Improving Implants and Wearable Devices

Abstract

An implant for use in a neural interface system includes a housing having a base and a flexible portion. The implant further includes at least two locking attachment structures disposed on the base, the locking attachment structures being spaced apart by an angle greater than about 90° and less than about 180° about a center of the base. The locking attachment structures may be connected by a curved connecting member disposed on a patient-facing surface of the base.

Description

Related Applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 269,023, filed March 8, 2022, the entire teachings of which are incorporated herein by reference. [Background technology]

[0002] Neural interface systems are used to monitor, treat, or both monitor and treat a variety of neurological disorders. Currently, monitoring and intervention of brain activity is typically performed by placing devices on the outside of the patient's scalp or inside the skull. Summary of the Invention [Problem to be solved by the invention]

[0003] The former approach essentially requires daily replacement of skin electrodes, which is uncomfortable and cumbersome for the patient. The latter approach allows for neural stimulation and provides stable high-resolution EEG recordings, but requires extensive surgery (i.e., craniotomy) and carries a small but significant surgical risk, as the system's electrodes must be in direct contact with the brain. For these reasons, the option of a permanent intracranial device with brain recording remains a last resort when all other options have been exhausted.

[0004] Intracranial recording, especially long-term intracranial recording, is useful for a variety of applications, such as epilepsy monitoring, neurorehabilitation, psychiatry, sleep medicine, etc. There is a demand for permanent monitoring of whole brain activity using a system that can be placed in a patient with less invasive means than electrode implants placed through the patient's skull, and that can be worn for longer periods of time with less intrusiveness than scalp electrodes. [Means for solving the problem]

[0005] Provided are components of a neural interface system with configurations that provide improved patient attachment and wearability, the neural interface system being suitable for subcutaneous or epiosseous placement on a patient.

[0006] An implant for use in a neural interface system includes a housing having a base and a flexible portion, and further includes at least two locking attachment structures disposed on the base, the locking attachment structures being spaced apart by an angle greater than about 90° (degrees) and less than about 180° about a center of the base.

[0007] The locking attachment structures may be connected by a curved connecting member provided on a patient-facing surface of the base.

[0008] The two locking attachment structures may each comprise an attachment leg having an inflection point that biases at least a portion of the locking attachment structure toward a patient-facing surface of the base.

[0009] The housing is generally configured to be placed subcutaneously relative to a patient's skull, and the anchoring attachment structure is configured to anchor the housing to the skull.

[0010] The implant may further include electronics configured to record electroencephalogram (EEG) signals detected by sensors in the leads (e.g., 32 channels of electrical brain activity detected from the leads may be recorded), and the electronics may be configured to transmit the recorded EEG signals to a wearable device (also referred to as a wearable headpiece) outside the body. The recording and transmission of the EEG signals may be continuous.

[0011] The body of the implant may include a lead connection region configured to engage a lead extending from the implant. For example, the lead connection region may comprise at least four lead connection structures arranged in a generally flat configuration. The implant may further include a magnetic alignment component configured to align an external wearable device to the implant. The magnetic alignment component may be removable.

[0012] The wearable device of the neural interface system comprises a housing and a removable cover configured to cover at least a patient-facing surface of the housing.

[0013] The removable cover may have multiple recesses, multiple protrusions, or a combination thereof. For example, the recesses and / or protrusions may be a path extending from an inner location of the patient surface of the cover toward an edge of the patient surface of the cover. The path may extend radially from a center of the patient surface of the cover. The recesses and / or protrusions may be of the same size or may be of different sizes. For example, the recesses and / or protrusions may be comprised of multiple recesses and protrusions of different sizes. The multiple recesses and / or protrusions of different sizes may be arranged to increase in size from an inner location of the patient surface of the cover toward an edge of the patient surface of the cover, or may be arranged to increase in size from an edge of the patient surface of the cover toward an inner location of the patient surface of the cover.

