WO2025235943A1

WO2025235943A1 - Systems, devices, and methods for accessing an extravascular space and delivery of devices into the extravascular space

Info

Publication number: WO2025235943A1
Application number: PCT/US2025/028731
Authority: WO
Inventors: Dustin G. ANDRIST
Original assignee: Endovascular Horizons Inc
Current assignee: Endovascular Horizons Inc
Priority date: 2024-05-09
Filing date: 2025-05-09
Publication date: 2025-11-13
Anticipated expiration: 2026-11-09

Abstract

Systems, devices, and methods for intracranial access through vasculature (e.g., the superior sagittal sinus and/or the middle meningeal artery) to deliver devices on or near a brain of a patient. The system includes a catheter and a perforating element for puncturing the dura such that the distal portion of the catheter can be positioned in or near the subdural space. Devices that can be delivered include, for example, brain-computer interfaces (BCI) devices, intracranial pressure monitoring (ICP) devices, biopsy devices, or devices for injection or aspiration of fluid materials.

Description

SYSTEMS, DEVICES, AND METHODS FOR ACCESSING AN EXTRAVASCULAR

SPACE AND DELIVERY OF DEVICES INTO THE EXTRAVASCULAR SPACE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 63/645,045, filed May 9, 2024, entitled “SYSTEMS, DEVICES, AND METHODS FOR ACCESSING AN EXTRAVASCULAR SPACE AND DELIVERY OF DEVICES INTO THE EXTRAVASCULAR SPACE,” and U.S. Provisional Application No. 63/645,061, filed May 9, 2024, entitled “SYSTEMS, DEVICES, AND METHODS FOR ACCESSING AN EXTRAVASCULAR SPACE AND DELIVERY OF DEVICES INTO THE EXTRAVASCULAR SPACE,” the disclosure of each of which is incorporated by reference herein.

[0002] This application is also a continuation-in-part of U.S. Provisional Application No 63/645,053, filed May 9, 2024, entitled, “SYSTEMS, DEVICES, AND METHODS FOR ACCESSING AN EXTRAVASCULAR SPACE AND REMOVAL OF FLUIDS THEREFROM,” the disclosure of which is incorporated by reference herein.

TECHNICAL FIELD

[0003] Devices, systems, and methods herein relate to minimally invasive procedures for access of an intracranial extravascular space in a subject, including, for example, access of an intracranial space for delivery of devices into the intracranial space.

BACKGROUND

[0004] Current methods for delivering brain implants include performing a craniotomy and inserting the brain implant through the opening in the skull. These procedures are invasive, can lead to complications after implantation, and present challenges for retrieval and/or removal of an implant after delivery.

SUMMARY

[0005] Described here are systems, devices, and methods useful for minimally invasive surgical procedures. These systems, devices, and methods may, for example, access an extravascular space (e.g., subdural space, intradural cavity). [0006] In some embodiments, a method of accessing an intracranial extravascular space of a patient comprises advancing a catheter within a vasculature of a patient until a distal end of the catheter is disposed within an intracranial vessel of the patient, the catheter defining a lumen; advancing a perforating element through at least a portion of the lumen of the catheter such that a distal end of the perforating element is disposed in the intracranial vessel; directing, using the catheter, the distal end of the perforating element toward the wall of the intracranial vessel to form an opening in the wall of the intracranial vessel; advancing the distal end of the perforating element through the opening and into the intracranial extravascular space; advancing the catheter over the perforating element until a distal portion of the catheter is disposed in the intracranial extravascular space; administering therapy or delivering an implant via the catheter after the distal end of the catheter is disposed in the intracranial extravascular space; and closing, after administering the therapy or delivering the implant, the opening using an occlusion device.

[0007] In some embodiments, a method of accessing an intracranial extravascular space of a patient comprises advancing a catheter within a vasculature of a patient until a distal end of the catheter is disposed within the superior sagittal sinus of the patient, the catheter defining a lumen and an opening coupled thereto; supporting a first portion of the catheter against a first portion of a wall of the superior sagittal sinus while directing a second portion of the catheter including the opening toward a second portion of the wall of the superior sagittal sinus; advancing a perforating element through the lumen of the catheter and out through the opening such that a distal end of the perforating element perforates the second portion of the wall of the superior sagittal sinus and forms an opening therethrough; advancing the distal end of the perforating element through the opening in the wall of the superior sagittal sinus and into the intracranial extravascular space; and advancing the catheter over the perforating element until a distal portion of the catheter is disposed in the intracranial extravascular space.

[0008] In some embodiments, a method of forming a passageway through a wall of an intracranial vessel and dura comprises advancing a catheter within a vasculature of a patient until a distal end of the catheter is disposed within the intracranial vessel, the catheter defining a lumen and a opening coupled thereto; positioning the opening of the catheter adjacent to a wall of the intracranial vessel; advancing a perforating element through the lumen of the catheter and out through the opening such that a distal end of the perforating element perforates the wall of the intracranial vessel and dura adjacent thereto to form a passageway through the wall of the intracranial vessel and the dura into a subdural space; advancing the catheter over the perforating element until a distal portion of the catheter is disposed in the subdural space; and administering therapy or delivering an implant via the catheter after the distal end of the catheter is disposed in the subdural space.

[0009] In some embodiments, a method of accessing a lower brain of a patient comprises or shaft within a vasculature of a patient until a distal end of the guidewire or shaft is disposed within an intracranial vessel in the lower brain of the patient; advancing a catheter over the guidewire or shaft until a distal end of the catheter is disposed within the intracranial vessel in the lower brain, the catheter defining a lumen; and delivering, via the lumen of the catheter, one or more devices to at least one of: an intravascular space, an extravascular space, or an epidural space, the one of more devices configured to measure neural activity of a brain of the patient.

[0010] A method for removing internal structures within the superior sagittal sinus of a patient comprises advancing a catheter within a vasculature of a patient until a distal end of the catheter is disposed within the superior sagittal sinus, the catheter defining a lumen; advancing a cutting device through at least a portion of the lumen of the catheter until a distal end of the cutting device is disposed adjacent to an internal structure within the superior sagittal sinus, the cutting device having one or more atraumatic distal features; and severing the internal structure by using a cutting edge of the internal structure or using energy applied by a conductive portion of the cutting device.

[0011] In some embodiments, an apparatus comprises an elongate body defining a lumen, the elongate body including a distal end configured to be disposed in an intracranial vessel; and an opening disposed on the distal end of the elongate body, the opening being in communication with the lumen, the elongate body configured to transition into a curved configuration to position the opening adjacent to a wall of the intracranial vessel such that a perforating device received through the lumen of the catheter can be advanced through the lumen and the opening and into the wall of the intracranial vessel to form a passageway into an intracranial extravascular space, the elongate body in the curved configuration having a portion configured to be in contact with a portion of the wall of the intracranial vessel to provide support for advancing the perforating device. [0012] In some embodiments, an apparatus comprises an elongate body defining at least one lumen, the elongate body including a distal end configured to be disposed in an intracranial vessel or an intracranial extravascular space of a patient; and a delivery element disposable within the elongate body, the delivery element configured to support an electrode device including one or more electrodes configured to measure neural activity of the patient, the delivery element configured to be manipulated to position the electrode device in the intracranial vessel or the intracranial extravascular space.

[0013] In some embodiments, an apparatus comprises a sheath configured to be navigated through vasculature to a lower brain of a patient; a catheter configured to be advanced through the sheath and into an intracranial vessel, the catheter including a lumen and an opening coupled thereto, the catheter configured to be positioned to align the opening of the catheter with a perforation location; and a perforating device configured to be advanced through the lumen of the catheter and out through the opening to perforate a wall of the intracranial vessel at the perforation location to form a passageway into an intracranial extravascular space, the catheter further configured to be advanced through the passageway and into the intracranial extravascular space and to be distally advanced to a target location.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] FIG. 1 A is a three-dimensional image of a set of veins and dural sinuses in a head of a subject. FIG. IB is a schematic top view of a head of a subject.

[0015] FIG. 2A is a coronal cross-sectional view of a head of a subject. FIG. 2B is a schematic coronal cross-sectional view of a head of a subject.

[0016] FIG. 3 is a schematic block diagram of a system including a catheter for transvenous delivery of devices, according to embodiments.

[0017] FIG. 4A is a cross-section view of a side wall of a catheter taken along the axis A-A showing layers of the side wall of the catheter, according to embodiments.

[0018] FIG. 4B is an illustration of a proximal end of a delivery catheter, according to embodiments. [0019] FIG. 4C illustrates a proximal control mechanism for steering a delivery catheter, according to embodiments.

[0020] FIGS. 5A-5F show a catheter assembly perforating a wall of the Superior Sagittal Sinus, according to embodiments.

[0021] FIG. 6A is a top view of the Super Sagittal Sinus with a catheter disposed therein, according to embodiments.

[0022] FIG. 6B is a coronal cross-sectional view of the catheter disposed in the Superior Sagittal Sinus and positioned relative to a cortex of a patient, according to embodiments.

[0023] FIG. 7 illustrates a proximal control mechanism for steering a catheter assembly, according to embodiments.

[0024] FIGS. 8A-8B illustrates a catheter including a plurality of sections having different flexibility to shape the catheter, according to embodiments.

[0025] FIG. 9 is a schematic of four different catheters including sections with varying flexibility, according to embodiments.

[0026] FIGS. 10A-10B is a schematic of a steerability of a catheter, according to embodiments.

[0027] FIGS. 11A-11B illustrate a catheter including a distal end with an opening in a sidewall thereof for advancing a perforating member, according to embodiments.

[0028] FIGS. 12A-12B illustrate a catheter configured to curve along a geometry of a vein and including a plurality of openings in a sidewall thereof for advancing a perforating member, according to embodiments.

[0029] FIGS. 13A-13D is a schematic of a mechanism for guiding a perforating member out of an opening of the delivery catheter, according to embodiments.

[0030] FIGS. 14A-14D illustrate biasing mechanisms for stabilizing a delivery catheter inside a vein, according to embodiments. [0031] FIG. 15 is a diagram of a port of the delivery catheter configured to be coupled to a fluid source and/or a vacuum source, according to embodiments.

[0032] FIGS. 16A-16B illustrate biasing mechanisms for stabilizing a delivery catheter inside a vein, according to embodiments.

[0033] FIG. 17 is a schematic of a distal end of a delivery catheter including a vacuum channel, according to embodiments.

[0034] FIGS. 18A-18C illustrate a catheter including a plurality of lumens configured to expand away from one another to stabilize the catheter in a vein, according to embodiments.

[0035] FIG. 19 is a diagram of different configurations of a distal end of a catheter, according to embodiments.

[0036] FIG. 20 is a diagram of different perforating elements at a distal end of a delivery catheter for perforating a dura of a patient, according to embodiments.

[0037] FIG. 21 is a diagram of different configurations of perforating member, according to embodiments.

[0038] FIG. 22 is a diagram of different perforating elements of a perforating member of a delivery catheter, according to embodiments.

[0039] FIG. 23 is a diagram of a distal end of a perforating member including an electrode and insulation around the electrode, according to embodiments.

[0040] FIG. 24 is a diagram of different needles of a delivery system for perforating a dura of a subject, according to embodiments.

[0041] FIG. 25 is a side cross-sectional view of a catheter accessing a subdural space of a patient to deliver electrodes to a brain of the patient, according to embodiments.

[0042] FIG. 26A-26H are side cross-sectional views of transvenous delivery of different types of electrodes to a brain of a patient, according to embodiments.

[0043] FIG. 27 is a schematic of a brain implant including leads (left) and a wireless brain implant (right) delivered using a delivery catheter, according to embodiments. [0044] FIG. 28 is a close-up view of self-expanding electrode arrays for implantation in a brain of a patient, according to embodiments.

[0045] FIG. 29 shows examples of self-expanding electrode arrays for implantation in a brain of a patient, according to embodiments.

[0046] FIG. 30 illustrates a brain implant transitioning from a delivery configuration to a deployed configuration, according to embodiments.

[0047] FIG. 31 shows a delivery configuration and a deployed configuration for two types of brain implants, according to embodiments.

[0048] FIG. 32 shows a delivery configuration of a brain implant, according to embodiments.

[0049] FIGS. 33 A-33B show a delivery catheter with a plurality of inner channels along the length of the delivery catheter, according to embodiment.

[0050] FIG. 34 shows a delivery configuration and a deployed configuration for different types of microelectrode arrays according to embodiments.

[0051] FIGS. 35A-35C shows a deployment mechanism of a delivery catheter for supporting a brain implant in a delivery configuration and transitioning the brain implant to a delivery configuration, according to embodiments.

[0052] FIG. 36 shows a deployment mechanism for a wireless brain implant, according to embodiments.

[0053] FIGS. 37A-37C illustrate sealing of a puncture site of a vein after delivery of electrodes, according to embodiments.

[0054] FIG. 38 is a flow chart of an example method for transvenous delivery of brain implants into a subdural space of a patient, according to an embodiment.

[0055] FIG. 39 is a diagram of an underside of a brain showing a Middle Meningeal Artery.

[0056] FIGS. 40A-40D are cross-sectional side views of a method of accessing an extravascular space, according to embodiments. [0057] FIGS. 41A-41G show examples of brain implants implanted in a brain of a patient via a vessel, according to embodiments.

[0058] FIG. 42 is a schematic of a brain implant including leads (left) and a wireless brain implant (right) delivered using a delivery catheter, according to embodiments.

[0059] FIGS. 43A and 43B show catheters for accessing an extravascular space, according to embodiments. FIGS. 43 C and 43D show the catheters navigating intracranially, according to embodiments.

[0060] FIG. 44A shows a delivery catheter for accessing an extravascular space, according to embodiments. FIGS. 44B-44C show the delivery catheter navigating intracranially, according to embodiments.

[0061] FIGS. 45A-45C show cutting devices for cutting a vessel septum, according to embodiments.

[0062] FIGS. 46A-46B show hooked devices for cutting a vessel septum, according to embodiments.

[0063] FIGS. 47A-47B show a hooked device for cutting a vessel septum including three tines, according to embodiments.

[0064] FIGS. 48A-48D show devices for removing granulations on an inner wall of a vessel, according to embodiments.

[0065] FIGS. 49A-49B show a lasso device including three loops for removing granulations on an inner wall of a vessel, according to embodiments.

[0066] FIGS. 50A-50B are coronal cross-sectional views of a head of a subject, according to embodiments.

[0067] FIG. 51 A is a schematic cross-sectional axial view of a head of a subject, according to embodiments. FIG. 5 IB is a schematic cross-sectional coronal view of a head of a subject, according to embodiments. FIG. 51C is a schematic cross-sectional sagittal view of a head of a subject, according to embodiments. FIG. 5 ID is a diagram of a coordinate system, according to embodiments. FIG. 5 IE is a schematic side view of imaging of a head of a subject, according to embodiments.

[0068] FIG. 52 is a flow diagram of a method of accessing an extravascular space, according to embodiments.

[0069] FIGS. 53 A-53D are schematic cross-sectional views of a catheter assembly in a head of a subject, according to embodiments.

[0070] FIG. 54A is a schematic cross-sectional view of a catheter assembly, according to embodiments. FIG. 54B is a schematic perspective view of a catheter assembly, according to embodiments. FIG. 54C is a schematic cross-sectional axial view of a catheter assembly in a head of a subject, according to embodiments. FIG. 54D is a schematic cross-sectional coronal view of a catheter assembly in a head of a subject, according to embodiments. FIG. 54E is a schematic cross-sectional sagittal view of a catheter assembly in a head of a subject, according to embodiments.

[0071] FIG. 55A is a schematic side view of a catheter assembly in a head of a subject, according to embodiments. FIG. 55B is a schematic side view of a catheter assembly in a first configuration, according to embodiments.

[0072] FIGS. 56A-56C are schematic diagrams of a catheter assembly, according to embodiments.

[0073] FIG. 57A-57E are schematic cross-sectional views of a shaft of a catheter assembly, according to embodiments.

[0074] FIGS. 58A-58C are schematic diagrams of catheter assemblies in head of a subject, according to embodiments.

[0075] FIGS. 59A-59E are schematic cross-sectional views of a catheter assembly in a head of a subject, according to embodiments.

DETAILED DESCRIPTION

[0076] Current methods for delivering therapeutic or implantable devices to the intracranial space include performing a craniotomy and inserting the brain implant through the opening in the skull. These procedures are invasive, can lead to complications after implantation, and present challenges to retrieval and/or removal of an implant after delivery. The embodiments described herein address these drawbacks by providing a system for delivering therapeutics or implantable devices through the vasculature of the patient.

[0077] Described here are systems, devices, and methods for use in minimally invasive surgical procedures enabling transvascular neurosurgery without opening the skull. For example, the systems, devices, and methods described herein may improve access to an extravascular space (e.g., subdural space, epidural space, subarachnoid space, extravascular spinal cord space) and extravascular organ (e.g., brain, spinal cord) of a subject. The systems, devices, and methods may be performed under minimal sedation; may reduce one or more of procedural complexity, may improve sterile field management, and time; may enable continual use of anticoagulation and antiplatelet medications; may provide quicker post-surgical recovery and shortening hospitalization time; and may reduce complications when compared to conventional open surgical procedures. For example, access to an extravascular space may include navigation within a body compartment without causing blood extravasation while the blood vessel is patent or causing tissue damage (e.g., due to perforation).

[0078] General endovascular procedures are conducted by inserting a guide wire using percutaneous access techniques such as the Seidinger technique and an introducer sheath in the vessel in one of the access targets. The access guide wire is removed, and a specialty neurovascular guide wire is inserted then traversed under fluoroscopy into the left or right jugular vein to the Sigmoid Sinus to the Transverse Sinus into the Superior Sagittal Sinus. The disclosed devices, systems, and methods described herein can traverse the vasculature under fluoroscopy over the prepositioned guide wire into the target location or locations within the Superior Sagittal Sinus.

[0079] The disclosure herein describes further methods of delivery catheter shapes, stiffnesses and articulating mechanisms as well as bleed prevention mechanisms. Also described herein this disclosure and perforating devices and mechanisms to achieve a hole in the vessel wall/dura.

[0080] Systems, devices, and methods described herein can be used to access an extravascular space of a subject, including, for example, intradural extravascular spaces along a spinal cord of a subject or in a brain of a subject. [0081] In addition to examples and embodiments described herein, other suitable examples of systems, devices, and methods are described in International Application No. PCT/US2021/029276, filed on April 27, 2021, and International Application No. PCT/US2023/078841, filed on November 6, 2023, the disclosure of each of which is hereby incorporated by reference in their entirety.

[0082] The endovascular approach for the disclosed devices, systems, and methods. There could be multiple venous access sites such as femoral, brachial, radial, subclavian/axillary, or jugular. The devices or systems will transverse the respective vasculature to the internal jugular vein to the Sigmoid Sinus to the Transverse Sinus to the Superior Sagittal Sinus. The target vessel for the devices, systems and methods described herein is the Superior Sagittal Sinus for intracranial access. However, the devices, systems, and methods described herein are not limited to use in the Superior Sagittal Sinus.

[0083] FIG. 1 A is a three-dimensional image 10 of a set of veins and dural sinuses in a head of a subject including the Superior Sagittal Sinus (SSS) 105 and cortical veins 103 branching therefrom. FIG. IB is a corresponding schematic diagram 30 of a top view of cranial anatomy including a brain 101, SSS 105, and cortical veins 103. The SSS 105 runs along a midline of the brain 101, and the cortical veins 103 drain into the SSS 105. FIG. 2A is a coronal cross- sectional view 20 of a head of a subject. FIG. 2B is a corresponding schematic diagram 40 of a coronal cross-sectional view of cranial anatomy including the brain 201, SSS 205, bone 204, subdural space 206 (e.g., between brain 201 and SSS 205), and falx cerebri 208.

[0084] The Superior Sagittal Sinus 105, 205 sits between the left and right hemisphere of the brain and extends from the base of the skull in the rear of the head to the front of the head. The SSS 105, 205 is formed through the dura mater, the most superficial layer of the meninges, and has a triangular cross-sectional shape. The systems, devices, and methods described herein account for the geometric structure of the SSS 105, 205 to gain access to intracranial spaces for applications such as brain computer interfaces (BCI) delivery, for example.

I. SYSTEMS AND DEVICES

[0085] FIG. 3 is a schematic block diagram of a delivery system 300 including a catheter assembly 302, a vacuum source 350, a signal generator 360, and a visualization device 370, and a proximal control mechanism 380. The catheter assembly 302 may be configured to form an opening in a blood vessel to access an extravascular space of a subject. In some embodiments, the catheter assembly 302 may include a catheter 310, a shaft 320, a hemostatic device 330, and optionally one or more optional sensors 340, and an optional sheath (e.g., delivery catheter, guide catheter) (not depicted).

[0086] In some embodiments, one or more components of the catheter assembly 302 may include one or more of a hypotube, single solid rod, multiple roads, bundle, tubing (with one or more lumens), shaft strands, cable (two or more wires running side by side, bonded, twisted or braided), coil, braid, combinations thereof, and the like. In some embodiments, one or more components of the catheter assembly 302 may include one or more of stainless steel, nitinol, silver, titanium, copper, cobalt chromium, nickel chromium, platinum iridium, polymer, nylon, polyamides, fluoropolymers, polyolefins, polytetrafluoroethylene, high density polyethylene, polyurethanes and polyimides, ceramic, bio-absorbable or dissolvable material, combinations thereof, and the like.

[0087] In some embodiments, one or more components of the catheter assembly 302 may have a tip bending stiffness between about 0.0002 lb/in2 to about 0.15 lb/in2, including all ranges and sub-values in-between. The components of the catheter assembly 302 (e.g., the catheter 310 and/or shaft 320) may have a variable tip bending stiffness along a respective length of each component.

[0088] In some embodiments, one or more components of the catheter assembly 302 may include scoring (e.g., openings, slits, slots in the sidewall) configured to increase flexibility (e.g., to traverse the curves of foramen spinosum). The scoring may include, but is not limited to, a spiral scoring pattern (e.g., continuous, interrupted), a radial scoring pattern, a bespoke scoring pattern, a radial ring pattern, a longitudinal scoring, an oblique scoring, a window, a tab, a hole, combinations thereof, and the like.

[0089] In some embodiments, one or more components of the catheter assembly 302 may have a cross-sectional shape including, but not limited to, a circle, an oval, a square, a star, a diamond, a rectangle, a triangle, a flat shape, combinations thereof, and the like.

Catheter: [0090] The catheter 310 can be configured to deliver therapeutics or devices (e.g., brain implants such as electrodes arrays, brain computer interface (BCI), etc.) and/or to remove and/or deliver fluid to an extravascular space (e.g., a space between the dura and the brain). In some embodiments, the catheter assembly 302 may be sufficiently small and flexible to navigate intracranially and cross multiple complex angles and have high and precise torqueability to direct perforation towards the subdural space from an access site more than about 170 cm away.

[0091] As described in more detail herein, the catheter 310 may include one or more apertures 314 disposed on a distal portion 312 and may include a coupling portion 314. The catheter 310 may define a lumen or a major channel (having a corresponding inner diameter) extending from a proximal end to a distal end of the catheter 310. In some embodiments, the catheter 310 may define an aperture 314 at a distal tip of the catheter 310. In some embodiments, the catheter 310 may include a plurality of lumens and each lumen on the plurality of lumens may define an aperture 314. In some embodiments, one or more of the lumens and/or apertures 312 may be configured for suction and/or fluid delivery and/or for accommodating a delivery system (e.g., for a neural device) therethrough. In some embodiments, the coupling portion 316 may be configured to releasably couple to one or more components of the catheter assembly 302 such as a guidewire and/or shaft 320.

[0092] In some embodiments, the catheter 310 may be slidably disposed within a lumen of a sheath. For example, the sheath may include one or more of a guide catheter intermediate delivery catheter, and a microcatheter .

[0093] In some embodiments, one or more components of the catheter 310 may include one or more of a coating (e.g., hydrophobic coating) configured to decrease transvascular bleeding around the catheter 310. For example, a catheter 310 coating may be composed of polymers including, but not limited to, polystyrene (PS), polybutadiene (PB), polyisoprene (PI), poly(methyl methacrylate) (PMMA), poly(methylacrylate) (PMA), polypropylene oxide) (PPO), poly(hydroxyethylmethacrylate) (PHEMA), poly(vinyl ether) (PVE), poly(vinyl methyl ether) (PVME), poly(vinyl butyl ether) (PVBE), polyimide and poly(dimethylsiloxane) (PDMS), and poly(N-isopropylacrylamide) (PNIPAM).

