Systems and methods for moving material and devices between a brain area and an external location

Abstract

A system including an elongate shaft configured to be placed into an access lumen of an access catheter having a side access port that communicates with the access lumen, the shaft including a dilator catheter lumen extending therethrough and a distal portion including a tapered distal tip, the distal portion configured to be passed out of the side access port, a puncture device including an elongate shaft including a distal end configured to penetrate through vascular tissue, a first engagement feature carried by the dilator catheter, and a second engagement feature carried by the puncture device, wherein the second engagement feature is configured to engage the first engagement feature at a first relative longitudinal position between the dilator catheter and the puncture device at which the distal end of the shaft of the puncture device is fully exposed from the dilator catheter and is located at a preconfigured amount of extension out of the dilator catheter lumen.

Description

JUADN.004WO PATENTSYSTEMS AND METHODS FOR MOVING MATERIAL AND DEVICES BETWEENA BRAIN AREA AND AN EXTERNAL LOCATIONBACKGROUND OF THE INVENTIONField of the Invention

[0001] The field of the invention generally relates to systems and methods that enable endovascular access to the subdural or subarachnoid space. The field additionally relates to systems and methods for drainage of subdural or subarachnoid fluid collections (e.g., without burr holes or craniotomy), specifically subdural hemorrhage, hygroma, abscesses, or empyema. The field also relates to irrigation of subdural or subarachnoid fluid collections (e.g., without burr holes or craniotomy), specifically subdural hemorrhage, hygroma, abscesses, or empyema.SUMMARY OF THE INVENTION

[0002] In one embodiment of the present disclosure, a system for creating an access site from the interior of a blood vessel at or adjacent to the surface of a brain through the wall of the blood vessel and into or onto tissue of the brain includes a dilator catheter including an elongate shaft configured to be placed into an access lumen of an access catheter having a side access port that communicates with the access lumen, the shaft including a dilator catheter lumen extending therethrough and a distal portion including a tapered distal tip, the distal portion configured to be passed out of the side access port, a puncture device including an elongate shaft including a distal end configured to penetrate through vascular tissue, a first engagement feature carried by the dilator catheter, and a second engagement feature carried by the puncture device, wherein the second engagement feature is configured to engage the first engagement feature at a first relative longitudinal position between the dilator catheter and the puncture device at which the distal end of the shaft of the puncture device is fully exposed from the dilator catheter and is located at a preconfigured amount of extension out of the dilator catheter lumen.

[0003] In another embodiment of the present disclosure, a system for creating an access site from the interior of a blood vessel at or adjacent to the surface of a brain through the wall of the blood vessel and into or onto tissue of the brain includes an access catheter includingan access lumen extending therethrough and including a side access port that communicates with the access lumen, a sub-selective device including an elongate shaft configured to be placed into the access lumen, the shaft including a distal portion configured to be passed out of the side access port, and a blocking device including an elongate shaft and a distal blocker, the distal blocker configured to be inserted through the access lumen to a location in the access lumen that is distal to the side access port, wherein the distal blocker is configured to block the passage of the distal portion of the shaft of the sub-selective device to force the distal portion out the side access port.

[0004] In yet another embodiment of the present disclosure, a system for creating an access site from the interior of a blood vessel at or adjacent to the surface of a brain through the wall of the blood vessel and into or onto tissue of the brain includes a dilator catheter including an elongate shaft configured to be placed into an access lumen of an access catheter having a side access port that communicates with the access lumen, the shaft including a dilator catheter lumen extending therethrough and a distal portion including a tapered distal tip, the distal portion configured to be passed out of the side access port, and a puncture device including an elongate shaft including a distal end configured to be extended from the dilator catheter lumen and to penetrate through vascular tissue, wherein the shaft of the dilator catheter includes an outer wall having a first aperture passing therethrough, the first aperture communicating with the dilator catheter lumen.

[0005] In still another embodiment of the present disclosure, a system for creating an access site from the interior of a blood vessel at or adjacent to the surface of a brain through the wall of the blood vessel and into or onto tissue of the brain includes a dilator catheter including an elongate shaft configured to be placed into an access lumen of an access catheter having a side access port that communicates with the access lumen, the shaft including a dilator catheter lumen extending therethrough and a distal portion including a tapered distal tip, the distal portion configured to be passed out of the side access port, and a puncture device including an elongate shaft including a distal end configured to be extended from the dilator catheter lumen and to penetrate through vascular tissue, and including a hollow elongate longitudinally-compressible protector having a proximal end configured to couple to the first shaft portion of the shaft of the puncture device, and having and unstressed state having a maximum length and a longitudinally-compressed state having a shortened length.

[0006] In yet another embodiment of the present disclosure, a method for removing tissue or fluid from the brain area of a patient includes providing a guide / access catheter including an elongate tubular body having a proximal end, a distal end, and a lumen extending betweenthe proximal end and the distal end, the distal end including an atraumatic tip and a side exit port located on a side of the catheter and communicating with the lumen, providing a drainage, aspiration, and / or irrigation catheter including a proximal end, a distal end, and a transport lumen extending between the proximal end and the distal end, wherein a distal portion of the aspiration or drainage, aspiration and / or irrigation catheter is configured to be placed through at least a portion of the lumen of the of the guide / access catheter and out through the side exit port of the guide / access catheter, endovascularly inserting the distal end of the guide / access catheter into a dural venous sinus or cerebral vein of a subject such that the side exit port is adjacent a wall of the dural venous sinus or cerebral vein, advancing the distal portion of the drainage, aspiration and / or irrigation catheter through the portion of the lumen of the guide / access catheter and out the side exit port such that the distal portion of the drainage, aspiration, and / or irrigation catheter is oriented at an angle between 30° and 90° to the endoluminal surface of the vessel wall, advancing the distal portion of the drainage, aspiration and / or irrigation catheter through a puncture in the wall of the dural venous sinus or cerebral vein to an extravascular space beneath a portion of the dura mater of the subject, and actively causing tissue or fluid that is located under or on the dura mater of the subject and on or in brain tissue of the patient to flow through the transport lumen of the drainage, aspiration and / or irrigation catheter from the distal end to the proximal end.

[0007] In still another embodiment of the present disclosure, a method for delivering tissue or fluid to the brain area of a patient includes providing a guide / access catheter including an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the distal end including an atraumatic tip and a side exit port located on a side of the catheter and communicating with the lumen, providing a drainage, aspiration, and / or irrigation catheter including a proximal end, a distal end, and a transport lumen extending between the proximal end and the distal end, wherein a distal portion of the aspiration or drainage, aspiration and / or irrigation catheter is configured to be placed through at least a portion of the lumen of the of the guide / access catheter and out through the side exit port of the guide / access catheter, endovascularly inserting the distal end of the guide / access catheter into a dural venous sinus or cerebral vein of a subject such that the side exit port is adjacent a wall of the dural venous sinus or cerebral vein, advancing the distal portion of the drainage, aspiration and / or irrigation catheter through the portion of the lumen of the guide / access catheter and out the side exit port such that the distal portion of the drainage, aspiration, and / or irrigation catheter is oriented at an angle between 30° and 90° to the endoluminal surface of the vessel wall, advancing the distal portion of the drainage,aspiration and / or irrigation catheter through a puncture in the wall of the dural venous sinus or cerebral vein to an extravascular space beneath a portion of the dura mater of the subject, and actively causing tissue or fluid to be delivered onto or into the dura mater of the subject and onto or into brain tissue of the patient by flowing through the transport lumen of the drainage, aspiration and / or irrigation catheter from the proximal end to the distal end.

[0008] In yet another embodiment of the present disclosure, a system for providing transvascular access to an extravascular site includes an access catheter for supporting transvascular access, the access catheter including an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end and a side exit port in the tubular body, in communication with the lumen, and a diversion catheter configured for placement within the lumen of the access catheter, the diversion catheter including a proximal shaft having a first diameter and a distal section having a second diameter, greater than the first diameter, wherein the second diameter is configured to significantly block the lumen of the access catheter distal to the side exit port.

[0009] In still another embodiment of the present disclosure, a catheter includes an elongate shaft, a first lumen extending between a proximal end and a distal end of the elongate shaft and configured for aspirating fluid, a second lumen extending between a proximal portion of the elongate shaft and a distal portion of the elongate shaft, a plurality of apertures in an external wall of the elongate shaft, each of the plurality of apertures communicating with the second lumen, a first port at the proximal portion of the elongate shaft and hydraulically coupled to the first lumen, and a second port at the proximal portion of the elongate shaft and hydraulically coupled to the second lumen.

[0010] In yet another embodiment of the present disclosure, a catheter includes an elongate shaft, a first lumen extending between a proximal end and a distal end of the elongate shaft and configured for aspirating fluid, two or more infusion lumens extending between a proximal portion of the elongate shaft and a distal portion of the elongate shaft, a plurality of apertures in an external wall of the elongate shaft, a first of the plurality of apertures communicating with a first of the two or more infusion lumens and a second of the plurality of apertures communicating with a second of the two or more infusion lumens, a first port at the proximal portion of the elongate shaft and hydraulically coupled to the first lumen, and a second port at the proximal portion of the elongate shaft and hydraulically coupled to the at least the first of the two or more infusion lumens.

[0011] In still another embodiment of the present disclosure, a system includes an elongate device configured to be inserted through a lumen of an access catheter and to passout of a side exit port of the access catheter communicating with the lumen including a first electrode located at a distal portion of the elongate device and a second electrode located on the elongate device proximal to the first electrode, circuitry configured to generate a current through the first and second electrodes, and a processor configured to measure real-time voltage from the current through the first and second electrodes and to identify a sudden change in voltage caused by a change of impedance as at least one of the electrodes is moved with the elongate device from an intravascular space to an extravascular space.

[0012] In yet another embodiment of the present disclosure, a system includes an elongate device configured to be inserted through a lumen of an access catheter and to pass out of a side exit port of the access catheter communicating with the lumen including at least one sensor including a coil including a conductive material located at a distal portion of the elongate device, the sensor configured to generate, in response to an externally generated magnetic field, an electrical signal representative of the position and orientation of the distal portion of the elongate device, a field generator configured to a low-intensity, varying electromagnetic field, and a processor configured to track position and orientation of the elongate device from an electrical signal output by the sensor in response to the varying electromagnetic field.

[0013] In still another embodiment of the present disclosure, a puncture guidewire includes an elongate shaft, a puncturing distal tip, and a curve having a degree of curvature of between about 160° and about 200° between the puncturing distal tip and the shaft.

[0014] In yet another embodiment of the present disclosure, a system for providing transvascular access to an extravascular site includes an access catheter for supporting transvascular access, the access catheter including an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end and a side exit port in the tubular body, in communication with the lumen, and a dilator configured for placement within the lumen of the access catheter and through the side exit port, the dilator having a thru lumen and a frustoconical tip, the frustoconical tip having a curve.

[0015] In still another embodiment of the present disclosure, a system for providing transvascular access to an extravascular site includes an access catheter for supporting transvascular access, the access catheter including an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end and a side exit port in the tubular body, in communication with the lumen, a dilator configured for placement within the lumen of the access catheter and through the side exitport, the dilator having a thru lumen and a frustoconical tip, and a puncturing guidewire having a puncturing tip and configured to be insertable through the thru lumen of the dilator, a distal end of the puncturing guidewire having a curve.

[0016] In yet another embodiment of the present disclosure, a system for providing transvascular access to an extravascular site includes an access catheter for supporting transvascular access, the access catheter including an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end and a side exit port in the tubular body, in communication with the lumen, and a dilator configured for placement within the lumen of the access catheter and through the side exit port, the dilator having a thru lumen and a frustoconical distal portion tapering down to a distal-most outer diameter that is between 101% and 110% of a distal -most inner diameter of the thru lumen.

[0017] In still another embodiment of the present disclosure, a system for providing transvascular access to an extravascular site includes an access catheter for supporting transvascular access, the access catheter including an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end and a side exit port in the tubular body, in communication with the lumen, and a dilator configured for placement within the lumen of the access catheter and through the side exit port, the dilator having a thru lumen and including a first frustoconical distal portion having a first taper angle and a second frustoconical portion proximally adjacent the first frustoconical portion and having a second taper angle, the first taper angle greater than the second taper angle.

[0018] In yet another embodiment of the present disclosure, a system for providing transvascular access to an extravascular site includes an access catheter for supporting transvascular access, the access catheter including an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end and a side exit port in the tubular body, in communication with the lumen, and a dilator configured for placement within the lumen of the access catheter and through the side exit port, a dilator configured for placement within the lumen of the access catheter and through the side exit port, the dilator having a thru lumen and including a first filleted distal portion having a radius of curvature and a second frustoconical portion proximally adjacent the first filleted distal portion and having an included taper angle.

[0019] In still another embodiment of the present disclosure a balloon for an access catheter having a side exit port including a main inflatable body having a first longitudinalaxis, a non-inflatable, hollow, tubular interface portion integral with the main inflatable body and having a second longitudinal axis, wherein the second longitudinal is not colinear with the first longitudinal axis, and an elongate opening between the main inflatable body and the tubular interface portion.

[0020] In yet another embodiment of the present disclosure, a method for moving tissue or fluid to or from the brain area of a patient includes providing a guide / access catheter including an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the distal end including an atraumatic tip and a side exit port located on a side of the catheter and communicating with the lumen, providing a drainage, aspiration, and / or irrigation catheter including a proximal end, a distal end, and a transport lumen extending between the proximal end and the distal end, wherein a distal portion of the aspiration or drainage, aspiration and / or irrigation catheter is configured to be placed through at least a portion of the lumen of the of the guide / access catheter and out through the side exit port of the guide / access catheter, endovascularly inserting the distal end of the guide / access catheter into a dural venous sinus or cerebral vein of a subject such that the side exit port is adjacent a wall of the dural venous sinus or cerebral vein, advancing the distal portion of the drainage, aspiration and / or irrigation catheter through the portion of the lumen of the guide / access catheter and out the side exit port such that the distal portion of the drainage, aspiration, and / or irrigation catheter is oriented at an angle between 30° and 90° to the endoluminal surface of the vessel wall, advancing the distal portion of the drainage, aspiration and / or irrigation catheter through a puncture in the wall of the dural venous sinus or cerebral vein to an extravascular space beneath a portion of the dura mater of the subject, and actively causing tissue or fluid to or from the extravascular space.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG. 1 is a sectional view of a system for providing transvascular access to an extravascular site being utilized within a patient, according to an embodiment of the present disclosure.

[0022] FIG. 2 is an elevation view of a system for transvascularly providing irrigation and aspiration to an intracranial site, according to an embodiment of the present disclosure.

[0023] FIG. 3A is a detailed view of a distal portion of an access catheter taken from encircled area 3 of FIG. 2, according to an embodiment of the present disclosure.

[0024] FIG. 3B is a sectional view of the detailed view of FIG. 3A, according to an embodiment of the present disclosure.

[0025] FIG. 3C is an exploded perspective view of the distal portion of the access catheter of FIG. 3 A, according to an embodiment of the present disclosure.

[0026] FIG. 4 is a detailed view of a shaft of the access catheter taken from encircled area 4 of FIG. 2, according to an embodiment of the present disclosure.

[0027] FIG. 5 is a sectional view of a proximal section of the access catheter taken from encircled area 5 of FIG. 2, according to an embodiment of the present disclosure.

[0028] FIG. 6A is a detailed view of a distal portion of a dilator catheter taken from encircled area 6 of FIG. 2, according to an embodiment of the present disclosure.

[0029] FIG. 6B is a sectional view of the detailed view of FIG. 6A, according to an embodiment of the present disclosure.

[0030] FIG. 7 is a sectional view of a proximal section of the dilator catheter taken from encircled area 7 of FIG. 2, according to an embodiment of the present disclosure.

[0031] FIG. 8 is a detailed view of a distal portion of a puncture device taken from encircled area 8 of FIG. 2, according to an embodiment of the present disclosure.

[0032] FIG. 9 is a detailed view of an alternative distal portion of a puncture device taken from encircled area 8 of FIG. 2, according to an embodiment of the present disclosure.

[0033] FIG. 10 is a detailed view of an alternative distal portion of a puncture device taken from encircled area 8 of FIG. 2, according to an embodiment of the present disclosure.

[0034] FIG. 11 is a sectional view of a puncture device within a distal portion of a dilator catheter in a first position, according to an embodiment of the present disclosure.

[0035] FIG. 12 is a sectional view of a puncture device within a distal portion of a dilator catheter in a second position, according to an embodiment of the present disclosure.

[0036] FIG. 13 is a sectional view of a puncture device within a distal portion of a dilator catheter in a third position, according to an embodiment of the present disclosure.

[0037] FIG. 14 is a sectional view of a puncture device within a distal portion of a dilator catheter in use in vivo in a first step, according to an embodiment of the present disclosure.

[0038] FIG. 15 is a sectional view of a puncture device within a distal portion of a dilator catheter in use in vivo in a second step, according to an embodiment of the present disclosure.

[0039] FIG. 16 is a sectional view of a puncture device within a distal portion of a dilator catheter in use in vivo in a third step, according to an embodiment of the present disclosure.

[0040] FIG. 17 is a sectional view of a puncture device within a distal portion of a dilator catheter in use in vivo in a fourth step, according to an embodiment of the present disclosure.

[0041] FIG. 18 is a sectional view of a puncture device within a distal portion of a dilator catheter in use in vivo in a fifth step, according to an embodiment of the present disclosure.

[0042] FIG. 19 is a sectional view of the system of FIG. 2 being utilized within a patient, according to an embodiment of the present disclosure.

[0043] FIG. 20 is an elevation view of a system for transvascularly providing irrigation and aspiration to an intracranial site, according to an embodiment of the present disclosure.

[0044] FIG. 21 is a perspective partially-exploded view of a handle of the system of FIG. 20.

[0045] FIG. 22 is an exploded view of a handle of the system of FIG. 20.

[0046] FIG. 23 is a detailed internal left side view of the handle of the system of FIG. 20.

[0047] FIG. 24 is a partially-exploded perspective view of the handle of the system of FIG. 20.

[0048] FIG. 25 is a perspective view of the shaft of an access catheter, according to an embodiment of the present disclosure.

[0049] FIG. 26 is a detailed view of a shaft of the access catheter taken from encircled area 26 of FIG. 25, according to an embodiment of the present disclosure.

[0050] FIG. 27 is a detailed view of a shaft of the access catheter taken from encircled area 27 of FIG. 25, according to an embodiment of the present disclosure.

[0051] FIG. 28 illustrates a blocking catheter, according to an embodiment of the present disclosure.

[0052] FIG. 29 a distal portion of the blocking catheter of FIG. 28, taken from encircled area 29 of FIG. 28, according to an embodiment of the present disclosure.

[0053] FIG. 30 a shaft transition portion of the blocking catheter of FIG. 28, taken from encircled area 30 of FIG. 28, according to an embodiment of the present disclosure.

[0054] FIG. 31 is a perspective view of a system for transvascularly providing irrigation and aspiration to an intracranial site, according to an embodiment of the present disclosure.

[0055] FIG. 32 is partial sectional view of a blocking catheter being inserted through the access lumen of an access catheter in a vein of the brain, in a first amount of advancement, according to an embodiment of the present disclosure.

[0056] FIG. 33 is partial sectional view of a blocking catheter being inserted through the access lumen of an access catheter in a vein of the brain, in a second amount of advancement, according to an embodiment of the present disclosure.

[0057] FIG. 34 is partial sectional view of a blocking catheter being inserted through the access lumen of an access catheter in a vein of the brain, in a third amount of advancement, according to an embodiment of the present disclosure.

[0058] FIG. 35 is partial sectional view of a blocking catheter being inserted through the access lumen of an access catheter in a vein of the brain, in a first amount of advancement in a deflated state, according to an embodiment of the present disclosure.

[0059] FIG. 36 is partial sectional view of a blocking catheter being inserted through the access lumen of an access catheter in a vein of the brain, in a second amount of advancement in a deflated state, according to an embodiment of the present disclosure.

[0060] FIG. 37 is partial sectional view of a blocking catheter being inserted through the access lumen of an access catheter in a vein of the brain, in the second amount of advancement in an inflated state, according to an embodiment of the present disclosure.

[0061] FIG. 38 is partial sectional view of a blocking catheter being inserted through the access lumen of an access catheter in a vein of the brain, in the second amount of advancement in the inflated state, with a dilator catheter extending from the side exit port, according to an embodiment of the present disclosure.

[0062] FIG. 39 is a side view of a blocking catheter, according to an embodiment of the present disclosure.

[0063] FIG. 40 is a side view of a blocking catheter, according to an embodiment of the present disclosure.

[0064] FIG. 41 is a side view of a blocking catheter, according to an embodiment of the present disclosure.

[0065] FIG. 42 is a side view of a blocking catheter, according to an embodiment of the present disclosure.

[0066] FIG. 43 is a perspective view of an aspiration and irrigation catheter, according to an embodiment of the present disclosure.

[0067] FIG. 44 is a detailed view of a distal portion of a shaft of the aspiration and irrigation catheter taken from encircled area 44 of FIG. 43.

[0068] FIG. 45A is a cross-section of the shaft of the aspiration and irrigation catheter of FIG. 44, taken at point 45 A.

[0069] FIG. 45B is a cross-section of the shaft of the aspiration and irrigation catheter of FIG. 44, taken at point 45B.

[0070] FIG. 46 is a perspective view of a dilator catheter capable of aspiration and irrigation, according to an embodiment of the present disclosure.

[0071] FIG. 47 is a detailed view of a distal portion of a shaft of the dilator catheter taken from encircled area 47 of FIG. 46.

[0072] FIG. 48A is a cross-section of the shaft of the dilator catheter of FIG. 47, taken at point 48A.

[0073] FIG. 48B is a cross-section of the shaft of the dilator catheter of FIG. 47, taken at point 48B.

[0074] FIG. 49 is a perspective view of a distal shaft of an aspiration / irrigation catheter, according to an embodiment of the present disclosure.

[0075] FIG. 50 is a perspective view of a distal shaft of a dilator catheter, according to an embodiment of the present disclosure.

[0076] FIG. 51 A is a cross-section of the shaft of the dilator catheter of FIG. 50, taken at point 51 A.

[0077] FIG. 5 IB is a cross-section of the shaft of the dilator catheter of FIG. 50, taken at point 5 IB.

[0078] FIG. 52 is a y-connector attached to multi-lumen tubing of the catheters of FIGS. 49 and 50, according to an embodiment of the present disclosure.

[0079] FIG. 53 is a cross-section of an alternative aspiration / irrigation catheter shaft or dilator catheter shaft, according to an embodiment of the present disclosure.

[0080] FIG. 54 is a cross-section of an alternative aspiration / irrigation catheter shaft or dilator catheter shaft, according to an embodiment of the present disclosure.

[0081] FIG. 55 is an elevation view of a ramp tip plug tube of an access catheter, according to an embodiment of the present disclosure.

[0082] FIG. 56 is a sectional view of the ramp tip plug tube of FIG. 55.

[0083] FIG. 57 is a perspective view of an elongate shaft portion of a valving tube, according to an embodiment of the present disclosure.

[0084] FIG. 58 is a sectional view of a valving tube device of the valving tube of FIG. 57, according to an embodiment of the present disclosure.

[0085] FIG. 59 is a dilator catheter / valving tube system in a first position, according to an embodiment of the present disclosure.

[0086] FIG. 60 is the dilator catheter / valving tube system in a second position, according to an embodiment of the present disclosure.

[0087] FIG. 61 is an elevation view of a puncture device, according to an embodiment of the present disclosure.

[0088] FIG. 62 is an exploded view of the puncture wire device of FIG. 61.

[0089] FIG. 63 is a system of the puncture device of FIG. 61 and a dilator catheter, according to embodiment of the present disclosure.

[0090] FIG. 64 is the system of FIG. 63 with a coil compressed to show a piercing tip of the puncture device, according to an embodiment of the present disclosure.

[0091] FIG. 65 is the system of FIG. 63 in use during a first clinical step, according to an embodiment of the present disclosure.

[0092] FIG. 66 is the system of FIG. 63 in use during a second clinical step, according to an embodiment of the present disclosure. FIG. 67 is an elevation view of a puncturing device comprising a curved puncturing guidewire without a formed tip section, according to an embodiment of the present disclosure.

[0093] FIG. 68 is an elevation view of a puncturing device comprising a puncturing guidewire with a formed tip section, according to an embodiment of the present disclosure.

[0094] FIG. 69 is an elevation view of a system of the puncturing guidewire of FIG. 68 with a formed curved tip section, straightened by a dilator catheter and piercing tissue, according to an embodiment of the present disclosure.

[0095] FIG. 70 is an elevation view of the system of the puncturing guidewire of FIG. 69 with the formed curved tip section extended from the dilator catheter after piercing tissue in an atraumatic condition, according to an embodiment of the present disclosure.

[0096] FIG. 71 is an elevation view of a magnetic localization coil, according to an embodiment of the present disclosure.

[0097] FIG. 72 is a partial sectional view of an access catheter having a magnetic localization coil, according to an embodiment of the present disclosure.

[0098] FIG. 72A is a partial sectional view of a first alternative embodiment of the access catheter of FIG. 72.

[0099] FIG. 72B is a partial sectional view of a second alternative embodiment of the access catheter of FIG. 72.

[0100] FIG. 73 is a partial sectional view of a dilator catheter having a magnetic localization coil, according to an embodiment of the present disclosure.

[0101] FIG. 74 is a partial sectional view of a puncturing device having a magnetic localization coil, according to an embodiment of the present disclosure.

[0102] FIG. 75 is a diagrammatic view of a magnetic localization system in use in a patient, according to an embodiment of the present disclosure.

[0103] FIG. 76A is a general diagram of an impedance sensing system, according to an embodiment of the present disclosure.

[0104] FIG. 76B is an exemplary readout of measured voltage over time from an impedance sensing system, according to an embodiment of the present disclosure.

[0105] FIG. 77 is a perspective view of an access catheter having impedance system electrodes, according to an embodiment of the present disclosure.

[0106] FIG. 78 is a perspective view of a dilator catheter having impedance system electrodes, according to an embodiment of the present disclosure.

[0107] FIG. 79 is a perspective view of a puncturing device having impedance system electrodes, according to an embodiment of the present disclosure.

[0108] FIG. 80 is a diagrammatic view of an impedance sensing system in use in a patient, according to an embodiment of the present disclosure.

[0109] FIG. 81 is a perspective view of a pressure sensing aspiration and irrigation catheter, according to an embodiment of the present disclosure.

[0110] FIG. 82 is a perspective view of a sensor assembly of the aspiration and irrigation catheter, according to an embodiment of the present disclosure.

[0111] FIG. 83 is a detailed view of a proximal portion of the sensor assembly taken from encircled area 83 of FIG. 82, according to an embodiment of the present disclosure.

[0112] FIG. 84 is a detailed view of a distal portion of the sensor assembly taken from encircled area 84 of FIG. 81, according to an embodiment of the present disclosure.

[0113] FIG. 85 is a cross-sectional view of the distal portion of the sensor assembly of FIG. 82.

[0114] FIG. 86 is a perspective view of a pressure sensing guidewire within an aspiration and irrigation catheter, according to an embodiment of the present disclosure.

[0115] FIG. 87 is an elevation view of the guidewire of FIG. 86, according to an embodiment of the present disclosure.

[0116] FIG. 88 is a perspective view of a sensor assembly of the guidewire, according to an embodiment of the present disclosure.

[0117] FIG. 89 is a detailed view of a proximal portion of the sensor assembly taken from encircled area 89 of FIG. 88, according to an embodiment of the present disclosure.

[0118] FIG. 90 is a detailed view of a distal portion of the sensor assembly taken from encircled area 90 of FIG. 88, according to an embodiment of the present disclosure.

