Robot drive system and method of use for facilitating treatment of the neurovascular system

Abstract

A robotic treatment system for treating a patient's neurovascular system, comprising: a guide sheath; a catheter system having a support catheter and a navigation catheter; and a robotic drive system configured to drive the catheter system within the patient's blood vessel. The robotic drive system includes a cassette having at least a first set of rollers and at least a second set of rollers, and a controller operably coupled to the cassette. The first set of rollers is configured to engage a proximal control element of the support catheter, and the second set of rollers is configured to engage a proximal extension of the navigation catheter. The controller is configured to control the first set of rollers and the second set of rollers to determine the magnitude of the linear translation of the support catheter and the magnitude of the linear translation of the navigation catheter. Related devices, systems, and methods are provided.

Description

Cross - Reference to Related Applications

[0001] This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 346,733, filed May 27, 2022. The disclosure of which is hereby incorporated by reference in its entirety.

Technical Field

[0002] The present disclosure generally relates to the field of catheter treatment systems, and more particularly to a robotic system and method for the automated movement of an elongate medical device configured to advance within the neurovascular system for the treatment of intracranial lesions such as occlusions in acute ischemic stroke, ICAD, aneurysms, and other intracranial lesions.

Background Art

[0003] Interventions are performed via catheter - based systems to treat various vascular diseases, including neurovascular interventions. Vascular stenosis or intracranial atherosclerotic disease (ICAD) can be treated by endovascular implantation of a scaffold device, such as a stent, often in combination with balloon angioplasty, to increase the inner diameter or cross - sectional area of the vascular lumen. Other vascular defects include aneurysms where a bulge or bubble projects radially from the blood vessel and, if left untreated, can continue to expand until rupture, which can cause bleeding from the blood vessel. Additionally, acute ischemic stroke (AIS) or occlusion of intracranial blood vessels leading to a sudden interruption of proper blood flow to a part of the brain can be treated endovascularly, such as by aspiration thrombectomy to assist in removing blood clots and / or delivery of a large - bore catheter for delivery of a retrievable stent device.

[0004] Treatment of cerebral blood vessels is particularly difficult, partly due to the tortuosity of the vascular system and the small size of the blood vessels. Furthermore, the risk of stroke and thromboembolic complications is high due to the release of thrombotic substances during delivery and treatment. The internal carotid artery (ICA) originates from the bifurcation of the common carotid artery at the level of the intervertebral disc between the C3 and C4 vertebrae. The course of the ICA is divided into four parts: the neck, the vertebral body, the cavernous body, and the brain. In the anterior circulation, the consistently tortuous terminal carotid artery is fixed in its position by bony elements. The cervical carotid artery enters the vertebral body and is locked into a set of turns when it is surrounded by bone. The cavernous carotid artery is an artery that passes through the venous bed and the cavernous sinus, is soft, but is locked when it exits the cavernous sinus by another bony element that surrounds and fixes the entrance to the cranial cavity. Due to these bony fixation points, the vertebral carotid artery and beyond have relatively consistent tortuosity. The carotid siphon S (see Figure 1B) is the S-shaped part of the terminal ICA. The carotid siphon S begins at the posterior bend of the cavernous ICA and ends at the ICA bifurcation to the anterior cerebral artery and the middle cerebral artery. The ophthalmic artery originates from the cerebral ICA, which represents a common point of catheter hang-up when accessing the anterior circulation. These points of catheter hang-up can significantly increase the amount of time required to access the blood vessels of the brain. When the procedure involves readjusting blood perfusion to the brain, the additional time and difficulty of catheter system navigation are obvious drawbacks with serious consequences.

[0005] With a robotic control system, a clinician can deliver various surgical instruments to locations within a patient's body. There is a need for a robotic control system for the delivery of a neurointerventional catheter system to assist in the guidance of a catheter system to distal sites within the brain, particularly a system for the delivery of a catheter designed to guide through the difficult anatomical structures of the brain while improving the delivery of suction force to distal sites. SUMMARY OF THE INVENTION

[0006] In one aspect, a robotic treatment system for treating a patient's neurovascular system is provided. The system includes a guide sheath having a sheath body with at least one lumen extending between a proximal end region and a distal end region defining a distal opening from the at least one lumen, and a hub coupled to the proximal end region of the sheath body. The system includes a catheter system, the catheter system including a support catheter having a distal lumen portion sized to be disposed within at least one lumen of the guide sheath, the distal lumen portion being coupled at the proximal end region to a proximal control element adjacent to a proximal opening from a single lumen of the distal lumen portion, a guide wire lumen, and a navigation catheter having a distal tip region that tapers from an outer diameter sized to fill the single lumen of the support catheter to an opening from the guide wire lumen at the most distal end, and a proximal extension. The system includes a robotic drive system configured to drive the catheter system within a patient's blood vessel. The robotic drive system includes a cassette having at least a first set of rollers and at least a second set of rollers. The first set of rollers is configured to engage a proximal control element of the support catheter, and the second set of rollers is configured to engage a proximal extension of the navigation catheter. The second set of rollers is disposed proximal to the first set of rollers. The system includes a controller operably coupled to the cassette. The controller is configured to control the first set of rollers and the second set of rollers to determine a magnitude of linear translation of the support catheter and a magnitude of linear translation of the navigation catheter.

[0007] The system can further include a guide wire and a third set of rollers disposed proximally to a second set of rollers configured to engage the guide wire. The spacing of the third set of rollers can be designed to allow for the full range of movement of the navigation catheter through the second set of rollers. The proximal control element of the support catheter can be a ribbon, a hypotube, or a solid round wire. The proximal extension of the navigation catheter can be a polymer-coated rigid component. At least one of the first and second sets of rollers can be configured to accommodate different outer diameters. The rollers of the first set of rollers can be spaced closer to each other than the rollers of the second set of rollers. The first set of rollers can be proximal to and offset from the axis of the guide sheath working lumen.

[0008] The system can further include a suction system operably coupled to the controller. The suction system can be configured to apply static or periodic suction. Periodic suction can be applied using a spring-actuated pressure release valve or a solenoid valve. The suction system can be actuated manually or by software operating on the controller. The guide sheath can be coupled to the robotic drive system by fixing the hub to the cassette via at least one connector and / or cavity within the cassette. At least one connector can be configured to rotate the guide sheath about the longitudinal axis of the sheath body. At least one of the first set of rollers and the second set of rollers can be configured to change the magnitude, angle, or both of the linear translation. The first set of rollers and the second set of rollers can be configured to be driven together. The first set of rollers and the second set of rollers can be driven together by a mechanical linkage mechanism.

[0009] The system can include one or more markers on a support catheter and / or one or more markers on a navigation catheter. The controller can be programmed to detect one or more markers on the support catheter and one or more markers on the navigation catheter to evaluate the extension of the support catheter relative to the navigation catheter. The controller can be programmed to detect one or more markers on the support catheter and one or more markers on the navigation catheter to evaluate the total forward distance. The system can include one or more flow sensors and one or more pressure transducers. The system can further include a vibration input configured to cause the support catheter to follow one or more retraction and one or more forward patterns. The vibration input can be programmable by a user. The vibration input can initiate a pattern of a short retraction of the support catheter that withdraws the distal opening of the distal lumen portion from a first position relative to an occlusion to a second position relative to the occlusion, and a forward movement of the support catheter that advances the distal opening from the second position toward the first position. The pattern can be initiated after a period of static suction through the support catheter.

[0010] In related aspects, a method for performing robotic surgery on a patient within the neurovascular system is provided. The method includes coupling a catheter system to a robotic drive system, the robotic drive system being operably coupled to a controller operable by an operator input, the robotic drive system having a plurality of rollers movable in response to the operator input. The catheter system includes a support catheter having a distal lumen portion with a distal opening and a proximal opening, a single lumen extending between the proximal opening and the distal opening, and a proximal control element without a lumen coupled to the distal lumen portion near the proximal opening, and a navigation catheter having a guidewire lumen, an outer diameter sized to fill the single lumen of the support catheter, a distal tip region, and a proximal extension. The navigation catheter is axially disposed through the single lumen of the support catheter such that the distal tip region of the navigation catheter is extendable from the distal opening of the distal lumen portion of the support catheter. The support catheter having the navigation catheter disposed within the single lumen is navigable to the distal blood vessels of the pyramidal portion of the internal carotid artery. The method includes coupling the proximal control element of the support catheter to a first set of the plurality of rollers, coupling the proximal extension of the navigation catheter to a second set of the plurality of rollers, the second set of rollers being positioned proximal to the first set of rollers, and moving the first and second sets of navigation rollers in at least one degree of freedom in response to the operator input.

[0011] In related aspects, a robotic control treatment system for removing blood clots from a patient is provided. The system includes a guide sheath having at least one working lumen and a catheter system including a catheter having a distal lumen portion sized to be disposed within the working lumen, the distal lumen portion being coupled at a proximal end region to a proximal control element adjacent to a proximal opening from a single lumen of the distal lumen portion. The guide sheath is operably coupled to a suction system for performing a suction function on the blood clot via adjacent lumens formed from the working lumen of the guide sheath and the single lumen of the catheter. The system includes an instrument drive system for driving the catheter system. The instrument drive system includes a first instrument drive for driving the catheter and a second instrument drive for driving an intervention device. The system includes a remote control station for controlling the instrument drive system and the suction system.

[0012] In related aspects, a robotic catheter system is provided, the system including a controller including a master input device configured to be operated by a physician at a location remote from the patient, and a device drive in communication with the controller, the device drive including a housing having a catheter interface movable relative to the housing, the catheter interface including a plurality of catheter drive elements coupled to respective motors disposed within the housing, the motors responsive to control signals generated by at least partial movement of the master input device and movement of the catheter interface relative to the housing to actuate the catheter drive elements. The system includes a catheter having a proximal ribbon coupled to a distal lumen portion having a single working lumen, the proximal ribbon being operably coupled to the catheter interface, the catheter being axially movable relative to a guide sheath such that movement of the catheter can be controlled by the master input device. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] These and other aspects will be described in detail with reference to the following drawings. In general, the drawings are not to scale in absolute terms or in comparison, but are intended to be illustrative. Also, the relative arrangement of features and elements can be changed to clarify the illustration.

[0014]

Figure 1A

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Figure 6D

[0015] It should be understood that the drawings are for illustrative purposes only and are not to scale. It should be understood that the devices described herein may include features not necessarily shown in each figure.

Best Mode for Carrying Out the Invention

[0016] FIGS. 1A and 1B show a patient 5 and a robotic treatment system 10 including a distal vascular access system 100 driven within the intracranial vasculature by a robotic drive system 600. FIG. 1B shows a distal access system 100 having a guide sheath 400 disposed within the internal carotid artery, a catheter 200 extending from the distal opening of the guide sheath 400, and a navigation catheter 300 extending from the distal opening of the catheter 200 and disposed such that at least a portion thereof is distal to the carotid siphon. The robotic treatment system 10 enables safe and rapid neurovascular access. The procedures performed by the robotic treatment system 10 can be varied and include diagnostic procedures as well as therapeutic procedures such as clot removal, angioplasty, stent placement, treatment of AV malformations, and treatment of aneurysms. The distal access system 100 is particularly useful for withdrawing suction through the catheter 200 at the location of an embolism or for delivering an intervention device through the catheter 200 for intracranial procedures.

[0017] FIG. 2 is a schematic block diagram of the robotic treatment system 10. Some components of the robotic treatment system 10 may be located adjacent to the patient, and other components may be remote from the patient. As used herein, "remote" may mean outside the fluoroscopic field but in the same room as the patient, or it may mean outside the same room as the patient. An operator remotely outside the same room as the patient need not be in the same building and can be remote from the hospital where the patient is located.