[0094] In some embodiments, an inner diameter of the catheter 310 may include a coating (e.g., hydrophilic coating) configured to decrease resistance to fluid flow and enhance the delivery of therapeutic or implantable devices or the drainage of a SDH. For example, the inner diameter coating of the catheter 310 may be composed of polymers including, but not limited to, poly (lactams) such as polyvinylpyrrolidone (PVP), polyurethane, homopolymers and copolymers of acrylic acid and methacrylic acid, polyvinyl alcohol, polyvinyl ether, maleic anhydride copolymers, polyesters, vinylamines, polyethyleneimines, Polyethylene oxide, poly (carboxylic acid), polyamide, polyanhydride, polyphosphazene, cellulose (e.g., methylcellulose), carboxymethylcellulose, hydroxymethylcellulose, and hydroxypropylcellulose, heparin, dextran, polypeptides (e.g., collagen, fibrin, and elastin), sugars (e.g., chitosan), hyaluronic acid, alginate, gelatin, and chitin, polyesters (e.g., Rirakuchido, polyglycolide, polycaprolactones, polypeptides). Additionally or alternatively, the inner diameter coating of the catheter 310 may be configured to reduce thrombosis and occlusion. For example, the inner diameter coating of the catheter 310 may comprise one or more of heparin, an anticoagulant (e.g., Dabigatran, Rivaroxaban, Apixaban, Warfarin, Enoxaparin, Edoxaban, Aspirin, Arixtra), a thrombolytic substance, a thrombin inhibitor.

[0095] In some embodiments, at least one portion (e.g., distal portion, proximal portion) of an outer surface of the catheter 310 may include a coating (e.g., hydrophilic coating, hydrophobic coating). For example, a distal portion 312 of the catheter 310 may comprise a hydrophilic coating configured to facilitate transvascular access.

[0096] In some embodiments, the distal portion 312 may comprise a length from a distal tip of the catheter 310 of up to about 10 cm, of up to about 8 cm, of up to about 5 cm, of up to about 3 cm, of up to about 1 cm, including all ranges and subranges therebetween. In some embodiments, a proximal portion of the catheter 310 may comprise a hydrophobic coating configured to minimize bleeding at a transvascular access site. In some embodiments, the proximal portion may comprise a length of up to about 10 cm, of up to about 8 cm, of up to about 5 cm, of up to about 3 cm, of up to about 1 cm, including all ranges and sub-values inbetween.

[0097] The catheter 310 can be designed to have high flexibility. In some embodiments, the catheter 310 has sufficient flexibility so as to take the shape of a shaft 320 slidably disposed therein. However, the shape of the catheter 310 and shaft 320 may be constrained by the shape of the lumen or body cavity (e.g., artery, vein, subdural space) in which the catheter is disposed. In some embodiments, the catheter 310 may be pre-shaped or preformed to form a shape corresponding to the geometry of the vessel. In some embodiments, the catheter 310 may be steered by one or more articulating elements (e.g., pull wires) disposed in a wall of the catheter 310. In some embodiments, the catheter assembly 302 may be configured to prevent catheter herniation during advancement, catheter ovalization, and catching of the catheter against the opening. Furthermore, the catheter may be configured to remain patent with no kinks when a shaft is withdrawn without collapsing when negative suction is applied through a lumen of the catheter.

[0098] In some embodiments, a catheter configured to reach a radial and/or a femoral access point may have a working length of at least about 90 cm, and between about 150 cm and 170 cm, including all ranges and sub-values in-between. In some embodiments, the catheter 310 may be configured to advance through a minimal curve angle of 70° without kinking to facilitate advancement into the intracranial compartment through the foramen spinosum.

[0099] In some embodiments, the catheter 310 has sufficient column strength to generate greater than about 1 N forward load without kinking, ovalizing, or herniating into a vessel (e.g., branching artery) to perforate the SSS and dura, as well as receive a negative pressure of greater than about 29 inHg without collapsing for fluid removal.

[00100] The catheter 310 may define a lumen (having a corresponding inner diameter) extending from a proximal end to a distal end of the catheter 310. In some embodiments, an inner and/or outer diameter of the catheter 310 may be tapered. In some embodiments, an inner diameter at a distal end of the catheter 310 may be smaller than an inner diameter at a proximal end of the catheter 310, e.g., to facilitate increased fluid flow (e.g., during suction).

[00101] In some embodiments, a distal end of the catheter 310 may include a radiopaque element. The radiopaque element can be configured to facilitate alignment between the distal end of the catheter 310 and a feature of the shaft, such as, for example, a wider or larger area of the shaft for preventing ovalization, as further described below.

[00102] In some embodiments, the catheter may include a plurality of lumens and one or more distal openings. In some embodiments, one or more of the lumens may be configured for suction and/or fluid injection. For example, the catheter may be configured to inject non-ionic dextrose during RF energy delivery to reduce current leaks in order to increase vaporization efficiency of a target tissue. [00103] In some embodiments, the catheter 310 may be configured to minimize, prevent, and/or treat catheter occlusion including slidable elements and deployable elements. For example, the catheter may include two telescoping hypotubes. An outer catheter (e.g., proximal hypotube) may have an inner diameter sufficient to accommodate an inner catheter (e.g., distal hypotube) advanced using, for example, a push wire. These inner and outer hypotubes may include one or more tapers to progressively decrease the gap between the inner hypotube outer diameter and the outer hypotube inner diameter until there is no significant clearance left for a predetermined section of the catheter. The predetermined section may be configured to form a seal that maximizes the cross-section as well as suction force and flow. In addition, a dualhypotube catheter may have the advantage of obtaining flow arrest in an intraosseous or extracranial SSS with the catheter while providing a lumen for distal instrumentation in the SSS and through a transvascular passageway.

[00104] In some embodiments, the catheter 310 may comprise a proximal segment configured for navigation coupled to a distal segment defining a lumen. For example, the proximal segment may be configured to control translation (e.g., longitudinal bidirectional movement, push, pull) and/or flexion or curving of the catheter 310 through a vessel. In some embodiments, the proximal segment may be absent a lumen to aid pushability. For example, the proximal segment may comprise one or more of a hypotube, a single solid rod, a wire (e.g., with one of more cross-sectional shapes including round, flat, square, diamond), a plurality of roads, a bundle, one or more tubes (with one or more lumens), a plurality of shaft strands, a cable (e.g., two or more wires running side by side, bonded, twisted or braided), a coil, a braid, a wire (e.g., round, flat, square, diamond), combinations thereof, and the like. The distal segment may comprise a second catheter defining a lumen configured to receive one or more of the shaft 320, negative pressure, SDH, hemostatic device 330, etc. The proximal segment may have a smaller diameter than the distal segment. In some embodiments, the distal segment of the catheter 310 may have length of between about 7 cm and about 20 cm.

[00105] In some embodiments, a proximal portion of the distal segment may have an outer diameter that substantially matches an inner diameter of a distal portion of a sheath such that the distal segment may be coupled to the sheath via a friction fit. In some embodiments, the distal segment includes a proximal portion having an outer diameter that tapers from a first outer diameter substantially equal to an inner diameter of the sheath to a second outer diameter, such that the proximal portion is configured to restrict a length that the distal segment can advance distally beyond the distal end of the sheath. In some embodiments, an inner diameter of a distal end of a sheath may decrease or narrow gradually and/or in step -wise increments. Accordingly, a catheter 310 may be advanced through a sheath until a proximal portion of the distal segment of the catheter 310 abuts a distal portion of the sheath at a “seal region” where the inner diameter of the sheath substantially matches the outer diameter of the catheter 310.

[00106] In some embodiments, the system 300 may include a proximal control mechanism 380 configured to control movement of the catheter 310, expansion of one or more biasing mechanism, and/or delivery of fluid. The proximal control mechanism 380 may be a handle assembly including an actuator (e.g., a knob) configured to control tension of one or more articulating members (e.g., pull wires) extending the length of the catheter 310. Tensioning the one or more articulating members using the actuator may control a shape of the distal portion 312 of the catheter 310 to position the distal portion 312 for perforation of the vessel wall and/or delivery of devices.

[00107] FIG. 4A is a cross-sectional view of layers of a catheter 410, according to embodiments. In some embodiments, the catheter 410 includes a main lumen or channel 421 that allows for the access and/or delivery of ancillary devices described herein to traverse the catheter 410. As shown, a wall of the catheter 410 may include an outer layer 413 and an inner layer 419. In some embodiments, the wall of the catheter 410 may be formed from or include a polymer with the inner layer 419 including a lubricious polymer. In some embodiments, the inner layer 419 may include, for example, polytetrafluoroethylene (PTFE) or equivalent, and the outer layer(s) 413 may include, for example, poly ether block amide (PEBAX), polyethylene, polyurethane, or equivalent. In some embodiments, one or more coatings 411 may be applied to the inner layer 419 or an outer surface of the outer layer 413 of the catheter wall to promote lubricity. For example, one or more hydrophilic or hydrophobic coatings may be applied to the catheter wall. In some embodiments, the catheter 410 may be reinforced with one or more elongate members 417 such as, for example, a metal wire and/or polymer fiber in a braid pattern and/or a coil pattern. In some embodiments, the catheter 410 may be reinforced by slotted metal tubing (e.g., stainless steel, nitinol, or a nitinol alloy) embedded in the wall of the catheter 410 (e.g., the outer layer between the main lumen 421 and the outer surface), as shown in FIG. 4A. [00108] FIG. 4B is an illustration of a proximal end 580 of a delivery system including a catheter 510, according to embodiments. The proximal end 580 of the catheter 510 may be coupled to a connector 581 (e.g., a Luer connector (hub), y-connector, etc.). FIG. 4C is an illustration of a proximal end 680 of a delivery system including a catheter 610. In some embodiments, a proximal end 680 of a catheter 610 may be coupled to a proximal control mechanism 682 (e.g., a handle assembly) for manipulating a shape of the catheter 610 along the length of the catheter 610.

[00109] FIG. 5A-5C show schematic top views and FIGS. 5D-5F show coronal cross- sectional views of perforation of a vessel wall and dura of the SSS 705 to enter the subdural space 706 using a delivery system 700, according to embodiments. As shown, the delivery system 700 includes a shaft 720 (e.g., a perforating member 720) disposed in a main lumen or main channel of a catheter 710. The shaft 720 and the catheter 710 may be advanced through the SSS 705 from a rear of the head of a patient toward the front of the head. The shaft 720 may have a perforating element 724 disposed at a distal end of the shaft 720 and configured to create an opening (e.g., perforate, puncture, pierce, ablate, etc.) in a wall of the SSS 705 and dura such that a distal end of the delivery system 700 (e.g., distal ends of the shaft 720 and the catheter 710) may be disposed through the wall of the SSS 705 and dura and into the subdural space 706. In some embodiments, a guide catheter (not shown) may be configured to navigate the catheter assembly 700 into the SSS 705. The shaft 720 and catheter 710 may include components that are structurally and/or functionally similar to any of the shafts and catheters described herein.

[00110] In some embodiments, upon reaching a target perforation location, the catheter 710 may be transitioned from a navigation configuration, in which the catheter 710 may extend substantially axially along the vessel in which it is disposed (e.g., within 30 degrees of a longitudinal axis of the vessel) to a perforating configuration, in which the catheter 710 and the shaft 720 may include a sharp curve (e.g., greater than 30 degree angle with the longitudinal axis) along a length of the catheter 710. For example, the distal tip of the catheter 710 may extend toward a first wall of the vessel (and therefore toward the subdural space 706) and a portion 715 of the catheter 710 proximal to the distal end of the catheter 710 may abut a second wall of the vessel opposite the first wall to provide support for the perforating member 724 to perforate the dura, as shown in FIGS. 5A-5F. [00111] In some embodiments, the curved shape of the delivery catheter 710 in the perforating configuration may be created passively. For example, at least a portion of the catheter 710 may be pre-shaped in the perforating configuration (e.g., a curved shape), and the guidewire or shaft (e.g., perforating wire) 720 may constrain the catheter 710 into the navigation configuration (e.g., a straight shape) during insertion into the body and while traversing the vasculature. The catheter 710 may return to the perforating configuration (e.g., the curved shape) as the guidewire or shaft 720 is withdrawn from the pre-shaped portion of the catheter 710. Removal of the guidewire or shaft 720 may cause the catheter 710 to return to the curved shape through kinetic energy build up. In some embodiments, the catheter 710 is pre-shaped and/or mechanically shaped in a desired configuration or shape (e.g., a predefined angle of curvature at a predefined point along a length of the catheter 710) prior to use. In some embodiments, the delivery catheter 710 may additionally or alternatively transition from the navigation configuration to the perforating configuration mechanically with an articulating or deflection mechanism (e.g., pull wires) to orient the distal tip of the catheter 710.

[00112] In some embodiments, the desired shape or configuration of the catheter 710 is formed in the operating room prior to insertion by applying heat (e.g., via steaming and/or any suitable heating method) to the catheter 710 over a preformed shaping wire. This method enables formation of a customized shape or configuration (e.g., to accommodate a specific patient’s needs) prior to insertion into the body. In some embodiments, the catheter 710 may include radiopaque material (e.g., radiopaque markers disposed on along the catheter 710) visible using fluoroscopy such that the shape, orientation and location of the radiopaque portion of the catheter 710 can be confirmed under fluoroscopy. In some embodiments one or more ancillary devices (e.g., for delivering electrodes, BCI, etc.) described herein (e.g., see FIGS. 28-37) may be inserted into the main lumen or channel of the catheter 710 and aligned under fluoroscopy to the distal tip and/or a radiopaque marker of the catheter 710 prior to perforation of the dura matter (e.g., by the perforating element 724).

[00113] Once the distal tip portion of the delivery catheter 710 is positioned at or near a target perforation location on the first wall of the vessel and the delivery catheter 710 is stabilized (e.g., transitioned to the perforating configuration in which a portion of the catheter 710 abuts the second wall of the vessel), the shaft 720 including the perforating element 724 may be advanced distally to an aperture in the distal portion of the catheter 710 and used to cross the vessel wall/dura into the subdural space, as shown in FIGS. 5B, 5C, 5E, and 5F. In some embodiments, the distal portion of the catheter 710 and/or a distal tip portion 722 of the perforating wire 720 (e.g., the perforating element 724) may include one or more electrodes connected to an energy source such as a radiofrequency (RF) source, for example. In some embodiments the catheter 710 may be inserted through the opening or perforation created by the perforating element 724 into the subdural compartment (as shown in FIGS. 5C and 5F) and the main lumen of the catheter 710 may be used to deliver therapeutic devices to the brain 701.

[00114] In some embodiments, a distal portion 722 of the shaft 720 can have a smaller diameter than other portions of the shaft 720. In other words, the shaft may be tapered at the distal end 722. In this way, further advancement of the shaft 720 through the vessel wall (e.g., the sinus wall) and dura may temporarily expand the tissue and facilitate advancement of larger catheters (e.g., the catheter 710). Additionally and/or alternatively, the catheter 710 may include a tapered diameter to expand the perforation.

[00115] In some embodiments, the shaft 720 includes three segments, shown in FIG 5F and FIG. 26. The three segments may include (1) a perforating segment 722 arranged most distally, (2) an advancing and stabilization segment 726 arranged directly proximal to the perforating segment, and (3) a proximal support segment 728 arranged proximal to the advancing and stabilizing segment 726. A stiffness of the perforating segment 722 of the shaft 720 may be low enough such that when introduced, the stiffness of the perforating segment 722 of the shaft 720 does not overcome a stiffness of the catheter 710 and cause the catheter to deform and/or lose its position in the SSS 705. The stiffness of the perforating segment 722 of the shaft 720 may be large enough such that the perforating segment 722 can be advanced through the vessel wall/dura to cross into the intracranial space.

[00116] As shown in FIGS. 5A-5F, an outer diameter of the advancing and stabilization segment 726 of the shaft 720 may increase in a proximal direction, thereby (1) increasing a stiffness of the shaft 720 to allow the shaft 720 to be inserted into the subdural space and (2) to dilate the perforation hole in the vessel wall and dura. The increase in the stiffness of the advancing and stabilization segment 726 may provide rail support needed to advance the perforation wire through the dura and deep (e.g., about 0.5 mm to about 100 mm) into the subdural space 706. An outer diameter of the proximal support segment may be substantially equal to, within a tolerance (e.g., +/- 10%), to an inner diameter of a distal portion of the catheter 710. As the perforating element 724 punctures the wall of the vessel, the proximal support segment 728 may be disposed near the distal tip of the catheter 710, allowing the catheter 710 to be inserted into the subdural space 706. At least one of the following can occur to allow the catheter 720 to be inserted into the subdural space 706: (1) the passive stiffness of the pre-shaped catheter 710 can be overcome (e.g., by the shaft 720) to straighten the catheter 710 and/or (2) tension or compression of the articulating mechanisms of the catheter 710 may be released, thereby transitioning the catheter 710 into the navigation configuration and relaxing the catheter 710 to be flexible and advance easily.

[00117] Once the catheter 710 is at least partially disposed in the intracranial space 706, the catheter 710 can be manipulated (e.g., via the pre-shaped forces and/or or mechanically with articulating elements) to a target surface of the brain 701. The catheter 710 may be “locked” in place by (1) a predefined stiffness of the catheter 710, (2) a locking mechanism on a proximal control mechanism for controlling articulation (e.g., the articulating elements) of the catheter 710, or (3) friction between the durotomy (e.g., the opening created by the perforating element 724) and the catheter 710, which may create a fixation point for the catheter 710 relative to the intracranial space 706. By having the catheter 710 anchored and positioned in a predetermined direction near the target surface of the brain 701, a therapeutic device such as a BCI, for example, can be delivered to the brain surface. After the therapeutic device is disposed on the brain 701, the catheter 710 can be relaxed (e.g., transitioned to the navigation configuration) and withdrawn from the subdural space 706. In some embodiments, a BCI can be delivered on the surface of the brain, and one or more leads connected to the BCI may extend through the lumen of the catheter 710, and as the catheter 710 is withdrawn, the leads may be disposed through the hole in the vessel wall/dura, thereby occluding durotomy of the hole and preventing any bleed back. In some embodiments, a sealing device may be deployed to seal the hole in the vessel wall and dura to prevent bleeding, described in further detail with respect to FIG. 37.

[00118] FIGS. 6A-6B show a top view and coronal cross-sectional views, respectively, of the geometry of the catheter 810 in the perforating configuration to promote contact of a perforating element of the shaft (not shown) with a vessel wall/dura 809. As shown, the catheter 810 may be configured to navigate through the SSS 805 to a target perforation location on the vessel wall/dura and perforate or puncture the vessel wall for access to the subdural space 806, for example. The catheter 810 may include components that are structurally and/or functionally similar to any of the catheters described herein. In some embodiments, a shape of the catheter in the perforating configuration may be constructed by pre-shaping the catheter, shaping the catheter in the clinical setting, and/or by using articulating elements (e.g., pull wires) that deflect the tip of the catheter 810 during use. In some embodiments, the distal tip of the catheter 810 may contact a first wall of the vessel/dura 809, and the perforating element can be directed out of an aperture defined by a distal tip of the catheter 810, through the first wall of the vessel, and into the subdural space 806 between the skull and brain/arachnoid membrane or between the brain/arachnoid membrane and the dura 809 toward the inner brain 801. As shown, the apex of the curve 815 of the catheter 810 can rest on a second wall and/or a corner of the SSS 805 opposite the first wall to provide support and facilitate perforation by the perforating element and/or a distal end of the catheter 810.

[00119] In some embodiments, a distal tip portion of the shaft (not shown) may be formed of a memory shape material (e.g., nitinol) having a predetermined curve such that the distal tip portion of the shaft curves as it is advanced from a distal end of the catheter 810. A shape of the predetermined curve may include, but is not limited to, a simple curve, a compound curve, a reverse curve, a spiral curve complex curves, combinations thereof, and the like. The predetermined curve may be in one or more planes (e.g., horizontal plane, vertical plane). The configurations of the shaft are described in further detail with respect to FIG. 21.

[00120] In some embodiments, the catheter 810 and/or the shaft in the perforating configuration may have a shape corresponding to a geometry of the SSS 805. Typically, the SSS 805 is longer in a medio-lateral direction than a cranio-caudal direction such that the SSS 805 approximately has a shape of an obtuse isosceles triangle. In some cases, the SSS 805 can be focally larger in a cranio-caudal direction where the SSS 805 approximates an acute isosceles triangle with the base of the triangle extending along the bone. The SSS 805 may have a triangular shape cross-section with a width W between about 3 mm and about 18 mm and a height H between about 3 mm and about 14 mm. The cross-sectional area of the SSS may be between about 15 mm² and about 90 mm². An angle a between the sinus wall 809 and a midline may be between about 25° to about 65°. The width W, the height H, and the angle a of the SSS 805 may vary between subjects and/or within the same subject along a length of the SSS 805 (e.g., the length being defined between the rear of the head and the front of the head). In some embodiments, the dimensions of the SSS 805 may be assessed by conventional medical images including computed tomography angiography (CTA), magnetic resonance angiography (MRA), angiography, ultrasound imaging, and/or optical coherence tomography (OCT). [00121] In some embodiments, a target perforation location of the SSS 805 along the length of the SSS 805 can be selected based on the absence of tributary veins, an absence of paccioni granulations, and/or a portion of the SSS having about a 10 mm width W and about 5 mm height H. In some embodiments, a catheter 810 having a portion distal to the apex 815 with a length larger than the height H (e.g., larger than about 5 mm) of the SSS 805 may cause the catheter 810 to self-orient and/or mechanically align toward a plane substantially equivalent to the base or width W of the triangle (e.g., the medial -lateral projection of the vessel), as shown in the top diagram of FIG. 6B. Placing a catheter 810 with the portion distal to the apex 815 having a length substantially equivalent to (e.g., within 5% of) the width W (e.g., about 10mm) may cause the catheter 810 to self-orient in a plane substantially equivalent to the base of the triangle and likely adjacent to the base of the triangle, as shown in the top diagram of FIG. 6B. Implementing dimensions of the catheter 810 that cause the catheter to align with the base of the triangle of the SSS 805 may provide consistent wall apposition that minimizes herniation and kickback while receiving an anterograde longitudinal mechanical load, thereby providing a location of perforation at or near base angle (e.g., lateral vertex LV1) of the generally triangular-shaped sinus 805. Placing a catheter 810 with the portion distal to the apex 815 having a length substantially equivalent to and/or smaller than the height (e.g., less than about 5mm) may cause the catheter 810 to self-orient in a plane between the base and the side of the triangle, which could be modified and maintained by torquing or holding the catheter 810, as shown in the bottom diagram of FIG. 6B. Similar principles apply when the shape is given to other elements of the delivery system (e.g., the shaft, a hypodermic needle, a delivery element, etc.). The distal end of the delivery system can have one or more curves, in the same direction or in opposing directions.

[00122] In some embodiments, the shaft may enter the subdural space 806 along a trajectory substantially parallel to the dura and brain surface. For example, a transvascular access trajectory parallel to a base of the triangular-shaped SSS 805 may facilitate implantation of a closure device (e.g., a seal to close the opening or perforation) further from a center of a venous lumen, which may enhance patency of the vessel after the delivery system is removed. In some embodiments, one or more of the shaft, catheter 810, and delivery catheter may have a predetermined curve to facilitate self-orientation to the SSS 805. In some embodiments, the target location to be perforated may be accessed using one or more of a predetermined curve and by torquing one or more of the shaft, catheter 810, and delivery catheter. [00123] FIG. 7 illustrates a proximal control mechanism for steering the catheter 910, according to embodiments. As described in FIGS. 7, a proximal end 980 of the delivery system may include the proximal control mechanism 982 including one or more actuators 984 (e.g., rotating knobs) connected to a respective articulating member 925 (e.g., a pull wire). The knob 984 of the proximal control mechanism 982 may control a degree of flexion of the catheter 910 by actuating the pull wires 925. For example, when the knob 984 is rotated in a first direction, tension is placed on a first pull wire and/or set of pull wires, translating to an annular member (e.g., a pull ring) embedded in the catheter 910, thereby putting the segments in compression tangent to the pull wire and/or set of pull wires and pulling the catheter 910 into shape. In some embodiments, the proximal control mechanism 982 can have a locking mechanism 981 for the knob 984 configured to secure the pull wire 925, and therefore the catheter 910, in a locked shape. The locking mechanism 981 may include an internal gear 983 on the knob 984, and the lock 981 may slide into one or more teeth in the internal gear 983 to prevent the knob 984 from rotating. The proximal control mechanism 982 may have any suitable number of actuators 984 and corresponding locks 983 depending on a number of articulating members (i.e., pull wires) 925 in the catheter 910. For example, the proximal control mechanism 982 can have 1 actuator, 2 actuators, 3 actuators, 4 actuators, 5 actuators, 6 actuators, 7 actuators, 8 actuators, 9 actuators, or 10 actuators, inclusive of all ranges and subranges therebetween. In some embodiments, the proximal control mechanism 982 can have 1 lock, 2 locks, 3 locks, 4 locks, 5 locks, 6 locks, 7 locks, 8 locks, 9 locks, or 10 locks, inclusive of all ranges and subranges therebetween. In some embodiments, the actuators 984 (e.g., the knobs) can be in series along the length of the handle. In some embodiments, the actuators 984 (e.g., the knobs) can be side- by-side or parallel to one another.

[00124] In some embodiments the catheter wall may include one or more minor channels that allow for the injection of fluid through a y-connector (e.g., see FIG. 4B) to elongate the catheter 910 into a desired shape via an increase in pressure in the minor channel(s) of the catheter wall. In such embodiments, the catheter 910 may be connected proximally to one or more connectors (e.g., a Leur connector), and each of the one or more channels may be hermetically sealed to a connector or side-arm/tubing to allow selective fluid injection into a respective minor channel to articulate each segment of the catheter independently.

