the individual's relatives) to observe the BCI operation. This allows multiple people to monitor the individual's activities. For example, the dashboard can indicate history information regarding the operation of the system (e.g., whether the system was in autonomous mode or not in autonomous mode). While it may not be possible to prevent a caregiver from turning off the BCI, a clinician or other family member can check on a timeline whether part or all of the system had previously been disabled.

[0093] A variant of the BCI system described herein that enables improved self-discipline includes a low-calibration system, which is a measure of how easily a user can start using the BCI system after a period of non-use. Calibration can be quantitatively evaluated by measuring the time it takes for the BCI system to be calibrated for the user and ready for use. For example, a low-calibration BCI system is one in which the time from activation (e.g., switch-on, end of idle mode) to being ready for use is less than 30 seconds.

[0094] In one variant, the low-calibration BCI system includes minimal or no external hardware components that need to be placed on or against the patient and connected to the BCI system in order for the system to operate as intended. For example, the systems described above are already embedded or coupled to the individual and can be electronically activated from an idle or off mode to initiate the BCI system. As described above, a system with minimal components includes a charger, an SCU, and a screen / device for an implantable receiver / transmitter unit that are all wirelessly connected. In contrast, systems that require external hardware such as a gaze-tracking device require physically positioning the paralyzed user in front of the gaze-tracking hardware.

[0095] The systems and methods described herein provide restoration of self-discipline to patients, including those with severe motor disabilities. Accordingly, these systems and methods provide an option of being continuously available, providing independent system activation, having minimal calibration, having no wearable components or hardware that require adjustment, and providing enhanced decision-making to the individual, by providing a BCI system.

[0096] In an additional variation, the BCI system that enhances autonomy includes a system with a short latency, where the latency is measured as the time from presenting a cue (e.g., indicating that the individual should select an action for the BCI) until the individual triggers an action (e.g., the time from presenting an option until the individual "clicks" on the option). In other words, the individual can generate more clicks over any period, supporting the user to remain more engaged and for a longer duration. U.S. Provisional Application No. 63 / 480,746, filed on January 20, 2023, the content of which is incorporated by reference, discusses a brain-computer interface, system, and method for controlling a device based on the detection of transient oscillation bursts or pseudo-oscillation bursts. A system that uses the detection of transient oscillation bursts or pseudo-oscillation bursts can provide a low-latency system.

[0097] Such an autonomous BCI system also requires high accuracy, and the accuracy of the system can be measured by the rate at which the BCI system generates an action initiated by the individual and the rate at which no action is initiated when the individual does not initiate an action.

[0098] As described above, the behavioral mechanism regarding the implanted MNP in a BCI system can use the detection of a movement intention in an individual and the conversion of that movement intention into an alternative control signal to enable the individual to perform a functionally meaningful output task. Therefore, the core performance measurement criteria for NMP and BCI systems should represent the ability to reliably convert a neural movement intention into a digital output. This can be regarded as a digital movement output (DMO). The DMO carrying the movement intention information can then be mapped to specific or generalized computer actions that can be used to control a personal computer or device. For example, as shown in FIG. 10, the implanted probe 100 and the internal transmission unit 130 can convert the neural movement intention of the individual 10 into an electronic device 120, and the electronic device 120 provides any number of generalized computer actions 18a - 18d for directly controlling the device 120 or enabling the device 120 to further control a secondary device 12a. In the illustrated variant, the transmission 150 occurs via the external system control unit 140, but the system can use direct transmission. The ability of the implanted MNP BCI 100 / 130 to generate a highly reliable DMO serves as a device-independent approach for clinical measurements.

[0099] The goal of evaluating the effectiveness of any MNP can be hindered by the variability of the operating system and the variability of the software for each computer action use case, by the use of performance metrics such as secondary computer actions (e.g., typing). For example, adding features such as predictive or generative text to an NMP operating system can lead to an inconsistent evaluation of the basic effectiveness and usefulness of that MNP. In contrast, creating a metrics structure around the DMO itself represents an implicitly valid and reliable way to evaluate the basic usefulness of any MNP. For example, evaluating how well any newly emerging MNP can generate a DMO and incorporating objective performance metrics that capture the reliability of the DMO in a way that reflects the intended use by an individual. This can be incorporated by using tasks that capture the performance of the basic DMO executed at an appropriately selected point in time after embedding or activation, and evaluating the accuracy of the DMO over a sufficient number of repetitions of the task. Here, accuracy is equal to the number of correct trials divided by all trials.

