Fully portable speech neuroprostheses, systems, and methods for using them.

Abstract

A fully portable speech neuroprosthesis device and system is provided. An aspect of the present invention includes an in vivo positionable device comprising a housing, a first component extending from the housing in a first plane, and a second component extending from the housing in a second plane parallel to the first plane, wherein the first and second planes are non-overlapping. A further aspect of the present invention includes a detection system comprising an in vivo positionable sensor comprising the device according to the present disclosure and an ex vivo power supply unit connectable to the sensor. Another further aspect of the present invention includes an in vivo positionable sensor comprising the device according to the present disclosure and an ex vivo receiver unit operably connected to the sensor. Methods for using the devices and systems of the present invention, such as in relation to speech decoding and / or synthesis, are also provided.

Description

Technical Field

[0001] Cross-reference This application claims priority to the filing date of U.S. Provisional Patent Application No. 63 / 461,993, filed Apr. 26, 2023, pursuant to 35 U.S.C. § 119(e), the disclosure of which is incorporated herein by reference in its entirety.

[0002] Introduction Communication ability lies at the center of our daily lives. The loss of communication is one of the most devastating consequences in severe paralysis from various disorders such as ALS, brainstem stroke, muscular dystrophy, etc. Beyond the frustration of being unable to express oneself, there is often a subsequent sense of loneliness and depression. Patients often choose death rather than living without meaningful communication ability (Hayashi and Oppenheimer, 2003; Linse et al., 2018). Effective and fluent communication is essential for building and maintaining meaningful relationships. In the elderly, the presence of strong social connections is associated with both physical and mental quality of life (Belvis et al., 2008). Among hospice and stroke patients, emotional intimacy, communication, and the feeling of being understood are strongly correlated with quality of life (Lynch et al., 2008; Liebert et al., 2008).

[0003] Some patients in conditions such as high cervical spinal cord injury (SCI), basilar artery stroke, or progressive amyotrophic lateral sclerosis (ALS) are unable to communicate by speaking due to paralysis of the oral structures or by typing due to quadriplegia. People with severe traumatic brain injury or high cervical injuries requiring mechanical ventilation may also have limited communication ability (Kennedy et al., 1994; Kubler et al., 2001; Monti et al., 2010).

[0004] Lock-in syndrome, characterized by quadriplegia and loss of speech, can occur after brainstem stroke and in ALS, with a prevalence of 11.4% (Merwick and Werring, 2014; Linse et al., 2018). In ALS, approximately 75% of individuals will require some form of communication assistance due to joint and severe joint abnormalities (Brownlee, 2007). Overall, more than 2 million people in the United States use augmentative alternative communication ("AAC") devices (American Speech-Language-Hearing Association), and an estimated 3,000 suffer from lock-in syndrome (Kohnen et al., 2013; Pels et al., 2017). While standard AAC devices are widely available, they may not be suitable for individuals with severe or complete paralysis of the voluntary motor system (Selzer et al., 2014). For example, a commonly used device is an eye-tracking device that allows control of a computer cursor through eye movements (Spataro et al., 2014). However, eye-tracking technology may have a limited role in advanced ALS cases and after brainstem stroke, where eye movements are frequently affected (Birbaumer et al., 1999; Kennedy and Bakay, 1998). They require sustained visual attention and can result in a high cognitive load.

[0005] Brain-computer interface (BCI) technology has the potential to reduce the adverse effects of disability and improve quality of life by enabling independence, social interaction, and community participation (Brumberg et al., 2018; Bamdad et al., 2015; Linse et al., 2018). Multiple neural signals, including non-invasive electroencephalography ("EEG") signals and other neural signals such as spike and cortical measurements ("ECoG") which require invasive electrode placement, can be used in BCI. Non-invasive BCI has been studied for at least 20 years. Known limitations of surface EEG recordings include, for example, a low signal-to-noise ratio and contamination by muscle activity (Wolpaw et al., 2002). Recent studies suggest that BCIs using invasive recordings of neural signals (e.g., spikes or ECoG) can enable faster and more intuitive control of complex devices (Carmena et al., 2003; Leuthardt et al., 2009; Leuthardt et al., 2004; Schwartz et al., 2006; Taylor, Tillery and Schwartz, 2002). Currently, significant basic scientific and clinical efforts are being made to develop BCIs based on invasive recordings of action potentials. However, this work relies on cursor control and typing-based decoding as functional communication output. Although substantial development has been made in this area (Willet et al., 2021), typing-based interfaces may only reach the average typing speed of 40 words per minute, compared to 150 words per minute for natural speech during conversation. [Overview of the project]

[0006] Therefore, it remains important to develop and deploy new technologies for restoring communication. Embodiments of the present invention described herein provide such novel and useful devices, systems, methods, and kits. Such devices, systems, methods, and kits may have the potential to enable communication in subjects with severe disabilities and potentially promote a higher quality of life.

[0007] Since speech is the most natural and efficient mode of communication, embodiments of the present invention leverage speech neuroprosthesis alternative technology to enable user control via attempted speech through a fully portable speech neuroprosthesis (Moses, Metzger, Liu et al., 2021). Speech decoding appears to be the most successful of the ECoG-based methods, potentially due to the spatial coverage of distributed speech networks and the reduced need for frequent model readjustment resulting from signal stability. Furthermore, direct speech control allows subjects to spend more time directly interacting with their environment and peers, reducing the need for constant attention to a screen and facilitating natural and spontaneous conversation.

[0008] Embodiments of the present invention comprise a fully implantable, skull-mounted, wireless, battery-free device having multiple channel sensing capabilities positioned on the speech motor cortex of a subject. Such an embodiment of the implantable device wirelessly communicates with a portable computer running a customized brain-to-speech application. This enables real-time decoding of intended speech and transmission via both text (e.g., tablet or smartphone display screen) and synthesized speech (e.g., tablet or smartphone speaker). In the embodiment, continuous use is enabled by a low-profile, battery-powered wireless charger, and the overall portability of such a system allows for real-life, portable integration of the system into everyday, natural communication environments. Embodiments of the present invention enable iterative training phases using easily updateable decoding algorithms on the portable computer for immediate use.

[0009] Fully implantable devices, as well as systems, methods, and kits for speech neuroprostheses are provided. Aspects of the invention include an in vivo positionable device comprising a housing, a first component extending from the housing in a first plane, and a second component extending from the housing in a second plane parallel to the first plane, wherein the first and second planes are non-overlapping. Further aspects of the invention include a detection system comprising an in vivo positionable sensor comprising the device according to the disclosure, and an ex vivo power supply unit connectable to the sensor. Another further aspect of the invention includes an in vivo positionable sensor comprising the device according to the disclosure and an ex vivo receiver unit operably connected to the sensor. Methods for speech decoding and / or synthesis are also provided.

[0010] Devices, systems, methods, and kits are found to have use in a variety of different applications, for example, in connection with the treatment and / or rehabilitation of subjects who are completely or partially unable to form expressive speech as a result of paralysis or injury to brain regions associated with expressive speech. Devices, systems, methods, and kits are found to have use in subjects who are unable to speak due to conditions such as stroke, ALS, or lock-in syndrome, or arthropathy. Embodiments of the present invention are found to have use as a widely deployable communication solution, provided they offer safety (i.e., no transcutaneous connection required, no implanted battery required), ease of use, and scalability (i.e., embodiments of the present invention are portable and do not require team-based expertise for maintenance and use; i.e., embodiments of the present invention are fully portable and intended to seamlessly fit into the daily lives of subjects and enable autonomous use both inside and outside the home), as well as sufficient performance to support real-time speech decoding and synthesis (i.e., a large number of contacts or channels or electrodes, for example, more than 128 channels, such as 256 channels or more in some embodiments; increasing both the number of channels and electrode density). (Muller et al., 2016, Conant et al., 2014, Yousry et al., 1997) Indications in subjects for use of embodiments of the present invention include, for example, severe prosthesis with limb dysfunction or progressive motor degeneration. Examples of use of embodiments of the present invention include, for example, real-time speech decoding and synthesis, and extensions to assistive technologies and prosthesis control (i.e., motor-brain-computer interfaces). Embodiments of the device of the present invention have shapes and features that facilitate safe transfer through the dural layer of the subject when the device is implanted. [Brief explanation of the drawing]

[0011] The present invention can be best understood from the following detailed description when read in conjunction with the accompanying drawings. The drawings include the following figures. [Figure 1] Embodiments of the device according to this disclosure are described. [Figure 2A] Different figures illustrating embodiments of the device according to this disclosure are shown. [Figure 2B] Different figures illustrating embodiments of the device according to this disclosure are shown. [Figure 2C] Different figures illustrating embodiments of the device according to this disclosure are shown. [Figure 2D] Different figures illustrating embodiments of the device according to this disclosure are shown. [Figure 2E] Different figures illustrating embodiments of the device according to this disclosure are shown. [Figure 2F] Different figures illustrating embodiments of the device according to this disclosure are shown. [Figure 2G] Different figures illustrating embodiments of the device according to this disclosure are shown. [Figure 2H] Different figures illustrating embodiments of the device according to this disclosure are shown. [Figure 2I] Different figures illustrating embodiments of the device according to this disclosure are shown. [Figure 2A] Different figures illustrating embodiments of the device according to this disclosure are shown. [Figure 3A] Two top views of the first component of the device according to this disclosure are shown. [Figure 3B] Two top views of the first component of the device according to this disclosure are shown. [Figure 4A] The interconnection between electrodes and an electronic package in an embodiment of the device described herein will be illustrated as an example. [Figure 4B] The interconnection between electrodes and an electronic package in an embodiment of the device described herein will be illustrated as an example. [Figure 4C] The interconnection between electrodes and an electronic package in an embodiment of the device described herein will be illustrated as an example. [Figure 5A] An embodiment of the device implanted in the subject is depicted. [Figure 5B] An embodiment of the device implanted in the subject is depicted. [Figure 5C]Depicts an embodiment of a device implanted in a subject. [Figure 6] Depicts a side view of an embodiment of a device implanted in a subject. [Figure 7A] Depicts an example of fully implanting an embodiment of a device in a subject. [Figure 7B] Depicts an example of fully implanting an embodiment of a device in a subject. [Figure 7C] Depicts an example of fully implanting an embodiment of a device in a subject. [Figure 7D] Depicts an example of fully implanting an embodiment of a device in a subject. [Figure 8] Depicts a schematic diagram of the electronic technology of an embodiment of a system including a device according to the present disclosure. [Figure 9A] Depicts an alternative printed circuit board design of the electronic package of a device according to the present disclosure. [Figure 9B] Depicts an alternative printed circuit board design of the electronic package of a device according to the present disclosure. [Figure 9C] Depicts an alternative printed circuit board design of the electronic package of a device according to the present disclosure. [Figure 10] Depicts a block diagram of an embodiment of a system according to the present disclosure. [Figure 11] Depicts an embodiment of a system present in a subject. [Figure 12] Depicts an embodiment of a system used by a subject for speech decoding and synthesis. [Figure 13] Depicts an embodiment of a system according to the present invention. [Figure 14] Depicts an embodiment of a device fully implanted in a subject and an ex vivo power source integrated into glasses. [Figure 15A] Depicts a flowchart of the method of use and installation of embodiments of a device and a system according to the present disclosure. [Figure 15B] Depicts a flowchart of the method of use and installation of embodiments of a device and a system according to the present disclosure. [Figure 15C] A flowchart illustrating the use and installation methods of the embodiments of the device and system described herein is shown. [Figure 16A] Different diagrams of prototypes of embodiments of the device according to the present invention are shown. [Figure 16B] Different diagrams of prototypes of embodiments of the device according to the present invention are shown. [Figure 16C] Different diagrams of prototypes of embodiments of the device according to the present invention are shown. [Figure 16D] Different diagrams of prototypes of embodiments of the device according to the present invention are shown. [Figure 17] A prototype of an embodiment of the device according to the present invention, fully implanted in a subject, is depicted. [Figure 18A] The experimental results of using the system according to the present invention on subjects are described. [Figure 18B] The experimental results of using the system according to the present invention on subjects are described. [Figure 18C] The experimental results of using the system according to the present invention on subjects are described. [Figure 18D] The experimental results of using the system according to the present invention on subjects are described. [Figure 18E] The experimental results of using the system according to the present invention on subjects are described. [Figure 18F] The experimental results of using the system according to the present invention on subjects are described. [Modes for carrying out the invention]

[0012] Aspects of the present invention include an in-vivo positionable device comprising a housing, a first component extending from the housing in a first plane, and a second component extending from the housing in a second plane parallel to the first plane, wherein the first and second planes are non-overlapping. Further aspects of the present invention include a detection system comprising an in-vivo positionable sensor comprising the device according to the present disclosure and an ex-vivo power supply unit connectable to the sensor. Another further aspect of the present invention includes an in-vivo positionable sensor comprising the device according to the present disclosure and an ex-vivo receiver unit operably connected to the sensor. Methods for speech decoding and / or synthesis are also provided.

[0013] Before the present invention is described in more detail, it should be understood that the present invention is not limited to the specific embodiments described and is therefore, of course, subject to change. Furthermore, since the scope of the present invention is limited only by the appended claims, it should also be understood that the terms used herein are for the purpose of describing only specific embodiments and are not intended to limit them.

[0014] Where a range of values ​​is provided, unless the context otherwise explicitly states, each intermediary value will be understood to encompass up to one-tenth of the lower limit unit between its upper and lower limits and any other stated or intermediary values ​​within that stated range. The upper and lower limits of these smaller ranges may be individually included within smaller ranges and are likewise included in the invention, according to any specifically excluded limits in the stated range. Where a stated range includes one or both of the limits, ranges excluding one or both of those included limits are also included in the invention.

[0015] In this specification, a particular range is presented preceded by the term “approximately.” In this specification, the term “approximately” is used to provide literal support for the exact number it precedes, as well as for any number that is close to or approximates the number it precedes. When determining whether a number is close to or approximately close to a specifically listed number, an unlisted number that is close to or approximately close to that number may, in the context in which it is presented, provide a substantial equivalence to the specifically listed number.

[0016] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art to which the present invention pertains. Any methods and materials similar or equivalent to those described herein may also be used in carrying out or testing the present invention, but representative illustrative methods and materials are described herein.

[0017] All publications and patents cited herein are incorporated herein by reference, and by being incorporated herein by reference, disclose and describe the relevant methods and / or materials from which those publications are cited, as if each individual publication or patent were specifically and individually indicated to be incorporated by reference. Any citation of a publication relates to its disclosure prior to the filing date of this application and should not be construed as accepting that the present invention is not entitled to precede such publication by prior invention. Furthermore, the dates of publications provided may differ from the actual publication dates and may need to be independently verified.

[0018] It should be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” refer to multiple subjects unless the context clearly indicates otherwise. It should also be noted that the claims may be drafted to exclude any optional element. Therefore, this statement is intended to function as an antecedent to the use of such exclusive terms as “alone,” “only,” or “negative” limitation relating to the enumeration of elements of the claims.

[0019] As will be apparent to those skilled in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has distinct components and features that can be readily separated from or combined with any of the features of any of the other various embodiments without departing from the scope or spirit of the invention. Any described method may be carried out in the order of the described events or in any other logically possible order.

[0020] Devices and methods may be described in a functional description for grammatical fluidity, but claims should not be interpreted as necessarily limited by “means” or “step” constructs unless explicitly stated under Section 112 of the U.S. Patent Act, and should be granted the full scope of the definitions and equivalents provided by the claims under the statutory doctrine of equivalents, and it should be clearly understood that claims should be granted the full statutory equivalents under Section 112 of the U.S. Patent Act if explicitly stated under Section 112.

[0021] As summarized above, the Disclosure provides fully portable speech neuroprostheses devices and systems. An aspect of the Invention includes an in vivo positionable device comprising a housing, a first component extending from the housing in a first plane, and a second component extending from the housing in a second plane parallel to the first plane, wherein the first and second planes are non-overlapping. A further aspect of the Invention includes a detection system comprising an in vivo positionable sensor comprising the device according to the Disclosure, and an ex vivo power supply unit connectable to the sensor. Another further aspect of the Invention includes an in vivo positionable sensor comprising the device according to the Disclosure, and an ex vivo receiver unit operably connected to the sensor. Kits comprising aspects of the devices and systems described herein are also provided. Methods for speech decoding and / or synthesis are also provided.

[0022] In vivo positioning device Aspects of the present disclosure include fully portable speech neuroprosthesis devices. In particular, the present disclosure includes an in vivo positionable device comprising a housing, a first component extending from the housing in a first plane, and a second component extending from the housing in a second plane parallel to the first plane, wherein the first and second planes are non-overlapping. Non-overlapping means that the first plane on which the first component resides does not intersect, intersect, or otherwise connect with the second plane on which the second component resides. The second plane parallel to the first plane means that the first plane on which the first component resides is substantially equidistant from the second plane on which the second component resides. That is, the second plane remains substantially the same distance from the first plane over the entire extent of the first and second components.

[0023] In the embodiment, the first and second components do not overlap. The non-overlapping first and second components mean that, when viewed from above (i.e., along an axis perpendicular to the plane of the device, or along each of the two longest axes of the device, or looking down at an embodiment of the device implanted in a subject), the first component is substantially separate from the second component, and when viewed in this way, the first component does not obstruct the view of the second component (i.e., they do not overlap), and vice versa. The non-overlapping first and second components mean that, when the device is implanted in a subject, the first component lies in a first plane coinciding with the brain surface (i.e., the “lower” part of the subject’s skull), and the second component lies in a second plane coinciding with the skull surface (i.e., the “upper” part of the subject’s skull), and therefore do not overlap with the first plane.

[0024] Embodiments of the device are fully implantable. Fully implantable means that the device can be surgically implanted in a subject, such as a human subject, so that the entire device is implanted within the subject. In embodiments, a fully implantable device means that no aspect of the device is located ex vivo or protrudes through the subject's skin. In other embodiments, a fully implantable device means that connections to the device (e.g., electrical connections or cables to the device, or other physical, operable connections) are located partially in vivo and partially ex vivo. In other embodiments, a fully implantable device means that there is no transcutaneous interface to the device.

[0025] Portable first component In embodiments, the first component is implantable in the subdural space. The subdural space refers to the space beneath the subject's dura mater, i.e., beneath the dural layer surrounding the subject's brain. Being beneath the dural layer means being in close proximity to the surface of the subject's brain relative to the dural layer. In embodiments, the first component is implantable on the cortical surface. In embodiments, the first component may include a shape that allows it to be inserted into the subdural space and / or the cortical surface through a minimal incision through the dural layer, such as a single incision. That is, the first component may include a shape that allows it to be inserted into the subdural space while minimizing the need to expose the subdural region. In some cases, the first component includes any convenient shape that allows it to slide onto a brain surface, such as the cortical surface, through an incision in the dural layer. Being implantable on the cortical surface means that the first component can be implanted so as to be substantially flat on the cortical surface, i.e., substantially contiguous with the surface of the cortical surface.

[0026] In embodiments, the first component is implantable in the speech region of the brain. That is, in embodiments, the first component is implantable in such a way that it can be implanted on the speech region of the brain in a manner that is substantially flat. By "across the speech region of the brain," it means that the first component is implantable on a surface of the brain that overlaps with, or otherwise substantially adjacent to, a region of the brain associated with receptive and / or expressive speech. In some cases, such a speech region of the brain is the speech motor region.