[00125] FIGS. 8A-8B illustrate catheters 1010, 1110 including a plurality of sections having different flexibility, according to embodiments. As shown, the sections having the highest flexibility are denoted with a “3,” the sections having the second highest flexibility are denoted with a “2,” and the sections with the third highest flexibility are denoted with a “1.” While FIGS. 8A-8B show catheter 1010, 1110 including three different flexibility levels, it can be appreciated that any suitable levels of flexibility may be included throughout the length of the catheter (e.g., 1 2, 3, 4, 5, 6, 7, 8, 9, or 10 levels of flexibility, inclusive of all ranges and subranges therebetween). In some embodiments, a level of flexibility of the catheter 1010, 1110 may gradually change (e.g., no abrupt transitions between flexibility levels) along the length of the catheters, 1010, 1110. In some embodiments the catheters 1010, 1110 may include a plurality of channels: a major lumen or channel 1021, 1121 used for compatible ancillary, accessory, and/or or therapeutic devices, and one or more minor lumens or channels 1019, 1119 defined by a sidewall wall of the catheter 1010, 1110 between the major channel 1021, 1121 and an outer wall. In some embodiments, the minor channels 1019, 1110 may include articulating elements (e.g., pull wires) 1025a, 1025b, 1125 disposed therein and/or may be open to fluid that can flex, deflect, articulate or “accordion” specific segments of the catheter 1010, 1110.

[00126] In some embodiments the shape of the catheter 1010, 1110 is created by a pull wire 1025a, 1025b, 1025 affixed to an annular member 1027a, 1027b, 1127. The pull wires 1025a, 1025b, 1125 may be formed from any suitable material including, for example, polymers, metals, metal alloys (e.g., Nitinol), or a combination thereof. In some embodiments, the pull wires 1025a, 1025b, 1125 may be metal wires. In some embodiments, the pull wires 1025a, 1025b, 1125 may have any suitable cross-sectional shape such as, for example, a circle, oval, square, rectangle, etc. In some embodiments, the pull wires 1025a, 1025b, 1125 may be round. In some embodiments, the pull wires 1025a, 1025b, 1125 may be flat. The pull wires 1025a, 1025b, 1125 may extend at least a portion of the length of the catheter 1010, 1110 or the entire length of the catheter 1010, 1110. In some embodiments, the annular element 1027a, 1027b, 1127 (e.g., a metal ring) may be embedded in or coupled to the wall of the catheter 1010, 1110 at a predetermined point along the length of the catheter 1010, 1110 (e.g., a point of desired flexion of the catheter).

[00127] As shown in FIG. 8 A, the catheter 1010 can include a first pull wire 1025a on a first side of the catheter 1010 and a second pull wire 1025b on a second side of the catheter 1010 opposite the first side. A distal end of the first pull wire 1025a and the second pull wire 1025b may couple to a first annular member 1027a and a second annular member 1027b, respectively. The first annular member 1027a and the second annular member 1027b may have different positions along the length of the catheter 1010 that impact a shape of the catheter when the first and second pull wires 1025a, 1025b are tensioned. For example, the first annular member 1027a is positioned proximal to the second annular member 1027b such that when the first and second pull wires 1025a, 1025b are tensioned, the catheter 1010, 1110 forms a hooked shape or “U” shape.

[00128] As shown in FIG. 8B, the catheter 1110 can include one pull wire 1125 disposed along a side of the catheter 1110 and having a distal end coupled to an annual member 1127. When the pull wire 1125 is tensioned, the catheter 1110 bends toward a side on which the pull wire 1125 is disposed. It can be appreciated a catheter can include any number of pull wires disposed around a radius of the catheter such that the catheter can form different shapes depending on the anatomy of the patient.

[00129] In some embodiments, the annular member 1027a, 1027b, 1127 may include a radiopaque material such as, for example, stainless steel or Platinum/Iridium. For example, the radiopaque material may be embedded in the wall of the catheter 1010, 1110, between the inner and outer layers, in the distal segment of the catheter 1010, 1110 in positions whereupon the catheter 1010, 1110 is configured to bend or flex. The stiffness (denoted by 1, 2 & 3) of a segment may control a degree at which the catheter 1010, 1100 may flex, deflect, articulate or “accordion” into a desired shape to direct an aperture or orifice at the distal end of the catheter 1010, 1110 toward the vessel wall/dura (and therefore direct a guidewire, perforation wire, additional catheters and/or other compatible devices toward or through the vessel wall/dura into the subdural compartment). The pull wires 1025a, 1025b, 1125 may be encased or embedded in the catheter wall along the entire length of the catheter 1010, 1110 and may exit the catheter shaft into a proximal control mechanism (e.g., proximal control mechanism 982), where the pull wires 1025a, 1025b, 1125 may be affixed to the one or more actuators for graduated activation (e.g., the knobs 994). In some embodiments, pull wires 1025a, 1025b, 1125 may deflect the distal segment of the catheter 1010, 1110 to direct the perforation element proximate to a first wall of the vessel and a proximal support segment of the catheter 1010, 1110 against a second wall of the vessel and may increase an overall stiffness of a distal end of the system. The catheters 1010, 1110 may be functionally and/or structurally similar to any of the catheters previously described, and therefore certain details of the catheters 1010, 1110 are not described herein with respect to FIGS. 8A-8B. [00130] FIG. 9 is a schematic of examples of four different catheters 1210, 1310, 1410, 1510 including segments (labeled 1, 2, 3, 4) with varying flexibility, according to embodiments. The varying flexibility may be achieved by different patterns of reinforcement material disposed in the wall of the catheter 1210, 1310, 1410, 1510. For example, a pattern of braid 1210, coil 1310, or slotted tubing 1410 from stiffest (1) to most flexible (4) is shown. In catheter 1210 including a braided wall, the braid picks per inch (PPI defined as the number of times the braid crosses itself) in segment 1 is less than the PPI in segment 2; the PPI in segment 2 is less than the PPI in segment 3; and the PPI in segment 3 is less than the PPI in segment 4. In some embodiments, the PPI may be in a range of about 45 PPI to about 130 PPI, inclusive of all ranges and subranges therebetween.

[00131] In catheter 1310 including the coil wall, the pitch (e.g., the distance between wires) in segment 1 is larger than the pitch in segment 2; the pitch in segment 2 is larger than the pitch in segment 3; and the pitch in segment 3 is larger than the pitch in segment 4. In some embodiments, the pitch may be in a range of about 0.0005 inches to about 0.01 inches, inclusive of all ranges and subranges therebetween.

[00132] In catheter 1410 including slotted hypodermic tubing, the slots are spaced out more in segment 1 than the slots in segment 2; the slots in segment 2 are spaced out more than the slots in segment 3; and the slots in segment 3 are spaced out more than the slates in segment 4. The catheter devices described herein can use any one or combination of the depicted methods to differ stiffness and flexibility.

[00133] In some embodiments the material and/or configuration of the reinforcement members (e.g., the PPI, pitch, and/or spacing between braided/crossed and/or coiled wires or fibers) can allow the catheter 1210, 1310, 1410, 1510 to be pre-shaped and/or mechanically shaped into a desired shape or configuration. In some embodiments, the catheter wall includes segments having braids, coil, and/or slots with different spacing, length, and/or width to allow the catheter 1210, 1310, 1410, 1510 to be pre-shaped or mechanically shaped in a desired shape or configuration. In some embodiments, the catheter 1510 may be formed from or include a polymer material, the composition of the polymer material may correspond to a degree of flexibility of the catheter 1510. In some embodiments, the composition of the polymer material may vary between segment 1, segment 2, segment 3, and segment 4. The catheters 1210, 1310, 1410, 1510, may be functionally and/or structurally similar to any of the catheters previously described, and therefore certain details of the catheters 1210, 1310, 1410, 1510, 1610 are not described herein with respect to FIG. 9.

[00134] FIG. 10A illustrates pull wires 1625 tensioned at different amounts to impart a flexion, deflection, and/or articulation of the catheter 1610 into desired shapes or configuration. The pull wires 1625 may be tensions to position or steer opening(s) or aperture(s) at a distal end of the catheter 1610 toward a vessel wall. As shown, the catheter 1610 is articulated to different positions along a first plane. The catheter 1610 may include one or two pull wires 1625 that impart a flexion of the catheter 1610 along a single plane in a first direction and a second direction. In some embodiments, a different amount of tension applied to a pull wire 1625 or a set of pull wires 1625 may bend or articulate the catheter 1610 to a different degree. As shown, no tension applied to the pull wires 1625 may result in the catheter 1610 remaining in a straight position DI . A predefined amount of tension applied to a first pull wire may cause the catheter to bend a predefined amount in the first direction and the first amount of tension applied to a second pull wire may cause the catheter to bend a predefined amount in a second direction. The catheter 1610 may be articulated into any of the positions DI, D2, D3, D4, or a mirrored position thereof, depending on the pull wire actuated and the amount of tension applied to the actuated pull wire.

[00135] In some embodiments, the catheter 1710 may include a plurality of pull wires 1725 and/or annular elements that impart a flexion, deflection, or articulation in multiple segments (denoted by 1, 2 and 3) at different locations LI, L2, L3 along the catheter 1710. In some embodiments, the segment (1, 2, 3) may have different flexibility such that varying an amount of tension applied to one or more pull wires 1725 may vary a degree of curvature of the catheter 1710. For example, a segment may include a less flexible (e.g., stiffer) reinforcement structure such that a higher amount of tension deflects the catheter 1710 in this segment. In some embodiments, each segment (1, 2, 3) may deflect at tension applied to the pull wire 1725 in a predetermined range corresponding. In some embodiments the catheter 1710 may be articulated to control a position of a shaft including the perforating element relative to the vessel wall as well as to dispose the catheter through the perforation in the subdural compartment such that the main lumen of the catheter 1710 can be used to deliver therapeutic devices (e.g., BCI, electrodes, etc.). The catheter 1710 may be articulated into any of the positions DI, D5, D6, D7, D8, D9, D10, or a mirrored position thereof. While the catheter 1710 is shown to articulate in one degree-of-freedom, it can be appreciated the catheter 1710 can articulate in a plurality of degrees-of-freedom depending on placement of pull wires 1725 in the catheter 1710, placement of channels in the catheter wall, and/or a pattern of openings in the catheter wall. The catheter 1710 may be functionally and/or structurally similar to any of the catheters previously described, and therefore certain details of the catheter 1710 are not described herein with respect to FIGS. 10A-10B.

[00136] FIGS. 11A-11B illustrate a catheter 1810 including a distal end with an opening or aperture 1814 in a sidewall thereof for advancing a shaft (not shown) including a perforating element therethrough, according to embodiments. As shown, the catheter 1810 may be configured (e.g., may be pre-formed and/or include pull wires) such that a side wall of the catheter 1810 and opening 1814 therein has parallel surface contact with the vessel wall/dura 1809. The side wall of the catheter contacting the vessel wall/dura 1809 may better support or brace the catheter 1810 as the perforating element punctures the vessel wall/dura 1809, thereby enhancing stability of the perforating assembly (e.g., the distal end of the catheter 1810 and the perforating wire). The catheter 1810 may be functionally and/or structurally similar to any of the catheters previously described, and therefore certain details of the catheter 1810 are not described herein with respect to FIGS. 11 A-l IB. The distal segment of the shaft can be directed through the catheter side wall (e.g., aperture 1814) into the subdural space 1806 between the skull and brain/arachnoid membrane or between the brain/arachnoid membrane and the dura 1809 toward the inner brain 1801. As described previously with respect to FIGS. 6A-6B, a shape of the catheter 1810 may be predetermined to be substantially similar to the SSS for the device to self-orientate and/or mechanically align with the wall of the vessel and project perforation target vector using the geometry of the vascular structure as similarly described with respect to FIGS. 5A-6B.

[00137] The catheter 1810 is configured to form a curve having an apex 1815 contacting a wall and/or corner opposite the opening 1814, as shown in FIG. 11 A. In some embodiments, an opening 1814 can be positioned at any suitable location along the catheter 1810 such as, for example, (1) on a side of the distal catheter segment opposite the curved section, (2) at the apex of the curve 1815, and/or or a combination of the two. In some embodiments, the catheter 1810 including the opening 1814 in the sidewall thereof may provide more support and 3- dimensional stability in comparison to a catheter including the opening on the distal tip. This is because the catheter 1810 with the opening 1814 defined in the sidewall provides a larger support radially around (e.g., around two or more sides of) the opening. In some embodiments, the catheter may include a plurality of openings 1814 (e.g., perforation assembly exit holes).

[00138] FIGS. 12A-12B illustrate a catheter 1910 configured to curve along a geometry of a vein and including a plurality of openings 1914 in a sidewall thereof for advancing a perforation member, according to embodiments. Similar to FIGS. 11 A-l IB, FIGS. 12A-12B illustrate the general shape the catheter 1910 would form to make surface contact with the vessel wall/dura 1909 in multiple locations within a vascular structure (e.g., the SSS 1905). The catheter 1910 or other element of the perforation assembly (e.g., shaft, hypodermic needle, etc.) can include any suitable shape such as, for example, as a spiral, helix, corkscrew or a substantially similar shape in XYZ planes. In some embodiments, the spiral or helix shape may form a substantially triangular cross-section corresponding to the geometry of the SSS 1905, as shown in FIG. 12B, bottom panel. These 3D shapes can be advantageous to self-position and temporarily anchor the perforation assembly in the vascular structure as well as provide one or more perforation openings 1914 that span the vascular structure circumference. Implementing a plurality of perforation openings 1914 can allow perforation of the dura 1809 at different orientations and/or different coordinates along the SSS 1905. In some embodiments, multiple devices may be delivered simultaneously through the plurality of openings 1914.

[00139] In some embodiments, locations on the catheter 1910 configured to make contact with the vessel wall (e.g., via pre-forming and/or mechanical articulation) have holes, slots, or slits to allow for a perforation wire to be advanced through the vessel wall/dura. In some embodiments the locations configured to contact the vessel wall may include radiopaque material and/or markers such that the locations are visible under fluoroscopy. For example, the locations configured to contact the vessel wall may include a polymer with radiopaque additives and/or a radiopaque metal ring with a hole, slot, or slit. In some embodiments, a metal ring may include a ferrous polar magnet to attract opposing magnetism of the distal tip of the perforation element while repelling like magnetism of the distal tip of the perforation elements such that the metal ring can be visualized to ensure the perforation elements have been delivered to the desired location.

[00140] In some embodiments, the shape of the catheter 1910 may be pre-formed and/or designed for mechanical articulation such that a distance between apexes 1915a, 1915b, 1915c of the curved portions may be in a range of about 3 mm and 18 mm across (e.g., in a medial- lateral direction). In some embodiments, a height of the spiral or helix shape may be no more than about 14 mm. These dimensions allow the catheter 1910 to self-orient and/or mechanically align with the wall of the vessel using the comers created by the triangular shape of the vessel to seat the catheter 1910 along a perforation target vector using the geometry of the SSS 1905. The design may also enable orientation and anchoring in other cross-sectional shapes (e.g. circular, oval and triangular) and other longitudinal shapes (e.g. linear, simple curves, compound curves, complex curves, spiral curves, reverse curve, or sigmoid).

[00141] In some embodiments the shape of the catheter 1910 may be created by a pull wire and annular element or multiple pull wires and annular elements, as described in the embodiments above. In some embodiments, the pull wire and annular elements may spiral around the main channel of the catheter 1910 in combination with segments having different flexibility along the length of the catheter 1910 to allow for the catheter 1910 to form (e.g., spiral into) a specific geometry in an X, Y or Z plane. In some embodiments, perforation may be completed through aperture 1914 in the catheter 1910 that have a metallic element, ring, band or otherwise that can be energized with radiofrequency or another energizing source.

[00142] FIGS. 13 A-13D illustrate different mechanisms for guiding a shaft 2020, 2120, 2220, 2320 through an aperture 2014, 2114, 2224, 2324 defined in a sidewall of a distal portion 2012, 2112, 2222, 2322 of a catheter 2010, 2110, 2210, 2310. In some embodiments, one or more mechanisms may couple the shaft 2020, 2120, 2220, 2320 to the aperture 2014, 2114, 2224, 2324, for example, based on a size, a shape, an angle, a curve, and/or other features of the shaft 2020, 2120, 2220, 2320, the aperture 2014, 2114, 2224, 2324, and/or the catheter 2010, 2110, 2210, 2310. In some embodiments, apertures 2014, 2114, 2214, 2314 may have a size corresponding to a respective shaft 2020, 2120, 2220, 2320 such that only a shaft with the corresponding size or smaller size may extend therethrough and a shaft with a larger size may be deflected to larger apertures. For example, in a procedure in which more than one shaft 2020, 2120, 2220, 2320 is extended through the catheter 2010, 2110, 2210, 2310, sizing of apertures 2014, 2114, 2224, 2324 and shafts 2010, 2110, 2210, 2310 may be matched such that the desired shaft 2010, 2110, 2210, 2310 extends through the desired aperture 2014, 2114, 2224, 2324.

[00143] As shown in FIG. 13A, the shaft 2020 may be guided out of the aperture 2014 using the geometry of the side walls of the catheter 2010 when the catheter 2010 forms a curved shape or configuration. For example, a flexibility of the shaft 2020 may be greater than a flexibility of the side walls of the catheter 2010 such that the shaft 2020 conforms to the curved shape of the catheter 2010. The aperture 2014 may be positioned such that the shaft 2020 is directed to aperture 2014 by following the sidewall wall of the catheter 2010.

[00144] As shown in FIG. 13B, in some embodiments, the aperture 2114 may be angled (e.g., may project at an angle through the sidewall of the catheter 2110) to “catch” or “hook” the shaft 2120 and guide the shaft 2120 through the aperture 2114.

[00145] As shown in FIG. 13C, the aperture 2214 may have an open/close mechanism 2213 (e.g., a gating mechanism) that transitions the aperture 2214 between an open configuration in which the shaft 2220 may extend therethrough and a closed configuration in which the shaft 2220 is blocked from extending therethrough. The open/close mechanism 2213 may resemble that of a gate or “trap door” such that when the catheter 2210 forms a curved shape, the open/close mechanism 2213 transitions to the open configuration. In some embodiments, the open/close mechanism 2213 may be actuated in response to deflection of the catheter 2210. In some embodiments, the open/close mechanism 2213 may be actuated by magnets disposed on or embedded in the sidewall of the catheter 2210 and/or on the distal tip of the shaft 2220 (e.g., such that a portion of the sidewall of the catheter 2210 including a magnet moves toward or away from a magnet in the shaft 2220). In some embodiments, the open/close mechanism 2213 may be actuated by one or more articulation elements or pull wires disposed in the side wall of the catheter 2210. The open/close mechanism 2213 may be any suitable mechanism such as a flap, hinge, deformable material, or any other suitable mechanism. Similar to catheter 2010 and shaft 2020, the shaft 2220 may be guided through the aperture 2214 by the side walls of the catheter 2210 when the catheter 2210 enters a curved shape.

[00146] As shown in FIG. 13D, the shaft 2310 may be guided through the aperture 2314 by a biasing mechanism 2313 (e.g., an expandable member, balloon, expandable mesh, spring, etc.) disposed in or on the catheter 2310. The biasing mechanism 2313 may be configured to transition from a compressed configuration (not shown) to an expanded configuration. In some embodiments, the biasing mechanism 2313 may be disposed distal to the aperture 2314. In some embodiments, the biasing mechanism 2313 may be disposed in a main lumen of the catheter 2310. The biasing mechanism 2313 in the expanded configuration may block or obstruct the lumen of the catheter 2310 distal to the aperture 2314, thereby guiding the shaft 2320 through the aperture 2314. The biasing mechanism 2313 may be expanded or inflated using methods described in FIGS. 14A-15.

[00147] In some embodiments, the catheter 2010, 2110, 2210, 2310 may be repositioned by using a guidewire (e.g., larger than the aperture 2014, 2114, 2214, 2314) in the lumen of the catheter 2010, 2110, 2210, 2310. In some embodiments, the mechanisms 2213, 2313 that open and/or close the apertures 2014, 2114, 2214, 2314 may be deactivated and/or remain in the open configuration to allow for safe passage of the guidewire through the catheter 2010, 2110, 2210, 2310 for repositioning with reduced risk of penetrating the apertures 2014, 2114, 2214, 2314. In some embodiments, the catheter may be straightened 2010, 2110, 2210, 2310 (1) by pulling the proximal end of the catheter 2010, 2110, 2210, 2310 out of the body (e.g., a handle assembly, a sheath, etc.) slightly while the distal tip of the catheter 2010, 2110, 2210, 2310 remains at a target location to relieve a compressive force acting on the catheter 2010, 2110, 2210, 2310 and elongate it, and/or (2) by activating or deactivating the articulation, deflection, or “accordion” mechanism (e.g., pull wires) of the catheter to allow for passage of the guidewire such that it does not penetrate the apertures. The catheter 2010, 2110, 2210, 2310 may be functionally and/or structurally similar to any of the catheters previously described, and therefore certain details of the catheter 1810 are not described herein with respect to FIGS. 13A-13D.

[00148] FIGS. 14A-14D illustrate biasing mechanisms 2413, 2513 for stabilizing a catheter 2410, 2510 inside a vein (e.g., the SSS 2405, 2505), according to embodiments. In some embodiments, one or more biasing mechanism 2413, 2513 may include an expandable member coupled to or disposed around a portion of the catheter 2410, 2510. In some embodiments, the expandable member may include a balloon, an expandable mesh, a spring, a coil, etc. In some embodiments, the expandable member may be configured to transition from a deflated or compressed configuration during navigation of the catheter 2410, 2510 to a target location to an inflated or expanded configuration before or during perforation of the vessel wall or dura.

[00149] In some embodiments, the expandable member(s) may be configured to inflate or expand circumferentially around the catheter 2410, as shown in FIGS. 14A-14B. In some embodiments, the biasing mechanism 2413 may include a first balloon distal to the aperture 2414 or perforation point and a second balloon proximal to the aperture 2414 or perforation point. The first balloon and the second balloon may be configured to expand to support the aperture 2414 against an inner wall of the vessel and stabilize the catheter 2410 during perforation. In some embodiments, a radius to which the first balloon and the second balloon expand may correspond to a radius of the vessel such that the catheter 2410 is fixed along a length of the vessel when the first and second balloons are in the expanded configuration. Additionally, the first balloon and/or the second balloon in the expanded configuration may prevent blood from flowing from the vessel into the perforation area, and therefore, prevent blood from flowing into the extravascular space (e.g., the intracranial space).

[00150] In some embodiments, the biasing mechanism 2513 may include a balloon coupled to the catheter 2510 opposite the aperture 2514 and/or opposite the apex of the curved portion of the catheter 2510. The target perforation location may be on a first wall of the vessel, and the biasing mechanism 2514 may be configured to abut a second wall of the vessel opposite the first wall. For example, the balloon may be skewed to one side of the catheter body 2510 and may be inflated against the second vessel wall opposite the target perforation location. In some embodiments, the balloon when expanded may be operable to press the apex of the curved portion of the catheter 2510, and therefore the aperture 2514, against the first vessel wall/dura, thereby stabilizing the catheter 2510 for perforation as well as preventing blood from flowing into the extravascular space (e.g., the subdural space). The catheter 2410, 2510 may include a major channel 2421, 2521 and one or more minor channels 2423, 2523. In some embodiments, a proximal end of the catheter has a connecter (e.g., a y-connector, a port, valve, etc.) that provides two channels: a first channel that is in fluid communication with the major channel 2421, 2521 of the catheter 2410, 2510 for the insertion and withdrawal of ancillary, accessory and therapeutic devices, and a second channel that is in fluid communication with the minor channel 2423, 2523 (e.g., the minor inflation channel). The second channel coupled to the minor channel 2423, 2523 may be sealed (e.g., hermetically sealed) proximally to allow a fluid (e.g., saline, gas, water, etc.) to be delivered through a side hole 2427, 2527 within a segment of the catheter 2410, 2510 including the balloon, the side hole 2427, 2527 for inflation and deflation of the balloon distally. For example, the balloon may be disposed around the side hole 2427, 2527 such that as fluid exits the side hole 2427, 2527, the fluid inflates the balloon. FIG. 15 is a drawing of a proximal end 2680 of the delivery system including a connector or port 2681 of the delivery system configured to be coupled to a fluid source and/or a vacuum source, according to embodiments. As shown, the connector or port 2681 may be in fluid communication with a minor channel 2623 (or inflation channel) and may be configured to transport fluid from an external source to the minor channel 2623 (e.g., to fill an expandable member) and/or to be coupled to a vacuum source to create a vacuum in an inner volume defined by the minor channel 2623, as described in further detail with respect to FIG. 17.

[00151] FIGS. 16A-16B illustrate biasing mechanisms 2713 for stabilizing a delivery catheter 2710 inside a vein, according to embodiments. In some embodiments the biasing mechanism 2713 may include a stent structure (e.g., including a mesh and/or textile material) disposed circumferentially around the catheter 2710 that pushes a portion of the catheter 2710 against the vessel wall/dura when the catheter 2710 is positioned for perforation. In some embodiments, the biasing mechanism 2713 may be self-expanding or mechanically expanding. In some embodiments, the stent structure may be elongated or compressed when constrained in the delivery catheter (not shown), or when there is a guidewire, shaft, or smaller catheter in the major channel of the catheter 2710 occupying space in the inner volume defined by the major channel. Once this stent structure is through the delivery catheter, or the guidewire, perforation wire or smaller catheter is removed from the major channel, the kinetic force of the stent structure may cause the stent structure to expand (e.g., automatically).