[0100] In an additional variation, the present disclosure includes a BCI system having a subsystem that can be detached from the “full system,” where the full system provides additional functionality / interaction to the patient, but the subsystem enables the patient to seek help at any time. “Functionality in the components.” For example, in FIG. 10, the full system includes an electronic device 120 (optionally controlling additional devices or just a computer), an external system control unit 140 (optionally interfacing between the individual 10 and the electronic device 120), and implantable components, such as 100 and 130. In practice, the system can also include additional components that enhance the individual's ability to interact with the device but require a significant amount of time for setup / removal. For example, many BCI systems use eye-tracking devices. The ability of the BCI system to operate as a subsystem provides the individual (especially a completely or partially paralyzed individual) with the ability to use the sub-components to interact with the caregiver when the additional components are removed. This is particularly useful when the individual is detached from the system during rest periods or in other situations where it is not practical for the individual to be involved with the full BCI system and components.

[0101] Accordingly, the present disclosure includes a brain-computer interface system for enhancing the autonomy of an individual who is partially or completely paralyzed to interact with an electronic device. For example, such a brain-computer interface system can include a nerve monitoring device coupled to the individual and configured to detect nerve activity from the individual. For example, FIG. 10 shows an implant 100 and an internal transmission / control unit 130 operably coupled to a system control unit 140, where the system control unit 140 is operably coupled to the nerve monitoring device 100 and removably coupled to the individual 10.

[0102] The present disclosure also includes methods for enhancing an individual's autonomy using a brain-computer interface when the individual is completely or partially paralyzed. For example, such methods can include placing a nerve monitoring device inside or on the body of the patient, the nerve monitoring device being configured to detect nerve activity from the individual; disconnecting a control unit from the individual, the control unit being configured to be operably coupled to the nerve monitoring device and configured to interact with one or more electronic devices when the individual generates nerve activity; and coupling the nerve monitoring device to an electronic network so that the individual maintains the ability to communicate with the electronic network using nerve activity.

[0103] Another example of a brain-computer interface system for enhancing the autonomy of an individual who is completely or partially paralyzed and who interacts with an electronic device includes a nerve monitoring device coupled to the individual and configured to detect nerve activity from the individual, and a control unit operably coupled to the nerve monitoring device and removably coupled to the patient, the control unit being configured to interact with the electronic device when the individual generates nerve activity, and the control unit being further configured to electronically communicate with an electronic network so that when the electronic device is disconnected from the individual, the individual maintains the ability to communicate with the electronic network using nerve activity.

[0104] The system control unit 140 is configured to interact with the electronic device 120 when an individual generates neural activity, and the neural monitoring device 100 is further configured to electronically communicate with an electronic network using neural activity so as to maintain a state where it can communicate with the electronic network when the control unit 140 is disconnected from the individual, directly wirelessly with a cloud server or via a wireless connection with the system control unit 140 or the like. The wireless connection can include a WIFI connection, Bluetooth, RFID, etc. In another variation, the use of the system control unit 140 is optional, and the internal control unit 130 is configured to wirelessly participate with the electronic device 120 and / or the cloud server. In another variation, the neural monitoring devices 100, 130 are configured to electronically communicate with an electronic network independently of the control unit 140.

[0105] All existing subjects (e.g., publications, patents, patent applications) referred to in this specification are incorporated herein by reference in their entirety, except where such subject matter may conflict with the subject matter of the present invention (in which case, what is present in this specification shall prevail). The items referred to are provided solely for the purpose of their disclosure prior to the filing date of the present application. Nothing in this specification shall be construed as an admission that the present invention has no right to antedate such material by virtue of prior invention.

