Neurostimulation system and method

Abstract

Systems and methods are described that provide electrical stimulation to a person while also facilitating EEG recording. The EEG records may be analyzed to identify cerebral hemorrhage. In some examples, the EEG analysis may identify increased slow wave activity within a delta frequency range of about 1-4 Hz and / or decreased alpha activity within an alpha frequency range of about 8-13 Hz. Systems and methods may include delivering electrical stimulation and / or notifying a person or a medical provider of cerebral hemorrhage in response to EEG analysis.

Description

[0001] Priority declaration

[0002] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 371,496, filed on August 15, 2022, entitled “NEUROSTIMULATION SYSTEMS AND METHODS,” which is incorporated herein by reference in its entirety.

[0003] Incorporated by Reference

[0004] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0005] background

[0006] Electrical brain stimulation has been shown to be a potentially effective treatment for many brain disorders, including epilepsy, migraine, fibromyalgia, major depressive disorder, stroke rehabilitation, and Parkinson's disease. External stimulation is often unfocused, and direct cortical stimulation is often highly invasive, involving craniotomy or drilling holes in the skull to target specific cortical locations. It would be beneficial to find a brain stimulation solution that provides targeted cortical stimulation without the need for surgical procedures that penetrate the skull.

[0007] Electrical brain stimulation can be delivered in several ways. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive technique that uses a coil to deliver a series of high-energy magnetic pulses to the brain, inducing electrical current to flow in the cortex beneath the coil. rTMS has been shown to be effective in treating major depressive disorder and other psychiatric disorders. However, it cannot be easily directed to a specific location and involves large, expensive equipment to generate the high current pulses to the coil. rTMS is not portable and requires a therapy administrator to deliver the treatment to the patient.

[0008] Transcranial direct current stimulation (tDCS) uses electrodes on the outside of the head to deliver small amounts of electrical current to the brain. tDCS was originally used for stroke recovery and has shown promise in treating some psychiatric disorders and improving cognition. Electrodes are placed on the surface of the skin on the outside of the subject's head near the area of ​​interest for stimulation. The vast majority of the current is shunted between the electrodes because the skull is a very effective electrical insulator. However, a portion of the current does cause current to flow within the brain, which may increase or decrease neuronal excitability and alter brain function. The exact method of action is unclear. tDCS current intensity is limited due to the excitability of the nerves in the scalp, which can cause patient discomfort if the current is set too high.

[0009] Vagus nerve stimulation involves electrically stimulating the vagus nerve in the patient's neck. This can be done by using electrodes on the skin, which may produce a sensation of pain in the patient, or by surgically implanting electrodes near the vagus nerve, which typically implants the power source elsewhere in the body. This involves a major surgical procedure and has shown efficacy in treating epilepsy and depression.

[0010] Deep brain stimulation (DBS) uses electrodes that are implanted bilaterally and placed in the basal ganglia, cerebellum, predominant nucleus, central nucleus, caudate nucleus, thalamus, or subthalamic region. Stimulation can also be delivered subcortically. Delivering sequences of stimulation is used to treat many conditions, including epilepsy, Parkinson's disease, and major depressive disorder. DBS is typically a very invasive procedure that requires a long wire to be penetrated through the skull with multiple electrodes near its tip. The procedure is considered major surgery and is not usually used unless other methods have been exhausted.

[0011] Direct cortical stimulation (DCS) is similar to DBS, except that the wires are located on the surface of the cortex, either subdural or epidural. Sutures are used to secure the electrodes in place. This technique typically involves removing a portion of the skull to access the cortical surface and, possibly, to make room for a power source. DCS has been shown to be effective in treating epilepsy and neuropathic pain. (Shanechi et al., 2013) A brain-computer interface that uses EEG to automatically titrate drugs during drug-induced coma was introduced. (Liu et al., 2006) Anesthesia was automatically adjusted during surgery using the bispectral index (BIS) calculated from the EEG. Aspect Medical, Inc. was created to develop equipment for this application. In addition, Drager Medical, Inc. developed Zeus for closed-circuit anesthesia ventilation. (Doufas et al., 2003) An automated response test was used to optimize propofol administration during conscious sedation. Phillips (US 9,872,996, US 10,780,286) used a subcutaneous pulse generator and conductive paths through the skull at multiple locations to create a current loop. The Phillips method and apparatus still involves at least two burr holes in the skull.