[00152] In some embodiments, a first end of the stent structure (e.g., a proximal end) and a second end of the stent structure (e.g. a distal end) may each be coupled to the catheter 2710 via a first coupling mechanism 2729a and a second coupling mechanism 2729b, respectively. The first coupling mechanism 2729a and the second coupling mechanism 2729b may be annular elements or ring members embedded in the distal end of the catheter 2710. In some embodiments, at least one of the first coupling mechanism 2729a and the second coupling mechanism 2729b may be slidable along the length of the catheter 2710. Therefore, the stent structure may be in a compressed configuration when the first coupling mechanism 2729a and the second coupling mechanism 2729b are separated by a first distance, and the stent structure may transition to the expanded configuration when the first coupling mechanism 2729a and the second coupling mechanism 2729b are separated by a second distance smaller than the first distance. For example, one of the first coupling mechanism 2729a or the second coupling mechanism 2729b may move toward the other of the first coupling mechanism 2729a or the second coupling mechanism 2729b to expand the stent structure. The stent structure may be expanded via a pull wire 2725 coupled to the first coupling mechanism 2729a and/or the second coupling mechanism 2729b. For example, the second coupling mechanism 2729b (e.g., the distal coupling mechanism) may be coupled to one or more pull wires 2725, as shown in FIG. 16B. The pull wire(s) 2725 may compress the distal segment of the catheter proximally. When the pull wire(s) are tensioned, the second coupling mechanism 2729b may be moved proximally, foreshortening the catheter length and causing the stent structure 2713 to expand outward.

[00153] FIG. 17 is a front view and a side view, respectively, of a distal end 2812 of a catheter including a vacuum channel 2852, according to embodiments. In some embodiments, the catheter has a minor channel 2852 in the wall surrounding the aperture 2814 of the main channel 2821 to which a vacuum may be applied to draw the vessel wall/dura against the catheter around the aperture 2814. For example, the vacuum may cause a seal to form between the catheter and the vessel wall. The vacuum can maintain a position of the vessel wall and hold it taut, e.g., to maintain a stability of the vessel while perforating and/or delivering devices. The vacuum may rely on surface conditions of the mating vessel to apply the vacuum force. In some embodiments, a connector in fluid communication with the minor channel 2852 that extends the length of the catheter (e.g., the same connector and minor channel used for the biasing mechanism, see FIG. 15) may be used to apply the vacuum. In some embodiments, the vacuum may be applied to the minor channel 2852 with a syringe or other vacuum implement. The catheter may be functionally and/or structurally similar to any of the catheters previously described, and therefore certain details of the catheter 1810 are not described herein with respect to FIGS. 17.

[00154] In some embodiments, because the catheters 2410, 2510, 2710 of FIG. 14 and FIGS. 16A-16B is coupled to an external compressive element (e.g., the biasing mechanism 2413, 2513, 2713), the catheter 2410, 2510, 2710 may be able to control, position and generate more occlusive force than the catheter 2810.

[00155] FIGS. 18A-18B illustrates a top view and a front view, respectively, of a catheter 2910 including a plurality of lumens 2910a, 2910b, 2910c, 2910d (e.g., a multichannel configuration) in an expanded configuration to stabilize the delivery catheter 2910 in a vein, according to embodiments. FIG. 18C shows a front view of the catheter 2910 in a compressed configuration, according to embodiments. In some embodiments, the distal end 2912 of the catheter 2910 may be configured to expand in a 3 -dimensional shape corresponding to the geometry of the vessel. For example, the lumens 2910a, 2910b, 2910c, 2910d may be configured to move away from one another when the catheter 2910 is in the target location in the vessel, thereby resulting in self-orientation, anchoring and/or alignment of each individual lumen 2910a, 2910b, 2910c, 2910d across the circumference orborder of the vascular structure. For example, the catheter 2910 may be configured to expand in a triangular shape to contact each of the comers of the SSS 2905. Each lumen 2910a, 2910b, 2910c, 2910d of the catheter 2910 once the catheter 2910 is expanded and in contact with the vessel wall/dura 2909 can be used to access a respective perforation location. The distal end of the catheter 2912 may be configured to expand in response to one or more pull wires 2925 and/or annular elements 2929 attached to the distal tip 2911 of the catheter 2910 (e.g., where each of the lumens intersect). When the pull wires 2925 are put in tension (e.g., by twisting a knob on the handle of the proximal end of the catheter 2910), the distal end 2912 of the catheter 2910 may be expanded such that each lumen 2910a, 2910b, 2910c, 2910d occupies space in the X, Y and Z planes, respectively.

[00156] The shape of the distal end 2912 of the catheter 2910 may have predetermined dimensions. For example, the distal end 2912 of the catheter 2910 may have a width (e.g., a maximum dimension of the catheter 2910 along the medial-lateral direction) between about 3 mm to 18 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the distal end 2912 of the catheter 2910 may have a height (e.g., a maximum dimension of the catheter 2910 along the cranio-caudal direction) in a range between about 3 mm to 14 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the distal end of the catheter 2910 may have a length (e.g., a length between a separation point of the lumens and an intersection point of the lumens at the distal tip 2911) in a range of about 30 mm to about 60 mm (e.g., 50 mm). The dimensions allow for the catheter 2910 to self-orient and/or mechanically align with the wall of the vessel wall/dura using the triangular corners to seat and project perforation target vector using the geometry of the SSS 2905. Certain aspects of the catheter 2910 may be functionally and/or structurally similar to any of the catheters previously described, and therefore certain details of the catheter 2910 are not described herein with respect to FIGS. 18A-18C.

[00157] FIG. 19 shows different configurations of a distal end of a catheter 3010, 3110, 3210, 3310, 3410, according to embodiments. These differing catheter shapes can be used separately or in combination with the guidewire, perforation wire, hypodermic tubing/needle, or catheter embodiments described herein by working with the guidewire or hypodermic tubing/needle or directing the perforation device towards the vessel wall. In some embodiments, the catheter 3010 may have a straight configuration, the straight configuration may be shaped toward the vessel for point contact or surface contact by the accessory perforation device. In some embodiments, the catheter 3110 may be shaped or pre-shaped to have an angled tip including a length L between about 3 mm to about 18 mm and forming an angle from the longitudinal axis of the catheter 3110 between about 30 and about 60degrees, inclusive of all ranges and subranges therebetween. The length L of the angled tip is defined between the apex of the curve and the distal tip of the catheter 3110. In some embodiments, the catheter 3210 may be shaped or pre-shaped to have a 90-degree bend at bend length up to 18 mm. The bend length may be defined as a length from the distal tip of the catheter 3210 at which the bend is located. In some embodiments, the catheter may be shaped or pre-shaped to a curvature that bends in multiple locations to span a 3 mm to 18 mm width (e.g., a “hook” or “swan neck” shape 3310 or a “Z” curve shape 3410). In other words, a lateral dimension of the curved shape shown in catheter 3310 may be between about 3 mm and about 18 mm, inclusive of all ranges and subranges therebetween. In these embodiments, the shapes have a shape length of up to 100 mm that may seat one side of the catheter against the vessel wall/dura in the corner of the SSS aligning the distal tip of the catheter to the other in the opposite vessel wall/dura of the SSS. In some embodiments, the catheter 3410 may form two opposing angles such that the catheter 3410 forms two linear section parallel to one another, as shown. Certain aspects of the catheters 3010, 3110, 3210, 3310, 3410 may be functionally and/or structurally similar to any of the catheters previously described, and therefore certain details of the catheter 1810 are not described herein with respect to FIGS. 19.

[00158] FIG. 20 is a diagram of different perforating elements 3524, 3624, 3724, 3824 at a distal end of a catheter 3510, 3610, 3710, 3810, the perforating elements 3524, 3624, 3724, 3824 for perforating a dura of a patient, according to embodiments. In some embodiments, the perforating element 3524, 3624, 3724 may be disposed on a distal tip of the catheter 3510, 3610, 3710, and may be bare, unshielded metallic and conductive material connected to a conductive wire 3532, 3632, 3732 traversing the length of the catheter 3510, 3610, 3710. The conductive wire 3532, 3632, 3732 may be disposed in the catheter wall or have an insulative covering such as polyolefin, PTFE, or the like to insulate the conductive wire 3532, 3632, 3732 from the user (e.g., the physician) and the patient. The perforation element 3524, 3624, 3724 can be connected to an energy source such as a radiofrequency generator such that the perforating element 3524, 3624, 3724 can apply energy to the vessel to perforate. Certain aspects of the catheters 3510, 3610, 3710, 3810 may be functionally and/or structurally similar to any of the catheters previously described, and therefore certain details of the catheter 3510, 3610, 3710, 3810 are not described herein with respect to FIGS. 20.

[00159] In some embodiments, the perforating element 3524 may be a flat, blunt and circumferential electrode. In some embodiments, the perforating element 3624 may be a beveled, circumferential electrode. In some embodiments the perforating element 3724 has an electrode tangent to the wall of the catheter 3710. For example, the electrode may form a flat surface extending outward from a sidewall of the catheter 3710. In some embodiments, the electrode tangent to the wall of the catheter 3710 may have a length between about 1 mm to about 5 mm, inclusive of all ranges and subranges therebetween, and/or may have an amount of circumferential surface area between about 15 mm² to about to 90 mm² unshielded, inclusive of all ranges and subranges therebetween.

[00160] In some embodiments, the tip of catheter 3810 may have an external thread element 3824. In some embodiments, the external thread element 3824 may include a metallic attachment and/or a polymer that allows for the catheter 3810 to screw or drill through the vessel wall/dura.

Perforating Device:

[00161] FIG. 21 is a diagram of different configurations of perforating elements 3924, 4024, 4124, 4224 on a perforating member (e.g., shaft, wire, hypotube, elongate member, etc.) 3920, 4020, 4120, 4220 configured to be disposed through a catheter, according to embodiments. Each shape of the perforating member 3920, 4020, 4120, 4220 directs the distal tip of the perforating member 3920, 4020, 4210, 4220 in different orientations for controlled perforation. In some embodiments, the shapes of the perforating member 3920, 4020, 4210, 4220 can be used separately or in combination with any of the catheter devices described herein. In some embodiments, the shape or configuration of the perforating member 3920, 4020, 4210, 4220 may determine the shape of the accompanying catheter device (when the perforating member 3920, 4020, 4210, 4220 has a higher stiffness than the catheter, for example).

[00162] In some embodiments, the perforating member 3920 can be formed in a straight configuration. In the straight configuration, the perforating member 3920 may be directed toward the vessel wall/dura via the shape of the catheter through which the perforating member 3920 extends.

[00163] In some embodiments, the perforating member 4020 may have an angled tip. A portion of the tip distal to the bend may have a length between about 3 mm to 18 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the angled tip may be at an angle from the centerline of the perforating member 4020 in a range between about 10 degrees to about 90 degrees, inclusive of all ranges and subranges therebetween. In some embodiments, the angle from the centerline of the perforating member 4020 may be in a range of about 30 to about 60 degrees, inclusive of all ranges and subranges therebetween. In some embodiments, the perforating member 4020 may form a “hockey stick” (about 60 to about 90 degrees) or an “elbow” shape (about 90 degrees) to orient the perforating element toward the vessel wall. The length of the angled tip, henceforth described as the “cord length” can be constructed and varied in length dependent on the width of the SSS and the location of the perforation site. In some embodiments, the cord length may be varied, but may not be greater than 18 mm.

[00164] In some embodiments the distal tip of the perforating member 4120 may form a 180- degree curve (e.g., a “Y” curve or “J curve) to which the radius of curvature may be up to about 6 mm from the centerline of the perforating member 4120. In some embodiments the perforating member 4220 may have a plurality bends along its length, hereby called a “swan neck” shape. The “swan neck” shape may (1) first bend and extend in a first direction toward a first vessel wall/dura and abut the first side, and then (2) bend and extend in an opposite direction in plane to abut the a second vessel wall/dura opposite the first wall, then (3) the distal tip may bend again toward the first side of the vessel wall/dura at which the first bend abuts. A width of each bend in the “swan neck” shape (e.g., a distance between an apex of each bend) may between about 3 mm and about 18 mm, inclusive of all ranges and subranges therebetween. This multi-bend design can promote additional security that the perforation member 4220 does not move out of the vessel and that the perforation member 4220 is seated or secured in the geometry of the vessel allowing for controlled perforation. The perforating members 3920, 4020, 4120, 4220 and perforating elements 3924, 4024, 4124, 4224 may be structurally and/or functionally similar to the shaft or perforating members and perforating elements described herein, and therefore certain details are not described in detail with respect to FIG. 21. [00165] FIG. 22 is a diagram of different configurations of a perforating member 4320, 4420, 4520, 4620, according to embodiments. Any or all of the perforation members 4320, 4420, 4520, 4620 may be used to perforate the vessel wall/dura in combination with any catheter device described herein. In some embodiments, the diameter and length of the perforation member 4320, 4420, 4520, 4620 may correspond to an inner diameter and length of the pairing catheter type device. In some embodiments, the perforation member tapers (e.g., via grinding, shaping, cutting, etc.) to a profile that allows for atraumatic perforation. The tapered segment of the perforation member (e.g., the advancing and stabilizing segment 4326) may include, for example, a linear taper, parabolic taper, and/or included predefined steps or flats 3422. The taper length (e.g., the length of the advancing and stabilization segment 4326) may be in a range of about 30 mm to 240 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the perforating member 4320, 4420, 4520, 4620 may have a constant outer diameter on a proximal end (e.g., the proximal support segment 4328) and/or at a distal tip (e.g., the perforating segment 4322). In some embodiments, a distal tip of the perforating member 4320, 4420, 4520, 4620 includes a sharp point. In some embodiments, the perforating member 4320, 4420, 4520, 4620 may be round and/or flattened. In some embodiments, the flat segment 4322 of the perforating member 4320 may align the distal tip of the perforating member toward the vessel wall/dura by self-orienting to the curve of the catheter.

[00166] In some embodiments, the perforating member 4320, 4420, 4520 may include a distal element (e.g., the perforating element 4324, 4424, 4524) that is coupled to a proximal energy source (e.g., radiofrequency, current source, etc.). Upon activation of the energy source, the distal tip of the perforating member 4320, 4420, 4520 may perforate the vessel wall/dura by heating the tissue to create a hole or opening. In some embodiments, the perforating member 4620 has an external thread element 4624 such that the perforating member 4620 can screw or drill through the vessel wall/dura to create a hole or opening. In some embodiments, the perforating element may be a wire including any suitable material such as, for example, a metal alloy, stainless steel, nitinol or a nitinol alloy derivative, cobalt chromium, or a suitable combination thereof.

[00167] FIG. 23 is a diagram of a distal end of a perforation member 4720 including an electrode 4724 and insulation 4736 disposed around the electrode 4724, according to embodiments. The electrode 4724 may be used for tissue vaporization to form an opening or hole in the vessel wall. In some embodiments, electrode 4724 may be comprised of a conductive material (e.g., a metal, a polymer, etc.) connected to a conductive wire.

[00168] In some embodiments, the electrode 4724 may have a diameter in a range of about 0.014” (0.35 mm) to about 0.027” (0.69 mm), inclusive of all ranges and subranges therebetween. In some embodiments, the electrode 4724 may have a length in a range of about 0.7 mm to about 1.5 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the electrode 4724 may have a minimum surface area in a range of about 1.15 mm² to about 4.75 mm², inclusive of all ranges and subranges therebetween.

[00169] In some embodiments, the electrode 4724 may comprise a diameter of between about 0.35 mm to about 0.70 mm, between about 0.35 mm to about 0.50 mm, between about 0.5 mm to about 0.70 mm, and between about 0.50 mm to about 0.60 mm, including all ranges and subvalues in-between. In some embodiments, the electrode 4724 may comprise a length of between about 0.7 mm to about 1.5 mm, between about 0.7 mm to about 1.00 mm, between about 1.0 mm to about 1.50 mm, and between about 0.90 mm to about 1.30 mm, including all ranges and sub-values in-between. In some embodiments, the electrode 4724 may comprise a surface area of between about 1.15 mm² to about 4.75 mm², between about 1.15 mm² to about 3 mm², between about 3 mm² to about 4.75 mm², and between about 2 mm² to about 4 mm², including all ranges and sub-values in-between.

[00170] In some embodiments, the electrode 4724 may be connected to a paddle structure 4735 on the distal end of the perforating member 4720. The paddle shape or structure 4735 may be configured to provide atraumatic advancement through a vessel and dura by providing a smooth transition between the electrode 4724 and the insulation 4735 disposed proximal of the electrode. The electrode 4724 can have a smooth proximal edge 4724a and a smooth distal edge (e.g., a domed sleeve) 4724b, which aids in insertion and withdrawal of the perforation member 4720 in the catheter as well as provides an atraumatic tip to prevent vessel wall/ damage during use. The smooth transition be achieved by matching the outer dimension of the insulation 4736 and the outer dimension of the electrode 4724 and/or by using a specific joining method such as, for example, welding or soldering, of the core of the perforating member and the electrode 4724. For example, the electrode 4724 may be joined to the paddle structure 4735 via welding or soldering to remove any sharp edges of the electrode 4724 and create an atraumatic surface. In some embodiments, the paddle structure 4735 may provide additional metallic material near the electrode configured to act as a heat sink during activation of the electrode 4724, consuming energy in the larger metallic mass of the paddle structure 4735 and preventing embrittlement of the metal in thinner areas such as the thin ground portion of the wire and preventing device failure when delivering RF energy. The electrode 4724 may have an atraumatic shape (e.g., rounded). For example, an outer diameter of the insulator 2422 may substantially match an outer diameter of the electrode 4724 or the conductive wire 2420 may be coupled (e.g., welded, soldered) to the electrode 4724. The electrode may be a metallic radio-fluorescent ring or tip such a domed sleeve 2724b comprised of a mixture of platinum iridium such as 90% platinum- 10% iridium.

[00171] FIG. 24 is a diagram of different needles 4820, 4920, 5020, 5120, 5220, 5320, 5420 of a delivery system for perforating a dura of a subject, according to embodiments. In some embodiments, any of the catheters described herein can use hypodermic tubing and/or needle type devices that can be used to perforate the vessel wall/dura. In some embodiments, the hypodermic tubing and/or needle 4820, 4920, 5020, 5120, 5220, 5320, 5420 may include a flexible metal such as, for example, stainless steel, nitinol, nitinol alloy, and/or cobalt chromium. In some embodiments, the hypodermic tubing and/or needle 4820, 4920, 5020, 5120, 5220, 5320, 5420 can be used separately or in combination with a catheter device described herein and the hypodermic tubing and/or needle 4820, 4920, 5020, 5120, 5220, 5320, 5420 may determine the shape of the accompanying catheter.

[00172] In some embodiments the hypodermic tubing and/or needle 4820 includes a tube defining an inner volume and having a beveled distal tip. In some embodiments, the hypodermic tubing and/or needle 4920, 5020, 5320, 5420 has one or more openings (e.g., slit, slots, cuts, etc.) in the wall of the tubing that control a flexibility of the tubing. For example, a higher area of the wall of the hypodermic tubing and/or needle that is removed, the higher flexibility of the hypodermic tubing and/or needle. The openings in the wall of the hypodermic tubing and/or needle can vary in geometry, dimension and spacing as illustrated by alternating openings (needle 4920), angular openings (with or without hooks) (needle 5320), circumferential spiral cut openings (needle 5020), or spinal openings (needle 5420). The aforementioned patterns dimensions and spacing allow for the mechanical control of the flexibility of the hypodermic tubing/needle device. [00173] In some embodiments the distal tip of the hypodermic tubing and/or needle 5120 can have an external thread type element such that the hypodermic tubing and/or needle 5120 can screw or drill through the vessel wall/dura to create an opening at the target perforation location. In some embodiments the hypodermic tubing and/or needle may include an articulating element (e.g., a pull wire) fixed to the distal tip of the hypodermic tubing/needle that when the articulating element is put in tension, the articulating member will impart flexion, deflection, or articulation on the distal tip of the hypodermic tubing/needle to a control direction of the distal tip toward the vessel wall/dura.

[00174] FIG. 25 is a side cross-sectional view of a catheter 5510 transvenously accessing a subdural compartment of a patient to deliver a therapeutic device such as a brain implant to the brain 5501 of the patient, according to embodiments. In some embodiments the access to the subdural compartment is direct through the SSS 5505 that runs from the base of the skull and extends posteriorly following a midline of the head to an anterior portion of the head. Devices that can be delivered through the catheter 5510 using the approach described herein include, for example, Brain-Computer Interface (BCI) devices, Intracranial Pressure Monitoring (ICP) devices, biopsy devices, or devices for the injection and/or or aspiration of fluid materials.

[00175] In some embodiments, the catheter 5510 may further include an expanding member (e.g., a balloon or expanding frame, not shown) distal as described herein for an additional delivery mechanism for the implant. For example, the expanding member may push the brain away from the skull to create space for delivering devices or completing a therapeutic procedure. In some embodiments, the catheter 5510 may include more than one expanding member (e.g., 2 expanding members, 3 expanding members, 4 expanding members, 5 expanding members, 6 expanding members, 7 expanding members, 8 expanding members etc.). In some embodiments, the catheter 5510 may include one expanding member (e.g., balloon) distal to the delivery portion of the catheter 5510 and one expanding member (e.g., balloon) proximal to the delivery portion of the catheter 5510.

Implants and Delivery of Same;.

[00176] FIG. 26A-26H are side cross-sectional views of transvenous delivery of different types of electrodes (e.g., BCI electrodes and/or electrode arrays) to a brain of a patient, according to embodiments. As shown in FIG. 26A, a sheet-type electrode 5696 that covers a portion of the cortex of the brain 5601 may be delivered with the catheter, and optionally leads 5696 may extend through the SSS 5605 to a power source (not shown) implanted in the body. As shown in FIG. 26B, depth electrodes 5795 can be delivered to targeted locations of the cortex of the brain 5701 and leads 5796 may extend through the SSS 5705. In some embodiments, the electrode device 5795 can include multiple branches including electrode contacts to span targeted locations of the cortex. In some embodiments, an electrode device including multiple tines 5895 (Fig. 26C), forks 5995 (FIG. 26D), or leads can be delivered to certain areas of the brain 5801, 5901 via the SSS 5805, 5905. The electrode devices may include leads 5896, 5996 that extend through the SSS 5806, 5905. As shown in FIG. 26E, an electrode 6095 can form an “S” shape or follow a circuitous path along the cortex of the brain 6001 to cover a targeted area. As shown in FIG. 26F, an electrode 6195 can include extensions arranged in “ribs” or the like that branch off of a backbone to cover target regions of the cortex of the brain 6101. The electrodes 6095 and 6195 may include leads 6096, 6196 that extend through an SSS 6005, 6105 of the patient. As shown in FIG. 26G, an electrode 6295 can spiral over the brain surface to cover a targeted area of the cortex. As shown in FIG. 26H, an array or multiple arrays of PCB films, or microneedle arrays 6395 can be delivered to targeted locations of the brain cortex.

[00177] These electrode devices, with the exception of FIG. 26B and 26H, can be delivered in the subdural space by passively transitioning to a desired shape or structure using pre-shaped metal (e.g., superelastic material such as Nitinol). For example, when the catheter is withdrawn proximally to expose the brain implant (e.g., the BCI) in the subdural space, kinetic energy stored due to the brain implant being constrained in the catheter during delivery may cause the brain implant to transition to its final form (e.g., a delivered configuration, a deployed configuration, an expanded configuration, etc.). In some embodiments the brain implants may include a hollow tube or channel defining an inner volume and including a metal, a polymer, or any other suitable material. A fluid, such as saline, may be injected into the inner volume of the hollow tube, thereby increasing pressure in the inner volume to cause the brain implant to transition to its final form (e.g., to expand, unfurl, unravel, etc.). In some embodiments, the channel of the brain implant can be used to insert a smaller elongate member (e.g., a wire) that can be used internally by creating tension or compression to manipulate branches and/or edges of the brain implant to open into a final form. In some embodiments, for brain implants including branches, the branches can include or be coupled to polar magnets such that when the brain implant is unconstrained (e.g., the catheter is withdrawn proximally), opposing forces from the magnets will promote the brain implant to take its final form (e.g., expand). In some embodiments, an external magnetic source outside of the skull can be used to create a magnetic field to pull the branches or edges of the brain implant to a final form.

[00178] In these embodiments, the brain implant can include radiopaque material and/or have radiopaque markers for confirmation under fluoroscopy that the brain implant opens and/or located in a desired position.