[0119] FIG. 91 is an end view of the distal portion of the guidewire of FIG. 87.DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0120] Subdural or subarachnoid collections are an abnormal collection of fluid and or tissue under the meningeal dura and overlying or involving the arachnoid meninges. For example, acute subdural hematomas are commonly caused by head trauma and the rupture ofbridging veins resulting in hematoma formation. Another example are chronic subdural hematomas (eSDH), and while the mechanism for formation remains a topic of investigation, it putatively develops from membrane formation and permeable neovessels due to a recurring cycle of inflammation, neovascularization, and re-hemorrhage. Subdural hygromas on the other hand may represent cerebrospinal fluid or serosanguinous collections within the dural border cell layer from tears in both the dural border cell and arachnoid layers, which can be caused by a variety of mechanisms, including trauma, infection, or venous congestion. Lastly, subdural empyema is a collection of pus between the dura and arachnoid mater caused by bacterial of fungal infections.

[0121] Surgical treatment of subdural or subarachnoid fluid collections is indicated when patients become clinically symptomatic and / or the collections exert mass effect (>10 mm in thickness, >5 mm of midline shift), increased intracranial pressure, or when there is evidence of a loculated infection. Surgical treatment usually consists of irrigation, drainage, evacuation, and / or sampling either by burr hole or craniotomy. This requires incision of the scalp, drilling a burr hole through the skull and / or creating a craniotomy, and incision of the dura to place a drain for evacuation. A major complication of surgical methods for subdural fluid drainage, evacuation, or sampling is neurologic deficit due to brain injury / tissue damage, infection, intracranial hemorrhage and / or recurrence. Recurrence of chronic subdural hematomas can occur in up to 30% of cases after initial surgical drainage or evacuation, and in turn requires repeat surgical intervention.

[0122] An emerging treatment for eSDH is middle meningeal artery (MMA) embolization due to the putative role of this vascular tree in supplying blood to an encapsulating outer capsular membrane in the subdural space, which is highly permeable and the site of aberrant microcapillary beds that promote hematoma recurrence. MMA embolization may decrease the recurrence rate of eSDH formation to 4%, from as much as 39% compared with surgical drainage alone. Pertinently, surgical treatment may impede MMA embolization by transection or disruption of the MMA vasculature resulting in high recurrence rates and repeat hospitalization. Moreover, conventional surgical evacuation poses significant risks to the patient and complications may occur an estimated 5-19% of the time. In addition, current workflow constraints require that the patient undergo two separate procedures and most commonly two separate general anesthesia procedures for eSDH evacuation / decompression, which also poses significant risk to the patient, increases length of stay, and increases healthcare costs. To optimize patient safety and consolidate the workflow, an endovascular solution for evacuating or draining subdural hematoma would represent asignificant improvement over conventional methods when there is evidence of extrinsic and / or symptomatic compression of the brain, as well as to improve the patient experience and reduce healthcare costs. Moreover, other subdural collections, such as hygroma or empyema, may require evacuation, cytologic analysis, or both to confirm the diagnosis and implement appropriate treatment strategies. The inventors have recognized that despite significant advances in our understanding of the pathophysiology of eSDH and the emergence of minimally invasive treatment modalities to prevent recurrence for eSDH, there remains a need for a non-surgical method to analyze / treat / evacuate subdural or subarachnoid fluid collections.

[0123] Furthermore, the inventors have recognized that there remains a need for non- surgical, minimally invasive evacuation and / or irrigation of subdural or subarachnoid collections, such as hygromas, abscesses, or empyemas to reduce the risks of surgery, which include pain, bleeding, recurrence, and / or infection.

[0124] The present disclosure is directed towards a guide access catheter device and related systems and methods for trans-dural venous sinus puncture and access to the extravascular extra-axial / sub dural spaces surrounding the brain. The devices disclosed herein pertain to endovascular guide / access catheters, co-axially introduced transcatheter instruments and transvascularly advanced / navigated catheters for transcatheter collection, evacuation, sampling, or irrigation of subdural or subarachnoid fluid collections for the diagnosis and treatment of subdural hemorrhages, hygromas, abscesses, or empyemas.

[0125] In humans, the cerebral venous system courses through and overlays a range of important brain structures and provide access to cortical structures and represents a promising avenue for fluid collection for diagnostic fluid or tissue (biopsy) sampling, drainage, decompression, and direct drug delivery. It also can provide an avenue for ablation, epilepsy mapping, neuronal recording, neurostimulation, neuromodulation, and brainmachine interface. Specifically, the Superior Sagittal Sinus, the Inferior Anastomotic Vein of Labbe, the Superior Anastomotic Vein of Trolard, Superficial Middle Cerebral Vein, Superior Petrosal Sinus, Great Vein of Galen, Internal Cerebral Veins, and the Basal Vein of Rosenthal, and their respective tributaries provide endovascular routes to the limbic structures, thalamus, basal ganglia, occipital, temporal, parietal, and frontal cortices. Specifically, the Superior Sagittal Sinus, among other dural venous sinuses, provides access to the occipital, temporal, parietal, and frontal cortices along the cerebral hemisphere. The diameter of the Superior Sagittal Sinus and Transverse Sinus in humans are reported to measure 5.5mm to 12mm and 5.4mm to 11.5 mm, respectively. Advantageously, the cerebralvenous system is a low flow system with pressures ranging between 4 to 10 mm Hg with patient in a supine position. Compared to the arterial system, cerebral veins and / or dural venous sinuses possess relatively large lumens intracranially providing an intracranial pathway with relatively large bore catheters. These low flow vessels represent a promising avenue for transvascular access to extravascular spaces in the intracranial vault with the proposed transvascular catheter-based approach.

[0126] The present disclosure is directed towards a guide / access catheter device, and related systems and methods for transvenous / transdural access and subdural or subarachnoid catheter advancement / navigation to extravascular regions of interest in the extra-axial and intra-axial compartments of the brain, including subdural or subarachnoid spaces, and / or tissue parenchyma. The devices disclosed herein pertain to endovascular guide / access catheters, coaxially-introduced transcatheter instruments, and transvascularly navigated catheters for transcatheter device delivery or deployment, implantation, and drug delivery directly to extra-vascular intracranial structures, tissues, media, and components for the evaluation, diagnosis, and treatment of neurologic disease and disorders. In some embodiments, the device can be used for tissue or media sampling and / or drainage / evacuation, targeted tissue biopsy of, in situ imaging of, device delivery to, device implantation into, or direct drug delivery to intracranial structures, such as the brain parenchyma, subdural or subarachnoid space. Of particular focus is the removal of acute or chronic subdural or subarachnoid tissue or fluid collections.

[0127] Described herein is a catheter-based endovascular transvenous approach and apparatus for directly accessing the brain and its constituent components. The present disclosure relates to a variety of methods and devices to enable transvascular, more particularly trans-dural venous access (tDVa) to the extravascular subdural space for removal of intracranial, extravascular tissue or fluid collections. The embodiments described herein can also be utilized for access to the subarachnoid space for removal of subarachnoid material, such as tissue or fluid.

[0128] The endovascular catheter proposed herein can be made from a specific set of polymers and reinforcement materials embedded within the walls of the catheter (such as metal alloys configured in braided or coiled patterns, varying weave density (pitch per inch), etc.) to confer an optimal combination of flexibility, tensile strength, torque, steerability, trackability, pushability, and compression / kink resistance. Endovascular catheters, unlike catheters used in stomas or through avascular tubular structures, must be thin walled yet confer a balance between high tensile strength, burst resistance, compression resistance, andflexibility. The endovascular catheters disclosed herein have superior biocompatibility, are biologically inert (i.e., do not promote an inflammatory response), and in some embodiments are coated with hydrophilic or lubricous materials to prevent thrombogenicity, and are nonmutagenic (non-toxic and do not contain leachable additives that could be cytotoxic or lead to systemic toxicity) and resist biofilm formation.

[0129] The systems and methods described herein are capable for use in low-pressure environments. For example, embodiments disclosed herein are intended for use in the cerebral veins (low pressure) for positioning, anchoring, and supporting subsequently introduced catheters and related instrumentation intended for navigating the sub dural / sub arachnoid space, as well as for buttressing the back propagation of forward insertion forces. Further, the present disclosure maintains a wide diameter lumen from the proximal end of the catheter through to the lateral wall working exit lumen port where coaxial catheters can be deployed. This contrasts with systems that were tailored for use in peripheral arterial systems and their lateral wall working exit lumen ports feature relatively small diameters allowing only for deployment of thin diameter or transverse dimension penetrators or guidewires.

[0130] Further, the disclosed embodiments, utilize advancements, such as low-profile monolithic tubing constructs, catheters with steerability, flexible / steerable needles, and submillimeter needle- / catheter- / wire-based fiber optic photonic, radiofrequency energy or sonographic imaging apparatuses, and catheter-deliverable super-elastic highly compressible shape memory materials or devices, provide distinct advantages to conventional systems which were not capable for use in connection with minimally invasive transvascular methods and devices for the diagnosis and treatment of neurologic disease and disorders as is described herein. The proposed methods disclosed herein would enable improved distal navigation through tortuous vessels, controlled transvascular access, in-situ imaging, untethered implantable devices, as well as catheter delivery of appropriately-scaled and / or biologically compatible or degradable medical devices (e.g., cyto-compatible compressible shape memory alloys / materials) through relatively small bore (2 to 8 Fr or 2 to 6 Fr) catheters with equal or superior efficacy to conventional systems requiring invasive neurosurgery mediated primarily through burr holes or craniotomy.

[0131] In some embodiments, an access / guide catheter system is used for extravascular procedures in the brain. The access / guide catheter can include an elongate, flexible tubular body, having a proximal end, a distal end and at least one lumen extending axially there through, a side exit port (side access port) positioned along the elongate, flexibletubular body, spaced proximally apart from the distal end and in communication with the lumen, a distal end port in communication with the lumen proximate the distal end, and a selective deflector positioned within the lumen, wherein the selective deflector is configured to deflect a procedure catheter having a diameter greater than a preset threshold out through the side exit port, and wherein the selective deflector is configured to permit a guide catheter having a diameter of less than the preset threshold to pass distally beyond the deflector and out through the distal end port. Additionally, in some embodiments, the access / guide catheter can incorporate source and sink electrodes and / or coils for impedance-based localization or magnetic localization. These electrodes or coils provide real-time tracking and feedback during the procedure by generating impedance measurements or electromagnetic signals. This functionality allows for the precise navigation of the access / guide catheter within the vasculature, improving safety by ensuring accurate placement and reducing the risk of vessel damage or misplacement during extravascular procedures. Additionally, an electrode or coil can be placed as an additional sensor on a known anatomical reference plane for real-time tracking and feedback, to allow for precise navigation of the access / guide catheter within the vasculature. Such an electrode or coil improves safety by aiding accurate placement of devices such as a guidewire, dilator catheter, puncture device, or other procedure catheter, and avoiding misplacement. It also reduces the risk of vessel damage.

[0132] Optionally, the selective deflector can include an inclined barrier positioned within and partially occluding the lumen. In some embodiments, the inclined barrier includes an aperture, and the aperture diameter can be less than a side exit port diameter of the side exit port. In some embodiments, the deflect can include a second co-axial elongate, flexible tubular body with a variable diameter, such that the distal end of the tubular body is a larger diameter. The larger diameter segment of the co-axial member can completely or partially occlude the lumen of the access / guide catheter distal to the side exit port, as well as function to reduce the ledge effect between the access / guide catheter and this second co-axial member to enable ease of access / guide catheter navigation to the region of interest. The access / guide catheter system can also include a laterally expandable support carried by the elongate, flexible tubular body, and the laterally expandable support can be positioned on an opposite side of the tubular body from the side exit port. Optionally, the laterally expandable support can include an inflatable balloon. Optionally, the laterally expandable support can include at least one laterally deflectable strut. Optionally, a re-sheathable radially expandable stent featuring a central or eccentric rail-wire and / or a pusher wire and an exit target ring radiopaque outlet that allows for selective orientation of the guide / access catheter, to alignwith the exit ring outlet and maintain endoluminal apposition to the intended puncture site along the vessel wall. The lateral support (e.g., balloon, strut, etc.) is configured, when expanded, to push laterally against an inner venous wall that is substantially on the opposite side of the vein from the intended puncture site, and to force or otherwise move the side exit port against the venous wall at the intended puncture site. In alternative embodiments, the access catheter system can include a first balloon and a second balloon, wherein the first balloon is positioned on the tubular body on a proximal side of the side exit port and the second balloon is positioned on the tubular body on a distal side of the side exit port.

[0133] Optionally, the procedure catheter can include at least one of a puncturing guidewire, flexible needle, a steerable needle, a retractable needle sheath, a retractable guard, a dilator, a steerable catheter, an imaging device, an ablation device, force sensors, temperature sensors, biopsy device, a convection-enhanced drug delivery microcatheter, a biodegradable one-way draining transvessel wall shunt or port, or an injectable drug eluting bioresorbable nanofluidic implant. The ablation device or the imaging device can include a microelectronic mechanical system, optical technology, a flexible laser-cut hypo tube, or coaxial actuating mechanical system. Additionally, in some embodiments, the procedure catheter can also incorporate source and sink electrodes and / or coils for impedance-based localization or magnetic localization. These electrodes or coils enable real-time tracking of the catheter's position within anatomical structures by providing impedance measurements or electromagnetic signals. This allows for precise navigation of the catheter relative to the vasculature and subdural space, enhancing the accuracy and safety of the procedure by providing continuous localization data during catheter placement and operation.

[0134] In some embodiments, a method of providing transvascular access to an extravascular access site in a vessel can include the steps of advancing a guide catheter over a guidewire or microsystem to precisely position a side exit port of the guide / access catheter adjacent to a target puncture site of the vessel unobstructed by bridging or cortical draining veins. In one embodied method, the next step involves retracting the guidewire or microsystem from the guide / access catheter, and advancing a co-axial assembly comprising a procedure (drainage or aspiration) catheter, a dilator, and a puncturing guidewire through the guide / access catheter and to the target side of the vessel via the side exit port of the guide / access catheter, wherein a selective deflector in the guide / access catheter deflects the co-axial assembly comprising a drainage or aspiration catheter, a dilator, and a guidewire out through the side exit port, but permit a distinct guidewire or microsystem to advance distally beyond the deflector and out of a distal end of the guide / access catheter. In otherembodiments, an elongate, tubular body with a distal segment featuring a larger diameter than the more proximal shaft is retained within the guide / access catheter and serves to deflect the guidewire, dilator, and procedure catheter assembly also acting as a fulcrum point to facilitate puncture with the guidewire plus dilator assembly. The aspiration or drainage catheter can feature a straight, angled, or bent tip. The distal end of the aspiration or drainage catheter can contain multiple irrigation holes in communication with fluid infusion port via smaller extruded lumens to enable the passage of saline or other media to aid in the aspiration or drainage of the subdural tissue or fluid collections.

[0135] The guidewire can have an outer diameter between 0.006” and 0.035”, or between 0.006” and 0.018”, or between 0.006” and 0.014”. The guidewire is constructed from a metal or alloy core material covered by coiled metal or alloy materials and / or an intermediate polymer layer. In some embodiments, the guidewire is pre-shaped or curved. In some embodiments, the wire is straight. In some embodiments, the guidewire features a beveled, fillet, or chamfered tip. In some embodiments, the wire features a flat or round tip. When the guidewire is partially or completely sheathed, the distal segment of the core material of the guidewire provides high loading force or column strength. Proximal to the distal segment, the guidewire features a flexible segment to enable curvature upon advancement of the guidewire from the dilator to prevent piercing through brain tissue, vessels, and the like once in the extravascular subdural or subarachnoid space. Additionally, in some embodiments, the guidewire further comprises integrated source and sink electrodes and / or coils positioned along its length for either impedance-based localization or magnetic localization. These electrodes or coils facilitate real-time tracking and navigation of the guidewire by providing either impedance measurements or electromagnetic signals, allowing for precise positioning within the vasculature and subdural space. This feature enhances safety during the procedure by helping to define access to the subdural space relative to surrounding anatomical structures. In some embodiments, the guidewire comprises a flexible fiber optic element with imaging, pressure sensing, and / or impedance sensing capabilities, allowing for precise positioning within the vasculature and subdural space.

[0136] FIG. 1 illustrates an embodiment of the access catheter 1013 comprising a shaft 1014 featuring discreet segments 1014a-f of alternating reinforcement members along its longitudinal extent in accordance with an embodiment of the present disclosure. The access catheter 1013 is depicted as accessing distal cerebral veins / sinuses from a peripheral site 1001. The access catheter 1013 is configured to transvascularly deploy an irrigation / aspiration catheter 1012 (also called an irrigation / evacuation catheter) from itslateral working exit lumen port 1010, which in turn enables subdural or subarachnoid navigation of the intracranial space 1031. Dura mater 1015 is shown after being punctured by a puncture device or puncture wire or puncturing guidewire or puncture instrument 103 (FIG. 2) and dilated by a dilator (e.g., dilator catheter 102, FIG. 2). The irrigation / aspiration catheter 1012 extends through the punctured, dilated dura mater 1015. As illustrated in FIG. 1, the shaft 1014 of the guide / access endovascular catheter 1013 is variably reinforced with braids along braided longitudinal segments 1008, 1014a, 1014c, 1014e to allow manipulation including torquing of the guide / access catheter 1013 within the cerebral venous anatomy1032 of the brain 1017 and reinforced with coils along coil segments 1007, 1014b, 1014d, 1014f to conform and allow free tracking along flexures / bends that are present along tortuous segments of the cerebral venous anatomy 1032. Distal to the lateral wall working exit lumen port 1010, a segment 1014f of the guide / access catheter shaft can be coil reinforced to aid in the guide / access catheter’s 1013 trackability and navigability through tortuous cerebral vessels. The most distal segment of the guide / access catheter 1013 can be heat shrunk or reflowed for a soft, atraumatic tip. An embodiment of the steerable catheter can feature a steering collar proximal to a lateral wall or distal end working exit lumen 1010 port laser- welded to a pull wire residing within a segregated lumen of the guide / access catheter shaft 1014.

[0137] Discrete longitudinal segments 1014a-f with alternating and variable reinforcement material to optimize the guide / access catheter’s 1013 trackability through the tortuous cerebral venous system 1032 and the guide / access catheter’s 1013 kink resistance at major stress points at acute flexures are illustrated. The transvascularly deployed steerable catheter 1013 is illustrated navigating the sub dural / sub arachnoid space and provides agile deployment of instruments, devices, biological, cyto-active agents / compounds / materials, or implants. Illustrated in FIG. 1 is the peripheral access site 1001 such as a subclavian vein1033 or the internal jugular vein 1002 communicates to the sigmoid sinus 1003, transverse sinus 1004, torcula herophili 1005, and superior sagittal sinus 1006. The guide / access catheter 1013 can include a variable pitch coiled reinforcement at the coil segments 1007, and variable pick per inch braided reinforcement at the braided segments 1008, a tapered tip 1009, and the lateral wall working exit lumen port 1010. In FIG. 1, the irrigation / aspiration catheter 1012 has been advanced into a subdural hematoma 1016 and it shown in position to aspirate out the contents of the subdural hematoma 1016 within the brain 1017.

[0138] The access catheter 1013 includes a proximal connector 1018 having an access hemostatic valve 1019 to access the thru lumen, and a sideport 1020 configured forconnection of a syringe 1021, or any other pressurization source to inflate and to deflate the eccentric or offset inflatable balloon 1022, which is shown in an inflated state in FIG. 1. As depicted in FIG. 1, the exit lumen port 1010 is located just proximally of the tapered tip, but in other embodiments, it can be within the tapered tip area, or can be spaced a distance proximal to the proximal beginning of the tapered tip.

[0139] The irrigation / aspiration catheter 1012 comprises a shaft 1023 having a proximal connector 1024 having an insertion valve 1025 (e.g., for inserting a guidewire) and a sideport 1030 having a female luer connector 1026. The insertion valve 1025 can comprise any hemostasis valve, such as a Touhy-Borst, a duckbill valve, or a spring-loaded open / close valve. An extension tube 1027 connects an aspiration unit 1028 (e.g., vacuum pump or syringe) and a canister 1029 has a distal male luer connector 1042 that connects to the female luer connector 1026 of the proximal connector, and thus to the thru lumen of the irrigation / aspiration catheter 1012. Aspiration of the subdural hematoma 1016 is then performed with the irrigation / aspiration catheter 1012 utilizing the aspiration unit 1028 and drawing portions of the subdural hematoma 1016 into the canister 1029. In other embodiments, the aspiration unit 1028 and canister 1029 can be replaced by a syringe.

[0140] Exemplary procedural steps for subdural hematoma removal follow. Using standard techniques, a select catheter is inserted into the body to select one of the following arteries (common / internal / external carotid or vertebral arteries). Contrast injection and delayed acquisition enables opacification of the cerebral venous system. At this time, middle meningeal artery embolization may be performed, if desired, prior to subdural hematoma evacuation. Cerebral venous phase images can be co-registered with pre-operative MR or CT cerebral venograms and / or pre- / intra-operative structural brain scans to enhance image guidance and anatomic fiducial markers.

[0141] Using ultrasound or manual palpation of anatomical landmarks, a brachial / axillary, femoral, subclavian, or internal jugular vein is accessed using the Seidinger technique. A supportive access sheath measuring between about 10 cm and about 40 cm can be inserted and docked in the access vein, for example one of the internal jugular veins. Next, the access catheter 1013 is inserted into the supportive access sheath (not shown) connected to a rotating hemostatic valve (RHV) (not shown) to which a continuous heparinized saline drip flush if connected at a sideport of the RHV. Assembled within the access catheter 1013 is a blocking catheter 304 (FIG. 28), for example, an embodiment using a deflector inner mold with a smaller aperture for catheter advancement through the distal end port of the access catheter 1013, or a variable outer diameter microcatheter. The microcatheter can beco-axially assembled over a 0.010” to 0.024” guidewire, which enables advancement of the access catheter 1013 to the superior sagittal sinus 1006 from the sigmoid 1003 / transverse sinuses 1004 and torcular herophili 1005. Radiopaque markers or radiopaque material on the access catheter 1013 enable visualization of the side exit port 307 (side access port), 1010, distal end port / opening, and balloon 1022, for example, in terms of length, extent, and orientation. These radiopaque markers are referenced to anatomical brain scan imaging obtained pre- / intra-operatively. In some embodiments, the radiopaque markers can comprise two markers: a marker band located near the tip of the access catheter 2, 1013 and a radiopaque portion of tubing at the balloon 1022. In another embodiment, there may be a marker band just distal to the balloon 1022 and another marker band just proximal to the balloon 1022. In any embodiments, the balloon 1022 can be inflated with contrast media, or dilute contrast media (e.g., 50% contrast media diluted with normal saline, 30%, 70%, etc.). The identification of the location of the radiopaque portions of the access catheter 1013, in relation to anatomical landmarks, can be performed at a venography. Alternatively, or in addition, delayed acquisition venous phase images are performed to also inform optimal positioning of access catheter 1013, the balloon 1022, and the side exit port 307, 1010 to a region of interest unobstructed by bridging cortical veins. Representative access systems, components, and methods that can be utilized to augment the present systems and methods are taught in in the co-owned International App. No. PCT / US20 / 41246, filed July 8, 2020, and published January 14, 2021 as WO 2021 / 007346 Al, which is hereby incorporated by reference in its entirety for all purposes. The balloon 1022 is configured, when expanded, to push laterally against an inner venous wall that is substantially on the opposite side of the vein from the intended puncture site, and to force or otherwise move the exit lumen port 1010 against the venous wall at the intended puncture site.

[0142] The irrigation / aspiration catheter 1012 of FIG. 1 is shown in a generic configuration comprising a shaft 1023 having a thru lumen (not shown) extending through the shaft 1023. The lumen is configured for injection, infusion, and irrigation into the intracranial space 1031 and also configured to aspiration of material from the intracranial space 1031. To irrigate down the thru lumen instead of aspirating, the male luer connector 1042 is detached from the female luer connector 1026 and a male luer connector 1039 extending from irrigation tubing 1040 of an irrigation pump 1041 is attached to the female luer connector. Alternatively, a syringe (with or without a syringe pump) or a saline bag or saline bottle can be used for irrigation instead of the irrigation pump 1041.

[0143] Turning to FIG. 2, a system 100 for providing transvascular access to an extravascular site being utilized within a patient comprises an access catheter 101, a dilator catheter 102, and a puncture device 103. The puncture device 103 comprises a piercing distal end 104, a proximal end 105, and an elongate shaft 106 coupled to and extending proximally from the distal end 104. The shaft 106 can comprise stainless steel or a shape-memory alloy. The proximal end 105 comprises a grip 127 for longitudinally translating the puncture device 103, distally and proximally. In some embodiments, if torquing of the puncture device 103 is desirable, the grip 127 can be configured for applying clockwise and counter-clockwise torques. The elongate shaft 106 of the puncture device 103 is configured for placement within a dilator lumen 107 of the dilator catheter 102. The dilator catheter 102 comprises a distal portion 108 comprising a tapered distal tip 109 and further comprises a proximal end 110. The tapered distal tip 109 comprises a frustoconical shape. The tapered distal tip 109 in some embodiments tapers down to a distal-most outer diameter that is between 101% and 110% of a distal-most inner diameter of the thru lumen. A y-connector 111 extends distally of the proximal end 110 and includes an internal lead-in 112 configured for inserting the distal end 104 of the puncture device 103, for placement of the shaft 106 of the puncture device 103 down the dilator lumen 107 and out a distal port 126. The piercing tip 104 can comprise a penetrating tip and / or a cutting or slicing tip, and can comprise a bevel, a frustoconical shape (e.g., cone) and can in some embodiments include a fillet. In some embodiments, the shaft 106 is monolithic. In some embodiments, a proximal portion of the shaft 106 can include a coil layer, a braid layer, a laser-machined hypo tube, or a polyimide to polyester tubular covering, or a PTFE coating. The shaft 106 can include a composite construction (e.g., metal and polymer) that further reinforces the proximal end (e.g., for pushability) and provides a smooth transition in flexibility toward the distal end.

[0144] The dilator catheter 102 comprises an elongate shaft 113 coupled to and extending proximally of the distal portion 108. In certain embodiments, the dilator catheter 102 further includes one or more ports 114 (holes, sideholes, apertures) extending through a wall of the shaft 113 to transversely allow the dilator lumen 107 to fluidly communicate with an external region. Fluid can be injected out of the port 114 and fluid can be aspirated into the port 114, depending on whether a positive pressure is placed on a luer connector 117 of a sideport 176 of the y-connector 111 or a negative pressure is placed on the luer connector 117 of the sideport 176 of the y-connector 111. The dilator lumen 107 is hydraulically coupled to and communicates with a first luer connector 115 (e.g., female luer -lock connector) on a main port 177. In some embodiments, the dilator lumen 107 is the only lumen of the dilatorcatheter 102. In the embodiment of FIG. 2, there is a second lumen extending through the shaft 113. The second lumen can extend either coaxially with the dilator lumen 107 (e.g., via a separate tube), or next to and parallel to the dilator lumen. The second lumen 116 is hydraulically coupled to and communicates with a second luer connector 117 (e.g., female luer-lock connector). In one clinical method, an irrigation fluid (normal saline, heparinized normal saline, or a concentrated or dilute lytic agent) can be injected via the first luer connector 115 down the dilator lumen 107, from proximal to distal, into an area of interest; thrombus or other biological material can be aspirated into the port 114 and through the second lumen 116, from distal to proximal, via a negative pressure placed on the second luer connector 117 by either an evacuated syringe, or by an aspiration device 1028 (vacuum pump, etc.).

[0145] In use, the dilator catheter 102 and the puncture device 103 can be placed, together or separately, through a delivery lumen or access lumen 118 of the access catheter 101 and out a side exit port 119. The access lumen 118 extends completely through the shaft 120 of the access catheter 101, but an internal ramp 129 (FIGS. 3A-3C), or selective feature is configured to direct the tapered distal tip 109 of the shaft 113 of the dilator catheter 102 out the side exit port 119. The access lumen 118 extends from a distal port 128 to a proximal luer connector 121 (e.g., female luer lock connector) on a y-connector 122. The access catheter 101 further comprises a positioning balloon 123 (shown inflated in FIG. 2) located on a side of the shaft 120, opposite the side exit port 119. The balloon 123 is coupled to an inflation lumen 124 that extends proximally to a proximal luer connector 125 (e.g., female luer lock connector).