[0018] Patient 5 can be supported on a table 7 adjacent to or attached to the robotic drive system 600. The robotic drive system 600 can be controlled locally by an operator on the patient side (i.e., a physician, for example), and / or remotely using a control station 700. The control station 700, which is remote from the patient, reduces the radiation exposure of the operator operating the control station 700, as the operator can stay well outside the fluoroscopic field and / or behind a radiation shield. The control station 700 also provides the operator with the physical advantage that the operator does not need to wear a protective cover such as a lead apron and can sit while operating the control station 700, as opposed to standing next to the operating table 7 during the procedure.

[0019] The robotic treatment system 10 can further include one or more other medical systems 800, including a suction system 805, an imaging system 810, a contrast agent injection 815, and other medical systems used during a particular procedure. The other medical systems 800 can be separate systems as shown in FIG. 2, or one or more medical systems incorporated within the robotic drive system 600. For example, the robotic drive system 600 can have an integrated contrast agent injection, imaging, or suction system. The other medical systems 800 can include various patient monitoring, including blood pressure, heart rate, carotid ultrasound, and the like. Each of the various components will be described in more detail with reference to FIGS. 3A-3C, FIGS. 4A-4B, and FIG. 5.

[0020] The robotic drive system 600 can include various drive mechanisms that cause independent movement of components of the distal access system 100 and / or other components such as guidewires. The movement can include forward and backward movement of the components. The movement can also include rotation of the components. The robotic drive system 600 can include a base console 601 and a cassette 605 that is matingly engageable with the console 601. The base console 601 can include a controller 610 having a user interface with one or more input portions 612 and one or more output portions 614, and one or more sensors 625. The cassette 605 can include a plurality of roller sets 615 and a plurality of connectors 620. The use of the term "roller" is not intended to exclude other types of operating mechanisms. For example, the components can be a pad system, teeth, a screw drive, a moving grip, a clamp, a gripper, or other mechanisms configured to grip, release, push, pull, twist, rotate, and / or otherwise supply movement to various components in one or more directions with respect to the patient and thereby move forward and / or backward.

[0021] The base console 601 can be a durable component supported by an articulated arm 603 disposed on a support, as is known in the art. The arm 603 can be locked in an infinite number of positions relative to the patient to position the base console 601, and thus the cassette 605, relative to the patient's access site. The articulated arm 603 and associated support can be a self - standing piece of equipment movable around the operating room. The articulated arm 603 and associated support can also be configured to clamp to another component, such as an area of the table 7 on which the patient is positioned. The base console 601 can be coupled to an area of the arm 603, such as on a rail that allows the base console 601 to move relative to the arm 603 once coupled. Movement of the base console 601 can be done manually by the user physically sliding the base console 601 along the rail of the arm 603. Movement of the base console 601 relative to the arm 603 can also be actuated by the user with an electronic input on the console 601 or the arm 603.

[0022] The base console 601 is configured to operably couple to a cassette 605, which may be a disposable article manufactured for single use. The cassette 605 and the console 601 are coupled to each other during use and can be positioned relative to a patient 5 on a table 7 using an arm 603. For example, the base console 601 can be placed over the patient 5 adjacent to the area where the access site of the catheter system to the patient is located. The coupling between the base console 601 and the cassette 605 can vary. Generally, the coupling achieves both an electrical and a mechanical coupling between the two such that the cassette 605 can be controlled by the base console 601. The base console 601 can incorporate one or more motors and transmission devices that couple to drive rollers 615 within the cartridge 605. Coupling a motor within the base console 601 to the roller 615 within the cassette 605 can also be achieved using magnets. For example, the base console 601 can include a motor configured to rotate a magnet within the base console 601. The base console magnet then rotates a corresponding magnet within the cassette roller 615. The use of magnets provides an interface with a minimal surface feature that needs to be cleaned between procedures. The base console 601 can be covered by a disposable sheath 607 and can be penetrated by an opening formed in the disposable sheath 607 or can be covered by a disposable sheath 620 designed to receive one or more connectors of the cassette 605. The sheath 607 maintains a sterile environment while still allowing the coupling between the base console 601 and the cassette 605. The cassette 605 can incorporate one or more covers, windows, doors that open to allow placement of catheter components along with a plurality of rollers 615 and connectors 620 and to enable closing of a latch after insertion.

[0023] One or more input units 612 can be used to manipulate the arm 603 and thus the position of the console 601 relative to the patient 5. As described above, one or more input units 612 can also be used to adjust the position of the console 601 (and thus the cassette 605) relative to the arm 603. For example, the console 601 can be coupled to the rail system of the arm 603 such that the console 601 and its attached cassette 605 can be slid gradually back and forth relative to the patient 5. In other embodiments, the cassette 605 can be moved relative to the console 601 after coupling. The incremental movement can be adjusted, for example, to seat components within an access container, to change the angle of the robotic drive system 600 relative to the base 7, or for other adjustments.

[0024] One or more input units 612 can also include inputs configured to set various parameters of the treatment before treatment control is performed remotely. The one or more input units 612 need not be actual physical buttons and can be on a touch screen or other type of display device that enables a user to initiate one or more functions of the robotic drive system 600. In some embodiments, one or more input units 612 of the robotic drive system 600 can include a scanner configured to scan a two-dimensional barcode, three-dimensional barcode, QR code (registered trademark), image-based code, optically readable code, or other code known in the art. For example, either the cassette 605 or various components used on the patient can include a product label having a code configured to be scanned, and the patient can have a hospital band having a code configured to be scanned. One or more input units 612 can be used to control the operation of catheter system components, including the guidewire 500, for example, by actuating a roller 615.

[0025] The robotic drive system 600 can include, for example, a sheath retainer 622 to assist in supporting the guide sheath 400 relative to the console 601 or cassette 605. The sheath retainer 622 can be a semi-rigid tube or slotted sleeve that can advance over at least a portion of the guide sheath 400, e.g., over a portion of the sheath body 420 that would otherwise not be supported and is on the outside of the patient. The sheath retainer 622 can include a telescoping or collapsible tube section that can be shortened or lengthened while providing columnar support to the body 420 of the guide sheath 400 during use. The sheath retainer 622 can prevent the body 420 from buckling when components such as catheters 200, 300 are advanced and retracted relative to the body 420 by the robotic drive system 600. The sheath retainer 622 can slide within a track in the cassette 605, e.g., when the console 601 and cassette 605 are moved by the arm 603. The sheath retainer 622 disposed on the guide sheath 400 can be secured to the patient with an introducer sheath in a femoral artery access to prevent buckling of the guide sheath 400 between the insertion site within the patient and the robot. The sheath retainer 622 supports the guide sheath 400 while allowing the sheath 400 to be advanced and retracted by movement of the cassette 605 and / or arm 603. The sheath retainer 622 can include one or more markers that can be used to monitor the position of the sheath retainer 622 within the cassette 605 by an optical monitoring mechanism on the console 601 or arm 603.

[0026] One or more of the plurality of cavities on cassette 605 and / or connectors 620 can engage guide sheath 400 to cassette 605. The first connector 620 can secure the proximal end of guide sheath 400 to a connector present within a cavity of cassette 605 and also secure robot drive system 600 to guide sheath 400. Another cavity or connector 620 can include one or more gears configured to engage teeth on a collar on guide sheath 400 such that guide sheath 400 can rotate about its longitudinal axis A. As will be described in more detail below, the proximal end of guide sheath 400 can include a y-connector or hub 434 having a rotary connector (referred to herein as a rotary hemostatic valve or RHV) that provides access to the working lumen of the guide sheath and also enables rotation of guide sheath 400. Guide sheath 400 can rotate via a gear collar attached distal to the hub even while the y-connector remains fixed within a cassette cavity or pocket. The y-connector can be releasably secured within cassette 605 by a connector or cavity that can be a clamp, snap-fit or other feature.

[0027] The plurality of rollers 615 can also act to engage one or more components with the cassette 605 and to linearly translate and / or rotate components of the distal access system 100 relative to the longitudinal axis A. The cassette 605 can have multiple sets of drive rollers 615. As will be described in more detail below with respect to FIGS. 4A and 4B, the first set of rollers 615 can be configured to engage the catheter 200, specifically the proximal control element 230 of the catheter 200. The second set of rollers 615 can be configured to engage the navigation catheter 300, specifically the proximal extension 366 of the navigation catheter 300. The navigation catheter 300 extends through the lumen of the catheter 200. The second set of rollers 615 can be disposed proximal to the first set of rollers 615. The cassette 605 can include, for example, an additional set of rollers 615 disposed proximal to the first and second sets of rollers 615 to engage a guide wire or another region of one or more catheters. The sets of drive rollers 615 include a first roller and a second roller spaced closely apart from each other to allow components of the system to be disposed therebetween and to contact the outer surface of the components with sufficient force to provide movement of the components upon rotation of the roller set 615. The roller set 615 can be composed of two rollers, but as described above, any of a variety of conveyance mechanisms are contemplated herein to cause forward and backward movement of the driven components.

[0028] Referring back to FIG. 2, the controller 610 of the robot drive system 600 communicates with a control station 700 configured to allow an operator to remotely control one or more functions of the robot drive system 600. The movement of the catheters 200, 300 achieved by the plurality of rollers 615 can be controlled by the controller 610 of the robot drive system 600 in electronic communication with the control station 700, which will be described in more detail below. The controller 610 of the robot drive system 600 enables components to be directly driven at the patient's location. For example, a technician may be tasked with performing a particular procedure by placing themselves next to the patient and directly operating the robot drive system 600 using one or more input units 612.

[0029] The technician can first use the controller 610 of the robot drive system 600 during the first stage of the procedure on the patient and then switch to the controller 710 of the control station 700 for another part of the procedure. During the procedure, if the user desires, the initial stage of advancement of the components of the catheter system can be manually performed by the operator until the components reach a particular advancement amount. The amount of manual advancement can depend on the user's preference as well as the procedure being performed. For example, the tip of the guide sheath 400 can be advanced into the common carotid artery, the cervical ICA, or a more distal portion of the ICA for carotid or anterior circulation procedures, or the subclavian or vertebral artery for posterior circulation procedures. The catheter system, including the catheter 200 and the navigation catheter 300, can be manually advanced through the guide sheath 400, for example, up to the distal end of the guide sheath 400, by a desired distance before being latched within the cassette 605. The guide wire can be further inserted, for example, up to and across the target treatment site before being latched to the cassette 605. The user can then actuate the elements or load them into the cassette 605 to enable movement of the components by the drive system 600.

[0030] The controller 610 of the robot drive system 600 can also communicate with a control station 700 that is separated from the patient, such that as a result, a physician can cause the robot drive system 600 to perform certain other functions via communication between the controller 710 of the control station 700 and the controller 610 of the robot drive system 600. The controller 610 of the robot drive system 600 can also communicate with one or more sensors 625 of the robot drive system 600. The one or more sensors 625 can detect any of a variety of conditions related to the robot drive system 600, the distal access system 100, and / or the patient 5. For example, the one or more sensors 625 can sense blood flow or pressure through one or more of the catheters.

[0031] The control station 700 can be in the same room as the robot drive system 600, or can be physically separated from the robot drive system 600 and the patient 5, such as in a different room. For example, the patient 5 can be present in a treatment room, and the control station 700 can be present in a separate control room associated with the treatment room, or in a room that is completely separate from the building in which the patient 5 is located.

[0032] The control station 700 can be a computing system 705 that includes, without limitation, a desktop computer, a laptop computer, a tablet computer, or other processing device. The computing system 705 of the control station 700 can include a controller 710, a communication port 715, and a user interface 720 that includes at least one input section 725 and at least one display 730. The user interface 720 can include a graphical user interface (GUI).