[00179] FIG. 27 is a schematic of a brain implant 6495 including leads 6496 (left) and a leadless or wireless brain implant 6595 (right) configured to be delivered using a catheter, according to embodiments. As shown on the left, the electrical leads 6496 can be connected to a pulse generator 6497 implanted subcutaneously elsewhere in the body (e.g., in the chest below the clavicle). In some embodiments, the electrical leads 6496 can extend through the Transverse Sinus, to the Sigmoid Sinus, down the jugular veins, and to the subclavian veins, where the leads can exit the vessel and connect to the implanted pulse generator 6497. In some embodiments the leadless implant 6595 may include a pulse generating unit 6597 built in or directly coupled the implant 6595. In either of these embodiments, the pulse generator 6497, 6597, can be located magnetically and charged using wireless fields for transfer of energy (e.g., via induction).

[00180] FIG. 28 is a close-up view of self-expanding electrode arrays 6695a, 6695b, 6695c for implantation in a brain of a patient, according to embodiments. In some embodiments, the brain implants may include a plurality of electrode arrays (e.g., mesh, printed-circuit-board (PCB) films, etc.). The electrodes and delivery mechanisms can be used for applications where large area coverage of the cortex is desired. These electrode arrays may be connected to a main shaft or lead chassis 6696, and the leads (e.g., rib extensions described below) for the electrode arrays 6695a, 6695b, 6695c extend through these main shaft or lead chassis 6696. In some embodiments, the electrode array 6695a, 6695b, 6695c may include a triangular shape (e.g., an acute right triangle 6695a or obtuse triangle 6695b). In the acute right triangle construct 6695a, the 90 degree angle may be positioned distal along the lead chassis 6696 and the acute angle may be positioned proximal along the lead chassis 6696. In the obtuse triangle construct 6695b, the side of the obtuse triangle 6695b with the longest length may be connected to the lead chassis 6696. The electrode arrays may be oriented along the lead chassis 6696 in a manner that allows for the electrode array 6695a, 6695b, 6695c to unfold, unfurl, or expand during deployment, but that also allows for the electrode array to be recaptured through the delivery catheter if desired. In some embodiments, the shallow angle of the triangular electrode arrays 6695a, 6695b may be positioned more proximal to enhance unfolding during deployment while allowing the electrode array 6695a, 6695b to be recaptured into the delivery catheter. In some embodiments, the electrode array 6695c may include a square-like shape including a rounded proximal upper corner. The rounded proximal upper corner may enhance feasibility of recapturing the electrode array 6695c in the delivery catheter.

[00181] In these embodiments, the electrode arrays 6695a, 6695b, 6695c may include a support structure such as a rib extension 6698a, 6698b, 6698c that supports the shape of the electrode array 6695a, 6695b, 6695c and also connects the electrode array 6695a, 6695b, 6695c to the lead chassis 6696. The rib extension 6698a, 6698b, 6698c may extend through the electrode array and may store kinetic energy while curled inside a delivery catheter, as shown in the top left corner of FIG. 28. Once the electrode array 6695a, 6695b, 6695c is released into the subdural space, the rib extension 6698a, 6698b, 6698c may cause or assist the array to open, unfold, unfurl or expand over the cortex of the brain. The rib extension 6698a, 6698b, 6698c may follow the geometry of the electrode array so that the rib extension 6698a, 6698b, 6698c does not impede recapture of the electrode array back into a catheter if needed. The rib extension may be built in as part of the electrode array and carry the lead of the electrode array back to the main branch. In some embodiments, the rib extension 6698a, 6698b, 6698c may be a polymer and/or a metal. The rib extension 6698a, 6698b, 6698c may include a conductive material (e.g., conductive polymer or metal) or a non-conductive material (e.g., non-conductive polymer or metal). FIG. 29 shows examples of the self-expanding electrode arrays 6695a for implantation in a brain of a patient.

[00182] FIGS. 30-36 illustrate various example embodiments of delivery devices for delivering one or more devices (e.g., electrode devices) to an intracranial vessel or intracranial extravascular space of a patient. FIG. 30 illustrates a brain implant (e.g., a BCI sheet array) 6795 transitioning from a delivery configuration to a deployed configuration, according to embodiments. In some embodiments, the BCI sheet array 6795 may be implanted by unraveling, or unfurling from a wire shaft 6793 that the BCI sheet 6795 may be wrapped around during delivery. In this embodiment, the wire shaft 6793 may be rotated by hand proximally outside of the catheter 6710, and the catheter 6710 and/or the wire shaft 6793 may be articulated, deflected, or maneuvered over the brain surface in the subdural space. The edge or corners of the BCI sheet 6795 may include a plurality of extensions (e.g., barbs, spikes, tines, etc.) that may latch onto the cortical surface and secure the BCI sheet array 6795 taut while being delivered.

[00183] FIG. 31 shows a delivery configuration and a deployed configuration for two types of brain implants 6895, 6995, according to embodiments. In some embodiments, the brain implant 6895, 6995 may include a self-expanding mechanism (e.g., an accordion-like mesh) 6892, 6992 that may be compressed in a main channel of a catheter 6810, 6910 and deliver a brain implant (e.g., a flexible film PCB) 6895, 6995. Any of the delivery systems described herein may be compatible with the self-expanding mechanism 6892, 6992. The self-expanding mechanism 6892 may include a series of connected wings or plates hinged together and connected to a shaft (e.g., a metal wire). The wings or plates may have a size corresponding to (1) the main channel of the catheter and (2) the size of the brain implant to be delivered such that the brain implant lays flat in the folds of the self-expanding mechanism 6892 until the brain implant 6895 is expelled from an opening of the catheter (e.g., a distal tip of the catheter) 6810.

[00184] Once the brain implant 6895 and the distal end of the self-expanding mechanism 6892 is expelled from the opening of the catheter 6810 (e.g., via a pusher or pushing device), the self-expanding mechanism 6892 may unfold in the subdural space lay the brain implant flat on the cortex. The self-expanding mechanism 6892 may fold due to the constraint subdural space. In some embodiments, the self-expanding mechanism 6892 may include spring-like features that may expand when the self-expanding mechanism is not constrained by the catheter 6810 to cause the brain implant 6895 to lay flat. The proximal geometry of self-expanding mechanism 6892 may be beveled or angled such that the self-expanding mechanism 6892 may automatically fold up as it enters the catheter after delivery of the brain implant 6895.

[00185] In some embodiments the self-expanding mechanism 6992 may include a plurality of ribs connected to a flat wire that the flexible brain implant 6995 may be wrapped around and constrained in the lumen of the catheter 6910. The flat wire may maintain the orientation of the delivery devices and brain implant 6995 such that that the brain implant is directed to the cortical surface during deployment. The delivery device 6992 and brain implant 6995 may exit through the distal tip of the catheter 6910, and once in the subdural compartment, kinetic energy stored in the ribs during delivery causes the ribs to lay flat, in turn flattening the brain implant 6995. The ribs may be angled distally allowing the ribs to fold and be recaptured by the catheter as the flat wire is pulled proximally. Each rib may include a rounded, atraumatic tip that keeps the rib from damaging any tissue once exposed and during recapture. In some embodiments the brain implant 6995 may be pressed firmly to the cortex using a balloon or expanded stent as described herein.

[00186] FIG. 32 shows a delivery configuration of a brain implant 7095, according to embodiments. In some embodiments the brain implant (e.g., a flexible film PCB) 7095 may be delivered through a catheter 7010 as described herein into the subdural compartment onto the surface of the brain. The brain implant may be delivered with a stent or stent-like structure 7092 extending from an inner catheter or shaft (e.g., a delivery wire) 7093. In these embodiments, the stent structure 7092 may include fasteners (e.g., clasps, hooks, Velcro, magnets) that may couple with the brain implant 7095 during insertion and implantation. Once in the subdural space, the stent structure 7092 can be rolled, flattened, made oval, or expanded (e.g., expanding a diameter) by articulating members (e.g., push/pull wire mechanism) that (1) place the brain implant 7095 on the surface of the brain and/or (2) decouple the brain implant 7095 from the stent structure 7092.

[00187] In some embodiments, any of the implants delivered by the delivery system may include a coating that promotes adhesion to the cortical surface. This coating may be inert, lubricious outside of the subdural compartment and may interact with the fluid in the subdural space, activating the coating causing it to become tacky such that the implant can remain in place and “adhere” to the cortical surface.

[00188] FIGS. 33A-33B illustrates a catheter 7190 with a plurality of inner channels along the length of the catheter 7190, according to embodiment. The catheter 7190 may be used to deliver depth electrodes or electrodes for dense placement. The plurality of inner channels may provide a conduit for a therapeutic device to be inserted into the subdural compartment and to contact the surface of the brain. For example, a single depth cortical electrode or BCI device may be connected to one or more leads and may be delivered using the catheter 7190. In some embodiments, a plurality of sensor wires from the depth cortical electrode or BCI device may extend through the plurality of inner channels of the catheter 7190 during delivery. A number of inner channels in the catheter 7190 may be limited by an outer diameter of the catheter and a diameter of each inner channel. The diameter of each inner channel may be determined based on the ancillary therapeutic device to be inserted. In some embodiments the multi-channel catheter 7190 may have an inflected distal segment (shown in top panel) to direct the ancillary inserted elements toward the brain surface 7101. In some embodiments, the inner channels may exit the side wall of the catheter 7190. The catheter 7190 can rotate in the subdural compartment to point the ancillary therapeutic device toward the surface of the brain 7101. In some embodiments, the catheter 7190 can be rotated and withdrawn proximally to deliver the brain implant and associated leads or wires (shown in bottom panel). In some embodiments the catheter 7190 may include apertures at different locations along the length of the catheter. The catheter 7190 may be structurally and/or functionally similar to any catheter described herein, and therefore certain details of catheter 7190 are not described in further detail with respect to FIGS. 33A-33B.

[00189] FIG. 34 shows a delivery configuration and a deployed configuration for different types of microelectrode arrays (e.g., cortical grids) 7295, 7395, according to embodiments. The delivery of cortical grids (e.g., microneedle arrays 7295 or flexible film with printed circuit boards (PCB) 7395 with wire leads) can also be achieved after gaining access to the subdural compartment using a catheter 7290 including a biasing mechanism 7213 (e.g., a balloon catheter). In some embodiments, a multi-modal catheter system can be configured to deliver a microneedle electrode array or flexible film PCB that is inserted through the inner channel of a catheter 7210. In some embodiments, the microelectrode array can be accompanied with a balloon catheter 7290 in the main inner channel, the biasing mechanism 7213 of the balloon catheter 7290 configured to push the electrode array 7295 or flexible film PCB 7395 through the 7210 and into the subdural space.

[00190] The outer catheter 7210 may be positioned over the cortex of the brain and the inner balloon catheter 7290 may push the electrode array 7295 or flexible PCB 7395 inserted in the outer catheter 7290 toward a target location. In some embodiments, the microneedle electrode array 7295 may be shaped into a circle with the microneedles pointing inward to each (top row). In some embodiments a flexible film PCB 7395 may follow a circumference of the inner main channel of the outer catheter 7210 (middle row). In some embodiments the flexible film PCB 7395 may be configured in an undulating configuration in the inner main channel of the outer catheter (bottom row, left). In some embodiment the flexible film PCB 7395 may be configured in a spiral configuration in the inner main channel of the outer catheter (bottom row, right). [00191] The electrode array 7295 or flexible film PCB 7395 may be pushed through the length of the outer catheter 7210 and out of the tip of the outer catheter 7210 using the inner balloon catheter 7290. Once the electrode array 7295 or flexible film PCB 7395 is expelled from the tip of the outer catheter 7210, the electrode array 7295 or flexible film PCB 7395 may splay open to its naturally flat shape. The balloon 7213 may be positioned over the opened electrode array 7295 or flexible film PCB 7395 and be inflated in the subdural compartment to apply a pressure (e.g., using the skull as a backstop) to the electrode array 7295 or flexible film PCB 7395 to seat the electrode array 7295 or flexible film PCB 7395 to the cortex of the brain. In some embodiments, the balloon catheter 7290 may include a beveled tip 7290a that allows for the leads directly connected to the electrode array 7295 or flexible film PCB 7395 to remain undamaged during insertion. The beveled tip 7290a may also allow for the recapture of the electrode array 7295 or flexible film PCB 7395 by orienting and shaping the BCI device into circular shape by pulling the leads through the inner lumen while the balloon 7213 is inflated to pull the electrode array 7295 or flexible film PCB 7395 off the cortex of the brain. In some embodiments, a balloon 7213 may be disposed at a distal tip of a sleeve/sheath coupled to the catheter 7290 to create expansion space by pushing the brain down away from the dura/skull.

[00192] FIGS. 35A-35C show a deployment mechanism of a catheter for supporting a brain implant 7695, 7795 in a delivery configuration and transitioning the brain implant 7695, 7795 to a delivery configuration, according to embodiments. In some embodiments, the catheter may be an outer catheter 7410, 7610, 7710, and an inner catheter device 7490, 7790 may be configured to extend through the outer catheter 7410, 7610, 7710. In some embodiments, the inner catheter device 7490 may include an extension (e.g., an atraumatic extension) 7492. In some embodiments, the inner catheter device 7790 (inner catheter device not shown in FIG. 35B) may include a plurality of atraumatic distal extensions 7692 7792. These extensions 7492, 7692, 7792 may include a material such as a polymer or a metal such as stainless steel, Nitinol or Nitinol Alloy, Cobalt Chromium, Titanium, or the like. The distal extensions 7492, 7692, 7792 may extend the length of the brain implant (e.g., the electrode array flexible film PCB) 7695, 7795 and can orient the brain implant 7695, 7795 such that it lays flat once extended out of the outer catheter 7610, 7710 in the subdural compartment. In some embodiments, the extensions 7692 may shape or support a microneedle electrode array 7695 in a circle with the microneedles pointing inward (top of FIG. 35). In some embodiments, the extensions 7792 may shape or support a flexible film PCB 7795 in an undulating configuration in the inner main channel of the outer catheter 7710 (bottom left of FIG. 35C). In some embodiment, the extensions 7792 may shape or support the flexible film PCB 7795 in a spiral configuration in the inner channel of the outer catheter 7710 (bottom right of FIG. 35C). In some embodiments the distal extensions 7792 may follow the shape of the electrode array 7695 or flexible film PCB 7795 inside of the inner channel of the outer catheter 7610, 7710 and once expelled from the tip of the outer catheter 7610, 7710 the shape of the extension will splay out the electrode array or flexible film PCB. In some embodiments, the extensions 7692, 7792 have opposing magnets configured to force or guide the extension open and splay out the electrode array 7695 or flexible film PCB 7795. In some embodiments, the inner catheter 7490, 7790 may include an inner channel configured to receive and/or contain the wire leads. In some embodiments, a tip of the catheter 7490, 7790 proximal of the extensions 7492, 7792 may be beveled for the recapture of the brain implant 7695, 7795 by orienting and shaping the BCI device into a circular shape by pulling the leads through the inner lumen to pull the electrode array 7695 or flexible film PCB 7795 off the cortex of the brain.

[00193] FIG. 36 shows deployment mechanisms for a wireless brain implant 7895, 7995, according to embodiments. Specific distal configurations may be used to deliver leadless brain implants 7895, 7995 into the subdural space. Such leadless brain implants 7895, 7995 were described above with reference to FIG. 27. In some embodiments, the leadless brain implant 7995 (shown in FIG. 36 on right) may be delivered using an expandable claw 7992 or a plurality of tines. The expandable claw 7992 may be configured to hold the leadless implant 7995 when in a compressed configuration in a main channel of the catheter 7990. In some embodiments, the expandable claw tines 7992 may be pressed through channels in the wall of the catheter 7990. The expandable claw tines 7992 may be extended distally when actuated with an actuator (e.g., a button or slider) at the proximal control mechanism of the delivery system. These expandable claw tines 7992 may be spring loaded such that when force is removed from the actuator (e.g., the button or slider) the expandable claw tines 7992 retract into the wall of the catheter 7990. In some embodiments, the catheter 7890 including cavity 7891 (shown in FIG. 36 on left) may provide an atraumatic method of delivery the leadless brain implant 7995, while the expandable claw 7995 may provide a more secure method of delivery.

[00194] In some embodiments, the distal tip of the catheter 7890 may include a cavity (e.g., an indentation, a nest, a cut-out) 7891 configured to receive the leadless brain implant 7895, as shown in FIG. 36 on left. In some embodiments the leadless brain implant 7895 is retained in the cavity 7891 using vacuum pressure (e.g., using the y-connector and vacuum channel described in FIGS. 14 and 17) and can be expelled by releasing the vacuum pressure and/or by injecting fluid (e.g., through a minor channel in the catheter wall) 7891. In some embodiments, a biologically safe tether, suture, wire or the like may retain the brain implant 7895 in the cavity 7891 of the distal tip of the catheter 7890 until the distal tip of the catheter 7890 and the implant 7895 are positioned within the subdural space. In these embodiments the tether, suture or wire can be used to help recapture the brain implant in the event of removal of the brain implant. In some embodiments the implant may be secured in the cavity using magnets.

[00195] FIG. 37A-37C depict sealing of a puncture site of a vein with sealing devices (e.g., a helical coil, a stent, or a plug, etc.) 8099, 8199, 8299 after delivery of electrodes, according to embodiments. After the therapeutic is administered and/or the device is implanted, the delivery system is to be removed for the intradural compartment and the perforation in the vessel wall/dura is closed to prevent bleeding into the intradural compartment (e.g., the extravascular space or subdural compartment). As shown in FIG. 37A, the perforation can be closed using a helical coil 8099 that is delivered from the distal tip of the catheter 8010. Catheter 8010 may be similar to any of the catheter devices described herein. The helical coil 8099 can be a bare coil, fiber coil, a coil coated with hydrogel or other coagulation promoting agent. In some embodiments, the helical coil may be partially deployed while the distal tip of the catheter 8010 is disposed in the intradural compartment. The helical coil 8099 may continue to be deployed as the catheter 8010 is withdrawn proximally such that a distal portion of the helical coil 8099 lies in the intradural compartment, a medial portion of the helical coil 8099 transverses the vessel wall, and a proximal portion of the helical coil 8099 lies in the inner volume of the vessel. The helical coil 8099 may plug the perforation and promote closure to prevent bleeding into the intradural compartment.

[00196] In some embodiments the perforation may be closed with a scaffold, or covered stent 8199, as shown in FIG. 37B. The stent may be constructed of superelastic shape memory alloys and/or a medical grade mesh or textile. While shown as being disposed in a vessel with a circular cross-section, it can be appreciated that the scaffold or stent 8199 can be self-forming or constructed into a triangular shape to match the SSS geometry. The scaffold 8199 may be pushed out of the distal tip of a catheter (not shown) and may cover a single perforation or multiple perforations made during the intervention. The scaffold 8199 may allow for blood to flow through the scaffold 8199 along the length of the scaffold 8199 passing over the apertures of the catheter, but the scaffold may prevent blood from flowing across a sidewall of the scaffold 8199 between the vessel and the intradural compartment.

[00197] In some embodiments, the perforation may be closed with a double-sided plug 8299 that can be extruded out of the distal tip of the catheter type devices described herein, as shown in FIG. 37C. The plug 8299 may be constructed of or include a superelastic shape memory alloy. The plug 8299 may include three distinct segments (e.g., a distal portion, a medial portion, and a proximal portion) secured distally, medially, and proximally, respectively. In some embodiments, the plug 8299 may be partially deployed while the distal tip of the catheter 8210 is disposed in the intradural compartment (FIG. 37C, left panel). The plug 8299 may continue to be deployed as the catheter 8210 is withdrawn proximally such that a distal portion of the plug 8299 lies in the intradural compartment, a medial portion of the plug 8299 transverses the vessel wall, and a proximal portion of the plug 8299 lies in the inner volume of the vessel. In some embodiments, the distal portion and the proximal portion of the plug 8299 may be expandable, such that the distal portion and the proximal portion seal the perforation in the vessel. In some embodiments, the plug 8299 may be covered with a medical mesh or textile and may be coupled to a wire element that allows the sealing device to stay straight in the catheter 8210 and to transition to a deployed configuration when released. The distal portion and the proximal portion of the plug 8299 in the deployed configuration may expand to a flat disc shape on both sides of the vessel wall/dura: one side in the intradural compartment and the other side in the vessel. The plug 8299 may be deployed in a taut configuration from the distal end of the catheter 8010. The plug 8299 may be aligned with a medial fluoroscopic marker placed in the perforation in the vessel wall/dura. Once the catheter 8010 with the sealing device is positioned, tension can be released, and the plug 8299 may flatten and expand covering the perforation on the intradural compartment side and the vessel side closing the perforation. The proximal end of the plug 8299 may include a mechanism that may cause the shaft delivering the plug to disengage with the plug once the plug 8299 is deployed.

[00198] In some embodiments, a segment of the delivery system (for example, a portion or layer of the catheter) can be detached from the rest of the assembly resulting in closure of transvenous passage. In some embodiments, a layer or a component of the delivery system can be detached resulting in closure of the perforation. For example, an outer coating of hydromorphic polymers on the catheter may be shed from the catheter and positioned across the perforation, resulting in rapid expansion and complete occlusion of the perforation. Detachment mechanisms of this layer include soft or pre-perforated polymer joints that may separate once the peak tensile force is achieved. In some embodiments, a component of the delivery system, such as a catheter or a lead, may remain in the perforation, resulting in closure of the venotomy/durotomy. In some embodiments, the sealing device may include expansile elements in an outer surface thereof to improve the seal across the vascular wall and dura. For example, the sealing device may include a material including hydromorphic polymers such as hydrogel.

II. METHODS

Accessing Extravascular Space:

[00199] Described herein are systems, devices, and methods for accessing the extravascular space (e.g., the intracranial space). Systems and devices described herein can be configured to enable transvascular surgery including, but not limited to, improving access to an extravascular space, treatment of a subdural hematoma, delivery of a drug or therapeutic agent, delivery of a device (e.g., sensor, electrode, biopsy device, ablation device, catheter, draining system), tissue sampling, implantation of a device, implantation of ancillary devise such as BCI and/or electrode arrays, etc. Similar systems, devices, and methods are described in U.S. Provisional Application No. 63/645,053, filed May 9, 2024, entitled, “SYSTEMS, DEVICES, AND METHODS FOR ACCESSING AN EXTRAVASCULAR SPACE AND REMOVAL OF FLUIDS THEREFROM,” the disclosure of which is incorporated by reference herein.

[00200] FIG. 38 is a flow chart of an example method for transvascular delivery of electrodes into a subdural space of a patient, according to an embodiment. At 10, the method may include navigating a catheter to a target perforation location in a vessel (e.g., an artery or vein such as the MMA or the transverse sinus) of a patient. The catheter may be structurally and/or functionally similar to any of the catheters described herein. At 12, the method includes transitioning the catheter into a perforation configuration to secure the catheter in the vessel. For example, in the perforation configuration, the catheter may form a curved shape with an apex of the curve configured to abut a wall or corner of the vessel. The perforation configuration may help brace the catheter during perforation of the vessel. At 14, the method includes advancing a shaft including a perforating element through an opening in the catheter toward the target perforation location. The opening in the catheter may be at a distal tip and/or on a sidewall of the catheter. In some embodiments, the catheter may include a plurality of openings, and one or more shafts may be disposed through a respective opening from the plurality of openings.

[00201] At 16, the method includes perforating a vessel wall using the perforation element to access an intracranial space of the patient. In some embodiments, perforation may be achieved by applying energy to the tissue (e.g., RF energy) via an electrode and/or be puncturing the tissue with a sharp surface and/or a drill-like tip. At 18, the method may optionally include advancing the distal end of the catheter through the perforation and into the intracranial space. At 20, the method includes delivering a therapeutic and/or a brain implant to a brain of the patient through the opening in the catheter. In some embodiments, one or more electrode arrays, BCI’s, and/or leadless BCI’s may be implanted on the surface of the cortex and or in a brain of the patient. At 22, the method includes withdrawing the catheter and/or a delivery system coupled to the catheter from the subdural space and into the vessel. At 24, the method includes sealing the perforation using a sealing device to prevent blood from flowing into the subdural space.

[00202] In some embodiments, arterial and/or venous endovascular approaches may be used for the delivery of devices into a intracranial space in the brain. Access may be accomplished via arterial access sites such as, for example, a femoral, radial, carotid, or subclavian/axillary. Access may also be accomplished via venous access sites such as, for example, a femoral, cephalic, jugular, or subclavian. In some embodiments, the bifurcation of a vessel may facilitate navigation and positioning of a catheter assembly to provide directional access to a intracranial space. This is particularly relevant for the vasculature associated to the dura, including the middle meningeal artery (MMA) travelling epidurally and the venous sinuses in an intradural location, venous structures including venous sinuses and veins of the brain and spine, etc.

[00203] FIG. 39 is a diagram of an underside of a brain showing a MMA 8355 and the Transverse Sinus 8358. A portion of the MMA 8355 located near a base of the skull as the vessel passes the foramen spinosum may be a target location for the devices, systems and methods described herein. However, the devices, systems, and methods herein may not be limited to use in the MMA 8355. For example, the Sigmoid sinus and Transverse sinus 8358 are also located near the base of the skull and can be utilized for the devices, systems, and methods described herein for a venous endovascular access. In some embodiments, a catheter (e.g., any of the catheters described herein) may traverse vasculature to common carotid arteries and then to the MMA 8355.