[0146] Turning to FIGS. 3A-3C, a distal portion 130 of the access catheter 101 is shown, comprising a radiopaque marker band 131, a multi -lumen shaft tip 132, a strain relief tube 133 (optional), the balloon 123, and a ramp tip plug tube 134. The balloon 123 comprises an expanded lozenge shape 135, and a collar 136 that extends parallel to the balloon at a lateral offset (not co-linear). The lozenge shape 135 and the collar 136 are integral to each other with an opening 137 between the lozenge shape 135 and the collar 136 to unite an interior 138 of the lozenge shape 135 and an interior 139 of the collar 136. A distal extension 140 of the collar 136 extends distally of the opening 137 and comprises a full cylinder. A proximal extension 141 of the collar 136 extends proximally of the opening 137 and comprises a full cylinder. The opening 137 can comprise an elongate opening, including an oval opening. The opening 137, for example, can extend between points bs and b? (FIG. 3B), or slightly distal to b? and slightly proximal to bs. The distal extension 140 and theproximal extension 141 are configured for being thermally bonded to the multi -lumen shaft tip 132 between points bi and b? (distal extension 140) and between points bs and b4 (proximal extension 141). Thus, each of the extensions 140, 141 (or necks) have a full cylindrical internal area 142, 143 to bond to an opposing full cylindrical outer area 144, 145 (distal and proximal) of the multi -lumen shaft tip 132. The multi -lumen shaft tip 132 comprises a thru lumen 146 and an inflation lumen 147, extending parallel and non-colinear to each other. A distal end 148 of the inflation lumen 147 is closed or occluded at a closure 150, by thermally compressing it, or by filling it with a melted polymer, or with an adhesive or epoxy. A proximal aperture 149 is created so that the inflation lumen 147 communicates with the interior 138 of the lozenge shape 135. The proximal aperture 149 can be longitudinally located anywhere proximal to the closure 150 and longitudinally along the extent of the opening 137. The multi-lumen shaft tip 132 comprises a first sidehole 151 between the distal full cylindrical outer area 144 and the proximal full cylindrical outer area 145. The first sidehole 151 passes through a wall 152 of the multi-lumen shaft tip 132 to the thru lumen 146. The balloon 123 comprises a second sidehole 153 passing through the wall 154 of the collar 136. The two sideholes 151, 153 are configured to be aligned when the balloon 123 is bonded. The balloon 123 can comprise thermoplastic polyurethane (TPU), or polyether block amide (PEBA) and have a shore hardness of between about 70A and about 90A, or between about 70A and about 80A. In some embodiments, the multi-lumen shaft tip 132 can also include a tubular braid layer.

[0147] Prior to bonding, the ramp tip plug tube 134 is inserted within the thru lumen 146 at a distal portion 155 of the multi-lumen shaft tip 132. A mandrel can be placed within the thru lumen 146 to maintain patency during a thermal bonding operation. Alternatively, adhesive or epoxy bonds can be used. The radiopaque marker band 131 is a split cylinder having a longitudinal slit 156 that facilitates its placement over the multi -lumen shaft tip 132. The radiopaque marker band 131 is slid over the proximal full cylindrical outer area 145 of the multi-lumen shaft tip 132, and then the polymeric strain relief tube 133 is slid over marker band 131, a proximal portion of the multi -lumen shaft tip 132 and a distal portion of the proximally extending catheter shaft 120. After the thermal bonding process, the strain relief tube 133 provides a smooth bending transition between the different components. However, in some embodiments, the proximal extension 141 of the balloon 123 is bonded directly to the multi -lumen shaft tip 132. Before or after the distal bond 157 and the proximal bond 158 are created at the full cylindrical internal areas 142, 143 and the full cylindrical outer areas 144, 145, a fully circular bond 159 (360°) is made at each with a thermal bond(e.g., searing or ironing) or with adhesive or epoxy, as indicated by the pattern 159 shown in FIG. 3C. The marker band 131 can comprise radiopaque materials such as gold, platinum, tantalum, or 90 / 10 platinum / iridium.

[0148] As shown in FIG. 3B, the internal ramp 129 comprises an angled or skived cut that is oblique in relation to the longitudinal axis of the ramp tip plug tube 134. Prior to the bonding or fusing operation, the ramp 129 is oriented such that the angle leads toward the side exit port 119, with a transverse component and a distal component. The access lumen 118 through the ramp tip plug tube 134 has a smaller diameter of the tapered distal tip 109 of the dilator catheter 102. Thus, when the tapered distal tip 109 of the dilator catheter 102 is advanced within the access lumen 118 proximal to the side exit port 119, it reaches the ramp 129 and cannot pass through the access lumen 118 at the ramp tip plug tube 134, and is redirected along the ramp 129 and out the side exit port 119. The ramp tip plug tube comprises a distal taper 160 extending to a distal end 161 to aid tracking within the venous vasculature. The tracking can be performed without a guidewire, or with a standard guidewire passed through the access lumen 118. The guidewire can then be removed from the access lumen 118, to allow for placement of the dilator catheter 102 and the puncture device 103. At the very distal end 161, distal to the distal taper 160 is a fillet 162 that is configured to avoid catching of the distal end 161 when being tracked. In some embodiments, the radius of curvature of the fillet is between about 0.0127 mm and 0.127 mm and the included taper angle of the distal taper 160 is between about 10° and 50°. In some embodiments, instead of the fillet 162, the wall thickness can decrease to a very thin amount at the tip, to have virtually no ledge over the guidewire outer diameter that can get caught on tissue. In some embodiments, the ramp tip plug tube 134 comprises a polymer that is doped with a radiopaque material such as tantalum, tungsten, barium sulfate, or titanium dioxide. The radi opacity of the ramp tip plug tube 134 is significantly more visible on fluoroscopy or radiography than the non-radi opaque (or significantly less radiopaque) portion 491 of the access catheter 101 just proximal to the side exit port 119 and also significantly more visible than the side exit port 119 opening. Thus, the internal ramp 129 is clearly delineated to a user on fluoroscopy or radiography. This allows the user to orient the ramp 129 longitudinally be advancing or retracting the access catheter 101, and / or be rotating (torquing) the access catheter 101, to a desirable location and orientation. It also allows the user to watch closely on fluoroscopy during critical portions of the procedure, such as the piercing of the venous wall 1034 and / or dura mater by the puncture device 103 or the dilating of the venous wall 1034 and / or dura mater by the distal taper 160 of the dilator catheter 102. The visible ramptip plug tube 134 on fluoroscopy provides a visual marker to help a user identify the precise position of the distal end 161 when being tracked. Finally, the ramp tip plug tube 134 can have a known length (e.g., 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, etc.) that can serve as a measurement device reference to anatomy, or to other devices being used. In other embodiments, short lengths of a radiopaque material can be alternated with short lengths of non-radiopaque or low-radiopacity material, to serve as a visual ruler.

[0149] An alternative ramp tip plug tube 490 is illustrated in FIGS. 55-56, and comprises a smaller inner diameter lumen 492, and a longer distal fillet 493 than the ramp tip plug tube 134. The inner diameter of the lumens 118, 492 can be sized depending on the type of wire or device that is to be passed distally, and to optimize the deflation of the devices that are to be passed through the side exit port 119. In some embodiments, the inner diameter of the lumen 492 can be between 0.3 mm and 1.1 mm, or between 0.3 mm and 0.56 mm, or between 0.75 mm and 1.1 mm. The distal taper 160, 494 shapes, lengths and diameters can be modified (e.g., multiple models), to optimize the navigation through blood vessels, such as the Superior Sagittal Sinus. The internal ramp 129, 495 angle, shape and size, and the side exit port 119 size, opening shape, and orientation in relation to the internal ramp 129, 495 minimizes the risk of entanglement in septations within the brain of devices passed out the side exit port 119. This can be important because of several factors: how the tapered distal tip 109 of the dilator catheter 102 is oriented when it tents venous wall 1034 and / or dura mater (this is illustrated in FIG. 16), how the how the puncture device 103 is oriented when it passes through tissue (this is illustrated in FIG. 17), and how the dilator catheter 102 dilates the venous wall 1034 and / or dura mater (this is illustrated in FIG. 18). Many different orientations may be required in different clinical situations. Device or device model choice, device orientation or mechanical or backup support, positioning balloon 123 size, inflation pressure, or inflation sequence (e.g., low pressure, then high pressure, then low pressure) can be varied to optimize the particular entry angles or entry depths for the indicated treatment. Such entry angles can be between 10° and 90°, or between 15° and 90°, or between 15° and 80°, or between 30° and 90°, or between 30° and 80°, or between 30° and 60°, or between 15° and 60°. A less-than-90° puncture can create width to the two opposite portions of venous wall and / or dura matter, and / or other tissue, that can facilitate more rapid healing of the puncture. The larger width can beget a larger surface area of opposing tissue to interface that can be compressed together with a balloon.

[0150] FIG. 4 illustrates detail of a braided portion 163 of the shaft 120 of the access catheter 101. An outer polymeric layer 164 encloses a tubular braid 165 having a plurality ofwires 166 braidingly formed with a plurality of crossovers or picks 167. In inner tube 168 having an outer wall 169 defines the inflation lumen 124 that leads distally to the interior 138 of the balloon 123. The access lumen 118 extends within the tubular braid 165, from an interior 174 of the access port 175 of the y-connector 122 to the distal port 128. Turning to FIG. 5, a skived opening 170 in an outer wall 171 of the inner tube 168 allows communication between the interior 172 of the sideport 173 of the y-connector 122 and the inflation lumen 124, while maintaining it isolated from the access lumen 118. The outer polymeric layer 164 can comprise an overextrusion, or can comprise a layer of shrink tubing that is shrunk over the tubular braid 165. The y-connector 122 can be insert molded over the shaft 120, or the shaft can be bonded into the y-connector 122.

[0151] In some embodiments, the balloon 123 is located approximately 180° around the circumference of the shaft 120 from the side exit port 1010. The balloon 123 can be inflated to force the exit port 1010 against a target area in a blood vessel. The balloon 123 is configured, when expanded, to push laterally against an inner venous wall that is substantially on the opposite side of the vein from the intended puncture site, and to force or otherwise move the side exit port 119 against the venous wall at the intended puncture site. For example, a portion of blood vessel wall that is adjacent to a portion of extravascular space or brain tissue that is desired for access for diagnostic and / or therapeutic intervention. In some embodiments, the access catheter 101 can have an eccentric rail lumen for selective advancement and positioning of the catheter eccentrically within a stent structure for endoluminal apposition. In some cases, the access catheter 101 is delivered from a puncture entry site in a vein of a patient, such as a subclavian vein, a femoral vein, a brachial vein, or a jugular vein, and tracked to a superior sagittal sinus of a patient. In some cases the target area is a wall portion of the superior sagittal sinus. The entry site can be percutaneously directed into the vein, or can be done through the lumen of an introducer sheath.

[0152] Turning to FIG. 6A, the tapered distal tip 109 of the dilator catheter 102 comprises a proximal taper portion 178 and a distal taper portion 179. The distal taper portion 179 comprises a chamfer and has a larger included taper angle than the proximal taper portion 178 and serves to strengthen the tapered distal tip 109 at the extreme distal end 180, by minimizing the length of an extra thin wall section. The included angle of the taper at the proximal taper portion 178 can range between 0.5° and 60°, or between 1° and 50°, or between 1° and 45°, or between 1° and 20°, or between 1° and 10°. The included angle of the taper at the distal taper portion 179 can range between 1° and 120°, or between 5° and 100° or between 45° and 100°, or between 40° and 75°, or between 60° and 95°.

[0153] FIG. 6B illustrates the second lumen 116 communicating with a port 114 at a distal portion 181 of the second lumen 116. Turning to FIG. 7, a skived opening 183 in an outer wall 184 of the second lumen 116 allows communication between the interior 116 of the sideport 176 of the y-connector 111 and the second lumen 116, while maintaining it isolated from the dilator lumen 107. An evacuated syringe or an aspiration pump 1028 (FIG. 1) are attached to the luer connector 117 of the sideport 176 of the y-connector 111, and material is aspirated into the port 114, through the second lumen 116, and through an interior 182 of the sideport 176 to a canister 1029 (FIG. 1). If alternatively the second lumen 116 is used for irrigation (infusion, injection), a positive pressure on a filled syringe or injection pump (not shown) attached to the luer connector 117 of the sideport 176 injects the fluid through the interior 182 of the sideport 176, through the second lumen 116 and out the port 114 (e.g., into a vascular or non-vascular area, such as a intracranial hematoma).

[0154] If the dilator lumen 107 is used for irrigation (infusion, injection), a positive pressure on a filled syringe or injection pump (irrigation pump 1041) attached to the luer connector 115 of the main port 177 of the y-connector 111 via the male luer connector 1039 of the irrigation tubing 1040 injects the fluid through the interior 112 of the main port 177, through the dilator lumen 107 and out the distal port 126 (e.g., into a vascular or non-vascular area, such as a intracranial hematoma). Alternatively, a syringe (with or without a syringe pump) or a saline bag or saline bottle can be used for irrigation instead of the irrigation pump 1041. If alternatively the dilator lumen 107 is used for aspiration, an evacuated syringe or an aspiration pump 1028 (FIG. 1) are attached to the luer connector 115 of the main port 177, and material is aspirated into the distal port 126, through the dilator lumen 107, and through an interior 112 of the main port 177 to a canister 1029 (FIG. 1). A clinical procedure utilizing the system 100 of FIG. 2 is illustrated in FIG. 19. A majority of the distal portion 108 of the shaft 113 of the dilator catheter 102 has been passed out through the side exit port 119 and into a subdural hematoma 1016 within the brain 1017. The material of the subdural hematoma 1016 is being aspirated through the port 114 with the aspiration pump 1028. When needed, irrigation fluid (e.g., saline, heparinized saline, and / or a lytic agent) is injected by the irrigation pump 1041, or a syringe, with or without a syringe pump, or via a saline bag or bottle drip, and out the distal port 126 into the subdural hematoma 1016. In the specific illustration of FIG. 19, the irrigation is being done at a distal location in the subdural hematoma 1016 (in relation to the side exit port 119), and the aspiration is being done at a proximal location in the subdural hematoma 1016. The irrigation can be performed at aspecific flow rate or drip rate, and can be initiated or can be increased when aspiration begins to become difficult.

[0155] In some embodiments, the dilator catheter 102, including the shaft 113, comprises polymer material (thermoplastic polyurethane (TPU), polyether block amide (PEBA)) which can be tungsten loaded / doped, and can utilize refined necking and tipping processes to reduce the ledge effect of the dilator with the puncture device 103, e.g., a puncturing microguidewire. Alternatively, the dilator catheter 102 can have chamfered end. Alternatively, the dilator catheter 102 has a tapered end. Alternatively, the dilator catheter 102 has a beveled end. Alternatively, the dilator catheter 102 can feature a filleted end. The reduced ledge effect with with coaxial advancement of the puncture device 103 or another procedure catheter extending from the dilator lumen 107, can be effective such that the dural fibers are deformed in a manner wherein they remain below maximum acceptable stress / strain moduli. Reducing the ledge effect between coaxial members enables reformation of the dural fibers and avoids permanent distortion or laceration of the dural fibers. In some embodiments, lubricious coatings or materials can be applied to outer surfaces of at least a distal portion of the dilator catheter 102 and / or to the puncture device 103 or another procedure catheter to ease advancement of each coaxial member across the blood vessel wall and across the dura mater with minimal friction. Additionally, in some embodiments, the dilator catheter 102 can incorporate integrated source and sink electrodes and / or coils for impedance-based localization or magnetic localization. These electrodes or coils allow for real-time tracking and precise navigation of the dilator catheter 102 during advancement through anatomical structures, helping to define safe access to the subdural space relative to the vasculature. This feature improves procedural safety by providing continuous feedback on the position of the dilator catheter 102, or at least the distal portion 108 of the shaft 113 of the dilator catheter 102, in relation to the surrounding tissues and vessels.

[0156] FIG 8 illustrates a first embodiment of the puncture device 103 wherein the piercing tip 104 comprises a bevel 185. FIG 9 illustrates a second embodiment of the puncture device 103 wherein the piercing tip 104 comprises a sharp frustoconical shape 186, or pointed cone. FIG 10 illustrates a third embodiment of the puncture device 103 wherein the piercing tip 104 comprises a short, small -diameter wire 187. In each of the embodiments of FIGS. 8-10, the shaft 106 comprises a proximal shaft portion 188 that tapers to a distal shaft portion 189 that has a smaller diameter than the proximal shaft portion 188. The change in diameter occurs at a linear taper 190. The linear taper 190 comprises a frustoconical surface 198. In other embodiments, the change in diameter can comprise a non-linear changein diameter wherein the linear taper 190 is replaced by a concave surface or by a convex surface. In the embodiment of FIG. 10, a fillet 199 can be provided between the distal shaft portion 189 and the small-diameter wire 187 to make a smooth transition. In some embodiments, this fillet 199 can comprise a weld, when the small -diameter wire 187 and the distal shaft portion are not monolithic from a centerless grind, but begin as two different wire pieces. In other embodiments, the distal shaft portion 189 can comprise hypodermic tubing (e.g., stainless steel) and the small-diameter wire 187 can be inserted into a lumen of the hypodermic tubing and then welded, or brazed, or soldered to the distal shaft portion 189. In some embodiments, instead of the fillet 199, the transition can comprise a ball-shape or spherical outer surface. The bevel 185 can be angled at a bevel angle of between 10° and 60°, or between 20° and 50° (in relation to the longitudinal axis). The included cone angle of the frustoconical shape 186 can be between 10° to 120°, or between 20° and 100°, or between 30° and 90°. The included cone angle of the linear taper 190 can be between 0.5° to 180°, or between 1° and 120°, or between 3° and 90°, or between 5° and 45°.

[0157] In some embodiments, the small -diameter wire 187 can advance and contract from the fillet 119. For example, the fillet 199 can comprise a hollow hemispherical shell fused to the distal shaft portion 189, and having a center hole through which the smalldiameter wire 187 can slide. A proximal end of the small -diameter wire is enlarged, by a solder ball or by a crushed flat end, to thus movable lock it in relation to the hemispherical shell fillet. The fillet 199 in some embodiments can be replaced by a frustoconical chamfer having an included cone angle of between 10° and 120°, or between 20° and 100°, or between 30° and 95°. The puncture device 103 can comprise a monolithic metal, such as stainless steel or nickel -titanium. The puncture device 103 can comprise a shape-memory alloy in its Austenite super-elastic state. The puncture device 103 can also comprise a polymer or include a coil.

[0158] Returning to FIG. 6B, the dilator lumen 107 comprises a proximal large- diameter section 191 extending from the proximal end 192 of the shaft 113 (FIG. 7) to a proximal end 194 of an internal taper 193. The dilator lumen 107 further comprises a distal small-diameter section 196 extending from a distal end 195 of the internal taper 193 to the distal port 126. The internal taper 193 has a frustoconical inner surface 197 that is configured to abuttingly interface with the surface 198 of the linear taper 190 of the shaft 106 of the puncture device 103. This mechanical abutment is configured to allow the piercing tip 104 of the puncture device 103 to exit from the distal port 126 of the dilator catheter 102, but to be stopped at a particular amount of extension of the distal shaft portion 189 out of the dilatorlumen 107. The internal taper 193 and its surface 197 comprise a first engagement feature and the taper 190 and its surface 198 comprise a second engagement feature. In this embodiment, the two tapers 193, 190 match each other in taper angle. However, in other embodiments the internal taper 193 can comprise a linear or non-linear taper, and the taper 190 can be replaced by a ball, or lozenge-shape, or another non -tapered shape. The construction of the lengths of each the distal shaft portion 189 and the distal small -diameter section 193 combined with the engagement characteristics of the first and second engagement features provides a specific amount of extension of the distal shaft portion out of the dilator catheter 102 when the first and second engagement when the engagement (e.g., a hard stop) occurs. The engagement stops the relative longitudinal displacement of the dilator catheter102 and the puncture device 103 at a preconfigured amount, and thus sets the amount of extension of the distal shaft portion from the dilator lumen 107 at a preconfigured amount. In some embodiments, the taper 190 (or any of the alternative shapes) can comprise a different material than the remained of the shaft 106, for example a softer or harder material to provide the desired engagement with the internal taper 193.

[0159] FIGS. 11-13 illustrate the relative longitudinal (or axial) displacement between the puncture device 103 and the dilator catheter 102, at their distal portions, in three different positions. FIG. illustrates the hard stop provided by the first and second engagement features (tapers 190, 193). This hard stop is a non-locking, non-sticking hard stop. A user can manipulate either device’s longitudinal position, separately, or manipulating the both together, by distally-oriented compression or proximally-oriented tension, applied on the proximal ends of each device 102, 103. The user can grip, for example, the grip 127 of the puncture device 103 with one hand and the y-connector 111 of the dilator catheter 102 with the other hand. In other cases, the user can manipulate the grip 127 of the puncture device103 with one or more finger of a hand, and can manipulate the y-connector 111 of the dilator catheter 102 with another one or more finger of the same hand. Alternatively, a manipulation handle can be utilized that connects to proximal portions of both the shaft 106 of the puncture device 103 and the shaft 113 of the dilator catheter 102 and is configured to control each of their longitudinal motions, or at least move one of them longitudinally in relation to the other.

[0160] In FIG. 11, the puncture device 103 has been positioned such that the piercing tip 104 is located at a relative longitudinal location that is proximal to the extreme distal end 180 of the dilator catheter 102. Thus, the piercing tip 104 is completely protected within the tapered distal tip 109 of the dilator catheter 102. There is a longitudinal, Z-axis difference between the piercing tip 104 and the extreme distal end 180 of Zi (a negative number). Thereis no contact / engagement between the tapers 190, 193. In FIG. 12, the puncture device 103 has been advanced distally relative to the dilator catheter 102, by movement of the puncture device 103 and / or movement of the dilator catheter 102, such that all of the piercing tip 104 of the puncture device 103 extends from the dilator lumen 107 of the dilator catheter 102, with a longitudinal Z-axis difference between the piercing tip 104 and the extreme distal end 180 of Z2 (a positive number). However, there is still no contact / engagement between the tapers 190, 193, although they have moved toward each other. In this second position (relative longitudinal locations of the puncture device 103 and dilator catheter 102), the piercing tip 104 is extended for piercing (cutting or puncturing) through human tissue (including vessel wall tissue and dura mater), but the tip 104 can still be extended further into tissue, or past tissue, if desired. In FIG. 13, the puncture device 103 has been advanced still further distally relative to the dilator catheter 102, by movement of the puncture device 103 and / or movement of the dilator catheter 102, such that all of the piercing tip 104 of the puncture device 103 extends from the dilator lumen 107 of the dilator catheter 102, even further, with a longitudinal Z-axis difference between the piercing tip 104 and the extreme distal end 180 of Z3 (a positive number, larger than Z2). Now there is contact / engagement between the tapers 190, 193. They have been moved toward each other further and have contacted each other, creating a full stop engagement. In this third position (relative longitudinal locations of the puncture device 103 and dilator catheter 102), the piercing tip is extended for piercing (cutting or puncturing), and cannot be extended further. The lengths of the distal small-diameter section 196 and the distal shaft portion 189, and the shapes and dimensions of the tapers 190, 193 have been configured to control this Z3 dimension, the maximum amount of extension, to avoid possible deleterious clinical events, such as unwanted damage to tissue of the patient. Z3 can be configured such that it is between about 1mm and about 12 mm, or between about 1 mm and about 10 mm, or between about 2 mm and about 10 mm, or between about 6 mm and about 10 mm, or between about 7 mm and about 9 mm, or between about 7.5 mm and about 8.5 mm.

[0161] In alternative embodiments, the surface 197 and the surface 198 can be configured to frictionally engage each other, to create, on their own, a longitudinal lock to maintain the relative longitudinal positions of the dilator catheter 102 and the puncture device 103. The frictional lock is configured such that it requires a particular minimum tension (retracting the puncture device 103 from the dilator catheter 102) to separate the surface 197 from the surface 198, and thus separate the dilator catheter 102 and the puncture device 103. In some embodiment, this can be achieved by a slight mismatch in the tapers 190, 193. Forexample, the included taper angle of the taper 190 can be 1% to 15% smaller than the included taper angle of the taper 193, or 1% to 10%, or 1% to 5%. In other embodiments, the polymeric material at the surface 197 can be a lower durometer than the surrounding material of the distal portion 108 of the shaft 113, thus causing a sufficient increase in “sticking.” The frictional lock can also be configured such that it requires a particular minimum torque (applied on the shaft 106 of the puncture device 103) to separate the surface 197 from the surface 198, and thus separate the dilator catheter 102 and the puncture device 103.

[0162] In an alternative embodiment, a portion of one of the dilator catheter 102 or the puncture device 103 comprises a first magnet and a portion of the other of the dilator catheter 102 or the puncture device 103 comprises a second magnet, such that a first pole of the first magnet is attracted to a second, opposite, pole of the second magnet. In another alternative embodiment, a portion of one of the dilator catheter 102 or the puncture device 103 comprises a magnet and a portion of the other of the dilator catheter 102 or the puncture device 103 comprises a magnetic material (iron or 400 series stainless steel), such that a first pole of the magnet is attracted to the magnetic material. The magnet and / or magnetic material are placed such that, when magnetically engaged with each other, the amount of extension of the distal end 104 of the puncture device 103 out of the dilator catheter 102 is the desired maximum (or desired amount in general). The magnets and / or magnetic material can comprise cylindrical or band shapes, or tapered band shapes. The location of the magnets and / or magnetic materials can be proximally (e.g., on connectors), distally (in a similar longitudinal location as the tapers 109, 193 of the embodiment of FIGS. 11-13, or in an intermediate location along the shafts 106, 113.

[0163] Another type of mechanical engagement comprises a bottoming out of a distal end of the grip 127 into the internal luer taper of the luer connector 115 of the main port 177. The y-connector 111 and the grip 127 can each be reconfigured as simple precision hubs wherein the hub of the puncture device 103 fits into the hub of the dilator catheter 102. In some embodiments, there can be adjustment (e.g., rotational adjustment) that causes slight, precision changes in the relative longitudinal positions between the puncture device 103 and the dilator catheter 102, when the hubs are engaged.

[0164] In alternative embodiments, the taper 190 and be replaced with an abrupt, substantially transverse diameter change or transition comprising two distinct diameter longitudinal sections, and the taper 193 can be replaced with a counterbore, wherein the counter bore is configured to bottom out in the diameter change portion. The counterbore at the diameter change of the dilator catheter 102 comprises an annular substantially proximallyfacing surface. The diameter change portion of the puncture device 103 comprises an annular substantially distally facing surface, configured to at least partially match the substantially proximally facing surface. Thus, the dilator catheter 103 comprises a first inner diameter distal to the internal diameter change and a second inner diameter proximal to the internal diameter change. The first inner diameter can extend further distally with the same diameter, or can increase or decrease. The second inner diameter can extend further proximally with the same diameter or can increase or decrease. In some embodiments, the decrease is less than 10%, or less than 20%, or less than 50%.

[0165] In any clinical applications in which there are no risks of damage from over- extension, the first and second engagement features can potentially be disregarded. However, it may still be chosen to include the first and second engagement featured in applications such as these, to avoid potential damage to the devices themselves.

[0166] FIGS. 14-18 illustrate the system 100 comprising the puncture device 103 and the dilator catheter 102 in use clinically to endovascularly make a puncture 1035 at a puncture site 1036 through a venous wall 1034 and dura mater 1015. In other clinical applications, the system 100 can be utilized to make a puncture only through a venous wall, an arterial wall, an atrial septum, or to pass subintimally (e.g., between an atherosclerotic plaque and an arterial adventitia. FIGS. 14-18, relate to a method of use within the clinical application illustrated in FIG. 19. FIGS. 11-18 can represent manipulation of the puncture device 103 and the dilator catheter 102 either by the users hand or hands, or using a manipulation handle coupled to the puncture device 103 and the dilator catheter 102, as will be further described.