[0033] The controller 710 of the computing system 705 can include at least one processor and a memory device. The memory device may be configured to receive and store user input data as well as data acquired during the use of the robot drive system 600. The memory device can include any type of memory that can store data and communicate that data to one or more other components of the system 10 such as a processor. The memory may be one or more of flash memory, SRAM, ROM, DRAM, RAM, EPROM, dynamic storage devices, etc. The controller 710 of the computing system 710 can execute software to initiate the operation of the robot drive system 600 regardless of the presence or absence of user input. The controller 710 can synchronize the movement of one or more of the components, such as by driving a plurality of rollers 615 at the same speed to achieve the simultaneous forward movement of two catheters 200, 300 as a catheter assembly. The controller 710 can execute software programmed to detect / sense various markers on the components to evaluate the relative elongation and / or total forward distance of the components, and / or the speed of forward or backward movement. For example, the controller 710 can determine the magnitude of the linear translation of one or more of the components (e.g., catheter 200, catheter 300) by, for example, one or more markers on the components detected by the sensor 625 of the robot drive system 600 or the rotation of a plurality of rollers 615. For example, the linear translation of one or more of the components including radial markers or magnets can be detected by an optical sensor or a hall sensor respectively and can be controlled by a programmable logic control system or software. The movement of the rollers can be controlled by a servo motor whose rotation is controlled by a programmable logic control system. The software of the controller 710 can be programmed to drive a plurality of rollers 615 at a specific relative speed or elongation with respect to one or more of the components depending on where the anatomical structure of the component is being advanced.The software of the controller 710 can include clog detection based on the detection of the flow through the catheter by one or more sensors 625 of the robot drive system 600. It should be understood that the controller 610 of the robot drive system 600 and the controller 710 of the control station 700 can be integrated into a single controller of the system 10 as a whole (i.e., only one of the controller 610 and the controller 710 affects the movement of the robot drive system, and the other controller 610, 710 that does not affect the movement can provide, store, and / or display the status, data, etc.). The controller 610 of the robot drive system 600 and the controller 710 of the control station 700 can be different communicating controllers, with one controller (either 610 or 710) being the primary controller and the other controller being the secondary controller. In other words, if the control information from one controller conflicts with the second controller, the primary controller takes precedence so that the two controllers 610, 710 operate according to a master / slave configuration.

[0034] One or both of the controllers 610 and / or 710 can display the status of the components of the robot display system. For example, the controller can display red light when the components of the distal access system 100 are not loaded and / or latched in the associated cassette position and can switch to green when correctly loaded and / or latched. The user interface functions of the system will be described in more detail below.

[0035] Communication port 715 is configured to communicate with a corresponding one of the robot drive systems 600. The communication port 715 can be a wired communication port such as an RS22 connection, a USB connection, a Firewire connection, a proprietary connection, or any other suitable type of wired connection configured to receive and / or transmit information to the robot drive system 600. The communication port 715 can alternatively or additionally include a wireless communication port so as to be able to supply information between the control station 700 and the robot drive system 600 via a wireless link, for example to display information in real time on the display 730. For example, the display can indicate the loading and latching status of all components of the distal access system 100 at the relevant positions within the cassette 605. The display can further display a status identifier such as one or more words (e.g., "READY") when all components are loaded and latched. The display can also prompt the order of component loading during the loading process. The wireless connection can use any suitable wireless system such as Bluetooth, Wi-Fi, radio frequency, ZigBee communication protocol, infrared, or a cellular phone system, and can also use encoding or authentication to verify the origin of the received information. The wireless connection can also be any of a variety of proprietary wireless connection protocols.

[0036] At least one input unit 725 can include a touch screen, one or more joysticks, scroll wheels, buttons, sliders, foot pedals, microphones, voice commands, and / or other inputs. The input unit 725 is configured to cause forward, backward, and / or rotation of one or more of various components including one or more guide sheaths, catheters, microcatheters, guide wires, or other components by driving the rollers 615 of the robot drive system 600. The input unit 725 can include an emergency button, a speed control button or slider, or other inputs designed to achieve a particular movement or operation of one or more components. The input unit 725 can move multiple rollers with at least one degree of freedom, for example. The first and second sets of rollers 615, for example, can be moved in response to an operator input to advance the catheters 200, 300 and / or guide the guide sheath 400 in the distal and proximal directions.

[0037] The user interface 720 can include one or more displays 730 configured to display information regarding the patient, components, and / or treatment. The user interface 720 can be a graphical user interface (GUI) (see FIG. 5). The GUI can display image data (e.g., X-ray images, MRI images, CT images, ultrasound images, etc.), patient vitals (e.g., blood pressure, heart rate, rhythm, etc.), patient medical history (e.g., age, weight, medical history), component data (e.g., catheter length, bore size, etc.), treatment evaluation data (e.g., suction pressure, suction cycle, etc.), and any other information useful for the treatment being performed. The same information can be displayed on a patient table on an additional user interface display. Thereby, a technician in the same room as the patient on the operating table can view the same information as an operator located remotely from the patient and the operating table. As described above, the information displayed can be input and adjusted to provide a better orientation for the user. These and other aspects will be described in more detail below.

[0038] Aspects of the subject matter described in this specification can be implemented in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and / or combinations thereof. These various embodiments can be implemented in one or more computer programs that are executable and / or interpretable on a programmable system including at least one programmable processor coupled to receive signals, data, and instructions from, and to transmit signals, data, and instructions to, a memory system, at least one input device, and at least one output device.

[0039] These computer programs (also called programs, software, software applications or code) include machine instructions for a programmable processor and may be implemented in a high-level procedural and / or object-oriented programming language, and / or in assembly / machine language. As used herein, the term "machine-readable medium" refers to any computer program product, apparatus, and / or device (e.g., magnetic disks, optical disks, memory, programmable logic device (PLD)) used to provide machine instructions and / or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal. The term "machine-readable signal" refers to any signal used to provide machine instructions and / or data to a programmable processor.

[0040] Each component of the robotic treatment system 10, including the catheter system 100 and the robotic drive system 600, is described in more detail below.

[0041] Components of the Catheter System Using the robot drive system 600 of the treatment system 10, one or more catheters, catheter systems, and / or devices designed to be delivered through a catheter or catheter system can be delivered. As described above, the treatments performed by the treatment system 10 can be diverse, including diagnostic treatments as well as treatment treatments such as blood clot removal, angioplasty, stent placement, treatment of AV malformations, aneurysm treatment, and the like. In some embodiments, the catheter systems described herein can be used to treat acute ischemic stroke (AIS). The systems described herein provide rapid and easy access to distal target anatomical structures, particularly the tortuous anatomical structures of the cerebrovascular system, at a single operating point. With rapid exchange and monopoint operation, the robot drive system can be used with a multi-component catheter system that would be impossible due to the overall length that would inappropriately create a large footprint in the operating room.

[0042] The medical methods, devices, and systems described herein enable navigation of complex and tortuous anatomical structures, for example, to deliver intracranial medical devices. The extreme flexibility and deliverability of the distal access catheter systems described herein allow the catheter to conform to the shape of the tortuous anatomical structure rather than applying corrective forces that create new anatomical structures. The distal access catheter systems described herein can pass through tortuous loops while maintaining the natural curvature of the anatomical structures therein, reducing the risk of the blood vessels straightening. The distal access catheter systems described herein can thereby create a safe conduit through the neurovascular system that maintains the natural tortuosity of the anatomical structures for other catheters to traverse (e.g., a suction catheter of larger caliber, a stent, or a support catheter for delivery of a flow diverter, etc.).

[0043] Although several embodiments are described herein with respect to access to neurovascular anatomical structures for the application of suction or treatment of AIS, the systems and methods described herein should not be limited thereto and may be applicable to other procedures as referred to elsewhere herein. The catheter systems described herein can be used to deliver working devices to target vessels of coronary anatomical structures or other vascular anatomical structures. When the terms "distal access catheter" or "reverse aspiration catheter" are used herein, the catheter facilitates and guides the aspiration, delivery of fluid to or as a support catheter to the treatment site, or delivery or exchange of other devices such as guidewires or interventional devices such as stent retrievers, stents, shunts, coils, balloons, and other devices, and can be used for distal access that provides a conduit.

[0044] The devices and systems described herein are related to, and can be combined with or used alternatively to, the devices and systems described in U.S. Patent No. 10,327,790, filed on August 3, 2012; U.S. Patent No. 9,561,345, filed on December 19, 2014; U.S. Patent No. 9,820,761, filed on February 4, 2016; U.S. Patent Application Publication No. 2018 / 0193042, filed on January 9, 2018; U.S. Patent Application Publication No. 2018 / 0361114, filed on January 19, 2018; U.S. Patent Application Publication No. 2019 / 0351182, filed on May 16, 2019; U.S. Patent No. 11,400,255, filed on November 14, 2019; and U.S. Patent Application Publication No. 2020 / 0289136, filed on June 2, 2020. The disclosure of each of these publications and applications is hereby incorporated by reference in its entirety.

[0045] Figures 3A and 3B show an embodiment of a distal access system 100 that includes a catheter assembly 150 configured to advance using a robotic drive system 600. The catheter assembly 150 can include a first catheter 200 and a second catheter 300 configured to be positioned inside the first catheter 200. The first catheter 200 may be referred to herein as the distal catheter or outer catheter. The second catheter 300 may be referred to herein as the navigation catheter or inner catheter. FIG. 3A is an exploded view of the system 100, and FIG. 3B is an assembled view of the system 100 of FIG. 3A. FIG. 3C is a detailed view of the navigation catheter 300 of the catheter assembly 150 of FIG. 3A along circle C-C. The system 100 can provide rapid and easy access to a distal target anatomical structure, particularly the tortuous anatomical structure of the cerebrovascular system. As described in more detail below, all wire and catheter manipulations can be performed at or near a single rotary hemostatic valve (RHV) or multiple single RHVs arranged in the same location in the same device. The manipulations can be performed as a result of the robotic drive system 600 and also via manual manipulation by an operator on the patient side. The procedures described herein can include a combination of both manual operator manipulation and robotic drive system operation.

[0046] System 100 can include one or more catheter assemblies 150, each having a first catheter 200 and an inner navigation catheter 300. The first catheter 200 can be a suction catheter designed to seal with the catheter through which it extends, or an access catheter designed without a seal. The first catheter 200 need not be sealed and can be used as a support catheter for other components. The catheter assembly 150 is configured to advance through an access guide sheath 400. The catheter 200 is configured to be received through the guide sheath 400 and is designed to have exceptional deliverability. The catheter 200 can be a spine catheter that provides a step-up in the lumen and inner diameter of the guide sheath 400 when assembled within the guide sheath. The catheter 200 can be delivered using a navigation catheter 300 inserted through the lumen 223 of the catheter 200. The flexibility and deliverability of the first catheter 200 allow it to conform to the shape of tortuous anatomical structures as the catheter 200 advances, avoiding applying corrective forces to the anatomical structures. The first catheter 200 enables this even in the presence of a navigation catheter 300 extending through its lumen. Thus, both the flexibility and deliverability of the navigation catheter 300 are configured to reach the middle cerebral artery (MCA) circulation without straightening the curvature of the anatomical structure en route, and are equal to or greater than the flexibility and deliverability of the distal lumen portion 222 of the first catheter 200 in this regard.