[0106] References to items in the singular include the possibility that there may be multiple identical items. More specifically, the singular forms "a", "an", "the", and "said" as used in this specification and the appended claims include the plural referents unless the context clearly dictates otherwise. It should further be noted that the claims may be drafted to exclude any optional elements. Accordingly, this description is intended to serve as a basis for the use of exclusive terms such as "alone", "only", etc. or the use of "negative" limitations in connection with the recitation of claim elements. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0107] In understanding the scope of the present disclosure, the term "comprising" and derivatives thereof as used herein are intended to be open-ended terms specifying the presence of the recited features, elements, components, groups, integers, and / or steps, but do not preclude the presence of other unrecited features, elements, components, groups, integers, and / or steps. The above also applies to words having similar meanings such as the terms "including", "having", and derivatives thereof. Also, the terms "portion", "section", "part", "member", "element", or "component" may have a dual meaning of a single part or multiple parts when used in the singular. The following directional terms "front, rear, above, below, vertical, horizontal, down, across, transverse, and vertical" and any other similar directional terms used herein refer to those positions of a device or apparatus, or those directions of a device or apparatus being translated or moved. Finally, terms of degree such as "substantially", "about", and "approximately" as used herein mean a reasonable amount of deviation from the specified value so that the final result is not materially or significantly changed (e.g., a deviation of up to ±0.1%, ±1%, ±5%, or ±10% such that such variation is appropriate).

[0108] The present disclosure is not intended to be limited to the specific forms described, and is intended to cover alternatives, modifications, and equivalents of the variations or embodiments described herein. Further, the scope of the present disclosure fully encompasses other variations or embodiments that may become apparent to those skilled in the art from the perspective of the present disclosure.

Explanation of Signs

[0109] 8 Incision 10 Individuals 11 Individuals 12 Brain 12a Secondary device 18a~18d Generalized computer actions 40 Blood vessel 50 Region of interest, target region 62 Network, information, data 64 Data 66 Data, data transfer 68 Data, data transfer 70 External device or machine, machine, external machine 72 Airplane or drone, drone 74 Automobile 80 Monitoring site 100 Micro wire monitoring / stimulation probe, probe, monitoring probe, device, micro wire monitoring probe device, implant, implanted probe, implanted MNP BCI, nerve monitoring device 102 Micro wire, wire 104 Non-invasive tip 106 Spiral or sinusoidal portion, non-linear distal portion, distal portion, non-linear shape, electrode portion 108 Distal electrode, electrode 110 Connector base, controller 112 Proximal end 120 Electronic / computing device, computing device, electronic device 130 Monitoring device, embedded unit, control unit, internal transmission unit, embedded MNP BCI, embedded component, internal transmission / control unit, internal control unit, nerve monitoring device 132 Control unit 140 Personal electronic device, external device, electronic equipment, electronic unit, external system control unit, system control unit, control unit 142 Electronic device 150 Communication, transmission

Claims

Claim 1 A method for adjusting a neural interface by monitoring an individual's neural activity, the neural interface comprising a neural monitoring device operably connected to a control unit, the control unit being configured to generate an output control signal for interacting with an external electronic device, the method comprising: providing a signal from the neural monitoring device embedded within the individual to the control unit, the signal representing the neural activity of the individual, detection of a predetermined neural activity causing the control unit to generate the output control signal; determining an activity level of the individual by monitoring the neural activity of the individual; comprising; wherein the control unit is configured to adjust the neural interface from a first operating configuration to a second operating configuration when it determines that the activity level satisfies a first predetermined condition, the power consumption of the neural interface in the first operating configuration being different from the power consumption of the neural interface in the second operating configuration. Claim 2 The method of claim 1, wherein the first predetermined condition includes a sleep state of the individual, and the step of determining the activity level includes determining the sleep state of the individual by evaluating the neural activity with respect to a neural sleep metric. Claim 3 The method of claim 1, wherein the first predetermined condition includes an inability to generate the output control signal within a predefined period. Claim 4 The method of claim 1, wherein the control unit is further configured to adjust the neural interface from the first operating configuration to the second operating configuration when the output control signal is associated with an idle command instruction. Claim 5 The method of claim 1, wherein the neural interface is configured to provide a perceptible feedback to the individual to indicate whether the neural interface is in the first operating configuration or the second operating configuration. Claim 6 The method of claim 1, wherein the neural interface is configured to enable the individual to keep the neural interface in the first operating configuration. Claim 7 The method according to claim 1, further configured such that the control unit transmits an idle signal to the external electronic device when adjusting to, or before adjusting to, the second operation configuration.