[0014] The angle between the two locking attachment structures may be within a range of about 130° to about 150°, or may be about 145°. Each locking attachment structure may be provided with a locking attachment leg having an inflection point. For example, the inflection point biases each leg toward the patient surface of the base. The locking attachment legs may be biased toward the patient surface of the base by about 5° to about 30°, or about 20°. The locking attachment legs may be deflectable at each inflection point. Alternatively or additionally, the locking attachment legs may be made of a compliant material configured to conform to the curvature of the skull. The locking attachment legs may be made of a material that resists or inhibits osseointegration. For example, the locking attachment legs may each be formed from a material or combination of materials, such as polyetheretherketone (PEEK), polysulfone (PSU), polyethyleneimine (PEI), thermoplastic polyurethane (TPU), etc., which may facilitate preventing bony integration of the leg with patient tissue and may advantageously facilitate removal of the device, or may be overmolded from such a material or combination of materials.

[0015] The flexible portion of the implant may have an inflection point that causes the flexible portion to be biased toward the patient surface of the base, i.e., toward the skull of the patient wearing the implant. For example, the flexible portion may be biased 1° to about 90°, about 5° to about 45°, or about 15° toward the patient surface of the base. The flexible portion may have multiple inflections and / or a curved shape.

[0016] A method of implanting components of a neural interface system includes making an incision in the patient's scalp about 30 mm to about 50 mm in length, and placing an implant having a housing including a base and a flexible portion through the incision and subcutaneously relative to the patient's skull in a subscalp space. The incision can be, for example, a curved incision. The system can be small because it does not require a recess in the skull to accommodate the system. The system can be thin enough to fit under the scalp, eliminating the need to drill holes in the skull.

[0017] The method may further include securing the implant to the patient's skull with at least one attachment structure on the base of the implant, for example, the at least one attachment structure may comprise two attachment structures spaced apart by an angle between greater than 90° and less than 180°. [Brief description of the drawings]

