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WO2025155575A1 - Système d'insertion minimalement invasif pour interfaces neurales - Google Patents

Système d'insertion minimalement invasif pour interfaces neurales

Info

Publication number
WO2025155575A1
WO2025155575A1 PCT/US2025/011619 US2025011619W WO2025155575A1 WO 2025155575 A1 WO2025155575 A1 WO 2025155575A1 US 2025011619 W US2025011619 W US 2025011619W WO 2025155575 A1 WO2025155575 A1 WO 2025155575A1
Authority
WO
WIPO (PCT)
Prior art keywords
cranial
subject
guide
drill
depicts
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/011619
Other languages
English (en)
Inventor
Adam J. POOLE
Morgan LAMARCA
Benjamin I. Rapoport
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Precision Neuroscience Corp
Original Assignee
Precision Neuroscience Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US18/434,008 external-priority patent/US20250228534A1/en
Application filed by Precision Neuroscience Corp filed Critical Precision Neuroscience Corp
Publication of WO2025155575A1 publication Critical patent/WO2025155575A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/14—Surgical saws
    • A61B17/15—Guides therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/14—Surgical saws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/14—Surgical saws
    • A61B17/149—Chain, wire or band saws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1695—Trepans or craniotomes, i.e. specially adapted for drilling thin bones such as the skull
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8872—Instruments for putting said fixation devices against or away from the bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation

Definitions

  • a necessary capability of any brain-computer interface is the ability to accurately decode electrophysiologic signals recorded from individual neurons, or populations of neurons, and correlate such activity with one or more sensory stimuli or intended motor response.
  • a system may record activity from the primary motor cortex in an animal or a paralyzed human patient and attempt to predict the actual or intended movement in a specific body part; or the system may record activity from the visual cortex and attempt to predict both the location and nature of the stimuli present in the patient’s visual field.
  • a cranial guide for surgically preparing a subject for an implantable neural device, the cranial guide comprising: a saw slot for receiving an oscillating saw blade, the saw slot oriented to form an angular slit in the subject oriented from about 45° to about 65°; and a drill aperture for receiving a drill bit therethrough, the drill aperture coextensive with the saw slot.
  • a method for surgically preparing a subject for an implantable neural device comprising: placing an incision template on a head of the subject, the incision template comprising a first portion and a second portion arranged orthogonally with respect to the first portion, the first portion defining a slit configured to receive a cutting instrument therethrough, wherein a first length of the slit corresponds to a second length of an angular slit to be formed in the subject; using the incision template, making an incision in a scalp of the subject with the cutting instrument; placing a cranial guide on the scalp of the subject at the incision, the cranial guide comprising a saw slot for receiving an oscillating saw blade and a drill aperture for receiving a drill bit therethrough, wherein the drill aperture is coextensive with the saw slot; using the drill aperture of the cranial guide, drilling a pilot hole through the scalp and into a skull of the subject; and using the saw slot, cutting the angular
  • the cranial guide system further comprises a friction-reducing coating disposed on an inner surface of the saw slot.
  • the drill aperture is disposed at a midpoint of the saw slot.
  • a width of the drill aperture is from about 0.5 mm to about 3 mm.
  • FIG. 1 depicts a block diagram of a secure neural device data transfer system, in accordance with an embodiment of the present disclosure.
  • FIG. 2 depicts a diagram of a neural device, in accordance with an embodiment of the present disclosure.
  • FIG. 3 depicts a diagram of a thin- film, microelectrode array neural device and implantation method, in accordance with an embodiment of the present disclosure.
  • FIG. 4 depicts a flow diagram of a process for preparing a subject for implantation of a neural device in a minimally invasive manner, in accordance with an embodiment of the present disclosure.
  • FIG. 5A depicts an osteotomy created using the minimally invasive process described in connection with FIG. 4, in accordance with an embodiment of the present disclosure.
  • FIG. 5B depicts a neural device being inserted through the osteotomy shown in FIG. 5A, in accordance with an embodiment of the present disclosure.
  • FIG. 5C depicts the deployed neural device shown in FIG. 5B, in accordance with an embodiment of the present disclosure.
  • FIG. 6A depicts a diagram showing the placement of the skin incision and cranial guide for the planned trajectory between the target location for the neural device against the cortical surface and the entry point of the patient’s skull, in accordance with an embodiment of the present disclosure.