[0027] In other embodiments, the first component is implantable in a motor area of ​​the brain. That is, in embodiments, the first component is implantable in such a way that it is substantially flat on a motor area of ​​the brain. For example, the first component may be implantable in such a way that it is substantially flat on a motor area of ​​the brain associated with speech. In other cases, the first component may be implantable in such a way that it is substantially flat on a motor area of ​​the brain associated with motor functions other than speech. In certain embodiments, the first component is implantable on the surface of a sensorimotor cortical region. In such embodiments, the first component may be implantable on the surface of a sensorimotor cortical region within the subdural space. In embodiments, the sensorimotor cortical region is selected from the gyrus gyrus, postcentral gyrus, posterior middle frontal gyrus, posterior superior frontal gyrus, posterior inferior frontal gyrus region, or any combination thereof.

[0028] Shape of the first component In embodiments, the first component may include any convenient shape as desired. As discussed above, implanting the first component of the device according to the present invention requires multiple incisions in the dura mater of the brain; however, the first component may include a shape that facilitates implantation of the first component on the brain surface using minimally invasive surgery, such as minimizing the number of incisions in the dura mater of the brain (e.g., a single or nearly single incision).

[0029] In some embodiments, the first component conforms to the brain surface. In such embodiments, the first component may include a shape that conforms to the brain surface. In such cases, the shape may include curvature corresponding to the brain surface. In certain embodiments, the shape includes a plurality of fingers. A plurality of fingers means a plurality of distinct shapes extending from the central portion of the first component. In some cases, the plurality of fingers have a rectangular, semi-elliptical, semi-rectangular, triangular, or other shape, and in any case extend from the central portion of the first component to the periphery of the first component. In embodiments, the first component may have any convenient number of fingers, and such number may vary. For example, the number of fingers present in an embodiment of the first component may vary depending on the desired size of the fingers relative to the size of the first component. Some embodiments include a plurality of fingers having different shapes and / or sizes. In embodiments, the plurality of fingers may be shaped and arranged to facilitate the ability of the first component to conform to the brain surface. Embodiments including a plurality of fingers may further include a plurality of slots between each finger. Such slots are gaps between each finger of a plurality of fingers and may be included to facilitate the ability of the first component to conform to the surface of the brain. The number of slots present in one embodiment of the first component is related to the number of fingers included in such embodiment. Such slots may include any convenient size (i.e., the depth of the slot from the periphery of the first component toward the center of the first component, and the distance between each finger of the first component), and such may vary as desired. In embodiments of the first component, the configuration of fingers and slots may be selected to achieve a desired balance between maintaining the structural integrity of the first component and the ability of the first component to be implanted sufficiently and flexibly on the surface of the brain, while allowing space for routing interconnections between components present in the first component (e.g., electrodes).In some cases, the shape of the first component and / or any fingers present thereon may include rounded shapes, such as rounded corners.

[0030] The first component of interest may include any convenient length and width, which may vary as desired based on the preferred number of electrodes present on the first component and the pitch between the electrodes, as well as the desired brain region in which the first component is positioned. In embodiments, the first component includes lengths from 10 mm to 200 mm, such as 10 mm, 20 mm, 30 mm, 40 mm, 50 mm, 60 mm, 67 mm, 70 mm, 80 mm, 90 mm, 100 mm, 150 mm, or 200 mm. In embodiments, the first component includes widths from 10 mm to 100 mm, such as 10 mm, 20 mm, 30 mm, 32 mm, 40 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm, or 100 mm. In one embodiment, the first component is 32 mm long and 67 mm wide.

[0031] Flexible substrate of the first component In some embodiments, the first component comprises a flexible substrate. In some cases, the flexible substrate is foldable. In other cases, the flexible substrate conforms to the movement of the brain. That is, the flexible substrate is flexible enough to maintain its position and configuration relative to the brain surface without being affected by the movement of the brain relative to the surrounding structure, including the movement of the brain or surrounding structure in connection with the implantation of the device. In some cases, the flexible substrate is a spring. That is, the first component may comprise a flexible substrate that, when a force is applied to the flexible substrate to stretch or compress it, acts in opposition to the change in the length of the flexible substrate. Such properties may be configured as desired so that the first component can remain in a substantially fixed position relative to the brain surface without being affected by the forces applied to the first component in connection with the implantation of the device. That is, the first component may be configured to maintain its position relative to a desired region of the brain, such as the speech or motor region, while the device is implanted.

[0032] In some embodiments, the flexible substrate comprises a thin-film substrate. In some embodiments, the flexible substrate comprises a liquid crystal polymer (LCP). Any convenient biocompatible LCP can be applied. LCPs are long-lived and have approximately 25 times lower water permeability than commonly used flexible printed circuit board (FPC) materials such as polyimide (Jeong et al., 2016), dramatically extending the reliability and lifespan of the implanted array. LCPs are also self-adhesive thermoplastic materials and do not require additional adhesives or glues when combining multiple sheets. In certain embodiments, the liquid crystal polymer comprises a metal layer. Such a metal layer may comprise any convenient conductive material. The conductive material of interest comprises a material that allows electrical connections to be routed throughout the first component such that electrical signals are sufficiently isolated from other aspects of the first component and surrounding anatomical structures. The conductive material of interest further comprises a material that allows electrical signals to be transmitted across the first component through such a metal layer. In some cases, the liquid crystal polymer comprises multiple metal layers, such as at least three metal layers. In this embodiment, a three-metal layer configuration is used with two dedicated embedding layers for signal routing and another layer for electrodes, e.g., the top layer. The trace width and spacing at the production level may be 25 / 35 μm. To maximize isolation and minimize trace resistance, a wider trace width and spacing of 50 / 50 μm is used in the design, resulting in a 50 μm trace pitch, i.e., 12.8 mm, using two trace routing layers to route 256 channels. The trace square resistance is 6-8 Ωcm. -1 In such embodiments, the maximum trace resistance across the entire array would be well below 100Ω.

[0033] In embodiments, the first component comprises a flexible cover layer. Any suitable cover layer may be selected so as to provide a boundary between the internal portion of the first component and the external portion of the first component, for example, including one or more metal layers. That is, the cover layer may be selected so as to protect the internal portion of the first component from the surrounding anatomical environment when the first component is implanted. For example, in embodiments, the flexible cover layer is waterproof. Any suitable biocompatible material may be applied to the cover. In some cases, the flexible cover layer is a silicone layer.

[0034] Partition of the first component In embodiments, the first component comprises multiple partitions. For example, in embodiments, the first component comprises an electrode partition, a transition partition, and a connection partition. In such embodiments, the electrode partition may be implantable in the subdural space. In embodiments, the electrode partition may comprise multiple electrodes. When the device (including its first component) is implanted in a subject, any convenient electrodes can detect desired electrical signals, for example, from the brain. In embodiments, the connection partition may be implantable on the dura mater. In embodiments, the connection partition may be operably connected to the housing. A connection partition means a partition of the first component that facilitates one or more connections between the first component and other aspects of the device. For example, a connection partition may connect the first component to the device housing. More specifically, a connection partition may connect electrodes of the first component to other electrical components present within the device housing.

[0035] In other embodiments, the transition partition includes a foldable material. That is, the transition partition of the first component may have any convenient shape or material or other configuration that can be folded itself, i.e., can chronically maintain such a position without structural failure. Embodiments of the device characterized by such a folded orientation of the first component and electrode array relative to the device housing allow a greater length of the first component or its electrode array, e.g., the entire length, to be inserted into the cortical surface through a dural incision, e.g., a single dural incision. Positioning the device in this manner helps maximize exposure to the motor cortex while avoiding the midline vascular system. In such a folded configuration, the connection between the electrode array and, for example, a ceramic feedthrough, is on the upper side of the device. Additional covers, such as a metal cover with tabs, may be used to protect the connection, protect the electrode array from the wireless power field, and secure the device to the skull. In such embodiments, the first component may include a fold in the transition partition. In such embodiments, the first component may fold over itself in the transition partition. That is, the first component may include a substantially 180° fold. In some cases, the transition partition may have multiple branches or legs. Alternatively, from a different perspective, it may have a central opening or one or more slots. That is, the transition partition may include a shape with notches to facilitate the transition partition of the first component that folds over itself, while maintaining the integrity of the first component, with multiple branches or legs extending between the electrode partition and the connecting partition. In embodiments, each branch or leg of the transition partition of the first component may have a width of approximately 5 mm to 25 mm, for example, 5 mm, 10 mm, 15 mm, 20 mm, or 25 mm. The number of branches or legs may vary from 2 to 10, for example, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10.

[0036] First component function In some embodiments, the first component detects electrical activity. For example, the first component detects electrical activity of the brain, such as electrical activity from the surface of the brain. In some cases, the surface is the outer surface of the brain, thereby allowing the first component to detect electrical activity from the outer surface of the brain, i.e., electrical signals originating from the brain and detectable from the outer surface of the brain. In certain embodiments, the first component detects electrical activity of the cerebral cortex. In other embodiments, the first component detects electrical activity of the ventral sensorimotor cortex. In some embodiments, the first component is a cerebral cortex measuring electrode.

[0037] Electrodes of the first component In the embodiment, the first component comprises multiple electrodes. Any convenient electrodes capable of receiving, i.e., detecting, electrical signals may be applied. The electrodes of interest include electrodes capable of detecting electrical activity of the brain from the surface of the brain when the device is implanted. In some cases, the multiple electrodes comprise an electrode array. The first component may comprise any convenient number of electrodes, such as 2, 3, 4, 5, 6, 7, 8, 9, 10, 100, 200, 500, 1,000, 2,000 or 5,000 or more electrodes (e.g., including 250 to 1,000 electrodes).

[0038] In some embodiments, the electrodes include surface electrodes. Surface electrodes mean electrodes that are placed on the surface of a structure, such as the brain, and from which electrical signals can be detected. In such embodiments, the surface electrodes of interest can detect electrical signals from the underlying structure, i.e., the brain, while being present on the surface of such a structure, i.e., the brain. In other embodiments, the electrodes include through electrodes. Through electrodes mean electrodes that penetrate, i.e., pierce, a structure (i.e., the brain), or otherwise, when placed within such an underlying structure, i.e., the brain, they can detect electrical signals from such a structure, i.e., the brain.

[0039] In embodiments, any convenient electrode that can be attached to the first component and detect a desired electrical signal may be applied, and such electrodes can be diverse. In embodiments, the diameter of the electrode is in the range of 0.1 mm to 5 mm, such as a diameter of about 0.1 mm, or 0.5 mm, or 1 mm, or 2 mm, or 3 mm, or 4 mm, or 5 mm. In some embodiments, the electrode protrudes from the surface of the first component. In other embodiments, the electrode is coplanar with the surface of the first component (i.e., with a flexible substrate, such as LCP, or only the layer). The electrode of interest may include any convenient thickness, such as 50 μm to 1 mm, such as 50 μm, or 100 μm, or 125 μm, or 200 μm, or 300 μm, or 400 μm, or 500 μm, or 1 mm. In other embodiments, the electrode (i.e., the cover, for example, having a silicone layer) may include any convenient thickness such as 50 μm to 2 mm, such as 50 μm, 100 μm, 125 μm, 200 μm, 300 μm, 400 μm, 500 μm, 1 mm, 1.5 mm, or 2 mm.

[0040] In embodiments, electrodes may be arranged on a first component in any convenient manner, i.e., such that the electrodes substantially cover the surface of a desired area of ​​the brain, or otherwise can detect electrical signals from a desired area of ​​the brain. In embodiments, the electrodes may include any convenient longitudinal pitch between electrodes, i.e., the distance between electrodes along the long axis of the first component, and any convenient transverse pitch, i.e., the distance between electrodes along an axis perpendicular to such a longitudinal axis. In embodiments, the electrode array may include areas on the first component having a length of about 10 mm to 100 mm, such as about 10 mm, or 20 mm, or 23.5 mm, or 30 mm, or 40 mm, or 50 mm, or 60 mm, or 70 mm, or 80 mm, or 90 mm, or 100 mm. In such embodiments, the electrode array may include an area on a first component having a width of approximately 20 mm to 200 mm, such as 20 mm, 23.5 mm, 30 mm, 40 mm, 50 mm, 51 mm, 60 mm, 70 mm, 80 mm, 90 mm, 100 mm, 150 mm, or 200 mm. In some cases, the longitudinal pitch between electrodes is approximately 0.5 mm to 10 mm, such as 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm, and the lateral pitch between electrodes is approximately 0.5 mm to 10 mm, such as 1 mm, 2 mm, 2.5 mm, 3 mm, 4 mm, or 5 mm. In some cases, the electrode array includes an area of ​​23.5 mm × 51 mm, and the electrodes have a diameter of 1 mm and a pitch between electrodes of 2 mm × 2.5 mm.

[0041] As described above, certain embodiments include electrodes located within a liquid crystal polymer layer. The electrodes of interest include LCP electrodes manufactured by Dyconex. Such electrodes have successfully passed ISO 10993-5 and have been shown to cause no adverse effects when similar LCP electrodes are implanted in the retina of rabbits for 2.5 years. In the embodiments, metals considered to be biocompatible (including, for example, Au, PtIr, and trace Pd) are used. In the embodiments, the electrode contacts are manufactured with gold as the base metal and electroplated with PtIr to reduce electrode impedance. Such electrodeposited PtIr coatings have demonstrated low impedances of less than 10 kΩ for all electrodes, including electrodes with a diameter of 200 μm.

[0042] In some embodiments, the LCP electrodes can be sterilized by ethylene oxide (EtO) or vaporized hydrogen peroxide (VHP) sterilization. In some cases, the LCP electrode array (of the first component) includes an outer coating on the non-electrode side to improve handling and adjust the flexibility of the LCP electrode array.

[0043] Second component In some embodiments, the second component is a power supply component. In some cases, the second component wirelessly powers the device. As described above, fully portable devices are not directly interconnected via solid or fixed connections to a power source (i.e., physically connected to a power source). Embodiments of the device do not include a battery, i.e., a battery is not included when the device is fully portable. Thus, in some cases, the second component provides transcutaneous power to the device. In other cases, the second component comprises an inductive power supply unit, e.g., a power supply unit configured to provide transcutaneous power to the device in conjunction with an external power source. In certain specific cases, the second component comprises a wire coil, e.g., a wire coil configured to provide transcutaneous power to the device in conjunction with an external power source.

[0044] In embodiments, the second component interfaces with a power supply unit. In such cases, the power supply unit may be an ex-vivo unit, i.e., an external power supply unit. In certain cases, the second component further comprises a magnet. That is, the magnet can be ported as part of the second component of a fully portable device. In such cases, the magnet attracts the ex-vivo power supply unit. In some cases, the magnet attracts the second component and aligns the second component with the ex-vivo power supply unit. That is, the magnet is positioned in the device relative to the second component such that the in-vivo magnet facilitates the convenient positioning of the ex-vivo power supply unit to the in-vivo second component of the device. In embodiments, the device does not include a battery. That is, the power source for the device is the second component of the device, as described above, in conjunction with an external wireless power supply.

[0045] In some cases, when the device is implanted in a subject, the second component can be folded onto the housing so that, instead of extending outward and detached from the device, it folds onto the device. In some cases, such a configuration facilitates more efficient surgical implantation of the device into the subject. In some cases, such a configuration facilitates a reduction in the extent of surgical incisions or other surgical operations required to implant and / or configure the device. In some cases, such a configuration results in a smaller "footprint" of the device; that is, a smaller volume of the subject's skull and surrounding tissues required to accommodate the device; or, in other words, a smaller area where the device interfaces with the subject's tissues, e.g., the surface area of ​​the skull. In embodiments, the housing is fabricated from one or more materials selected so that such a folded configuration does not impair the functionality of the second component or the contents of the housing, i.e., the electronic components. In other words, the housing can be made from one or more materials such that the functionality of any electrical components present in the housing is not affected, and the functionality of the second component is not affected, even when the second component is folded onto the housing, and even when the second component interacts with an external wireless power supply unit. That is, in embodiments, the second component can be folded onto the housing without hindering its ability to supply power transcutaneously to the device, and without hindering other functions of the device, such as electronic components of other objects present in the housing controlling the device.

[0046] In some embodiments, the second component folds onto the housing. In some embodiments, the second component folds on itself onto the housing. In other embodiments, a substantial portion of the second component folds onto the housing. A substantial portion means, in some cases, that a large portion of the area of ​​the second component folds on itself, or in other cases, that the wire coil present within the second component is present within the folded portion of the second component as a result of the second component being folded. In yet another embodiment, the foldable portion of the second component is configured to allow the second component to fold on itself. That is, the second component may have a foldable section, i.e., made of a more flexible material, or may have perforations or other mechanical features that facilitate the device being folded on itself. In some cases, the foldable portion of the second component includes a flexible material. Any convenient biocompatible flexible material may be applied. In other cases, the second component rests on the surface of the housing. In yet another case, the second component is folded over the housing so that the second component rests on the surface of the housing. In a particular embodiment, the second component comprises a wire coil, and the second component is folded over the housing so that the wire coil rests on the surface of the housing. In a particular case, the second component is folded over the housing and attached to the surface of the housing. The second component, such as adhesive, epoxy, bonding material, mechanical support, or structure, can be attached to the surface of the housing by applying any convenient technique.

[0047] In some embodiments, the housing includes an electromagnetic shielding material. In some embodiments, the housing includes a material that reduces interaction with electromagnetic fields. In other embodiments, the housing includes a material that reduces electromagnetic field losses. In yet another embodiment, the housing is a ceramic housing. In some cases, the housing is a magnetic housing.

[0048] housing In one embodiment, the housing is implantable within a skull opening. In another embodiment, the housing comprises a sealed package; that is, the housing is enclosed within a seal to isolate the housing and its contents from the surrounding anatomical environment. For example, the housing may be sealed so that fluids or other tissues surrounding the implanted housing cannot enter it. The housing may be formed using any convenient material, shape, or other configuration so that it can interconnect with, for example, embodiments of the first and second components.

[0049] In certain cases, the housing comprises a ceramic substrate. The ceramic substrate may be of interest when the second component is folded onto the housing to reduce electrical interference between the housing (or its contents) and the second component. In other cases, the housing comprises a magnetic substrate. The magnetic substrate may be of interest when the second component is folded onto the housing to reduce electrical interference between the housing (or its contents) and the second component. In yet other cases, the housing comprises a metal substrate. In some cases, the housing comprises a plastic substrate. In yet other cases, the housing comprises a ferromagnetic substrate.

[0050] In some embodiments, the first component can be folded around the periphery of the housing. That is, the first component can be folded so as to wrap around one surface of the housing, such as the bottom surface of the housing, and extend away from the housing from the side of the housing opposite to the side of the housing to which the first component is attached. In certain embodiments, a partition of the first component exists within the housing.

[0051] In some embodiments, the housing may include any convenient length, such as a length of 10mm to 50mm, such as 10mm, 20mm, 25mm, 30mm, 40mm, or 50mm or more. In such embodiments, the housing may include any convenient width, such as a width of 10mm to 100mm, such as 10mm, 20mm, 30mm, 35mm, 40mm, 50mm, 60mm, 70mm, 80mm, 90mm, or 100mm. In some embodiments, the housing may include a height of 1mm to 10mm, such as 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 6.5mm, 7mm, 8mm, 9mm, or 10mm. In some embodiments, the housing may include a length of 25mm, a width of 35mm, and a height of approximately 6.5mm.

[0052] Device cover In embodiments, the device further comprises a cover, such as a cover attached to the device housing. The cover may extend synchronously with the device housing or extend beyond the sides of the housing. In embodiments, the cover is attached to one side or surface of the housing. In some cases, the housing is attached to a side of the cover parallel to the first and second components, such that the cover is substantially parallel to the first and second components. In some embodiments, the cover can be mounted coplanar with the skull surface. That is, the cover is positioned within an opening in the skull (i.e., a portion of the skull removed in connection with the implantation of an embodiment of the device), and the cover may be shaped so that it substantially fits within such an opening in the skull, i.e., is filled and sits coplanar with the skull surface. In some cases, the cover comprises a tab, such as a tab that can be fixed to the skull surface. For example, the cover may comprise a tab extending laterally away from the center of the cover, thereby allowing the tab to be attached to the unremoved skull surface using, for example, screws or adhesive, or any other convenient means of attaching biological material.