8. The method according to claim 1, further comprising the step of determining the activity level of the individual by monitoring the neural activity of the individual while the neural interface is in the second operation configuration, and the control unit is further configured to adjust the neural interface from the second operation configuration to the first operation configuration when it is determined that the activity level satisfies a second predetermined condition.

9. The method according to claim 8, wherein the control unit is further configured to adjust the neural interface from the second operation configuration to the first operation configuration when the output control signal is associated with an active command instruction.

10. The method according to claim 8, wherein the control unit is further configured to adjust the neural interface from the second operation configuration to the first operation configuration when the individual generates at least one output control signal.

11. A method of changing the frequency of communication within a neural interface by monitoring an individual's neural activity, the neural interface comprising a neural monitoring device operably configured to communicate with a control unit at a communication speed, the control unit being configured to generate an output control signal for interacting with an external electronic device, the method comprising: providing a signal from the neural monitoring device embedded in the individual to the control unit, the signal representing the neural activity of the individual, and detection of a predetermined neural activity causing the control unit to generate the output control signal; determining the activity level of the individual by monitoring the neural activity of the individual; comprising wherein the control unit is configured to change the neural interface from a first operation configuration to a second operation configuration when it is determined that the activity level satisfies a first predetermined condition, and the communication speed in the first operation configuration is different from the communication speed in the second operation configuration.

12. A method of enhancing the autonomy of a paralyzed individual operating an external electronic device, Providing a brain-computer interface configured to monitor the neural activity of the paralyzed individual, wherein the brain-computer interface comprises a neural monitoring device operably connected to a control unit, and the control unit is configured to generate an output signal for interacting with the external electronic device, The step that the brain-computer interface is configured to enter an idle mode that consumes less power than the active mode, Receiving an activation signal from the paralyzed individual to switch the brain-computer interface from the idle mode to the active mode without assistance from a caregiver, A method comprising.

13. The method according to claim 12, further comprising coupling the control unit and the external electronic device to shorten the calibration time of the brain-computer interface when entering the active mode.

14. The method according to claim 13, wherein the step of coupling the control unit and the external electronic device occurs wirelessly.

15. The method according to claim 12, wherein the brain-computer interface is configured to be coupled to a rechargeable power source by the paralyzed individual.

16. The method according to claim 12, wherein the brain-computer interface is configured to transmit operation data from the brain-computer interface to a remote electronic dashboard, and the remote electronic dashboard enables an individual to monitor the activity of the brain-computer interface.

17. The method according to claim 16, wherein the brain-computer interface is configured to wirelessly transmit operation data from the brain-computer interface to the remote electronic dashboard.

18. The method according to claim 12, wherein the brain-computer interface is configured to have a waiting time of 5 seconds or less.

19. The method according to claim 12, wherein the brain-computer interface is configured to enable the paralyzed individual to start calibration of the brain-computer interface when entering the active mode.

20. A method for enhancing the autonomy of a paralyzed individual in operating an external electronic device, Providing a brain-computer interface configured to monitor the neural activity of the paralyzed individual, the brain-computer interface comprising a neural monitoring device operably connected to a control unit, the control unit being configured to generate an output control signal for interacting with the external electronic device in response to the neural activity of the paralyzed individual associated with a cue signal generated by the brain-computer interface, the step of Calibrating the brain-computer interface within a minimum period, enabling the paralyzed individual to activate the output control signal after a certain period of non-use of the brain-computer interface by the paralyzed individual, the step of A method comprising

21. A method for enhancing the autonomy of a paralyzed individual in operating an external electronic device, Comprising the step of providing a brain-computer interface configured to monitor the neural activity of the paralyzed individual, the brain-computer interface comprising a neural monitoring device operably connected to a control unit, the control unit being configured to generate an output control signal for interacting with the external electronic device when the paralyzed individual generates neural activity in response to a cue generated by the brain-computer interface, the brain-computer interface comprising a high-precision interface ratio, the high-precision interface ratio being a measured value of intentional neural activity associated with the cue relative to neural activity not associated with the cue, the method.