[00204] FIGS. 40A-40D are cross-sectional side views of a method of accessing an extravascular space via the MMA 8355, according to embodiments. As shown in FIG. 40A, the MMA 8355 includes multiple segments including (1) an extracranial segment, (2) a bony (or intra-osseous) segment 8355a, and (3) an intracranial segment 8355b. The bony segment 8355a is surrounded by bone, straight in geometry and turns 90 degrees laterally at the foramen spinosum 8356 to continue as the intracranial segment 8355b. Also shown is the general location of the brain and temporal horn of the lateral ventricle 8352. The MMA 8355 passes the foramen spinosum 8356 at the base of the skull 8304 and traverses between the dura 8309 and skull 8304. This particular anatomy provides a predictable, stable (e.g., due to bone for anchoring delivery devices), and a favorable trajectory to obtain transvascular access to the intradural compartment and related structures (sub-temporal subdural space (i.e., subdural space 8306), brain 8301, ventricles 8352, etc.). The trajectory for transvascular access at the foramen spinosum 8356 is substantially parallel to the arterial lumen of the bony segment 8355a of the MMA 8355, and substantially perpendicular to the dura 8309 and brain surface. Therefore, the brain 8301 may be accessed using minimally invasive endovascular techniques and devices.

[00205] In some embodiments, a delivery system including a sheath 8385 and a catheter 8310 may be used to navigate through the MMA 8355 to a target perforation location, as shown in FIGS. 40B-40D. Once at the target perforation location, a shaft 8320 including a perforating element on a distal end of the shaft 8320 may be used to perforate the vessel wall/dura 8309. In some embodiments, the perforating element may include a radiofrequency (RF) element, for example, to perforate the vessel wall/dura 8309 leading to the subdural compartment 8306 and the temporal lobe of the brain 8301. Once vessel wall/dura 8309 is perforated, the shaft 8320 and/or the catheter 8310 may be advanced toward the brain 8301, along a surface of the brain 8301, and/or toward the ventricle 8352, as shown in FIGS. 40C-40D. Therapies can then be administered and/or devices can be delivered to a subdural compartment 8306, brain 8301, or ventricle 8352, once access is achieved. In some embodiments, the catheter 8310 and shaft 8320 may be structurally and/or functionally similar to the any catheter and shaft described herein, and therefore the catheter 8310 and shaft 8320 are not described in further detail with respect to FIGS. 40A-40D. [00206] FIGS. 41A-41G illustrates different types of brain implants, specifically BCI type devices, that can be transvascularly delivered to the brain surface or brain parenchyma by a catheter after gaining intradural access from a perforation point, for example, in the MMA at the foramen spinosum. In some embodiments, a sheet or PCB film electrodes 8395 that covers a portion of the cortex may be implanted via the MMA 8455, as shown in FIG. 41 A. In some embodiments microneedle arrays 8595a, 8595b and individual depth electrodes 8695 and 8795 can be delivered to targeted locations of the cortex, as shown in FIG. 41B. In some embodiments, an electrode with multiple forks, tines 9295, or branches 9395 can be delivered to span targeted locations of the cortex, as shown in FIG. 41G. In some embodiments, the electrode can “S” or snake 8995 along the cortex of the brain covering a targeted area, as shown in FIG. 4 IE right. In some embodiments the electrode can have “ribs” the branch off a backbone 8895, as shown in FIG. 4 IE left. In some embodiments, the electrode can spiral over the brain surface 9095 covering a targeted area of the cortex, as shown in FIG. 4 IF left. In some embodiments, individual lead depth electrodes 9195 can be delivered to targeted locations of the brain cortex, as shown in FIG. 4 IF right.

[00207] These electrode constructs 8495, 8595, 8695, 8795, 8895, 8995, 9095, 9195, 9295, 9395 can be formed in the intracranial space and may open into a respective form using preshaped material such as, for example, superelastic metals such as nitinol or nitinol alloys. The brain implants including the electrode constructs 8495, 8595, 8695, 8795, 8895, 8995, 9095, 9195, 9295, 9395 may be similar to the brain implants described with respect to FIGS. 26-29, and therefore certain details of the electrodes and brain implants are not described with respect to FIGS. 41A-41G. For example, when the catheter is withdrawn proximally to expose the electrode constructs 8495, 8595, 8695, 8795, 8895, 8995, 9095, 9195, 9295, 9395 of the brain implant (e.g., the BCI) in the intracranial space, kinetic energy stored due to the brain implant being constrained in the catheter during delivery may cause the brain implant to transition into its final form (e.g., a delivered configuration, an expanded configuration, etc.). In some embodiments, the electrode constructs 8495, 8595, 8695, 8795, 8895, 8995, 9095, 9195, 9295, 9395 may include hollow tubing, metal, or polymers. In some embodiments, a fluid, such as saline, may be injected (e.g., via catheter 8310) through an inner channel or lumen of the catheter, thereby creating a pressure build up at a distal end of the catheter that may promote the electrode constructs 8495, 8595, 8695, 8795, 8895, 8995, 9095, 9195, 9295, 9395 to transition into a final form. In some embodiments, the inner channel or lumen of the catheter may be used to insert a wire device (e.g., similar to FIG. 35) that can be used internally by either creating tension or compression to manipulate the branches of the electrode constructs 8495, 8595, 8695, 8795, 8895, 8995, 9095, 9195, 9295, 9395 to open into the final form. In some embodiments, the branches of the electrode constructs 8495, 8595, 8695, 8795, 8895, 8995, 9095, 9195, 9295, 9395 can include polar magnets. When the brain implant is unconstrained by the catheter, the opposing forces of the polar magnets may cause the electrode constructs 8495, 8595, 8695, 8795, 8895, 8995, 9095, 9195, 9295, 9395 of the brain implant to take a final form. Additionally or alternatively, an external magnetic source around the skull can be used to guide the branches of the electrode constructs 8495, 8595, 8695, 8795, 8895, 8995, 9095, 9195, 9295, 9395 to a final form. In these embodiments, these electrode constructs 8495, 8595, 8695, 8795, 8895, 8995, 9095, 9195, 9295, 9395 are radiopaque or have radiopaque markers for confirmation under fluoroscopy that the constructs are open, located appropriately and in their final form.

[00208] FIG. 42 is a schematic of an example position within the head space of a brain implant including electrical leads 9495 (left) and a wireless brain implant 9595 (right) delivered using a catheter, according to embodiments. As shown, the electrical leads 9496 of the brain implant 9495 with electrical leads (left) are connected to a pulse generator 9497 implanted subcutaneously elsewhere in the body, usually in the chest below the clavicle. In some embodiments, the leads 9496 may traverse the MMA to the subclavian arteries where the leads exit the vessel and connect to the implanted pulse generator 9497. In some embodiments, the leadless implant 9595 may include a pulse generator 9597 built into the brain implant 9595. In either of these embodiments, the pulse generators 9497, 9597 may be located magnetically and charged using wireless fields for transfer of energy.

[00209] FIGS. 43 A-43B show a delivery system including a catheter 9610, 9710 for accessing an extravascular space, according to embodiments. FIGS. 43C-43D show the delivery system including the catheter 9610, 9710 navigating intracranially showing a lateral ventricle, 9652, 9752 of the brain 9601, 9701, according to embodiments. The catheter 9610, 9710 may be navigated to the brain 9601, 9701 through a sheath 9685, 9785. As shown in FIGS. 43A-43B, the catheter 9610, 9710 defines a main channel or lumen 9621, 9721 therethrough and a sidewall aperture 9614, 9714 in a sidewall thereof. The catheter 9610, 9710 includes a perforating element 9624, 9724 (e.g., an electrode element) on a distal tip thereof for perforating the dura 9609, 9709 such that the catheter 9610, 9710 can be advanced through the dura 9609, 9709 and into the subdural space 9606, 9706. In some embodiments, the perforating element 9624 may be constructed from a material including stainless steel, nitinol, nitinol alloy, silver, platinum, iridium or tungsten connected to supply wire 9632, 9732 of the same respective material embedded in the wall of the catheter 9610, 9710 to deliver energy such as radiofrequency (RF) used to perforate the vessel wall/dura.

[00210] As shown in FIG. 43B, in some embodiments, the catheter 9710 may include a stopper 9733 disposed a predetermined distance from the distal tip of the catheter 9710. The stopper 9733 may aid in delivery of devices and therapeutics to the sub -temporal subdural space 9706. The stopper 9733 may include a focal increase in an outer diameter of the catheter 9710 for depth-controlled perforation. For perforations at the MMA at the foramen spinosum, the stopper 9733 may be about 0.002 inches to about 0.020 inches larger than the outer diameter of the catheter 9710 and located about 0.5 mm to about 2.5 mm proximal to the side wall aperture 9714, inclusive of all ranges and subranges therebetween. This design results in advancement of the side wall aperture 9714 through the vessel wall and dura 9709 but not into the brain 9701. In a method of use, recognition of alignment of the side wall aperture 9714 with the subdural space 9706 can be obtained by injection of liquid (including contrast) or advancement of a wire into the subdural space 9706. In some embodiments, the catheter 9610, 9710 may include one or more fiducial markers 9674, 9774 disposed near a distal tip of the catheter 9610, 9710. In some embodiments, the fiducial markers 9774 may be aligned with the stopper 9773 along a length of the catheter 9710, as shown in FIG. 43B.

[00211] Once the catheter 9610, 9710 has perforated the dura 9609, 9709 and accessed an subdural space 9606, 9706, one or more ancillary devices (e.g., for accessing subdural space and/or delivery brain implants) may be advanced through the main channel 9621, 9721 and out of the sidewall aperture 9614, 9714. The main channel 9621, 9721 may form a sharp curve (e.g., about 90 degrees) at a distal end of the catheter 9610, 9710 such that the one or more ancillary devices may be guided to exit the aperture 9614, 9714 at approximately a 90 degree angle and extend between the brain 9601 and dura 9609 in the subdural space 9606. In some embodiments, the catheter 9610, 9710 have flexibility such that the catheter 9610, 9710 flexes and bends with the anatomy of the vasculature. In some embodiments, the catheter 9610, 9710 may include one or more articulating elements (e.g., pull wires) such that the catheter 9610, 9710 may be articulated into different configurations to accommodate the anatomy of the subject. The articulating elements may enable the catheter to navigate through the sharp curves of the MMA to access the intracranial space.

[00212] The catheter 9610, 9710 may be structurally and/or functionally similar to any of the catheters described herein, and therefore the catheter 9610, 9710 is not described in further detail with respect to FIGS. 43 A-43D.

[00213] FIG. 44 A shows a catheter 9810 including a hypodermic tubing/needle 9820 for accessing a lower subdural compartment 9806, according to embodiments. FIGS. 44B-44C show the delivery system including the catheter 9810 and hypodermic tubing/needle 9820 navigating intracranially showing a lateral ventricle, 9852 of the brain 9801. The catheter 9810 may be navigated to the brain 9801 through a sheath 9885. As shown in FIGS. 44A, the catheter 9810 defines a main channel or lumen therethrough and a sidewall aperture 9814 in a sidewall thereof. The catheter 9810 includes a perforating element 9824 (e.g., a distal electrode element) on a distal tip thereof for perforating the dura 9809 such that the catheter 9810 can be advanced through the dura 9809 and into the subdural space 9806.

[00214] In some embodiments, the perforating element 9824 may be constructed from a material including either stainless steel, nitinol, nitinol alloy, silver, platinum, iridium, or tungsten connected to supply wire 9832 of the same respective material embedded in the wall of the catheter 9810 that can deliver energy such as radiofrequency (RF) used to perforate the vessel wall/dura 9809. The aperture 9814 can be used as a conduit to deliver therapeutics, liquids, interventional devices, and implants. In some embodiments, the catheter can be used in combination with a hypodermic tube/needle 9820 constructed of a material including stainless steel, nitinol, nitinol alloy, or cobalt chromium that is used in the delivery of the aforementioned devices as well as take biopsies to the subdural compartment 9806 or the brain cortex 9801.

[00215] The main channel may form a curve (e.g., about 90 degrees) at a distal end of the catheter 9810 such that the hypodermic tubing/needle 9820 and/or one or more ancillary devices may be guided to exit the aperture 9814 at approximately a 90 degree angle and extend between the brain 9801 and dura 9809 in the subdural space 9806, as shown in FIG. 44B. The hypodermic tubing/needle 9820 may have a flexibility such that when the hypodermic tubing/needle 9820 is advanced through the catheter 9810 and into the subdural space 9806, the hypodermic tubing/needle 9820 is guided by a shape of the catheter 9810 and a shape of the skull, respectively. One or more ancillary devices may be extended through the hypodermic tubing/needle 9820 and into the subdural space 9806 and/or the cortex. In some embodiments, the catheter 9810 may be extended into the subdural space toward the brain 9801, and the hypodermic tubing/needle 9820 may extend out of the aperture such that ancillary devices can target a portion of the brain 9801, as shown in FIG. 44C. The hypodermic tubing/needle 9820 may provide better access for ancillary devices disposed therethrough, as the hypodermic tubing/needle 9820 can extend at about a 90 degree angle from the sidewall aperture 9814. The catheter 9810 and hypodermic tubing/needle 9820 may be structurally and/or functionally similar to any of the catheters and hypodermic tubing/needles described herein, and therefore the catheter 9810 and hypodermic tubing/needle 9820 are not described in further detail with respect to FIGS. 44A-44C.

Implantation:

[00216] In some embodiments, the transvascular delivery system and/or an ancillary device used with the transvascular delivery system may be designed for long term implantation. Implantation may be required for diagnostic and therapeutic purposes, for example. In some embodiments, at least a portion of a catheter assembly can be implanted for delivery of pharmacological agents into the central nervous system and/or an electrode assembly can be implanted for sensing and/or recording. In some embodiments, a proximal end of the implanted catheter assembly may be coupled to a pump, a reservoir, and/or an injection port for delivery of the pharmacological agents. In some embodiments, a proximal end of the electrode assembly may be coupled to a pulse generator or wireless technology.

[00217] Embodiments for implantation may have specific features to anchor the device assembly (e.g., the catheter assembly and/or the electrode assembly) in a transvascular position, including expanding elements (e.g. balloons, stents, baskets, coils) and deployable elements (fingers, ribs, fins). In some embodiments, the device assembly may acquire a three- dimensional (3D) shape. For example the device assembly may have a preformed 3D shape prior to use and may elongate/straighten when constrained in (1) the vessel, (2) a delivery catheter (e.g., an outer shaft), and/or (3) by a guidewire or inner shaft in the lumen of the device assembly. When the guidewire or constraining outer/inner shaft is removed and/or when a pull wire is actuated, the device assembly may form a 3D spiral shape that results in radial expansion and anchorage to the surrounding vascular wall. These elements can provide anchorage in an extravascular, transvascular, or intravascular position. In a typical method of use, after gaining transvascular access, the anchoring systems are actuated resulting in fixation of a least of segment of the implant (e.g., the implantable portion of the catheter assembly and/or the electrode assembly) to the surrounding tissues.

[00218] In some embodiments, embolic agents are delivered intravascularly to anchor the device assembly to the vessel and to ensure hemostasis. Embolization agents include, for example, cyanoacrylate glues, and/or ethylene vinyl-alcohol copolymers. In some embodiments, the embolization agents are delivered by additional lumens of the device assembly with side wall apertures oriented towards the vascular lumen (for example, trunk of the MMA) while the distal segment of the implant is in a transvascular position. In a typical embodiment, the side wall apertures are substantially close to the transvascular access point in the segment of the device that remains intravascularly. In a typical method of use, after gaining transvascular access and placing the implant in the intended location, embolic agents may be injected through the accessory lumen into the target vessel resulting in a cast that surrounds the implant, anchors the implant to the vascular wall, and prevents blood inflow and bleeding. Typically, the cast of the embolization agent surrounds 5mm to 50mm of the device proximal to the perforation point, and 1mm to 20mm the vascular segment distal to the perforation point, including all ranges and subranges therebetween.

[00219] In some embodiments and methods of use, sclerosing agents including ethanol and sodium tetradecyl sulfate are delivered to contract the artery around the implant resulting in anchoring and hemostasis.

[00220] In some embodiments, expandable substances including hydrogel polymer and gelatin are included in the assembly design to expand intravascularly and through the perforation point resulting in anchoring and hemostasis.

[00221] In some embodiments, electrosurgery electrodes are included in the device assembly (e.g., catheter assembly and/or the electrode assembly) for electrocoagulation of the vasculature in monopolar or bipolar mode. In a typical method of use, after gaining and maintaining transvascular access, electrosurgery energy is delivered to the intravascular electrodes systems resulting in coagulation of proteins with vascular contraction and clot formation resulting in rapid anchoring and hemostasis. Severing Septum:

[00222] FIGS. 45A-45C show devices for cutting a vessel septum 9901, according to embodiments. In some cases, a septum or septations 9901 can be found in a venous system, for example, in the SSS 9905. These septation 9901 can block the path of the delivery systems, catheter devices, and/or therapeutic devices described herein and/or direct these devices along unintended paths. Therefore, septations 9901 may need to be severed or removed to allow for devices to pass through the vessel (e.g., such that the devices can reach a target perforation location). In some embodiments, a cutting device 9932 (e.g., a wire type device, a severing device, a blade, or a tined device) can be used to sever the septum 9901, as shown in FIG. 45B. The cutting device 9932 may include an elongate member or shaft 9930 and a distal feature configured to sever the septum 9901. In some embodiments, a catheter or shaft 9910 may be disposed in the vessel, and the cutting device 9932 may be slidably disposed through the catheter 9910. The catheter 9910 may be similar to any of the catheters described herein. The cutting device 9932 may be disposed through the catheter 9910 to sever the septum 9901, and after severing the septum(s) 9901, the cutting device 9932 may be withdrawn such that subsequent devices (e.g., a perforating member) may be disposed through the catheter 9910.

[00223] The septum 9901 may be severed by advancing the cutting device 9932 forward (i.e., distally) into the septum 9901 to cut the septum 9901 with the distal feature. In some embodiments, the distal feature of the cutting device 9932 may include one or more tines or blades 9935 (e.g., 1 tine, 2 tines, 3 tines, 4 tines, 5 tines). In some embodiments, an inner edge or interior surface 9934 of each tine 9935 may include a sharp edge or blade. In some embodiments, an outer edges 9933 of each tine 9935 can include an atraumatic portion such as a smooth or rounded surface or edge to prevent damage to the catheter 9910 or vessel. In some embodiments, the tines 9935 of the distal feature may each include an atraumatic tip 9931. For example, the tines 9935 may include a round ball, bulbous shape, deformable material, and/or a rounded edge at a distal end thereof to prevent damage to the catheter 9910 and/or the surrounding vessel. In some embodiments, the atraumatic tip 9932 can include a round ball having a diameter between about 0.1 mm and about 0.5 mm, inclusive of all ranges and subranges therebetween.

[00224] As shown in FIG. 45C, a cutting device 10032 may include two tines 10035, each tine 10035 including a sharp edge on the interior of each tine 10035. In some embodiments, the cutting device 10132 may include laparoscopic style forceps (e.g., a pair of blades that can move relative to one another). In some embodiments, the cutting device 10232, 10332 may be coupled to an energy source and configured to be energized on the interior of the tine 10234, 10334. For example, RF energy may be localized on the interior of the tine 10232, 10334 to more easily cut through tissue. In some embodiments, the tines of the distal feature of any of the cutting devices described herein can be between about 0.1 mm to about 15.0 mm in length, inclusive of all ranges and subranges therebetween. In some embodiments, the distal feature can form a shape configured to receive the septum and guide the septum toward a sharp or energized edge. For example, the distal feature 9932, 10032, 10132, 10232, 10332 may form a U-shape or V-shape. In some embodiments, the distal feature 10132 can be spring loaded in a manner such that it is recapturable in the catheter. In some embodiments, the cutting device can include any combination of the distal features (e.g., number of tines, blades, energized surfaces, movable tines, etc.) described herein.

[00225] FIGS. 46A-46B show cutting devices 10432, 10532, 10632 for cutting a vessel septum 10401, according to embodiments. In some embodiments the cutting device 10432, 10532, 10632 can include a hook 10435, or a plurality of hooks, used to extend past the septation 10401 (e.g., distally) and be withdrawn or retracted (e.g., proximally) into the catheter 10410. In some embodiments, severing the septum 10401 can be accomplished by slidably disposing the cutting device 10432, 10532, 10632 including the distal feature including one or more hooks inside a previously placed catheter 10410, extending the distal feature 10432, 10352, 10632 distally past the septum 10401, and retracting the distal feature 10432, 10532, 10632 into the catheter 10410 to cut the septum 10401. Therefore, the septum 10401 may be severed during proximal motion of the cutting device 10432, 10532, 10632. The hooks can include atraumatic rounded tips that prevent damage to the catheter 10410 and/or vessel. In some embodiments, the hooked distal feature may form a rounded, blunt, or atraumatic distal end to prevent damage to the catheter 10410 and surrounding tissue. In some embodiments, interior edge(s) of the hooks 10432, 10532, 10632 configured to make contact with the septum 10401 can (i) include a sharp portion so that the septum can be cut, or (ii) have RF energy supplied to a portion of the interior edge(s) to vaporize the septum 10401. In some embodiments, an outer edge 10433 of each hook can include an atraumatic surface (as described above with respect to FIG. 45A-45C) to prevent damage to the catheter 10410 and/or the vessel. In some embodiments, the cutting device 10432, 10352, 10632 can include any suitable number of hooks such as, for example, 1 hook, 2 hooks, 3 hooks, 4 hooks, 5 hooks, inclusive of all ranges and subranges therebetween. In some embodiments, the hook may be moveable. For example, the hook may be configured to move laterally toward and away from a shaft of the cutting device to help guide the tissue toward a sharp or energized portion of the hook.

[00226] FIGS. 47A-47B shows a cutting device 10732 including a hooked distal feature for cutting a vessel septum 10701 in the SSS 10705, according to embodiments. As shown, the distal feature includes three tines 10735 (e.g., hooked tines) forming a trident configuration. In some embodiments, the trident configuration can be used to positively locate the distal feature of the cutting device 10732 in the SSS 10705. For example, the three tines or hooks 10735 can be configured to sit in the corners of the triangular SSS 10705, as shown in FIG. 47A. In some embodiments, the tines or hooks 10735 can be sized, spaced, and/or geometrically located such that the edges of the cutting device seat in the comers of the SSS 10705. In some embodiments, the cutting device 10732 can be slidably disposed through and/or moved along any length of the SSS 10705, cutting any and/or all septations 10701 in the devices path, thereby opening up the vessel for delivery of devices. In some embodiments, the cutting device 10705 may be disposed through the catheter and used to cut one or more septations prior to using the catheter for perforating and/or delivering ancillary devices.

Treating Granulations:

[00227] FIGS. 48A-48D show devices for removing granulations 10801 on an inner wall of a vessel, according to embodiments. In some cases, granulations 10801 can be found in the venous system, for example, the SSS 10805, as shown in FIG. 48A. These granulations 10801 can direct or block the path of the delivery system and/or therapeutic devices described herein. Therefore, granulations 10801 can be severed and/or removed from the vessel to open up the vessel and to allow devices to pass. In some embodiments, the granulation 10801 can be removed using a catheter 10830 including an electrode tip 10833 disposed a distal end (e.g., at a distal edge) of the catheter 10830 and configured to apply energy, as shown in FIG. 48B. For example, the distal edge of the catheter 10830 can be disposed near and/or pressed into the granulation 10801 and energy can be applied to the electrode tip 10833 of the catheter device 10830 through monopolar or bipolar electrocoagulation, or argon-plasma coagulation. In some embodiments, the electrode tip 10833 can be a heat probe. In some embodiments, a sclerosing agent can be used to loosen the granulation 10801 for removal. For example, a channel can be fed through the catheter 10830 such that a distal end of the channel is disposed near the granulation 10801, and the channel can be configured to deliver a sclerosing agent to the granulation 10801.

[00228] In some embodiments, a lasso device 10932 can include a lasso, loop, or hoop 10933 at a distal end thereof and be used to mechanically cut the granulation 10901, and/or to supply RF energy to vaporize the tissue around the granulation 10901 for removal. In some embodiments, the lasso device 10932 may be navigated to the granulation 10933 in a delivery configuration (e.g., shown in FIG. 48C on far right). The lasso device 10932 may be advanced from the catheter 10930 such that the granulation 10901 is disposed within the lasso 10933, shown in FIG. 48 A on far left. The lasso device 10932 can include a sharp edge or blade and/or an energized portion (e.g., on an inner edge of the lasso) such that when the lasso device 10932 is withdrawn proximally, the lasso device 10932 severs the granulation 10901 from the vessel wall. In some embodiments, the lasso device 10932 may include any suitable number of lassoes or loops 10933 such as, for example, 1 lasso, 2 lassoes, 3 lassoes, 4 lassoes, and/or 5 lassoes.

[00229] In some embodiments, a granulation 11001 can be removed by using a cutting device 11032 including tines or forceps 11033 (e.g., similar to the cutting devices described in FIGS. 45B and 45C). In some embodiments, the cutting device 11032 can be advanced through a catheter 11030 and configured to cut the tissue at the base of the granulation 11001. In some embodiments, the tines 11033 may include a surface configured to supply RF energy to vaporize the tissue for granulation removal. In these examples a vacuum source can be connected to the proximal end of the catheter to pull the granulation 11001 into the device for removal. In some embodiments a rotational or orbital atherectomy device can be used to mechanically dislodge and remove the granulation under vacuum.