[0053] In some cases, the cover provides electromagnetic shielding. That is, the cover may be made from a material that can provide electromagnetic shielding. Electromagnetic shielding means adequately shielding electrical components present within the device housing so that such electrical components can function consistently and correctly.

[0054] In some embodiments, the cover may include any convenient length, such as a length of 10mm to 100mm, such as 10mm, 20mm, 30mm, 35mm, 40mm, 50mm, 60mm, 70mm, 80mm, 90mm, or 100mm. In such embodiments, the cover may include any convenient width, such as a width of 10mm to 100mm, such as 10mm, 20mm, 30mm, 35mm, 40mm, 50mm, 60mm, 70mm, 80mm, 90mm, or 100mm. In some embodiments, the cover may include any convenient height, such as a height of 1mm to 10mm, such as 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 6.5mm, 7mm, 8mm, 9mm, or 10mm. In some embodiments, the cover may include a length of 35mm and a width of 35mm. In some embodiments, the height of both the housing and the cover is approximately 6.5 mm.

[0055] In embodiments of covers with tabs, such tabs may include any convenient thickness, such as 0.25 mm to 2 mm, such as 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, 1.5 mm, or 2 mm. In embodiments of covers with tabs having holes, i.e., tabs for surgically screwing the cover into the skull, the center of the hole in the tab may extend outward from the periphery of the cover by about 1 mm to 10 mm, such as about 1 mm, 2 mm, 3 mm, 4 mm, 4.5 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm.

[0056] Electronic components In embodiments of the present invention, the housing comprises electronic components. Such electronic components may be operably connected to one or both of the first and second components. In embodiments, the operable connections between the electronic components and the first and / or second components are located within the housing.

[0057] In some embodiments, the electronic component comprises a plurality of sensing amplifiers. Such sensing amplifiers may be operably connected to electrodes, such as electrodes present on a first component of the device. In certain embodiments, the electronic component comprises a plurality of analog-to-digital converters. In some embodiments, the analog-to-digital converters are operably connected to electrodes of the first component. In some embodiments, the analog-to-digital converters receive signals detected by the first component. In some embodiments, the electronic component comprises pins that are operably, i.e., electrically connected to electrodes of the first component. In some cases, the operable connections comprise wire bonding. In certain particular cases, the electronic component blocks DC current to (and from) the first component. In such cases, the electronic component may comprise a plurality of capacitors, each operably connected to electrodes of the first component.

[0058] In one embodiment, the electronic component includes a temperature sensor. In such an embodiment, the electronic component may be turned off based on the temperature detected by the temperature sensor.

[0059] In yet another embodiment, the electronic component comprises multiple Bluetooth Low Energy (BLE) modules. That is, the device may have one or more modules that enable wireless communication via the Bluetooth Low Energy (BLE) protocol.

[0060] Wireless communication In some embodiments, the device transmits data wirelessly. For example, the device may transmit data wirelessly based on a signal detected by a first component. In some embodiments, the device receives data wirelessly. For example, the device may receive data wirelessly that includes device control information or device configuration information. In some embodiments, the device transmits and receives data wirelessly via a Bluetooth connection. In such embodiments, the Bluetooth connection may be a Bluetooth Low Energy (BLE) connection.

[0061] In some embodiments, the second component comprises an antenna. In some embodiments, the devices communicate wirelessly via the antenna. In certain cases, the antenna comprises a wire coil, for example, a separate wire coil present in the second component.

[0062] Stylet for insertion during surgery In embodiments, the device of the present invention further comprises a stylet. For example, embodiments may further comprise a stylet that facilitates the implantation of the device, such as surgically implanting the device near or on the surface of the brain. In embodiments, the stylet secures the configuration of the first component. Secures the configuration of the first component means that the stylet prevents the first component from folding over itself when the device is implanted or otherwise subjected to stress. In embodiments, the stylet stabilizes the device against the surface of the brain. Stabilizing the device against the surface of the brain means that the stylet facilitates the maintenance of the orientation of the device, for example, the first component of the device, relative to the surface of the brain. In some cases, the stylet is removable from the device. In certain particular cases, the stylet is located at the boundary of the first component.

[0063] subject In some embodiments, the device is fully implantable in a subject (e.g., a human subject of any age, e.g., an adult human subject or a male or female human subject, a human subject of any height or weight, etc.). In some embodiments, the device is fully implantable under the subject's skin. In certain cases, the subject has difficulty with verbal communication. In some cases, the subject may have arthropathy or joint dysfunction. For example, the subject may have difficulty with verbal communication due to stroke, muscular dystrophy, traumatic brain injury, brain tumor, or amyotrophic lateral sclerosis. In some cases, the subject is paralyzed.

[0064] Exemplary Embodiments The embodiments of the device of the present invention are described in relation to the embodiments of the device depicted in Figures 1 to 9, but this is for illustrative purposes only and the present invention is not limited to such embodiments.

[0065] Exemplary Embodiment of an In Vivo Positioning Device Figure 1 illustrates embodiments of an in vivo positionable device 100 according to several aspects of the present disclosure. Figure 1 illustrates the device 100 from a top view. The device 100 comprises a housing 110, a first component 140, and a second component 170. The housing 110 is connected to each of the first component 140 and the second component 170. The first component 140 is located in a first plane, i.e., it is depicted as being seated flat (substantially located in the first plane). Similarly, the second component 170 is located in a second plane, i.e., it is depicted as being seated flat (substantially located in the second plane). The first component 140 and the second component 170 do not overlap when viewed from the top view in Figure 1. The first component 140 has a substantially rectangular shape with a major axis extending away from the housing 110. The second component 170 is substantially circular in shape, that is, capable of accommodating, for example, a wire coil.

[0066] Figure 2A illustrates embodiments of the in vivo positionable device 200 according to several aspects of the present disclosure. Figure 2A depicts the device 200 from the bottom. The device 200 comprises a housing 210, a first component 240, and a second component 270. The housing 210 is substantially rectangular with rounded corners. Attached to the top surface of the housing 210 is a cover 220. The cover 220 extends beyond the perimeter of the housing 210 and includes tabs 225a, 225b, 225c, and 225d having holes for securing the cover 220 to the skull surface via surgical screws. The housing 210 is connected to the first component 240 and the second component 270.

[0067] The first component 240 is located in a first plane and does not overlap with the second component 270. The first component 240 is formed from a flexible substrate 265 and comprises an electrode array 250 consisting of a plurality of electrodes 245. The electrodes 245 are positioned spaced apart from one another over a substantially rectangular area of ​​the first component 240, so that when the first component 240 is positioned on the surface of the brain, the electrodes 245 of the electrode array 250 cover a sufficient area of ​​the brain surface to detect desired signals, such as sensorimotor signals from specific brain regions, such as speech motor areas. The first component 240 also comprises a cover 260 which may be formed from any convenient waterproof and biocompatible material, such as silicone. The first component 240 folds over itself at a transition partition 255 near the location where the first component 240 is connected to the housing 210. The transition partition 255 is provided with two branches or legs that facilitate the first component 240 to fold stably over itself and connect to the housing 210.

[0068] The second component 270 is located in a second plane and does not overlap with the first component 240. The second component 270 is mounted to the housing 210 on a side of the housing 210 that is separate from the side connected to the first component 240. The second component comprises one or more wire coils 273 for using the power supply device 200 via inductive power supply, and for broadcasting and receiving wireless communications between the device and an ex-vivo receiver (not shown). The second component 270 comprises a magnet 280. The magnet 280, located substantially in the center of the second component 270, attracts a magnet or other embodiment of an ex-vivo power supply unit (not shown) and is positioned to substantially fix such a power supply unit in an ex-vivo position relative to the second component 270, thereby facilitating the inductive power supply of the one or more wire coils 273 to the device.

[0069] Figure 2B shows a side view of an embodiment of the in vivo positionable device 200 shown in Figure 2A. Here, the embodiments of the device 200 described above in relation to Figure 2A are not repeated. The first component 240 is shown to be substantially present in the first plane, i.e., the first component 240 is depicted as being seated flat (substantially present in the first plane). The first component 240 is folded over itself in the transition partition 255 near the location where the first component 240 is connected to the housing 210. In Figure 2B, the view of the second component 270 is obscured by the housing 210 and cover 220.

[0070] Figure 2C illustrates an embodiment of the in vivo positionable device 200 as shown in Figures 2A and 2B. Figure 2C presents the device 200 in an exploded isometric view. Here, the embodiments of the device 200 described above in relation to Figures 2A and 2B are not repeated. In Figure 2C, the first component 240 is shown in the first plane, and the second component 270 is shown in the second plane, and the first and second planes are non-overlapping. Therefore, the first component 240 and the second component 270 are non-overlapping.

[0071] Figure 2C is an exploded view showing the cover 220 not attached to the housing 210, allowing the interior of the housing 210 to be seen. The first component 240 comprises a connection partition 256. The connection partition 256 is a partition of the first component 240 that folds over itself and is located within the housing 210. The connection partition comprises multiple connections for electrically connecting electrodes 245 present on the first component 240 to electronic components (not shown) located within the housing 210. Such electrical connections allow signals detected from the brain region where the first component 240 is located to be sampled or otherwise processed via the electronic components, and transmitted wirelessly from the device 200 via one or more wire coils 273.

[0072] Figure 2D illustrates an embodiment of the in vivo positionable device 200 as seen in Figures 2A-C. Figure 2D presents the device 200 in a top view. Here, the embodiments of the device 200 described above in relation to Figures 2A-C are not repeated. Figure 2D shows the device 200 from above, and the cover 220 extends beyond the perimeter of the housing 210, so in Figure 2D the view of the housing 210 is obscured by the cover 220. Figure 2D presents the device 200 in a orientation where the observer is looking down toward the skull of the subject to which the device 200 has been implanted, in the case where the device 200 has been implanted in the subject. Such an orientation illustrates how the tabs 225a, 225b, 225c, and 225d extend outward from the device 200 so that the device 200 can be attached to the skull via the tabs 225a, 225b, 225c, and 225d.

[0073] Figure 2E illustrates an embodiment of the in vivo positionable device 200 shown in Figures 2A-D. Figure 2E presents the device 200 in a side view. The side view shown in Figure 2E is rotated 90 degrees from the side view shown in Figure 2B. Here, the embodiments of the device 200 described above in relation to Figures 2A-D are not repeated. In Figure 2E, the first component 240 is shown in the first plane, and the second component 270 is shown in the second plane, and the first and second planes are non-overlapping. Therefore, the first component 240 and the second component 270 are non-overlapping.

[0074] Figure 2F illustrates an embodiment of the in vivo positionable device 200 similar to those shown in Figures 2A-E. Figure 2F depicts the device 200 in isometric view. The isometric view shown in Figure 2F provides a perspective view of the device 200 from a bottom view. Here, the embodiments of the device 200 described above in relation to Figures 2A-E are not repeated. In Figure 2F, the first component 240 is shown in the first plane and the second component 270 is shown in the second plane, and the first and second planes are non-overlapping. Thus, the first component 240 and the second component 270 are non-overlapping.

[0075] The first component 240 comprises a flexible substrate 265 located within the cover 260. The flexible substrate 265 shown in Figure 2F has an alternative shape comprising multiple fingers 266 extending from the central axis of the first component 240, such that a space 267 is formed between the fingers 266. Such a shape of the flexible substrate 265 facilitates positioning the first component 240 on the brain surface so that the first component 240 conforms more easily to the brain surface. Despite the alternative configuration of the flexible substrate 265 (i.e., with space between fingers 266 and fingers 267), the shape of the cover 260 of the first component 240 remains unchanged compared to those shown in Figures 2A-E.

[0076] Figure 2G illustrates an embodiment of the in vivo positionable device 200 similar to those shown in Figures 2A-F. Figure 2G presents the device 200 in isometric view. The isometric view shown in Figure 2G provides a perspective view of the device 200 from a top view. Here, the embodiments of the device 200 described above in relation to Figures 2A-F are not repeated. In Figure 2G, the first component 240 is shown in the first plane and the second component 270 is shown in the second plane, and the first and second planes are non-overlapping. Thus, the first component 240 and the second component 270 are non-overlapping. Figure 2G shows the device 200 from a top isometric view, and in Figure 2G, the view of the housing 210 is obscured by the cover 220 because the cover 220 extends beyond the perimeter of the housing 210.

[0077] Figure 2H illustrates an embodiment of the in vivo positionable device 200 similar to that shown in Figures 2A-G. Figure 2H presents the device 200 in an exploded isometric view. The isometric view shown in Figure 2G provides a perspective view of the device 200 from a top view. Here, the embodiments of the device 200 described above in relation to Figures 2A-G are not repeated.

[0078] The exploded view in Figure 2H shows the contents of the housing 210 of the device 200. The housing comprises a titanium (Ti) band 222, a gold (Au) ring 228, and a titanium (Ti) cap 221. Inside the housing 210 are an electronic package 226 and a ceramic block 227 having feedthroughs for interconnection with an aspect of the connecting partition 256 of the first component 240. The first component 240 is also present inside the housing 210. The cover 220 is shown as a titanium (Ti) cover 220 that is not sealed to the housing 210. Instead, a silicone overmold 276, i.e., a cover for the wire coil 273 of the second component 270, is present inside the housing 210 and extends to be available for sealing the housing 210. The cover 220 has holes 223 that receive projections from the silicone overmold 276 and align the silicone overmold 276 with the cover 220 and the housing 210. The first component 240 is shown folded over itself in the transition partition 255. The first component 240 is shown as a thermoformed liquid crystal polymer (LCP) in which the electrode array is located, and a silicone overmold provides a cover for the first component 240.

[0079] Figure 2I illustrates an embodiment of the in vivo positionable device 200 similar to those shown in Figures 2A-H. Figure 2I presents the device 200 in a bottom view. Here, the embodiments of the device 200 described above in relation to Figures 2A-H are not repeated. In Figure 2I, the flexible substrate 265 further comprises an electrode array 250 having a plurality of fingers 266 with space between the fingers 267 and a plurality of electrodes 245. The magnet 280 is located in the central part of the second component 270.

[0080] Exemplary Embodiment of the First Component Figure 3A presents an exemplary embodiment of the flexible substrate 365 of the first component of the device according to the present invention. Figure 3A shows the top surface of the flexible substrate 365 to illustrate the exemplary shape of the flexible substrate 365 of the first component.

[0081] In Figure 3A, the flexible substrate 365 has a substantially rectangular shape with a rounded corner on one side, i.e., the side closest to the electrode array 350, and a rounded end on the other side. The flexible substrate 365 is divided into three partitions: an electrode partition 354, a transition partition 355, and a connecting partition 356. The electrode array 350 is located within the electrode partition 354. The electrode array 350 comprises a plurality of electrodes 345 embedded within the flexible substrate 365. In Figure 3A, the transition partition 355 is shown in an unfolded or planar position. However, the transition partition 355 is configured to allow the flexible substrate 365 to fold over itself when implanted in a subject. The transition partition 355 has two branches (or, from a different perspective, a slot cutout in the center of the transition partition 355), which facilitates the folding over itself within the transition partition 355. When the flexible substrate 365 of the first component is installed in the device of the present invention, the connection partition 356 is located within the housing of such device. The connection partition 356 comprises an array of terminals or connections 357, each electrically connected to an electrode 345 of an electrode array 350. The connection partition 356 is located within the housing so that the terminals or connections 357 can be connected to electronic components that can receive signals detected by the electrodes 345 of the electrode array 350. The terminals or connections 357 may have any convenient mechanism for interconnecting with electronic components such as wire bonds having feedthrough pins.

[0082] Figure 3B presents an alternative embodiment of the flexible substrate 365 of the first component of the device according to the present invention. Figure 3B shows a top view of the flexible substrate 365 to illustrate an additional exemplary shape of the flexible substrate 365 of the first component. Here, the embodiments of the flexible substrate 365 described above in relation to Figure 3A are not repeated. In Figure 3B, the flexible substrate 365 includes a substantially rectangular shape having an interdigitated pattern including fingers 366 and spaces 367 between the fingers, the pattern extending outward from the center of the electrode partition 354 of the flexible substrate 365. The flexible substrate 365 further comprises a central notch slot 368 within the electrode partition area. Such a pattern of the flexible substrate 365 with fingers 366 and notches 368 allows the flexible substrate 365 to conform better to the brain surface. In other words, the mating pattern of the flexible substrate 365 with the notches 368 shown in Figure 3B allows the flexible substrate 365 to conform to the substantially rounded planar pattern of the brain surface (i.e., be positioned flat) without folding, twisting, or rising from the brain surface. As described, enabling the conformation of the flexible substrate 365 to the brain surface allows the electrode array 350 to cover desired brain regions more effectively and efficiently so that signals generated within such brain regions are detected more accurately.

[0083] Exemplary Embodiment of Interconnection of First Components Figure 4A presents an exemplary embodiment of device 400 according to the present invention. Figure 4A shows an isometric view of device 400 having an expanded section inside the device housing, showing the electrical connections available on the connection partition 457 of the first component 440.

[0084] Device 400 comprises a first component 440 located at the top of the device housing, a second component 470, and a cover 420. In the inflated cutout of device 400 shown at the bottom of Figure 4A, the transition partition 455 of the first component 440 is shown to fold the first component 440 into the device housing. The section of the first component 440 located within the housing of device 400 comprises an array of terminals or connections 457 for electrically connecting the electrodes of the first component 440 to an electronic package located within the housing of device 400. Each terminal or connection in the array of terminals and connections 457 comprises a gold (Au) wire bond 458, as well as a space or opening 459 for feedthrough pins of the electronic component, which are also located within the device housing.

[0085] Attaching thin-film (e.g., liquid crystal polymer (LCP)) electrode arrays to a sealed device and protecting the connections is typically a major challenge for high-channel implants. The choice of methods and materials can be limited due to biocompatibility requirements. A conventional method for forming connections between an electronic package and electrodes such as the electrodes of a first component 440 is to connect the electrode array 440 to a feedthrough 459 on a sealed package (typically a ceramic substrate) using welding (e.g., laser welding or resistance welding). Challenges of such approaches include the relatively small amount of metal required for welding in thin-film designs, and the tight tolerances for assembly, especially for the many feedthroughs 459. Wire bonding techniques can overcome these challenges, as they are suited to device-connected designs. The wire bonding approach represents a proven technique for mass semiconductor manufacturing and is suitable for production with relatively relaxed tolerance requirements.

[0086] Figure 4B shows an exemplary wire bond 458 configuration located on the connection partition of the first component 440 of device 400. The wire bond 458 comprises a gold (Au) bond pad 458a located on the flexible substrate (i.e., liquid crystal polymer (LCP) substrate) of the first component, a 200 μm platinum (Pt) feedthrough 458b connected to the electronic package of the device, and gold (Au) double-stitch bond wires 458c interconnecting bond pad 458a and feedthrough 458b. In this embodiment, 100% wire bonding success is achievable, and destructive pull tests have demonstrated that the strength of the wire bond 458c can satisfy applicable mil-std standards.

[0087] Figure 4C presents an exemplary embodiment of an electrical interconnection between a first component of the device according to the present disclosure and an electronic package present in the housing of such a device, in any case according to an embodiment of the present invention. Figure 4C presents a series of steps for constructing such an interconnection and sealing the device housing, proceeding to steps (i) to (v).