  • FIG. 6B depicts an angular slit and pilot hole formed in a skull, in accordance with an embodiment of the present disclosure.
  • FIG. 7 depicts an incision template, in accordance with an embodiment of the present disclosure.
  • FIG. 8C depicts a third perspective view of the mount of a cranial guide system, in accordance with an embodiment of the present disclosure.
  • FIG. 8D a perspective view of an alternative embodiment of the mount of a cranial guide system, in accordance with an embodiment of the present disclosure.
  • FIG. 8E depicts a phantom view of a guide portion affixed to a mount, in accordance with an embodiment of the present disclosure.
  • FIG. 8F depicts a perspective view of the cranial guide system secured to a subject’s skull with adjustable leveling pins, in accordance with an embodiment of the present disclosure.
  • FIG. 8G depicts another perspective view of the cranial guide system to secured to a subject’s skull, in accordance with an embodiment of the present disclosure.
  • FIG. 8H depicts an overhead view of the cranial guide system to secured to a subject’s skull, in accordance with an embodiment of the present disclosure.
  • FIG. 81 depicts another perspective view of the cranial guide system to secured to a subject’s skull, in accordance with an embodiment of the present disclosure.
  • FIG. 8J depicts various views of the cranial guide system with illustrative dimensions, in accordance with an embodiment of the present disclosure.
  • FIG. 8K depicts a perspective view of a screw leveling pin with illustrative dimensions, in accordance with an embodiment of the present disclosure.
  • FIG. 8L depicts another perspective view of the screw leveling pin depicted in FIG. 8K, in accordance with an embodiment of the present disclosure.
  • FIG. 8M depicts a phantom view of the threaded aperture in the cranial guide system mount configured to receive a screw leveling pin, in accordance with an embodiment of the present disclosure.
  • FIG. 80 depicts different embodiments of the guide portion configured for different surgical trajectories, in accordance with embodiments of the present disclosure.
  • FIG. 9A depicts a first view of a cranial guide system being used to drill the pilot hole, in accordance with an embodiment of the present disclosure.
  • FIG. 9B depicts a second view of a cranial guide system being used to drill the pilot hole, in accordance with an embodiment of the present disclosure.
  • FIG. 9C depicts a third view of a cranial guide system being used to drill the pilot hole, in accordance with an embodiment of the present disclosure.
  • FIG. 9D depicts the drill bit for drilling the pilot hole having a friction-reducing coating, in accordance with an embodiment of the present disclosure.
  • FIG. 9E depicts the drill stop for drilling the pilot hole having a friction-reducing coating, in accordance with an embodiment of the present disclosure.
  • FIG. 9F depicts a drill engaged with a drill stop set at a first depth, in accordance with an embodiment of the present disclosure.
  • FIG. 9G depicts the drill stop being moved from the first depth to a second depth, in accordance with an embodiment of the present disclosure.
  • FIG. 9H depicts a drill engaged with a drill stop set at a second depth, in accordance with an embodiment of the present disclosure.
  • FIG. 91 depicts an exploded view of the adjustable drill stop, in accordance with an embodiment of the present disclosure.
  • FIG. 9J depicts a phantom view of the portions of the drill stop engaged with each other to set a desired depth, in accordance with an embodiment of the present disclosure.
  • FIG. 10A depicts a first perspective view of a guide portion of a cranial guide system, in accordance with an embodiment of the present disclosure.
  • FIG. 10B depicts a second perspective view of a guide portion of a cranial guide system, in accordance with an embodiment of the present disclosure.
  • FIG. 10C depicts a third perspective view of a guide portion of a cranial guide system, in accordance with an embodiment of the present disclosure.
  • FIG. 10D depicts a fourth perspective view of a guide portion of a cranial guide system, in accordance with an embodiment of the present disclosure.
  • FIG. 10E depicts a sectional view of a guide portion having a double width saw slot, in accordance with an embodiment of the present disclosure.
  • FIG. 11 A depicts a first exploded view of a cranial guide system, in accordance with an embodiment of the present disclosure.
  • FIG. 1 IB depicts a second exploded view of a cranial guide system, in accordance with an embodiment of the present disclosure.
  • FIG. 11C depicts a perspective view of a cranial guide system in a partially assembled configuration, in accordance with an embodiment of the present disclosure.