[0018] The foregoing will be apparent from the following more detailed description of exemplary embodiments, as illustrated in the accompanying drawings. The same reference characters refer to the same structures / components throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the embodiments. [Figure 1] FIG. 1 is a schematic diagram of a neural interface system. [Figure 2A] FIG. 1 is a schematic diagram illustrating an example of an implant for a neural interface system. [Figure 2B] FIG. 2B is a side view of the implant of FIG. 2A. [Figure 2C] FIG. 2B is a bottom view of the implant of FIG. 2A. [Figure 2D] FIG. 2B shows the patient-facing surface of the implant of FIG. 2A. [Diagram 3] 1 illustrates an example of the placement of an implant relative to a patient. [Figure 4] FIG. 1 is a schematic diagram illustrating a wearable example of the neural interface system. [Figure 5A] FIG. 2 is a schematic diagram showing an example of a wearable cover. [Figure 5B] FIG. 5B is another view showing the same example of the cover as in FIG. 5A. [Figure 5C] FIG. 11 is a front view showing another example of the cover. [Figure 5D] FIG. 5D is a rear view showing the same example of the cover as in FIG. 5C. [Figure 5E] FIG. 5D is a plan view showing the same example of the cover as in FIG. 5C. [Figure 5F] FIG. 5D is a bottom view showing the same example cover as in FIG. 5C. [Figure 5G] FIG. 5D is a right side view showing the same example cover as in FIG. 5C. [Figure 5H] FIG. 5D is a left side view showing the same example of the cover as in FIG. 5C. [Figure 5I] FIG. 5D is a top perspective view showing the same example of the cover as in FIG. 5C. [Figure 5J] FIG. 5D is a bottom perspective view showing the same example cover as in FIG. 5C. [Figure 6A] 13 is a schematic diagram showing yet another example of a wearable cover. FIG. [Figure 6B] FIG. 6B is another view showing the same example of the cover as in FIG. 6A. [Figure 6C] FIG. 11 is a front view showing still another example of the cover. [Figure 6D] FIG. 6D is a rear view showing the same example of the cover as in FIG. 6C. [Figure 6E] FIG. 6D is a plan view showing the same example of the cover as in FIG. 6C. [Figure 6F] FIG. 6D is a bottom view showing the same example of the cover as in FIG. 6C. [Figure 6G] FIG. 6D is a right side view showing the same example of the cover as in FIG. 6C. [Figure 6H] FIG. 6D is a left side view showing the same example of the cover as in FIG. 6C. [Figure 6I] FIG. 6D is a top perspective view showing the same example of the cover as in FIG. 6C. [Figure 6J] FIG. 6D is a bottom perspective view showing the same example cover as FIG. 6C. [Figure 7]FIG. 1 is a schematic diagram showing an example of an implant having a lead wire connection structure in the form of a substantially flat lead wire. [Figure 8] FIG. 1 is a schematic diagram illustrating an example of an implant with attachment legs having multiple inflections. [Figure 9] FIG. 1 is a schematic diagram showing an example of an implant having a lead wire connection structure in the form of a bundled lead wire. [Figure 10] FIG. 1 is a schematic diagram showing an example of an implant having a lead connection structure in the form of a laminated lead. [Figure 11A] FIG. 8 is a side view of the implant of FIG. 7 including a flexible portion having a single inflection. [Figure 11B] FIG. 11B is another side view of the implant of FIGS. 7 and 11A showing the relative bending of the flexible portion. [Figure 12A] FIG. 13 is a side view of another example of the implant including a flexible section having two inflections. [Figure 12B] FIG. 12B is a side view of the implant of FIG. 12A showing the relative bending of the flexible portion. [Figure 13A] FIG. 13 is a schematic diagram illustrating an example of a cover that engages with a wearable device of the neural interface system. [Figure 13B] FIG. 13B is a schematic diagram showing the cover of FIG. 13A in a disengaged state with the wearable device. [Figure 14] 1 is a schematic diagram showing an example of a patient-facing surface of a cover for a wearable device. FIG. [Figure 14A] FIG. 11 is a front view showing another example of the cover. [Figure 14B] FIG. 14B is a rear view showing the same example of the cover as in FIG. 14A. [Figure 14C] FIG. 14B is a plan view showing the same example of the cover as in FIG. 14A. [Figure 14D] FIG. 14B is a bottom view showing the same example of the cover as in FIG. 14A. [Figure 14E] FIG. 14B is a right side view showing the same example of the cover as in FIG. 14A. [Figure 14F] FIG. 14B is a left side view showing the same example of the cover as in FIG. 14A. [Figure 14G] FIG. 14B is a plan perspective view showing the same example of the cover as in FIG. 14A. [Figure 14H] FIG. 14B is a bottom perspective view showing the same example cover as in FIG. 14A. [Figure 15] 13 is a schematic diagram showing another example of the patient side surface of a cover for a wearable device. FIG. [Figure 15A] FIG. 11 is a front view showing another example of the cover. [Figure 15B] FIG. 15B is a rear view showing the same example of the cover as in FIG. 15A. [Figure 15C] FIG. 15B is a plan view showing the same example of the cover as in FIG. 15A. [Figure 15D] FIG. 15B is a bottom view showing the same example of the cover as in FIG. 15A. [Figure 15E] FIG. 15B is a right side view showing the same example of the cover as in FIG. 15A. [Figure 15F] FIG. 15B is a left side view showing the same example of the cover as in FIG. 15A. [Figure 15G] FIG. 15B is a plan perspective view showing the same example of the cover as in FIG. 15A. [Figure 15H] FIG. 15B is a bottom perspective view showing the same example cover as in FIG. 15A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] In the following, exemplary embodiments are described.

[0020] An example of a neural interface system is shown in Figure 1. The neural interface system 100 includes a component 110 that is worn externally on the patient and a component 120 that is implanted internally on the patient. The external component 110 includes a wearable device 114 connected to a recording device 112 by a cable 116. The implantable component 120 includes a lead 122 connected to an implant 124. The lead may be in the form of one or more trifurcated wires that are placed near the patient's skull. The implantable component may be configured to be placed on the patient's bone or subcutaneously.

[0021] The neural interface system 100 may be used to continuously record subcutaneous electroencephalogram (EEG) signals of a patient. Briefly, the leads 122 include EEG sensors configured to be placed on or under the patient's bone. The implant 124 may be an implantable telemetry unit (ITU) capable of detecting and acquiring EEG signals on the leads 122 and transmitting the acquired EEG signals through the patient's skin to the wearable device 114. The wearable device 114 may be an electronic device worn on the patient's body. The wearable device 114 may power the implant 124 and receive EEG data from the implant. The received EEG data may then be stored in the recording device 112 and transmitted (e.g., wirelessly) from there to another device.