[0012] Approximately 40% of untreated aneurysms will eventually rupture. Rupture can be prevented by a technique called coiling, which blocks blood from entering the aneurysm. However, up to 5% of coiled aneurysms may still rupture. Aneurysmal subarachnoid hemorrhage (aSAH) has a mortality rate of 40%-50%, with most survivors dependent on others for their daily lives. Delayed cerebral ischemia (DCI), the initial bleeding event following a ruptured cerebral aneurysm, is one of the most important causes of death and poor neurological outcome. Neurological monitoring is essential for early DCI detection and intervention. By detecting DCI early, drug-induced hypertension reverses existing neurological deficits in 70% of patients. Clinical examination and intermittent transcranial Doppler ultrasound and CT are most commonly used to detect DCI, but they rely on patients coming to the clinic and making appointments with precious resources, significantly delaying the response.

[0013] Overview

[0014] A device for electrically stimulating a subject's brain is provided, the device comprising: a shell adapted to be implanted against the subject's skull; a first electrode disposed on or in the shell; a probe connected to the shell and configured to extend through a bore in the skull into the subject's brain; a second electrode disposed on the probe and configured to deliver electrical stimulation to a target area of ​​the brain and sense electrical signals of the brain; and an electronic device disposed in the shell and configured to generate electrical pulses, initiate EEG recording of the subject's brain, and communicate with an external device; wherein the device is configured to record EEG signals of the brain in response to an EEG recording request from the external device.

[0015] In one aspect, the probe is flexible.

[0016] In some aspects, the apparatus includes an insulating seal configured to fill a space between the burr hole and the probe. In one aspect, the insulating seal prevents fluid flow and current flow around the subcranial electrode.

[0017] In some aspects, the first electrode comprises a ring electrode. In some aspects, the ring electrode is integrated into the housing.

[0018] In one aspect, the electronic device is configured to generate a current pulse between a first electrode and a second electrode.

[0019] In one aspect, the current pulse is configured to follow a path that proceeds from the second electrode, through the target area, through the conductive path at a location in the skull separate from the burr hole, and beneath the scalp to the first electrode.

[0020] In some aspects, the electronics are further configured to analyze the EEG signal to identify brain hemorrhage in the target area.

[0021] In some aspects, analyzing the EEG signal further includes identifying increased slow wave activity in the Delta frequency range of approximately 1-4 Hz.

[0022] In other aspects, analyzing the EEG signal further comprises identifying reduced alpha activity in the alpha frequency range of approximately 8-13 Hz.

[0023] In one aspect, the device is configured to transmit the EEG signals wirelessly to an external device.

[0024] In some aspects, the external device is further configured to analyze the EEG signal to identify brain hemorrhage in the target area.

[0025] In some aspects, analyzing the EEG signal further includes identifying increased slow wave activity in the delta frequency range of approximately 1-4 Hz.

[0026] In another aspect, analyzing the EEG signal further comprises identifying reduced alpha activity in an alpha frequency range of approximately 8-13 Hz.

[0027] In some aspects, the device is configured to transmit the EEG signals wirelessly to a cloud computing device.

[0028] In one aspect, the cloud computing device is further configured to analyze the EEG signals to identify brain hemorrhage in the target area.

[0029] In some aspects, analyzing the EEG signal further includes identifying increased slow wave activity in the delta frequency range of approximately 1-4 Hz.

[0030] In other aspects, analyzing the EEG signal further includes identifying reduced alpha activity in the alpha frequency range of approximately 8-13 Hz.

[0031] A system comprising two or more devices according to claim 1 is also provided.

[0032] In some aspects, two or more devices are configured to jointly record EEG signals of the subject's brain in response to an EEG recording request from an external device.

