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

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

[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 The plug 8299 may continue to be deployed as the catheter 8210 is withdrawn proximally such that a distal portion of the plug 8299 lies in the intradural compartment, a medial portion of the plug 8299 transverses the vessel wall, and a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 55 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. 4IE right. In some embodiments the electrode can have “ribs” the branch off a backbone 8895, as shown in FIG. 4IE left. In some embodiments, the electrode can spiral over the brain surface 9095 covering a targeted area of the cortex, as shown in FIG. 4IF 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 59 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. 44A 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 61 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 threedimensional (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. 49A 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 threedimensional 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 twodimensional plane. In the Sagittal view (FIG. 5 IC), 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. 5IE. 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. 5 5 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. 58A, 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 76 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 83 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; andclosing, 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; andadvancing 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; andadministering 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, andwherein 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; anddelivering, 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; anddetermining 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 ofa 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; andsevering 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; andadministering 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; andan 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; anda 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; anda 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.

Images