[0047] System 100 can be a distal access system that can form a variable length from an access point in a percutaneous arterial cutdown (e.g., femoral artery or other access point) to a target control point of a distal catheter. Conventional distal access systems for neurointervention typically include a long guide sheath or guide catheter placed through a shorter (e.g., 11 - 30 cm in length) sheath in the groin. The long guide sheath is typically placed in the ICA to assist with neurovascular interventions including stroke thrombectomy (sometimes called "thrombectomy"). For additional support, these can be advanced to the osseous terminal cone and, if possible, can hardly be advanced to the cavernous or angulated or supra-angulated terminal ICA. To reach a target in the M1 or M2 distribution using devices for mechanical thrombectomy such as devices for manual aspiration thrombectomy (MAT), stent retrievers (SR), aspiration first pass technique (ADAPT), and "Solumbra" (aspiration + SR), additional catheters can be inserted through the long guide catheter. These catheters are typically large-bore aspiration catheters that can be, for example, 130 cm or more in length. As will be described in more detail below, the distal access system 100 described herein can be shorter, for example, only 115 cm in length when considered as a system, measured from the access point, typically the common femoral artery. Further, the system described herein can be inserted through a single rotary hemostatic valve (RHV) 434 on the guide sheath 400 or multiple RHVs placed in the same location on the same device such as a dual-head RHV.

[0048] With further reference to FIGS. 3A and 3B, the distal access system 100 can include an access guide sheath 400 having a body 402, with a working lumen extending through the body from a proximal hemostatic valve 434 coupled to a proximal end region 403 of the body 402 to a distal opening 408 of a distal end region. The working lumen is configured to receive a catheter 200 such that a distal end of the catheter 200 can extend through the distal opening 408 and beyond a distal end of the sheath 400. The guide sheath 400 can be used to deliver any of the catheters described herein, as well as various working devices known in the art. For example, the working device can be configured to provide thrombotic therapy and can include large bore catheters, aspiration thrombectomy (sometimes referred to as thromboembolectomy), advanced catheters, wires, balloons, retrievable structures such as coil tipped retrievable stents “stent retrievers”, stents, and flow diverters.

[0049] The sheath body 402 can extend from a proximal branch or a rotary hemostatic valve (RHV) 434 in the proximal region 403 of the body 402 to the distal region 407. The proximal RHV 434 can include one or more lumens formed in a connector body for connection to the working lumen 405 of the body 402 of the guide sheath 400. The working lumen can receive any of a variety of working devices for delivery to the catheter 200 and / or the target anatomical structure. The RHV 434 can be composed of a thick-walled polymer tube or a reinforced polymer tube. The RHV 434 enables introduction of a device into the vasculature through the guide sheath 400 while preventing or minimizing blood loss and preventing introduction of air into the guide sheath 400. The RHV 434 can be integrated with the guide sheath 400, or the guide sheath 400 can terminate at the proximal end of a female Luer adapter to which a separate hemostatic valve component such as a passive seal valve, a Toyoboost valve or an RHV can be attached. The RHV 434 can have an adjustable opening that is large enough to allow removal of a device having adherent clot on the distal opening 408 without removing the clot with the RHV 434 during removal. Alternatively, the RHV 434 may be removable, such as when the device is removed from the sheath 400 to prevent dislodgement of the clot in the RHV 434. The RHV 434 can be a dual RHV or a multi-head RHV.

[0050] The RHV434 can be used to insert a working catheter into the working lumen of the sheath 400 through the first port of the RHV434, and a Y-connector can be formed in the proximal end region 403 of the sheath 400 so that the second port to the arm 412 can be used for another purpose. For example, a syringe or other device can be connected to the arm 412 via the connector 432 to deliver a flush line for injecting forward drip, contrast agent, or saline through the body 402 towards the distal opening 408, regardless of the presence or absence of a catheter within the target anatomical structure. The arm 412 can also be connected to a vacuum source. The vacuum source can be an active suction source such as a suction pump, a stationary or lock syringe, a portable suction device, a hospital suction device, etc., configured to draw suction through the working lumen. In one embodiment, the vacuum source is a lock syringe (e.g., a VacLok syringe) attached to a flow controller. The operator can pull the plunger on the syringe back to the locked position while the connection to the blood flow line is closed prior to the embolus removal step of the procedure. In another embodiment, the arm 412 can be connected to a vacuum source that is a pump configured to apply a constant or variable suction pressure through the working lumen of the guide sheath 400. Even if multiple suction catheters 200 are nested within each other through the working lumen of the guide sheath 400, a single shared suction source is sufficient to draw suction throughout the system 100. The arm 412 can also be capable of flushing the guide sheath 400 with saline or a radiopaque contrast agent during the procedure. The working lumen can extend from the distal opening 408 to the working proximal port in the proximal end region 403 of the sheath body 402.

[0051] A contrast agent (e.g., from the contrast agent injection system 815) can be injected intravascularly through the guide sheath 400 to visualize the occlusion site by angiography. For example, the guide sheath 400 can be positioned such that at least a portion thereof is disposed within the carotid artery. When the contrast agent is positioned at this location, it may be injected through the sheath 400. The contrast agent can also be injected through one or more catheters inserted through the guide sheath 400. The baseline angiogram can be obtained prior to device insertion, for example, in anterior-posterior (AP) and / or lateral views, and the occlusion position can be evaluated by injecting the contrast agent through the sheath 400 with fluoroscopic visualization (e.g., part of the imaging system 810). Fluoroscopic visualization can continue as the catheter system advances, and subsequent angiograms can be captured periodically, particularly after any attempt to retrieve emboli to evaluate reperfusion. The baseline angiogram image can be overlaid, such as by digital subtraction angiography, so that the vasculature and / or occlusion site can be seen while the catheter system is advancing. Once the catheter assembly 150 has advanced to a predetermined position (positioning will be described in more detail below), the navigation catheter 300 can be withdrawn and removed from the system. In some embodiments, such as the treatment of occlusion by aspiration thrombectomy, a vacuum source, such as a pump, can be connected to the sheath 400 and activated to direct suction to the distal end of the catheter 200. Suction can be applied for a period of time (e.g., about 30 seconds to about 3 minutes, preferably about 2 minutes) to enable capture and uptake of emboli within the catheter 200. The flow rate of suction can vary and, in one example, can be between about 25 inches of mercury (inHg) (12.279 psi) and about 28 inHg (13.752 psi). In some embodiments, the pump can be activated to build a vacuum outside the patient for a first period of time before applying the vacuum to the container, for example, by switching a flow control switch to the "on" position. In other embodiments, the pump is turned on at a specific flow rate and immediately applied to the container to allow for the accumulation of vacuum through the system.After applying suction to the catheter for a period of time, the catheter 200 can be slowly withdrawn. When a free flow observable by continuous collection of the fluid in the container is achieved, the suction source can be disconnected from the sheath 400 and angiography for confirmation can be performed. Angiography can be carried out by injecting a contrast agent through the suction catheter 200 still disposed through the working lumen of the sheath 400. Angiography can also be performed through the guide sheath 400 after completely removing the suction catheter 200 from the guide sheath 400.

[0052] Suction can be performed under the control of the control station 700 (see FIG. 2), respectively, by the suction system 805, the contrast agent injected by the contrast agent injection system 815, and the angiography performed by the imaging system 810.

[0053] The vacuum source can increase the suction level when the flow rate is slow and decrease it when the flow rate increases. In this way, the force is maximum when the catheter is blocked or partially blocked, but decreases to a minimum level when there is free flow to ensure protection from distal plugs while limiting the amount of blood being aspirated. In this way, the system can optimize plug aspiration while limiting the amount of blood being aspirated. When the flow within catheter 200 is blocked or restricted, the pump can generate a higher level of vacuum. In this example, the suction force can be configured to increase when a higher vacuum is detected, such as by one or more sensors 625 (see FIG. 2). The vacuum source can include a vacuum gauge, or the vacuum gauge may be incorporated at the proximal end of the RHV or luer or guide sheath 400. In yet another embodiment, the robotic drive system 600 incorporates one or more sensors 625 configured to evaluate the state of one or more functions of the system, such as flow rate, blockage, vacuum level, etc., in order to automatically adjust the parameters of the system. The various controls of the systems described herein can be performed by an operator at a control station 700, or manually at the operating table 7, or a combination thereof.

[0054] In one embodiment, the guide sheath 400 includes one or more radiopaque markers 411. The radiopaque markers 411 can be disposed near the distal opening 408. For example, a pair of radiopaque bands may be provided. The radiopaque markers 411 or markers of any of the system components can be swaged, painted, embedded, or otherwise disposed in or on the body. In some embodiments, the radiopaque markers include barium polymers, tungsten polymer blends, tungsten-filled or platinum-filled markers that maintain the flexibility of the device and improve its resistance to migration and torsion along the length of the component. In some embodiments, the radiopaque marker is tungsten-filled PEBAX or polyurethane thermally welded to the component.

[0055] The guide sheath marker 411 is shown in the figure as a ring around one or more regions of the body 402. However, the marker 411 can have other shapes that provide orientation to the operator with respect to the position of the distal opening 408 within the blood vessel, or can create various patterns. Thus, the operator can visualize the position of the distal opening 408 under fluoroscopy (which can be displayed to the operator on the display 730 of the control system 700) to confirm that the distal opening 408 is oriented towards the target anatomical structure into which the catheter 200 is being delivered. For example, the radiopaque marker 411 enables rotation of the body 402 of the guide sheath 400 at an anatomical access point, such as the patient's groin, thereby providing access to the ICA by subsequent working devices, such as a catheter and wire advanced into the ICA. In some embodiments, the radiopaque marker 411 comprises platinum, gold, tantalum, tungsten, or any other material visible under a fluoroscopy device. Any of the various components of the systems described herein can incorporate a radiopaque marker.

[0056] With further reference to FIGS. 3A and 3B, catheter 200 can include a relatively flexible distal lumen portion 222 coupled to a more rigid and torsion-resistant proximal extension or proximal control element 230. As used herein, the term "control element" can refer to a proximal region configured for pushing movement in the distal direction and pulling movement in the proximal direction. The control element can be manually pushed or pulled by an operator or by a robotic drive system 600, as described elsewhere herein. The control elements described herein can also be referred to as a spine, a tether, a push wire, a push tube, or other elements having any of a variety of configurations. The proximal control element 230 can be a hollow or tubular element. The proximal control element 230 can also be solid and may not have a lumen, such as a solid rod, ribbon, or other solid wire-type element coupled at its proximal end to a tab 234 or other type of component. Generally, the proximal control elements described herein are configured to move their respective components (which may be attached or integral) bidirectionally through the lumen.

[0057] A single lumen 223 extends through the lumen portion 222 between the proximal and distal ends of the lumen portion 222. In some embodiments, the proximal opening 242 to the lumen 223 can be located near where the proximal control element 230 is coupled to the distal lumen portion 222. In other embodiments, the proximal opening 242 to the lumen 223 is in the proximal end region of the catheter 200. The distal opening 231 from the lumen 223 can be located near or at the most distal end 215 of the lumen portion 222. The lumen 223 of the catheter 200 can have a first inner diameter, and the working lumen 405 of the guide sheath 400 can have a larger second inner diameter. When the catheter 200 is inserted through the working lumen 405 of the sheath 400, the lumen 223 of the catheter 200 can be configured to be in fluid connection and continuous with the working lumen of the sheath 400 such that fluid flow into and out of the system 100 is possible, such as by applying suction from a vacuum source coupled to the system 100 at the proximal end. The combination of the sheath 400 and the catheter 200 can be in continuous communication with the blood flow during suction at the proximal end as the catheter 200 is advanced and retracted.