[0033] A system for electrically stimulating the brain of a subject is provided, comprising: a plurality of implantable neurostimulators configured to be implanted in the subject, each of the implantable neurostimulators comprising; a shell adapted to be implanted against the skull of the subject; a first electrode disposed on or in the shell; a probe connected to the shell and configured to extend through a bore in the skull into the brain of the subject; a second electrode disposed on the probe and configured to deliver electrical stimulation to a target area of ​​the brain and sense electrical signals of the brain; and an electronic device disposed in the shell and configured to generate electrical pulses, initiate EEG recording of the subject's brain, and communicate with an external device; wherein the system is configured to record EEG signals of the brain using the plurality of implantable neurostimulators in response to an EEG recording request from the external device.

[0034] In one aspect, the probe is flexible.

[0035] In some aspects, each stimulator of the system includes an insulating seal configured to fill a space between the burr hole and the probe. In one aspect, the insulating seal prevents fluid flow and current flow around the subcranial electrode.

[0036] In some aspects, the first electrode comprises a ring electrode. In some aspects, the ring electrode is integrated into the housing.

[0037] In one aspect, the electronic device is configured to generate a current pulse between a first electrode and a second electrode.

[0038] In one aspect, the current pulse is configured to follow a path that proceeds from the second electrode, through the target area, through the conductive path at a location in the skull separate from the burr hole, and beneath the scalp to the first electrode.

[0039] In some aspects, the electronics are further configured to analyze the EEG signal to identify brain hemorrhage in the target area.

[0040] In some aspects, analyzing the EEG signal further includes identifying increased slow wave activity in the delta frequency range of approximately 1-4 Hz.

[0041] In other aspects, analyzing the EEG signal further includes identifying reduced alpha activity in the alpha frequency range of approximately 8-13 Hz.

[0042] In one aspect, the system is configured to transmit the EEG signals wirelessly to an external device.

[0043] In some aspects, the external device is further configured to analyze the EEG signal to identify brain hemorrhage in the target area.

[0044] In some aspects, analyzing the EEG signal further includes identifying increased slow wave activity in the delta frequency range of approximately 1-4 Hz.

[0045] In another aspect, analyzing the EEG signal further comprises identifying reduced alpha activity in an alpha frequency range of approximately 8-13 Hz.

[0046] In some aspects, the system is configured to transmit the EEG signals wirelessly to a cloud computing device.

[0047] In one aspect, the cloud computing device is further configured to analyze the EEG signals to identify brain hemorrhage in the target area.

[0048] In some aspects, analyzing the EEG signal further includes identifying increased slow wave activity in the delta frequency range of approximately 1-4 Hz.

[0049] In other aspects, analyzing the EEG signal further includes identifying reduced alpha activity in the alpha frequency range of approximately 8-13 Hz.

[0050] A method of monitoring an aneurysm in the brain of a subject is provided, comprising: initiating an EEG recording in one or more implanted neurostimulator devices using an external device; analyzing the EEG recording to identify a cerebral hemorrhage in the brain; and indicating to the subject or a medical provider that a cerebral hemorrhage has been identified.

[0051] In some aspects, prior to the initiating step, one or more neurostimulator devices are implanted in the brain of the subject.

[0052] In some aspects, the method includes transmitting the EEG recordings from one or more implanted neurostimulator devices to a remote server.

[0053] In one aspect, the analyzing step is performed in a remote server.

[0054] In another aspect, the method includes generating a report on the analyzed EEG and transmitting the report to a medical provider of the subject.

[0055] In one aspect, the EEG recording is initiated by a smartphone, tablet or PC.

[0056] In some examples, the analyzing step is performed locally on one or more implanted neurostimulator devices.

[0057] In one example, analyzing the EEG recording further includes identifying increased slow wave activity in the delta frequency range of approximately 1-4 Hz.

[0058] In another example, analyzing the EEG recording further includes identifying reduced alpha activity in the alpha frequency range of approximately 8-13 Hz.

[0059] In another example, the method includes providing electrical stimulation to the brain using one or more implanted neurostimulator devices. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] Figure 1 A neurostimulator device is shown.

[0062] Figure 2A-2B Shown is an EEG recording of a subject with an aneurysm.

[0063] Figure 3 is a diagram showing one or more neurostimulators implanted near an aneurysm.