[0022] Examples of neural interface systems are described in detail in WO 2019 / 211314 ("Neural Interface System"), the entire contents of which are incorporated herein by reference.

[0023] FIG. 2A shows an example of an implant for a neural interface system. The implant 200 comprises a base 210 and a flexible part 212. The flexible part 212 can be, for example, a flexible sleeve, an overmolded part, etc. The base 210 can house electronics for registering and / or digitizing and / or transmitting EEG data. The base can be made of a rigid biocompatible material, such as ceramics, epoxies, metals, rigid polymers, etc., to ensure encapsulation of the electronics, or a combination of these materials. The base can be overmolded, for example, with an elastomeric material, which can form a continuum that also constitutes the flexible part of the implant 200. Examples of suitable elastomeric materials include silicone, polyurethane rubber (PUR), thermoplastic elastomers (TPE), etc. Alternatively, the flexible part can be attached to the base. The leads of the system (e.g., lead 122) may be connected to electronics housed in the base 210 of the implant at a lead connection region 214. The lead connection region 214 may consist of lead connection structures 215a-d arranged to maintain each lead in a compact configuration. The illustrated lead connection region 214 consists of a bundle of four lead connection structures 215a-d. Alternatively, the lead connection structures may be arranged side-by-side with the leads.

[0024] Lead connection area 214 provides for the connection of multiple leads (e.g., up to four cables) in a compact format, such as lead 122, which may include sensors configured to provide, for example, 32 channels of electrical brain activity.

[0025] Other examples of the structural form of the lead wire connection region of the implant are shown in Fig. 7, Fig. 9 and Fig. 10. In the implant 600 of Fig. 7, the lead wire connection structure 614 is depicted as connecting the lead wires 615a-615d in a substantially flat form. The substantially flat form makes it easier to keep the overall height of the implant to a minimum. In the implant 800 of Fig. 9, the lead wire connection structure 814 is depicted as connecting the lead wires 815a-815d in a bundled form, and in the implant 900 of Fig. 10, the lead wire connection structure 914 is depicted as connecting the lead wires 915a-915d in a stacked form (e.g., a 2x2 form of four lead wires). The bundled form or stacked form makes it easier to keep the width of the lead wire connection region to a minimum. 7, 9 and 10, the protrusions 617, 817, 917 are relatively gentler than the lead connection structures 215a-215d shown in Fig. 2A, and the lead connection regions are simplified while reducing the area occupied by the lead connection regions. The lead connection structures may be formed as part of the flexible sleeve of the device (e.g., flexible portion 212 in Fig. 2A).

[0026] The base of the housing may include at least two locking attachment structures 221, 223. These may be a unitary structure such as a lock 225 (FIG. 2D) with a connecting member 226 between locking attachment legs 222, 225, or may be individual locking attachment legs extending from the base. Locking attachment legs 222, 224 are provided on the base housing 210 for securing the implant to a patient. Locking attachment legs 222, 224 may be angularly spaced relative to one another to secure the implant to a patient at two separate attachment points. For example, at least two locking attachment legs may be spaced apart by an angle greater than about 90° and less than about 180° about the approximate center of the base 210.

[0027] As shown in FIG. 2A, the locking attachment legs 222, 224 are spaced apart by an angle A of about 145°. Specifically, one locking attachment leg 224 is disposed along an axis C that is generally parallel to the horizontal width W of the implant, and another locking attachment leg 222 is disposed along an axis B. The base 210 of the implant may include more than two locking attachment legs, or may include at least two locking attachment legs that are disposed at an obtuse angle. Specifically, the locking attachment legs 222, 224 may be spaced apart by an angle greater than 90° and less than 180°. For example, the angle A may be within a range of about 120° to about 160°, about 130° to about 150°, or about 135° to about 145°. This arrangement advantageously allows the base 210 of the implant to be securely attached to the patient while minimizing the size of the incision required to place and secure the implant to the patient. For example, this arrangement allows for an incision of only about 30 mm to about 50 mm, or even about 45 mm in length to provide access to the device, minimizing the surgical invasiveness to the patient. As shown in FIG. 2A, one or more of the locking attachment legs may be located at or near the lead connection region 214, thereby eliminating or reducing the effect of movement of the implant relative to the lead or movement of the lead relative to the implant.