[0088] In Figure 4C, the ceramic substrate 427 has a total of 262 feedthroughs 459, 256 for electrode sensing and 6 for wireless power transfer and dual antennas. The 25mm × 35mm device form factor and such a number of feedthroughs 459 can be achieved using feedthrough pitch sizes of 1mm in one direction and 1.5mm in the other direction to facilitate routing of the electrode array 457. This configuration provides a relatively modest sealed package technique using ceramic and metal. Given that embodiments of the device of the present invention do not include batteries, sealing is crucial for the device to function as a chronic implant. For example, packaging using only liquid crystal polymer (LCP), such as using LCP for both the electrode array and the printed circuit board substrate, may not provide sufficient reliability for a device intended as a chronic implant.

[0089] Considering the challenges of misalignment during combustion across 256 feedthroughs and 459 during the welding process, the manufacturing method of interest is unaffected by misalignment of up to approximately 100 μm. The manufacturing of the packaging requires fine laser welding capabilities, and the laser welding system of interest can feature laser spot sizes down to 25 μm.

[0090] Subfigure (i) of Figure 4C shows an electronic package 426 located within a device housing having a metal (titanium (Ti)) lid. Inside the device housing is also a ceramic substrate 427 connected to the electronic package 426, which has feedthrough holes.

[0091] Subfigure (ii) of Figure 4C shows that a connection partition 457 for the first component, which includes a thin-film electrode array, is introduced into the device housing. A feedthrough 459 is shown aligned with a space or opening within the connection partition 457 for the first component (as seen in the feedthrough 459 in Figure 4A). The connection partition 457 for the first component contains wire bonding pads 458, which provide electrical connections to the electrodes of the first component.

[0092] In subfigure (iii) of Figure 4C, a wire bonding 458c is introduced between the feedthrough 459 from the electronic package 426 and the wire bonding pad 458, forming an electrical connection between the electronic package 426 and the electrodes of the first component.

[0093] In subfigure (iv) of Figure 4C, an epoxy protective layer 429 is introduced that surrounds and seals the wire bond 458c, feedthrough 459, and wire bonding pad 458.

[0094] In the lower diagram (iv) of Figure 4C, a bottom cover 421, for example made of metal, is introduced to further seal the inside of the device housing. The bottom cover 421 provides protection for the wire bonding connections 458c, as well as shielding the electronic package 426, including the wire bonding connections 458c, feedthrough 459, and wire bonding pads 458, from electromagnetic fields. The bottom cover 421 provides an additional seal 421a around the opening into which the connection partition 457 of the first component enters the device housing.

[0095] Exemplary Embodiments of a Ported Device Design considerations for embodiments of the present invention include the following: The target location on the speech motor cortex, an area of ​​approximately 3 cm × 7 cm, requires a device of comparable size. A safe surgery requires craniectomy. Accordingly, the design of interest features, as a sensing amplifier, a battery-less topology, Bluetooth Low Energy (BLE) 5.0 communication (e.g., dual modules in the training phase and a single module in the normal use phase), 13.56 MHz wireless power transfer (compatible with short-range wireless communication), conventional ceramic / metal feedthrough and sealed packaging, a commercially available 64-channel digital electrophysiological integrated circuit (e.g., the RHD2164 chip from Intan), and 3D electronic packaging.

[0096] Figure 5A presents an exemplary embodiment of the device 500 according to the present invention. Figure 5A shows the device 500 present on the surface of the brain 599 when intended for chronic implantation. The device 500 comprises a housing 510, a first component 540, and a second component 570. The housing 510 comprises a sealed electronic package into which the electrode array 570, located within the housing 510, is connected. When the device 500 is implanted in a subject, the housing 510 sits within the subject's skull and is coplanar with the subject's skull. The first component 540 extends over a region of the brain 599 surface where it is desired to detect signals related to speech formation. Once implanted, the first component 540 is implanted in the subdural region so as to be in contact with the cortex of the brain 599. The first component 540 comprises, for example, a grid electrode array having 250 to 1,000 electrodes. The first component 540 can position electrodes of an electrode array on a relatively large area of ​​the surface of the brain 599. The second component 570 comprises a wire coil 573, i.e., a wireless power supply coil and an antenna. When the device 500 is implanted in a subject, the second component 570 sits on top of the subject's skull.

[0097] Figure 5B shows a magnified view of the device 500 implanted in vivo so that a first component 540, comprising an electrode grid array, covers a portion of the surface of the brain 599. The device 500 comprises a housing 510 having an electronic package sealed inside. The electronic package of the housing 510 is electrically connected to the electrode array of the first component 540, as described above. When implanted in vivo, the housing 510 sits within the skull and is coplanar with the skull. The first component 540 comprises a grid electrode array having any convenient number of electrodes, such as 250 to 1,000 electrodes. When implanted in vivo, the first component 540 comprises a flexible substrate such that the first component 540 shrinks the cortex of the brain 599, allowing the electrodes of the grid electrode array to detect electrical signals from the portion of the brain 599. The second component 570 comprises a wireless power supply coil and an antenna. Such wireless power transfer coils and antennas comprise one or more metal wires that are externally coated with a cover made of any suitable biocompatible material such as silicone.

[0098] Figure 5C shows the device 500 in a cross-sectional view after surgical placement. That is, the device 500 is shown in a configuration implanted in vivo into the brain 599 and skull 598 (i.e., chronic implantation). The device 500 comprises a housing 510 having a cover that seats within the skull 598 and is coplanar with the skull 598. The device 500 is attached to the skull 598 by surgical screws through tabs 598a, 598b, 598c, and 598d. The second component 570 is located on the surface of the skull 598. The housing 510 comprises an electronic package located within the housing 510, which is connected to the electrode array of the first component 540 via burr holes or limited craniectomy.

[0099] Figure 6 shows a side view of device 600 according to an embodiment of the present invention after surgical placement. Device 600 comprises a housing 610 having a cover 620, a first component 640 having a transition partition 655, and an electrode array 650 including a plurality of electrodes. Since Figure 6 shows a side view of device 600, the image of the second component of device 600 is obscured. Device 600 is fully implanted in vivo. Specifically, device 600 is implanted such that the electrode array 650 of the first component 640 is located beneath the dura mater 697 on the cortical surface 699 of the brain. The first component 640 is connected to the housing via a transition partition 655 that traverses the dura mater 697 around the dural suture 697 of a dural incision used to position the electrode array 650 of the first component 640 via the dura mater 697. The housing 610 is located within the skull 698 and is coplanar with the skull 698. The cover 620 of the housing 610 is attached to the surface of the skull 698. The device 600 is entirely located beneath the skin 696, and as a result, the device 600 is fully implanted. A second component (not shown) is located on the surface of the skull 698 beneath the skin 696.

[0100] Figures 7A–D illustrate the sequential steps of a surgical implantation procedure for device 700, characterized by positioning the electrode array of the first component 740 on the surface of the precentral gyrus of the brain 799, with reference to the median sulcus 799a and the Sylvian fissure 799b, through a skin incision 796a and a craniectomy 798a. The electrode array of the first component 740 is connected at the upper end of device 700, rather than at the lower side of device 700. Such a position allows almost the entire length of the electrode array of the first component 740 to be inserted through a dural incision 797a (i.e., a surgical incision of the dura mater 797), after which a dural suture 797b is fabricated, and the housing 710 of device 700 is neatly placed within the craniectomy on top of the dura mater 797 overlapping the top of the electrode array of the first component 740 (as seen in Figures 7C–D). The device cover 720 is seated within the surface of the skull 798 and is coplanar with the surface of the skull 798. Figure 7C shows the charging coil 773 of the second component 770 inserted beneath the scalp 796. Figure 7D shows a cross-sectional view of the implanted device 700 in its final position before closure of the flap of skin 796.

[0101] Electronic Packages Figure 8 illustrates an overall schematic diagram of an embodiment of the electronic package 800 of the device according to an aspect of the present invention. Such an embodiment of the device of the present invention comprises an electrode array 850, which is a 256-channel liquid crystal polymer (LCP) electrode array, as located on a first component, and a wire coil 870, as located on a second component.

[0102] Cortical signal acquisition. Sensing across 256 channels of the 850 electrode array is supported by four 64-channel digital electrophysiology integrated circuits (e.g., the RHD2164 integrated circuit available from Intan Technologies LLC). Intan chips such as the RHD2164 integrated circuit are commonly used in many brain sensing systems and have a 2.4 μV output. rmsIt has been proven reliable with appropriate signal resolution. At a sample rate of 512Hz, the total power consumption of the 256 channels recorded simultaneously is approximately 6mA from a 3.3V power supply, which does not dominate the system's power consumption.

[0103] High-speed communication for data telemetry, wireless power transfer, and chargers is crucial for brain-machine interface applications with hundreds of sensing channels. High-speed communication technologies using short-range wireless links, ultra-high frequency communication, or optical communication can be applied. Embodiments of the device of the present invention employ a reliable and practical design for high-speed communication, including the application of Bluetooth Low Energy (BLE) technology. BLE communication is increasingly being adopted in devices, including commercially available portable pacemakers and neural control devices. In embodiments of the device of the present invention, the maximum communication speed requirement is applied during training phases where simultaneous streaming of all 256 channels is desired to optimize model training. For example, with 12-bit data (10mV amplitude with 2μV resolution) and a 500Hz sample rate, the total streaming data rate is 1.5Mbit / s. Although the BLE 5.0 protocol supports a data rate of 2Mbit, the maximum effective data rate for the payload required for the communication prototype is approximately 1.3Mbit / s to 1.4Mbit / s. In embodiments of the device of the present invention, dual BLE modules are used, as shown in Figure 8, to overcome the limitations due to the trade-off between two sets of electronic hardware and reliable, ready-to-use communication. In this embodiment, the secondary BLE module is used only during the training phase (the receiving dual BLE module may be used, for example, to connect to a portable computer for the training phase) and can be shut down during normal use to conserve power. The dual monopole antenna may be located next to the wireless power coil, i.e., the second component, which is connected to the BLE module via a feedthrough.

[0104] In alternative embodiments, the nRF52832 integrated circuit, available from Nordic Semi (such chips are considered for illustrative purposes, understanding that other comparable commercially available or custom-designed integrated circuits may also be used in embodiments of the present invention), may be used, offering the advantages of a small footprint, efficient wireless, and minimal auxiliary components. The nRF52832 integrated circuit has a wafer-level chip-skeleton package with dimensions of just 3 mm × 3.2 mm × 0.4 mm. The nRF52832 integrated circuit has an Arm® Cortex®-M4 CPU with a floating-point unit operating at 64 MHz. The wireless consumes a peak current of 10.6 mA with dual BLE modules during the training phase and a peak current of only 5.3 mA during the normal use phase, which is within the desirable budget for embodiments of the device according to the present invention.

[0105] The internal magnet is incorporated into a wireless power supply module (i.e., a second component of the device of the present invention) to facilitate alignment between the exvivo power supply unit and the wireless power supply model of the device. In embodiments, the magnet design is preferably compatible with 3T MRI. In embodiments, a chipset, e.g., the PTX100W from Panthronics or other commercially available chipsets, may be used for wireless power supply. In such embodiments, the operating frequency is 13.56 MHz and is compatible with a short-range wireless communication module used to establish a stable power level. Embodiments of the present invention may have a wireless power supply link to achieve an efficiency of 35% over a skin thickness of 4 to 10 mm.

[0106] Device Safety Considerations Embodiments of the device of the present invention include DC blocking capacitors, as shown in the schematic diagram of the electronic package in Figure 8. In some embodiments, 256 1μF 0201 capacitors are connected between each electrode of the electrode array 850 and the amplifier input. Such a configuration blocks any potential DC leakage current between the device, i.e., the electronic package 800, and brain tissue due to a malfunction of the electronic package 800, such as the Intan chip RHD2164-4 depicted in Figure 8. In some situations, DC blocking capacitors may not be necessary for sensing-only devices (such as embodiments of the present invention), however, for example, if the electrostatic discharge (ESD) structure in the chip fails, the amplifier input may short-circuit the device power supply to potentially create a DC path to brain tissue. In embodiments, monitoring circuits can be developed to monitor each current path, but such circuits significantly increase the complexity of the electronic package 800 of the device according to embodiments of the present invention. In embodiments, DC capacitors may be used to provide a simple and robust design. The trade-off of this approach is the additional space required for the 256 capacitors, but this is typically not a concern for the device form factor or 3D electronic packaging.

[0107] In temperature monitoring embodiments, it is important to protect tissues such as brain tissue from heat-induced damage. According to recent revisions to IEC standards, it is desirable that power supply units that maintain surface contact with the subject's skin do not have chronic temperatures exceeding 41°C or 43°C. According to ISO 14708-1, implanted devices must not have a surface temperature exceeding 39°C under any in vivo conditions. In embodiments, the electronic package 800 comprises at least one temperature sensor. In embodiments, for example, each Intan chip or equivalent includes a temperature sensor. Detected high temperatures alert the device to shut down the wireless charger. In embodiments, the average of four temperature sensors in four Intan chips can be used to achieve higher accuracy.

[0108] As a good estimate for a portable device which is an embodiment of the present invention, 20 mW / cm² 2 Power consumption below this level corresponds to approximately 300mW and can be considered safe. In this embodiment, peak power consumption during the training phase is approximately 60mW (main power is 6mA from the Intan amplifier and 5.3mA from each BLE module), and 35mW during normal operation, which is far lower than the 300mW benchmark. Furthermore, the neuroprosthesis does not need to run at all times, and the average current can be much lower.

[0109] The impedance measurement chip from Intan includes impedance measurement capabilities, which are crucial for device diagnostics to monitor electrode contact continuity and performance, changes in neural interfaces, and potential infections.

[0110] Device Safety Profile: Embodiments of the device of the present invention for speech neuroprostheses do not have a battery and have only sensing ability (i.e., such devices lack stimulation therapy). Such embodiments of the present invention, coupled with the implemented DC-blocking capacitor and power consumption equivalent to that of cochlear implant technology, result in a low safety risk for the embodiments of the present invention as a whole.

[0111] Figures 9A-C illustrate various configurations of a printed circuit board design having one or more Intan chips, as described above. In the embodiment, the device uses an Intan RHD2164 chip in a 9mm x 7mm 104-pinball grid array (BGA) package. Figures 9A-B illustrate configurations having one and two Intan RHD2164 chips. Another embodiment features a four-bare-die configuration illustrated in Figure 9C, reducing the printed circuit board (PCB) area by 50%, which also enables 3D electronic packaging. In the embodiment, a dual monopole antenna may be designed and positioned next to one or more wireless power coils connected via a feedthrough to a Bluetooth Low Energy module.

[0112] Detection system Aspects of the present disclosure include systems capable of powering a fully implantable speech neuroprosthesis device. In particular, the present disclosure includes a detection system comprising an in vivo positionable sensor with a device that is an embodiment of the present invention, as described in detail above, and an ex vivo power supply unit connectable to the sensor. That is, the sensor of the embodiment of the system is the in vivo component of the system, and the power supply unit of the system is the ex vivo component of the system. Thus, the sensor is located beneath the skin of the subject, but the power supply unit does not penetrate the skin of the subject.

[0113] Embodiments of the present invention further include a power supply unit, such as a power supply unit that supplies power to a device, i.e., an in vivo positionable sensor. In embodiments, the power supply unit supplies power to the device transcutaneously. In some embodiments, the power supply unit interfaces with a second component of the device. In certain cases, the power supply unit comprises a battery. In other embodiments, the power supply unit is integrated into a pair of glasses; that is, the power supply unit may be present in a pair of glasses so that the sensor is powered by the user wearing the glasses.

[0114] Aspects of the present disclosure include systems capable of receiving signals transmitted from a fully portable speech neuroprosthesis device. In particular, the present disclosure includes a detection system comprising an in vivo positionable sensor having a device that is an embodiment of the present invention, as described in detail above, and an ex vivo receiver unit operably connected to the sensor. The receiver unit of interest includes, for example, a commercially available tablet device such as a 12.9-inch Apple iPad Pro having an M1 processor (8-core CPU, 8-core GPU, 16-core neural engine, 16GB RAM, and 2TB storage). Such embodiments may perform real-time speech synthesis. That is, such embodiments may utilize the signals detected by the sensor device to perform real-time speech synthesis on the receiver unit or on another component operably connected to the receiver unit.

[0115] In some embodiments, the operable connection between the sensor and the receiver unit is a wireless connection. In some embodiments, the wireless connection is a Bluetooth connection. In certain embodiments, the Bluetooth connection is a Bluetooth Low Energy (BLE) connection. In some embodiments, the system implements an authentication protocol between the sensor and the receiver unit. In some embodiments, the sensor transmits data to the receiver unit. In such embodiments, the transmitted data may include signals detected by the sensor, sensor status, sensor diagnostic information, a timestamp, or any combination thereof. In some cases, the receiver unit transmits data to the sensor. In such cases, the transmitted data may include sensor control information, sensor configuration information, or any combination thereof.

[0116] In some embodiments, the system is fully portable. In some cases, the receiver unit performs speech decoding, including, for example, real-time or near real-time. In other cases, the receiver unit performs speech synthesis, including, for example, real-time or near real-time. In some embodiments, the receiver unit automates speech detection, word classification, and sentence decoding based on the identification of neural activity patterns in data transmitted from the sensor to the receiver unit, which includes detected electroencephalometric data associated with attempted word generation. In some embodiments, the receiver unit uses machine learning algorithms for speech detection, word classification, and sentence decoding.

[0117] In some cases, the receiver unit further comprises a speaker. In such cases, the receiver unit may output audible sound through the speaker based on data transmitted from the sensor. In other cases, the receiver unit further comprises a display. In such cases, the receiver unit may display information based on data transmitted from the sensor. In yet another case, the receiver unit further comprises a camera. In such cases, the camera detects eye movement patterns or blinking patterns. For example, the camera may detect eye movement patterns or blinking patterns of a subject to whom the device is implanted. In embodiments, the receiver unit turns the system on or off based on the detected eye movement pattern or blinking pattern.

[0118] In some embodiments, the receiver unit is a portable device. In some embodiments, the receiver unit is a handheld device. In other embodiments, the receiver unit is configured to be mounted on the subject's body. In yet another embodiment, the receiver unit is configured to be mounted on a wheelchair. In some cases, the receiver unit is a tablet device, smartphone, or laptop.

[0119] Receiver unit In one embodiment, the receiver unit is provided with a network connection. In another embodiment, the receiver unit is operably connected to a cloud-based server via the network connection. In yet another embodiment, the cloud-based server trains a model based on the data received from the receiver unit. In yet another embodiment, the cloud-based server transmits the trained model data to the receiver unit.

[0120] System having a receiver unit and a power supply unit Embodiments of the system of the present invention, including a receiver unit, further comprise a power supply unit, such as the power supply unit described above. In some embodiments, the power supply unit supplies power to the device. In other embodiments, the power supply unit supplies power to the device transcutaneously. In some embodiments, the power supply unit interfaces with a second component of the device. In some cases, the power supply unit comprises a battery. In other cases, the power supply unit is integrated into a pair of glasses.

[0121] subject In embodiments of the system of the present invention, the sensor is fully implantable in a subject (e.g., a human subject of any age, e.g., an adult human subject, or a male or female human subject, or a human subject of any height or weight). Subjects to whom the sensor can be implanted are described in detail above.