  • FIG. 1 ID depicts a perspective view of a cranial guide system in a fully assembled configuration, in accordance with an embodiment of the present disclosure.
  • FIG. 12A depicts a first perspective view of a guide portion wherein the saw slot includes a coating, in accordance with an embodiment of the present disclosure.
  • FIG. 12B depicts a second perspective view of a guide portion wherein the saw slot includes a coating, in accordance with an embodiment of the present disclosure.
  • FIG. 13C depicts a perspective view of a saw blade fully inserted into the cranial guide system, in accordance with an embodiment of the present disclosure.
  • FIG. 14C depicts a second perspective view of the saw blade depicted in FIG. 14A, in accordance with an embodiment of the present disclosure.
  • FIG. 15A depicts a first perspective view of a saw blade secured to a saw handpiece, in accordance with an embodiment of the present disclosure.
  • FIG. 15B depicts a second perspective view of a saw blade secured to a saw handpiece, in accordance with an embodiment of the present disclosure.
  • FIG. 15C depicts a third perspective view of a saw blade secured to a saw handpiece, in accordance with an embodiment of the present disclosure.
  • FIG 151 depicts a first side view of the adjustable stop attachment, in accordance with an embodiment of the present disclosure.
  • FIG. 17B depicts a perspective view of the micro Kerrison rongeur of FIG. 17A in a closed configuration, in accordance with an embodiment of the present disclosure.
  • FIG. 2 IF depicts a pair of the tissue picks depicted in FIG. 2 IB, in accordance with an embodiment of the present disclosure.
  • FIG. 21G depicts a first view of the tissue pick depicted in FIGS. 21B-21F being used to lift dura tissue, in accordance with an embodiment of the present disclosure.
  • FIG. 22 depicts views of a pick knife, in accordance with an embodiment of the present disclosure.
  • FIG. 23A depicts a first perspective view of a hook knife, in accordance with an embodiment of the present disclosure.
  • FIG. 24A depicts a surgical setup for an endoscope and various surgical tools, in accordance with an embodiment of the present disclosure.
  • FIG. 24B depicts another surgical setup for an endoscope and various surgical tools, in accordance with an embodiment of the present disclosure.
  • FIG. 25A depicts anchors securing electrode array cables in place, in accordance with an embodiment of the present disclosure.
  • FIG. 25B depicts a first side of an electrode array anchor, in accordance with an embodiment of the present disclosure.
  • FIG. 25 C depicts a second side of an electrode array anchor, in accordance with an embodiment of the present disclosure.
  • the present disclosure is generally directed to surgical systems and methods for implanting neural devices, particularly neural devices having non-penetrating electrodes.
  • the present is disclosure to surgical techniques and tools for implanting neural devices in a minimally invasive manner.
  • Embodiments may include the surgical approach and mechanical system for implantation of biocompatible devices that can be implanted into the brain to form a brain-computer interface.
  • Embodiments of the present disclosure include the surgical technique for implantation of high-bandwidth neural interfaces.
  • a slit-like incision may be made in the skull tangentially to the cortical surface using an oscillating bone saw or other tool.
  • novel microsurgical instruments may be used to safely incise the dura mater through the osteotomy without damaging the brain surface.
  • Embodiments of the present disclosure include the surgical delivery system for implanting high-bandwidth neural interfaces.
  • the surgical delivery system can be used to make one or more slit-like incisions through the scalp, skull, and dura matter that are oriented tangentially to the surface of the brain.
  • the surgical delivery system may deploy the neural interface in the subdural space onto the surface of the cortex through the mechanical guidance of a semi-flexible stylet.
  • the deployment system may implement precision tooling and fixturing that is compatible with existing stereotactic neurosurgical systems, such as the stereotactic system from Leksell® or the head frame from Mayfield®, and/or existing neurosurgical navigation and robotic systems, such as the ROSA ONE® robot from Zimmer Biomet®, StealthStationTM from Medtronic®, or the neurosurgical system from Brainlab®.
  • existing stereotactic neurosurgical systems such as the stereotactic system from Leksell® or the head frame from Mayfield®
  • existing neurosurgical navigation and robotic systems such as the ROSA ONE® robot from Zimmer Biomet®, StealthStationTM from Medtronic®, or the neurosurgical system from Brainlab®.
  • Embodiments of the present disclosure may include methods of validation for the deployment and positional accuracy of the microelectrode array.