[00230] FIGS. 49A-49B show a lasso device 11132 configured to remove granulations 11101 on an inner wall of a vessel 11105, according to embodiments. In some embodiments, a combination of lassoes 11133 can be disposed at the distal end of the lasso device 11132. As shown, the lasso device 11132 can include three lassoes 11133. In some embodiments, the lassoes 11133 can have a geometry corresponding to the SSS 11105. For example, the lassoesl 1133, as shown in FIG. 49 A can be sized and geometrically located, such that the edges of the lasso device 11132 sit in the comers of the triangular SSS 11105. In some embodiments, the lassoes 11133 can be used to positively locate the lasso device 11132 in the SSS 11105. In some embodiments, the lasso device 11133 can be slidably disposed through any length of the SSS 11105 cutting any and all granulations 11101 in the devices path, thereby preparing the vessel for perforation and/or delivery of devices (e.g., BCI implants).

Pre-operative Planning and Device Advancement:

[00231] Embodiments described herein include methods and apparatuses for transvascular stereotaxis. Embodiments described herein can provide a minimally invasive transvascular technique that uses a three-dimensional coordinate system to precisely locate and target specific areas within the body, particularly the brain, for procedures such as biopsies, injections, ablations, or electrode implantation. In some embodiments, transvascular stereotaxis can be endovascularly framed or frameless. For example, being endovascularly framed refers to using the natural anatomy (e.g., inflection points of vessels, small passageways through bone, etc.) to provide reference points to create a coordinate system and/or to provide anchor points that can help fix a portion of an endovascular apparatus being navigated at particular points within the coordinate system. Therefore, embodiments described herein allow for precise localization of targets within the body (e.g., head) without any external structures or framing. In transvascular stereotaxic procedures to the brain, the dural vessels can provide a stable spatial position (e.g., relative to a target location in the brain) given their attachment to the skull. At least a portion of the endovascular apparatus (e.g., a portion of a catheter or guide sheath) can therefore be anchored to the dural vessel and bone to act as an endovascular frame for transvascular stereotaxis. For example, the MMA is fixed to the skull at the foramen spinosum. Because the MMA routes through the base of the skull, the MMA can be advantageous to target specific locations of the lower brain. FIGS. 50A is a coronal views of a brain 11201 of a patient depicting the location of the temporal lobe 11203 with relationship to the MMA 11255. FIG. 50B is a sagittal view of the brain 11201 showing a location of the Amygdala and hippocampus 11204 in relation to the MMA 11255.

[00232] FIGS. 51A-51E illustrates a Cartesian coordinate system to portray the three- dimensional operational space for targeted access and delivery of therapy to a brain of a patient. In some embodiments, one or more images can be captured using one or more imaging modalities to create the Cartesian coordinate system for the brain of the patient prior to or during a procedure. In some embodiments, preoperative images such as magnetic resonance imaging (MRI) or computerized tomography (CT) can be merged with intraoperative images such as fluoroscopy and flat-panel CTs to acquire volumetric renderings of the anatomy and provide the coordinate system to guide procedures. Boney structures such as the skull that are identified in pre-operative images and intraoperative images can be used during registration to increase the accuracy of the merge or fusion overlay of the pre-operative and intraoperative images. For example, boney structures in the pre-operative images may be aligned with the same boney structures in intraoperative images to merge, align, or fuse the images to generate merged images. During the procedure the trajectory between the starting point (e.g., a point of entry into the skull) and the target point (e.g., location to treat or implant) can be selected in the merged images and followed in real time fluoroscopically by the displacement of radiopaque markers.

[00233] During operation, the three-dimensional operational space is determined through imaging such as flat panel CT, traditional CT, functional magnetic resonance imaging (MRI) or positron emission tomography (PET). These imaging techniques can be used to create and define views for guided stereotaxis in the brain (e.g., the lower brain). For example, in an Axial view (FIG. 51 A), an X plane and Z plane can be defined as a way of identifying a target location “T” in the Axial two-dimensional plane. In the Coronal view (FIG. 5 IB), an X plane and Y plane can be defined as a way of identifying a target location “T” in the Coronal two- dimensional plane. In the Sagittal view (FIG. 51C), a Y plane and Z plane can be defined as a way of identifying a target location “T” in the Sagittal plane.

[00234] The three axes can be combined into a three-dimensional coordinate system (FIG. 5 ID) for determining trajectories of an endovascular apparatus relative to the target location. The combination of the three views and target locations define a specific three-dimensional X, Y and Z target location in the brain 11201 as well as identify locations of fiducials, such as bone, dura, anatomical landmarks such as the ventricles 11252 or particular features of the device/system (such as radiopaque markers) in guidance of the devices to deliver therapy. Fiducials can be both internal (part of the patient anatomy or apparatus) or external, for example attached to the skin or outer surface of the patient.

[00235] In some embodiments, pre-operative and intraprocedural images are acquired with the fiducials in place. The fiducials remain fixed to the patient’s anatomy when they are part of the reference frame during registration and the stereotaxic procedure. There are other dynamic fiducials (e.g., radiopaque markers on the catheter) that are part of the transvascular system moving to the target. The relative position in space between these two types of fiducials within the Cartesian system enables the operator to locate the devices in the anatomy.

[00236] The trajectory in the X and Y planes between the starting point and the target can be obtained with a bullseye view by aligning the central X-ray beam of the fluoroscopic machine 11262 to the starting point and target point. The distance between the fluoromarkers, in the Z plane, at the starting and target points can be obtained by a perpendicular fluoroscopy 11261, shown in FIG. 5 IE. The trajectory to the target can also be obtained by one or more fluoroscopic images sufficiently perpendicular to the trajectory of the aligned X and Y planes. Planning prior to delivering therapy, perforation and advancement of devices to the brain target is a target-pivot or target centered system and is critical to this concept to avoid damage to the sulci, blood vessels, ependyma and/or ventricles, and relies on intraoperative imaging/feedback, the ability to operate in one or more three-dimensional space such as a spherical, cylindrical, conical, or Cartesian coordinate system, as well as a firm understanding of the torque, angulation and the degrees of freedom of the devices used in the anatomy. The following embodiments utilize this concept and discuss the methods and devices to achieve targeted stereotaxic therapy in the lower brain.

[00237] FIG. 52 is a method flow chart 11300 for navigating to a target location in a brain, according to embodiments. The method 11300 includes selecting a perforation point and a trajectory in Computed Tomography Angiography (CTA), at 11302. The method includes navigating a catheter system into an intracranial vasculature of a patient, at 11304. In some embodiments, the catheter system can include an inner element slidably disposed within a deflectable device. The method can include aligning an outlet on a distal portion of the catheter to the perforation point 11306. In some embodiments, one or more portions of the catheter, including the distal portion of the catheter, can include radiopaque markers such that a location of the catheter relative to the perforation point can be tracked using one or more imaging modalities. The method can include perforating the vessel wall / dura following the trajectory, at 11308. The vessel wall / dura can be perforated using any of the devices and methods described herein. The method can include confirming that the target location in the subdural space and/or brain can be reached in a straight vector from the perforation point, at 11310. [00238] If it is confirmed that the target location can be reached in a straight vector, then the method includes confirming a bullseye target is formed (e.g., using a central X-ray beam), at 11312. The bullseye target refers to a shape that is visible in the image that is a result of the catheter being perpendicular or near perpendicular to the XY plane (e.g., from above), as shown and described with reference to FIG. 54C. If the target location cannot be reached in a straight vector, the method includes advancing the catheter system disposed in the deflectable device intracranially to a pivot point of the deflectable device, at 11314. In some embodiments, the placement of the catheter system at the pivot point can be confirmed. In some embodiments, flat panel CT can be used to monitor the catheter system and confirm the catheter system is disposed properly at the pivot point (e.g., by visualizing markers on a distal portion the catheter system). In some embodiments, the method can include orienting the pivot point of the deflectable device to a target direction, at 11316. In some embodiments, orienting the pivot point of the deflectable device can include torquing the deflectable device and aligning the deflectable device and the central X-ray beam. In some embodiments, the method can include deflecting the deflectable device toward the target and confirming that a bullseye target is formed (e.g., using the central X-ray beam), at 11318. In some embodiments, once the bullseye target is formed (e.g., at 11312 or 11318), the method can include advancing the inner element to the target under direct fluoroscopic view, at 11322. In some embodiments, the fluoroscopic imaging system can capture images perpendicular to the X-ray images captured. For example, the X-ray images can capture images in the XY plane, and the fluoroscopic images can be captured in a Z plane to provide depth information, while the bullseye target is maintained.

[00239] FIGS. 53A-53D show different methods of navigating toward a target location “T” using an endovascular stereotaxis system, according to embodiments. In some embodiments, the device or system of devices can be navigated toward the brain through the vasculature (e.g., the MMA 11455) through a sheath 11485. Once at an entry point to the skull 11404, the devices can be navigated to a target location “T” using different methods. In some embodiments the target location “T” can be reached directly (e.g., frameless) by (i) adjusting an entry angle of the delivery system; (ii) confirming the direction of the delivery system in the Axial (X, Y) and Coronal (X, Z) views through the vessel wall/dura into the subdural space; and (ii) confirming the depth of penetration to the target through the Coronal (X, Z) and Sagittal (Y, Z) views. As shown in FIG. 53A, a conical entry can be made in any three-dimensional angle of plus or minus 30 degrees from the point of entry (point “A”) into the subdural space (e.g., an angle measured from a line defined between point “A” and point “B”).

[00240] In some embodiments the device or system of devices can be deflected toward the target (e.g., framed). As shown in FIG. 53B, a vector can be identified, which is defined between a point of exit from the access device (point “A”) and a point of entry into the lower subdural space through the vessel wall/dura (point “B”). The vector can linearly direct the devices to a third point in the brain (point “C”). The device(s) can be configured to pivot or rotate (shown in FIG. 53C) such that a distal portion of the device(s) can be angled, deflected, or be directed to the target point “T” (shown in FIG. 53D). In some embodiments, a deflectable device 11410 (e.g., similar to the deflectable device described in FIG. 52) can be navigated through the dura toward point “C” and a distal portion of the deflectable device 11410 can be angled toward the target “T”. Then, an inner element 11495 can be advanced (e.g., linearly) from point “C” toward the target “T.” In some embodiments, the vector defined by “A” and “B” is fixed by the anatomy or boney channel by which the devices traverse. For example, the anatomy constrains the devices to a trajectory aligned with the vector defined between point “A” to point “B.” As in the previous examples these points, vectors, and deflections can be managed and confirmed by the Axial, Coronal and Sagittal views of the head under fluoroscopy. In some embodiments, once the device(s) are advanced to the target “T,” the device(s) can be used to perform a procedure at the target “T” (e.g., draining a subdural hematoma, delivering a therapeutic agent, implanting a device).

[00241] In some embodiments devices can be delivered, traversed and located within a stereotaxic environment using magnets affixed to the internal devices and an external attractive magnetic source/field. In some embodiments magnets affixed to the devices can be used for three-dimensional spatial recognition in the Cartesian system

[00242] FIGS. 54A-54B show a distal end of a delivery catheter 11510 including markers 11572, 11574, 11576 for guiding navigation, according to embodiments. In some embodiments, a distal portion (e.g., the portion distal to the deflectable point) of the catheter 11510 for navigating to a target location has a series of two or more radiopaque markers 11572, 11574, 11576 (e.g., radio fluorescent markers) that surround the shaft (or portions of the shaft) circumferentially. The series of markers 11572, 11574, 11576 can have a predetermined spacing therebetween. For example, the markers 11572, 11574, 11576 may have a space therebetween between about 0.01 mm to 50 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the markers 11572, 11574, 11576 can have differing diameters such that one or more of the diameters of the markers 11572, 11574, 11576 can be visually distinguishable. For example, as shown in FIGS. 54A-54B, the catheter 11510 includes a first marker 11574 having a first diameter 01 and a second marker 11576 having a second diameter 02 larger than the first diameter. The second marker 11576 may be disposed proximal to the first maker 11574. However, when imaged, a distal edge of the catheter may appear as a bullseye shape. Therefore, when the catheter 11510 is viewed under fluoroscopy in a combination of views (described in FIGS. 51A-51D), the plane at which the shaft 11510 can be pointed directly (e.g., linearly) to the target can be determined by aligning the differing diameter markers into the bullseye configuration, shown in FIG. 54C. In some embodiments the markers 11574, 11576 may or may not be connected by a perpendicular marker 11575, as shown in FIGS. 54A-54B. In some embodiments, the perpendicular marker 11575 is positioned in the shaft in the direction by which the shaft is configured to pivot, angle, deflect or be directed toward the target and can be appropriately positioned (e.g., aligned relative to the target) by torquing the device prior to pivoting, angling, deflecting or directing the tip to the target. For example, the shaft may bend toward a side on which the perpendicular marker 11575 is located. Confirmation of the target engagement can be obtained, for example, by intraoperative imaging (visualization of fiducials by fluoroscopy or flat-panel CT), or by electrophysiology (EEG, micro-recordings or motor units) and the clinical efficacy or sideeffects.

[00243] FIGS. 54C-54E depict a method of confirming visually that the device 11510 is accurately directed to the target “T,” according to embodiments. As shown in FIG. 54C, Axial images of the brain 11501 show the bullseye target shape formed by the markers of the catheter 11510. The surgeon can visualize a horizontal position of a distal end of the catheter 11510 relative to anatomical structures (e.g., the ventricles 11552) or the target “T ” As shown in FIG. 54D, the Coronal images of the brain 11501 show a view of the catheter 11510 where the first marker 11574 and the second marker 11576 are spaced vertically from one another. FIG. 54E shows the Sagittal image of the brain 11501 while the catheter 11510 is deflected at a deflectable point 11578 toward the target “T ” The markers 11574, 11576 can guide navigation of the catheter 11510 toward the target. [00244] In some embodiments the lower subdural space can be accessed using a series of devices, as illustrated in FIGS. 55A-55B. In some embodiments, a catheter shaft 11510 can be slidably disposed in the MMA through a guide catheter or guide sheath 11585 placed lower in the anatomy such as in the maxillary artery. In some embodiments, the catheter shaft 11510 can have a diameter in a range of about 0.020 inches to about 0.048 inches in diameter, inclusive of all ranges and subranges therebetween. The catheter 11510 can define two exits (e.g., openings, apertures, ports, etc.) from the internal, delivery lumen. A first exit can be defined at a distal tip of the catheter 11510 used for placement and tracking over ancillary devices 11595 such as a guidewire or microcatheter. The catheter 11510 can include a second exit proximal to the first exit. In some embodiments, the proximal exit can have a diameter between about 0.5 mm to about 5 mm and may be disposed about 0.1 cm to about 10 cm from a tip of the device with specific radio markers 11576, 11578 disposed near the second exit that aid in locating the shaft 11510 in a position where entry to subdural space can be achieved through the vessel wall/dura by a perforating element, as shown in FIG. 55A. For example, a first marker 11576 can be disposed just distal to the second exit, and the second marker 11578 can be disposed just proximal to the second exit. In some embodiments, the first exit may include a marker 11574 disposed adjacent thereto to indicate a location of the first exit. In some embodiments, this configuration of the distal portion of the catheter shaft 11510 when extended into the MMA can ensure that the vessel is occluded both distally and proximally to the perforation site, as the shaft 11510 is sufficiently sized to consume the luminal space of the artery, as shown in FIG. 55 A.

[00245] FIG. 56 illustrates a distal portion of a catheter shaft 11510 that is configured to pivot, angle or deflect towards a target. In some embodiments, the shaft 11510 can include an internal reinforcement 11513 such as, for example, a slotted metallic tube, disposed between an outer surface and an inner lumen of the shaft 11510. In some embodiments, the slotted metallic tube can include any suitable material such as, for example, stainless steel, nitinol, nitinol alloy, platinum, titanium, or cobalt chromium. In some embodiments, the slots can be circumferential and can be aligned linearly tangential to the tube. In some embodiments, the slots of the internal reinforcement 11513 can be cut mechanically or can be laser cut out of a tube. In some embodiments, the slots may be cut out of at least a portion of a circumference of the tube. In some embodiments, the slots may be cut to have an arc length of about 3.0 degrees to about 357.0 degrees, inclusive of all ranges and subranges therebetween. As such, the slots may create creating slotted segment or “spine” on one side of the reinforcement 11513. In some embodiments, the slotted segment portion of the reinforcement 11513 may be configured as a dense radiopaque marker. In some embodiments, the slotted segment may create a fixed structure that the device can articulate, deflect, pivot, or angle toward. In some embodiments, a portion of the reinforcement 11513 (e.g., a distal portion or tip) may be coupled to a pull element, metallic wire or monofilament 11525, that when in tension can articulate, deflect, pivot, or angle the slotted segment.

[00246] In some embodiments, a proximal end of the shaft 11510 can be connected to a handle mechanism 11584 that contains a graduated rotational knob. The rotational knob can be coupled to the pull element 11525 and configured to apply and/or release tension to the pull element 11525 when rotated. When the knob is rotated and creates tension on the pull element 11525, the graduations of the knob can determine the articulation, deflection, or pivot angle of the distal tip of the shaft 11510.

[00247] FIGS. 57A-57E show distal tips of shafts 11510, 11512, 11514, 11516, 11518 formed or constructed with an internal ramp with a predefined angle. For example, straight (zero degrees), 15 degrees, 30 degrees, 45 degrees, 60 degrees, or 90 degrees from straight, inclusive of all values and ranges therebetween. The internal ramp can be configured to direct a shaft, guidewire, inner element, or other internal component to the target location using the aforementioned method(s). In some embodiments, the ramp can be formed with polymers or can fixed with an internal metallic element.

[00248] FIGS. 58A-58C illustrate the degrees of freedom that can be achieved through using the devices and methods described herein. As shown, the distal end portion of a delivery system can gain access to the subdural space 11601 by being disposed through a sheath 11685 disposed in the MMA 11655. As shown in FIG. 58 A, straight access into the subdural space allows for an inner element or ancillary devices 11695 to traverse, articulate, and torque along a plurality of paths relative to the location/placement of the access device (e.g., catheter) 11610. In another example, the access device (e.g., catheter) 11710 can articulate in the subdural space 11701 along a plurality of paths. In another example, the access device (e.g., catheter 11810) can articulate in the subdural space 11801 and can be used in combination with an inner element or ancillary devices 11895 to target locations. [00249] In some embodiments, one or more devices may be anchored or fixed to a tissue structure such as bone in order to facilitate access into an intracranial space and/or position a device within or relative to the intracranial space. For example, an anchor portion of a catheter assembly may be configured to mechanically affix and lock a perforating device in place relative to tissue for framed stereotaxis with direct access into the intracranial space. FIGS. 59A-59E are schematic cross-sectional views of a catheter assembly in a head of a subject including a skull 11930, a vessel (e.g., MMA) 11940, and a dura 11950. A catheter assembly 11910 may be disposed within the vessel 11940 where a distal portion of the catheter assembly 11910 may be advanced distal to a foramen spinosum and through the dura 11950 and into a subdural space. In some embodiments, the catheter assembly 11910 (e.g., sheath, catheter, perforating device, shaft) may comprise an expandable member 11925-5629 configured to transition between a delivery configuration and an expanded configuration when disposed within a bony channel 11932 (e.g., foramen spinosum). In the expanded configuration, the expandable member 11925-11929 may expand to occlude the bony channel 11932 such that the catheter assembly 11910 is affixed to the skull 11930. The expandable member may include one or more of a balloon 11925, oblong balloon 11926, a frame 11927 disposed above and below the bony channel 11932, a frame (e.g., stent, basket, ring, braid) 11928 disposed within the bony channel 11932, and an expandable shaft 11929 configured to increase its diameter through one or more of compression and an internal expanding element. Additionally or alternatively, a predetermined portion of the shaft 11929 may have a larger diameter compared to the rest of the shaft such that the shaft 11929 will form an interference fit within the foramen spinosum 11932.

Examples:

[00250] In some embodiments, a method of accessing an intracranial extravascular space of a patient may include advancing a catheter defining a lumen within a vasculature of a patient until a distal end of the catheter is disposed within an intracranial vessel of the patient; advancing a perforating element through at least a portion of the lumen of the catheter such that a distal end of the perforating element is disposed in the intracranial vessel; directing, using the catheter, the distal end of the perforating element toward the wall of the intracranial vessel to form an opening in the wall of the intracranial vessel; advancing the distal end of the perforating element through the opening and into the intracranial extravascular space; advancing the catheter over the perforating element until a distal portion of the catheter is disposed in the intracranial extravascular space; administering therapy or delivering an implant via the catheter after the distal end of the catheter is disposed in the intracranial extravascular space; and closing, after administering the therapy or delivering the implant, the opening using an occlusion device. In some embodiments, the method can include forming, using the perforating element, an epidural channel, wherein closing the opening using the occlusion device includes placing the occlusion device in the intracranial extravascular space and occluding the epidural channel and the intracranial vessel using the occlusion device.

[00251] In some embodiments, the method can include advancing the perforating element within the intracranial extravascular space to a target location, wherein administering the therapy or delivering the implant is to the target location. In some embodiments, the advancing the catheter over the perforating element includes advancing the catheter over the perforating element by more than 0.5 cm within the intracranial extravascular space. In some embodiments, the administering the therapy or delivering the implant includes at least one of: draining fluid or matter from the intracranial extravascular space, performing a biopsy of brain matter, delivering a therapeutic agent, or delivering one or more electronic devices to a surface of the brain or an interior of the brain. In some embodiments, the forming the opening in the wall of the intracranial vessel includes applying energy via the perforating element to the wall of the intracranial vessel.

[00252] In some embodiments, a method of accessing an intracranial extravascular space of a patient includes advancing a catheter within a vasculature of a patient until a distal end of the catheter is disposed within the superior sagittal sinus of the patient, the catheter defining a lumen and an opening coupled thereto; supporting a first portion of the catheter against a first portion of a wall of the superior sagittal sinus while directing a second portion of the catheter including the opening toward a second portion of the wall of the superior sagittal sinus; advancing a perforating element through the lumen of the catheter and out through the opening such that a distal end of the perforating element perforates the second portion of the wall of the superior sagittal sinus and forms an opening therethrough; advancing the distal end of the perforating element through the opening in the wall of the superior sagittal sinus and into the intracranial extravascular space; and advancing the catheter over the perforating element until a distal portion of the catheter is disposed in the intracranial extravascular space. [00253] In some embodiments, the method further includes draining, using the catheter, fluid or matter from the intracranial extravascular space. In some embodiments, the method further includes delivering, via the catheter, one or more of a solution, a therapeutic agent, or a particle into the intracranial extravascular space. In some embodiments, the method further includes delivering, via the catheter, one or more devices into the intracranial extravascular space. In some embodiments, the one or more devices includes at least one of: a penetrating lead, a nonpenetrating array of electrodes, or a non-penetrating film. In some embodiments, the method further includes closing the opening in the wall of the superior sagittal sinus using an occlusion device. In some embodiments, the supporting the first portion of the catheter against the first portion of the wall of the superior sagittal sinus includes curving the catheter such that the first portion of the catheter contacts the first portion of the wall of the superior sagittal sinus while the second portion of the catheter contacts the second portion of the wall of the superior sagittal sinus. In some embodiments, the method further includes delivering an embolic agent via the catheter to the superior sagittal sinus to maintain hemostasis. In some embodiments, the forming the opening in the wall of the superior sagittal sinus includes applying energy via the perforating element to perforate the wall of the superior sagittal sinus. In some embodiments, the opening of the catheter is disposed on a side wall of the catheter.

[00254] In some embodiments, a method of forming a passageway through a wall of an intracranial vessel and dura includes advancing a catheter within a vasculature of a patient until a distal end of the catheter is disposed within the intracranial vessel, the catheter defining a lumen and a opening coupled thereto; positioning the opening of the catheter adjacent to a wall of the intracranial vessel; advancing a perforating element through the lumen of the catheter and out through the opening such that a distal end of the perforating element perforates the wall of the intracranial vessel and dura adjacent thereto to form a passageway through the wall of the intracranial vessel and the dura into a subdural space; advancing the catheter over the perforating element until a distal portion of the catheter is disposed in the subdural space; and administering therapy or delivering an implant via the catheter after the distal end of the catheter is disposed in the subdural space.

[00255] In some embodiments, the passageway is formed through the intracranial vessel and the dura at the lower skull. In some embodiments, the intracranial vessel is the middle meningeal artery. In some embodiments, the intracranial vessel is the transverse sinus. In some embodiments, the lumen of the catheter is a first lumen, and the catheter further includes a second lumen configured to receive a guidewire, the method further comprising navigating, before forming the passageway, the guidewire through the vasculature of the patient to a location downstream of a site of the passageway, wherein the catheter is advanced over the guidewire and positioned such that the opening of the catheter is at the site of the passageway, and wherein the perforating element is advanced out through the opening of the catheter after the opening is positioned at the site of the passageway. In some embodiments, the method further includes delivering, via the catheter, one or more devices into the intracranial extravascular space. In some embodiments, the one or more devices includes at least one of a penetrating lead, a non-penetrating array of electrodes, or a non-penetrating film. In some embodiments, the opening of the catheter is disposed on a side wall of the catheter. In some embodiments, the positioning the opening of the catheter adjacent to the wall of the intracranial vessel includes curving the catheter such that the side wall of the catheter including the opening are engaged with the wall of the intracranial vessel.