[0122] Exemplary Embodiment of a Detection System Figure 10 shows a schematic diagram of an embodiment of system 1000 according to an aspect of the present invention. Figure 10 particularly illustrates the in vivo versus ex vivo division between the components of system 1000. The sensor / transmitter 1010 is fully portable in vivo, as described in detail above. The sensor / transmitter 1010 receives power supplied by a power supply unit 1050, which is ex vivo. In the embodiment, the sensor / transmitter 1010 is powered transcutaneously by the power supply unit 1050. The sensor / transmitter 1010 communicates wirelessly with a receiver unit 1020, which is present ex vivo. Such wireless communication may consist of a Bluetooth Low Energy connection, as described in detail above. The receiver unit 1020 may be operably connected to a cloud-based server 1060 to transmit data related to speech synthesis based on signals detected from the subject's brain by the sensor / transmitter 1010. The receiver unit 1020 may be operably connected to each of the following: a data input unit 1030, such as a camera for detecting eye movements or blinking patterns; and a data output unit 1040, such as a speaker or output screen for displaying speech synthesized based on signals detected from the subject's brain by the sensor / transmitter 1010. The cloud-based server 1060, the data input unit 1030, and the data output unit 1040 are all present in ExVivo.

[0123] Figure 11 outlines an embodiment of the system of the present invention used by a subject. Subject 1099 has an implanted device sensor (not shown), as described in detail above. The device sensor comprises a wireless transmitter 1150 used to perform telemetry of signals detected from a brain region of subject 1199. The device sensor wirelessly transmits data to a receiver unit comprising a laptop 1160. The laptop 1160 is used, potentially in combination with a cloud-based server, to perform real-time speech decoding based on signals detected from a brain region of subject 1199. Such decoded and synthesized speech is then wirelessly transmitted, for example, to a speaker worn by subject 1199. Such speech synthesis telemetry is transmitted by a wireless transmitter 1170 located in the laptop 1060.

[0124] Figures 12A and 12B illustrate embodiments of a fully implantable speech neuroprosthesis system 1200 according to an aspect of the present invention. Figure 12A shows a subject, who is a device user, using the device in a real-world setting. In Figure 12A, the implanted device in the subject is a fully implantable, skull-mounted, wireless, and battery-free device positioned on the speech motor cortex of the brain, and the implanted device, which has 256 channel sensing capabilities, communicates with a portable computer via Bluetooth, which implements a customized brain-to-speech application that enables real-time decoding and communication of intended speech via both text (e.g., through a portable tablet screen such as a Microsoft Surface or iPad Pro) and synthesized speech (e.g., through a portable tablet with a Microsoft Surface or iPad Pro speaker). A slim, battery-powered wireless charger enables continuous use, and the overall portability of the system allows for natural daily communication and real-world portable integration with the system. System 1200 allows for iterative training phases, for example, by easily updating the decoding algorithm on an iPad Pro for immediate use. The neural signal 1210 is sensed or detected by the system's implanted device and communicated to a personal tablet device 1220, such as an iPad, via a wireless connection such as Bluetooth. Onboard decoding software residing on device 1220 then uses machine learning-based algorithms to decode the speech in real time and generate text and / or synthesized speech 1230 according to the subject's preferences. Sensor components such as microphones and cameras that help optimize communication capabilities are not shown in Figures 12A and 12B. Figure 12B shows the implanted device sensor component 1250, which comprises a 256-channel electrode array of a first component 1270 placed subdurally across the surface of the speech motor cortex of the subject's brain.Such an electrode array is connected to a device 1250 electronic device, i.e., a housing with a cover, contained within a package 1260 attached to the skull. A power coil 1280 extends from the body of the package 1260, rests on the skull, and is located beneath the scalp in the subgalea space. A thin external charger 1290, magnetically held in place on the scalp above the coil 1280, delivers wireless power 1285 to the device 1250. The device 1250 (without the external charger 1290) is fully implanted, i.e., in vivo (the scalp is not shown in Figure 12B).

[0125] Figure 13 shows a schematic illustrative diagram of a fully portable speech neuroprosthesis system according to an aspect of the present invention. System 1300 comprises a device 1310 having a housing 1313 and a battery-powered external charger 1316 for wireless transcutaneous power supply. Device 1310 wirelessly transmits data to and receives data from a receiver unit 1320, which is a personal device such as an iPad. The receiver unit 1320 is operably connected to a cloud-based server 1330 for the exchange of data related to a trained model used to decode speech, and for the exchange of data and metadata collected from or associated with signals detected by device 1310.

[0126] In system 1300, communication between the speech neuroprosthesis device 1310 and the receiver unit 1320, a personal device that enables the transfer of data and control commands between the two, can be established using a wireless connection such as Bluetooth. A device software app running on the receiver unit 1320, the personal device, will read streaming data from the wireless connection in real time. After quality checks to ensure data integrity, the signals received from device 1310 are processed to extract relevant neural features, such as high gamma activity. The activity detector analyzes the timing of neural features point by point, and when an attempt to generate speech or non-speech movement is detected, the relevant neural features are passed to a decoding model (along with any relevant synchronized context data that can be used by the decoder to improve predictions). The activity detection and decoding models used to decode speech can be any convenient custom model and may evolve or change over time based on additional data collected, including additional data collected by the system and devices of the present invention. The decoded output is displayed as text on the screen of the receiver unit 1320, or it is synthesized into direct speech and played back through the speaker of the receiver unit 1320. All data collected during the use of the device system may be periodically uploaded to the cloud-based server 1330 for long-term memory, model training, and performance analysis.

[0127] Figure 14 depicts a specific external, i.e., ex-vivo component of one embodiment of the system according to an aspect of the present invention. System 1400 comprises a device / sensor 1410 mounted on the subject's skull 1499 so that the electrode array of the device / sensor 1410 is positioned on the surface of the subject's brain. System 1400 comprises a power supply unit 1420 positioned on the device 1410 to wirelessly power the device 1410 transcutaneously via inductive power supply. The power supply unit 1420 is mounted via wire 1430 to eyeglasses 1440 and a battery power supply integrated therewith. The power supply unit 1420 is positioned on the surface of the subject's skin 1498 (ex-vivo). As described above, the power supply unit 1420 wirelessly powers the device 1410. The power supply unit 1420 is a lightweight power supply component seated on the scalp 1498 on top of a power coil embedded for transcutaneous power supply. The power supply unit 1420 aligns with the implanted device via a magnet (e.g., a magnet compatible with a 3T MRI). The external (i.e., exvivo) component comprises glasses 1440 having a battery component that slides over the earpieces of the glasses 1440, and a flat, low-profile power supply cable 1430 that rests on the crown of the head and connects to the opposite earpiece of the glasses 1440 to ensure a fit. The glasses 1440 allows for the integration of additional functions, such as a speaker for training, augmented reality (AR), or virtual reality (VR).

[0128] Method for detecting electrical signals from a subject As summarized above, aspects of the present disclosure include methods for detecting electrical signals from a subject. A method according to a particular embodiment includes (i) implanting an in vivo positionable device in a subject, wherein the device comprises a housing, a first component extending from the housing in a first plane, and a second component extending from the housing in a second plane parallel to the first plane, the first and second planes being non-overlapping, and (ii) using the device to detect electrical activity in the subject's brain. In embodiments, the method is a method for assisting a subject using communication. Embodiments of a method according to aspects of the present invention include implanting an in vivo positionable device, such device being embodiments of the in vivo positionable device of the present invention as described in detail above.

[0129] Any convenient neurosurgical technique or technique that results in the device being fully implanted so that it functions as desired may be applied to fully implant an in vivo positionable device. In some cases, implanting the device includes (1) preoperative planning, (2) a skin incision, (3) a craniotomy such as a 37 mm long and 44 mm wide craniotomy, further, the craniotomy may be located in a targeted speech motor area (including the M1 cortex, if desired) at a distance from the midline to avoid the major vascular system, (4) a dural incision such as a 34 mm dural incision or a dural incision extending more than 1 mm in width to the first components (i.e., the electrode array) on both sides of the electrode array to provide clearance to facilitate placement, (5) placement of the electrodes, and (6) closure of the dural incision such as a 5.44 mm long dural suture on the opposite side of the dural incision, and in some cases, closure of the dural incision including electrode fixation, (7) fixation of the device to the skull, and (8) skin closure. In some embodiments, the components of the device of the present invention do not penetrate the cortical surface.

[0130] Such steps applied in relation to the complete porting of the device are illustrated in particular in relation to Figures 7A-D discussed above.

[0131] Embodiments of the method according to aspects of the present invention further include detecting electrical activity using a first component. In some cases, the first component is a cerebral cortex measuring electrode. In other cases, the first component comprises a plurality of electrodes. In yet other cases, the plurality of electrodes comprises an electrode array. In certain particular cases, the first component comprises 250 to 1,000 electrodes. The electrodes of interest comprises surface electrodes or through electrodes. Embodiments include electrodes having a diameter of about 1 mm. In some cases, the electrodes protrude from the surface of the electrode component. In other cases, the electrodes are coplanar with the surface of the electrode component. In embodiments, the longitudinal pitch between electrodes is about 2 mm, and the lateral pitch between electrodes is about 2.5 mm.

[0132] Other embodiments of the method according to aspects of the present invention further include wirelessly powering a device. In some cases, the second component wirelessly powers the device, for example, by transcutaneously powering the device. In certain cases, the second component comprises an inductive power supply unit. In some cases, the second component comprises a wire coil.

[0133] Embodiments of the method according to aspects of the present invention further include an interface with a power supply unit. In embodiments, a second component interfaces with the power supply unit. In certain embodiments, the power supply unit is an exvivo unit.

[0134] A further embodiment of the method according to an aspect of the present invention further includes using a magnet to align a second component with an exvivo power supply unit. In the embodiment, the second component further comprises a magnet. In some cases, the magnet attracts the exvivo power supply unit.

[0135] Embodiments of the method according to aspects of the present invention further include transcutaneous power supply to a device. In some cases, transcutaneous power supply to a device includes using an ex vivo power supply unit to supply power to the device. In other cases, transcutaneous power supply to a device includes positioning the ex vivo power supply unit so that the power supply unit interfaces with a second component of the device. In certain particular cases, transcutaneous power supply to a device includes positioning the ex vivo power supply unit on the head of a subject. In embodiments, the device does not include a battery.

[0136] In some embodiments, the second component folds onto the housing. In some embodiments, the second component folds itself onto the housing. In other embodiments, a substantial portion of the second component folds onto the housing. In yet another embodiment, the foldable portion of the second component is configured to allow the second component to fold onto itself. In some cases, the foldable portion of the second component includes a flexible material. In other cases, the second component rests on the surface of the housing. In yet another case, the second component folds onto the housing such that the second component rests on the surface of the housing.

[0137] In one embodiment, the second component comprises a wire coil, and the second component is folded over the housing so that the wire coil rests on the surface of the housing. In another embodiment, the second component is folded over the housing and attached to the surface of the housing.

[0138] In some embodiments, the housing includes an electromagnetic shielding material. In some embodiments, the housing includes a material that reduces interaction with the electromagnetic field, i.e., disturbances in the electromagnetic field. In other embodiments, the housing includes a material that reduces electromagnetic field losses. In yet another embodiment, the housing is a ceramic housing. In some cases, the housing is a magnetic housing.

[0139] Embodiments of the method according to aspects of the present invention further include folding the second component onto the housing. Embodiments of the method according to aspects of the present invention further include folding the second component onto the surface of the housing. Embodiments of the method according to aspects of the present invention further include attaching the second component to the housing. Embodiments of the method according to aspects of the present invention further include attaching the second component to the surface of the housing.

[0140] Embodiments of the method according to aspects of the present invention further include implanting a housing into an opening in the skull. In some cases, the housing comprises a sealed package.

[0141] Embodiments of the method according to aspects of the present invention further include folding a first component around a housing. In embodiments, the partition of the first component is located within the housing. In some cases, the housing comprises a ceramic substrate. In other cases, the housing comprises a magnetic substrate, a metal substrate, a plastic substrate, or a ferromagnetic substrate. In yet other cases, the housing comprises a substrate selected to facilitate the folding of a second component onto the housing, i.e., selected to minimize the harmful effects of exposing the housing to an electromagnetic field emanating from the second component.

[0142] In some embodiments, the device further comprises a cover. In some cases, the cover is attached to the housing.

[0143] Embodiments of the method according to aspects of the present invention further include mounting a cover coplanar with the surface of the skull. In embodiments, the cover comprises tabs. Other embodiments of the method according to aspects of the present invention further include fixing the tabs to the surface of the skull. In embodiments, the cover provides an electromagnetic shield. In other embodiments, the housing comprises an electronic component which can be operably connected to a first component, and such operable connection may be located within the housing. In some cases, the electronic component is operably connected to a second component, and this operable connection may be located within the housing. In embodiments, the electronic component comprises a plurality of sensing amplifiers. In some cases, the sensing amplifiers are operably connected to electrodes. In other embodiments, the electronic component comprises a plurality of analog-to-digital converters. In some cases, the analog-to-digital converters are operably connected to electrodes of the first component. In embodiments, the analog-to-digital converters receive signals detected by the first component. In other embodiments, the electronic component comprises pins which are operably connected to electrodes of the first component, and such operable connection may comprise wire bonding. In an embodiment, the electronic component blocks DC current to the first component. In a particular case, the electronic component comprises a plurality of capacitors, each operably connected to an electrode of the first component. In an embodiment, the electronic component comprises a temperature sensor, and in some cases, the electronic component turns off the device based on the temperature detected by the temperature sensor. Embodiments of the method according to aspects of the present invention further include using the electronic component to turn off the device based on the temperature detected by the temperature sensor.

[0144] Embodiments of the method according to aspects of the present invention further include wirelessly transmitting data from a device. In an embodiment, the electronic component comprises a plurality of Bluetooth Low Energy (BLE) modules. In an embodiment, the device wirelessly transmits data based on a signal detected by a first component. In another embodiment, the device wirelessly receives data. Embodiments of the method according to aspects of the present invention further include wirelessly receiving data to a device. In an embodiment, the device wirelessly receives data including device control information or device configuration information. In a particular embodiment, the device wirelessly transmits and receives data via a Bluetooth connection, and such a Bluetooth connection may be a Bluetooth Low Energy (BLE) connection. In an embodiment, a second component comprises an antenna, and the device may communicate wirelessly via the antenna.

[0145] Embodiments of the method according to aspects of the present invention further include using an antenna to wirelessly communicate data to and / or from a device. In embodiments, the antenna comprises a wire coil.

[0146] In yet another embodiment, the device further comprises a stylet. Embodiments of the method according to aspects of the present invention further include implanting the device using a stylet. Other embodiments of the method according to aspects of the present invention further include securing the configuration of the first component using a stylet. Yet another embodiment of the method according to aspects of the present invention further includes stabilizing the device against the surface of the brain using a stylet. In embodiments, the stylet can be removed from the device. Certain embodiments of the method according to aspects of the present invention further include removing the stylet when implanting the device. In embodiments, the stylet is located at the boundary of the first component. In other embodiments, the device is implanted such that the housing is located within the opening of the skull. In certain embodiments, the device is implanted such that the housing is positioned coplanar with the surface of the skull. In some cases, the first component is folded around the housing. In other cases, the device is implanted such that the second component is positioned on the surface of the subject's skull.

[0147] Embodiments of the method according to aspects of the present invention further include decoding speech using electrical activity detected in the brain. In embodiments, decoding speech includes decoding words, phrases, or sentences from electrical activity detected in the brain. In some cases, decoding speech includes decoding words, phrases, or sentences based on data transmitted by a device using a receiver unit. In other cases, decoding speech includes operably connecting a receiver unit to a device so that the receiver unit receives data transmitted by the device based on electrical activity detected from the subject's brain.

[0148] Embodiments of the method according to aspects of the present invention further include outputting the decoded word, phrase, or sentence as an audible sound through a speaker operably connected to the receiver unit. Other embodiments of the method according to aspects of the present invention further include displaying the decoded word, phrase, or sentence through a display operably connected to the receiver unit.

[0149] In some cases, subjects have difficulty with verbal communication due to, for example, dysarthria, stroke, traumatic brain injury, brain tumor, or amyotrophic lateral sclerosis. In some cases, subjects are paralyzed. In embodiments, the method further includes evaluating the accuracy of decoding speech based on electrical activity detected in the brain.

[0150] Embodiments of methods of interest for decoding speech, including those based on electrical activity detected from the brain, are, but are not limited to, those described below. See International Publication WO2014 / 066855(A1), U.S. Patent No. 9,905,239(B2), U.S. Patent No. 10,438,603(B2), U.S. Patent No. 10,438,603(B2), U.S. Patent No. 2022 / 0208173(A1), and U.S. Patent No. 2022 / 0301563(A1). These disclosures are incorporated herein by reference in their entirety for all purposes.

[0151] Exemplary Embodiments Figures 15A–C illustrate exemplary embodiments of a method according to an aspect of the present invention. Figure 15A presents a flowchart for detecting electrical signals from a subject 1500 according to an aspect of the present invention. Flowchart 1500 begins with step 1503 in which a fully implantable in vivo positionable device, such as the device of the present invention described herein, is implanted in the subject. Implantation in the subject may include, among other things, surgical procedures for implanting the device, including craniotomy and dural incision. The device is implanted in the subject such that a first component of the device is located on the brain surface beneath the dura mater, the housing of the device is located within the skull and coplanar with the skull, and a second component is located on the lateral cranial surface beneath the skin. Fully implanting the device means that the device is fully implanted in the subject such that an aspect of the device does not exist ex vivo, or is otherwise not physically connected ex vivo.

[0152] Once step 1503 is complete in implanting the device in the subject, flowchart 1500 then moves on to step 1506.

[0153] In step 1506, the device is used to detect electrical signals in the subject's brain. For example, the first component of the device is implanted such that the electrodes of the first component are in contact with the brain surface and the first component detects electrical activity in the brain beneath and near the implanted brain surface.

[0154] Once step 1506 is complete in which electrical signals in the subject's brain are detected, flowchart 1500 is finished.

[0155] Figure 15B presents a flowchart 1510 for the complete implantation of an in vivo positionable device in a subject according to an aspect of the present invention. Flowchart 1510 begins at step 1513, where a first component of the device is positioned on the surface of the subject's brain. In particular, the first component of the device is positioned on the surface of the subject's brain in the subdural space. The first component is positioned such that it sits substantially flat against the brain surface without bending, twisting, or flexing. The first component can be positioned on any convenient surface of the brain, and such can vary as desired. Exemplary locations where the first component can be positioned include cortical surfaces such as the speech area of ​​the brain, the speech motor area of ​​the brain, the motor area of ​​the brain, the surface of the sensorimotor cortical region of the brain, the surface of the sensorimotor cortical region in the subdural space, the sensorimotor cortical region, for example, the gyrus gyrus, postcentral gyrus, posterior middle frontal gyrus, posterior superior frontal gyrus, posterior inferior frontal gyrus region, or any combination thereof.

[0156] Once step 1513 is complete in which the first component is positioned within the brain surface, flowchart 1510 then moves on to step 1516.

[0157] In step 1516, the device housing is positioned within an opening in the subject's skull. The opening may be formed, for example, by a craniectomy or a burr hole. The device housing may be positioned so that it sits flat within such an opening in the skull and is coplanar with the surface of the skull. That is, the housing may be positioned so that it sits substantially within the opening in the skull and does not extend beyond such an opening.

[0158] Once the positioning of the housing within the skull opening is complete in step 1516, flowchart 1510 then moves on to step 1520.

[0159] In step 1520, the second component is positioned on the skull surface. As described above, the second component may comprise, for example, one or more wire coils for powering the device and / or wireless communication, and a cover such as a silicone cover. In step 1513, the wire coils and cover of the second component may be oriented so that they sit flat against the skull surface. That is, the second component may extend laterally from the housing away from the opening in the skull on which the housing sits, thereby extending away from the skull surface. As described above, the second component is positioned so that it sits substantially flat against the skull surface such that the second component is substantially free from bending, twisting, or curving.

[0160] Once step 1520 is complete in which the second component is positioned on the skull surface, flowchart 1510 then moves on to step 1523.