[0058] The distal lumen portion 222 of the catheter 200 can have a plurality of radiopaque markings 224. A first radiopaque marker 224a can be disposed near the most distal end 215 to assist in guiding and proper positioning of the most distal end 215 under fluoroscopy. Further, the proximal region of the catheter 200 can have one or more proximal radiopaque markers 224b such that an overlap region 348 can be visualized as the relationship between a radiopaque marker 411 on the guide sheath 400 and a radiopaque marker 224b on the catheter 200. The proximal region of the catheter 200 can also have one or more radiopaque markings that provide visualization, for example, in a single lumen 223 of the catheter 200 near the proximal opening 242, as will be described in more detail below. In one embodiment, two radiopaque markers (marker 224a near the most distal end 215 and more proximal marker 224b) are distinguished to minimize confusion in the fluoroscopic image; for example, the catheter proximal marker 224b can be a single band, the marker 411 on the guide sheath 400 can be a double band, and any marker on a working device delivered via the distal access system can have a different type of band or mark. The radiopaque markers 224 of the distal lumen portion 222, particularly those near the distal end region navigating a very tortuous anatomical structure, can be relatively flexible so as not to affect the overall flexibility of the distal lumen portion 222 near the distal end region. The radiopaque markers 224 can be tungsten-loaded or platinum-loaded markers that are relatively flexible compared to other types of radiopaque markers used in devices where flexibility is not of the utmost importance. In some embodiments, the radiopaque marker can be a band of tungsten-filled PEBAX having a durometer of Shore 35D.

[0059] The proximal control element 230 can include one or more markers 232 for indicating an overlap between the distal lumen portion 222 of the catheter 200 and the sheath body 402, as well as an overlap between the distal lumen portion 222 of the catheter 200 and other interventional devices that can extend through the distal lumen portion 222. At least a first mark can be an RHV proximity marker arranged such that when the mark is aligned with the sheath proximal hemostasis valve 434 during insertion of the catheter 200 through the guide sheath 400, the catheter 200 is positioned at the most distal position with a minimum overlap length necessary to form a seal between the catheter 200 and the working lumen. At least a second mark 232 can be a fluorescence saving marker that can be arranged on the control element 230 and can be arranged away from the most distal end 215 of the distal lumen portion 222. In some embodiments, the mark 232 can be arranged about 100 cm away from the most distal end 215 of the distal lumen portion 222.

[0060] The various markers can be sensed by one or more sensors 625 of the robotic drive system 600 to provide information regarding the relative extension of the various components and the position of the components within the anatomical structure based on the total extension achieved.

[0061] The navigation catheter 300 is described herein with reference to the catheter 200, but can be used to advance other catheters and is not intended to be limiting in its use. For example, the navigation catheter 300 can be used to deliver a 5MAX reperfusion catheter (Penumbra, Inc., Alameda, Calif.), a REACT aspiration catheter (Medtronic), or a Sophia Plus aspiration catheter (Terumo), or other reperfusion catheters known in the art, for clot removal in patients with acute ischemic stroke. Thus, where a catheter is described as having a proximal control element, the catheter can be a full-length catheter and the proximal control element 230 can simply refer to the proximal tubular portion of the catheter.

[0062] Furthermore, with reference to FIGS. 3A, 3B, and 3C, the navigation catheter 300 can include a non-expandable flexible elongate body 360 coupled to a proximal extension 366. Similar to the catheter 200, the navigation catheter 300 may be configured for a rapid exchange method. The flexible elongate body 360 can also be configured for an over-the-wire method and can be a tubular portion having a guidewire lumen 368 that extends along the entire length of the navigation catheter 300. In this embodiment, the navigation catheter 300 can have a proximal opening from the lumen 368 configured to remain outside the patient's body during use. Alternatively, the tubular portion can have a proximal opening arranged such that the proximal opening remains inside the patient's body during use. The lumen 368 for the guidewire can extend only a limited distance from the distal opening (e.g., 5 cm to 25 cm) of the navigation catheter to the proximal opening. The proximal extension 366 can be a proximal element coupled to and extending proximally from the distal tubular portion 360. The proximal opening from the tubular portion 360 can be located near where the proximal element 366 is coupled to the tubular portion 360. Alternatively, the proximal extension 366 can be a proximal extension of the tubular portion 360 having a length that extends to a proximal opening near the proximal end of the navigation catheter 300 (i.e., outside the patient's body). A luer 364 can be coupled to the proximal extension 366 in the proximal end region so that an instrument such as a guidewire can be advanced through the lumen 368 of the navigation catheter 300. A syringe or other component can be coupled to the luer 364 to draw a vacuum and / or inject fluid through the lumen 368. A syringe coupled to the luer 364 can also be used to close the lumen of the navigation catheter 300 to maximize the piston effect described elsewhere herein.

[0063] The configuration of the proximal extension 366 of the navigation catheter 300 can vary. In some embodiments, the proximal extension 366 is simply the proximal extension of a flexible elongated body 360 whose structure does not change significantly but whose flexibility changes significantly. For example, the proximal extension 366 transitions from a very flexible distal region of the navigation catheter 300 towards a less flexible proximal region of the navigation catheter 300. The proximal extension 366 provides a relatively rigid proximal end suitable for manipulating and applying torque to more distal regions of the navigation catheter 300. In other embodiments, the proximal extension 366 is a hypo tube. The hypo tube may be exposed or may be coated with a polymer. In yet another embodiment, the proximal extension 366 may be a tubular polymer portion reinforced by a coiled ribbon or braid. The proximal extension 366 can have the same outer diameter as the flexible elongated body or can have an outer diameter smaller than that of the flexible elongated body.

[0064] The proximal extension 366 need not include a lumen. For example, the proximal extension 366 may be a solid rod, ribbon, or wire and may couple to the tubular elongated body 360 and not have a lumen extending therethrough. It should be understood that if the proximal extension 366 is described herein as having a lumen, the proximal extension 366 can also be solid and not have a lumen. The proximal extension 366 is generally less flexible than the elongated body 360 and can transition to be even more rigid towards the most proximal end of the proximal extension 366. Thus, the navigation catheter 300 can have a very flexible and flexible distal end region 346 that transitions proximally to a proximal extension 366 of sufficient rigidity suitable for pushing and / or applying torque to the distal elongated body 360.

[0065] The elongated body 360 can be received within the inner lumen 223 of the distal lumen portion 222 of the catheter 200 and can extend through the inner lumen (see FIG. 3B). The elongated body 360 or tubular portion can have an outer diameter. The tubular portion of the navigation catheter 300 can have an outer diameter having at least one snag point. The difference between the inner diameter of the catheter 200 (e.g., the inner diameter of the lumen at the distal end of the distal catheter portion) and the outer diameter of the tubular portion at the snag point is about 0.015 inches (0.381 mm) or less, or about 0.010 inches (0.254 mm) or less, for example, from about 0.003 inches (0.0762 mm) to about 0.012 inches (0.3048 mm), preferably from about 0.005 inches (0.127 mm) to about 0.010 inches (0.254 mm), more preferably from about 0.007 inches (0.1778 mm) to about 0.009 inches (0.2286 mm). At least one snag point of this tubular portion can be a point along the length of the tubular portion. At least one snag point of this tubular portion can have a length of at least about 5 cm to about 50 cm, including, for example, at least about 6 cm, at least about 7 cm, at least about 8 cm, at least about 9 cm, at least about 10 cm, at least about 11 cm, or at least about 12 cm to about 50 cm. This length need not be uniform such that the length fits exactly along its entire length. For example, the snag point region can include ridges, grooves, slits, or other surface features.

[0066] As will be described in more detail below, the navigation catheter 300 can also include a distal end region 346 located distally of at least one snag point of the tubular portion. The distal end region 346 can have a length and can taper along at least a portion of the length. The distal end region 346 of the navigation catheter 300 can extend beyond the distal end of the catheter 200, as shown in FIG. 3B. The proximal extension 366 or proximal extension of the navigation catheter 300 is coupled to the proximal end region of the elongated body 360 and extends proximally therefrom. The proximal extension 366 is less flexible than the elongated body 360 and can be configured for bidirectional movement of the elongated body 360 of the navigation catheter 200 within the lumen portion 222 of the catheter 300, as well as for movement of the entire catheter assembly 150. The elongated body 360 can be coaxially inserted through the inner lumen 223 of the lumen portion 222. The outer diameter of at least one region of the elongated body 360 can be sized to substantially fill at least a portion of the inner lumen 223 of the lumen portion 222.

[0067] The overall length of the navigation catheter 300 (e.g., between the proximal end and the most distal end 325) can vary, but generally, it is long enough to extend at least a certain distance through the support catheter 200 and beyond the distal end of the support catheter 200 while at least the length of the proximal extension 366 remains outside the proximal end of the guide sheath 400 and outside the patient's body. In some embodiments, the overall length of the navigation catheter 300 is from about 145 to about 150 cm, and the working length from the proximal tab or hub to the most distal end 325 is from about 140 cm to about 145 cm. The elongated body 360 can have at least the same length as the lumen portion 222 of the catheter 200, but the elongated body 360 can be shorter than the lumen portion 222 as long as at least a minimum length of the elongated body 360 remains inside the lumen portion 222 when the distal portion of the elongated body 360 extends distally relative to the distal end of the lumen portion 222 to form a snag point or snag region with the catheter. In some embodiments, this minimum length of the elongated body 360 that remains inside the lumen portion 222 when the distal end region 346 is disposed in its optimal advanced configuration is from at least about 5 cm, at least about 6 cm, at least about 7 cm, at least about 8 cm, at least about 9 cm, at least about 10 cm, at least about 11 cm, or at least about 12 cm to about 50 cm. In some embodiments, the shaft length of the distal lumen portion 222 can be from about 35 cm to about 75 cm, which is shorter than the working length of the guide sheath, and the insert length of the elongated body 360 can be at least about 45 cm, 46 cm, 47 cm, 48 cm, 48.5 cm, 49 cm, 49.5 cm to about 85 cm.

[0068] The length of the elongated body 360 enables the distal end of the elongated body 360 to reach a cerebrovascular target or occlusion within a bifurcation from segments of the internal carotid artery, including, for example, the cervical (C1), vertebral (C2), lacerum (C3), cavernous (C4), clinoid (C5), ophthalmic (C6), and communicating (C7) segments, and these segments including the M1 or M2 segment of the middle cerebral artery (MCA), anterior cerebral artery (ACA), anterior temporal branch (ATB), and / or posterior cerebral artery (PCA). The distal end region of the elongated body 360 can reach these distal target locations, while the proximal end region of the elongated body 360 remains proximal to or less than the level of severe tortuosity along the insertion path. For example, the entry position of the catheter system may be within the femoral artery, and the target occlusion position may be distal to the right common carotid artery, such as within the M1 segment of the right middle cerebral artery. The proximal end region of the elongated body 360 transitioning to the proximal extension 366 can remain within a blood vessel proximal to severely tortuous anatomical structures such as the carotid siphon, right common carotid artery, brachiocephalic trunk, the takeoff of the brachiocephalic artery from the aortic arch, and the aortic arch during transition from the descending aorta. This avoids inserting a stiffer proximal extension 366, or a material transition section between a stiffer proximal extension 366 and the elongated body 360, and rotation of the aortic arch or the takeoff of the brachiocephalic from the aortic arch, both of which can be very serious. The lengths described herein for the distal lumen portion 222 can also apply to the elongated body 360 of the navigation catheter.

[0069] The proximal extension 366 can have a length that varies similarly. In some embodiments, the proximal extension 366 is from about 90 cm to about 95 cm. The distal portion that extends distally relative to the distal end of the lumen portion 222 can include a distal end region 346 that projects in length beyond the distal end of the lumen portion 222 during use of the navigation catheter 300. As will be described in more detail below, the distal end region 346 of the elongated body 360 configured to project distally from the distal end of the lumen portion 222 while advancing the catheter 200 through the tortuous anatomical structure of the cerebral blood vessels. The proximal extension 366 coupled to and extending proximally from the elongated body 360 can be aligned substantially alongside the proximal control element 230 of the catheter 200. As will be described in more detail below, the arrangement between the elongated body 360 and the lumen portion 222 can be maintained while advancing the catheter 200 through the tortuous anatomical structure to reach a target position for treatment within the distal blood vessel, helping to prevent the distal end of the catheter 200 from getting caught on the tortuous branched blood vessels.