[0028] By way of background, subscalp implants are typically placed through an incision made in the patient's scalp. Once the implant is placed in the patient, pressure between the scalp and skull can provide some retention and positional control for the implant, but movement of the implant can still cause discomfort to the patient and affect the position of the leads attached to the implant, so it is desirable to minimize or eliminate movement of the implant. As such, the implant may be provided with one or more locking attachment structures to secure the implant to the patient's skull. A single locking attachment structure may not be sufficient, as a single attachment point may allow the implant to rotate about the single locking point or movement at another end of the device. However, if the device provides locking points for the implant on both sides, the incision must be significantly larger to accommodate the width of the implant, as well as to provide sufficient space to accommodate and secure the implant on both sides of the device. Providing the implant with a locking attachment structure as shown in Figures 2A-2C advantageously allows the implant to be securely held in place at two locking points while reducing the size of the incision.

[0029] As shown in detail in FIGS. 2B and 2C, the locking attachment legs 222, 224 may have inflection points 222A, 224A, respectively, that deflect the locking attachment legs 222, 224 from a plane D defined by the patient-facing surface 230 of the base 210. For example, the inflection point 224A causes at least a portion of the locking attachment legs 224 to be oriented along an axis E that is inclined at an angle F of about 5° to about 40° or about 10° to about 25° relative to the plane D, deflecting the legs toward a patient-facing surface of the device, i.e., toward the skull when the device is placed on the patient. The locking attachment legs 222, 224 may be deflectable at their respective inflection points, which allows them to conform to the patient's skull and provide a secure fit. Although each leg is shown with only one inflection point, there may be multiple inflection points and the legs may be curved. For example, the attachment legs 722, 724 of the implant 700 shown in Figure 8 each have two inflection points 722A, 722B, 724A, and 724B.

[0030] As shown in Figures 2B-2D, the locking attachment legs 222, 224 may be connected by a connecting member 226. However, the locking attachment legs may be individually secured to the base 210 without the connecting member 226. The locking attachment legs 222, 224 and connecting member 226 may be integrally or separately formed of a metallic material (e.g., titanium) that may be integral with or welded to the base 210 of the device while providing some flexibility for bending at the inflection points 222A, 224A during implantation of the device. Alternatively, the locking attachment legs may be formed of an overmolded material, such as an overmolded piece that provides the flexible portion 212 of the device and optionally encapsulates the base 210 of the device. The angle at which the locking attachment legs 222, 224 are tilted may be an angle that can accommodate the curvature of the skull. For example, the deflection angle F of the locking mounting legs can be within the range of about 5° to about 25°, or about 10° to about 20°.

[0031] As shown in FIG. 2D, the connecting member 226 can be a curved member. The curved shape of the connecting member 226 simplifies the manufacture of the anchor 225 and allows for a minimal amount of manufacturing material (e.g., titanium) to support and securely connect the anchor attachment structures 221, 223 to the implant. As shown, the connecting member 226 is curved such that its overall shape conforms to the curved edge or end of the patient-facing surface of the base 210. The curved shape of the connecting member 226 allows for a generally flush attachment of the anchor 225 to the patient-facing surface of the base 210. As best seen in FIG. 2C, the inflection points 222A, 224A can be located at the end of the base 210. This allows for the anchor attachment structures 221, 223 to bend while still keeping them near the base, which helps minimize the size of the incision to implant the device.