[0064] Figure 4A-4E A method of monitoring an aneurysm using one or more implanted neurostimulators is shown.

[0065] Figure 5A-Figure 5B Shown is a series of EEG recordings of a subject with an aneurysm.

[0066] Detailed Description

[0067] Although certain embodiments have been provided and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. It should be understood that various alternatives to the embodiments described herein can be employed and are part of the invention described herein.

[0068] The present disclosure provides a minimally invasive solution for on-demand cortical EEG recording. Quantitative EEG (qEEG) analysis provides evidence of ischemic events and can be detected using automated machine learning algorithms. Ischemia can lead to an increase in slow wave activity and a decrease in alpha power in the infarct region.

[0069] Figure 1An embodiment is shown in which a neurostimulator device 104 is implanted beneath a subject's scalp 101 and includes a housing 110, a probe-shaped subcranial electrode 106 inserted into a borehole in a skull 102, and a subcutaneous ring electrode 105 disposed around or integrated into the housing 110. In one embodiment, the subcranial electrode 106 may include a screw adapted to be screwed into the subject's skull. The system may also include an electrically insulating seal 111 configured to fill a space between the device and an inner wall of the borehole that prevents fluid flow and current flow around the subcranial electrode. The housing 110 may be configured to rest on the surface of the skull and may include a current or voltage pulse generator to generate current pulses between the subcranial electrode and the subcutaneous electrode. Due to the high impedance of the skull 102, most of the current is forced to follow path 107, which travels from the subskull electrode through the target area 112 of the brain 103, through a conductive path 108 at a location in the skull separated from the burr hole, and returns to the subcutaneous ring electrode 105 along path 109 beneath the scalp.

[0070] In one embodiment, the device 104 may include an electronic device, such as a voltage or current pulse generator, configured to generate a current waveform between the subcranial electrode 106 and the subcutaneous ring electrode 105. The device may also include a power source such as a battery or a capacitor, or alternatively may be powered from the outside using wireless power transmission (e.g., inductive coupling). The electronic device may also include one or more processors, microcontrollers, or CPUs configured to control the operation of the device and process and / or evaluate the data sensed by the electrode. In some embodiments, the electronic device may also include a memory configured to store recorded data and / or instructions related to the operation of the device and / or the sensing parameters (e.g., EEG) of the patient. For example, the electronic device may be set or positioned in the housing 110. In some embodiments, the electronic device is positioned outside the device and the subject. In these embodiments, current pulses may be generated in vitro, wherein the percutaneous lead transmits the current pulses to the subcutaneous / subcranial electrodes. The electronic device may further include wireless communication electronics to facilitate communication between the neurostimulator device and an external device. In some embodiments, the external device may include a smart phone, a computer, a tablet, etc. In some embodiments, the external device may be configured to control the operation of the neurostimulator device. For example, in one embodiment, a smartphone, tablet, or PC may be configured to turn on or off a function of a neurostimulator device, such as initiating EEG recording or stimulation therapy.

[0071] The device can be configured to record the EEG and automatically determine the natural frequency from the EEG recording and specify the pulse frequency, pulse amplitude, pulse shape, pulse width or pulse duty cycle and other parameters. The recorded EEG can also be wirelessly transmitted to an external module, such as a mobile device running a software application, wherein the software application determines the natural frequency and specifies the pulse frequency, pulse amplitude, pulse shape, pulse width or pulse duty cycle and other parameters and transmits the parameters to the device.

[0072] Figure 2A The EEG power distribution of a patient with a localized cerebral hemorrhage in the left posterior region under multiple frequency ranges is shown, as shown. The frequency ranges may include a delta frequency range (1-4 Hz), a theta frequency range (4-8 Hz), an alpha frequency range (8-13 Hz), and a beta frequency range (13-25 Hz). As shown, the EEG of the brain indicates an increase in slow wave activity at the location of the cerebral hemorrhage in the delta frequency range (1-4 Hz) and a decrease in alpha activity in the alpha frequency range (8-13 Hz), as shown by reference numerals 214 and 216, respectively. The device of the present disclosure can be configured to identify areas in the brain where slow wave activity increases in the delta frequency range and / or alpha activity decreases in the alpha frequency range to identify cerebral hemorrhage and / or other traumatic brain events.