[0070] In some embodiments, the elongated body 360 can have a region of relatively uniform outer diameter extending along at least a portion of its length, and the distal end region 346 tapers downward from the uniform outer diameter. The outer diameter of the elongated body 360 can include a decrease at a position along its length, for example, a decrease in the outer diameter at the proximal end region where the elongated body 360 is coupled to the proximal extension 366. Depending on the inner diameter of the catheter 200, the difference between the inner diameter of the catheter 200 and the outer diameter of the elongated body 360 along at least a portion of its length, for example, at least 10 cm, preferably at least 15 cm of its length, can be less than about 0.015 inches (0.381 mm), such as in the range of about 0.003 inches to 0.015 inches (0.0762 mm to 0.381 mm) or about 0.006 inches to 0.010 inches (0.1524 mm to 0.254 mm). Thus, the gap between the catheter 200 and the elongated body 360 can provide a space of less than about 0.008 inches (0.2032 mm) on both sides, or less than about 0.005 inches (0.127 mm), for example, about 0.001 inches to about 0.006 inches (0.0254 mm to 0.1524 mm), preferably about 0.002 inches to about 0.005 inches (0.0508 mm to 0.127 mm), more preferably about 0.003 inches to about 0.005 inches (0.0762 mm to 0.0508 mm).

[0071] The navigation catheter 300 has a large outer diameter and a relatively small inner diameter, especially when the guide wire extends within or through the lumen of the navigation catheter 300. The lumen of the navigation catheter 300, substantially filled by the guide wire and / or liquid, forms a closed system with the catheter 200. The navigation catheter 300 substantially fills or substantially occludes the catheter 200 to form a piston configuration within the catheter lumen. When the occluding navigation catheter 300 is retracted through the catheter lumen, an internal vacuum is created within the catheter 200, similar to a plunger within a syringe barrel. The internal vacuum formed within the distal end region of the catheter 200 can draw the embolization material toward and / or through the distal end 215 of the catheter 200, which is disposed on or near the surface of the plug. As described above, before withdrawing the navigation catheter 300 from the catheter lumen, a syringe or water wash can be coupled to the Luer 364. The syringe coupled to the Luer 364 of the navigation catheter 300 closes the system and maximizes the piston effect during recovery. The internal vacuum can begin to remove the thrombus material proximal to the plug or draw the plug itself toward the distal end of the catheter even before external suction is applied to the proximal RHV of the base sheath. Further, the catheter system can store energy or force, for example, in the compression of the catheter 300 before the navigation catheter 200 is withdrawn, when advancing through a tortuous neuroanatomical structure. Extreme tortuosity within the cerebral vasculature, particularly around the bony structures of the skull, may require greater force to traverse in combination with a dramatic shift in vessel size to reach the occlusion site. For example, the large aorta and target vessels sized 1 - 3 mm can cause the force or energy stored within the catheter. Withdrawal of the navigation catheter 300 can release this stored energy and cause distal movement of the distal catheter portion 222. The distal movement of the distal catheter portion 222 can be utilized, for example, when treating an embolism by aspiration thrombectomy.The distal catheter portion 222 can be moved toward the plug (i.e., by the operator and / or the robotic system 600 releasing its grip on the catheter) to non-invasively nest, seat, and / or embed the distal end 215 of the catheter 200 at the proximal surface of the plug in order to optimally position the catheter 200 relative to the plug. Retracting the navigation catheter 300 through the catheter lumen, either alone or in combination with distal movement of the distal catheter portion 222, can achieve more successful one-pass thrombectomy by creating an initial internal vacuum within the distal end region of the catheter 200.

[0072] During use of the system, various movements of the catheter 200 and / or the navigation catheter 300, such as the withdrawal of the navigation catheter to achieve a piston effect, can be performed manually by an operator positioned at the operating table 7 or by a robotic drive system 600 controlled, for example, by an operator at a control station 700. The drive system 600 can be programmed to withdraw the navigation catheter 300 from the catheter lumen at a selected speed. The selected speed can vary anywhere from a withdrawal of about 4 cm / second to a withdrawal of about 165 cm / second. In some embodiments, the recovery speed is selected to generate a suction pressure in the distal end region of the catheter 200 where the piston device remains at a predetermined position of occlusion. As an example, the catheter system 150 can be assembled such that the tapered distal end region 346 of the navigation catheter 300 extends distally relative to the distal end of the catheter 200. The outer dimensions of the navigation catheter can substantially fill at least a portion of the lumen of the catheter 200 that forms the piston configuration. The length forming the piston device can be at least about 10 cm of the catheter length. The length can be from about 4 mm to about 75 cm. The assembled catheter system can be advanced together (by a clip that joins the two components or by two roller sets synchronized to advance them simultaneously) toward an occlusion site within the cerebral blood vessel. The syringe can be coupled to the luer 364 of the navigation catheter 300 before being withdrawn from the catheter lumen. The syringe closes the lumen and thus the system 150 thereby maximizes the piston effect during withdrawal of the navigation catheter 300. The navigation catheter 300 can then be withdrawn at a selected speed (e.g., from 20 to 25 cm per second to about 160 cm per second) using the robotic drive system 600.

[0073] The elongated body 360 can have an overall shape profile from a proximal end to a distal end that transitions from a first outer diameter having a first length to a tapered outer diameter having a second length. The first length of this first outer diameter region (i.e., the snap-fit region between the distal lumen portion 222 and the elongated body 360) can be at least about 5 cm, or 10 cm, up to about 50 cm. In other embodiments, the snag fit region can extend from the proximal tab or luer 364 to the substantially tapered distal end region 346, which can be up to about 170 cm depending on the length of the navigation catheter 300.

[0074] In some embodiments, the length of the tapered outer diameter of the distal end region 346 can be from 1 cm to 4 cm. In other embodiments, the length of the tapered outer diameter can span a length from 0.5 cm to 5 cm. In yet other embodiments, the length of the tapered outer diameter can span a length from 2 cm to 3 cm. The distal end region 346 of the elongated body 360 can also be shaped with or without a taper. When the navigation catheter 300 is inserted through the catheter 200, this distal end region 346 is configured to extend beyond and protrude through the most distal end 215 of the lumen portion 222, while the more proximal region of the body 360 (i.e., the first length described above) remains within the lumen portion 222.

[0075] As described above, the distal end 215 of the lumen portion 222 is blunt and can have no change in the outer diameter dimension, but the distal end region 346 is tapered and can provide an overall elongated tapered shape of the catheter system. The outer diameter of the elongated body 360 also approaches the inner diameter of the lumen portion 222 such that the step-up from the outer diameter of the elongated body 360 to the outer diameter of the lumen portion 222 is minimized. By minimizing this step-up, when the distal end region 346, in combination with the distal end region of the catheter 200, bends and curves along the vascular anatomical structure, the problem of lips formed by the distal end of the lumen portion 222 getting caught on a tortuous neurovascular system such as around the carotid siphon near the ophthalmic artery bifurcation is prevented. In some embodiments, the inner diameter of the lumen portion 222 can be at least about 0.052 inches (1.321 mm), about 0.054 inches (1.372 mm), the maximum outer diameter of the elongated body 360 can be about 0.048 inches (1.219 mm), and the difference between them is about 0.006 inches (0.1524 mm). In some embodiments, the inner diameter of the lumen portion 222 can be about 0.070 inches (1.778 mm), the maximum outer diameter of the elongated body 360 can be about 0.062 inches (1.575 mm), and the difference between them is about 0.008 inches (0.2032 mm). In some embodiments, the inner diameter of the lumen portion 222 can be about 0.088 inches (2.235 mm), the maximum outer diameter of the elongated body 360 can be about 0.080 inches (2.032 mm), and the difference between them is about 0.008 inches (0.2032 mm). In some embodiments, the inner diameter of the lumen portion 222 can be about 0.072 inches (1.829 mm), the maximum outer diameter of the elongated body 360 can be about 0.070 inches (1.778 mm), and the difference between them is only two thousandths of an inch (0.002 inches / 0.0508 mm). In other embodiments, the maximum outer diameter of the elongated body 360 is about 0.062 inches (1.575 mm) such that the difference between them is about 0.010 inches (0.254 mm).Despite the outer diameter of the elongated body 360 extending through the lumen of the lumen portion 222, the lumen portion 222 and the elongated body 360 extending coaxially therethrough are flexible enough to navigate tortuous anatomical structures that reach the level of the M1 or M2 artery without twisting and damaging the blood vessel.

[0076] The dimensions provided herein are approximate values, and each dimension can have design tolerances or acceptable limits of variation. The use of the terms "about," "approximately," or "substantially" is intended to provide such an allowable tolerance to the dimension being referred to. "About" or "approximately" or "substantially" is not used herein for specific dimensions where the dimension need not be exact.

[0077] The length of the tapered distal end region 346 can vary. In some embodiments, the length of the distal end region 346 can range from about 0.50 cm to about 4.0 cm, or from about 1.0 cm to about 3.0 cm, from the most distal end of the elongated body 360. In other embodiments, the length of the distal end region 346 is from 2.0 cm to about 2.5 cm. In some embodiments, the length of the distal end region 346 varies according to the inner diameter of the catheter 300 in which the navigation catheter 200 is used. For example, the length of the distal end region 346 can be shorter (e.g., 1.2 cm) for a navigation catheter 300 sized to be used with a catheter 200 having an inner diameter of about 0.054 inches (1.372 mm), and can be longer (e.g., 2.5 cm) for a navigation catheter 300 sized to be used with a catheter 200 having an inner diameter of about 0.088 inches (2.235 mm). The distal end region 346 can have a constant taper from a larger outer diameter of the elongated body 360 to a second, smaller outer diameter at the most distal end. In some embodiments, the constant taper of the distal end region 346 can be from an outer diameter of about 0.048 inches to an outer diameter of about 0.031 inches (0.787 mm) over a length of about 1 cm. In some embodiments, the constant taper of the distal end region 346 can be from an outer diameter of 0.062 inches (1.575 mm) to an outer diameter of about 0.031 inches (0.787 mm) over a length of about 2 cm. In yet another embodiment, the constant taper of the distal end region 346 can be from an outer diameter of 0.080 inches (2.032 mm) to an outer diameter of about 0.031 inches (0.787 mm) over a length of about 2.5 cm. The length of the constant taper of the distal end region 346 can vary, for example, between 0.8 cm and about 2.5 cm, or between 1 cm and 3 cm, or between 2.0 cm and 2.5 cm. The angle of the taper can vary according to the outer diameter of the elongated body 360. For example, the angle of the taper can be between 0.9 degrees and 1.6 degrees relative to the horizontal. The angle of the taper can be between 2 and 3 degrees from the centerline of the elongated body 360. The length of the taper of the distal end region 346 can be from about 5 mm to 20 mm or from about 20 mm to about 50 mm.

[0078] The lumen 368 of the elongated body 360 of the navigation catheter 300 can have an inner diameter that does not vary over the length of the elongated body even in the presence of the taper of the distal end region 346. Thus, the inner diameter of the lumen 368 extending through the tubular portion of the navigation catheter 300 can remain uniform, and the wall thickness of the distal end region 346 can be decreased to provide a taper. The wall thickness can be thinned distally along the length of the taper. Thus, all of the material properties combined with the wall thickness, angle, and length of the taper can contribute to the overall maximum flexibility of the most distal end of the distal end region 346. The navigation catheter 300 transitions in flexibility from the most distal end toward the snag point, where it achieves an outer diameter that differs from the inner diameter of the catheter 200 by about 0.010 inches (0.254 mm) or less.