[0032] The locking attachment legs 222, 224 may be formed or comprised of a material that resists (e.g., inhibits, prevents, retards) bony integration. For example, the illustrated locking attachment legs 222, 224 comprise an overmolded part 222B, 224B. The overmolded part may be comprised of a material that inhibits bony integration of the locking attachment legs 222, 224 with patient tissue, such as the skull. Examples of the overmolded part include polyetheretherketone (PEEK), polysulfone (PSU), polyethyleneimine (PEI), thermoplastic polyurethane (TPU), or the like, or combinations thereof. As shown in FIGS. 2A-2C, the overmolded part is disposed within the screw recess 222C, 224C and extends across the upper and lower surfaces of the locking attachment legs 222, 224. Alternatively or additionally, the overmold may be disposed around the edges of the mounting legs 222, 224. The overmold may completely or partially cover the upper and lower surfaces of the locking mounting legs 222, 224.

[0033] A flexible portion 212, also referred to as a sleeve, may house a coil (not shown in FIG. 2) that wirelessly powers the implant when it is in proximity to a wearable (e.g., wearable 114). The sleeve may be made of a material that allows for infrared (IR), radio frequency (RF), or other EEG signal transmission methods to the wearable, such as silicone, polyurethane rubber (PUR), thermoplastic elastomer (TPE), etc. Optionally, the sleeve may have an opening 214 through which a magnet 230 may be inserted or removed. The magnet 230 allows a wearable device (e.g., wearable device 114, also referred to as a headpiece) to be removably attached to the implant at the location of the patient. The sleeve 212 may be made of a flexible or deformable material. For example, the material may be about 10 to about 80 on the Shore 00 hardness scale. The deformable material may be configured to conform to the curvature of the skull. A flexible sleeve can provide comfort, ease of placement on the patient, and ease of movement of the magnet in and out of the opening 214.

[0034] As best seen in FIG. 2B, the sleeve 212 may have an inflection point 212A, which deflects at least a portion of the sleeve from a plane G defined by the patient-facing surface 230 of the base 210. For example, the inflection point 212A causes at least a portion of the sleeve to be oriented along an axis H that is at an angle J of about 15° with respect to the plane G. The sleeve 212 may be flexible at one or more inflection points (e.g., inflection point 212A) to conform to the patient's skull and provide a secure fit. The angle at which the sleeve 212 is tilted may be an angle that can accommodate the curvature of the skull. For example, the deflection angle J of the sleeve may be within a range of about 1° to about 90°, about 5° to about 25°, or about 10° to about 20°. Alternatively or additionally, the sleeve may have multiple inflection points or may have a curved shape, such as a complex curve or one or more multiple inflection points along the length of the sleeve. FIGS. 11A-12B show examples of curved sleeve configurations in implants. The implant 600 of FIGS. 11A and 11B includes a sleeve 612 with one inflection point 612A. The implant 1000 of FIGS. 12A and 12B includes a sleeve 1012 with two inflection points 1012A, 1012B. FIG. 3 shows an example of placement of the implant 200, including the corresponding lead wires, in the skull of a subject.

[0035] The deflection of the flexible sleeve and the locking attachment legs provides at least three connection points to securely hold the implant in place. For example, the deflection of the flexible sleeve provides pressure at the end 212B of the device to allow frictional engagement with the skull. Thus, the deflection of at least a portion of the implant sleeve 212 facilitates securing the implant to the patient at the opposite end of the device from the locking attachment legs. The at least two locking attachment legs 222, 224 are spaced apart at an angle (e.g., an obtuse angle) at the base 210 of the device, and the deflection of the flexible sleeve 212 at the end 212B of the device allows for a generally triangular arrangement of attachment points. This triangular arrangement allows for a secure attachment to the subject while minimizing the size of the incision and the number of screw attachment points to the patient.

[0036] FIG. 4 illustrates an example of a wearable device configured to engage with an implant (e.g., implant 200). The wearable device 300 may include a housing 310. Optionally, the housing 310 may have an opening 315 for accessing a magnet (not shown) housed therein. As shown, the opening is configured to receive a removable part 317, such as a screw-on disk, sliding cover, hinged cover, or the like, that securely houses the magnet within the housing and allows for insertion and removal of the magnet. The housing 310 may be of a complementary size and shape for engaging with an implant. As shown, a portion 312 of the housing 310 that houses the electronics of the device is configured to at least partially overlap the base 210 of the implant 200. Another portion 314 of the housing may house a coil (not shown) that wirelessly powers the implant. The portion 314 of the housing may be smaller in size than the portion 312, allowing for a smaller overall size of the wearable.