  • the delivery system may include the implementation of a small diameter endoscope coaxial to the slit incision for visual feedback and confirmation.
  • one or more components of the surgical system that are introduced into the subdural space can be individually trackable and/or uniquely identifiable through electromagnetic detection and/or radiopaque markers for fluoroscopy, computed tomography (CT), or other imaging modalities.
  • CT computed tomography
  • electrode array placement can be validated via endoscopy to directly visualize the placement of the electrode array(s) on the cortical surface.
  • fluoroscopy can be used to track radiopaque features on the electrode array to validate array placement.
  • the subject’s electrophysiologic response to evoked potentials can be used to validate array placement.
  • other forms of target location validation may be implemented through use of real time electrophysiology techniques.
  • Conventional neural devices typically include electrode arrays that penetrate a subject’s brain in order to sense and/or stimulate the brain.
  • the present disclosure is directed to the use of non-penetrating neural devices, i.e., neural devices having electrode arrays that do not penetrate the cortical surface.
  • Such non-penetrating neural devices are minimally invasive and minimize the amount of impact on the subject’s cortical tissue.
  • Neural devices can sense and record brain activity, receive instructions for stimulating the subject’s brain, and otherwise interact with a subject’s brain as generally described herein.
  • the external device 130 can include any device to which the neural device 110 can be communicatively coupled, such as a computer system or mobile device (e.g., a tablet, a smartphone, a laptop, a desktop, a secure server, a smartwatch, a head-mounted virtual reality device, a head-mounted augmented reality device, or a smart inductive charger device).
  • the external device 130 can include a processor 140 and a memory 142.
  • the computer system or mobile device can include a server or a cloud-based computing system.
  • the external device 130 can further include or be communicatively coupled to storage 140.
  • the storage 140 can include a database stored on the external device 130.
  • the storage 140 can include a cloud computing system (e.g., Amazon Web Services or Azure).
  • the external device 130 can include a processor 170 and a memory 172.
  • the external device 130 can include a server or a cloud-based computing system.
  • the external device 130 can further include or be communicatively coupled to storage 140.
  • the storage 140 can include a database stored on the external device 130.
  • the storage 140 can include a cloud computing system (e.g., Amazon Web Services or Azure).
  • the electrode array 180 of the neural device 110 can have electrodes that are sufficiently small and spaced at sufficiently small distances in order to define a high-density electrode array 180 that can, accordingly, capture high resolution electrocortical data. Such high-resolution data can be used to resolve electrographic features that can otherwise not be identified using lower resolution electrode arrays.
  • the electrodes of the electrode array 180 can be from about 10 pm to about 500 pm in width. In one illustrative embodiment, the electrodes of the electrode array 180 can be about 50 pm in width. In some embodiments, the electrodes of the electrode array 180 can be spaced by about 200 pm (i.e., 0.2 mm) to about 3,000 pm (i.e., 3 mm). In illustrative one embodiment, adjacent electrodes of the electrode array 180 can be spaced by about 400 pm.
  • the neural device 110 can further include a flexible substrate 212 supporting the electrode array 180 and/or other components of the neural device 110.
  • the flexible substrate 212 can be flexible enough to permit the electrode array 180 to be inserted through an osteotomy into the subdural space 204, then along the cortical surface.
  • the neural device 110 can include a range of electrical or electronic components.
  • the neural device 110 includes an electrode-amplifier stage 112, an analog front-end stage 114, an analog-to-digital converter (ADC) stage 116, a digital signal processing (DSP) stage 118, and a transceiver stage 120 that are communicatively coupled together.
  • the electrodeamplifier stage 112 can include an electrode array, such as is described below, that is able to physically interface with the brain 102 of the subject in order to sense brain signals and/or apply electrical signals thereto.
  • the analog front-end stage 114 can be configured, amplify signals that are sensed from or applied to the brain 102, perform conditioning of the sensed or applied analog signals, perform analog filtering, and so on.
  • the front-end stage 114 can include, for example, one or more application-specific integrated circuits (ASICs) or other electronics.
  • ASICs application-specific integrated circuits
  • the ADC stage 116 can be configured to convert received analog signals to digital signals.
  • the DSP stage 118 can be configured to perform various DSP techniques, including multiplexing of digital signals received via the electrode-amplifier stage 112 and/or from the external device 130.
  • the DSP stage 118 can be configured to convert instructions from the external device 130 to a corresponding digital signal.