[0167] In FIG. 14, the dilator catheter 102 is advanced toward a desired target area 1037 within a vein, such as the superior sagittal sinus. The extreme distal end 180 is placed adjacent the target area 1037. The distal portion 108 of the shaft 113 of the dilator catheter 102 can comprise a radiopaque material, either as a doping agent or via one or more radiopaque marker bands. In an alternative embodiment, the polymeric material is not doped with a radiopaque powder, but the very distal portion of the tapered distal tip 109 further comprises a radiopaque hollow tip element that is bonded or insert molded in place, e.g., comprising a metal, such as platinum, tantalum, or an alloy of either. The distal portion 108 or simply the tapered tip 109 can comprise a first material having a first bulk flexural modulus and the shaft 113 proximal to it can comprise a second material having a second bulk flexural modulus, wherein the second bulk flexural modulus is higher than the first bulk flexural modulus, for example, at least 10% higher, or at least 20% higher, or at least 30%higher, or at least 40% higher. In FIG. 15, the extreme distal end 180 is forced against the venous wall 1034 interior within the target area 1037 via compressive force applied to the proximal end of the shaft 113 of the dilator catheter 102. In FIG. 16, further advancement of the dilator catheter 102 is performed, causing the extreme distal end 180 to cause the venous wall 1034 and the dura mater 1015 to “tent.” A tent shape 1038 is created, and stressing and straining of the venous wall 1034, and often the dura mater 1015, occurs. This often results in some thinning of the venous wall 1034, and can also cause thinning of the dura mater 1015. The puncture device 103 has remained in substantially the same general position (retracted) during the steps of FIGS. 14-16.

[0168] In FIG. 17, the forward pressure is maintained on the dilator catheter 102, and the puncture device 103 is advanced, causing the piercing tip 104 to pierce the venous wall 1034 and the dura mater 1015, causing a puncture 1035. Pressure on the dilator catheter 102 can then be increased, if needed, as the dilator catheter 102 is advanced through the puncture 1035, causing the tapered distal tip 109 to dilate the puncture 1035, increasing its effective inner diameter. The puncture device 103 can be retracted as the dilator catheter 102 is advanced through the venous wall 1034 and the dura mater 1015, as is shown in FIG. 18. In some particular clinical cases, it may be desired to only partially pass the tapered distal tip 109 through the puncture 1035, in order to control a particular amount of dilation of the puncture 1035. However, generally, the dilator catheter 102 is advanced so that the tapered distal tip 109 completely passes through the puncture 1035 and completely dilates it, as shown in FIG. 19. The puncture device 103 can remain retracted, or, as shown in FIG. 19, is completely removed from the dilator lumen 107 of the dilator catheter 102. This leaves the entirety of the dilator lumen 107 open for minimal resistance of fluid or material movement (injection or aspiration).

[0169] Turning to FIG. 20, a system 200 for providing transvascular access to an extravascular site being utilized within a patient comprises the access catheter 101 of FIG. 2, a dilator catheter 202, and a puncture device 203. The puncture device 203 comprises a piercing distal end 204, a proximal end 205, and an elongate shaft 206 coupled to and extending proximally from the distal end 204. The shaft 206 comprises a proximal shaft portion 288 that tapers and a distal shaft portion 289. The system 200 further comprises a handle 210 configured to couple to a proximal portion 211 of the shaft 213 of the dilator catheter 202 and configured to couple to the proximal shaft portion 288 of the shaft 206 of the puncture device 203. The handle 210 is configured to longitudinally translate the puncture device 203, distally and proximally, in relation to the dilator catheter 202. In alternativeembodiments, if torquing of the puncture device 203 is desirable, the handle 210 can be further configured for applying clockwise and counter-clockwise torques to the puncture device 203. The elongate shaft 206 of the puncture device 203 is configured for placement within the dilator lumen 207 of the dilator catheter 202. The dilator catheter 202 comprises a distal portion 208 comprising a tapered distal tip 209 and further comprises a proximal end 214. A length of hypodermic tubing 264 is bonded over the shaft 206 at the proximal portion 211 to protect the proximal portion 211, and to allow improved interface with the handle 210. The dilator lumen 207 exits distally at a distal port 226. There are no sidehole ports (e.g., port 114) in the dilator catheter 202 as there are in the dilator catheter 102. The piercing tip 204 can comprise a penetrating tip and / or a cutting or slicing tip, and can comprise a bevel, a frustoconical shape (e.g., cone) and can in some embodiments include a fillet, as illustrates in the embodiments of FIGS. 8-10. The handle 210 is also configured to longitudinally translate the dilator catheter 202.

[0170] The handle 210 comprises a proximal end 215 and a distal end 216 and a housing 225 (or base). The distal end 216 comprises a male luer lock connector 217 comprising a male luer taper 218 and a female thread 219. The female thread 219 is configured to screw onto a male thread 220 of the proximal luer connector 121 (e.g., female luer lock connector) on the y-connector 122 of the access catheter 101. The male luer taper 218 is configured to slidingly seal against a female luer taper 221 within the access port 175 of the y-connector 122 of the access catheter 101. Attachment of the male luer lock connector 217 to the proximal luer connector 121 maintains the access catheter 101 and the handle 210 longitudinally static relative to each other. A joint 224 between the male luer lock connector 217 and the housing 225, in a first configuration, is rotationally static (non-rotating), thus, when connected, maintaining the access catheter 101 and the handle 210 rotationally static relative to each other. The joint 224 between the male luer lock connector 217 and the housing 225, in a second configuration, has free rotation, allowing 360° rotation of the male luer lock connector 217 relative to the housing 225, thus, when connected, allowing relative rotation between the access catheter 101 and the handle 210. In this second configuration, it is possible to rotate the dilator catheter 202 and the puncture device 203 together as a unit, within the access lumen 118 of the access catheter 101. This allows selected rotational orientation of the tapered distal tip 209 as it is passed out of the side exit port 119. Such rotation can be especially helpful if the tapered distal tip 209 is configured with a curve. The handle 210 is configured to allow a user to control the relative movement between the puncture device 203 and the dilator catheter 202. In some cases, a user can hold the handle210 in a first hand, and can use fingers of a second hand to manipulate sliders 222, 223 connected to the proximal portion 211 of the shaft 213 of the dilator catheter 202 and to the proximal shaft portion 288 of the shaft 206 of the puncture device 203, respectively. In other cases, a user can hold the handle 210 in a first hand, and can use fingers of the first hand to manipulate sliders 222, 223 connected to the proximal portion 211 of the shaft 213 of the dilator catheter 202 and to the proximal shaft portion 288 of the shaft 206 of the puncture device 203, respectively.

[0171] Turning to FIGS. 21-24, the housing 225 includes a first housing side 227 (shown removed in FIG. 21), a second housing side 228, a proximal end cap 229, and a distal end cap 230. The first housing side 227 and the second housing side 228 each comprise four screw holes 231 configured for the passage of socket screws 232. The threaded portion of the socket screws 232 threadingly engage with threaded holes 233 of the proximal end cap 229 and with threaded holes 234 of the distal end cap 230, allowing the four sections of the housing 227, 228, 229, 230 to be securely held together. Carried by the housing 225 is a translation assembly 235 that is configured to control the longitudinal movement of the dilator catheter 202 and the longitudinal movement of the puncture device 203 via user input. The translation assembly 235 is carried within the housing 225, but also extends from the housing 225 in the form of slider buttons 249, 250. A dowel block 236 is located opposite a proximal end face 237 of a longitudinal cavity 238 in the first housing side 227. An opposing face 239 in the second housing side 228 faces a left face 240 of the dowel block 236. A first dowel pin 241 and a second dowel pin 242 are carried within longitudinal holes 243, 244, respectively, and are secured in place relative to the dowel block 236 by set screws 245 that threadingly engage transverse threaded holes 246 that extend from the left face 240. In alternative embodiments, the dowel pins 241, 242 can be adhesively or epoxy bonded, or can be frictionally press fit into the holes 243, 244. However, in the embodiment of FIGS. 20-24, the dowel pins 241, 242 can be adjusted by loosening the set screws 245 and sliding them to a desired longitudinal location within the dowel block 236, followed by retightening the set screws 245. This sets up a controlled specific amount of total possible longitudinal movement of the dilator catheter 202, as will be explained further below.

[0172] A dilator catheter slider block 247 and a puncture device slider block 248 (e.g., carriages) are each configured to slide within the longitudinal cavity 238. The slider block 247 comprises longitudinal holes 265, 266 sized for frictional press fit of the dowel pins 241, 242, respectively. As an alternative or in addition to longitudinally adjusting the dowel pins 241, 242 within the dowel block 236, as described, the amount of longitudinalpress fit of the dowel pins 241, 242 into the holes 265, 266 can also be controlled to a specific amount. The slider block 248 comprises longitudinal holes 267, 268 sized for sliding over dowel pins 241, 242, respectively. The holes 267, 268 have diameters that have enough clearance over the outer diameter of the outer diameter of the dowel pins 241, 242 to promote smooth, and substantially straight movement. In alternative embodiments, one or both of the slider blocks 247, 248 is / are also configured to be lockable in any particular longitudinal position relative to the housing 225, e.g., by a set screw or a friction member (not shown). The slider 222 comprises the slider block 247 and a slider button 249. The slider 223 comprises the slider block 248 and a slider button 250. The slider buttons 249, 250 are secured to the slider blocks 247, 248 with set screws 269 that pass through threaded holes 270, 271 on both sides of the slider buttons 249, 250, and through clearance holes on top central thinned-out fin portions 297, 298 of the slider blocks 247, 248 that each fit into an internal cavity 299 underneath each of the slider buttons 249, 250 (see FIG. 24). The slider buttons 249, 250 are configured to be manipulated (pushed, pulled, or gripped) by the user. The slider button 249 comprises a base portion 251 and a substantially transverse projection 252. The slider button 250 comprises a base portion 253 and a substantially transverse projection 254. The slider button 249 comprises a distal surface 255 configured for placing a proximally-directed force (e.g., by one or more finger of the user), and also comprises proximal surface 256 configured for placing a distally-directed force (e.g., by one or more finger of the user). The slider button 250 comprises a distal surface 257 configured for placing a proximally-directed force (e.g., by one or more finger of the user), and also comprises proximal surface 258 configured for placing a distally -directed force (e.g., by one or more finger of the user). As described further, spring loading can make the distal surface 257 optional, but alternative embodiments without spring loading are also possible.

[0173] The proximal end cap 229 includes a longitudinally-extending through hole 259 configured for insertion of the puncture device 203 and / or the dilator catheter 202, if loaded from the proximal end (front loaded). The distal end cap 230 includes a longitudinally-extending through hole 260 configured for insertion of the puncture device 203 and / or the dilator catheter 202, if loaded from the distal end (back loaded). The dowel block 236 includes a longitudinally-extending through hole 261 configured for insertion of the puncture device 203 and / or the dilator catheter 202, if loaded from the proximal end (front loaded). The slider block 248 includes a longitudinally-extending through hole 262 configured for insertion of the puncture device 203 and / or the dilator catheter 202, if loaded from the proximal end (front loaded), and configured for insertion of the puncture device 203,if loaded from the distal end (back loaded). The slider block 247 includes a longitudinally- extending through hole 263 configured for insertion of the puncture device 203 and / or the dilator catheter 202, if loaded from the proximal end (front loaded), and configured for insertion of the puncture device 203 and / or the dilator catheter 202, if loaded from the distal end (back loaded).

[0174] In some embodiments, the housing 225 is permanently connected to the puncture device 203 and the dilator catheter 202. In some embodiments, the housing 225 is permanently connected to the dilator catheter 202 but not to the puncture device 203; the puncture device 203 is configured to be front loaded or back loaded and secured to the slider block 248. In the embodiment shown in FIGS. 21-24, the housing 225 is configured to allow attachment to and removal from the puncture device 203 and the dilator catheter 202. The second housing side 228 (FIG. 22) includes an access door 272 having a projection, tab, or handle 273 which allows the access door to pulled open or pulled off. The access door 272 can further include a hinged side 274, or can be configured to be completely removed for access, and then closed or otherwise repositioned. Opening the access door 272 exposes the left side of the translation assembly 235, as shown in detail in FIG. 23. The puncture device slider block 248 is shown butting up against the dowel block 236, with a proximal end face 275 of the slider block 248 abutting a distal end face 276 of the dowel block 236. A first compression spring 277 is substantially coaxially placed (with some radial clearance) over the dowel pin 241. A second compression spring 278 is substantially coaxially placed (with some radial clearance) over the dowel pin 242. Proximal ends 279, 280 of the compression springs 277, 278, respectively, abut a distal end face 281 of the slider block 248. Distal ends 282, 283 of the compression springs 277, 278 abut bottom annular flats 284, 285, respectively, of clearance holes 286, 287 of the dilator catheter slider block 247. The diameter of the compression springs 277, 278 fits into the holes 286, 287. A distal edge 290 of the slider block 247 abuts a distal inner edge 291 of an oval encircling slider liner 292, which is carried by the second housing side 228. The edges of the first housing side 227 and the second housing side 228 come together at line L in FIG. 24. As the slider 222 is moved, the dowel block 236 moves in unison with it, whereas the slider 223 and the slider 222 have independent movement, over the total range defined by the slider liner 292.

[0175] The hypodermic tubing 264 of the proximal portion 211 the shaft 213 of the dilator catheter 202 is inserted into the longitudinally -extending through hole 263, and two set screws 293, in two threaded holes 294 in the left side of the slider block 247 are tightened. There are two of the threaded holes 294 on the left side of the slider block 247, and twodowel pins 303 on the right side can press fit to a particular depth such that the tightening of the two set screws 293 on the left side is required to secure to the hypodermic tubing 264, and thus secure the shaft 213 of the dilator catheter 202. Loosening these two set screws 293 releases the hypodermic tubing 264, thus releasing the shaft 213 of the dilator catheter 202. When tightened, the shaft 213 of the dilator catheter 202 moves in unison with the longitudinal movement of the slider 222.

[0176] The proximal shaft portion 288 of the shaft 206 of the puncture device 203 is inserted into the longitudinally-extending through hole 294 and a set screw 295, in a threaded hole 296 in the side of the slider block 248 is tightened. There is one threaded hole 296 on each side of the slider block 248, but the set screw 295 on the right side can be pre-adjusted to a particular depth such that only tightening the set screw 295 on the left side is required to secure to the proximal shaft portion 288, and thus secure the shaft 206 of the puncture device 203. Loosening the set screw 295 releases the shaft 206, thus releasing the shaft 206 of the puncture device 203. When tightened, the shaft 206 of the puncture device 203 moves in unison with the sliding of the slider 223.

[0177] Thus, with the parts fastened as and assembled as described, a user can press the slider 223 distally (e.g., via forward pressure on the proximal surface 258 of the slider button 250) and this action will cause the compression springs 277, 278 to compress, because of the bottomed-out ends 279 / 280, 282 / 283 of the springs 277, 278 as the slider blocks 247, 248 approach each other. This corresponds to movement of the distal end 204 of the puncture device 203 distally relative to a stationary dilator catheter 202. By releasing the slider button 250, at once or gradually, the bias of the compressed compression springs 277, 278 will cause the slider 223 to move proximally until the slider block 248 abuts the dowel block 236.

[0178] The user can also press the slider 222 proximally (e.g., via rearward pressure on the distal surface 255 of the slider button 249) and this action will cause the compression springs 277, 278 to compress, because of the bottomed-out ends 279 / 280, 282 / 283 of the springs 277, 278 as the slider blocks 247, 248 approach each other. This corresponds to movement of the tapered distal tip 209 of the dilator catheter 202 proximally relative to a stationary puncture device 203. By releasing the slider button 249, at once or gradually, the bias of the compressed compression springs 277, 278 will cause the slider 222 to move distally until the slider block 247 abuts the slider liner 292.

[0179] In some cases, the user can press the slider 223 distally while simultaneously pressing the slider 222 proximally. This corresponds to movement of the distal end 204 of thepuncture device 203 distally during movement of the tapered distal tip 209 of the dilator catheter 202 proximally. One or both of the sliders 222, 223 can then be released.

[0180] In any of these three scenarios, a total amount of extension of the puncture device 203 from the dilator catheter 202 at a maximum, that occurs when the distal extreme301 of the slider button 250 contacts the slider button 249 and / or when the proximal extreme302 of the slider button 249 contacts the slider button 250. Thus, for example the distal end 204 of the puncture device 203 can be configured to extend a maximum of between about 1 mm and about 15 mm out of the distal end of the tapered distal tip 209 of the dilator catheter 202, or between about 5 mm and about 10 mm, or between about 6 mm and about 10 mm. In some embodiments, multiple sizes of the slider liner 292 (e.g., with varying total inner cavity length) can be supplied with the handle 210, and can be removed and placed such that a particular precision amount of total travel for the slider 222 and the slider 223 are achieved.

[0181] FIGS. 25-27 illustrate an alternative access catheter 300 to the access catheter 101 of FIGS. 2-5 and 19-20. The access catheter 300 comprises similar features, materials, and components as the access catheter 101, however it does not include the internal ramp 129. Instead, the internal ramp is provided by a separate blocking catheter 304 (FIGS. 28-30 and 32-34) that is configured to be placed down the access lumen 305 to block a distal portion 306 of the access lumen 305, the force any one or more elongate devices out the side exit (access) port 307. FIGS. 25-27 illustrate features of a shaft 308 of the access catheter 300. The shaft 308 comprises a first inner tube 309 having an annular or cylindrical wall 310 that defines the access lumen 305. The tube 309 can comprise a polymeric material such as thermoplastic polyurethane (TPE) or polyether block amide (PEBA). A polyimide or polyamide thin-walled tube 310 extends in parallel with the tube 309, and comprises an annular wall 311 that defines a balloon inflation lumen 312. A tubular braid 313 is formed over the two tubes 309, 310, and a tubular outer layer 314 is formed over the tubes 309, 310 and the braiding 313. The tubular outer layer 314 is some embodiments comprises polyester shrink tubing that is heat shrunk over the outside of the inner components 309, 310, 313. In other embodiments, the tubular outer layer 314 is an overextrusion. In other embodiments, the tubular outer layer is a coating.

[0182] In FIG. 27, the balloon inflation lumen 312 is exposed by cutting away the braid 313 and the tubular outer layer 314, at a skive 315. This creates a proximal aperture 316, akin to the proximal aperture 149 of the access catheter 101 of FIGS. 3 A and 3C. The balloon inflation lumen 312 is blocked with an epoxy, adhesive, or plug 317 distally of the skive 315. The skive 315 can include the removal of approximately a semi -cylindrical piece(about 180°) of the tube 310 (as shown in FIG. 26), or can comprise a series of holes in the wall 311, such as elongate holes or circular holes.

[0183] FIGS. 28-30 illustrate a blocking catheter 304 comprising a proximal end 318 and a distal end 332. The blocking catheter 304 is configured to place into the access lumen 305 of the access catheter 300 by inserting it into the proximal end (e.g., into the interior 174 of the access port 175 of the y-connector 122 of FIG. 5), and advancing it. The blocking catheter 304 comprises an elongate shaft 319 having a proximal hypo tube 320 and a distal composite tube 321, coupled together at a fuse 322. The proximal end 318 comprises a cylindrical grip 328 for grasping by a user, though the user can also or alternatively grasp the shaft 319.

[0184] The distal composite member comprises polymeric tubing with either a braid and / or a coil and / or a laser-machined hypo tube. The distal composite tube 321 of the shaft 319 carries distally a blocking member 323 (or blocker) having a proximal end 324 and a distal end 325. The blocking member 323 includes a distal surface 326 that is blunt or tapered, and configured to aid in the smooth advancement of the blocking member 323 within the access lumen 305 and the smooth advancement past the side exit port 307. FIGS. 32-33. The blocking member 323 further includes a central portion 327 configured to substantially fill the access lumen while having an outer diameter that is at least 0.025 mm smaller than the inner diameter of the access lumen 305, for unimpeded movement, or at least 0.050 mm smaller, or at least 0.100 mm smaller. The length LB of the central portion 327 compares to the diameter DB of the central portion 327 with an L:D ratio of at least 2. Or at least 3, or at least 4, or at least 5, or at least 8, or at least 10 (L:D ratio = LB / DB). The central portion 327 has a diameter of between 0.3 mm and 4.0 mm, or between 0.5 mm and 3.0 mm, or between 1 mm and 2.5 mm, or between 1.2 mm and 2.2 mm. In some embodiments, the shaft 319 is between 0.1 mm and 1.0 mm, and where the blocking member 323 is between 1.1 times and 3 times the shaft 319 diameter.

[0185] The blocking member 323 comprises a proximal wedge 329 having a surface 330 a substantially convex bowl shape. In some embodiment, the shape of the wedge is substantially hemispheric. In some embodiments, the shape is a fillet, extending 360° around the longitudinal axis. In some embodiments, the shape is a frustoconical taper. In some embodiments, the taper is a linear taper. In some embodiments, the taper includes a concavity. In some embodiments, the taper includes a convexity. The proximal wedge 329 when in position just distal to the side exit port 307 of the access catheter 300 stops a elongate semi-selective device from advancing into the distal portion 306 of the access lumen305, and urges the semi-selective device to bend toward the side exit port 307 when advanced, and the pass out of the side exit port 307. The blocking catheter 304 can further include a distal elongate extension 331 connected to and extending distally of the blocking member 323. The distal elongate extension 331 is configured to aid insertion of the blocking catheter 304 into the interior 174 of the access port 175 of the y-connector 122 and passage through the access lumen 305, past the side exit port 307, and into the distal portion 306 of the access lumen 305. As shown in FIGS. 29 and 31, the distal elongate extension 331 can include a radiopaque marker band 333 attached at the distal end 332. The blocking member 323 can comprise a solid or hollow polymeric component, and can be doped with a radiopaque material such as tantalum or titanium dioxide. In the embodiment of FIG. 29, the blocking catheter 304 includes two radiopaque marker bands 334, 335, immediately distal to and immediately proximal to, respectively, the blocking member 323. The distal elongate extension 331 has a diameter of between 0.2 mm and 2.0 mm, or between 0.3 mm and 1.5 mm, or between 0.5 mm and 1.0 mm. The distal elongate extension 331 has a length of between 0.35 cm and 3.5 cm, or between 0.5 cm and 3.0 cm, or between 0.75 cm and 2.5 cm, or between 1.0 cm and 2.0 cm. The tube 321 has a diameter of between 0.3 mm and 2.2 mm, or between 0.5 mm and 1.7 mm, or between 0.7 mm and 1.0 mm. The catheter usable length can comprise any length that allows for sufficient proximal access (e.g., to the grip 328) and sufficient extension of the distal end 46 to its desired access point in the patient. The tube 321 can in some embodiments have a thru lumen or guidewire lumen) having an inner diameter of between 0.2 mm to 1.0 mm, or between 0.3 mm and 0.8 mm, or between 0.4 mm and 0.6 mm, or about 0.53 mm. In some embodiments, the usable length is between 80 cm and 300 cm, or between 100 cm and 220 cm, or between 140 cm and 200 cm. The tube 321 comprises a polymeric material, such as polyamide, polyether block amide, polyurethane, or a polyolefin. The tube 321 can also include a composite structure using coil reinforcement, laser-machined hypo tube reinforcement, braiding, coextrusion, overextrusion and multisectional joining technology.

[0186] FIG. 31 illustrates a system 336 comprising the access catheter 300 and the blocking catheter 304, as well as a dilator catheter 337 having a distal taper 338. The dilator catheter 337 is somewhat similar to either of the dilator catheters 102, 202 previously described, however the distal taper 338 has a preformed curve 339. The curve 339 can be preformed by heating within a curved die or curved glass tube, or by heating with a curved mandrel within the dilator lumen (not shown). In FIG. 31, a puncture device (not shown) is within the dilator lumen, but is retracted such that it does not extend from the dilator catheter337. The curved shape of the distal taper 338 is configured to aid the selective passage out of the side exit port 307, with the blocking member 323 in place, or even in some cases without the blocking member 323 in place. The curve of the distal taper 338 can comprise a curve of about 10° to about 60°, or about 30° to about 60°. In some embodiments, the distal end of the puncture device can also be formed with a curve to give further aid to the selectability.

[0187] In FIG. 32, the blocking member 323 is advanced by the user by pushing the shaft 319, either directly or via the grip 328. The distal elongate extension 331 is within the distal portion 306 of the access lumen 305. The distal surface 326 of the blocking member 323 has just begun to longitudinally traverse the side exit port 307. In FIG. 33, the blocking member 323 has been advanced further, and is now blocking the distal portion 306 of the access lumen 305, just distal to the side exit port 307. The surface 330 of the proximal wedge 329 extends just proximally of the distal portion 306 of the access lumen 305, forming a ramp for the distal taper 338 of the dilator catheter 337 to be diverted toward the side exit port 307. In FIG. 34, the dilator catheter 337 is advanced further, and the surface 330 of the proximal wedge 329 further diverts the distal taper 338 of the dilator catheter 337 transversely and distally so that it is in position such that it tents the venous wall 1034 and dura mater 1015. In this particular position, the distal taper 338 receives support from the proximal wedge 329, and also from a catheter wall portion 340 at the distal end 341 of the side exit port 307. The two-point contact from the surface 330 and the catheter wall portion 340 relatively stabilizes the distal taper 338 at or near a particular tenting angle TA in relation to the longitudinal axis AL. The dilator catheter 337 is one particular elongate sub-selective device that can utilize the blocking member 323 to be passed out the side exit port 307 (and through the venous wall 1034 and dura mater 1015, either puncturing or dilating it, or simply passing through an already-made puncture). Other sub-selective devices that can be utilized with the blocking member 323 or any of the blocking catheters presented herein are: a puncture device (e.g., puncture wire), an aspiration catheter, an irrigation catheter, an aspiration / irrigation catheter, a delivery catheter, and an electrode array. Representative electrode arrays that can be utilized are taught in in the co-owned International App. No. PCT / US21 / 39962, filed June 20, 2021, and published January 6, 2022 as WO 2022 / 006317 Al, which is hereby incorporated by reference in its entirety for all purposes. The blocking member 323 can comprise a lubricious and elastic or semi-elastic material, or an elastic or semi-elastic material with a silicone or hydrophobic coating or a hydrophilic coating. The blocking member 323 in some embodiments comprises a thermoplastic elastomer (TPE).

[0188] FIGS. 35-38 illustrate a system 342 comprising the access catheter 300 and a blocking catheter 343, as well as the dilator catheter 344 having a distal taper 345. The dilator catheter 344 does not have a preformed curve at the distal taper 345. In FIG. 35, a puncture device (not shown) is within the dilator lumen, but is retracted such that it does not extend from the dilator catheter 344. The blocking member 352 comprises an inflatable balloon which is inflated via a proximal y-connector (similar to y-connector 122 of FIG. 5) through a balloon inflation lumen 346.

[0189] In FIG. 35, the blocking member 352 is in a deflated state. A negative pressure and be applied to the contents of the balloon via an evacuated syringe and a stopcock. The blocking catheter 343 is advanced by the user by pushing the shaft 347, either directly or via the grip (similar to grip 328). The distal elongate extension 348 is within the distal portion 306 of the access lumen 305. The distal end 349 of the blocking member 352 has just begun to longitudinally traverse the side exit port 307. In FIG. 33, the blocking member 352 has been advanced further, and is now within the distal portion 306 of the access lumen 305, substantially distal to the side exit port 307. In FIG. 36, the blocking member 352 is inflated by injecting pressurized fluid (saline) through the inflation lumen 346 into an interior 350 of the balloon (blocking member 352). The inflated blocking member 352 is now blocking the distal portion 306 of the access lumen 305, adjacent the side exit port 307. The surface 351 of the proximal wedge 353 extends just proximally of the distal portion 306 of the access lumen 305, forming a ramp for the distal taper 345 of the dilator catheter 344 to be diverted toward the side exit port 307. In FIG. 38, the dilator catheter 344 is advanced further, and the surface 351 of the proximal wedge 353 further diverts the distal taper 345 of the dilator catheter 344 transversely and distally so that it is in position such that it tents the venous wall 1034 and dura mater 1015. In this particular position, the distal taper 345 receives support from the inflated proximal wedge 353, and also from a catheter wall portion 340 at the distal end 341 of the side exit port 307. The two-point contact from the surface 351 and the catheter wall portion 340 relatively stabilizes the distal taper 345. The distal taper 345 is pressed into the venous wall 1034, or venous wall 1034 / dura mater 1015 by controlled advancement out of the side exit port 307, causing tenting of at least the venous wall 1034. This can thin the wall of the venous wall 1034 (or venous wall 1034 / dura mater 1015) at the distal end of the dilator catheter 344 and prepare the venous wall 1034 to receive the piercing tip 104, 204 for a puncture. The distal taper 345 is then advanced through the puncture, dilating it, and preparing it for further passage of the dilator catheter 344, or for the passage of any other sub- selective device. The dilator catheter 344 is one particular elongate sub-selective device thatcan utilize the blocking member 352 to be passed out the side exit port 307 (and through the venous wall 1034 and dura mater 1015, either puncturing or dilating it, or simply passing through an already-made puncture). Other sub-selective devices that can be utilized with the blocking member 352 or any of the blocking catheters presented herein are: a puncture device (e.g., puncture wire), an aspiration catheter, an irrigation catheter, an aspiration / irrigation catheter, a delivery catheter, and an electrode array. In some embodiments, the shaft 347 is between 0.1 mm and 1.0 mm, and where the blocking member 352 in an inflated state is between 1.1 times and 3 times the shaft 347 diameter.