[0037] The wearable may further include a removable cover. An example of a removable cover is shown in Figures 5A and 5B. The removable cover 400 may be configured to cover at least the patient-facing surface 330 of the wearable (Figure 4). For example, as shown in Figure 5A, the removable cover 400 is configured to cover the patient-facing surface 330 of the wearable 300 while leaving the non-patient-facing surface 332 of the wearable 300 substantially exposed. The removable cover 400 has a lip 410 configured to engage with an edge of the wearable 300 to be attached to and detached from the wearable. Other examples of removable covers are shown in Figures 5C-5J.

[0038] 13A and 13B show another example of a wearable cover that engages with a wearable device. The cover 1130 is configured to encase the top of the wearable device 1100 and have a patient-facing surface 1113.

[0039] 5B, the patient-facing surface 430 of the cover includes a plurality of recesses 410. The recesses 410 may be in the form of channels extending radially from an inner location 412 of the patient-facing surface 430 toward an edge 414 of the surface 430.

[0040] 6A and 6B show another example of a removable cover. The removable cover 500 covers both the patient-facing surface 330 of the wearable 300 and at least a portion of the non-patient-facing surface 332. As shown, the removable cover 500 has a number of recesses 510 of various sizes. These recesses may be arranged in a radial pattern around an inner position 512 of the patient-facing surface 530 of the cover. For example, the recesses 510 may be arranged to increase in size from the inner position 512 of the surface 530 toward the edge 514 of the surface 530, or may be arranged to increase in size from the edge 514 of the surface 530 toward the inner position 512 of the surface 530. FIGS. 6C to 6J show another example of a removable cover.

[0041] The recessed configurations as shown in Figs. 5A-6B can advantageously wick away moisture when the subject wears the device, improve patient comfort, and protect the wearable. Although Figs. 5A-6B depict a cover with recesses, the cover may alternatively or additionally include protrusions to facilitate ventilation, as shown in Figs. 14 and 15. In the wearable cover 1200 shown in Fig. 14, the patient-facing surface includes a plurality of hemispherical protrusions 1210. In another configuration example, the patient-facing surface of the wearable cover 1300 includes a plurality of protrusions 1310 arranged in a pattern extending in a substantially radial direction. These protrusions may be arranged in a regular pattern or randomly. Since the neurological function monitoring system may be required to be worn by a patient for a long period of time (e.g., several days or weeks), the cover can protect the device, make the device comfortable, and make the device easier to clean. Moisture build-up between the wearable and the patient's skin can adversely affect the attachment of the device to the patient, cause discomfort to the patient, or be harmful to the patient. The configuration of recesses and / or protrusions, for example in a radial configuration extending from an inner position of the patient-facing surface toward the edge, advantageously allows ventilation toward the edge of the cover where moisture is most likely to accumulate. Alternatively or additionally, the wearable device itself may include recesses and / or protrusions as exemplified for the cover. Other examples of covers are shown in Figures 14A-14H and 15A-15H.

[0042] All patents, published patent applications and publications cited herein are incorporated by reference in their entirety.

[0043] While exemplary embodiments have been specifically shown and described, those skilled in the art will recognize that various changes in form and detail may be made therein without departing from the scope of the embodiments encompassed by the appended claims.

Claims

1. 1. An implant for use in a neural interface system, comprising: a housing including a base and a flexible portion; two locking attachment structures provided on the base, the two locking attachment structures being spaced apart by an angle between 90° and 180° about an approximate center of the base and connected by a curved connecting member provided on a patient-facing surface of the base; The implant comprises:

2. 2. The implant of claim 1, wherein the angle is within the range of about 130 degrees to about 150 degrees.

3. The implant of claim 2 , wherein the angle is about 145°.

4. The implant of claim 1 , wherein at least two of the locking attachment structures each comprise an attachment leg.

5. The implant of claim 4 , wherein the mounting legs are made of a deformable material configured to conform to the curvature of the skull.