22. The method according to claim 21, wherein the high-precision interface ratio comprises 95%.

23. A brain-computer interface for enhancing the autonomy of a paralyzed individual when operating an external electronic device, A neural monitoring device configured to detect neural activity from the paralyzed individual, A control unit operably connected to the neural monitoring device, the control unit being configured to generate a cue on a display, the cue being associated with one or more commands, the control unit comprising, when the paralyzed individual generates neural activity associated with an intention to select the cue, the control unit generating an output control signal for interacting with the external electronic device, the control unit being configured to generate the cue and the output control signal within a shortest time, a brain-computer interface. **Claim 24** The brain-computer interface according to claim 23, wherein the shortest time includes 5 seconds. **Claim 25** A brain-computer interface system for enhancing the autonomy of an individual who is completely or partially paralyzed and who interacts with an electronic device, a nerve monitoring device coupled to the individual and configured to detect neural activity from the individual, a control unit operably coupled to the nerve monitoring device and removably coupled to the individual, the control unit being configured to interact with the electronic device when the individual generates the neural activity, comprising, the nerve monitoring device being further configured to communicate electronically with the electronic network so as to maintain a state in which the individual can communicate with the electronic network using the neural activity when the control unit is detached from the individual. **Claim 26** The brain-computer interface system according to claim 25, wherein the nerve monitoring device comprises an implant configured to be disposed adjacent to or within nerve tissue, and an internal unit in electrical communication with the implant. **Claim 27** The brain-computer interface system according to claim 25, wherein the nerve monitoring device is configured to communicate electronically with the electronic network independently of the control unit. **Claim 28** The brain-computer interface system according to claim 25, wherein the nerve monitoring device is configured to communicate electronically with the electronic network using the control unit. **Claim 29** A brain-computer interface system for enhancing the autonomy of an individual who is completely or partially paralyzed and who interacts with an electronic device, a nerve monitoring device coupled to the individual and configured to detect neural activity from the individual, A control unit operably coupled to the nerve monitoring device and removably coupled to the individual, the control unit being configured to interact with the electronic device when the individual generates the nerve activity. Comprising A brain-computer interface system further configured to electronically communicate with the electronic network such that when the electronic device is disconnected from the individual, the individual can maintain communication with the electronic network using the nerve activity.

30. A method for enhancing the autonomy of an individual using a brain-computer interface when the individual is completely or partially paralyzed, Placing a nerve monitoring device inside or on the body of the individual, the nerve monitoring device being configured to detect nerve activity from the individual. Disconnecting a control unit from the individual, the control unit being configured to be operably coupled to the nerve monitoring device and to interact with one or more electronic devices when the individual generates the nerve activity. Coupling the nerve monitoring device to the electronic network such that the individual maintains the ability to communicate with the electronic network using the nerve activity. A method comprising

31. The method of claim 30, wherein the step of coupling the nerve monitoring device to the electronic network includes coupling the nerve monitoring device to the electronic network using the control unit when the control unit is disconnected from the one or more electronic devices.

32. The method of claim 30, wherein the step of coupling the nerve monitoring device to the electronic network includes coupling the nerve monitoring device to the electronic network without using the control unit.

33. The method of claim 30, wherein the step of coupling the nerve monitoring device to the electronic network includes disconnecting the control unit from the individual.

34. The method according to claim 30, wherein the nerve monitoring device comprises an implant configured to be disposed adjacent to or within nerve tissue, and an internal unit in electrical communication with the implant.

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