[0073] Figure 2B shows EEG recordings of the same patient taken at multiple locations within the brain, including location F P1 、F P2 , F3, F4, F7, F8, F Z , C Z ,C3,C4,T3,T4,T5,T6,P Z , P3, P4, O1 and O2. Again, this detailed EEG map shows a decrease in alpha power and an increase in delta / theta power in the area of ​​cerebral hemorrhage damage (e.g., in the left posterior region of the brain).

[0074] refer to Figure 3 , one or more neurostimulator devices 104 (such as Figure 1 The neurostimulator device 104 can be positioned above or near the aneurysm 112 in the patient's brain. By precisely positioning the neurostimulator device near the aneurysm, the device is able to record the EEG of the highest quality possible just at the cerebral cortex. In some implementations, only a single neurostimulator device 104 is placed near the aneurysm. In other embodiments, a plurality of neurostimulator devices are placed near the aneurysm. The devices can each be individually configured to record EEG signals from the brain. In some embodiments, the devices can collect and record EEG signals from the brain jointly or collaboratively.

[0075] Figure 4A-4EA general sequence of events including implantation and use of one or more neurostimulator devices for aneurysm monitoring is shown. The process can be used for patients with a history of or risk for aneurysm or other brain event. Figure 4A In some embodiments, the neurostimulator can be implanted so that the probe-shaped subcranial electrode (from Figure 1 ) is inserted into a drill hole in the skull, and the subcutaneous ring electrode and / or housing is positioned against the skull and beneath the scalp.

[0076] refer to Figure 4B At some point after implantation, the patient may begin to experience symptoms of a leaking or ruptured aneurysm. For example, the patient may begin to feel symptoms associated with a ruptured aneurysm, including a stiff neck, drowsiness, confusion, dizziness, balance problems, difficulty speaking, and weakness or loss of feeling in the arms or legs.

[0077] refer to Figure 4C , the patient can start EEG recording in one or more implanted neurostimulator devices 104. In one example, the EEG recording can be started wirelessly via an external electronic device 118 (such as a smart phone, tablet or pc). In other embodiments, the patient can start the EEG recording by directly interacting with the neurostimulator device (for example, by pressing a button on the device or on the hardware or a lead extending from the device to another location on the patient's body). Once started, one or more implanted neurostimulators can be configured to record the EEG of the patient's brain. The EEG can record a predetermined time period. In some examples, the time of recording can be customized by a medical provider or user, such as using an external electronic device.

[0078] exist Figure 4D In some embodiments, the recorded EEG can be wirelessly transmitted from the implanted device itself or from an external device (e.g., a smart phone, tablet, or PC) to a remote or cloud-based server 120 or another computing system 122. The remote server may include one or more processors configured to automatically analyze the recorded EEG using one or more algorithms (including machine learning algorithms) to detect slow waves in the affected area and generate a report. The report can be, for example, an electronic report that includes details of the EEG recording and / or instructions or subsequent steps to be performed by the patient or medical provider. In some embodiments, the recorded EEG can be analyzed directly on the implanted stimulator, or alternatively in an external device of the patient.

[0079] exist Figure 4EIn the embodiment, the report can be transmitted to a medical clinic 124 or a physician associated with the patient. For example, the transmission to the medical clinic 124 can include one or more computers, smart phones, or tablet computers of the medical clinic.

[0080] If analysis of the recorded EEG indicates that a rupture or leak has occurred, an alert may be issued to the clinic, medical provider, and / or patient. The clinic and / or medical provider may be instructed to contact the patient for immediate evaluation and attention to the ruptured or leaking aneurysm.