[0190] In other embodiments, the blocking member 323 comprises a permanently inflated compressible balloon. In some embodiments, the inflation media can be compressible (e.g., air, nitrogen), and in other embodiments can be substantially non-compressible (e.g., normal saline, water, contrast media, or a mixture thereof). In some embodiments, the permanently inflated balloon can be filled with a non-compressible media, but can have a proximally-located (on the microcatheter 40) expansion element that adds some effective compressibility to the balloon. In other embodiments, the blocking member 323 comprises a non-compressible balloon.

[0191] Several different shape and contour configurations for blocking members are illustrated in FIGS. 39-42. Any feature, distal and / or proximal of any of the embodiments can be utilized in either the non-inflatable blocking member 323 or the inflatable blocking member 352. FIG. 39 illustrates a blocking catheter 355 comprising a shaft 319 and a blocking member 356 attached distally to the shaft 319. The blocking catheter 355 further comprises a distal elongate extension 357. The blocking member 356 comprises a proximal wedge 358 and a distal end 359. The proximal wedge 358 comprises a proximal concave transition 360 and a distal convex transition 361, distally adjacent to the proximal concave transition 360. The distal end 359 comprises a proximal convex transition 362 and a distal concave transition 363, distally adjacent to the proximal convex transition 362. The distal elongate extension 357 comprises a solid polymeric cylindrical member, having a distal end skive 364. Between the proximal wedge 358 and the distal end 359 is a substantially cylindrical section 365.

[0192] FIG. 40 illustrates a blocking catheter 366 comprising a shaft 319 and a blocking member 367 attached distally to the shaft 319. The blocking catheter 366 further comprises a distal elongate extension 368. The blocking member 367 comprises a proximal wedge 369 and a distal end 370. The proximal wedge 369 comprises a concave transition 371. The distal end 370 comprises a concave transition 372. The distal elongate extension368 comprises a spring coil 373, similar to the distal end of a guidewire. The spring coil 373 is configured to aid insertion into the access lumen 305, and passage through the access lumen 305. It can be shaped for avoidance of the side exit port 307. Between the proximal wedge 369 and the distal end 370 is a convex, elongate globular shape or zeppelin shape 374. At the midpoint 375 of the convex shape 374 is the maximum diameter. This diameter is configured to be equal to or slightly larger than the inner diameter of the access lumen 305 of the access catheter 300 at its distal portion 306. Thus, the maximum diameter at the midpoint 375 frictionally engages the inner wall surface of the access lumen 305, but only over a short length, because the portions distally 376 and proximally 377 to the midpoint 375 have diameters that are configured to be less than the inner diameter of the access lumen 305. The frictional engagement can keep the blocking member 367 in place relative to the access catheter 300, but because of the short length of engagement, the blocking member 367 can be easily pulled out by the user by applying tension on the shaft 319 of the blocking catheter 366.

[0193] FIG. 41 illustrates a blocking catheter 378 comprising a shaft 319 and a blocking member 379 attached distally to the shaft 319. The blocking catheter 378 further comprises a distal elongate extension 380. The blocking member 379 comprises a proximal wedge 381 and a distal end 382. The proximal wedge 381 comprises a linear tapered transition 383 having an obtuse included angle along a longitudinal plane. The distal end 382 comprises a linear tapered transition 384 having an obtuse included angle along a longitudinal plane. The distal elongate extension 380 comprises a proximal elongate portion 385 and a distal ball end 386. The ball end 386 is configured to aid insertion into the access lumen 305, and passage through the access lumen 305. Between the proximal wedge 381 and the distal end 382 is a longitudinally composite shape 387 comprising a convex, lozenge shape 388 at the proximal end 389 and having a maximum diameter, and a smaller diameter cylindrical shape 390, distal to the lozenge shape 388 and extending to the distal end 391. The maximum diameter at the lozenge shape 388 is configured to be equal to or slightly larger than the inner diameter of the access lumen 305 of the access catheter 300 at its distal portion 306. Thus, the maximum diameter at the lozenge shape 388 frictionally engages the inner wall surface of the access lumen 305, but only over a short length, because the cylindrical shape 390 has a diameter that is configured to be less than the inner diameter of the access lumen 305. The frictional engagement can keep the blocking member 379 in place relative to the access catheter 300, but because of the short length of engagement, theblocking member 379 can be easily pulled out by the user by applying tension on the shaft 319 of the blocking catheter 378.

[0194] FIG. 42 illustrates a blocking catheter 392 comprising a shaft 319 and a blocking member 393 attached distally to the shaft 319. The blocking catheter 392 further comprises a distal elongate extension 393 having a distal hemispheric shape 394. The blocking member 393 comprises a proximal wedge 395 and a distal end 396. The proximal wedge 395 comprises a linear tapered transition 397 having an acute included angle along a longitudinal plane. The distal end 396 comprises a linear tapered transition 398 having an acute included angle along a longitudinal plane. A 90° include angle can also be configured. The distal hemispheric shape 394 is configured to aid insertion into the access lumen 305, and passage through the access lumen 305. Between the proximal wedge 395 and the distal end 396 is a tapered shape 399 that is at a maximum diameter at or near its proximal end 401 and tapers down to a minimum diameter at or near its distal end 402. The maximum diameter at or near the proximal end 401 is configured to be equal to or slightly larger than the inner diameter of the access lumen 305 of the access catheter 300 at its distal portion 306. Thus, the maximum diameter at or near the proximal end 401 frictionally engages the inner wall surface of the access lumen 305, but only over a short length, because the tapering portion 403 distal to the maximum diameter is configured to be less than the inner diameter of the access lumen 305. The frictional engagement can keep the blocking member 393 in place relative to the access catheter 300, but because of the short length of engagement, the blocking member 393 can be easily pulled out by the user by applying tension on the shaft 319 of the blocking catheter 392. The shape of each proximal wedge 358, 369, 381, 395 can be configured in order to help control the tenting angle TA (FIG. 34), or more generally, the angle TA at which any sub-selective device is aimed out the side exit port 307.

[0195] FIGS. 43-45B illustrate an aspiration and irrigation catheter 400 configured for placement within the access lumen 118, 305 of an access catheter 1013, 101, 300, similar to the manner that the irrigation / aspiration catheter 1012 in FIG. 1 is delivered through the access catheter 1013. The aspiration and irrigation catheter 400 comprises a y-connector 111 with a main port 177 and a side port 176, as previously described. The aspiration and irrigation catheter 400 comprises an elongate shaft 404 having a distal tip 405 comprising a radiopaque marker band 406. The shaft 404 has a composite design with a two-lumen extruded tube 407, a tubular braid 408, and an outer tubular jacket 409. The outer tubular jacket 409 can comprise polyester shrink tubing, or an overextrusion, or a coating. The two- lumen extruded tube 407 includes a D-shaped thru lumen 410, and a D-shaped side portlumen 411. The flats of the two D-shapes face each other and are separated by an internal longitudinally-extending wall 412. The two-lumen extruded tube 407 also comprises an outer wall 413. A longitudinal array 415 of sideholes 414a-l is shown in FIG. 44, with each sidehole 414 passing transversely through the outer wall 413 into the side port lumen 411. The array 415 comprises twelve total sideholes 414, and is arranged in a proximal sub-array 417 and a distal sub-array 416, each having six holes. A distal tip portion 418 is thermally tip formed onto the distal end 419 of the shaft 404. The distal tip portion 418 comprises an outer cylindrical surface 420 and an inner lumen 421, which extends the thru lumen 410 to the distal tip 405. In a first application, the side port lumen 411 and the sideholes 414 are used for aspiration and the thru lumen 410 is used as a guidewire lumen (or puncture device lumen), and as an irrigation (infusion, injection, drip) lumen.

[0196] In a second application, the thru lumen 410 is used as an aspiration lumen and as a guidewire lumen, and the side port lumen 411 and the sideholes 414 are used for irrigation (infusion, injection, drip). The thru lumen 410 can be used for irrigation or aspiration either with a guidewire removed, or with the guidewire in place.

[0197] The sideholes 414 can be formed via a coring tool, for example, a hypo tube with a sharpened end, that is rotated like a drill bit, to remove material from the outer wall 413. As seen in FIG. 44, the sideholes 414 are each located in between the diamond shaped spaces 422 between crossings or picks in the tubular braid 408. This avoids the coring tool’s sharpened end from being dulled by the metal (e.g., stainless steel) wires that forms the tubular braid 408. In applications where the wires of the tubular braid 408 must be cut, a laser hole cutting technique can be utilized. In some embodiments, the diameter of the sideholes 414 in the distal sub-array 416 is larger than the diameter of the sideholes 414 in the proximal sub-array 417, in order to adjust for the effect of the pressure head loss in the longitudinal portion 423 between the distal sub-array 416 and the proximal sub-array 417. In other embodiments, each hole gets gradually larger in size from the proximal hole 414a to the distal hole 4141, also to combat pressure head loss, over the entire array 415. In other embodiments, one of more of the sideholes has a non-circular shape such as a rectangular cut or a slit.

[0198] FIGS. 46-48B illustrate a dilator catheter 424 configured for placement within the access lumen 118, 305 of an access catheter 1013, 101, 300, similar to the manner that the dilator catheter 102 in FIG. 19 is delivered through the access catheter 101. The dilator catheter 424 comprises a y-connector 111 with a main port 177 and a side port 176, as previously described. The dilator catheter 424 comprises an elongate shaft 425 having a proximal shaft portion 426 comprising braiding, coil reinforcement, a hypo tube, and a distalshaft portion 427. The shaft also includes a tapered distal dilating tip 428. The shaft 425 throughout its length includes a two-lumen extruded tube 429. The two-lumen extruded tube 429 includes a D-shaped thru lumen 430, and a D-shaped side port lumen 431. The flats of the two D-shapes face each other and are separated by an internal longitudinally-extending wall 432. The two-lumen extruded tube 429 also comprises an outer wall 433. A longitudinal array 434 of sideholes 435a-l is shown in FIG. 47, with each sidehole 435 passing transversely through the outer wall 433 into the side port lumen 431. The array 434 comprises twelve total sideholes 435, and is arranged in a proximal sub-array 437 and a distal sub-array 436, each having six holes. A distal shaft portion 427 is thermally tip formed onto the distal end 438 of the shaft 425. The distal shaft portion 427 comprises an frustoconical surface 438 and an inner lumen 439, which extends the thru lumen 430 to the distal tip 438. In a first application, the side port lumen 431 and the sideholes 434 are used for aspiration and the thru lumen 430 is used as a guidewire lumen (or puncture device lumen), and as an irrigation (infusion, injection, drip) lumen.

[0199] In a second application, the thru lumen 430 is used as an aspiration lumen and as a guidewire lumen, and the side port lumen 431 and the sideholes 434 are used for irrigation (infusion, injection, drip). The thru lumen 430 can be used for irrigation or aspiration either with a guidewire removed, or with the guidewire in place.

[0200] The sideholes 414 can be formed, shaped, and / or sized, as described in relation to the aspiration and irrigation catheter 400. The distal shaft portion 427 can have coil reinforcement, or even braiding, although the embodiment shown in FIGS. 46-48B does not. An alternative two-lumen extruded tubing 480 to the two-lumen extruded tubes 407, 429 of FIGS. 45 A and 48A is illustrated in FIG. 53. A circular, off-center thru lumen 481 and a rounded, arc-shaped side port lumen 482 run parallel to each other within the two-lumen extruded tube 480. The two-lumen extruded tubing 480 includes a side port lumen outer wall 483, a thru lumen outer wall 484, and a curved dividing wall 485. The circular thru lumen 481 provides improved guidewire movement. The side port lumen 482 optimizes space for decreased flow resistance to aspiration or irrigation.

[0201] A distal portion 441 of an alternative aspiration and irrigation catheter 440 is illustrated in FIG. 49, and a distal portion 443 of an alternative dilator catheter 442 is illustrated in FIG. 50. The aspiration and irrigation catheter 440 and the dilator catheter 442 are similar to the aspiration and irrigation catheter 400 and the dilator catheter 424 of FIGS. 43 and 46, respectively, however instead of a single side port lumen 411, 431 there are four side port lumens 444, 445, 446, 447 within the outer wall 448 of the multi -lumen tubing 449of the elongate shaft 450a, 450b. The multi-lumen tubing 449 further comprises a circular central thru lumen 451.

[0202] A longitudinal array 453 of sideholes 454al-45414 of the aspiration and irrigation catheter shaft 450a is shown in FIGS. 49 and 5 IB, with each sidehole 454 passing transversely through the outer wall 448 into one of the side port lumens 444, 445, 446, 447. The array 453 comprises 48 (12 x 4) total sideholes 454, and is arranged in a proximal subarray 455 and a distal sub-array 456, each having 24 (6 x 4) holes. Twelve sideholes 454al- 45411, 454a2 -45412, 454a3 -45413, 454a4-45414, communicate with each of the four side port lumens 444, 445, 446, 447. A distal tip portion 457 is thermally tip formed onto the distal end 458 of the shaft 450a. The distal tip portion 457 comprises an outer cylindrical surface 459 and an inner lumen 460, which extends the thru lumen 451 to the distal tip 458. In a first application, the side port lumens 444, 445, 446, 447 and the sideholes 454 are used for aspiration and the thru lumen 451 is used as a guidewire lumen (or puncture device lumen), and as an irrigation (infusion, injection, drip) lumen. Each longitudinal row of holes can be separated from the adjacent longitudinal row of holes by an angle less than 180°, for example by about 30° to 120°, or by about 40° to 90°, or by about 60°.

[0203] In a second application, the thru lumen 451 is used as an aspiration lumen and as a guidewire lumen, and the side port lumens 444, 445, 446, 447 and the sideholes 454 are used for irrigation (infusion, injection, drip). The thru lumen 451 can be used for irrigation or aspiration either with a guidewire removed, or with the guidewire in place.

[0204] A longitudinal array 461 of sideholes 462al -46214 of the dilator catheter shaft 450b is shown in FIGS. 50 and 5 IB, with each sidehole 462 passing transversely through the outer wall 448 into one of the side port lumens 444, 445, 446, 447. The array 461 comprises 48 (12 x 4) total sideholes 462, and is arranged in a proximal sub-array 464 and a distal subarray 465, each having 24 (6 x 4) holes. Twelve sideholes 462al-46211, 462a2 -46212, 462a3- 46213, 462a4-46214, communicate with each of the four side port lumens 444, 445, 446, 447. A distal shaft portion 466 is thermally tip formed onto the distal end 467 of the shaft 450b. The distal shaft portion 466 comprises an frustoconical surface 468 and an inner lumen 469, which extends the thru lumen 451 to the distal tip 470. In a first application, the side port lumens 444, 445, 446, 447 and the sideholes 462 are used for aspiration and the thru lumen 451 is used as a guidewire lumen (or puncture device lumen), and as an irrigation (infusion, injection, drip) lumen.

[0205] In a second application, the thru lumen 451 is used as an aspiration lumen and as a guidewire lumen, and the side port lumens 444, 445, 446, 447 and the sideholes 462 areused for irrigation (infusion, injection, drip). The thru lumen 451 can be used for irrigation or aspiration either with a guidewire removed, or with the guidewire in place. Alternatively, multiple blocking flow directors carried in an annular lumen define interstitial openings. The openings can communicate with the distal end of the shaft to allow the fluid (e.g., medicant, etc.) delivered through the lumen to exit are several openings that are circumferentially- arrayed around the shaft. Alternatively, several transverse holes in the outer wall, each over one of the sideholes, can be provided to allow the fluid to be delivered in an outward radial direction, instead of a forward longitudinal direction. The shaft can have a circular outer shape, a ribbed-shape, or a gear-shaped cross-section having elevated portions and indented portions.

[0206] An alternative y-connector 111' is illustrated in FIG. 52. A proximal end 471 of the multi -lumen tubing 449 extends into the interior 472 of the y-connector 111' and four extension tubes 473a-c and 473d not shown) are cast with a casting material 477 (with adhesive, epoxy, or a hot melt) within the interior 472 of the y-connector, adjacent to the interior 474 of the sideport 176. Prior to insertion, the proximal exterior 475 of the multilumen tubing 449 is skived, exposing the interior of each of the side port lumens 444, 445, 446, 447 at the skived portion 478. Thus, injection or aspiration through the side port 176 equally injects or aspirates through the four side port lumens 444, 445, 446, 447, while isolating them each from the thru lumen 451.

[0207] An alternative multi-lumen tubing 486 to the multi-lumen tubing 449 of FIG. 51 A is illustrated in FIG. 54. A circular, central thru lumen 487 and a four circular side port lumens 488a-d run parallel to each other within the multi-lumen tubing 486. The four side port lumens 488a-d are arrayed in a circle around the thru lumen 487. The circular thru lumen 487 provides improved guidewire movement. In both the multi-lumen tubing 449 of FIG. 51 A and the multi-lumen tubing 486, there is sufficient space in the outer wall 448, 489 for more than four side port lumens 444, 445, 446, 447, 488, for example five, six, seven, eight, nine, ten, eleven, twelve, or more.

[0208] FIGS. 59 and 60 illustrate a system for irrigation and aspiration 500 through a single lumen dilator catheter 501, that utilizes an elongate valving device 502. The valving device 502 comprises a valving tube 503 comprising a tubular shaft 504 and a plug 505, or sealing interface, carried on the distal end of the tubular shaft 504. In some embodiments, the plug 505 is insert molded onto the distal end 506 of the tubular shaft 504. The tubular shaft 504 and the plug 505 can each comprise thermoplastic polyurethane (TPU) or polyether block amide (PEBA). The valving device 502 comprises a thru lumen 507 extending throughthe tubular shaft 504 and through the plug 505. The thru lumen 507 is configured for placement of a guidewire therethrough, or placement of a puncture device 103, 203. The thru lumen 507 is also configured to irrigation, or for aspiration.

[0209] The plug 505 comprises a distal end 508 and a proximal end 509. The plug 505 includes a maximum diameter portion 510. The dilator catheter 501 comprises a thru lumen 511 that includes a distal lumen portion 512 passing through a distal taper 513. The distal lumen portion 512 is colinear with and communicates with a proximal lumen portion 514. Between the distal lumen portion 512 and the proximal lumen portion 514 is an internal taper 515 comprising a frustoconical inner surface 516. The maximum diameter portion 510 of the plug 505 has an outer diameter that is equal to or slightly larger than the inner diameter of the proximal lumen portion 514. The interference between the maximum diameter portion 510 of the plug 505 and an inner surface 524 of the inner diameter of the proximal lumen portion 514 combined with radial compression of the plug 505 within its elastic limit creates a valve that is slidable within the entire length of the proximal lumen portion 514, with minimal resistance so that advancement of the plug 505 and retraction of the plug 505 can be controllably performed by the user via compression and traction, respectively. In alternative embodiments, the maximum diameter portion 510 has an outer diameter that is slightly smaller than the inner diameter of the proximal lumen portion, but the annulus between the two is thin enough that fluid resistance is high. In either embodiment, the plug 505 is configured to substantially block the flow of proximally injected fluid through a section of the proximal lumen portion 514 that is distal to the distal end 508 of the plug 505. Furthermore, in either embodiment, the plug 505 is configured to substantially block the effect of proximally applied negative pressure through a section of the proximal lumen portion 514 that is distal to the distal end 508 of the plug 505.

[0210] The plug further comprises a distal taper 517 extending distally from the maximum diameter portion 510, and a proximal taper 518 extending proximally from the maximum diameter portion. As shown in FIGS. 57-58, the tapers 517, 518 are each linear tapers that define two frustoconical surfaces 519, 520, respectively. A proximal grip 521 is attached to the proximal end 522 of the tubular shaft 504. The proximal grip 521 includes a lead-in internal taper 523, to aid the insertion of a guidewire or a puncture device 103, 203. A user can move the valving device 502 distally or proximally within the proximal lumen portion 514 of the dilator catheter 501 by either gripping on the grip 521, or gripping on the tubular shaft 504, itself. The plug 505 can be moved by the user to different longitudinal positions in relation to the dilator catheter 501. The movement to different positions controlsthe effect of two different effective lumens: (1) a composite lumen 525 that is the union of the thru lumen 507 / proximal lumen portion 514 / distal lumen portion 512 (FIG. 59), or, (2) a composite lumen 526 that is the union of the thru lumen 507 / distal lumen portion 512 (FIG. 60). The dilator catheter 501 comprises a tip plug tube 527 that carries the distal taper 513, and has a distal end 528 and a proximal stepped-down portion 529. The distal end 506 of the tubular shaft 504 surrounds the proximal stepped-down portion 529 and is sealingly bonded to it, by thermal welding (e.g., laser welding), or fusing in a removable glass tube, or adhesive or epoxy bonding. A proximal end 530 of the dilator catheter 501 comprises a y- connector like the proximal connector 1024 of FIG. 1, with the sideport 1030 hydraulically coupled to an annular lumen 531 that extends between an outer cylindrical surface 532 of the tubular shaft 504 and a longitudinally adjustable (variable) proximal portion 533 of the inner surface 524 of the proximal lumen portion 514. The insertion valve 1025 of the proximal connector 1024 (y-connector) is sealed over the outer cylindrical surface 532 of the tubular shaft 504. As the plug 505 is pulled proximally, the annular lumen 531 decreases in length, and as the plug is advanced distally, the annular lumen 531 increases in length. In some embodiments, the grip 521 can snap into the proximal connector 1024 to help maintain the longitudinal relative positions of the dilator catheter 501 and the valving device 502.

[0211] The thru lumen 507 is a composite lumen, as mentioned, and injection or aspiration can be performed with the thru lumen via a female luer lock fitting 534 carried by the grip 521. Thus, the grip 521 is also a luer lock connector. The dilator catheter 501, proximal to the bonded tip plug tube 527, has a cylindrical outer wall 535. There are two holes 536, 537, or apertures, passing through the cylindrical outer wall 535. In FIG. 59, the plug 505 of the valving device 502 has advanced to a first position, wherein the plug 505 seals against the proximal portion 533 of the inner surface 524 of the proximal lumen portion 514 at a location proximal to the distal hole 536, but distal to the proximal hole 537. The insertion valve 1025 of the proximal connector 1024 (y-connector) is sealed over the outer cylindrical surface 532 of the tubular shaft 504. Thus, fluid and / or material injected through the luer lock fitting 534 passes through the entirety of the thru lumen 507 of the valving device 502 (proximal to distal), and exits through both a distal tip orifice 538 of the valving device 502 at a distal end of the composite lumen 525, and transversely out the distal hole 536. During manufacture, by controlling the cross-sectional area and shape of the distal hole 536 (or, for example, the diameter, when it is circular) and / or by controlling the inner diameter and / or the length of the distal lumen portion 512, flow resistance can be adjustedsuch that a certain percent of fluid of a particular viscosity exits through the distal hole 536 and the remainder exits through the distal tip orifice 538.

[0212] Furthermore, fluid and / or material aspirated from the luer lock fitting 534 passes into the distal tip orifice 538 of the valving device 502 at a distal end of the composite lumen 525, and transversely into the distal hole 536 and through the entirety of the thru lumen 507 (distal to proximal) of the valving device 502 and out the luer lock fitting 534 (e.g., into a canister 1029). During manufacture, by controlling the cross-sectional area and shape of the distal hole 536 (or, for example, the diameter, when it is circular) and / or by controlling the inner diameter and / or the length of the distal lumen portion 512, flow resistance can be adjusted such that a certain percent of fluid of a particular viscosity enters into the distal hole 536 and the remainder enters into the distal tip orifice 538. The viscosity of material being aspirated, for example from a subdural hematoma 1016 can be complex, non-Newtonian, and therefore more difficult to control than fluids of a known viscosity and / or temperature that are injected. Thus, a variety of models with different numbers of holes, or hole diameters can be available, in order to achieve optimized aspiration. In a dilator catheter 501 with more than two holes 536, 537, a first position can be utilized, and if aspiration or irrigation is not as effective as desired, the plug 505 can be moved (e.g., retracted proximally) to utilize an increased number of holes 536, 537.

[0213] The sideport 1030 of the proximal connector 1024 (y-connector) is used for aspiration into the proximal hole 537, through the annular lumen 531 (distal to proximal) and out the sideport 1030. Furthermore, the sideport 1030 can be used for injection through the annular lumen 531 (proximal to distal) and out the proximal hole 537.

[0214] In FIG. 60, the plug 505 of the valving device 502 has advanced to a second position that is the furthest distal position, and wherein the plug 505 seals against the proximal portion 533 of the inner surface 524 of the proximal lumen portion 514 at a location distal to the distal hole 536. Furthermore, the taper 517 seals against the taper 515. The insertion valve 1025 of the proximal connector 1024 (y-connector) is sealed over the outer cylindrical surface 532 of the tubular shaft 504. In the position of FIG. 60, the distal end 508 of the plug 505 is immediately adjacent to the distal lumen portion 512. Thus, fluid and / or material injected through the luer lock fitting 534 passes through the entirety of the thru lumen 507 of the valving device 502 (proximal to distal), passes through the distal lumen portion 512 (proximal to distal), and exits through only the distal tip orifice 538 of the valving device 502 at a distal end of the composite lumen 526.

[0215] Furthermore, fluid and / or material aspirated from the luer lock fitting 534 passes into the distal tip orifice 538 of the valving device 502 at a distal end of the composite lumen 525, through the distal lumen portion 512 (distal to proximal), and through the entirety of the thru lumen 507 (distal to proximal) of the valving device 502 and out the luer lock fitting 534 (e.g., into a canister 1029).

[0216] The sideport 1030 of the proximal connector 1024 (y-connector) is used for aspiration into the distal hole 536 and the proximal hole 537, through the annular lumen 531 (distal to proximal) and out the sideport 1030. Furthermore, the sideport 1030 can be used for injection through the annular lumen 531 (proximal to distal) and out the proximal hole 537 and the distal hole 536. In some cases, the dilator catheter 501 can be used with a guidewire or puncture device 103, 203 and then the guidewire or puncture device 103, 203 can be removed from the thru lumen 511, to begin use of the valving device 502. Although the annular lumen 531 is described as “annular,” users of catheters in curved blood vessels or other curved areas are aware that an inner tube can move toward one side of an inner wall of an outer tube, thus the amount of true annular shape of the lumen between the two tubes can vary over the length of the curved catheter(s). Thus, the term “annular lumen” or more a description of a cylindrical or mostly cylindrical device inside a cylindrical or mostly cylindrical lumen. If maximum injection or aspiration is desired through all of the holes 536, 537 and the distal tip orifice 538, the valving device 502 can be completely removed from the thru lumen 511 of the dilator catheter 501 and the insertion valve 1025 can be completely closed. The sideport 1030 can then be used for the injection or aspiration with maximal lumen size. FIGS. 61-62 illustrate a alternative puncture device 540 configured to pierce tissue, while also providing controlled protection from its piercing tip 541. A longitudinally - compressible protector coil 542 is attached at its proximal end 543 to a core wire 544 at a core wire taper 545 with a solder joint 546. The protector coil 542 is an open-wound compression spring and is carried co-axially on the distal, small-diameter portion 547 of the core wire 544. The inner diameter of the protector coil 542 is sized larger than the smalldiameter portion 547 so that they clear each other at an annular space. The core wire 544 has a distal end 548 and a proximal end 549. The proximal end 549 of the core wire is attached to a grip 557, that allows the advancement, tracking, and torquing of the puncture device 540 (the core wire 544 and protector coil 542 can be torqued together). Proximal to the core wire taper 545 is an elongate large diameter portion 550. A radiopaque marker band 551 is attached over the distal end 552 of the protector coil 542 in order to visualize the tip. In alternative embodiments, the marker band 551 can be replaced by a short length ofradiopaque coil, which can be screwed into the distal end 552 of the protector coil 542. The marker band 551 (or radiopaque coil) is then soldered to the protector coil 542. The solder joint 546 of the soldering of the marker band 551 can be replaced by brazing, adhesive, or epoxy. The protector coil 542 is shown extending from a dilator catheter 553 in FIGS. 63-66. The dilator catheter 553 comprises a distal dilating taper 554 and a distal luminal opening 555. The opening 555 is located at a distal tip 556 of the dilator catheter 553 and is sized to allow smooth, controlled passage of the protector coil 542 as the user places forward pressure on the large diameter portion 550. The protector coil 542 has an unstressed, extended state (FIG. 63) that allows the distal end 558 of the marker band 551 (or distal end of the protector coil 542, whichever is most distal) to be further distal to the piercing tip 541 of the core wire 544, thus covering the piercing tip 541. This is the unstressed, undeflected safety state of the puncture device 540.