6. 5. The implant of claim 4, wherein the anchoring attachment legs are made of a material that resists osseous integration.

7. 7. The implant of claim 6, wherein the material comprises polyetheretherketone (PEEK), polysulfone (PSU), polyethyleneimine (PEI), thermoplastic polyurethane (TPU), or a combination thereof.

8. The implant of claim 4 , wherein the attachment leg has an inflection point.

9. The implant of claim 8 , wherein the inflection point biases the mounting foot toward a patient-facing surface of the base.

10. 10. The implant of claim 9, wherein the mounting legs are biased toward the patient-facing surface of the base by about 5 degrees to about 30 degrees.

11. 11. The implant of claim 10, wherein the mounting legs are biased toward the patient surface of the base by approximately 20 degrees.

12. The implant of claim 8 , wherein the mounting leg is deflectable at the inflection point.

13. The implant of claim 1 , wherein the flexible portion has at least one inflection point.

14. 14. The implant of claim 13, wherein the inflection point biases the flexible section toward a patient-facing surface of the base.

15. 15. The implant of claim 14, wherein the flexible section is deflected toward the patient-facing surface of the base by about 1° to about 90°, about 5° to about 45°, or about 15°.

16. The implant of claim 1 , wherein the flexible portion has a curved shape.

17. 10. The implant of claim 1 further comprising: a lead connection region configured to engage a lead extending from the implant; electronics disposed within the base of the housing and configured to record electroencephalogram (EEG) signals detected from the sensors in the leads; The implant comprises:

18. 20. The implant of claim 17, wherein the lead connection region comprises four lead connection structures arranged in a generally planar configuration.

19. 20. The implant of claim 17, wherein the lead connection region comprises four lead connection structures arranged in a bundle configuration.

20. 20. The implant of claim 17, wherein the lead connection region comprises four lead connection structures arranged in a stacked configuration.

21. 1. An implant for use in a neural interface system, comprising: a housing including a base and a flexible portion; two locking attachment structures on the base, the two locking attachment structures being spaced apart by an angle between greater than 90° and less than 180° about an approximate center of the base, each of the two locking attachment structures comprising an attachment leg having an inflection point that biases at least a portion of the locking attachment structure toward a patient-facing surface of the base; The implant comprises:

22. 22. The implant of claim 21, wherein the inflection point of each of the two locking attachment structures is located at an end of the base.

23. 1. A method of implanting a component of a neural interface system, comprising: making an incision in the patient's scalp about 30 mm to about 50 mm in length; placing an implant, the housing including a base and a flexible portion, through the incision and subcutaneously within the patient's subscalp space relative to a skull; A method comprising:

24. 24. The method of claim 23, wherein the incision is curvilinear.

25. 24. The method of claim 23 further comprising: fixing the implant to the patient's skull with at least one attachment structure provided at the base of the implant; A method comprising:

26. 26. The method of claim 25, wherein the at least one mounting structure comprises two mounting structures spaced apart by an angle greater than 90 degrees and less than 180 degrees.

27. 1. A wearable headpiece of a neural interface system, comprising: Housing and a removable cover configured to cover at least a patient-facing surface of the housing; and A wearable headpiece comprising:

28. 28. The wearable headpiece of claim 27, wherein the removable cover has a plurality of recesses, a plurality of protrusions, or a combination thereof.

29. 29. The wearable headpiece of claim 28, wherein the plurality of recesses, the plurality of protrusions, or the combination thereof form a path extending from an inner position on the patient-facing surface of the cover toward an edge of the patient-facing surface of the cover.

30. 30. The wearable headpiece of claim 29, wherein the pathway extends radially from an inner location on the patient-facing surface of the cover.

31. 30. The wearable headpiece of claim 29, wherein the plurality of recesses, the plurality of protrusions, or the combination thereof comprises a plurality of recesses of different sizes, a plurality of protrusions of different sizes, or a combination thereof.

32. A wearable headpiece as described in claim 31, wherein the multiple recesses or multiple protrusions of different sizes are arranged to increase in size from an inner position on the patient-facing surface of the cover toward an edge of the patient-facing surface of the cover.

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