[0081] In some embodiments, the implanted neurostimulator device can be adapted and configured to provide stimulation therapy immediately to the area of ​​the ruptured or leaking aneurysm in response to EEG analysis or electronic reports. The implanted devices are not only ideally positioned to record EEGs related to aneurysms, but they are also optimally positioned within the brain to potentially treat aneurysms with stimulation therapy. Therefore, in some embodiments, stimulation can be manually or automatically initiated in response to EEG recording and analysis identifying a ruptured or leaking aneurysm. In some embodiments, the patient can initiate treatment, such as through an external device (e.g., a smart phone, tablet computer, pc). In other embodiments, a medical provider can remotely initiate treatment after consulting a report on the EEG. Alternatively, the system can be configured to automatically initiate treatment in response to identifying a ruptured or leaking aneurysm.

[0082] Figure 5A A patient with a focal cerebral hemorrhage in the left posterior region (eg Figure 2A ) A series of EEGs recorded with an implanted neurostimulator over a period of time. In this example, three EEG recordings occurred over the course of about 6 weeks. During this period, stimulation therapy was provided to the patient using the implanted neurostimulator described herein, and follow-up visits and EEG recordings showed improvements in speech, motivation, sleep, and sensory improvement. Figure 5B is a detailed EEG graph showing improved alpha activity across the region. There is a significant reduction in slow wave activity compared to normal rhythmic alpha waves.

[0083] When a feature or element is referred to herein as being "on" another feature or element, it may be directly on other features or elements, or there may also be intermediate features or elements. On the contrary, when a feature or element is referred to as being "directly on another feature or element", there is no intermediate feature or element. It will also be understood that when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it may be directly connected, attached or coupled to other features or elements, or there may be intermediate features or elements. On the contrary, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there is no intermediate feature or element. Although described or shown with respect to one embodiment, the features and elements described or shown in this way may be applied to other embodiments. Those skilled in the art will also recognize that the structure or feature set with reference to "adjacent" another feature may have a portion overlapping or below an adjacent feature.

[0084] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to limit the present invention. For example, as used herein, the singular forms "a", "an", and "the" are intended to also include the plural forms, unless the context clearly indicates otherwise. It should be further understood that the terms "comprises" and / or "comprising" when used in this specification specify the presence of stated features, steps, operations, elements, and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or groups thereof. As used herein, the term "and / or" includes any combination and all combinations of one or more of the associated listed items, and may be abbreviated as " / ".

[0085] For ease of description, spatially related terms such as "under", "below", "lower", "over", "upper", etc. may be used herein to describe the relationship of one element or feature to other elements or features as illustrated in the accompanying drawings. It will be understood that spatially related terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the accompanying drawings. For example, if the device in the accompanying drawings is turned upside down, the elements described as "below other elements or features" or "below other elements or features" will then be oriented to be "above other elements or features". Therefore, the exemplary term "below" may include both "above" and "below". The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatially related descriptors used herein are interpreted accordingly. Similarly, unless otherwise specifically stated, the terms "upwardly", "downwardly", "vertical", "horizontal", etc. are used herein for illustrative purposes.

[0086] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Therefore, without departing from the teachings of the present invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0087] In this specification and the appended claims, unless the context requires otherwise, the term "comprise" and variations thereof such as "comprises" and "comprising" mean that various components can be used together in methods and articles (e.g., compositions and apparatus, including devices and methods). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0088] As used herein in the specification and claims, including in the examples and unless otherwise expressly stated, all numbers may be treated as being preceded by the words "about" or "approximately", even if the term does not appear explicitly. The phrase "about" or "approximately" may be used when describing amplitude and / or position to indicate that the value and / or position described is within the reasonable expected range of the value and / or position. Any numerical value given herein should also be understood to include about or approximately that value, unless the context otherwise indicates. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range listed herein is intended to include all sub-ranges contained therein. It should also be understood that when a value is disclosed, "less than or equal to" the value, "greater than or equal to the value" and possible ranges between the values ​​are also disclosed, as appropriately understood by those skilled in the art. For example, if the value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats and that the data represents endpoints and starting points and ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, and between 10 and 15 are considered disclosed. It should also be understood that every unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0089] Although various illustrative embodiments are described above, any of several changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may generally be changed, and in other alternative embodiments, one or more method steps may be skipped together. Optional features of the various device and system embodiments may be included in some embodiments and not included in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0090] The examples and descriptions included herein show specific embodiments in which the subject matter can be practiced by way of illustration and not limitation. As mentioned, other embodiments can be utilized and derived therefrom so that structural and logical replacements and changes can be made without departing from the scope of the present disclosure. For convenience only, such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention", and if in fact more than one is disclosed, it is not intended that the scope of the present application is actively limited to any single invention or inventive concept. Therefore, although specific embodiments have been illustrated and described herein, any arrangement that is considered to achieve the same purpose may replace the specific embodiments shown. The present disclosure is intended to cover any and all modifications or variations of various embodiments. After reading the above description, those skilled in the art will understand the combination of the above embodiments and other embodiments not specifically described herein.