[0161] In step 1523, the device cover is positioned so that it sits coplanar with the skull surface. As described above, in the embodiment, the device cover is located on one side of the device housing such that the device cover extends beyond the outer periphery of the device housing and includes tabs for surgically securing the cover to the skull. Positioning the device cover so that it sits coplanar with the skull surface may include positioning the cover so that any tabs present on the cover can be secured to the skull surface, thereby ensuring the cover is coplanar with the skull surface in its fully implanted configuration. In some cases, step 1523 is performed before step 1520, thereby positioning the device cover on the skull surface before positioning the second component on the skull surface.

[0162] In step 1523, once the device cover has been positioned so that it sits coplane with the surface of the skull, flowchart 1510 is complete.

[0163] Figure 15C presents a flowchart 1530 for using an embodiment of the system of the present invention, which comprises an in vivo positionable device implanted in a subject, together with a power supply unit, a receiver unit, and an output device for speech synthesis. Flowchart 1530 begins in step 1533, in which the in vivo positionable device is fully implanted in the subject. Step 1533 is identical to step 1503 of the flowchart 1500 described above in relation to Figure 15A.

[0164] Once step 1533 is complete in implanting the device in the subject, flowchart 1530 proceeds to step 1536.

[0165] In step 1536, a power supply unit, such as the power supply unit described above, is used to wirelessly power the device. As described above, the device is completely immobilized so that no physical connection to the device is available. Alternatively, the power supply unit is placed close to a second component of the device so that the power supply unit can wirelessly power the device, for example, via inductive power supply through a wire coil of the second component. That is, the device is powered transcutaneously. In some cases, the second component and / or the power supply unit are provided with magnets to hold the power supply unit close to the second component and in a substantially fixed position relative to the second component so that the power supply unit remains positioned to power the device. The power supply unit remains on the subject to continuously power the device over the remaining steps of flow chart 1530.

[0166] In step 1536, once the wireless power supply to the device using the power supply unit is complete, flow chart 1530 then proceeds to step 1540.

[0167] In step 1540, the receiver unit transmits configuration and / or control information to the device. The receiver unit may be any convenient receiver unit, such as the receiver unit described above in embodiments of the system of the present invention. A second component of the device comprises one or more wire coils capable of functioning as antennas for receiving wireless signals transcutaneously. The configuration and / or control information may include data used to instruct the device, for example, to turn on and begin sampling signals detected from the brain surface by the first component, to adjust the manner in which the signals are detected, such as sampling period, frequency, duty cycle, or other applicable configurations. The configuration and / or control information may be obtained from a subject in any convenient manner, in particular in a manner that accommodates a paralyzed and / or non-speaking subject. Such information obtained from a subject may involve tracking eye movement patterns using a camera, or using eye blink patterns to initiate or activate speech synthesis. In other cases, detection of motor control (e.g., attempts at finger movement) may be used to initiate or activate a speech synthesizer.

[0168] Once step 1540 is complete in which the receiver unit has transmitted configuration and / or control information to the device, the flowchart 1530 then moves on to step 1543.

[0169] In step 1543, the electrical activity of the brain is detected using the device. Specifically, the electrical activity of the brain is detected by the first component of the device from the surface of the brain where the first component is positioned, and such signals are transmitted to the electronic package of the device. Such signals are continuously detected by the first component throughout the process shown in flowchart 1530.

[0170] Once step 1543 is complete in which the device is used to sense the electrical activity of the brain, flowchart 1530 then proceeds to step 1546.

[0171] In step 1546, on-device signal processing is performed on the signals detected from the subject's brain in step 1543. That is, the electrical signals from the subject's brain detected by the first component in step 1543 and transmitted to the device's electronic package are sampled, evaluated (e.g., whether such signals rise above a certain threshold), adjusted (e.g., amplified), filtered, digitized, modified for transmission to a receiver unit, or otherwise manipulated as desired by one or more modules of the electronic package according to any convenient and relevant signal processing technique.

[0172] Once the on-device signal processing of the electrical activity detected in step 1546 is complete, the flowchart 1530 then moves on to step 1550.

[0173] In step 1550, the signal detected in step 1543 and processed in step 1546 is transmitted from the device to the receiver unit. As described above, the device and the receiver unit may communicate wirelessly, for example, via a Bluetooth connection applying the Bluetooth Low Energy protocol. Such a signal is ultimately transmitted to the receiver unit for further processing and / or decoding in connection with performing speech synthesis based on the electrical activity detected in the subject's brain.

[0174] In step 1550, once the data transmission from the device to the receiver unit is complete, the flowchart 1530 then proceeds to step 1553.

[0175] In step 1553, data received by the receiver unit is used to decode the utterance on the receiver unit. Any convenient model or other algorithm may be applied to decode the utterance, and such model may be trained or otherwise configured to utilize information about the electrical activity of the subject's brain present in the signals detected from the subject's brain in step 1543 to estimate the subject's intended speech expression. As described above, any convenient model, such as an artificial intelligence model, such as a machine learning model, such as a convolutional neural network model, may be applied to decode the utterance, and such may be varied as desired. In embodiments, the model may be updated, for example, continuously or substantially continuously, based on communication between the receiver unit and a cloud-based server that can retrain or improve the model or otherwise adjust it. The output resulting from step 1553 is an estimation of one or more units of the subject's expressive utterance, e.g., a word.

[0176] Once the decoding of the subject's speech is complete in step 1553, flowchart 1530 proceeds to step 1556.

[0177] In step 1556, the decoded utterance is sent to an output device, for example, to be broadcast to the subject's interlocutor. Any convenient output device may be used, such as a display screen that shows text corresponding to the decoded utterance, or a loudspeaker that generates sound based on the decoded utterance. The output device may be integrated with the receiver unit or may be separate from the receiver unit but operably connected to the receiver unit.

[0178] Once the decoded utterance has been output in step 1556, flowchart 1530 ends.

[0179] kit Furthermore, kits including the devices described above, as well as packaging for the devices, are also provided, the packaging of which may be sterile as desired. The components of the kit may be disposable or reusable as desired. In some cases, the kit may comprise multiple devices, including multiple versions of the same device having different characteristics, such as different sizes or different electrical characteristics (e.g., different number or characteristics of electrodes) tailored to different target subjects.

[0180] The kit according to the present invention may also include, for example, a receiver unit as described above, and packaging for the receiver unit, the packaging of which may be sterile as desired. Any convenient receiver unit, such as a tablet device, may be applied. Alternatively, the kit may include software, such as non-transient computer-readable media, which can be installed on a tablet device or the like, so that the tablet device can function as a receiver unit.

[0181] The kit according to the present invention may also include, for example, a power supply unit as described above, and packaging for the power supply unit, which may be sterile if desired. Any convenient power supply unit capable of powering the device may be applied wirelessly, for example, transdermally.

[0182] The kit of interest may further include an output device for outputting the decoded speech, such as one or more of a speaker, display, or camera.

[0183] usefulness The subject devices and methods are used in a variety of applications where it is desirable to detect the electrical activity of the subject's brain. The subject devices, systems, methods, and kits are used in applications where it is desirable to decode and synthesize speech based on the electrical activity of the subject's brain. In some embodiments, the devices, systems, methods, and kits described herein find use in clinical settings where the subject lacks the ability to speak, such as subjects who are paralyzed or have brain damage that renders their ability to speak unavailable or severely impaired. In addition, the devices, systems, methods, and kits of the embodiments described herein find use in rehabilitation settings, as well as in contexts where the subject benefits from speech synthesis mechanisms outside the clinical setting, i.e., in contexts where the subject returns to an improved routine outside the clinical setting.

[0184] As described above, the devices, systems, methods, and kits are found to be used in a variety of different applications, for example, in connection with the treatment and / or rehabilitation of subjects who are completely or partially unable to form expressive speech as a result of paralysis or injury to brain regions associated with expressive speech. The devices, systems, methods, and kits are found to be used in subjects with arthropathy or inability to speak, resulting from conditions such as stroke, ALS, or lock-in syndrome. Embodiments of the present invention are found to be used as widely deployable communication solutions, provided they offer safety (i.e., no transcutaneous connection required, no implanted battery required), ease of use, and scalability (i.e., embodiments of the present invention are portable and do not require team-based expertise for maintenance and use; i.e., embodiments of the present invention are fully portable and intended to seamlessly fit into the daily lives of subjects and enable autonomous use both inside and outside the home), as well as sufficient performance to support real-time speech decoding and synthesis (i.e., a large number of contacts or channels or electrodes, e.g., 128 channels or more, such as 256 channels or more in some embodiments; increasing both the number of channels and electrode density). (Muller et al., 2016, Conant et al., 2014, Yousry et al., 1997) Indications in subjects for use of embodiments of the present invention include, for example, severe prosthesis with limb dysfunction or progressive motor degeneration. Examples of use of embodiments of the present invention include, for example, real-time speech decoding and synthesis, and extensions to assistive technologies and prosthesis control (i.e., motor-brain-computer interfaces). Embodiments of the device of the present invention have shapes and features that facilitate safe transfer through the dural layer of the subject when the device is implanted.

[0185] The following experimental results and examples are presented for illustrative purposes only and are not intended to be limiting.

[0186] experiment Figures 16A–D provide illustrations of exemplary devices according to the present invention. Figure 16A shows exemplary device 1600 from a top isometric view, illustrating in particular how the device cover covers the device housing. Figure 16B shows exemplary device 1600 from a bottom isometric view, illustrating in particular how the first component folds over itself to connect with the housing. Figure 16C shows a substantially top view of device 1600. Figure 16D is a cross-section of a subject's skull, exposing the subject's skull (upper half of the figure), exposing the subject's skull (lower half of the figure), exposing the subject's brain 1699, and the device 1600 is attached, with the cover secured to the subject's skull so that the first component is positioned beneath the dura mater of the subject's brain, and the cover secured to the subject's skull so that the cover is coplanar with the subject's skull, and the second component is positioned flat against the subject's skull.

[0187] Figure 17 provides a diagram of an exemplary device according to the present invention implanted in a model skull. Device 1700 comprises a cover 1720 embedded coplanar with the outer surface of the skull 1728. Such a position of the cover 1720 provides protection for the device as well as for the inside of the subject's skull, as described above, and also provides electromagnetic signal shielding. The cover 1720 comprises tabs 1725a, 1725b, 1725c, and 1725d that sit on the subject's skull 1798 and are used to attach the cover to the skull 1798, for example, by using surgical screws through the tabs to the skull. Device 1700 further comprises a second component 1770 having one or more wire coils, as described above, and a power supply device 1700, for example, a magnet used to facilitate wireless power supply via an ExVivo power supply unit.

[0188] Figures 18A–F illustrate the experimental results of implanting a prototype of the device of the present invention into the brains of subjects. Figure 18A illustrates how data is collected from in vivo implantation of a first component 1840 of the device having an electrode array 1850 positioned flat on the surface of a subject's brain 1899. Specifically, the first component comprises a microECoG (μECoG) electrode array placed in the superior temporal gyrus (STG) and superior temporal sulcus (STS) of an epileptic patient receiving treatment. Figure 18B shows the average pairwise correlation across all electrodes, showing a higher pronation / sulcus correlation. Figure 18C shows pair electrode correlation as a function of distance during silence (left-leaning hash) or natural speech recognition (right-leaning hash, speech stimuli selected from the TIMIT sentence database). Even at a distance of 2 mm, the activity is almost independent. Figure 18D shows speech feature tuning (peak high gamma [70-150Hz]z score activity, maximum value across all phonemes), indicating that adjacent electrodes often show the greatest response to different phonemes at 2mm intervals. The existence of localized patches of similar tuning has been reported in previous studies at 4mm intervals (N. Mesgarani et al., Phonetic feature encoding in human superior temporal gyrus, Science. 2014 Feb 28;343(6174):1006-10, doi:10.1126 / science.1245994, the disclosure is incorporated herein in its entirety). Figure 18E shows that for several types of classification models (in this panel, LDA represents linear discriminant analysis), higher electrode densities improve the accuracy of binary classification of the perception of either obstructive sounds or sonolant phonemes. The 4mm density is based on subsampling of the μECoG grid. Figure 18F shows a comparison of standard commercially available grids from an epilepsy monitoring unit (EMU; 4 mm pitch) and a μECoG grid (2 mm pitch), demonstrating that the thin-film μECoG grid allows for the acquisition of more independent neural information, likely due to better contact with cortical tissue.

[0189] Although the above inventions have been described in some detail by illustration and examples for the sake of clear understanding, it will be readily apparent to those skilled in the art that certain changes and modifications can be made to these inventions in light of the teachings of the present invention without departing from the spirit or scope of the appended claims.

[0190] Therefore, the above merely illustrates the principles of the present invention. Those skilled in the art will understand that various configurations embodying the principles of the present invention and falling within its spirit and scope can be devised, although these are not explicitly described or illustrated herein. Furthermore, all examples and conditional statements listed herein are intended primarily to assist the reader in understanding the principles of the present invention and the concepts to which the inventors have contributed to the advancement of the art, and should be interpreted not as limitations to the examples and conditions thus specifically listed. In addition, all descriptions herein listing the principles, aspects, and embodiments of the present invention, as well as specific examples thereof, are intended to encompass both their structural and functional equivalents. Moreover, such equivalents are intended to include both currently known equivalents and equivalents to be developed in the future, regardless of their structure, i.e., any elements developed to perform the same function. Furthermore, nothing disclosed herein, whether such disclosure is explicitly stated in the claims or not, is intended to be made available to the public.

[0191] Accordingly, the scope of the present invention is not intended to be limited to the exemplary embodiments illustrated and described herein. Rather, the scope and spirit of the present invention are embodied in the appended claims. In the claims, § 112(f) or § 112(6) of the U.S. Patent Act is explicitly defined as applying to a limitation in a claim only if a phrase exactly matching “means for” or “step for” is included at the beginning of such limitation in the claim, and neither § 112(f) nor § 112(6) applies if such an exact matching phrase is not used in the limitation in the claim.

Claims

1. An in vivo positioning device, Housing and A first component extending from the housing in a first plane, A second component extending from the housing in a second plane parallel to the first plane, A device in which the first plane and the second plane are non-overlapping.

2. The device according to claim 1, wherein the device is fully portable.

3. The device according to any one of the prior claims, wherein the first component and the second component do not overlap.

4. The device according to any one of the prior claims, wherein the first component is implantable in the subdural space.

5. The device according to any one of the prior claims, wherein the first component is implantable on a cortical surface.

6. The device according to any one of the prior claims, wherein the first component is implantable in the speech region of the brain.

7. The device according to claim 6, wherein the speech region is a speech motion region.

8. The device according to any one of the prior claims, wherein the first component is implantable in the motor area of ​​the brain.

9. The device according to claim 7 or 8, wherein the first component is implantable on the surface of a sensorimotor cortical region.

10. The device according to claim 9, wherein the first component is implantable on the surface of the sensorimotor cortical region of the subdural space.

11. The device according to claim 9 or 10, wherein the sensorimotor cortical region is selected from the gyrus gyrus gyrus, postcentral gyrus, posterior middle frontal gyrus, posterior superior frontal gyrus, posterior inferior frontal gyrus region, or any combination thereof.

12. The device according to any one of the prior claims, wherein the first component is aligned with the surface of the brain.

13. The device according to claim 12, wherein the first component includes a shape that matches the surface of the brain.

14. The device according to claim 13, wherein the shape includes a curvature corresponding to the surface of the brain.

15. The device according to claim 13 or 14, wherein the shape includes a plurality of fingers.

16. The device according to claim 15, wherein the shape includes a plurality of slots between each finger.

17. The device according to any one of claims 13 to 16, wherein the shape includes rounded corners.

18. The device according to any one of the prior claims, wherein the first component comprises a flexible substrate.

19. The device according to claim 18, wherein the flexible substrate is foldable.

20. The device according to claim 18 or 19, wherein the flexible substrate is synchronized with brain movements.

21. The device according to any one of claims 18 to 20, wherein the flexible substrate is a spring.

22. The device according to any one of claims 18 to 21, wherein the flexible substrate comprises a thin film substrate.

23. The device according to any one of claims 18 to 22, wherein the flexible substrate comprises a liquid crystal polymer.

24. The device according to claim 23, wherein the liquid crystal polymer includes a metal layer.

25. The device according to claim 23 or 24, wherein the liquid crystal polymer comprises at least three metal layers.

26. The device according to any one of the prior claims, wherein the first component comprises a flexible cover layer.

27. The device according to claim 26, wherein the flexible cover layer is waterproof.

28. The device according to claim 26 or 27, wherein the flexible cover layer is a silicone layer.

29. The first component is, Electrode partition and Migration partition and A device according to any one of the prior claims, comprising a connecting partition.

30. The device according to claim 29, wherein the electrode partition is implantable in the subdural space.

31. The device according to claim 29 or 30, wherein the electrode partition comprises a plurality of electrodes.

32. The device according to any one of claims 29 to 31, wherein the connecting partition is implantable on the upper part of the dura mater.

33. The device according to any one of claims 29 to 32, wherein the connecting partition is operably connected to the housing.

34. The device according to any one of claims 29 to 33, wherein the transition partition is foldable.

35. The device according to any one of claims 29 to 34, wherein the transition partition comprises a foldable material.

36. The device according to any one of claims 29 to 35, wherein the first component includes a fold in the transition partition.

37. The device according to any one of claims 29 to 36, wherein the first component is folded on itself in the transition partition.

38. The device according to any one of claims 29 to 37, wherein the transition partition comprises a plurality of branches.

39. The device according to any one of the prior claims, wherein the first component detects electrical activity.

40. The device according to claim 39, wherein the first component detects electrical activity of the brain.

41. The device according to claim 40, wherein the first component detects electrical activity from the surface of the brain.

42. The device according to claim 41, wherein the surface is the outer surface of the brain.

43. The device according to any one of claims 40 to 42, wherein the first component detects electrical activity of the cerebral cortex.

44. The device according to any one of claims 40 to 43, wherein the first component detects electrical activity of the ventral sensorimotor cortex.

45. The device according to any one of the prior claims, wherein the first component is a cerebral cortex measurement electrode.

46. The device according to any one of the prior claims, wherein the first component comprises a plurality of electrodes.

47. The device according to claim 46, wherein the plurality of electrodes comprises an electrode array.

48. The device according to claim 46 or 47, wherein the first component comprises 250 to 1,000 electrodes.

49. The device according to any one of claims 46 to 48, wherein the plurality of electrodes include surface electrodes.

50. The device according to any one of claims 46 to 49, wherein the plurality of electrodes include through electrodes.

51. The device according to any one of claims 46 to 50, wherein the diameter of the electrode is approximately 1 mm.

52. The device according to any one of claims 46 to 51, wherein the electrode protrudes from the surface of the first component.

53. The device according to any one of claims 46 to 52, wherein the electrode is coplanar with the surface of the first component.

54. The device according to any one of claims 46 to 53, wherein the longitudinal pitch between electrodes is approximately 2 mm and the lateral pitch between electrodes is approximately 2.5 mm.

55. The device according to any one of the prior claims, wherein the second component wirelessly supplies power to the device.

56. The device according to claim 55, wherein the second component supplies power to the device transcutaneously.

57. The device according to claim 56, wherein the second component comprises an inductive power supply unit.

58. The device according to claim 57, wherein the second component comprises a wire coil.

59. The device according to claim 58, wherein the second component interfaces with a power supply unit.

60. The device according to claim 59, wherein the power supply unit is an exvivo unit.

61. The device according to any one of the prior claims, wherein the second component further comprises a magnet.

62. The device according to claim 61, wherein the magnet attracts the ExVivo power supply unit.

63. The device according to claim 62, wherein the magnet aligns the second component and the exvivo power supply unit.

64. The device according to any one of the prior claims, wherein the device does not include a battery.

65. The device according to any one of the prior claims, wherein the second component is folded on the housing.

66. The device according to any one of the prior claims, wherein the second component is folded on top of itself on the housing.