[00256] In some embodiments, a method of accessing a lower brain of a patient, includes navigating a guidewire or shaft within a vasculature of a patient until a distal end of the guidewire or shaft is disposed within an intracranial vessel in the lower brain of the patient; advancing a catheter over the guidewire or shaft until a distal end of the catheter is disposed within the intracranial vessel in the lower brain, the catheter defining a lumen; and delivering, via the lumen of the catheter, one or more devices to at least one of an intravascular space, an extravascular space, or an epidural space, the one of more devices configured to measure neural activity of a brain of the patient. In some embodiments, the perforating a wall of the intracranial vessel and forming a passageway into at least one of the extravascular space or the epidural space, wherein the one or more devices are delivered to the at least one of the extravascular space of the epidural space. In some embodiments, the one or more devices includes at least one of a penetrating lead, a non-penetrating array of electrodes, or a non-penetrating film.

[00257] In some embodiments, the method includes capturing, using an imaging device, one or more images of at least a portion of the brain of the patient to generate a three-dimensional representation of the brain; determining a target location in the three-dimensional representation for delivering the one or more devices; and determining a trajectory between a starting location and the target location; and performing the navigating, the advancing, and the delivering based on the trajectory. In some embodiments, the method includes electrically coupling the one or more devices to a pulse generator. [00258] In some embodiments, a method for removing internal structures within the superior sagittal sinus of a patient includes advancing a catheter within a vasculature of a patient until a distal end of the catheter is disposed within the superior sagittal sinus, the catheter defining a lumen; advancing a cutting device through at least a portion of the lumen of the catheter until a distal end of the cutting device is disposed adjacent to an internal structure within the superior sagittal sinus, the cutting device having one or more atraumatic distal features; and severing the internal structure by using a cutting edge of the internal structure or using energy applied by a conductive portion of the cutting device. In some embodiments, the method further includes removing, after severing the internal structure, the internal structure from the superior sagittal sinus. In some embodiments, the removing the internal structure includes applying a vacuum via the catheter to remove the internal structure. In some embodiments, the method further includes applying energy via the cutting device to vaporize the internal structure. In some embodiments, the cutting device includes one or more tines each having an atraumatic distal feature and an interior cutting edge, wherein severing the internal structure includes using the interior cutting edges of the one or more tines to sever the internal structure. In some embodiments, the cutting device includes one or more tines each having an atraumatic distal feature and a conductive portion, wherein severing the internal structure includes applying radiofrequency (RF) energy via the conductive portions of the one or more tines to sever the internal structure.

[00259] In some embodiments, the cutting device includes a hook-shaped element, the hooked-shaped element including an interior cutting edge, wherein severing the internal structure includes extending the hooked-shaped element distal of the internal structure and retracting the hooked-shaped element to contact and cut the internal structure using the interior cutting edge. In some embodiments, the cutting device includes one or more loops each including a cutting edge, wherein severing the internal structure includes using the cutting edges of the one or more loops to sever the internal structure. In some embodiments, the cutting device includes one or more loops each including an energized portion, wherein severing the internal structure includes using the energized portions of the one or more loops to apply RF energy. In some embodiments, the internal structure includes at least one of: a septation, or a granulation. In some embodiments, the method further includes advancing a perforating device into the superior sagittal sinus, after severing the internal structure, to form a passageway into the intracranial extravascular space; and administering therapy or delivering an implant into the intracranial extravascular space via the catheter.

[00260] An apparatus comprises an elongate body defining a lumen, the elongate body including a distal end configured to be disposed in an intracranial vessel; and an opening disposed on the distal end of the elongate body, the opening being in communication with the lumen, the elongate body configured to transition into a curved configuration to position the opening adjacent to a wall of the intracranial vessel such that a perforating device received through the lumen of the catheter can be advanced through the lumen and the opening and into the wall of the intracranial vessel to form a passageway into an intracranial extravascular space, the elongate body in the curved configuration having a portion configured to be in contact with a portion of the wall of the intracranial vessel to provide support for advancing the perforating device. In some embodiments, the lumen is angled or includes one or more guide mechanisms configured to direct the advancement of perforating device. In some embodiments, the apparatus further includes a pull wire configured to be actuated to transition the elongate body into the curved configuration. In some embodiments, the apparatus further includes a pull wire or a magnet configured to enable the elongate body to be steered within a vasculature of the patient to the intracranial vessel. In some embodiments, the apparatus further includes an expandable element configured to transition into an expanded configuration to support the opening against the wall of the intracranial vessel. In some embodiments, an apparatus further includes an expandable element configured to transition into an expanded configuration to prevent blood from flowing from the intracranial vessel into the passageway after the passageway is formed. In some embodiments, the lumen is a first lumen, and the elongate body further defines a second lumen, the first lumen configured to receive the perforating device, and the second lumen being configured to receive a guidewire such that the elongate body can be advanced over the guidewire to the intracranial vessel.

[00261] In some embodiments, the apparatus further includes a perforating device is configured to perforate through the wall of the intracranial vessel. In some embodiments, the perforating device includes a paddle structure configured to apply energy to the wall of the intracranial vessel to form the passageway into the intracranial extravascular space, the paddle structure configured to act as a heat sink during application of the energy. In some embodiments, the perforating device includes an insulating material disposed along a length of the perforating device proximal of the paddle structure, the paddle structure having an outer diameter that provides a smooth transition from the insulating material to the paddle structure.

[00262] In some embodiments, the perforating device includes a needle configured to mechanically perforate the wall of the intracranial vessel to form the passageway into the intracranial extravascular space. In some embodiments, the needle includes one or more of: an angled opening, a circumferential spiral cut opening, a spinal opening, or external threading. In some embodiments, the apparatus further includes a sealing device configured to close the passageway, the sealing device including one or more of: a coil or a stent structure.

[00263] In some embodiments, an apparatus includes an elongate body defining at least one lumen, the elongate body including a distal end configured to be disposed in an intracranial vessel or an intracranial extravascular space of a patient; and a delivery element disposable within the elongate body, the delivery element configured to support an electrode device including one or more electrodes configured to measure neural activity of the patient, the delivery element configured to be manipulated to position the electrode device in the intracranial vessel or the intracranial extravascular space.

[00264] In some embodiments, the electrode device is a brain-computer interface (BCI) sheet array, and the delivery element includes a shaft that the BCI sheet array can be wrapped around, the delivery device configured to be manipulated to unravel the BCI sheet array from around the shaft. In some embodiments, the electrode device includes a self-expanding structure, the delivery device configured to be manipulated to advance the electrode device out of the elongate body and into the intracranial vessel or the intracranial extravascular space such that the electrode device can self-expand to deploy within the intracranial vessel or the intracranial extravascular space. In some embodiments, the electrode device includes a plurality of depth electrodes, and the elongate body includes a plurality of lumens each configured to house at least one of the depth electrodes of the plurality of depth electrodes, the delivery device configured to be manipulated to advance the plurality of depth electrodes out of the elongate member and toward a surface of a brain of the subject. In some embodiments, the elongate body includes an inflected distal segment configured to direct the plurality of depth electrodes toward the surface of the brain upon exiting the elongate body. In some embodiments, the delivery device includes a biasing mechanism configured to push the electrode device toward a target location of a brain of the patient, the delivery device configured to be manipulated to push the electrode device such that the electrode device becomes seated in the target location of the brain. In some embodiments, the delivery device includes a plurality of tines configured to grasp the electrode device during delivery and to expand to release the electrode device, the delivery device configured to be manipulated to allow the plurality of tines to expand to release the electrode device.

[00265] In some embodiments, an apparatus includes a sheath configured to be navigated through vasculature to a lower brain of a patient; a catheter configured to be advanced through the sheath and into an intracranial vessel, the catheter including a lumen and an opening coupled thereto, the catheter configured to be positioned to align the opening of the catheter with a perforation location; and a perforating device configured to be advanced through the lumen of the catheter and out through the opening to perforate a wall of the intracranial vessel at the perforation location to form a passageway into an intracranial extravascular space, the catheter further configured to be advanced through the passageway and into the intracranial extravascular space and to be distally advanced to a target location. In some embodiments, the intracranial vessel is the middle meningeal artery. In some embodiments, the intracranial vessel is the transverse sinus. In some embodiments, a portion of the sheath or a portion of the catheter is configured to be anchored to the intracranial vessel or neighboring anatomy. In some embodiments, the perforating device includes an electrode configured to apply energy to the wall of the intracranial vessel to perforate the wall of the intracranial vessel. In some embodiments, the catheter includes one or more markers configured to indicate an angle of a distal portion of the catheter. In some embodiments, the catheter includes a portion configured to bend such that a distal portion of the catheter can be deflected toward the target location.

[00266] While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications and anatomy (e.g., intracranial and extracranial vascular structure) for which the inventive teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto; inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure.

[00267] Also, various inventive concepts may be embodied as one or more methods, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

[00268] As used herein, the terms “about” and/or “approximately” when used in conjunction with numerical values and/or ranges generally refer to those numerical values and/or ranges near to a recited numerical value and/or range. In some instances, the terms “about” and “approximately” may mean within ± 10% of the recited value. For example, in some instances, “about 100 [units]” may mean within ± 10% of 100 (e.g., from 90 to 110). The terms “about” and “approximately” may be used interchangeably.

[00269] Any and all references to publications or other documents, including but not limited to, patents, patent applications, articles, webpages, books, etc., presented anywhere in the present application, are herein incorporated by reference in their entirety. Moreover, all definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.

[00270] The specific examples and descriptions herein are exemplary in nature and embodiments may be developed by those skilled in the art based on the material taught herein without departing from the scope of the present invention.

Claims

1. A method of accessing an intracranial extravascular space of a patient, the method comprising: advancing a catheter within a vasculature of a patient until a distal end of the catheter is disposed within an intracranial vessel of the patient, the catheter defining a lumen; advancing a perforating element through at least a portion of the lumen of the catheter such that a distal end of the perforating element is disposed in the intracranial vessel; directing, using the catheter, the distal end of the perforating element toward the wall of the intracranial vessel to form an opening in the wall of the intracranial vessel; advancing the distal end of the perforating element through the opening and into the intracranial extravascular space; advancing the catheter over the perforating element until a distal portion of the catheter is disposed in the intracranial extravascular space; administering therapy or delivering an implant via the catheter after the distal end of the catheter is disposed in the intracranial extravascular space; and closing, after administering the therapy or delivering the implant, the opening using an occlusion device.

2. The method of claim 1, further comprising: forming, using the perforating element, an epidural channel, wherein closing the opening using the occlusion device includes placing the occlusion device in the intracranial extravascular space and occluding the epidural channel and the intracranial vessel using the occlusion device.

3. The method of any one of claims 1-2, further comprising: advancing the perforating element within the intracranial extravascular space to a target location, wherein administering the therapy or delivering the implant is to the target location.

4. The method of claim 3, wherein the target location is in a subdural space.

5. The method of any one of claims 1-4, wherein advancing the catheter over the perforating element includes advancing the catheter over the perforating element by more than 0.5 cm within the intracranial extravascular space.

6. The method of any one of claims 1-5, wherein administering the therapy or delivering the implant includes at least one of: draining fluid or matter from the intracranial extravascular space, performing a biopsy of brain matter, delivering a therapeutic agent, or delivering one or more electronic devices to a surface of the brain or an interior of the brain.

7. The method of any one of claims 1-6, wherein forming the opening in the wall of the intracranial vessel includes applying energy via the perforating element to the wall of the intracranial vessel.

8. The method of any one of claims 1-7, wherein the intracranial vessel is the superior sagittal sinus.

9. A method of accessing an intracranial extravascular space of a patient, the method comprising: advancing a catheter within a vasculature of a patient until a distal end of the catheter is disposed within the superior sagittal sinus of the patient, the catheter defining a lumen and an opening coupled thereto; supporting a first portion of the catheter against a first portion of a wall of the superior sagittal sinus while directing a second portion of the catheter including the opening toward a second portion of the wall of the superior sagittal sinus; advancing a perforating element through the lumen of the catheter and out through the opening such that a distal end of the perforating element perforates the second portion of the wall of the superior sagittal sinus and forms an opening therethrough; advancing the distal end of the perforating element through the opening in the wall of the superior sagittal sinus and into the intracranial extravascular space; and advancing the catheter over the perforating element until a distal portion of the catheter is disposed in the intracranial extravascular space.

10. The method of claim 9, further comprising draining, using the catheter, fluid or matter from the intracranial extravascular space.

11. The method of claim 9, further comprising delivering, via the catheter, one or more of a solution, a therapeutic agent, or a particle into the intracranial extravascular space.

12. The method of claim 9, further comprising delivering, via the catheter, one or more devices into the intracranial extravascular space.

13. The method of claim 12, wherein the one or more devices includes at least one of: a penetrating lead, a non-penetrating array of electrodes, or a non-penetrating film.

14. The method of claim 9, further comprising closing the opening in the wall of the superior sagittal sinus using an occlusion device.

15. The method of claim 9, wherein supporting the first portion of the catheter against the first portion of the wall of the superior sagittal sinus includes curving the catheter such that the first portion of the catheter contacts the first portion of the wall of the superior sagittal sinus while the second portion of the catheter contacts the second portion of the wall of the superior sagittal sinus.

16. The method of any one of claims 9-15, further comprising delivering an embolic agent via the catheter to the superior sagittal sinus to maintain hemostasis.

17. The method of any one of claims 9-15, wherein forming the opening in the wall of the superior sagittal sinus includes applying energy via the perforating element to perforate the wall of the superior sagittal sinus.

18. The method of any one of claims 9-15, wherein the opening of the catheter is disposed on a side wall of the catheter.

19. A method of forming a passageway through a wall of an intracranial vessel and dura, the method comprising: advancing a catheter within a vasculature of a patient until a distal end of the catheter is disposed within the intracranial vessel, the catheter defining a lumen and a opening coupled thereto; positioning the opening of the catheter adjacent to a wall of the intracranial vessel; advancing a perforating element through the lumen of the catheter and out through the opening such that a distal end of the perforating element perforates the wall of the intracranial vessel and dura adjacent thereto to form a passageway through the wall of the intracranial vessel and the dura into a subdural space; advancing the catheter over the perforating element until a distal portion of the catheter is disposed in the subdural space; and administering therapy or delivering an implant via the catheter after the distal end of the catheter is disposed in the subdural space.

20. The method of claim 19, wherein the passageway is formed through the intracranial vessel and the dura at the lower skull.

21. The method of claim 19, wherein the intracranial vessel is the middle meningeal artery.

22. The method of claim 20, wherein the intracranial vessel is the transverse sinus.

23. The method of claim 19, wherein the lumen of the catheter is a first lumen, and the catheter further includes a second lumen configured to receive a guidewire, the method further comprising: navigating, before forming the passageway, the guidewire through the vasculature of the patient to a location downstream of a site of the passageway, wherein the catheter is advanced over the guidewire and positioned such that the opening of the catheter is at the site of the passageway, and wherein the perforating element is advanced out through the opening of the catheter after the opening is positioned at the site of the passageway.

24. The method of any one of claims 19-23, further comprising delivering, via the catheter, one or more devices into the intracranial extravascular space.

25. The method of claim 24, wherein the one or more devices includes at least one of: a penetrating lead, a non-penetrating array of electrodes, or a non-penetrating film.

26. The method of any one of claims 19-23, wherein the opening of the catheter is disposed on a side wall of the catheter.

27. The method of claim 26, wherein positioning the opening of the catheter adjacent to the wall of the intracranial vessel includes curving the catheter such that the side wall of the catheter including the opening are engaged with the wall of the intracranial vessel.

28. A method of accessing a lower brain of a patient, the method comprising: navigating a guidewire or shaft within a vasculature of a patient until a distal end of the guidewire or shaft is disposed within an intracranial vessel in the lower brain of the patient; advancing a catheter over the guidewire or shaft until a distal end of the catheter is disposed within the intracranial vessel in the lower brain, the catheter defining a lumen; and delivering, via the lumen of the catheter, one or more devices to at least one of: an intravascular space, an extravascular space, or an epidural space, the one of more devices configured to measure neural activity of a brain of the patient.

29. The method of claim 28, further comprising perforating a wall of the intracranial vessel and forming a passageway into at least one of the extravascular space or the epidural space, wherein the one or more devices are delivered to the at least one of the extravascular space of the epidural space.

30. The method of claim 29, the one or more devices includes at least one of: a penetrating lead, a non-penetrating array of electrodes, or a non-penetrating film.

31. The method of any one of claims 28-30, further comprising: capturing, using an imaging device, one or more images of at least a portion of the brain of the patient to generate a three-dimensional representation of the brain; determining a target location in the three-dimensional representation for delivering the one or more devices; and determining a trajectory between a starting location and the target location; and performing the navigating, the advancing, and the delivering based on the trajectory.

32. The method of any one of claims 28-31, further comprising electrically coupling the one or more devices to a pulse generator.

33. The method of claim 28, wherein the intracranial vessel is the middle meningeal artery.

34. The method of claim 28, wherein the intracranial vessel is the transverse sinus.

35. A method for removing internal structures within the superior sagittal sinus of a patient, the method comprising: advancing a catheter within a vasculature of a patient until a distal end of the catheter is disposed within the superior sagittal sinus, the catheter defining a lumen; advancing a cutting device through at least a portion of the lumen of the catheter until a distal end of the cutting device is disposed adjacent to an internal structure within the superior sagittal sinus, the cutting device having one or more atraumatic distal features; and severing the internal structure by using a cutting edge of the internal structure or using energy applied by a conductive portion of the cutting device.

36. The method of claim 35, further comprising removing, after severing the internal structure, the internal structure from the superior sagittal sinus.

37. The method of claim 36, wherein removing the internal structure includes applying a vacuum via the catheter to remove the internal structure.

38. The method of claim 35, further comprising applying energy via the cutting device to vaporize the internal structure.

39. The method of claim 35, wherein the cutting device includes one or more tines each having an atraumatic distal feature and an interior cutting edge, wherein severing the internal structure includes using the interior cutting edges of the one or more tines to sever the internal structure.

40. The method of claim 35, wherein the cutting device includes one or more tines each having an atraumatic distal feature and a conductive portion, wherein severing the internal structure includes applying radiofrequency (RF) energy via the conductive portions of the one or more tines to sever the internal structure.

41. The method of claim 35, wherein the cutting device includes a hook-shaped element, the hooked-shaped element including an interior cutting edge, wherein severing the internal structure includes extending the hooked-shaped element distal of the internal structure and retracting the hooked-shaped element to contact and cut the internal structure using the interior cutting edge.

42. The method of claim 35, wherein the cutting device includes one or more loops each including a cutting edge, wherein severing the internal structure includes using the cutting edges of the one or more loops to sever the internal structure.

43. The method of claim 35, wherein the cutting device includes one or more loops each including an energized portion, wherein severing the internal structure includes using the energized portions of the one or more loops to apply RF energy.

44. The method of any one of claims 35-43, wherein the internal structure includes at least one of: a septation, or a granulation.

45. The method of claim 35, further comprising: advancing a perforating device into the superior sagittal sinus, after severing the internal structure, to form a passageway into the intracranial extravascular space; and administering therapy or delivering an implant into the intracranial extravascular space via the catheter.

46. An apparatus, comprising: an elongate body defining a lumen, the elongate body including a distal end configured to be disposed in an intracranial vessel; and an opening disposed on the distal end of the elongate body, the opening being in communication with the lumen, the elongate body configured to transition into a curved configuration to position the opening adjacent to a wall of the intracranial vessel such that a perforating device received through the lumen of the catheter can be advanced through the lumen and the opening and into the wall of the intracranial vessel to form a passageway into an intracranial extravascular space, the elongate body in the curved configuration having a portion configured to be in contact with a portion of the wall of the intracranial vessel to provide support for advancing the perforating device.

47. The apparatus of claim 46, wherein the lumen is angled or includes one or more guide mechanisms configured to direct the advancement of perforating device.

48. The apparatus of claim 46, further comprising a pull wire configured to be actuated to transition the elongate body into the curved configuration.

49. The apparatus of claim 46, further comprising a pull wire or a magnet configured to enable the elongate body to be steered within a vasculature of the patient to the intracranial vessel.

50. The apparatus of claim 46, further comprising an expandable element configured to transition into an expanded configuration to support the opening against the wall of the intracranial vessel.

51. The apparatus of claim 46, further comprising an expandable element configured to transition into an expanded configuration to prevent blood from flowing from the intracranial vessel into the passageway after the passageway is formed.

52. The apparatus of claim 46, wherein the lumen is a first lumen, and the elongate body further defines a second lumen, the first lumen configured to receive the perforating device, and the second lumen being configured to receive a guidewire such that the elongate body can be advanced over the guidewire to the intracranial vessel.

53. The apparatus of claim 46, further comprising the perforating device configured to perforate through the wall of the intracranial vessel.

54. The apparatus of claim 53, wherein the perforating device includes a paddle structure configured to apply energy to the wall of the intracranial vessel to form the passageway into the intracranial extravascular space, the paddle structure configured to act as a heat sink during application of the energy.

55. The apparatus of claim 54, wherein the perforating device includes an insulating material disposed along a length of the perforating device proximal of the paddle structure, the paddle structure having an outer diameter that provides a smooth transition from the insulating material to the paddle structure.

56. The apparatus of claim 53, wherein the perforating device includes a needle configured to mechanically perforate the wall of the intracranial vessel to form the passageway into the intracranial extravascular space.

57. The apparatus of claim 56, wherein the needle includes one or more of: an angled opening, a circumferential spiral cut opening, a spinal opening, or external threading.

58. The apparatus of claim 46, further comprising a sealing device configured to close the passageway, the sealing device including one or more of: a coil or a stent structure.

59. An apparatus, comprising: an elongate body defining at least one lumen, the elongate body including a distal end configured to be disposed in an intracranial vessel or an intracranial extravascular space of a patient; and a delivery element disposable within the elongate body, the delivery element configured to support an electrode device including one or more electrodes configured to measure neural activity of the patient, the delivery element configured to be manipulated to position the electrode device in the intracranial vessel or the intracranial extravascular space.

60. The apparatus of claim 59, wherein the electrode device is a brain-computer interface (BCI) sheet array, and the delivery element includes a shaft that the BCI sheet array can be wrapped around, the delivery device configured to be manipulated to unravel the BCI sheet array from around the shaft.

61. The apparatus of claim 59, wherein the electrode device includes a selfexpanding structure, the delivery device configured to be manipulated to advance the electrode device out of the elongate body and into the intracranial vessel or the intracranial extravascular space such that the electrode device can self-expand to deploy within the intracranial vessel or the intracranial extravascular space.

62. The apparatus of claim 59, wherein the electrode device includes a plurality of depth electrodes, and the elongate body includes a plurality of lumens each configured to house at least one of the depth electrodes of the plurality of depth electrodes, the delivery device configured to be manipulated to advance the plurality of depth electrodes out of the elongate member and toward a surface of a brain of the subject.

63. The apparatus of claim 62, wherein the elongate body includes an inflected distal segment configured to direct the plurality of depth electrodes toward the surface of the brain upon exiting the elongate body.

64. The apparatus of claim 59, wherein the delivery device includes a biasing mechanism configured to push the electrode device toward a target location of a brain of the patient, the delivery device configured to be manipulated to push the electrode device such that the electrode device becomes seated in the target location of the brain.

65. The apparatus of claim 59, wherein the delivery device includes a plurality of tines configured to grasp the electrode device during delivery and to expand to release the electrode device, the delivery device configured to be manipulated to allow the plurality of tines to expand to release the electrode device.

66. An apparatus, comprising: a sheath configured to be navigated through vasculature to a lower brain of a patient; a catheter configured to be advanced through the sheath and into an intracranial vessel, the catheter including a lumen and an opening coupled thereto, the catheter configured to be positioned to align the opening of the catheter with a perforation location; and a perforating device configured to be advanced through the lumen of the catheter and out through the opening to perforate a wall of the intracranial vessel at the perforation location to form a passageway into an intracranial extravascular space, the catheter further configured to be advanced through the passageway and into the intracranial extravascular space and to be distally advanced to a target location.

67. The apparatus of claim 66, wherein the intracranial vessel is the middle meningeal artery.

68. The apparatus of claim 66, wherein the intracranial vessel is the transverse sinus.

69. The apparatus of claim 66, wherein a portion of the sheath or a portion o the catheter is configured to be anchored to the intracranial vessel or neighboring anatomy.

70. The apparatus of claim 66, wherein the perforating device includes an electrode configured to apply energy to the wall of the intracranial vessel to perforate the wall of the intracranial vessel.

71. The apparatus of claim 66, wherein the catheter includes one or more markers configured to indicate an angle of a distal portion of the catheter.

72. The apparatus of claim 66, wherein the catheter includes a portion configured to bend such that a distal portion of the catheter can be deflected toward the target location.