[0079] The length of the taper can also vary according to the anatomical structure of the target region. The distal end region 346 can achieve its flexible and non-traumatic flexible properties due to material properties other than changes in outer dimensions in order to facilitate intravascular guidance to an embolism within a tortuous anatomical structure. Additionally or alternatively, the distal end region 346 of the elongate body 360 can have a flexible transition along its length. The most flexible region of the distal end region 346 can be its distal end. Move along the length of the distal end region 346 from the distal end towards a region proximal to the distal end. For example, the distal end region 346 can be formed of a material having a Shore material hardness of 35D or less or about 62A or less, transitioning proximally to a material having a material hardness of 55D and 72D or less up to the proximal extension 366, and the proximal extension 366 can be a stainless steel hypo tube, or a combination of material properties and taper shape. The material used to form the region of the elongate body 360 can include a blend of PEBAX (PEBAX 25D, 35D, 55D, 69D, 72D, etc.) or PEBAX (for example, a mixture of 25D and 35D, 25D and 55D, 25D and 72D, 35D and 55D, 35D and 72D, 55D and 72D, etc., and the blend ratio can range from 0.1% to 50% for each PEBAX durometer) and a lubricious additive compound such as silicone or Mobilize (Compounding Solutions, Lewiston, Maine). In some embodiments, the material used to form the region of the elongate body 360 can be Tecothane 62A. Incorporating a lubricious additive directly into the polymeric elongate body means that the incorporation of a separate lubricious liner such as PTFE, FEP, or HDPE liner is not required. This enables a more flexible element that can navigate the distal brain anatomy and is less likely to kink. Similar materials can be used to form the distal lumen portion 222 of the catheter 200 that provides similar advantages. The flexibility of the distal end region 346 can be achieved by a combination of a flexible lubricious material and a taper shape.For example, the length of the distal end region 346 can be kept shorter than 2 cm to 3 cm. However, since the flexible material changes from the most distal end 325 towards a more proximal region away from the most distal end 325, optimal deliverability can be maintained. In one embodiment, the elongated body 360 is formed of a PEBAX (polyether block amide) - embedded silicone designed to maintain the highest flexibility. The wall thickness at the distal end of the lumen portion 222 can also be made sufficiently thin so that the lip formed by the distal end of the lumen portion 222 with respect to the elongated body 360 is minimized.

[0080] The elongated body 360 can have a relatively large outer diameter that is slightly smaller than the inner diameter of the distal lumen portion 222 of the catheter 200 by 0.003 inches to 0.010 inches (0.0762 mm to 0.254 mm), and has an advantage over micro - catheters in that it still maintains a high flexibility for navigating tortuous anatomical structures. If the gap between the two components is overly narrow (e.g., less than about 0.003 inches (0.0762 mm)), the force required to slide the navigation catheter 300 relative to the catheter 200 may damage one or both of the components and increase the risk to the patient during the procedure. The gap results in a fit that is too tight to provide optimal relative sliding. If the gap between the two components is too loose (e.g., greater than about 0.010 inches / 0.254 mm), the distal end of the catheter 200 is likely to form a lip that catches on the branched blood vessels while advancing through a tortuous neurovascular system such as around the carotid siphon where the ophthalmic artery branches, and can reduce or lose the piston effect of the withdrawal of the elongated body 360.

[0081] The ID / OD gap between the elongated body 360 and the distal lumen portion 222 can be in this size range (e.g., 0.003 inches to 0.015 inches (0.0762 mm to 0.381 mm) or 0.006 inches to 0.010 inches (0.152 mm to 0.254 mm)) along most of their lengths. For example, the elongated body 360 can have a relatively uniform outer diameter between about 0.048 inches (1.219 mm) and about 0.080 inches (2.032 mm) from the proximal end region to the distal end region and up to the point where the taper of the distal end region 346 begins. Similarly, the distal lumen portion 222 of the catheter 200 can have a relatively uniform inner diameter that is about 0.054 inches (1.372 mm) to about 0.088 inches (2.235 mm) from the proximal end region to the distal end region. Thus, the difference between the respective inner and outer diameters along most of their lengths can be within this gap size range of 0.003 inches to 0.015 inches (0.0762 mm to 0.381 mm). The distal end region 346 of the tapered elongated body 360 has a larger gap size relative to the inner diameter of the distal lumen portion 222. However, in use, this tapered distal end region 346 is configured to extend distally relative to the distal end of the catheter 200 such that the region of the elongated body 360 having an outer diameter that matches the inner diameter of the distal lumen portion 222 is positioned within the lumen of the catheter 200 so as to minimize the distal lip of the catheter 200.

[0082] The elongated body 360 can be formed of various materials that provide suitable flexibility and lubricity. Exemplary materials include high density polyethylene, 77A PEBAX, 33D PEBAX, 42D PEBAX, 46D PEBAX, 54D PEBAX, 69D PEBAX, 72D PEBAX, 90D PEBAX, and mixtures thereof, or equivalent stiffness and lubricity materials. In some embodiments, the elongated body 360 is an un-reinforced non-torque transmitting catheter having a relatively large outer diameter designed to fill the lumen into which it is inserted and a relatively small inner diameter to minimize the gap at the end facing the distal end of the device. In other embodiments, at least a portion of the elongated body 360 can be reinforced to improve navigation and torque transmission (e.g., a braided reinforcement layer). The flexibility of the elongated body 360 can increase towards the distal end region 346, such that the distal region of the elongated body 360 is softer, more flexible, articulates, and bends more easily than the more proximal regions. For example, the more proximal regions of the elongated body can have a flexural stiffness that is flexible enough to navigate tortuous anatomical structures such as the carotid siphon without twisting. If the elongated body 360 has a braided reinforcement layer along at least a portion of its length, the braided reinforcement layer can terminate at a proximal distance from the distal end region 346. For example, the distance from the end of the braid to the most distal end 325 can be about 10 cm to about 15 cm, or about 4 cm to about 10 cm, or about 4 cm to about 15 cm.

[0083] As described above, the elongated body 360 can be generally tubular along at least a portion of its length such that a single lumen 368 extends parallel to the longitudinal axis of the navigation catheter 300 (see FIGS. 3A-3C). In one embodiment, the single lumen 368 of the elongated body 360 is sized to accommodate a guidewire 500, but use of the navigation catheter 300 generally obviates the need for a guidewire lead. Preferably, the assembled system is guidewire-free. The guidewire is designed to be very flexible so as to deflect to navigate tight curves in the anatomical structure. However, many workhorse guidewires are rigid along their longitudinal axes and / or have an outer diameter small enough to find their own path through rather than around an occlusion. In some cases, these guidewires can cause perforation and / or dissection of the blood vessel itself. Thus, even if the outer diameter of the distal tip region of the guidewire is small and the distal tip is very flexible, the guidewire typically cannot non-invasively probe an occlusion. The guidewire does not deflect upon encountering the proximal face of the occlusion. Instead, the guidewire embeds and penetrates the occlusion. The navigation catheter 300 has flexibility, taper, and sizing to find and / or create a space to slide between a portion of the occlusion and the vessel wall rather than penetrate like a guidewire. A method of using the navigation catheter 300 as a rescue guidewire to deliver a catheter to a distal region of the brain without a guidewire or using a guidewire 500 retained within the lumen 368.

[0084] The guide wire 500 can extend substantially concentrically through a single lumen 368 from the proximal opening to the distal opening 326 at the most distal end 325 of the navigation catheter 300. In some embodiments, the proximal opening is at the proximal end of the navigation catheter 300 such that the navigation catheter 300 is configured for an over-the-wire (OTW) method. In other embodiments, the proximal opening is a rapid exchange opening through the wall of the navigation catheter 300 such that the navigation catheter 300 is configured to be rapidly exchanged rather than or in addition to OTW. In this embodiment, the proximal opening extends through the side wall of the elongated body 360 and is located distally of the proximal tab or luer 364 and distally of the proximal extension 366. The proximal opening can be disposed at a distance from about 10 cm from the distal end region 346 to about 20 cm from the distal end region 346. In some embodiments, the proximal opening can be disposed near the region where the elongated body 360 is joined to the proximal extension 366, for example, immediately distal to the end of the hypo tube. In other embodiments, the proximal opening is disposed more distally, such as from about 10 cm to about 18 cm from the most distal end of the elongated body 360. A proximal opening located near the distal end region 346 allows for easier removal of the navigation catheter 300 from the catheter 200 while leaving the guide wire in place for a "rapid exchange" type of procedure. The rapid exchange can rely on only a single person to perform the exchange. The navigation catheter 300 can be easily replaced with another device using the same guide wire remaining in place. The single lumen 368 of the elongated body 360 can be configured to receive a guide wire in the range of 0.014 inches (0.356 mm) to 0.018 inches (0.457 mm) in diameter, or in the range of 0.014 inches to 0.022 inches (0.356 mm to 0.559 mm). In this embodiment, the inner lumen diameter of the elongated body 360 can be 0.020 inches to 0.024 inches (0.508 mm to 0.610 mm). The guide wire, the navigation catheter 300, and the catheter 200 can all be assembled coaxially for insertion through the working lumen of the guide sheath 400.The inner diameter of the lumen 368 of the elongated body 360 can be from 0.019 inches to about 0.021 inches (0.483 mm to 0.533 mm). The distal opening from the lumen 368 can have an inner diameter of from about 0.018 inches to about 0.024 inches (0.457 mm to 0.610 mm).

[0085] The region near the distal end region 346 can be tapered such that the outer diameter tapers over a length of from about 1 cm to about 4 cm. In some embodiments, the distal taper length is about 2.5 cm. In other embodiments, the distal taper is over a length of from about 0.5 cm to about 5 cm, or from about 1 cm to 4 cm, or from about 2 cm to about 3 cm. The larger outer diameter can be at least about 1.5 times, 2 times, 2.5 times, or about 3 times larger than the smaller outer diameter. The distal end region 346 can taper along the distance from the first outer diameter to the second outer diameter, and the first outer diameter is at least 1.5 times the second outer diameter. In some embodiments, the distal end region 346 tapers from about 0.080 inches (2.032 mm) to about 0.031 inches (0.787 mm). In some embodiments, the smaller outer diameter at the distal end of the taper can be from about 0.026 inches (0.66 mm) to about 0.040 inches (1.016 mm), and the larger outer diameter proximal to the taper can be from about 0.062 inches (1.575 mm) to about 0.080 inches (2.032 mm). Also, the distal end region 346 can be formed of a material having a material hardness that transitions in a proximal direction towards a stiffer material up to the proximal extension 366 (e.g., 55D and 72D) (e.g., 62A and 35D). The first segment of the elongated body 360 including the distal end region 346 can be formed of a material having a material hardness of 35D and a length of from about 10 cm to about 12.5 cm. The first segment of the elongated body 360 including the distal end region 346 can be formed from a material having a material hardness of 62A and a length of from about 10 cm to about 12.5 cm. The second segment of the elongated body 360 can be formed of a material having a material hardness of 55D and a length of from about 5 cm to about 8 cm. The third segment of the elongated body 360 can be formed of a material having a material hardness of 72D, which can have a length of from about 25 cm to about 35 cm. The combined three segments can form the insert length of the elongated body 360 from the location where the proximal extension 366 joins the elongated body 360 to the end of the distal end region 346, which can be a length of about 49 cm.