  • the transceiver stage 120 can be configured to transfer data from the neural device 110 to the external device 130 located outside of the body of the subject 102.
  • the neural device 110 can further include a controller 119 that is configured to perform various functions, including compressing electrophysiologic data generated by the electrode array 180.
  • the controller 119 can include hardware, software, firmware, or various combinations thereof that are operable to execute the functions described below.
  • the controller 119 can include a processor (e.g., a microprocessor) executing instructions stored in a memory.
  • the controller 119 can include a field- programmable gate array (FPGA) or application-specific integrated circuit (ASIC).
  • FPGA field- programmable gate array
  • ASIC application-specific integrated circuit
  • the neural device 110 described above can include a brain implant, such as is shown in FIG. 2.
  • the neural device 110 may be a biomedical device configured to study, investigate, diagnose, treat, and/or augment brain activity.
  • the neural device 110 may be positioned between the brain 200 and the scalp 202.
  • the neural device 110 can include an electrode array 180 (which may be a component of or coupled to the electrode-amplifier stage 112 described above) that is configured to record and/or stimulate an area of the brain 200.
  • the electrode array 180 can be connected to an electronics hub 182 (which can include one or more of the electrode-amplifier stage 112, analog front-end stage 114, ADC stage 116, and DSP stage 118) that is configured to transmit via wireless or wired transceiver 120 to the external device 130 (in some cases, referred to as a “receiver”).
  • an electronics hub 182 which can include one or more of the electrode-amplifier stage 112, analog front-end stage 114, ADC stage 116, and DSP stage 118) that is configured to transmit via wireless or wired transceiver 120 to the external device 130 (in some cases, referred to as a “receiver”).
  • the electrode array 180 can include non-penetrating cortical surface microelectrodes (i.e., the electrode array 180 does not penetrate the brain 200). Accordingly, the neural device 110 can provide a high spatialresolution, with minimal invasiveness and improved signal quality. The minimal invasiveness of the electrode array 180 is beneficial because it allows the neural device 110 to be used with larger population of patients than conventional brain implants, thereby expanding the application of the neural device 110 and allowing more individuals to benefit from brain-computer interface technologies. Furthermore, the surgical procedures for implanting the neural devices 110 are minimally invasive, reversible, and avoid damaging neural tissue. In some embodiments, the electrode array 180 can be a high-density microelectrode array that provides smaller features and improved spatial resolution relative to conventional neural implants.
  • the neural device 110 includes an electrode array configured to stimulate or record from neural tissue adjacent to the electrode array, and an integrated circuit in electrical communication with the electrode array, the integrated circuit having an analog-to-digital converter (ADC) producing digitized electrical signal output.
  • ADC analog-to-digital converter
  • the ADC or other electronic components of the neural device 110 can include an encryption module, such as is described below.
  • the neural device 110 can also include a wireless transmitter (e.g., the transceiver 120) communicatively coupled to the integrated circuit or the encryption module and an external device 130.
  • the neural device 1 10 can also include, for example, control logic for operating the integrated circuit or electrode array 180, memory for storing recordings from the electrode array, and a power management unit for providing power to the integrated circuit or electrode array 180.
  • the neural device 110 comprises an electrode array 180 comprising nonpenetrating microelectrodes.
  • the neural device 110 is configured for minimally invasive subdural implantation using a cranial micro-slit technique, i.e., is inserted into the subdural space 204 between the dura and the surface of the subject’s brain 200.
  • the neural device 110 is inserted into the subdural space 204 between the dura and the surface of the brain 200.
  • the microelectrodes of the electrode array 180 can be arranged in a variety of different configurations and can vary in size.
  • the electrode array 180 includes a first group 190 of electrodes (e.g., 200 pm microelectrodes) and a second group 192 of electrodes (e.g., 20 pm microelectrodes). Further, example stimulation waveforms in connection with the first group 190 of electrodes and the resulting post-stimulus activity recorded over the entire array is depicted for illustrative purposes. Still further, example traces from recorded neural activity recorded by the second group 192 of electrodes are likewise illustrated.
  • the electrode array 180 provides multichannel data that can be used in a variety of electrophysiologic paradigms to perform neural recording of both spontaneous and stimulus-evoked neural activity as well as decoding and focal stimulation of neural activity across a variety of functional brain regions.