67. The device according to any one of the prior claims, wherein a substantial portion of the second component is folded over the housing.

68. The device according to any one of the prior claims, wherein the foldable portion of the second component is configured to allow the second component to be folded on itself.

69. The device according to claim 68, wherein the foldable portion of the second component comprises a flexible material.

70. The device according to any one of the prior claims, wherein the second component is mounted on the surface of the housing.

71. The device according to any one of the prior claims, wherein the second component is folded on the housing so that the second component rests on the surface of the housing.

72. The second component comprises a wire coil, The device according to any one of the prior claims, wherein the second component is folded on the housing so that the wire coil is placed on the surface of the housing.

73. The device according to any one of the prior claims, wherein the second component is folded onto the housing and attached to the surface of the housing.

74. The device according to any one of the prior claims, wherein the housing includes an electromagnetic shielding material.

75. The device according to any one of the prior claims, wherein the housing includes a material that reduces interaction with an electromagnetic field.

76. The device according to any one of the prior claims, wherein the housing includes a material that reduces electromagnetic field losses.

77. The device according to any one of the prior claims, wherein the housing is a ceramic housing.

78. The device according to any one of the prior claims, wherein the housing is a magnetic housing.

79. The device according to any one of the prior claims, wherein the housing is implantable within an opening in the skull.

80. The device according to any one of the prior claims, wherein the housing comprises a sealed package.

81. The device according to any one of the prior claims, wherein the first component is foldable around the housing.

82. The device according to any one of the prior claims, wherein the partition of the first component is located within the housing.

83. The device according to any one of the prior claims, wherein the housing comprises a ceramic substrate.

84. The device according to any one of the prior claims, wherein the housing comprises a magnetic substrate.

85. The device according to any one of the prior claims, wherein the housing comprises a metal substrate.

86. The device according to any one of the prior claims, wherein the housing comprises a plastic substrate.

87. The device according to any one of the prior claims, wherein the housing comprises a ferromagnetic substrate.

88. The device according to any one of the prior claims, further comprising a cover.

89. The device according to claim 88, wherein the cover is attached to the housing.

90. The device according to claim 89, wherein the cover can be mounted in the same plane as the surface of the skull.

91. The device according to claim 90, wherein the cover comprises a tab.

92. The device according to claim 91, wherein the tab is fixable to the surface of the skull.

93. The device according to any one of claims 88 to 92, wherein the cover provides an electromagnetic shield.

94. The device according to any one of the prior claims, wherein the housing comprises an electronic component.

95. The device according to claim 94, wherein the electronic component is operably connected to the first component.

96. The device according to claim 95, wherein an operable connection between the electronic component and the first component is located within the housing.

97. The device according to claim 96, wherein the electronic component is operably connected to the second component.

98. The device according to claim 97, wherein an operable connection between the electronic component and the second component is located within the housing.

99. The device according to any one of claims 94 to 98, wherein the electronic component comprises a plurality of sensing amplifiers.

100. The device according to claim 99, wherein the sensing amplifier is operably connected to the electrode.

101. The device according to any one of claims 94 to 100, wherein the electronic component comprises a plurality of analog-to-digital converters.

102. The device according to claim 101, wherein the analog-to-digital converter is operably connected to the electrodes of the first component.

103. The device according to claim 101 or 102, wherein the analog-to-digital converter receives a signal detected by the first component.

104. The device according to any one of claims 94 to 103, wherein the electronic component comprises a pin operably connected to an electrode of the first component.

105. The device according to claim 104, wherein the operable connection includes wire bonding.

106. The device according to any one of claims 94 to 105, wherein the electronic component blocks DC current to the first component.

107. The device according to claim 106, wherein the electronic component comprises a plurality of capacitors, each operably connected to an electrode of the first component.

108. The device according to any one of claims 94 to 107, wherein the electronic component comprises a temperature sensor.

109. The device according to claim 108, wherein the electronic component turns off the device based on the temperature detected by the temperature sensor.

110. The device according to any one of claims 94 to 109, wherein the electronic component comprises a plurality of Bluetooth Low Energy (BLE) modules.

111. The device according to any one of the prior claims, wherein the device transmits data wirelessly.

112. The device according to claim 111, wherein the device wirelessly transmits data based on a signal detected by the first component.

113. The device according to any one of the prior claims, wherein the device wirelessly receives data.

114. The device according to claim 113, wherein the device wirelessly receives data including device control information or device configuration information.

115. The device according to any one of claims 111 to 114, wherein the device wirelessly transmits and receives data via a Bluetooth connection.

116. The device according to claim 115, wherein the Bluetooth connection is a Bluetooth Low Energy (BLE) connection.

117. The device according to any one of the prior claims, wherein the second component comprises an antenna.

118. The device according to claim 117, wherein the device communicates wirelessly via the antenna.

119. The device according to claim 118, wherein the antenna comprises a wire coil.

120. The device according to any one of the prior claims, further comprising a stylet.

121. The device according to claim 120, wherein the stylet facilitates the transplantation of the device.

122. The device according to claim 120 or 121, wherein the stylet secures the configuration of the first component.

123. The device according to any one of claims 120 to 122, wherein the stylet stabilizes the device with respect to the surface of the brain.

124. The device according to any one of claims 120 to 123, wherein the stylet is removable from the device.

125. The device according to any one of claims 120 to 124, wherein the stylet is located at the boundary of the first component.

126. The device according to any one of the prior claims, wherein the device is fully implantable in a subject.

127. The device according to claim 126, wherein the device is completely implantable beneath the skin of the subject.

128. The subject has difficulty with verbal communication, and the device is as described in any one of the prior claims.

129. The device according to claim 128, wherein the subject has difficulty with verbal communication due to dysarthria, stroke, traumatic brain injury, brain tumor, or amyotrophic lateral sclerosis.

130. The subject is in a paralyzed state, the device according to any one of the prior claims.

131. An in vivo positioning device, Electronic components and An electrode component extending in the first plane, The system comprises a power supply component extending in a second plane parallel to the first plane, The first plane and the second plane are non-overlapping, A device in which the electronic component is operably connected to the electrode component and the power supply component.

132. The device according to claim 131, wherein the device is fully portable.

133. The device according to claim 131 or 132, wherein the electrode component and the power supply component do not overlap.

134. The device according to any one of claims 131 to 133, wherein the electrode component is implantable in the subdural space.

135. The device according to claim 133 or 134, wherein the electrode component is implantable on the cortical surface.

136. The device according to claim 133 or 134, wherein the electrode component is implantable in the speech region of the brain.

137. The device according to claim 136, wherein the speech region is a speech motion region.

138. The device according to any one of claims 133 to 137, wherein the electrode component is implantable in the motor area of ​​the brain.

139. The device according to any one of claims 133 to 137, wherein the electrode component is implantable on the surface of a sensorimotor cortical region.

140. The device according to claim 139, wherein the electrode component is implantable on the surface of the sensorimotor cortical region in the subdural space.

141. The device according to claim 139 or 140, wherein the sensorimotor cortical region is selected from the gyrus gyrus gyrus, postcentral gyrus, posterior middle frontal gyrus, posterior superior frontal gyrus, posterior inferior frontal gyrus region, or any combination thereof.

142. The device according to any one of claims 133 to 141, wherein the electrode component is aligned with the surface of the brain.

143. The device according to claim 142, wherein the electrode component includes a shape that matches the surface of the brain.

144. The device according to claim 143, wherein the shape includes a curvature corresponding to the surface of the brain.

145. The device according to any one of claims 142 to 144, wherein the shape includes a plurality of fingers.

146. The device according to claim 145, wherein the shape includes a plurality of slots between each finger.

147. The device according to any one of claims 143 to 146, wherein the shape includes rounded corners.

148. The device according to any one of claims 133 to 147, wherein the electrode component comprises a flexible substrate.

149. The device according to claim 148, wherein the flexible substrate is foldable.

150. The device according to claim 148 or 149, wherein the flexible substrate is synchronized with brain movements.

151. The device according to any one of claims 148 to 150, wherein the flexible substrate is a spring.

152. The device according to any one of claims 148 to 151, wherein the flexible substrate comprises a thin film substrate.

153. The device according to any one of claims 148 to 152, wherein the flexible substrate comprises a liquid crystal polymer.

154. The device according to claim 153, wherein the liquid crystal polymer includes a metal layer.

155. The device according to claim 153 or 154, wherein the liquid crystal polymer comprises at least three metal layers.

156. The device according to any one of claims 133 to 155, wherein the electrode component comprises a flexible cover layer.

157. The device according to claim 156, wherein the flexible cover layer is waterproof.

158. The device according to claim 156 or 157, wherein the flexible cover layer is a silicone layer.

159. The electrode component is Electrode partition and Migration partition and A device according to any one of claims 133 to 158, comprising a connecting partition.

160. The device according to claim 159, wherein the electrode partition is implantable in the subdural space.

161. The device according to claim 159 or 160, wherein the electrode partition comprises a plurality of electrodes.

162. The device according to any one of claims 159 to 161, wherein the connecting partition is implantable on the upper part of the dura mater.

163. The device according to any one of claims 159 to 162, wherein the connecting partition is operably connected to the electronic component.

164. The device according to any one of claims 159 to 163, wherein the transition partition is foldable.

165. The device according to claim 164, wherein the transition partition comprises a foldable material.

166. The device according to any one of claims 159 to 165, wherein the electrode partition includes a fold in the transition partition.

167. The device according to claim 166, wherein the electrode partition is folded over itself in the transition partition.

168. The device according to any one of claims 159 to 167, wherein the transition partition comprises a plurality of branches.

169. The device according to any one of claims 133 to 168, wherein the electrode component detects electrical activity.

170. The device according to claim 169, wherein the electrode component detects electrical activity of the brain.

171. The device according to claim 170, wherein the electrode component detects electrical activity from the surface of the brain.

172. The device according to claim 171, wherein the surface is the outer surface of the brain.

173. The device according to any one of claims 169 to 172, wherein the electrode component detects electrical activity of the cerebral cortex.

174. The device according to any one of claims 169 to 173, wherein the electrode component detects electrical activity of the ventral sensorimotor cortex.

175. The device according to any one of claims 133 to 174, wherein the electrode component is a cerebral cortex measurement electrode.

176. The device according to any one of claims 133 to 175, wherein the electrode component comprises a plurality of electrodes.

177. The device according to claim 176, wherein the plurality of electrodes comprises an electrode array.

178. The device according to claim 176 or 177, wherein the electrode component comprises 250 to 1,000 electrodes.

179. The device according to any one of claims 176 to 178, wherein the plurality of electrodes include surface electrodes.

180. The device according to any one of claims 176 to 179, wherein multiple electrodes are provided with through electrodes.

181. The device according to any one of claims 176 to 180, wherein the diameter of the electrode is approximately 1 mm.

182. The device according to any one of claims 176 to 180, wherein the electrode protrudes from the surface of the electrode component.

183. The device according to any one of claims 176 to 182, wherein the electrode is coplanar with the surface of the electrode component.

184. The device according to any one of claims 176 to 183, wherein the longitudinal pitch between electrodes is approximately 2 mm and the lateral pitch between electrodes is approximately 2.5 mm.

185. The device according to any one of claims 133 to 184, wherein the power supply component wirelessly supplies power to the device.

186. The device according to claim 185, wherein the power supply component supplies power to the device transcutaneously.

187. The device according to any one of claims 133 to 186, wherein the power supply component comprises an inductive power supply unit.

188. The device according to any one of claims 133 to 187, wherein the power supply component comprises a wire coil.

189. The device according to any one of claims 133 to 188, wherein the power supply component interfaces with a power supply unit.

190. The device according to claim 189, wherein the power supply unit is an exvivo unit.

191. The device according to any one of claims 133 to 190, wherein the power supply component further comprises a magnet.

192. The device according to claim 191, wherein the magnet attracts the ExVivo power supply unit.

193. The device according to claim 192, wherein the magnet aligns the power supply component with the exvivo power supply unit.

194. The device according to any one of claims 133 to 193, wherein the device does not include a battery.

195. The device according to any one of claims 133 to 194, wherein the power supply component is folded on top of the electronic component.

196. The device according to any one of claims 133 to 195, wherein the power supply component is folded on top of itself on the electronic component.

197. The device according to any one of claims 133 to 196, wherein a substantial portion of the power supply component is folded onto the electronic component.

198. The device according to any one of claims 133 to 197, wherein the foldable portion of the power supply component is configured to allow the electronic component to be folded on itself.

199. The device according to claim 198, wherein the foldable portion of the power supply component comprises a flexible material.

200. The device according to any one of claims 133 to 199, wherein the power supply component is mounted on the surface of the electronic component.

201. The device according to any one of claims 133 to 200, wherein the power supply component is folded on the housing such that the power supply component is placed on the surface of the electronic component.

202. The power supply component comprises a wire coil, The device according to any one of claims 133 to 201, wherein the power supply component is folded on top of the electronic component such that the wire coil is placed on the surface of the electronic component.

203. The device according to any one of claims 133 to 202, wherein the power supply component is folded onto the electronic component and attached to the surface of the electronic component.

204. The device according to any one of claims 133 to 203, wherein the electronic component includes an electromagnetic shielding material.

205. The device according to any one of claims 133 to 204, wherein the electronic component includes a material that reduces interaction with an electromagnetic field.

206. The device according to any one of claims 133 to 205, wherein the electronic component includes a material that reduces electromagnetic field losses.

207. The device according to any one of claims 133 to 206, wherein the electronic component comprises a ceramic housing.

208. The device according to any one of claims 133 to 207, wherein the electronic component comprises a magnetic housing.

209. The device according to any one of claims 133 to 208, wherein the electronic component comprises a plurality of sensing amplifiers.

210. The device according to claim 209, wherein the sensing amplifier is operably connected to the electrode.

211. The device according to any one of claims 133 to 210, wherein the electronic component comprises a plurality of analog-to-digital converters.

212. The device according to claim 211, wherein the analog-to-digital converter is operably connected to the electrodes of the electrode component.

213. The device according to claim 212, wherein the analog-to-digital converter receives a signal detected by the electrode component.

214. The device according to any one of claims 133 to 213, wherein the electronic component comprises pins operably connected to electrodes of the electrode component.

215. The device according to claim 214, wherein the operable connection includes wire bonding.

216. The device according to any one of claims 133 to 215, wherein the electronic component blocks DC current to the electrode component.

217. The device according to claim 216, wherein the electronic component comprises a plurality of capacitors, each operably connected to an electrode of the electrode component.

218. The device according to any one of claims 133 to 217, wherein the electronic component comprises a temperature sensor.

219. The device according to claim 218, wherein the electronic component turns off the device based on the temperature detected by the temperature sensor.

220. The device according to claim 218 or 219, wherein the electronic component comprises a plurality of Bluetooth Low Energy (BLE) modules.

221. The device according to any one of claims 133 to 220, wherein the electronic component is implantable within an opening in the skull.

222. The device according to any one of claims 133 to 221, wherein the device transmits data wirelessly.

223. The device according to claim 222, wherein the device wirelessly transmits data based on a signal detected by the electrode component.

224. The device according to any one of claims 133 to 223, wherein the device wirelessly receives data.

225. The device according to claim 224, wherein the device wirelessly receives data including device control information or device configuration information.

226. The device according to any one of claims 133 to 225, wherein the device wirelessly transmits and receives data via a Bluetooth connection.

227. The device according to claim 226, wherein the Bluetooth connection is a Bluetooth Low Energy (BLE) connection.

228. The device according to any one of claims 133 to 227, wherein the power supply component comprises an antenna operably connected to the electronic component.

229. The device according to claim 228, wherein the device communicates wirelessly via the antenna.

230. The device according to claim 228 or 229, wherein the antenna comprises a wire coil.

231. The device according to any one of claims 133 to 230, wherein the device further comprises a housing.

232. The device according to claim 231, wherein the housing is implantable within an opening in the skull.

233. The device according to claim 232, wherein the electronic component is located within the housing.

234. The device according to claim 233, wherein the housing comprises a sealed package.

235. The device according to any one of claims 231 to 234, wherein the electronic component is foldable around the housing.

236. The device according to any one of claims 133 to 235, wherein the partition of the electrode component is located within the housing.

237. The device according to any one of claims 231 to 236, wherein the housing comprises a ceramic substrate.

238. The device according to any one of claims 231 to 237, wherein the housing comprises a magnetic substrate.

239. The device according to any one of claims 231 to 238, wherein the housing comprises a metal substrate.

240. The device according to any one of claims 231 to 239, wherein the housing comprises a plastic substrate.

241. The device according to any one of claims 231 to 240, wherein the housing comprises a ferromagnetic substrate.

242. The device according to any one of claims 133 to 241, further comprising a cover.

243. The device according to claim 242, wherein the cover can be mounted in the same plane as the surface of the skull.

244. The device according to claim 243, wherein the cover comprises a tab.

245. The device according to claim 244, wherein the tab is fixable to the surface of the skull.

246. The device according to any one of claims 242 to 245, wherein the cover provides an electromagnetic shield.

247. The device according to any one of claims 133 to 246, further comprising a stylet.

248. The device according to claim 247, wherein the stylet facilitates the implantation of the device.

249. The device according to claim 247 or 248, wherein the stylet secures the configuration of the first component.

250. The device according to any one of claims 247 to 249, wherein the stylet stabilizes the device with respect to the surface of the brain.

251. The device according to any one of claims 247 to 250, wherein the stylet is removable from the device.

252. The device according to any one of claims 247 to 251, wherein the stylet is located at the boundary of the electrode component.

253. The device according to any one of claims 247 to 252, wherein the device is fully implantable in a subject.

254. The device according to claim 253, wherein the device is fully implantable under the skin of the subject.

255. The device according to any one of claims 133 to 254, wherein the subject has difficulty with verbal communication.

256. The device according to claim 255, wherein the subject has difficulty with verbal communication due to dysarthria, stroke, traumatic brain injury, brain tumor, or amyotrophic lateral sclerosis.

257. The device according to any one of claims 133 to 256, wherein the subject is in a paralyzed state.

258. A detection system, An in vivo positioning sensor comprising the device described in any one of claims 1 to 257, A system comprising an exvivo power supply unit connectable to the aforementioned sensor.

259. The system according to claim 258, further comprising a power supply unit.

260. The system according to claim 259, wherein the power supply unit supplies power to the device.

261. The system according to claim 260, wherein the power supply unit supplies power to the device transcutaneously.

262. The system according to any one of claims 258 to 261, wherein the power supply unit interfaces with the second component of the device.

263. The system according to any one of claims 258 to 262, wherein the power supply unit comprises a battery.

264. The system according to any one of claims 258 to 263, wherein the power supply unit is integrated with a pair of eyeglasses.

265. A detection system, An in vivo positioning sensor comprising the device described in any one of claims 1 to 257, A system comprising: an ExVivo receiver unit operably connected to the aforementioned sensor.

266. The system according to claim 265, wherein the system performs real-time speech synthesis.

267. The system according to claim 265 or 266, wherein the operable connection between the sensor and the receiver unit is a wireless connection.

268. The system according to claim 267, wherein the wireless connection is a Bluetooth connection.

269. The system according to claim 268, wherein the Bluetooth connection is a Bluetooth Low Energy (BLE) connection.

270. The system according to any one of claims 265 to 269, wherein the system implements an authentication protocol between the sensor and the receiver unit.

271. The system according to any one of claims 265 to 270, wherein the sensor transmits data to the receiver unit.

272. The system according to claim 271, wherein the transmitted data includes a signal detected by the sensor, sensor status, diagnostic information of the sensor, a timestamp, or any combination thereof.