Claims

1. A device for electrically stimulating the brain of a subject, the device comprising: a housing adapted for implantation against a skull of the subject; a first electrode, the first electrode being disposed on or in the housing; a probe coupled to the housing and configured to extend through a burr hole in the skull and into the brain of the subject; a second electrode disposed on the probe and configured to deliver electrical stimulation to a target area of ​​the brain and sense electrical signals of the brain; and electronics disposed in the housing and configured to generate electrical pulses, initiate EEG recording of the subject's brain, and communicate with an external device; Wherein, the device is configured to record EEG signals of the brain in response to an EEG recording request from the external device.

2. The device according to claim 1, wherein: The probe is flexible. 3 . The apparatus of claim 1 , further comprising an insulating seal configured to fill a space between the borehole and the probe.

4. The device according to claim 3, wherein: The insulating seal prevents fluid flow and current flow around the subcranial electrode.

5. The device according to claim 1, wherein: The first electrode comprises a ring electrode.

6. The device according to claim 1, wherein: The ring electrode is integrated into the housing.

7. The device according to claim 1, wherein: The electronics are configured to generate a current pulse between the first electrode and the second electrode.

8. The device according to claim 1, wherein: The current pulse is configured to follow a path from the second electrode, through the target area, through a conductive path at a location in the skull separate from the burr hole, and beneath the scalp to the first electrode.

9. The device according to claim 1, wherein: The probe includes a screw.

10. The device of claim 1, further comprising a power source disposed in the housing.

11. The device according to claim 1, wherein: The electronics are also configured to analyze the EEG signals to identify a brain hemorrhage in the target area.

12. The device according to claim 11, wherein Analyzing the EEG signal also includes identifying increased slow wave activity in the delta frequency range of approximately 1-4 Hz.

13. The device according to claim 11, wherein: Analyzing the EEG signal also includes identifying reduced alpha activity in the alpha frequency range of approximately 8-13 Hz.

14. The apparatus according to claim 1, wherein: The device is configured to wirelessly transmit the EEG signal to the external device.

15. The device according to claim 14, wherein: The external device is also configured to analyze the EEG signal to identify a brain hemorrhage in the target area.

16. The device according to claim 15, wherein: Analyzing the EEG signal also includes identifying increased slow wave activity in the delta frequency range of approximately 1-4 Hz.

17. The apparatus according to claim 15, wherein: Analyzing the EEG signal also includes identifying reduced alpha activity in the alpha frequency range of approximately 8-13 Hz.

18. The apparatus according to claim 1, wherein: The device is configured to wirelessly transmit the EEG signal to a cloud computing device.

19. The apparatus according to claim 18, wherein: The cloud computing device is also configured to analyze the EEG signal to identify brain hemorrhage in the target area.

20. The apparatus of claim 19, wherein: Analyzing the EEG signal also includes identifying increased slow wave activity in the delta frequency range of approximately 1-4 Hz.

21. The apparatus of claim 19, wherein: Analyzing the EEG signal also includes identifying reduced alpha activity in the alpha frequency range of approximately 8-13 Hz.

22. A system comprising two or more devices according to claim 1.

23. The system of claim 22, wherein: The two or more devices are configured to jointly record EEG signals of the subject's brain in response to an EEG recording request from an external device.