  • the surgical team can place 402 an incision template against the patient’s scalp.
  • the incision template can be configured to guide the entry point and trajectory for the insertion of the neural device 110.
  • One embodiment of an incision template 600 is shown in FIG. 7 and described in greater detail below.
  • the surgical team can make 404 an incision in the scalp.
  • the incision can be made 404 via, for example, a freehand scalpel with suture retraction.
  • the incision template can be configured to mark the placement of the skin incision and cranial guide for the planned trajectory between the target location for the neural device 110 against the cortical surface and the entry point of the patient’s skull, as shown in FIG. 6A.
  • the angular slit 500 can be made via, for example, a sagittal saw. As illustrated in FIG. 6A, the length and angle of the angular slit 500 can be preplanned based on the location of the region of interest on the cortical surface and the desired angle of insertion for the neural device 110. In various embodiments, the length of the angular slit 500 can be from about 500 pm to about 900 pm. In various embodiments, the angle of the angular slit 500 can be from about 45° to about 65°.
  • trajectory planning and insertion can be performed using fluoroscopy or computed tomographic image guidance. Further, in some embodiments, electrode insertion can be monitored using neuroendoscopy.
  • the cranial guide can be about 52 mm in length, about 22 mm in width, and about 9.6 mm in height when the guide portion 720 is assembled to the mount 702.
  • the mount 702 can be about 5 mm in height without the guide portion affixed thereto.
  • the cranial guide can further include adjustable leveling pins 710 for controlling the position and/or orientation of the cranial guide with respect to the subject.
  • the leveling pins 710 can be adjustable from an undeployed position whereby the leveling pin 710 is flush with the bottom surface of the mount 702 (as shown by the left leveling pin 710 in the bottom right view in FIG. 8 J) to a deployed position, or any position therebetween.
  • the length of a leveling pin 710 can be about 3.85 mm in the deployed position.
  • the mount 702 can include frame 701 that is configured to receive the guide portion 720 (described below) and feet 704 that are configured to receive fasteners (e.g., screws) therethrough for securing the mount 702 to the patient’s skull.
  • the guide portion 720 can in turn be secured to the mount 702 via fasteners (e.g., screws).
  • the mount 702 can include a variety of different numbers of feet 704 for securing the mount 702 to the subject’s skull, such as is shown in FIGS. 8G and 8H.
  • the mount 702 can include two feet 704.
  • the mount 702 can include four feet 704.
  • the leveling pins 710 can be extended or otherwise adjusted to bear against the subject’s anatomy, thereby stabilizing the cranial guide in place and preventing the cranial guide from tilting or rotating during the surgical procedure.
  • the threaded portion 711 can be about 1 mm in length
  • the body portion 712 can be about 4.35 mm in length
  • the body portion 712 can be about 1 mm in width.
  • the leveling pins 710 can be adjustably extended and/or retracted using a variety of other mechanisms.
  • the guide portion 720 can include a drill aperture 722 configured to receive a drill therethrough for forming the pilot hole 502.
  • the guide portion 720 can include both the drill aperture 722 and the saw slot 724 for guiding the cutting of the angled slit in the patient’s skull.
  • the angle of the drill aperture 722 can correspond to the desired approach angle for the delivering of the neural device.
  • the angle of the saw slot 724 can correspond to the desired approach angle for the delivering of the neural device.
  • the angle of the drill aperture 722 and/or saw slot 724 can be from about 45° to about 65°; accordingly, the guide portion 720 can be configured to accommodate surgical approach angles ranging from about 45° to about 65°.
  • FIG. 80 depicts various illustrative embodiments of the guide portion 710 wherein the drill aperture 722 and the saw slot 724 are oriented at 45°, 50°, 55°, and 65°.
  • the drill aperture 722 and the saw slot 724 can be coextensive such that the pilot hole 502 is correspondingly formed so that it is coextensive with the angular slit 500.
  • the cranial guide system 700 can be manufactured having a variety of different approach angles.
  • the cranial guide system 700 can be configured such that it can be adjustable between a variety of different approach angles.
  • the cranial guide system 700 can further include or be used with a drill stop 730 that is configured to stop the drill bit at a predetermined depth, thereby ensuring that the drill bit goes through the skull but does not contact the cortical surface.