[0217] The protector coil 542 has a longitudinally compressed, stressed state (FIG. 64) wherein the shortening of the length of the protector coil 542 exposes the piercing tip 541 and a total longitudinal exposed length Z4 of the core wire 544. A minimum force F applied on the distal end 558 compresses the protector coil 542 and exposes the piercing tip 541. Thus, when the puncture device 540 is used, it is the distal end 558 that interfaces with and does the tenting of the tissue (e.g., venous wall / dura mater 559) (FIG. 65), and not the distal tip 556 of the dilator catheter 553. The distal dilating taper 554 of the dilator catheter 553 can remain retracted, as in FIG. 65, during the tenting. As the force ff applied by the distal tip 556 onto the venous wall / dura mater 559 is increased, via an increase in the force applied by the user, it reaches the minimum force F, and the protector coil 542 is compressed sufficiently to expose the piercing tip 541. The piercing tip 541, with the applied force, then pierces the venous wall / dura mater 559, as shown in FIG. 66. The distal dilating tip 554 of the dilator catheter 553 can then be advanced through the puncture hole 560 to begin dilate then hole 560 to a larger size (similar to FIG. 18). The distal dilating tip 554 can be completely pass through the hole 560 for full dilation, or can be partially passed through for sub-total dilation, whichever is the minimum amount of dilation needed for the devices that will need to pass through the dilated hole. The dilator catheter 553 can be removed from the puncture device 540, and one or more procedure catheters can be passed over the puncture device 540, used like a guidewire (e.g., into the area of interest in or on the brain 1017).

[0218] Or alternatively, the puncture device 540 can first be removed through the dilator catheter 553 while the dilator catheter 553 is in an extended position through the hole 560, and then a standard guidewire can be passed through the dilator catheter 553 (e.g., intothe area of interest in or on the brain 1017). Then the dilator catheter 553 can be removed over the guidewire and a procedure catheter can be passed over the guidewire. Or still alternatively, the puncture device 540 can first be removed through the dilator catheter 553 while the dilator catheter is in an extended position through the hole 560, and then an elongate procedure device can be passed through the dilator catheter 553 (e.g., into the area of interest in or on the brain 1017).

[0219] The puncture device 540 maintains an atraumatic tip at all times, except when it is being used the make the puncture hole 560. The entirety of the protector coil 542 can be advanced through the hole 560 before it is dilated by the distal dilating tip 554 of the dilator catheter 553. If this is done, the larger diameter of the protector coil 542, compared to the piercing tip 541, provides a certain, smaller, amount of dilation of the hole 560. The protector coil 542 can be advanced completely, or partially though the hole 560 and then retracted slightly, which will cause the protector coil 542 to move from its compressed state to its extended state, covering the piercing tip 541 and protecting the distal tissue from it. Thus, the compression is removed and the protector coil 542 reaches its maximum length. The compressed state of the protector coil 542 is between 70% and 90% of the extended state. The dimensions of the protector coil 542 are: length (between 0.5 cm and 2.0 cm in its extended state and between 0.35 cm and 1.80 cm in its compressed state); wire diameter between 0.015 mm and 0.080 mm; pitch in the extended state between 0.05 mm and 0.30 mm. Protector coil 542 outer diameter between 0.3 mm and 0.5 mm. The distance total longitudinal compression of the protector coil 542 from the extended state to a fully compressed state (Le- Lc) is between 0.5 mm and 6.0 mm.

[0220] FIG. 67 illustrates a puncturing guidewire 570 comprising an elongate core wire 571 having a proximal end 572 coupled to a torquer handle 573, a proximal large diameter section 574, and intermediate transition section comprising a taper 575, a distal small diameter section 576, and a distal end section 577 comprising a piercing tip 578. The distal end section 577 is shown in FIG. 67 prior to forming a curve. All of the core wire 571, or at least the portion at the distal end section 577, comprises a shape-memory alloy, such as Nickel -Titanium alloy. The distal end section 577 is formed into a curve 579 as shown in FIG. 68. The curve comprises a 180° curve , such that the piercing tip 578, in the core wire’s 571 unstressed state (FIG. 68) points directly backwards, such that forward movement of the puncturing guidewire 570 does not cause damage to tissue (e.g., brain tissue). The curve 579 has a radius of curvature r in the unstressed, unconstrained state. In the unstressed state, the curve 579 displays superelastic, or pseudoelastic, properties. The degree of curvature of thecurve 579 is between about 160° and about 200°, or between about 170° and about 190°, or between about 178° and about 185°.

[0221] In some embodiments, the puncturing guidewire 570 comprises an outer coil and an inner core wire having a curved shape, that causes the curve 579 when unconstrained (e.g., by a dilator lumen). The outer coil and the core wire can each have similar amounts or curve, as they tend to curve along with each other. In some embodiments, the core wire 571 comprises stainless steel. The puncturing guidewire 570 comprises a sharp, pointed or beveled piercing tip 578, which can comprise a ground angle or bevel. The diameter of the shaft of the guidewire can range from 0.20 mm to 0.46 mm, and the radius of curvature of the curve 579 can range from 1.5 mm to 13.0 mm, or 2.0 mm to 10.0 mm. The bend travel of the distal section 577 relative to distal section 576 can be between 30 and 360 degrees (all the way to a “pigtail” shape). FIG. 69 illustrates the puncturing guidewire 570 retracted into the lumen of the dilator catheter 580 having a distal tapered tip 581. The dilator catheter 580 has enough body and stiffness to cause the curve 579 to substantially straighten out, when the curve 579 is pulled into the dilator catheter 580 as shown in FIG. 69. Thus, when puncturing the wall of a blood vessel, such as an intracranial vein, or tissue combinations such as venous wall / dura mater 559, the position of the dilator catheter 580 allows the sharp distal piercing tip 578 of the puncturing guidewire 570 to be aimed at the target area 582, and pushed through the venous wall / dura mater 559 (from manipulation by the user at the proximal end of the puncturing guidewire 570, the torquer handle 573 or proximal large diameter section 574). The piercing tip 578 is able to maintain a substantially straight, forward-pointing shape during the first amount of length extended from the lumen of the dilator catheter 580. After a short distance that is reliably long enough to pierce the tissue, further advancement of the puncturing guidewire 570 causes the distal end section 577 with stresses now removed to reform its curve 579, as shown in FIG. 70.

[0222] In FIG. 70, the puncturing guidewire 570 is extended sufficiently such that the curve 579 having a radius of curvature r is unconstrained. Once the puncture 583 in the tissue wall is created, the puncturing guidewire 570 can then be pushed further forward in relation to the dilator catheter 580, and / or the dilator catheter 580 can be pulled back in relation to the puncturing guidewire 570, thus causing the relationship shown in FIG. 70, wherein, without support from the dilator catheter 580, the curve 579 is able to take its unrestrained shape. As shown in FIG. 70, the sharp, pointed, puncturing, piercing tip 578 of the guidewire is curved back, such that it is not leading during forward movement of the puncturing guidewire 570. Instead, the blunt distal-facing portion 584 at the convex portion of the curve 579 is theleading portion of the puncturing guidewire 570 during forward movement (e.g., through, around, on, or in brain 1017 tissue). The curve 579 takes the form of a safe, atraumatic J-tip. Furthermore, the effective stiffness of the dilator catheter 580 is increased when the relationship of FIG. 70 is utilized, to aid in support for the puncturing operation. For example, the composite effective flexural modulus can be greater than 5.0 MPa, while in the relationship of FIG. 69, it can be less than 2.0 MPa. When it is desired to retract the puncturing guidewire 570 from the position of FIG. 70, the dilator catheter 580, or another catheter having a lumen, such as a procedure catheter, can be advanced forward, to move the puncturing guidewire 570 into the position of FIG. 69, and allowing it to be safely removed. In other embodiments, the puncturing guidewire 570 can be constructed to enable variable stiffness, including adjustable / variable stiffness. For example, a tapered diameter inner core wire can be slidable within a hypo tube shaft or coil shaft.

[0223] Access catheters, such as the particular embodiments of access catheters 1013, 101, 300 described herein, can have an outer diameter from 4 French to 10 French, or from 6 French to 9 French, and an inner diameter of 1 mm to 3 mm, or 1.4 mm to 2.8 mm. Blocking catheters, such as the particular embodiments of blocking catheters 304, 343, 355, 366, 378, 392 can have an outer diameter along the proximal shaft of 1 French to 3.0 French, or 1.5 French to 2.0 French. Blocking members, such as the particular embodiments of blocking members 323, 352, 356, 367, 379, 393 of the blocking catheters 304, 343, 355, 366, 378, 392 can have an outer diameter of 2.0 French to 9.0 French, or 3.0 French to 8.0 French. Irrigation / aspiration catheters, such as the particular catheter 1012, or dilator catheters (including dilator catheter configured for irrigation / aspiration), such as the particular embodiments of catheters 1012 dilator catheters 102, 202, 337, 344, 424, 442, 501, 553, 580 can have a shaft outer diameter of 1.5 French to 6.0 French, or 3.0 French to 7.0 French, or 2.0 French to 5.5 French.

[0224] A number of materials, including fluids, drugs, or compounds can be infused through the irrigation lumens and / or the aspiration lumens (depending on the location desired for delivery) for any of the devices described herein, and delivered into the intracranial area of the patient, including subdural areas. A non-limiting list of the materials includes: biological fluids, thrombolytic drugs, anti-inflammatory media, antibiotics, commercial saline solution, Ringer’s lactate solution, neuroregenerative drugs, biologic compounds, anti-seizure drugs, chemotherapeutic drugs, and immunomodulatory drugs. The same materials can subsequently (partially or completely) be removed from the patient via aspiration through an aspiration lumen, or aspiration through an irrigation lumen. Other materials that can beremoved from the patient via aspiration through an aspiration lumen or aspiration through an irrigation lumen include, but are not limited to: thrombus, emboli, biopsied tissue, and brain tissue, which can include one or more of neurons, glia, tissue from a benign lesion, and / or tissue from a malignant lesion. In some embodiments, the fluid comprises previously injected water that when injected did not include significant amounts of sodium chloride.

[0225] Optionally or additionally, a catheter-delivered hemostatic agent can be implanted at the site of transvascular access / puncture site. Regardless, the access catheter 1013, 101, 300 will be rotated 180 degrees such that the balloon 1022, 123 now faces the transvascular access / puncture site. Venography is performed to evaluate for active extravasation to the subdural space. If none is noted, the operator can choose to repeat venography in five and / or in ten minutes to re-evaluate and ensure hemostasis (e.g., sufficient closure of the puncture site). If hemostasis is not achieved and there is evidence of active extravasation on venography, the balloon 1022, 123 on the access catheter 1013, 101, 300 is reinflated to tamponade the transvascular access / puncture site. Venography can then be performed to ensure hemostasis is achieved with balloon inflation. The balloon 1022, 123 can be deflated in about five minutes and venography repeated, to evaluate for hemostasis. If hemostasis has been achieved, delayed intra-operative imaging can then be obtained at five and / or in ten minutes to ensure that the subdural hematoma is, for example, <50 mL in residual volume. If hemostasis is not achieved, a stat neurosurgical consult is warranted in case there is a need for surgical intervention to “seal / fix” the access / puncture site and remove any re -accumulated subdural hemorrhage. If hemostasis is achieved, the access catheter 1013, 101, 300 can then be completely withdrawn from the patient’s body. Additional venography can be performed from the arterially-placed catheter after removal of the transvenous system. The access sheath is then removed from the patient with the patient in a flat or Trendelenburg position with their breath held by anesthesia. Manual pressure is held, often for a minimum of five minutes, or until hemostasis is achieved. Middle meningeal artery embolization can be performed at this stage in the procedure, with the aim of preventing recurrence of the subdural collection. The arterial catheter(s) and access sheath are then withdrawn and manual pressure or a closure device is applied for hemostasis of the arteriotomy site. Repeat imaging is normally obtained in 12 or 24 hours and again in three months to evaluate for any re -accumulation of the subdural hematoma.

[0226] FIG. 71 illustrates a metallic sensor 600 comprising one or more coil configured for placement in or on a puncture device 103, 203, 540, or a dilator catheter 102, 202, 337, 344, 424, 442, 501, 553, 580, or an access catheter 1013, 101, 300, or a procedure catheter oran irrigation / aspiration catheter. In some embodiments, the sensor 600 comprises two or more coils. In some embodiments, the sensor 600 comprises three coils, for example three orthogonal coils. FIG. 75 illustrates a magnetic localization system 601 utilizing a magnetic field generator 602 controlled by a controller 603. The magnetic field generator 602 energizes the metallic coil sensor 600 within an elongate medical device 607 that has been delivered to a target site 608 within a patient 609. The magnetic field generator 602 is coupled to the metallic coil sensor 600 by conductor wires 610. The magnetized coil sensor 600 outputs a signal 604 that is received wirelessly by a transceiver 605 of a data acquisition system 606. An additional (reference) coil sensor 64 is placed on the patient 609 as an anatomical reference to align the device to the target site 608. In some embodiments, the sensor 64 comprises two or more coils. In some embodiments, the sensor 64 comprises three coils, for example three orthogonal coils. The magnetic localization system 601 is utilized to both align devices to target safely, and then to confirm that the target is hit. Alternatively, the signal 604 is conducted to the data acquisition system 606 by wires extending proximally in the medical device 607. A coil sensor 600 can comprise a five-degrees-of-freedom (5-DOF) sensor, comprising three coils, for example the Aurora 5-DOF sensors supplied by Northern Digital, Inc. of Waterloo, Ontario, Canada. One 5-DOF EM micro sensor measures o0.3 mm x 2.5 mm, small enough for integration with 3F and 5F catheters and sheaths (single and multilumen), 0.018” (0.4572 mm) and 0.035” (0.889 mm) guidewires, and 22G (or larger) needles. This sensor is approximately 72% smaller (in cylindrical volume) than another sensor that measures o0.41 mm x 4.9 mm). In other embodiments, a coil sensor 600 can comprise a six- degrees-of-freedom (6-DOF) sensor.

[0227] In some embodiments, a system utilizes electromagnetic (EM) tracking to localize the position of the dilator, puncture device, guidewire, guide / access catheter, or procedure catheter within a defined EM field, ensuring safe navigation and access to the subdural space.

[0228] In some embodiments, EM sensors comprising one or more of the coil sensors 600 are embedded in the distal portion of the guide / access catheter and the procedure catheter, and the sensors are used as localization points for tracking the position and orientation of the catheters in 3D space during the procedure.

[0229] In some embodiments, the magnetic field generator 602 emits a low-intensity, varying EM field, establishing a measurement volume through which the guide / access catheter and procedure catheter are tracked in real-time. The voltage changes as the distance and orientation of the coil sensor 600 changes in relation to the reference coil sensor 64. Thiscan allow a precision determination of whether a device has entered the subdural space of a patient or not. The reference coil sensor 64 can be configured to be carried on an anatomical patient reference patch. The patch can be placed on the crest of the skull of the patient 609 to define the plane of the subdural space. Determination can be made of rotational alignment of exit port 119, 615 (FIG. 72) to the target site 608, and of whether or not a device has entered the subdural space.

[0230] In some embodiments, small currents are induced in the EM sensor coil sensors 600 when they enter the EM field, and these currents are relayed to a Sensor Interface Unit (SIU) 611, where the signals are amplified and digitized for tracking.

[0231] In some embodiments, the signals from the SIU 611 are transmitted to a System Control Unit (SCU) 612 in the controller 603, which calculates each sensor coil’s 600 position and orientation in real-time, allowing for continuous localization of the guide / access catheter and / or other device(s) relative to patient anatomy.

[0232] In some embodiments, the real-time tracking data are communicated to a host application interface 613, allowing for visualization and navigation of the guide / access catheter and / or other device(s) relative to preoperative or intraoperative patient image sets.

[0233] In some embodiments, the EM tracking system allows for continuous monitoring of the guide / access catheter’s trajectory and / or other device(s) trajectory(ies), minimizing the need for intraoperative fluoroscopy and reducing radiation exposure to the patient and clinical staff.

[0234] In some embodiments, the EM tracking system ensures precise navigation of the procedure catheter and / or other device(s) through anatomical tracts to target treatment areas within the subdural space, improving the safety and efficacy of the procedure.

[0235] In some embodiments, the EM sensors are embedded within the distal tips of the dilator catheter, puncture device, guidewire, guide / access catheter, or procedure catheter, allowing for precise tracking of delicate, minimally invasive maneuvers within the subdural space without requiring a direct line of sight for localization.

[0236] In some embodiments, the continuous EM tracking allows for real-time adjustments in device positioning based on patient movement or changes in anatomy during the procedure.

[0237] In some embodiments, the EM tracking system minimizes the risk of vessel or brain injury by ensuring controlled navigation through anatomical structures during access to the subdural space. One or more calibration cycles can be run to detect specific thresholds corresponding to the transition between blood and subdural space.

[0238] FIG. 72 illustrates an access catheter 614 having a side exit port 615 and a balloon 616 (shown uninflated) that is carried on the shaft 617 of the access catheter 614 on a side 180° form the side exit port 615. The coil sensor 600 is bonded within the access catheter 614 laterally adjacent to the side exit port 615. The balloon 616 will be used to force the side exit port 615 against a venous wall 618 that is adjacent to a target location 619 on or in the brain of the patient. The coil sensor 600 and its magnetic localization system 601 can be utilized as described to confirm that the longitudinal location of the side exit port 615 is as close to the desired location on the venous wall 618 as possible, for optimized access to the target location 619. The coil sensor 600 and / or the reference coil sensor 64 and the magnetic localization system 601 can be used to confirm that the rotational and longitudinal location of the side exit port 615 is correctly placed in relation to the venous wall 618, the target location 619, and the overall target space 65 as possible. The balloon 616 can then be inflated and the dilator catheter and puncture device used to create a puncture to deliver a device for diagnosis and / or treatment the target location 619.

[0239] FIG. 72A is an alternative embodiment of an access catheter 614' that is similar to access catheter 614, except that the coil sensor 600 is bonded just distally of the side exit port 615, on the same side of the access catheter 614' as the side exit port 615. In embodiments having an inclined ramp 63, the coil sensor 600 is located distally adjacent to the ramp 63. FIG. 72B is an alternative embodiment of an access catheter 614" that is similar to access catheter 614, except that the coil sensor 600 is bonded within the distal taper 62.

[0240] FIG. 73 illustrates a dilator catheter 620 having a distal taper 621 and a thru lumen622. The coil sensor 600 is bonded within the thru lumen 622 of the dilator catheter 620, or within a second lumen. The coil sensor 600 and its magnetic localization system 601 can be utilized as described to confirm that the location of the distal taper 621, or specifically the tip623, is as close to the desired location on the venous wall 618 as possible, for optimized access to the target location 619. A puncture device can then be used to create a puncture to deliver a device for diagnosis and / or treatment the target location 619.

[0241] FIG. 74 illustrates a puncture device 624 comprising a proximal hypo tube 625, a distal core wire 626 bonded to and extending distally from the hypo tube 625, and a piercing tip 627. The coil sensor 600 is bonded within the hypo tube 625. The coil sensor 600 and its magnetic localization system 601 can be utilized as described to confirm that the location of the piercing tip 627, is as close to the desired location on the venous wall 618 as possible, for optimized access to the target location 619. The puncture device 624 can then be used to create a puncture to deliver a device for diagnosis and / or treatment the target location 619.

[0242] FIG. 76A illustrates an impedance system 630 comprising a source electrode 631 and a sink electrode 632. A known AC current is passed through the source electrode 631 and the sink electrode 632, and the total voltage is measured, in the interface (e.g., tissue) between the two electrodes 631, 632. The calculation between the known current and the measured voltage to determine impedance (Z). The result is the ability to sense changes in the adjacent tissue type or tissue thickness as a device carrying the electrodes 631, 632 is advanced or retracted. FIG. 76B illustrates a graph 667 showing the voltage change between V3, V2, and VI, as a device carrying the impedance system 630 is moved through three different tissues or combinations of tissue. The system 630 can thus be used to determine when a device is in the correct location for performing a puncture, when the device has performed the puncture, and how far the device has been advanced past the puncture. An interface can be identified at the portion of the graph with an abrupt change in voltage V at a particular time T. This can indicate contact, puncture, or in general, a sudden force increase. The electrode system 630 is configured for placement in or on a puncture device 103, 203, 540, or a dilator catheter 102, 202, 337, 344, 424, 442, 501, 553, 580, or an access catheter 1013, 101, 300, or a procedure catheter or an irrigation / aspiration catheter.

[0243] FIG. 80 illustrates an impedance localization system 633 utilizing an AC current generator 634 controlled by a controller 635. The impedance localization system 633 using circuitry of the AC current generator 634 passes a known, controlled AC current through a distal electrode 636 and a proximal electrode 637 within an elongate medical device 638 that has been delivered to a target site 639 within a patient 640. The AC current generator 634 is coupled to the electrodes 637, 638 of the elongate medical device 638 by conductor wires 641. A voltage is measured that is received through the wires 641 by a data acquisition system 642. Alternatively, the signal 643 is conducted to the data acquisition system 642 wirelessly 643 to a transceiver 644. The voltages are relayed to an interface unit 645. Signals from the interface unit 645 are transmitted to a System Control Unit (SCU) 646 in the controller 635, which calculates each device position real-time, allowing for continuous localization of the device relative to patient anatomy. This can allow a precision determination of whether a device has entered the subdural space of a patient or not. One or more calibration cycles can be run to detect specific thresholds corresponding to the transition between blood and subdural space.

[0244] FIG. 77 illustrates an access catheter 647 having a side exit port 648 and a balloon 649 (shown uninflated) that is carried on the shaft 650 of the access catheter 647 on a side 180° form the side exit port 648. A distal electrode 651 can comprise a platinum / iridiumradiopaque marker band attached to an exterior of the shaft 650. A proximal electrode 652 can also comprise a platinum / iridium radiopaque marker band attached to an exterior of the shaft 650. The balloon 649 will be used to force the side exit port 648 against a venous wall 618 that is adjacent to a target location 619 on or in the brain of the patient. The impedance localization system 633 can be utilized as described to confirm that the longitudinal location of the side exit port 648 is as close to the desired location on the venous wall 618 as possible, for optimized access to the target location 619. The balloon 649 can then be inflated and the dilator catheter and puncture device used to create a puncture to deliver a device for diagnosis and / or treatment the target location 619.

[0245] FIG. 78 illustrates a dilator catheter 653 having a distal taper 654 and a thru lumen 655. A distal electrode 656 comprises a machined tip insert comprising platinum-iridium and configured to be bonded within the distal end 657 of the distal taper 654. The distal electrode 656 defines the very distal frustoconical shape, and this, combined with its high level of hardness, can greatly aid the beginning of the dilation process. A proximal electrode 658 can comprise a short platinum / iridium radiopaque marker band attached to an exterior of the a proximal portion 659 of the distal taper 654. The impedance localization system 633 can be utilized as described to confirm that the location of the distal taper 654, or specifically the distal electrode 656, is as close to the desired location on the venous wall 618 as possible, for optimized access to the target location 619. A puncture device can then be used to create a puncture to deliver a device for diagnosis and / or treatment the target location 619. Spacing between the distal electrode 656 and the proximal electrode 658 can be between 1 mm and 15 mm, or between 5 mm and 10 mm.

[0246] FIG. 79 illustrates a puncture device 660 comprising a proximal hypo tube 661, a distal core wire 662 bonded to and extending distally from the hypo tube 661, and a piercing tip 663. A polymeric layer or coating 664 covers the core wire 662, except for an uncovered distal tip portion 665 that serves as the distal electrode. In some embodiments, this distal tip portion can be sputter coated with gold or another metallic material. A proximal electrode 666 can comprise a short platinum / iridium radiopaque marker band and is carried on an exterior of the polymeric layer or coating 664, which electrically isolates it. The impedance localization system 633 can be utilized as described to confirm that the location of the piercing tip 663, is as close to the desired location on the venous wall 618 as possible, for optimized access to the target location 619. The puncture device 660 can then be used to create a puncture to deliver a device for diagnosis and / or treatment the target location 619. Wires 668, 669 electrically couple with the electrodes 665, 666, respectively. The devices647, 653, 660 are illustrated having a single pair of electrodes. However, in other embodiments, a device can have two or more pairs of electrodes, or three or more pairs, or four or mor pairs, or five or more pairs.

[0247] In some embodiments, the puncture device 103, 203, 540, 660, or a dilator catheter 102, 202, 337, 344, 424, 442, 501, 553, 580, 653, or an access catheter 1013, 101, 300, 647 or a procedure catheter or an irrigation / aspiration catheter can be equipped with a imaging enabling materials / constructs (piezoelectric IVUS -intravascular ultrasound), fiber optic, optical coherence tomography (OCT), or scanning fiber endoscopic imaging apparatus) to enable in situ imaging either for visualization prior to puncture (to visualize the sinus wall and adjacent cortical / bridging veins), during puncture (visualize entry into correct anatomical space), or after puncture (to visualize the subdural space and / or tissue or media in the subdural or subarachnoid space). This can allow a precision determination of whether a device has entered the subdural space of a patient or not. Some procedure catheters are configured to measure signals from nerves, as another way to determine location of the device. The electrode devices 647, 653, 660 can be configured to perform some of these functions.

[0248] FIG. 81 illustrates an irrigation / aspiration catheter 700 comprising an elongate shaft 701, a luer connector / optical interface 702 connected to a proximal end 703 of the shaft 701, and a lumen 704 extending from the distal end 705 to the proximal end 703. The luer connector / optical interface 702 includes a female luer lock 706 with wings 707 and an optical connector 708. One or more optical fibers 709 extend distally to form an optical pressure sensor 710 within a distal opening 711. A radiopaque marker band 712 is attached at the distal end 705. In alternative embodiments, the one or more optical fibers 709 do not terminate at an optical pressure sensor 710, but instead, terminate to polished distal ends, and are configured for imaging. FIG. 85 illustrates an alternative embodiment, further comprising four additional lumens 713, 714, 715, 716. The lumens 713, 714, 715, 716 can extend within a multi-lumen extrusion, or as illustrated, can comprise thin-walled tubes (e.g., polyimide) that are carried within an annulus between a lubricious inner tube 717, and an outer sheath 718. The lumens 713, 714, 715, 716 can be hydraulically coupled to a sideport of a y- connector, as described herein. The lumens 713, 714, 715, 716 can be utilized for positive pressure injection or negative pressure aspiration. The lumen 704 can also be utilized for positive pressure injection or negative pressure aspiration. The shaft 701 can comprise tubular braiding, coil reinforcement, or laser -machined hypo tubing support as intermediate layers. The optical pressure sensor 710 is configured to measure pressure of fluid that is beinginjected through the lumen 704. The optical pressure sensor 710 is also configured to measure (negative) pressure of fluid that is being aspirated through the lumen 704.