273. The system according to any one of claims 265 to 272, wherein the receiver unit transmits data to the sensor.

274. The system according to claim 273, wherein the transmitted data includes sensor control information, sensor configuration information, or any combination thereof.

275. The system according to any one of claims 265 to 274, wherein the system is completely portable.

276. The system according to any one of claims 265 to 275, wherein the receiver unit performs speech decoding.

277. The system according to claim 276, wherein the receiver unit performs speech decoding in real time.

278. The system according to any one of claims 265 to 277, wherein the receiver unit performs speech synthesis.

279. The system according to claim 278, wherein the receiver unit performs speech synthesis in real time.

280. The system according to any one of claims 265 to 279, wherein the receiver unit automates speech detection, word classification, and text decoding based on the identification of neural activity patterns in data transmitted from the sensor to the receiver unit, and the receiver unit includes detected electroencephalometric data associated with the attempted word generation.

281. The system according to claim 280, wherein the receiver unit uses machine learning algorithms for speech detection, word classification, and text decoding.

282. The system according to any one of claims 265 to 281, wherein the receiver unit further comprises a speaker.

283. The system according to claim 282, wherein the receiver unit outputs an audible sound through the speaker based on the data transmitted from the sensor.

284. The system according to any one of claims 265 to 283, wherein the receiver unit further comprises a display.

285. The system according to claim 284, wherein the receiver unit displays information based on data transmitted from the sensor.

286. The system according to any one of claims 265 to 285, wherein the receiver unit further comprises a camera.

287. The system according to claim 286, wherein the camera detects an eye movement pattern or a blinking pattern.

288. The system according to claim 287, wherein the receiver unit turns the system on or off based on the detected eye movement pattern or blinking pattern.

289. The system according to any one of claims 265 to 288, wherein the receiver unit is a portable device.

290. The system according to any one of claims 265 to 289, wherein the receiver unit is a handheld device.

291. The system according to any one of claims 265 to 290, wherein the receiver unit is configured to be mounted on the body of the subject.

292. The system according to any one of claims 265 to 291, wherein the receiver unit is configured to be mounted on a wheelchair.

293. The system according to any one of claims 265 to 292, wherein the receiver unit is a tablet device, a smartphone, or a laptop.

294. The system according to any one of claims 265 to 293, wherein the receiver unit is equipped with a network connection.

295. The system according to claim 294, wherein the receiver unit is operablely connected to a cloud-based server via the network connection.

296. The system according to claim 295, wherein the cloud-based server trains a model based on data received from the receiver unit.

297. The system according to claim 296, wherein the cloud-based server transmits the trained model data to the receiver unit.

298. The system according to any one of claims 265 to 297, further comprising a power supply unit.

299. The system according to claim 298, wherein the power supply unit supplies power to the device.

300. The system according to claim 299, wherein the power supply unit supplies power to the device transcutaneously.

301. The system according to any one of claims 298 to 300, wherein the power supply unit interfaces with the second component of the device.

302. The system according to any one of claims 298 to 301, wherein the power supply unit comprises a battery.

303. The system according to any one of claims 298 to 302, wherein the power supply unit is integrated into a pair of eyeglasses.

304. The system according to any one of claims 265 to 303, wherein the sensor is fully implantable in a subject.

305. The system according to claim 304, wherein the sensor is fully implantable beneath the skin of the subject.

306. The system according to claim 304 or 305, wherein the subject has difficulty with verbal communication.

307. The system according to claim 306, wherein the subject has difficulty with verbal communication due to dysarthria, stroke, traumatic brain injury, brain tumor, or amyotrophic lateral sclerosis.

308. The system according to any one of claims 304 to 307, wherein the subject is in a paralyzed state.

309. It's a kit, The device according to any one of claims 1 to 257, A kit comprising packaging for the aforementioned device.

310. The kit according to claim 309, wherein the packaging of the device comprises sterile packaging.

311. A receiver unit according to any one of claims 265 to 308, The kit according to claim 309 or 310, further comprising packaging for the receiver unit.

312. A power supply unit according to any one of claims 258 to 264, A kit according to any one of claims 309 to 311, further comprising packaging for the power supply unit.

313. The kit according to any one of claims 309 to 312, further comprising a speaker.

314. The kit according to any one of claims 309 to 313, further comprising a display.

315. The kit according to any one of claims 309 to 314, further comprising a camera.

316. A method for detecting electrical signals from a subject, The method involves completely implanting an in vivo positioning device into a subject, wherein the device is Housing and A first component extending from the housing in a first plane, A second component extending from the housing in a second plane parallel to the first plane, Transplantation is performed such that the first plane and the second plane do not overlap. A method comprising using the device to detect electrical activity in the brain of the subject.

317. The method according to claim 316, wherein the method is a method of supporting the subject using communication.

318. The method according to claim 316 or 317, wherein the first component and the second component do not overlap.

319. The method according to any one of claims 316 to 318, wherein the device is configured such that the first component is folded.

320. The method according to any one of claims 316 to 319, wherein the device is implanted so that the first component is positioned on the surface of the subject's brain.

321. The method according to any one of claims 316 to 320, wherein the device is implanted so that the first component is positioned in the subdural space.

322. The method according to any one of claims 316 to 321, wherein the device is implanted so that the first component is positioned on the cortical surface.

323. The method according to any one of claims 316 to 322, wherein the device is implanted so that the first component is positioned on the speech region of the brain.

324. The method according to claim 323, wherein the speech region is the speech motor region of the brain.

325. The method according to any one of claims 316 to 324, wherein the device is implanted so that the first component is positioned on the motor area of ​​the brain.

326. The method according to any one of claims 316 to 325, wherein the device is implanted such that the first component is positioned on the surface of the sensorimotor cortical region.

327. The method according to any one of claims 316 to 326, wherein the device is implanted so that the electrode component is positioned on the surface of the sensorimotor cortical region of the brain within the subdural space.

328. The method according to claim 327, wherein the sensorimotor cortical region is selected from the gyrus gyrus gyrus, postcentral gyrus, posterior middle frontal gyrus, posterior superior frontal gyrus, posterior inferior frontal gyrus region, or any combination thereof.

329. The method according to claim 328, wherein the first component is aligned with the surface of the brain.

330. The method according to claim 329, wherein the first component includes a shape that matches the surface of the brain.

331. The method according to claim 330, wherein the shape includes a curvature corresponding to the surface of the brain.

332. The method according to claim 331, wherein the shape includes a plurality of fingers.

333. The method according to claim 332, wherein the shape includes a plurality of slots between each finger.

334. The method according to any one of claims 330 to 333, wherein the shape includes rounded corners.

335. The method according to any one of claims 316 to 334, wherein the first component comprises a flexible substrate.

336. The method according to claim 335, wherein the flexible substrate is foldable.

337. The method according to claim 335 or 336, wherein the flexible substrate is in accordance with the movement of the brain.

338. The method according to any one of claims 335 to 337, wherein the flexible substrate is a spring.

339. The method according to any one of claims 335 to 338, wherein the flexible substrate comprises a thin film substrate.

340. The method according to any one of claims 335 to 339, wherein the flexible substrate comprises a liquid crystal polymer.

341. The method according to claim 340, wherein the liquid crystal polymer includes a metal layer.

342. The method according to claim 340 or 341, wherein the liquid crystal polymer comprises at least three metal layers.

343. The method according to any one of claims 316 to 342, wherein the first component comprises a flexible cover layer.

344. The method according to claim 343, wherein the flexible cover layer is waterproof.

345. The method according to claim 343 or 344, wherein the flexible cover layer is a silicone layer.

346. The first component is, Electrode partition and Migration partition and The method according to any one of claims 316 to 345, comprising a connecting partition.

347. The method according to claim 346, further comprising implanting the electrode partition into the subdural space.

348. The method according to claim 346 or 347, wherein the electrode partition comprises a plurality of electrodes.

349. The method according to any one of claims 346 to 348, further comprising transplanting the connecting partition onto the upper part of the dura mater.

350. The method according to any one of claims 346 to 349, wherein the connecting partition is operably connected to the housing.

351. The method according to any one of claims 346 to 350, wherein the transition partition is foldable.

352. The method according to any one of claims 346 to 350, wherein the transition partition comprises a foldable material.

353. The method according to any one of claims 346 to 352, wherein the first component includes a fold in the transition partition.

354. The method according to any one of claims 346 to 353, wherein the first component is folded on itself in the transition partition.

355. The method according to any one of claims 346 to 354, further comprising folding the first component onto itself in the transition partition.

356. The method according to any one of claims 346 to 355, wherein the transition partition comprises a plurality of branches.

357. The method according to any one of claims 316 to 356, wherein the first component detects electrical activity.

358. The method according to claim 357, wherein the first component detects electrical activity of the brain.

359. The method according to claim 358, wherein the first component detects electrical activity from the surface of the brain.

360. The method according to claim 359, wherein the surface is the outer surface of the brain.

361. The method according to any one of claims 316 to 360, wherein the first component detects electrical activity of the cerebral cortex.

362. The method according to any one of claims 316 to 361, wherein the first component detects electrical activity of the ventral sensorimotor cortex.

363. The method according to any one of claims 316 to 362, further comprising detecting electrical activity using the first component.

364. The method according to any one of claims 316 to 363, wherein the first component is a cerebral cortex measurement electrode.

365. The method according to any one of claims 316 to 364, wherein the first component comprises a plurality of electrodes.

366. The method according to claim 365, wherein the plurality of electrodes comprises an electrode array.

367. The method according to claim 365 or 366, wherein the first component comprises 250 to 1,000 electrodes.

368. The method according to any one of claims 365 to 367, wherein the plurality of electrodes include surface electrodes.

369. The method according to any one of claims 365 to 368, wherein the plurality of electrodes include through electrodes.

370. The method according to any one of claims 365 to 369, wherein the diameter of the electrode is approximately 1 mm.

371. The method according to any one of claims 365 to 370, wherein the electrode protrudes from the surface of the electrode component.

372. The method according to any one of claims 365 to 371, wherein the electrode is coplanar with the surface of the electrode component.

373. The method according to any one of claims 365 to 372, wherein the longitudinal pitch between electrodes is approximately 2 mm and the lateral pitch between electrodes is approximately 2.5 mm.

374. The method according to any one of claims 316 to 373, further comprising wirelessly supplying power to the device.

375. The method according to claim 374, wherein the second component wirelessly supplies power to the device.

376. The method according to claim 375, wherein the second component supplies power to the device transcutaneously.

377. The method according to any one of claims 316 to 376, wherein the second component comprises an inductive power supply unit.

378. The method according to any one of claims 316 to 377, wherein the second component comprises a wire coil.

379. The method according to any one of claims 316 to 378, further comprising interfacing with a power supply unit.

380. The method according to claim 379, wherein the second component interfaces with the power supply unit.

381. The method according to claim 380, wherein the power supply unit is an ExVivo unit.

382. The method according to any one of claims 316 to 381, further comprising using magnets to align the second component with the ExVivo power supply unit.

383. The method according to claim 382, ​​wherein the second component further comprises the magnet.

384. The method according to claim 383, wherein the magnet attracts the ExVivo power supply unit.

385. The method according to any one of claims 316 to 384, further comprising supplying power to the device transcutaneously.

386. The method according to claim 385, wherein supplying power to the device transcutaneously includes supplying power to the device using an ex vivo power supply unit.

387. The method according to claim 385 or 386, wherein the transcutaneous power supply to the device includes positioning the exvivo power supply unit such that the power supply unit interfaces with the second component of the device.

388. The method according to any one of claims 385 to 387, wherein supplying power to the device transcutaneously includes positioning the ex vivo power supply unit on the head of the subject.

389. The method according to any one of claims 316 to 388, wherein the device does not include a battery.

390. The method according to any one of claims 316 to 389, wherein the second component is folded onto the housing.

391. The method according to any one of claims 316 to 390, wherein the second component is folded on top of itself on the housing.

392. The method according to any one of claims 316 to 391, wherein a substantial portion of the second component is folded onto the housing.

393. The method according to any one of claims 316 to 392, wherein the foldable portion of the second component is configured to allow the second component to be folded on itself.

394. The method according to claim 393, wherein the foldable portion of the second component comprises a flexible material.

395. The method according to any one of claims 316 to 394, wherein the second component is placed on the surface of the housing.

396. The method according to any one of claims 316 to 395, wherein the second component is folded on the housing so that the second component rests on the surface of the housing.

397. The second component comprises a wire coil, The method according to any one of claims 316 to 396, wherein the second component is folded on the housing so that the wire coil is placed on the surface of the housing.

398. The method according to any one of claims 316 to 397, wherein the second component is folded onto the housing and attached to the surface of the housing.

399. The method according to any one of claims 316 to 398, wherein the housing includes an electromagnetic shielding material.

400. The method according to any one of claims 316 to 399, wherein the housing includes a material that reduces interaction with an electromagnetic field.

401. The method according to any one of claims 316 to 400, wherein the housing includes a material that reduces electromagnetic field losses.

402. The method according to any one of claims 316 to 401, wherein the housing is a ceramic housing.

403. The method according to any one of claims 316 to 402, wherein the housing is a magnetic housing.

404. The method according to any one of claims 316 to 403, further comprising folding the second component onto the housing.

405. The method according to any one of claims 316 to 404, further comprising folding the second component onto the surface of the housing.

406. The method according to any one of claims 316 to 405, further comprising attaching the second component to the housing.

407. The method according to any one of claims 316 to 406, further comprising attaching the second component to the surface of the housing.

408. The method according to any one of claims 316 to 407, further comprising implanting the housing into an opening in the skull.

409. The method according to claim 408, wherein the housing comprises a sealed package.

410. The method according to any one of claims 316 to 409, further comprising folding the first component around the housing.

411. The method according to any one of claims 316 to 410, wherein the partition of the first component is located within the housing.

412. The method according to any one of claims 316 to 411, wherein the housing comprises a ceramic substrate.

413. The method according to any one of claims 316 to 412, wherein the housing comprises a magnetic substrate.

414. The method according to any one of claims 316 to 413, wherein the housing comprises a metal substrate.

415. The method according to any one of claims 316 to 414, wherein the housing comprises a plastic substrate.

416. The method according to any one of claims 316 to 415, wherein the housing comprises a ferromagnetic substrate.

417. The method according to any one of claims 316 to 416, wherein the device further comprises a cover.

418. The method according to claim 417, wherein the cover is attached to the housing.

419. The method according to claim 418, further comprising mounting the cover in the same plane as the surface of the skull.

420. The method according to claim 419, wherein the cover comprises a tab.

421. The method according to claim 420, further comprising fixing the tab to the surface of the skull.

422. The method according to any one of claims 417 to 421, wherein the cover provides an electromagnetic shield.

423. The method according to any one of claims 316 to 422, wherein the housing comprises an electronic component.

424. The method according to claim 423, wherein the electronic component is operably connected to the first component.

425. The method according to claim 424, wherein an operable connection between the electronic component and the first component is located within the housing.

426. The method according to any one of claims 423 to 425, wherein the electronic component is operably connected to the second component.

427. The method according to claim 426, wherein an operable connection between the electronic component and the second component is located within the housing.

428. The method according to any one of claims 423 to 427, wherein the electronic component comprises a plurality of sensing amplifiers.

429. The method according to claim 428, wherein the sensing amplifier is operably connected to the electrode.

430. The method according to any one of claims 423 to 429, wherein the electronic component comprises a plurality of analog-to-digital converters.

431. The method according to claim 430, wherein the analog-to-digital converter is operably connected to the electrodes of the first component.

432. The method according to claim 430 or 431, wherein the analog-to-digital converter receives the signal detected by the first component.

433. The method according to any one of claims 423 to 432, wherein the electronic component comprises a pin operably connected to an electrode of the first component.

434. The method according to claim 433, wherein the operable connection includes wire bonding.

435. The method according to any one of claims 423 to 434, wherein the electronic component blocks the DC current to the first component.

436. The method according to claim 435, wherein the electronic component comprises a plurality of capacitors, each operably connected to an electrode of the first component.

437. The method according to any one of claims 423 to 436, wherein the electronic component comprises a temperature sensor.

438. The method according to claim 437, wherein the electronic component turns off the device based on the temperature detected by the temperature sensor.

439. The method according to claim 438, further comprising using the electronic component to turn off the device based on the temperature detected by the temperature sensor.

440. The method according to any one of claims 423 to 439, wherein the electronic component comprises a plurality of Bluetooth Low Energy (BLE) modules.

441. The method according to any one of claims 316 to 440, wherein the device transmits data wirelessly.

442. The method according to any one of claims 316 to 440, further comprising wirelessly transmitting data from the device.

443. The method according to claim 442, wherein the device wirelessly transmits data based on a signal detected by the first component.

444. The method according to any one of claims 316 to 443, wherein the device receives data wirelessly.

445. The method according to any one of claims 316 to 444, further comprising receiving data wirelessly to the device.

446. The method according to claim 445, wherein the device wirelessly receives data including device control information or device configuration information.

447. The method according to any one of claims 316 to 446, wherein the device wirelessly transmits and receives data via a Bluetooth connection.

448. The method according to claim 447, wherein the Bluetooth connection is a Bluetooth Low Energy (BLE) connection.

449. The method according to any one of claims 316 to 448, wherein the second component comprises an antenna.

450. The method according to claim 449, wherein the device communicates wirelessly via the antenna.

451. The method according to claim 450, further comprising using the antenna to wirelessly communicate data to and / or from the device.

452. The method according to claim 451, wherein the antenna comprises a wire coil.

453. The method according to any one of claims 316 to 452, wherein the device further comprises a stylet.

454. The method according to claim 453, further comprising implanting the device using the stylet.

455. The method according to claim 453 or 454, further comprising using the stylet to secure the configuration of the first component.

456. The method according to any one of claims 453 to 455, further comprising using the stylet to stabilize the device against the surface of the brain.

457. The method according to any one of claims 453 to 456, wherein the stylet is removable from the device.

458. The method according to claim 457, further comprising removing the stylet when the device is implanted.

459. The method according to any one of claims 453 to 458, wherein the stylet is located at the boundary of the first component.

460. The method according to any one of claims 316 to 459, wherein the device is implanted such that the housing is located within an opening in the skull.

461. The method according to claim 460, wherein the device is implanted such that the housing is positioned coplanar with the surface of the skull.

462. The method according to any one of claims 316 to 461, wherein the first component is folded around the housing.

463. The method according to any one of claims 316 to 462, wherein the device is implanted so that the second component is positioned on the surface of the skull of the subject.

464. The method according to any one of claims 316 to 463, further comprising decoding speech using the detected electrical activity in the brain.

465. The method according to claim 464, wherein decoding speech includes decoding words, phrases, or sentences from the detected electrical activity in the brain.

466. The method according to claim 465, wherein decoding the utterance includes decoding words, phrases, or sentences based on the data transmitted by the device using the receiver unit.

467. The method according to claim 466, wherein decoding speech includes operably connecting the receiver unit to the device such that the receiver unit receives data transmitted by the device based on electrical activity detected from the subject's brain.

468. The method according to any one of claims 316 to 467, further comprising outputting the decoded word, phrase, or sentence as an audible sound through a speaker operably connected to the receiver unit.

469. The method according to any one of claims 316 to 468, further comprising displaying the decoded word, phrase, or sentence via a display operably connected to the receiver unit.

470. The method according to any one of claims 316 to 469, wherein the subject has difficulty with verbal communication.

471. The method according to any one of claims 470, wherein the subject has difficulty with verbal communication due to dysarthria, stroke, traumatic brain injury, brain tumor, or amyotrophic lateral sclerosis.

472. The method according to any one of claims 316 to 471, wherein the subject is in a paralyzed state.

473. The method according to any one of claims 316 to 472, further comprising evaluating the accuracy of decoding speech based on the detected electrical activity in the brain.

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