24. A system for electrically stimulating the brain of a subject, comprising: A plurality of implantable neurostimulators configured to be implanted in a subject, each of the implantable neurostimulators comprising: a housing adapted for implantation against a skull of the subject; a first electrode, the first electrode being disposed on or in the housing; a probe coupled to the housing and configured to extend through a burr hole in the skull and into the brain of the subject; a second electrode disposed on the probe and configured to deliver electrical stimulation to a target area of ​​the brain and sense electrical signals of the brain; and electronics disposed in the housing and configured to generate electrical pulses, initiate EEG recording of the subject's brain, and communicate with an external device; The system is configured to record EEG signals of the brain using the multiple implantable neurostimulators in response to an EEG recording request from the external device.

25. The system of claim 24, wherein: Each of the probes is flexible.

26. The system of claim 24, wherein: Each implantable neurostimulator also includes an insulating seal configured to fill a space between the bore and the probe.

27. The system of claim 26, wherein: The insulating seal prevents fluid flow and current flow around the subcranial electrode.

28. The system of claim 24, wherein: Each first electrode comprises a ring electrode.

29. The system of claim 24, wherein: Each ring electrode is integrated into the housing.

30. The system of claim 24, wherein: The electronics are configured to generate a current pulse between the first electrode and the second electrode.

31. The system of claim 24, wherein: The current pulses of each implanted neurostimulator are configured to follow a path from the second electrode, through the target area, through a conductive path in the skull at a location separate from the burr hole, and beneath the scalp to the first electrode.

32. The system of claim 24, wherein: The electronics of each implanted neurostimulator are also configured to analyze the EEG signals to identify brain hemorrhage in the target area.

33. The system of claim 32, wherein: Analyzing the EEG signal also includes identifying increased slow wave activity in the delta frequency range of approximately 1-4 Hz.

34. The system of claim 32, wherein: Analyzing the EEG signal also includes identifying reduced alpha activity in the alpha frequency range of approximately 8-13 Hz.

35. The system of claim 24, wherein: The system is configured to wirelessly transmit the EEG signal to the external device.

36. The system of claim 35, wherein: The external device is also configured to analyze the EEG signal to identify a brain hemorrhage in the target area.

37. The system of claim 36, wherein: Analyzing the EEG signal also includes identifying increased slow wave activity in the delta frequency range of approximately 1-4 Hz.

38. The system of claim 36, wherein: Analyzing the EEG signal also includes identifying reduced alpha activity in the alpha frequency range of approximately 8-13 Hz.

39. The system of claim 24, wherein: The system is configured to wirelessly transmit the EEG signals to a cloud computing device.

40. The system of claim 39, wherein: The cloud computing device is also configured to analyze the EEG signal to identify brain hemorrhage in the target area.

41. The system of claim 40, wherein: Analyzing the EEG signal also includes identifying increased slow wave activity in the delta frequency range of approximately 1-4 Hz.

42. The system of claim 40, wherein: Analyzing the EEG signal also includes identifying reduced alpha activity in the alpha frequency range of approximately 8-13 Hz.

43. A method of monitoring an aneurysm in the brain of a subject, comprising: initiating EEG recording in one or more implanted neurostimulator devices using an external device; analyzing the EEG recording to identify an intracerebral hemorrhage in the brain; and An indication is given to the subject or a medical provider that the brain hemorrhage has been identified.

44. The method of claim 43, wherein prior to the initiating step, one or more neurostimulator devices are implanted in the subject's brain.

45. The method of claim 43, further comprising transmitting the EEG recording from the one or more implanted neurostimulator devices to a remote server.

46. ​​The method of claim 45, wherein: The analyzing step is performed in the remote server.

47. The method of claim 43, further comprising: A report on the analyzed EEG is generated and sent to the subject's medical provider.

48. The method of claim 43, wherein: The EEG recording is initiated using a smartphone, tablet or PC.

49. The method of claim 43, wherein: The analyzing step is performed locally on the one or more implanted neurostimulator devices.

50. The method of claim 43, wherein: Analyzing the EEG recordings also includes identifying increased slow wave activity in the delta frequency range of approximately 1-4 Hz.

51. The method of claim 43, wherein: Analyzing the EEG recording also includes identifying reduced alpha activity in the alpha frequency range of approximately 8-13 Hz.

52. The method of claim 43, further comprising providing electrical stimulation to the brain using the one or more implanted neurostimulator devices.

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