[0249] FIG. 86 illustrates an irrigation / aspiration catheter 720 comprising an elongate shaft 721, a female luer lock 722 connected to a proximal end 723 of the shaft 721, and a lumen 724 extending from the distal end 725 to the proximal end 723. An optical fiber guidewire 750 is placed through the lumen 724, with a distal end 751 extending distally of the distal end 725 of the shaft 721 and a proximal optical interface 752 coupled to a proximal end 753 of the guidewire 750. The optical interface 752 comprises optical connector 754. One or more optical fibers 756 extend distally to form an optical pressure sensor 757 within a distal opening 758. A radiopaque marker band 759 is attached at the distal end 751. In alternative embodiments, the one or more optical fibers 756 do not terminate at an optical pressure sensor 757, but instead, terminate to polished distal ends, and are configured for imaging. The optical pressure sensor 757 is configured to measure pressure of fluid that is being injected through the lumen 724, when the distal end 751 is pulled back inside the lumen 724. The optical pressure sensor 757 is also configured to measure (negative) pressure of fluid that is being aspirated through the lumen 724, when the distal end 751 is pulled back inside the lumen 724.

[0250] A method for moving tissue or fluid to or from the brain area of a patient includes providing a guide / access catheter including an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the distal end having an atraumatic tip, and a side exit port located on a side of the catheter and communicating with the lumen; providing a drainage, aspiration, and / or irrigation catheter having a proximal end, a distal end, and a transport lumen extending between the proximal end and the distal end, wherein a distal portion of the aspiration or drainage, aspiration and / or irrigation catheter is configured to be placed through at least a portion of the lumen of the of the guide / access catheter and out through the side exit port of the guide / access catheter; endovascularly inserting the distal end of the guide / access catheter into a dural venous sinus or cerebral vein of a subject such that the side exit port is adjacent a wall of the dural venous sinus or cerebral vein; advancing the distal portion of the drainage, aspiration and / or irrigation catheter through the portion of the lumen of the guide / access catheter and out the side exit port such that the distal portion of the drainage, aspiration, and / or irrigation catheter is oriented at an angle between 30° and 90° to the endoluminal surface of the vessel wall; advancing the distal portion of the drainage, aspiration and / or irrigation catheter through a puncture in the wall of the dural venous sinus or cerebral vein to an extravascular spacebeneath a portion of the dura mater of the subject; and actively causing tissue or fluid to or from the extravascular space. In some embodiments, the method includes measuring a pressure within the transport lumen or within the extravascular space. In some embodiments, the method includes obtaining an image within the transport lumen or within the extravascular space. The pressure measurement and the imaging can each be utilized to judge the quality, the progress, and the end result of the method. When measuring pressure, a pressure sensor can be carried by the aspiration and / or irrigation catheter, or a pressure sensor can be carried by a guidewire that is passed through the aspiration and / or irrigation catheter, or passed in parallel with the aspiration and / or irrigation catheter. In some embodiments, the pressure sensor comprises one or more optical fiber. When obtaining an image, an imaging element (optical fiber for a visual image producing scope or for OCT, piezoelectric sensor) can be carried by the aspiration and / or irrigation catheter, or an imaging element can be carried by a guidewire that is passed through the aspiration and / or irrigation catheter, or passed in parallel with the aspiration and / or irrigation catheter.

[0251] The subdural hematoma aspiration technique utilizing the embodiments described herein utilizes a puncture that temporarily displaces the collagen fibers that make up the superior sagittal sinus walls, and which thus enables reformation of the collagen fibers after device withdrawal from the transvascular access / puncture site. The puncture technique avoids lacerating or permanently distorting these fibers, which could result in subdural hemorrhage. Creating a permanent defect, for example with a more invasive thermal energy device, could very likely result in persistent subdural hemorrhage in the absence of hemostatic agent or closure device. This higher amount of damage by the thermal energy device could cause foreign material, particularly thrombogenic agents / materials, to in turn cause dural venous sinus thrombosis, which is associated with devastating neurologic sequelae secondary to venous hypertension and / or venous hemorrhage. In contrast, as taught herein, the puncture device 103, 203, 540, 660 is a mechanical device comprised of supple materials that only has sufficient column strength to puncture the sinus wall when arranged in specific co-axial configurations (e.g.., puncture device 103, 203, 540, 660 almost entirely sheathed in the dilator catheter 102, 202, 337, 344, 424, 442, 501, 553, 580, 653 or sheathed within itself (compressible coil); balloon inflation for endoluminal apposition and reinforcement of forward force propagation during puncture; the inner deflecting structure of the side port acting as fulcrum point). This reduces the risk of brain parenchymal injury, cortical / bridging vein avulsion, and disruption of the pia-arachnoid complex. Furthermore, the systems are configured to not permanently distort the Superior Sagittal Sinus 1006 wall at transvascularaccess / puncture, thus enabling spontaneously healing of the transvascular access / puncture site after withdrawal of transvascular instrumentation. The systems and techniques described herein also do not eliminate significant amounts of endothelium (e.g., by thermal ablation or other very invasive methods). This promotes potent endogenous hemostasis by activating platelets and forming a platelet plug, as well as promoting collagen healing. Some of the particular embodiments of devices described herein that comprise curves include unique features and radiopaque markers or radiopaque areas, or sensors, to enable more rapid and reliable orientation of the device to facilitate puncture across a region of interest. However, certain controlled thermal devices can adjunctively aid in the treatments described herein, if the temperatures are maintained within chosen ranges.

[0252] The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “approximately”, “about”, and “substantially” as used herein include the recited numbers (e.g., about 10%=10%), and also represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.

[0253] For purposes of the present disclosure and appended claims, the conjunction “or” is to be construed inclusively (e.g., “an apple or an orange” would be interpreted as “an apple, or an orange, or both”; e.g., “an apple, an orange, or an avocado” would be interpreted as “an apple, or an orange, or an avocado, or any two, or all three”), unless: (i) it is explicitly stated otherwise, e.g., by use of “either... or,” “only one of,” or similar language; or (ii) two or more of the listed alternatives are mutually exclusive within the particular context, in which case “or” would encompass only those combinations involving non-mutually- exclusive alternatives. For purposes of the present disclosure and appended claims, the words “comprising,” “including,” “having,” and variants thereof, wherever they appear, shall be construed as open-ended terminology, with the same meaning as if the phrase “at least” were appended after each instance thereof.

Claims

WHAT IS CLAIMED IS:

1. A system for creating an access site from the interior of a blood vessel at or adjacent to the surface of a brain through the wall of the blood vessel and into or onto tissue of the brain, the system comprising: a dilator catheter comprising an elongate shaft configured to be placed into an access lumen of an access catheter having a side access port that communicates with the access lumen, the shaft comprising a dilator catheter lumen extending therethrough and a distal portion comprising a tapered distal tip, the distal portion configured to be passed out of the side access port; a puncture device comprising an elongate shaft including a distal end configured to penetrate through vascular tissue; a first engagement feature carried by the dilator catheter; and a second engagement feature carried by the puncture device, wherein the second engagement feature is configured to engage the first engagement feature at a first relative longitudinal position between the dilator catheter and the puncture device at which the distal end of the shaft of the puncture device is fully exposed from the dilator catheter and is located at a preconfigured amount of extension out of the dilator catheter lumen.

2. The system of claim 1, wherein the second engagement feature is configured to mechanically engage the first engagement feature.

3. The system of claim 2, wherein the second engagement feature is configured to abut the first engagement feature.

4. The system of claim 2, wherein the second engagement feature is configured to frictionally engage the first engagement feature.

5. The system of claim 1, wherein the second engagement feature is configured to magnetically engage the first engagement feature.

6. The system of any one of claims 1-5, wherein the first engagement feature is located at a proximal end of the dilator catheter, and wherein the second engagement feature is carried at a proximal end of the of the puncture device.

7. The system of claim 3, wherein the first engagement feature is located at a substantially proximally-facing surface of a hub of the dilator catheter, and wherein the second engagement feature is carried at a substantially distally-facing surface of a hub of the puncture device.

8. The system of any one of claims 1-5, wherein the first engagement feature is located at an intermediate portion along the shaft of the dilator catheter, and wherein the second engagement feature is located at an intermediate portion along the shaft of the puncture device.

9. The system of claim 4, wherein the first engagement feature comprises a sublength of the dilator catheter lumen having a decreased inner diameter in relation to a majority of the total length of the dilator catheter lumen.

10. The system of either one of claims 4 or 9, wherein the second engagement feature comprises a sub-length of the shaft of the puncture device having an increased outer diameter in relation to a majority of the total length of the shaft of the puncture device.

11. The system of claim 5, wherein one of the first engagement feature or the second engagement feature comprises a first magnet.

12. The system of claim 11, wherein the other of the first engagement feature or the second engagement feature comprises a second magnet.

13. The system of claim 11, wherein the other of the first engagement feature or the second engagement feature comprises a magnetic metal.

14. The system of claim 13, wherein the magnetic metal comprises 400 series stainless steel.

15. The system of any one of claims 1-5, wherein the first engagement feature is located at or proximally adjacent to the distal portion of the shaft of the dilator catheter, and wherein the second engagement feature is located at or proximally adjacent to a distal portion of the shaft of the puncture device, proximal to the distal end.

16. The system of claim 3, wherein the first engagement feature is located at a substantially proximally-facing surface within the dilator catheter lumen, and wherein the second engagement feature is carried at a substantially distally -facing surface on the shaft of the puncture device.

17. The system of claim 2, wherein the first engagement feature is at a substantially distal location within the dilator catheter lumen, and wherein the second engagement feature is at a substantially distal location on the shaft of the puncture device.

18. The system of claim 17, wherein the first engagement feature comprises an internal diametric transition in the dilator catheter lumen.

19. The system of claim 18, wherein the dilator catheter lumen comprises a first inner diameter distal to the internal diametric transition and second inner diameter proximalto the internal diametric transition, the second inner diameter larger than the first inner diameter.

20. The system of claim 19, wherein a distal end of the internal diametric transition comprises a third inner diameter that is equal to the first inner diameter.

21. The system of claim 20, wherein a proximal end of the internal diametric transition comprises a fourth inner diameter that is less than the second inner diameter.

22. The system of claim 21, wherein the fourth inner diameter is at least 10% less than the second inner diameter.

23. The system of claim 21, wherein the fourth inner diameter is at least 20% less than the second inner diameter.

24. The system of claim 21, wherein the fourth inner diameter is at least 50% less than the second inner diameter.

25. The system of any one of claims 21-24, further comprising a proximally- facing annular surface extending between the fourth inner diameter and the second inner diameter.

26. The system of claim 25, wherein the first engagement feature comprises the proximally-facing annular surface.

27. The system of claim 26, wherein the first engagement feature comprises the internal diametric transition.

28. The system of claim 25, wherein the first engagement feature comprises the internal diametric transition.

29. The system of any one of claims 18-24, further comprising: a monolithic polymeric member comprising the tapered distal tip and the internal diametric transition.

30. The system of claim 29, wherein the monolithic polymeric member comprises a radiopaque material.

31. The system of claim 29, wherein the monolithic polymeric member comprises a first material having a first bulk flexural modulus and wherein a portion of the shaft of the dilator catheter immediately proximal to the monolithic polymeric member comprises a second material having a second bulk flexural modulus, the second bulk flexural modulus greater than the first bulk flexural modulus.

32. The system of claim 31, wherein the second bulk flexural modulus is at least 20% higher than the first bulk flexural modulus.

33. The system of any one of claims 18-24, wherein the internal diametric transition comprises a frustoconical shape.

34. The system of any one of claims 18-24, wherein the internal diametric transition comprises a non-linear transition in diameter.

35. The system of claim 34, where a surface of the non-linear transition comprises a concavity.

36. The system of claim 34, where a surface of the non-linear transition comprises a convexity.

37. The system of any one of claims 17-36, wherein the second engagement feature comprises a partial spherical surface.

38. The system of any one of claims 17-36, wherein the second engagement feature comprises a tapered transition.

39. The system of any one of claims 17-24, wherein the second engagement feature comprises an external diametric transition and wherein the shaft of the puncture device comprises a first shaft portion extending between the external diametric transition and the distal end, the first shaft portion having a first outer diameter at a location distally adjacent to the external diametric transition.

40. The system of claim 39, wherein the shaft of the puncture device further comprises a second shaft portion extending proximally from the external diametric transition, the second shaft portion having a second outer diameter at a location proximally adjacent to the external diametric transition.

41. The system of claim 40, wherein the external diametric transition comprises a frustoconical shape.

42. The system of claim 40, wherein the external diametric transition comprises a non-linear transition in diameter.

43. The system of claim 42, where a surface of the non-linear transition comprises a concavity.

44. The system of claim 42, where a surface of the non-linear transition comprises a convexity.

45. The system of claim 19, wherein the second engagement feature comprises an external diametric transition and wherein the shaft of the puncture device comprises a first shaft portion extending between the external diametric transition and the distal end, the first shaft portion having a first outer diameter at a location distally adjacent to the external diametric transition, and wherein the shaft of the puncture device further comprises a secondshaft portion extending proximally from the external diametric transition, the second shaft portion having a second outer diameter at a location proximally adjacent to the external diametric transition.

46. The system of claim 45, wherein the distal end of the shaft of the puncture device is configured to cut through vascular tissue.

47. The system of claim 45, wherein the distal end of the shaft of the puncture device is configured to pierce through vascular tissue.

48. The system of any one of claims 45-47, wherein the first shaft portion of the puncture device comprises stainless steel.

49. The system of claim 48, wherein the second shaft portion of the shaft of the puncture device comprises stainless steel.

50. The system of claim 48, wherein the second shaft portion of the shaft of the puncture device comprises a composite tubular structure.

51. The system of claim 50, wherein the composite tubular structure includes a metal and a polymer.

52. The system of claim 50, wherein the composite tubular structure includes coil.

53. The system of claim 50, wherein the composite tubular structure braiding.

54. The system of claim 50, wherein the composite tubular structure includes a laser-machined hypodermic tube.

55. The system of claim 49, wherein the shaft of the puncture device is a monolithic stainless steel structure.

56. The system of claim 49, wherein the external diametric transition comprises a different material than the second shaft portion.

57. The system of claim 56, wherein the external diametric transition comprises a different material than the first shaft portion.

58. The system of claim 45, wherein the second engagement feature is configured to lockingly engage the first engagement feature at the first relative longitudinal position between the dilator catheter and the puncture device.

59. The system of claim 58, wherein the locking engagement is via friction.

60. The system of claim 59, wherein the locking engagement is unlockable via rotation of the shaft of the puncture device.

61. The system of claim 59, wherein the locking engagement is unlockable via the application of tension to the shaft of the puncture device.

62. The system of claim 45, wherein the second engagement feature is configured to non-lockingly engage the first engagement feature at the first relative longitudinal position between the dilator catheter and the puncture device.

63. The system of claim 62, wherein the non-locking engagement comprises a hard stop.

64. The system of any one of claims 1-2, 17-19, 45, and 58-63, wherein when the second engagement feature engages the first engagement feature at the first relative longitudinal position between the dilator catheter and the puncture device, the distal end of the shaft of the puncture device is configured to extend between about 1 mm and about 15 mm out of the dilator catheter lumen.

65. The system of claim 64, wherein when the second engagement feature engages the first engagement feature at the first relative longitudinal position between the dilator catheter and the puncture device, the distal end of the shaft of the puncture device is configured to extend between about 2 mm and about 10 mm out of the dilator catheter lumen.

66. The system of claim 64, wherein when the second engagement feature engages the first engagement feature at the first relative longitudinal position between the dilator catheter and the puncture device, the distal end of the shaft of the puncture device is configured to extend between about 6 mm and about 10 mm out of the dilator catheter lumen.

67. The system of claim 45, further comprising: a hollow elongate longitudinally-compressible protector having a proximal end configured to couple to the first shaft portion of the shaft of the puncture device, and having and unstressed state having a maximum length and a longitudinally-compressed state having a shortened length.

68. The system of claim 67, wherein the protector comprises an open -wound spring having an outer spring diameter and an inner spring diameter in the unstressed state of the protector, wherein the first shaft portion of the shaft of the puncture device is configured to fit within the inner spring diameter.

69. The system of claim 68, wherein the first shaft portion of the shaft of the puncture device is configured to move longitudinally in relation to at least a distal portion of the protector as the spring is compressed as the protector is moved from its unstressed state toward its longitudinally-compressed state.

70. The system of claim 68, wherein the protector has a distal end portion configured to circumferentially surround and protect the distal end of the shaft of the puncture device when the spring is in its unstressed state.

71. The system of claim 70, wherein the distal end portion of the protector comprises a radiopaque marker band.

72. The system of claim 70, wherein the distal end portion of the protector is configured to abut an interior vascular surface, and wherein the distal end portion of the protector is configured to move proximally, exposing the distal end of the shaft of the puncture device as a proximal end of the shaft of the puncture device is placed in compression while at least some of the shaft of the puncture device is within the dilator catheter lumen of the dilator catheter.

73. The system of claim 72, wherein the exposure of the distal end of the shaft of the puncture device with the shaft in compression is configured to cause the distal end of the puncture device to penetrate tissue distal to the interior vascular surface.

74. The system of claim 73, wherein a distance of longitudinal compression of the protector to move from a protected state of the distal end of the puncture device to a state at which tissue is penetrated is between about 4 mm and about 12 mm.

75. The system of claim 72, wherein the distal end portion of the protector is configured to move distally with an increase in length of the protector to cover the distal end of the shaft of the puncture device, when compression is removed from the shaft of the puncture device.

76. The system of claim 19, wherein the shaft of the dilator catheter comprises an outer wall having a first aperture passing therethrough, the first aperture communicating with the dilator catheter lumen.

77. The system of claim 76, wherein the first aperture is located proximal to the distal portion of the shaft of the dilator catheter.

78. The system of claim 77, further comprising: an elongate valving tube configured to be inserted within the dilator catheter lumen, the valving tube comprising an inner lumen extending therethrough and a distal sealing interface.

79. The system of claim 78, wherein the valving tube is configured to be inserted within the dilator catheter lumen, when the puncture device has been fully removed from the dilator catheter lumen.

80. The system of claim 78, wherein the valving tube is configured to be inserted within the dilator catheter lumen, when the puncture device is not within the dilator catheter lumen.

81. The system of claim 80, wherein the distal sealing interface is configured to sealingly couple a distal portion of the dilator catheter lumen extending distally of the first inner diameter to the inner lumen of the valving tube.

82. The system of claim 81, wherein the distal sealing interface is configured to sealingly couple the distal portion of the dilator catheter lumen to the inner lumen of the valving tube at a location fully distal to the first aperture.

83. The system of claim 82, wherein when the distal sealing interface is sealingly coupled to the distal portion of the dilator catheter lumen, a composite inner lumen is formed by the uniting of the inner lumen of the valving tube and the distal portion of the dilator catheter lumen, and the dilator catheter lumen proximal to the first aperture is modified to be arranged at least partially around a portion of the valving tube that extends proximally of the distal sealing interface.

84. The system of claim 83, wherein the dilator catheter lumen proximal to the first aperture is modified to be arranged substantially annularly around the portion of the valving tube that extends proximally of the distal sealing interface.

85. The system of claim 84, wherein the substantially annular arrangement can vary to be non-annular, at curved portions of the shaft of the dilator catheter and / or the valving tube.

86. The system of any one of claims 76-85, wherein the outer wall of the shaft of the dilator catheter comprises a second aperture passing therethrough, the second aperture communicating with the dilator catheter lumen.

87. The system of claim 86, wherein the second aperture is proximal to the first aperture.

88. The system of claim 86, wherein the second aperture is distal to the first aperture.

89. The system of claim 83, wherein the composite inner lumen is configured for irrigation and wherein the dilator catheter lumen proximal to the first aperture is configured for aspiration.

90. The system of claim 89, wherein the valving tube further comprises a first female luer connector at a proximal end thereof and having an interior sealingly coupled to the inner lumen of the valving tube.

91. The system of claim 90, wherein the dilator catheter further comprises a y- connector at a proximal end thereof and configured to seal over an external portion of the valving tube, the y-connector including a sideport having a second female luer connectorhaving an interior sealingly coupled to the dilator catheter lumen proximal to the first aperture.

92. The system of claim 91, wherein the y-connector is configured to seal over the external portion of the valving tube via a hemostasis valve.

93. The system of claim 83, wherein the distal sealing interface is configured to mechanically engage the first engagement feature to sealingly couple the distal portion of the dilator catheter lumen to the inner lumen of the valving tube.

94. The system of claim 93, wherein the distal sealing interface comprises an external distal taper configured to engage and seal at the internal diametric transition.

95. The system of claim 94, wherein the distal sealing interface further comprises a maximum diameter portion configured to seal against the second inner diameter.

96. The system of claim 93, wherein a proximal end of the valving tube is configured to engage a proximal end the dilator catheter to maintain the relative longitudinal positions of the valving tube and the dilator catheter, to thus maintain the distal sealing interface engaged with the first engagement feature.

97. The system of claim 1, wherein the shaft of the puncture device further comprises a distal shaft portion extending proximally from the distal end of the shaft, the distal shaft portion comprising an unstressed curved shape and a substantially straightened stressed shape when placed within the dilator catheter lumen of the dilator catheter.

98. The system of claim 97, wherein the distal shaft portion comprises a shapememory alloy.

99. The system of claim 98, wherein the shape-memory alloy in an Austenite phase when the distal shaft portion is in the unstressed curved shape, and the shape-memory alloy in in a stress-induced Martensite phase when the distal shaft portion is in the stressed shape.

100. The system of any one of claims 97-99, wherein the shaft of the puncture device comprises a nickel -titanium alloy.

101. The system of any one of claims 97-99, wherein the distal end of the shaft of the puncture device comprises a bevel.

102. The system of any one of claims 97-99, wherein the distal end of the shaft of the puncture device comprises a frustoconical shape.

103. The system of any one of claims 97-99, wherein the distal end of the shaft of the puncture device comprises a fillet.

104. The system of any one of claims 97-99, wherein the curved shape has a radius of curvature between 1 mm and 4 mm.

105. The system of claim 104, wherein the curved shape has a radius of curvature of between 1.5 mm and 3.0 mm.

106. The system of any one of claims 97-99, wherein the curved shape has a degree of curvature of between about 160° and about 200° between the distal tip and the distal shaft portion.

107. The system of claim 1, wherein the tapered distal tip of the dilator catheter comprises a pre-formed curve.

108. The system of claim 107, where the pre-formed curve has a degree of curvature of between about 10° and about 60°.

109. The system of either one of claims 19 or 45, wherein the shaft of the puncture device comprises a proximal portion, and wherein the shaft of the dilator catheter comprises a proximal portion, and further comprising: a handle comprising: a base configured to be held by a user; a first carriage configured to be slidable in relation to the base and configured to engage the proximal portion of the shaft of the puncture device; an engager configured to engage the proximal portion of the shaft of the dilator catheter.

110. The system of claim 109, wherein the handle further comprises: a second carriage configured to be slidable in relation to the base carrying the engager.

111. The system of claim 110, further comprising a first spring coupled to the first carriage such that movement of the first carriage in a first direction causes deformation of the first spring causing a first bias in a direction opposite of the first direction.

112. The system of claim 111, further comprising a second spring coupled to the second carriage such that movement of the second carriage in a second direction causes deformation of the second spring causing a second bias opposite of the second direction.

113. The system of claim 112, wherein the second spring comprises a compression spring.

114. The system of any one of claims 111-113 wherein the first spring comprises a compression spring.

115. The system of claim 109, further comprising a first spring coupled to the first carriage such that movement of the first carriage in a first direction causes deformation of the first spring causing first bias in a direction opposite of the first direction.

116. A system for creating an access site from the interior of a blood vessel at or adjacent to the surface of a brain through the wall of the blood vessel and into or onto tissue of the brain, the system comprising: an access catheter comprising an access lumen extending therethrough and comprising a side access port that communicates with the access lumen; a sub-selective device comprising an elongate shaft configured to be placed into the access lumen, the shaft comprising a distal portion configured to be passed out of the side access port; and a blocking device comprising an elongate shaft and a distal blocker, the distal blocker configured to be inserted through the access lumen to a location in the access lumen that is distal to the side access port, wherein the distal blocker is configured to block the passage of the distal portion of the shaft of the sub-selective device to force the distal portion out the side access port.

117. The system of claim 116, wherein the blocker comprises an inflatable balloon.

118. The system of claim 116, wherein the blocker comprises a blocking body that is configured to substantially fill the access lumen at the location that is distal to the side access port.

119. The system of claim 118, wherein the blocking body comprises a wedge.

120. The system of claim 118, wherein the blocking body comprises a proximal taper.

121. The system of claim 118, wherein the blocking body comprises a proximal fillet.

122. The system of claim 118, wherein the blocking body comprises a proximal hemispheric shape.

123. The system of any one of claims 116-122, wherein the access catheter further comprises an expander opposite the side access port, the expander configured to force the side access port against an internal vascular wall.

124. The system of claim 123, wherein the expandable member comprises an inflatable balloon.

125. The system of any one of claims 116-122, wherein the sub-selective device comprises an elongate wire having a piercing tip.

126. The system of any one of claims 116-122, wherein the sub-selective device comprises a dilator catheter having a tapered distal tip and a lumen extending therethrough.

127. The system of any one of claims 116-122, wherein the sub-selective device comprises an aspiration catheter comprising an aspiration lumen.

128. The system of any one of claims 116-122, wherein the sub-selective device comprises an irrigation catheter comprising an irrigation lumen.

129. The system of any one of claims 116-122, wherein the sub-selective device comprises an array of electrodes.

130. A system for creating an access site from the interior of a blood vessel at or adjacent to the surface of a brain through the wall of the blood vessel and into or onto tissue of the brain, the system comprising: a dilator catheter comprising an elongate shaft configured to be placed into an access lumen of an access catheter having a side access port that communicates with the access lumen, the shaft comprising a dilator catheter lumen extending therethrough and a distal portion comprising a tapered distal tip, the distal portion configured to be passed out of the side access port; and a puncture device comprising an elongate shaft including a distal end configured to be extended from the dilator catheter lumen and to penetrate through vascular tissue, wherein the shaft of the dilator catheter comprises an outer wall having a first aperture passing therethrough, the first aperture communicating with the dilator catheter lumen.

131. The system of claim 130, wherein the first aperture is located proximal to the distal portion of the shaft of the dilator catheter.

132. The system of claim 131, further comprising: an elongate valving tube configured to be inserted within the dilator catheter lumen, the valving tube comprising an inner lumen extending therethrough and a distal sealing interface.

133. The system of claim 132, wherein the valving tube is configured to be inserted within the dilator catheter lumen, when the puncture device has been fully removed from the dilator catheter lumen.

134. The system of claim 132, wherein the valving tube is configured to be inserted within the dilator catheter lumen, when the puncture device is not within the dilator catheter lumen.

135. The system of claim 134, wherein the distal sealing interface is configured to sealingly couple a distal portion of the dilator catheter lumen extending distally of the first inner diameter to the inner lumen of the valving tube.

136. The system of claim 135, wherein the distal sealing interface is configured to sealingly couple the distal portion of the dilator catheter lumen to the inner lumen of the valving tube at a location fully distal to the first aperture.

137. The system of claim 136, wherein when the distal sealing interface is sealingly coupled to the distal portion of the dilator catheter lumen, a composite inner lumen is formed by the uniting of the inner lumen of the valving tube and the distal portion of the dilator catheter lumen, and the dilator catheter lumen proximal to the first aperture is modified to be arranged at least partially around a portion of the valving tube that extends proximally of the distal sealing interface.

138. The system of claim 137, wherein the dilator catheter lumen proximal to the first aperture is modified to be arranged substantially annularly around the portion of the valving tube that extends proximally of the distal sealing interface.

139. The system of claim 138, wherein the substantially annular arrangement can vary to be non-annular, at curved portions of the shaft of the dilator catheter and / or the valving tube.