  • the drill stop 730 can include a collar that is fitted to, or otherwise associated with, the drill aperture 722. The drill stop collar can have a predetermined length that physically stops the drill, thereby preventing the drill bit from being advanced further through the drill guide 700. Referring now to FIGS.
  • FIG. 9A-9C there are shown views of the cranial guide system 700 being used to drill the pilot hole 502, in association with the techniques as described above.
  • FIG. 9A illustrates a drill 750 having an unloaded drill bit 752 with drill stop 730 and the cranial guide system 700.
  • FIG. 9B the drill bit 752 has been loaded into cranial guide system 700 to begin drilling the pilot hole 502.
  • FIG. 9C the drill 750 has contacted the stop 730. Accordingly, the drill bit 752 is at its final position as the drill 750 makes contact with the drill stop 730 and prevents further drilling.
  • the drill stop 730 can be set to different positions (as shown in FIGS. 9F and 9G).
  • the second portion 732 can serve as a physical stop that contacts the collar 754 of the drill 750, thereby preventing the drill 750 from being inserted further into the cranial guide system 700. Accordingly, by setting the drill stop 730 to different positions, one set different depth stops for the drill 750.
  • the thickness of the coating can be from about 2 pm to about 80 pm.
  • the drill bit 752 can include one or more coatings.
  • the interior surface of the drill stop 730 can include one or more coatings.
  • a variety of different drills 750 and/or drill bit 752 can be used with the cranial guide system 700 described herein.
  • the drill 750 can include Midas Rex Jacobs Chuck handpiece from Medtronic®.
  • the drill bit 752 can include a 1/16 th inch, extended length, drill bit.
  • FIG. 10E illustrates an embodiment of the guide portion 720 wherein the saw slot 724 has a thickness that is sufficient to receive two saw blades. Accordingly, this embodiment allows two stacked saw blades to be inserted through the saw slot 724 for cutting a double width osteotomy.
  • FIG. 10F illustrates an embodiment of the guide portion 720 wherein the saw slot 724 has a width that is sufficient to receive a single saw blade. Accordingly, this embodiment allows a single saw blade to be inserted through the saw slot 724 for cutting a smaller osteotomy.
  • the thickness of the saw slot 724 can be from about 0.4 mm to about 0.8 mm. In another embodiment, the thickness of the saw slot 724 can be from about 0.8 mm to about 1 mm.
  • the hook knife 880 can be inserted through the angular slit 500 and used intraoperatively to lift and/or incise the dura or other tissue, which conventionally sized hook knives would be unable to do because of their size.
  • the hook knife 880 can be substantially linear as shown in FIGS. 23A and 23B.
  • the hook knife 880 can further include a bend 884 that causes the cutting edge 882 and tip 881 to be positioned off-center with respect to the longitudinal axis of the body of the hook knife 880. This alternative embodiment of the hook knife 880 can be beneficial in order to allow for improved endoscopic visualization of the tip 881 while in use, for example.

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  • Biomedical Technology (AREA)
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  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
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Abstract

Système chirurgical et méthode destinés à être utilisés dans l'implantation d'un dispositif neural d'une manière minimalement invasive. Le système chirurgical peut comprendre un guide crânien réglable et divers outils chirurgicaux qui sont dimensionnés pour créer une ostéotomie minimalement invasive et travailler à l'intérieur de l'espace sous-dural.
PCT/US2025/011619 2024-01-16 2025-01-15 Système d'insertion minimalement invasif pour interfaces neurales Pending WO2025155575A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US202463621353P 2024-01-16 2024-01-16
US63/621,353 2024-01-16
US18/434,008 US20250228534A1 (en) 2024-01-16 2024-02-06 Minimally invasive insertion system for neural interfaces
US18/434,008 2024-02-06
US18/738,231 2024-06-10
US18/738,231 US20250228535A1 (en) 2024-01-16 2024-06-10 Minimally invasive insertion system for neural interfaces

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110876652A (zh) * 2018-09-04 2020-03-13 卡尔莱宾格医疗技术有限责任两合公司 一种用于附接到骨骼的表面上的骨植入物

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110876652A (zh) * 2018-09-04 2020-03-13 卡尔莱宾格医疗技术有限责任两合公司 一种用于附接到骨骼的表面上的骨植入物

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
HO ET AL.: "The Layer 7 Cortical Interface: A Scalable and Minimally Invasive Brain-Computer Interface Platform", BIORXIV 2022.01.02.474656

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