140. The system of any one of claims 130-139, wherein the outer wall of the shaft of the dilator catheter comprises a second aperture passing therethrough, the second aperture communicating with the dilator catheter lumen.

141. The system of claim 140, wherein the second aperture is proximal to the first aperture.

142. The system of claim 140, wherein the second aperture is distal to the first aperture.

143. The system of claim 137, wherein the composite inner lumen is configured for irrigation and wherein the dilator catheter lumen proximal to the first aperture is configured for aspiration.

144. The system of claim 143, wherein the valving tube further comprises a first female luer connector at a proximal end thereof and having an interior sealingly coupled to the inner lumen of the valving tube.

145. The system of claim 144, wherein the dilator catheter further comprises a y- connector at a proximal end thereof and configured to seal over an external portion of the valving tube, the y-connector including a sideport having a second female luer connectorhaving an interior sealingly coupled to the dilator catheter lumen proximal to the first aperture.

146. The system of claim 145, wherein the y-connector is configured to seal over the external portion of the valving tube via a hemostasis valve.

147. A system for creating an access site from the interior of a blood vessel at or adjacent to the surface of a brain through the wall of the blood vessel and into or onto tissue of the brain, the system comprising: a dilator catheter comprising an elongate shaft configured to be placed into an access lumen of an access catheter having a side access port that communicates with the access lumen, the shaft comprising a dilator catheter lumen extending therethrough and a distal portion comprising a tapered distal tip, the distal portion configured to be passed out of the side access port; and a puncture device comprising an elongate shaft including a distal end configured to be extended from the dilator catheter lumen and to penetrate through vascular tissue, and comprising a hollow elongate longitudinally-compressible protector having a proximal end configured to couple to the first shaft portion of the shaft of the puncture device, and having and unstressed state having a maximum length and a longitudinally -compressed state having a shortened length.

148. The system of claim 147, wherein the protector comprises an open-wound spring having an outer spring diameter and an inner spring diameter in the unstressed state of the protector, wherein the first shaft portion of the shaft of the puncture device is configured to fit within the inner spring diameter.

149. The system of claim 148, wherein the first shaft portion of the shaft of the puncture device is configured to move longitudinally in relation to at least a distal portion of the protector as the spring is compressed as the protector is moved from its unstressed state toward its longitudinally-compressed state.

150. The system of claim 148, wherein the protector has a distal end portion configured to circumferentially surround and protect the distal end of the shaft of the puncture device when the spring is in its unstressed state.

151. The system of claim 150, wherein the distal end portion of the protector comprises a radiopaque marker band.

152. The system of claim 150, wherein the distal end portion of the protector is configured to abut an interior vascular surface, and wherein the distal end portion of the protector is configured to move proximally, exposing the distal end of the shaft of thepuncture device as a proximal end of the shaft of the puncture device is placed in compression while at least some of the shaft of the puncture device is within the dilator catheter lumen of the dilator catheter.

153. The system of claim 152, wherein the exposure of the distal end of the shaft of the puncture device with the shaft in compression is configured to cause the distal end of the puncture device to penetrate tissue distal to the interior vascular surface.

154. The system of claim 153, wherein a distance of longitudinal compression of the protector to move from a protected state of the distal end of the puncture device to a state at which tissue is penetrated is between about 4 mm and about 12 mm.

155. The system of claim 152, wherein the distal end portion of the protector is configured to move distally with an increase in length of the protector to cover the distal end of the shaft of the puncture device, when compression is removed from the shaft of the puncture device.

156. A method for removing tissue or fluid from the brain area of a patient, comprising: providing a guide / access catheter comprising: an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the distal end comprising an atraumatic tip; and a side exit port located on a side of the catheter and communicating with the lumen; providing a drainage, aspiration, and / or irrigation catheter comprising a proximal end, a distal end, and a transport lumen extending between the proximal end and the distal end, wherein a distal portion of the aspiration or drainage, aspiration and / or irrigation catheter is configured to be placed through at least a portion of the lumen of the of the guide / access catheter and out through the side exit port of the guide / access catheter; endovascularly inserting the distal end of the guide / access catheter into a dural venous sinus or cerebral vein of a subject such that the side exit port is adjacent a wall of the dural venous sinus or cerebral vein; advancing the distal portion of the drainage, aspiration and / or irrigation catheter through the portion of the lumen of the guide / access catheter and out the side exit port such that the distal portion of the drainage, aspiration, and / or irrigation catheter is oriented at an angle between 30° and 90° to the endoluminal surface of the vessel wall;advancing the distal portion of the drainage, aspiration and / or irrigation catheter through a puncture in the wall of the dural venous sinus or cerebral vein to an extravascular space beneath a portion of the dura mater of the subject; and actively causing tissue or fluid that is located under or on the dura mater of the subject and on or in brain tissue of the patient to flow through the transport lumen of the drainage, aspiration and / or irrigation catheter from the distal end to the proximal end.

157. The method of claim 156, further comprising: puncturing the wall of a dural venous sinus or a cerebral vein.

158. The method of either one of claims 156 or 157, further comprising: puncturing the portion of the dura mater.

159. The method of claim 158, wherein puncturing the portion of the dura mater comprises puncturing the dura mater with an elongate puncture element.

160. The method of claim 157, wherein puncturing the wall of the dural venous sinus or cerebral vein comprises puncturing the wall of the dural venous sinus or cerebral vein with an elongate puncture element.

161. The method of either one of claims 159 or 160, wherein the elongate puncture element is delivered through a portion of the lumen of the of the guide / access catheter that is proximal to an inclined barrier, the inclined barrier adjacent to the side exit port.

162. The method of any one of claims 156-161, wherein the portion of the dura mater of the subject is adjacent the wall of the dural venous sinus or cerebral vein.

163. The method of claim 131, wherein the tubular body further comprises: an aperture passing through the inclined barrier, the aperture having a first aperture diameter.

164. The method of claim 163, wherein the side port has a transverse dimension at a longitudinally central portion of the side exit port, wherein the aperture diameter is less than the transverse dimension.

165. The method of any one of claims 156-164, wherein the fluid comprises a biological fluid.

166. The method of any one of claims 156-165, wherein the fluid carries thrombus.

167. The method of any one of claims 156-164, wherein the fluid comprises a thrombolytic.

168. The method of any one of claims 156-164, wherein the fluid comprises antiinflammatory media.

169. The method of any one of claims 156-164, wherein the fluid comprises, an antibiotic.

170. The method of any one of claims 156-164, wherein the fluid comprises commercial saline solution.

171. The method of any one of claims 156-164, wherein the fluid comprises Ringer’s lactate solution.

172. The method of any one of claims 156-164, wherein the fluid carries biopsied tissue.

173. The method of any one of claims 156-164, wherein the fluid comprises an neuroregenerative drug.

174. The method of any one of claims 156-164, wherein the fluid carries a biologic compound.

175. The method of any one of claims 156-164, wherein the fluid comprises an anti-seizure drug.

176. The method of any one of claims 156-164, wherein the fluid comprises one or both of a chemotherapeutic drug and / or an immunomodulatory drug.

177. The method of any one of claims 165-176, wherein the fluid is caused to enter the subject prior to the actively causing step.

178. The method of claim 176, wherein the fluid is caused to enter the subject by causing the fluid to flow through the transport lumen of the drainage, aspiration, and / or irrigation catheter from the proximal end to the distal end and into the subject prior to the actively causing step.

179. The method of any one of claims 156-164, wherein the fluid comprises previously injected water that when injected did not include significant amounts of sodium chloride.

180. The method of any one of claims 156-179, wherein the actively causing step comprises providing a negative pressure on a proximal portion of the lumen of the drainage catheter.

181. The method of claim 180, wherein the negative pressure is provided by at least partially evacuating a syringe that is hydraulically coupled to the lumen of the drainage catheter.

182. The method of claim 180, wherein the negative pressure is provided by operating a vacuum pump that is hydraulically coupled to the lumen of the drainage catheter183. The method of either one of claims 161 or 163, wherein the inclined barrier is formed within the lumen at a distal portion of the tubular body either by a luminal molding or by a co-axial member having a distal diameter greater than its proximal shaft.

184. A method for delivering tissue or fluid to the brain area of a patient, comprising: providing a guide / access catheter comprising: an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the distal end comprising an atraumatic tip; and a side exit port located on a side of the catheter and communicating with the lumen; providing a drainage, aspiration, and / or irrigation catheter comprising a proximal end, a distal end, and a transport lumen extending between the proximal end and the distal end, wherein a distal portion of the aspiration or drainage, aspiration and / or irrigation catheter is configured to be placed through at least a portion of the lumen of the of the guide / access catheter and out through the side exit port of the guide / access catheter; endovascularly inserting the distal end of the guide / access catheter into a dural venous sinus or cerebral vein of a subject such that the side exit port is adjacent a wall of the dural venous sinus or cerebral vein; advancing the distal portion of the drainage, aspiration and / or irrigation catheter through the portion of the lumen of the guide / access catheter and out the side exit port such that the distal portion of the drainage, aspiration, and / or irrigation catheter is oriented at an angle between 30° and 90° to the endoluminal surface of the vessel wall; advancing the distal portion of the drainage, aspiration and / or irrigation catheter through a puncture in the wall of the dural venous sinus or cerebral vein to an extravascular space beneath a portion of the dura mater of the subject; and actively causing tissue or fluid to be delivered onto or into the dura mater of the subject and onto or into brain tissue of the patient by flowing through the transport lumen of the drainage, aspiration and / or irrigation catheter from the proximal end to the distal end.

185. The method of claim 184, further comprising: puncturing the wall of a dural venous sinus or a cerebral vein.

186. The method of either one of claims 184 or 185, further comprising: puncturing the portion of the dura mater.

187. The method of claim 186, wherein puncturing the portion of the dura mater comprises puncturing the dura mater with an elongate puncture element.

188. The method of claim 185, wherein puncturing the wall of the dural venous sinus or cerebral vein comprises puncturing the wall of the dural venous sinus or cerebral vein with an elongate puncture element.

189. The method of either one of claims 187 or 188, wherein the elongate puncture element is delivered through a portion of the lumen of the of the guide / access catheter that is proximal to an inclined barrier, the inclined barrier adjacent to the side exit port.

190. The method of any one of claims 184-89, wherein the portion of the dura mater of the subject is adjacent the wall of the dural venous sinus or cerebral vein.

191. The method of claim 189, wherein the tubular body further comprises: an aperture passing through the inclined barrier, the aperture having a first aperture diameter.

192. The method of claim 191, wherein the side port has a transverse dimension at a longitudinally central portion of the side exit port, wherein the aperture diameter is less than the transverse dimension.

193. The method of any one of claims 184-192, wherein the fluid comprises a biological fluid.

194. The method of any one of claims 184-193, wherein the fluid carries thrombus.

195. The method of any one of claims 184-192, wherein the fluid comprises a thrombolytic.

196. The method of any one of claims 184-192, wherein the fluid comprises antiinflammatory media.

197. The method of any one of claims 184-192, wherein the fluid comprises, an antibiotic.

198. The method of any one of claims 184-192, wherein the fluid comprises commercial saline solution.

199. The method of any one of claims 184-192, wherein the fluid comprises Ringer’s lactate solution.

200. The method of any one of claims 184-192, wherein the fluid comprises an neuroregenerative drug.

201. The method of any one of claims 184-192, wherein the fluid carries a biologic compound.

202. The method of any one of claims 184-192, wherein the fluid comprises an anti-seizure drug.

203. The method of any one of claims 184-192, wherein the fluid comprises one or both of a chemotherapeutic drug and / or an immunomodulatory drug.

204. The method of any one of claims 184-203, wherein at least some of the fluid is removed from the subject after the actively causing step.

205. The method of claim 204, wherein the at least some of the fluid is removed from the subject by causing the fluid to flow through the transport lumen of the drainage, aspiration, and / or irrigation catheter from the distal end to the proximal end and out of the subject.

206. The method of any one of claims 184-205, wherein the actively causing step comprises providing a positive pressure on a proximal portion of the lumen of the drainage catheter.

207. The method of claim 206, wherein the positive pressure is provided by at least a syringe.

208. The method of claim 206, wherein the positive pressure is provided by operating a pump that is hydraulically coupled to the lumen of the drainage catheter209. The method of either one of claims 189 or 191, wherein the inclined barrier is formed within the lumen at a distal portion of the tubular body either by a luminal molding or by a co-axial member having a distal diameter greater than its proximal shaft.

210. A system for providing transvascular access to an extravascular site, comprising: an access catheter for supporting transvascular access, the access catheter comprising: an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end; and a side exit port in the tubular body, in communication with the lumen; and a diversion catheter configured for placement within the lumen of the access catheter, the diversion catheter comprising a proximal shaft having a first diameter and a distal section having a second diameter, greater than the first diameter, wherein the second diameter is configured to significantly block the lumen of the access catheter distal to the side exit port.

211. The system of claim 210, wherein the diversion catheter further comprises a frustoconical portion at the proximal end of the distal section, wherein the diversion catheter is configured to be placed within the lumen of the access catheter such that the frustoconical portion is distally adjacent to the side exit port and configured to divert an elongate devicehaving a diameter that is smaller than a minimum dimension of the side exit port out the side exit port as the elongate device is advanced distally down the lumen of the access catheter.

212. The system of claim 210, wherein the diversion catheter further comprises a concavity at the proximal end of the distal section, wherein the diversion catheter is configured to be placed within the lumen of the access catheter such that the concavity is distally adjacent to the side exit port and configured to divert an elongate device having a diameter that is smaller than a minimum dimension of the side exit port out the side exit port as the elongate device is advanced distally down the lumen of the access catheter.

213. The system of claim 212, wherein the concavity comprises a 360° rotated radius.

214. The system of any one of claims 210-212, wherein the distal section of the diversion catheter is expandable and wherein the second diameter is an expanded diameter of the distal section.

215. The system of claim 214, wherein the distal section of the diversion catheter is expandable by a user.

216. The system of either one of claims 214 or 215, wherein the distal section of the diversion catheter is inflatable.

217. The system of claim 216, wherein the distal section of the diversion catheter is an inflatable balloon.

218. The system of any one of claims 210-217, wherein the first diameter is between 0.1 mm and 1.0 mm, and where the second diameter is between 1.1 times and 3 times the first diameter.

219. The system of any one of claims 210-218, wherein the second diameter substantially fills a cross-section of the lumen of the access catheter.

220. The system of either one of claims 212 or 213, wherein the second diameter substantially fills a cross-section of the lumen of the access catheter, and wherein the substantial filling reduces any ledge effect that would cause a distal portion of the elongate device to get caught.

221. A catheter comprising: an elongate shaft; a first lumen extending between a proximal end and a distal end of the elongate shaft and configured for aspirating fluid; a second lumen extending between a proximal portion of the elongate shaft and a distal portion of the elongate shaft;a plurality of apertures in an external wall of the elongate shaft, each of the plurality of apertures communicating with the second lumen; a first port at the proximal portion of the elongate shaft and hydraulically coupled to the first lumen; and a second port at the proximal portion of the elongate shaft and hydraulically coupled to the second lumen.

222. The catheter of claim 221, wherein the second lumen is extruded within the wall of the elongate shaft.

223. The catheter of claim 222, wherein the second lumen is bonded to the wall of the elongate shaft.

224. A catheter comprising: an elongate shaft; a first lumen extending between a proximal end and a distal end of the elongate shaft and configured for aspirating fluid; two or more infusion lumens extending between a proximal portion of the elongate shaft and a distal portion of the elongate shaft; a plurality of apertures in an external wall of the elongate shaft, a first of the plurality of apertures communicating with a first of the two or more infusion lumens and a second of the plurality of apertures communicating with a second of the two or more infusion lumens; a first port at the proximal portion of the elongate shaft and hydraulically coupled to the first lumen; and a second port at the proximal portion of the elongate shaft and hydraulically coupled to the at least the first of the two or more infusion lumens.

225. The catheter of claim 224, wherein the second port is hydraulically coupled to the second of the second of the two or more infusion lumens.

226. The catheter of any one of claims 224-225, wherein the first lumen is further configured for infusing fluid.

227. The catheter of any one of claims 224-226, wherein the second lumen is configured for infusing fluid.

228. The catheter of claim 227, wherein the second lumen is further configured for aspirating fluid.

229. The catheter of either one of claims 224 or 225, wherein the first of the two or more infusion lumens is further configured for aspirating fluid.

230. A system comprising:an elongate device configured to be inserted through a lumen of an access catheter and to pass out of a side exit port of the access catheter communicating with the lumen, comprising: a first electrode located at a distal portion of the elongate device; and a second electrode located on the elongate device proximal to the first electrode; circuitry configured to generate a current through the first and second electrodes; and a processor configured to measure real-time voltage from the current through the first and second electrodes and to identify a sudden change in voltage caused by a change of impedance as at least one of the electrodes is moved with the elongate device from an intravascular space to an extravascular space.

231. The system of claim 230, wherein the processor is configured to identify a sudden change in voltage caused by a change of impedance as at least one of the electrodes is moved with the elongate device from an intravascular space to an extravascular, subdural space in the brain.

232. The system of claim 231, wherein the processor is configured to identify a sudden change in voltage caused by a change of impedance as at least one of the electrodes is moved with the elongate device from an intravenous space to an extravascular, subdural space in the brain.

233. The system of claim 232, wherein the intravenous space comprises a location within the superior sagittal sinus.

234. The system of claim 230, wherein the processor is configured to identify a sudden change in voltage caused by a change of impedance as at least one of the electrodes is moved with the elongate device from contact with vascular wall tissue to an extravascular space.

235. The system of claim 234, wherein the processor is configured to identify a sudden change in voltage caused by a change of impedance as at least one of the electrodes is moved with the elongate device from contact with vascular wall tissue to an extravascular, subdural space in the brain.

236. The system of any one of claims 230-235, wherein the device comprises a dilator.

237. The system of any one of claims 230-235, wherein the device comprises a guidewire.

238. The system of any one of claims 230-235, wherein the device comprises a guidewire having a sharp, puncturing distal end.

239. The system of any one of claims 230-235, wherein the device comprises a procedure catheter.

240. The system of claim 239, wherein the procedure catheter is configured to aspirate fluid.

241. The system of claim 239, wherein the procedure catheter is configured to inject fluid.

242. The system of claim 239, wherein the procedure catheter is configured to measure signals from nerves.

243. The system of claim 239, wherein the procedure catheter is configured to delivery energy to brain tissue of a patient.

244. The system of claim 243, wherein the energy comprises thermal energy.

245. A method for using the system of any one of claims 230-244, comprising: running one or more calibration cycles to detect specific thresholds corresponding to the transition between blood and subdural space.

246. The method of claim 245, further comprising: providing real-time feedback to an operator during a procedure to identify the transition between blood and subdural space.

247. The method of any one of claims 245-246, further comprising: further utilizing one or more of: fluoroscopy, magnetic imaging, and / or ultrasound imaging to further enhance precision.

248. The system of any one of claims 230-244, further comprising: a monitor coupled to the processor and configured to display catheter position and adjustment during a procedure to ensure safe and accurate access to subdural space.

249. A system comprising: an elongate device configured to be inserted through a lumen of an access catheter and to pass out of a side exit port of the access catheter communicating with the lumen, comprising: at least one sensor comprising a coil comprising a conductive material located at a distal portion of the elongate device, the sensor configured to generate, in response to an externally generated magnetic field, an electrical signal representative of the position and orientation of the distal portion of the elongate device; a field generator configured to a low-intensity, varying electromagnetic field; anda processor configured to track position and orientation of the elongate device from an electrical signal output by the sensor in response to the varying electromagnetic field.

250. The system of claim 249, wherein the at least one sensor comprises two sensors.

251. The system of claim 249, wherein the at least one sensor comprises three sensors.

252. The system of any one of claims 249-251, further comprising an amplifier for amplifying the electrical signal.

253. The system of claim 252, further comprising a digitizer configured to digitize the signal.

254. The system of any one of claims 249-253, further comprising a host application interface configured to provide a patient image set and configured to visualizing real-time device location and orientation with respect to the patient image set.

255. The system of claim 254, wherein the patient image set comprises a preoperative patient image set.

256. The system of claim 254, wherein the patient image set comprises an intraoperative patient image set.

257. The system of claim 254, wherein the processor is configured to target specifically identified treatment areas.

258. The system of any one of claims 249-257, wherein the device comprises a dilator.

259. The system of any one of claims 249-257, wherein the device comprises a guidewire.

260. The system of any one of claims 249-257, wherein the device comprises a guidewire having a sharp, puncturing distal end.

261. The system of any one of claims 249-257, wherein the device comprises a procedure catheter.

262. The system of claim 261, wherein the procedure catheter is configured to aspirate fluid.

263. The system of claim 261, wherein the procedure catheter is configured to inject fluid.

264. The system of claim 261, wherein the procedure catheter is configured to measure signals from nerves.

265. The system of claim 261, wherein the procedure catheter is configured to delivery energy to brain tissue of a patient.

266. The system of claim 265, wherein the energy comprises thermal energy.

267. A puncture guidewire comprising: an elongate shaft; a puncturing distal tip; and a curve having a degree of curvature of between about 160° and about 200° between the puncturing distal tip and the shaft.

268. The guidewire of claim 267, wherein the degree of curvature is between about 170° and about 190°.

269. The guidewire of claim 267, wherein the degree of curvature is between about 175° and about 185°.

270. The guidewire of any one of claims 267-269, wherein the curve comprises an outer coil and an inner core wire, the core wire having an unstressed configuration having a core wire degree of curvature substantially the same as the degree of curvature.

271. The guidewire of claim 270, wherein the inner core wire comprises a nickeltitanium alloy.

272. The guidewire of any one of claims 267-271, wherein the puncturing distal tip comprises a bevel.

273. The guidewire of any one of claims 267-271, wherein the puncturing distal tip comprises a frustoconical tip.

274. The guidewire of any one of claims 267-271, wherein the puncturing distal tip comprises a fillet having a short wire extending distally therefrom, the short wire having a diameter at 25% or less of a diameter of the shaft of the guidewire.

275. A system for providing transvascular access to an extravascular site, comprising: an access catheter for supporting transvascular access, the access catheter comprising: an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end; and a side exit port in the tubular body, in communication with the lumen; and a dilator configured for placement within the lumen of the access catheter and through the side exit port, the dilator having a thru lumen and a frustoconical tip, the frustoconical tip having a curve.

276. The system of claim 275, wherein the degree of curvature of the curve is between about 10° and about 60°, or between about 30° and about 60°.

277. A system for providing transvascular access to an extravascular site, comprising: an access catheter for supporting transvascular access, the access catheter comprising: an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end; and a side exit port in the tubular body, in communication with the lumen; a dilator configured for placement within the lumen of the access catheter and through the side exit port, the dilator having a thru lumen and a frustoconical tip; and a puncturing guidewire having a puncturing tip and configured to be insertable through the thru lumen of the dilator, a distal end of the puncturing guidewire having a curve.

278. The system of claim 277, wherein the degree of curvature of the curve is between about 170° and about 190°, or between about 178° and about 185°.

279. A system for providing transvascular access to an extravascular site, comprising: an access catheter for supporting transvascular access, the access catheter comprising: an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end; and a side exit port in the tubular body, in communication with the lumen; and a dilator configured for placement within the lumen of the access catheter and through the side exit port, the dilator having a thru lumen and a frustoconical distal portion tapering down to a distal-most outer diameter that is between 101% and 110% of a distal-most inner diameter of the thru lumen.

280. A system for providing transvascular access to an extravascular site, comprising: an access catheter for supporting transvascular access, the access catheter comprising: an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end; and a side exit port in the tubular body, in communication with the lumen; and a dilator configured for placement within the lumen of the access catheter and through the side exit port, the dilator having a thru lumen and comprising a first frustoconical distal portion having a first taper angle and a second frustoconical portion proximally adjacent thefirst frustoconical portion and having a second taper angle, the first taper angle greater than the second taper angle.

281. The system of claim 280, wherein the first taper angle is an included angle of between about 40° and 75° and wherein the second taper angle is an included angle of between about 10° and about 50°.

282. A system for providing transvascular access to an extravascular site, comprising: an access catheter for supporting transvascular access, the access catheter comprising: an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end; and a side exit port in the tubular body, in communication with the lumen; and a dilator configured for placement within the lumen of the access catheter and through the side exit port, the dilator having a thru lumen and comprising a first filleted distal portion having a radius of curvature and a second frustoconical portion proximally adjacent the first filleted distal portion and having an included taper angle.

283. The system of claim 282, wherein the radius of curvature is between about 0.0127 mm and 0.127 mm and the included taper angle is between about 10° and 50°.

284. A balloon for an access catheter having a side exit port, the balloon comprising: a main inflatable body having a first longitudinal axis; a non-inflatable, hollow, tubular interface portion integral with the main inflatable body and having a second longitudinal axis, wherein the second longitudinal is not colinear with the first longitudinal axis; and an elongate opening between the main inflatable body and the tubular interface portion.

285. The balloon of claim 284, wherein the tubular interface portion comprises a distal tubular extension having a wall extending circumferentially 360° and extending distally of the opening.

286. The balloon of either one of claims 284-285, wherein the tubular interface portion comprises a proximal tubular extension having a wall extending circumferentially 360° and extending proximally of the opening.

287. The balloon of any one of claims 284-286, wherein the tubular interface portion comprises a sidehole on a side substantially opposite the opening.

288. The balloon of claim 287, wherein the sidehole is configured to match a sidehole in a catheter shaft over which the tubular interface portion is placed.

289. The balloon of claim 288, wherein a ring-shaped area of the tubular interface portion, surrounding the hole, is configured to be fused to the catheter shaft.

290. A method for moving tissue or fluid to or from the brain area of a patient, comprising: providing a guide / access catheter comprising: an elongate tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the distal end comprising an atraumatic tip; and a side exit port located on a side of the catheter and communicating with the lumen; providing a drainage, aspiration, and / or irrigation catheter comprising a proximal end, a distal end, and a transport lumen extending between the proximal end and the distal end, wherein a distal portion of the aspiration or drainage, aspiration and / or irrigation catheter is configured to be placed through at least a portion of the lumen of the of the guide / access catheter and out through the side exit port of the guide / access catheter; endovascularly inserting the distal end of the guide / access catheter into a dural venous sinus or cerebral vein of a subject such that the side exit port is adjacent a wall of the dural venous sinus or cerebral vein; advancing the distal portion of the drainage, aspiration and / or irrigation catheter through the portion of the lumen of the guide / access catheter and out the side exit port such that the distal portion of the drainage, aspiration, and / or irrigation catheter is oriented at an angle between 30° and 90° to the endoluminal surface of the vessel wall; advancing the distal portion of the drainage, aspiration and / or irrigation catheter through a puncture in the wall of the dural venous sinus or cerebral vein to an extravascular space beneath a portion of the dura mater of the subject; and actively causing tissue or fluid to or from the extravascular space.

291. The method of claim 290, further comprising: measuring a pressure within the transport lumen or within the extravascular space.

292. The method of claim 291, wherein measuring the pressure comprises measuring the pressure with a pressure sensor carried by a guidewire.

293. The method of claim 292, wherein the pressure sensor comprises an optical fiber.

294. The method of either one of claims 292-293, wherein the guidewire extends within the transport lumen.

295. The method of claim 291, wherein measuring the pressure comprises measuring the pressure with a pressure sensor carried by the drainage, aspiration, and / or irrigation catheter.

296. The method of claim 295, wherein the pressure sensor is carried at least partially within the transport lumen.

297. The method of either one of claims 295-296, wherein the pressure sensor comprises an optical fiber.

298. The method of claim 290, further comprising: obtaining an image within the transport lumen or within the extravascular space.

299. The method of claim 298, wherein obtaining the image comprises obtaining the image with an optical fiber carried by a guidewire.

300. The method of claim 298, wherein obtaining the image comprises obtaining the image with a piezoelectric transducer carried by the guidewire.

301. The method of either one of claims 299-300, wherein the guidewire extends within the transport lumen.

302. The method of claim 300, wherein obtaining the image comprises obtaining the image with an optical fiber carried by the drainage, aspiration, and / or irrigation catheter.

303. The method of claim 302, wherein the optical fiber is carried at least partially within the transport lumen.

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