[0086] The navigation catheter 300 has a flexible distal occlusive probe tip region 346 having a length in the range of 1 cm to 5 cm that tapers from a proximal outer diameter (e.g., about 1.58 mm to about 2.03 mm) to a distal outer diameter (e.g., about 0.66 mm to about 0.79 mm). The atraumatic tip region 346 is preferably radiopaque. The tapered tip region 346 has flexibility that allows it to bend away from the high-density occlusion generally toward the vessel wall. The deflection encounters resistance to further axial movement from a generally organized or high-density occlusion within the flexible blood vessel having an inner diameter of about 2 - 5 mm for an occlusion located within the MCA, or a larger inner diameter of up to about 8 mm for an occlusion located proximal to the MCA, such as within the ICA, when advancing the navigation catheter through the vessel. The tip region 346 is disposed to deflect from the proximal face of the occlusion generally toward the vessel wall and in some cases at least partially move under the proximal face of the occlusion, and when an additional force is applied to press the occlusive probe tip against the occlusion, about 0 mm to about 3 cm of the occlusive probe tip extends between the obstacle and the vessel wall. Conventional catheters and guidewires have tip structures that tend to embed in the occlusion, as opposed to probing the front face of the occlusion to find space or deflecting away from the proximal face. The guidewire has a small outer diameter and a flexible distal tip. Despite the small outer diameter and flexibility, the guidewire tip cannot explore the occlusion according to the methods provided herein. Rather, the guidewire tip structure results in the guidewire invading and embedding within or passing through the occlusion, particularly when used with a microcatheter that provides a centering effect to the guidewire, which is preferably avoided in aspiration thrombectomy. The tapered distal tip region 346 of the navigation catheter 300 explores the occlusion such that the tip deflects and slides between the proximal face of the occlusion and the vessel wall.

[0087] The distal end region of the guide wire has a profile that is much smaller compared to the profile of the distal tip region 346 of the navigation catheter. The outer diameter of the guide wire also remains small along its length compared to the navigation catheter which expands to a larger outer diameter that moves proximally by only a few centimeters. Similarly, the force per unit area of the guide wire is much higher compared to the navigation catheter. A guide wire used in the neurovascular system, particularly at the level of the MCA, can have an outer diameter of 0.014 inches (0.36 mm) at the distal end and a distal side contact area of approximately 1.50×10-4 square inches (0.100 mm2). The outer diameter of the distal end of the navigation catheter can be approximately 0.031 inches (0.79 mm), and the inner diameter of the distal end of the navigation catheter can be approximately 0.021 inches (0.53 mm). The distal side contact area of the navigation catheter can be approximately 8.00×10-4 square inches (0.5 mm2) when the lumen is filled with a column of fluid and / or a guide wire. The distal side contact area of the navigation catheter can be approximately 4.20×10-4 square inches (0.27 mm2) with just the annular distal side surface without a column of fluid or guide wire in the lumen. Nevertheless, the force per unit area of the guide wire is significantly greater (i.e., about 2 to 5 times greater) than the force per unit area of the navigation catheter. The force per unit area of a 0.014-inch guide wire for a 1 N force is about 6,700 N / square inch (10 N / mm2), whereas the force per unit area of the navigation catheter is about 1,300 N / square inch (2 N / mm2) to about 2,400 N / square inch (4 N / mm2). The profile of the guide wire, in combination with the force per unit area of the guide wire (and the centering effect provided by the microcatheter), increases the risk of embolism penetration rather than deflection when encountering the proximal face of the embolism. The profile of the navigation catheter, including a larger outer diameter at the distal end, a relatively short taper to an even larger outer diameter, and its high flexibility, results in the navigation catheter being unable to penetrate the embolism and instead deflecting away from the proximal face of the embolism when encountering an embolism within the blood vessel.The guide wire penetrates the plug or the blood vessel wall. In contrast, the navigation catheter probes and deflects from the plug and finds the space and wedge without penetrating the plug or the blood vessel wall until the final resting spot.

[0088] When encountering the plug or the blood vessel wall, it is desirable to have a specially configured tip region to ensure that the tip region deflects with respect to the plug and does not penetrate the plug or the blood vessel wall. The tip region deflects until a path or space is found. This is achieved by having a sufficient degree of flexibility of a fully polymeric distal tip region that includes a taper over its length such that the tip region easily flexes when contacting the proximal surface of the plug. The flexibility and shape of the tapered tip region result in a tip region that protrudes from the aspiration catheter while advancing through the blood vessel and passes through a less organized or less dense thrombotic material until the tip region encounters the true proximal surface of the plug. The tip region then deflects away from the organized or dense portion of the plug, for example, to wedge between the plug and the blood vessel wall. The tip region is configured to find a path of least resistance in a non-invasive manner such that it is flexible enough or not bendable enough to fold over itself and advance.

[0089] The most distal tip of the tip region can have a smooth and relatively round shape with a low friction outer surface that tends to facilitate the deflection of the tip region with respect to the proximal surface of the plug. The distal tip portion can also be radiopaque for embedding materials within the polymer, as described in more detail below.

[0090] The navigation catheter 300 can incorporate a reinforcement layer. The reinforcement layer can be a coil, braid, or other type of reinforcement for bridging components of the navigation catheter 300 having such differences in flexibility. The braided reinforcement layer can bridge the transition from the rigid proximal extension 366 to the flexible elongated body 360. In some embodiments, the reinforcement layer can be a braid disposed between an inner layer and an outer layer of PEBAX. The reinforcement layer can terminate at a proximal distance of the distal end region 346. The distal end region 346 can be formed of a material having a material hardness of up to about 35D. The first segment can be a non-reinforced polymer having a length from about 4 cm to about 12.5 cm without metal reinforcement. The third segment of the elongated body 360 located proximally to the first segment can include a reinforcement layer and can extend a total of about 37 cm to the non-reinforced distal segment. The proximal end region of the reinforcement layer can overlap the distal end region of the proximal extension 366 such that there is a slight overlap of the hypo tube and the reinforcement material near the transition between the proximal extension 366 and the elongated body 360.

[0091] The entry port for the treatment guide wire can be disposed away from the most distal end of the elongated body 360. In some embodiments, the entry / exit port can be about 18 cm from the most distal end and forms a rapid exchange wire entry / exit segment. The outer diameter of the elongated body 360 within the first two segments can be from about 0.080 inches to 0.082 inches (2.032 mm to 2.083 mm), but the third segment proximal to this rapid exchange wire entry / exit segment can have a decrease in outer diameter, such as from about 0.062 inches to 0.064 inches (1.575 mm to 1.626 mm).

[0092] In other embodiments, the entire navigation catheter 300 can be a tubular element configured to receive a guidewire through both the proximal extension 366 and the elongated body 360. For example, the proximal extension 366 can be a hypo tube or tubular element having a lumen that communicates with a lumen 368 that extends through the elongated body 360 (shown in FIG. 1C). In some embodiments, the proximal extension 366 can be a stainless steel skived hypo tube coated with PTFE having an outer diameter of 0.026 inches (0.660 mm). In other embodiments, the outer diameter can be from 0.024 inches (0.610 mm) to 0.030 inches (0.762 mm). In some embodiments, such as the over-the-wire version, the proximal extension 366 can be a skived hypo tube coupled to the proximal hub or luer 364. The proximal extension 366 can extend eccentrically or concentrically with respect to the distal lumen portion 222. The proximal extension 366 can be a stainless steel hypo tube. The proximal extension 366 can be a solid metal wire having a circular or oval cross-sectional shape. The proximal extension 366 can be a flat wire ribbon having a rectangular cross-sectional shape. The wire ribbon can be curved into a circular, oval, C-shaped, or 1 / 4 circle, or other cross-sectional shape along an arc. The proximal extension 366 can have any of a variety of cross-sectional shapes, including circular, oval, C-shaped, D-shaped, or other shapes, whether or not a lumen extends through it. In some embodiments, the proximal extension 366 is a hypo tube having a D-shaped cross-section where the inner-facing side is flat and the outer-facing side is rounded. The rounded side of the proximal extension 366 can be shaped to engage the corresponding rounded inner surface of the sheath 400. The hypo tube can have a lubricious coating such as PTFE. The hypo tube can have an inner diameter of about 0.021 inches (0.533 mm), an outer diameter of about 0.0275 inches (0.699 mm), and an overall length of about 94 cm that provides a working length of the navigation catheter 300 of about 143 cm. Including the proximal luer 364, the navigation catheter 300 can have an overall length of about 149 cm.In some embodiments, the hypotube can have a tapered portion that begins proximally at a thickness of 0.3 mm and ends at a thickness of 0.10 mm to 0.15 mm and has a length of approximately 100 mm. In yet another embodiment, the elongate body 360 can be a solid element coupled to a proximal extension 366 that does not have a guidewire lumen.

[0093] The proximal extension 366 is shown in FIG. 3A as having an outer diameter that is smaller compared to the outer diameter of the elongate body 360. The proximal extension 366 need not have a decreasing outer diameter and can have the same outer diameter as the elongate body 360. For example, the proximal extension 366 can incorporate a hypotube or other reinforcing element coated by one or more layers of polymer, resulting in a proximal extension 366 having substantially the same outer diameter as the elongate body 360.

[0094] At least a portion of the solid elongate body 360, such as the elongate distal region 346, can be formed of, embedded with, or attached to a malleable material that tapers to a smaller dimension at the distal end. The distal region 346 can be shaped into a desired angle or shape similar to the ways in which a guide wire can be used. The malleable length of the elongate body 360 can be at least about 1 cm, 3 cm, 5 cm, and up to about 10 cm, 15 cm, or more. In some embodiments, the malleable length can be about 1%, 2%, 5%, 10%, 20%, 25%, 50% or more of the total length of the elongate body 360. In some embodiments, the navigation catheter 300 can have an operating length of about 140 cm to about 143 cm, and the elongate body 360 can have an insertion length of about 49 cm. The insert length can be the PEBAX portion of the elongate body 360 that is about 49.5 cm. Thus, the malleable length of the elongate body 360 can be from about 0.5 cm to about 25 cm or more. The shape change can be a function of the operator manually shaping the malleable length prior to insertion into the patient, or the distal region 346 can be pre-shaped into a specific angle or curve during manufacture. Alternatively, the shape change can be a reversible and actuatable shape change such that the distal region 346 forms a shape when actuated by the operator, whereby the distal region 346 can be used in a straight configuration until the shape change is desired by the operator. The navigation catheter 300 can also include a shaping mandrel extending through the lumen of the elongate body 360 such that the physician can shape the distal region 346 into a desired shape during use. Thus, the shapeable distal region 346 can be incorporated into the elongate body 360 having a guide wire lumen.

[0095] The elongated body 360 can extend along the entire length of the catheter 200 including the distal lumen portion 222 and the proximal extension 230, or the elongated body 360 can incorporate a proximal extension 366 that aligns substantially alongside the proximal extension 230 of the catheter 200. The proximal extension 366 of the elongated body 360 can be disposed coaxially or eccentrically with respect to the elongated body 360. The proximal extension 366 of the elongated body 360 can have a lumen extending therethrough. Alternatively, portion 366 may be a solid rod or ribbon without a lumen.

[0096] Referring again to FIGS. 3A - 3C, similar to the distal lumen portion 222 of the catheter 200, the elongated body 360 can have one or more radiopaque markers 344 along its length. The one or more markers 344 can vary in size, shape, and position. One or more markers 344 can be incorporated along one or more portions of the navigation catheter 300, such as tip - to - tip markers, tip - to - taper markers, RHV proximity markers, fluoroscopy - saving markers, or other markers that provide various information regarding the relative positions of the navigation catheter 300 and its components. The tubular portion 360 of the navigation catheter 300 can have a radiopaque marker band embedded within or disposed on the wall of the tubular portion 360 near the distal end region 346. In some embodiments, as best shown in FIG. 3C, the distal end region can have a first radiopaque marker 344a, and a second radiopaque marker 344b can be positioned to indicate the boundary between the tapered distal end region 346 and a more proximal region of the elongated body 360 having a uniform or maximum outer diameter. The first radiopaque marker band 344a can be found at the distal end of the tapered distal end region 346, and the second radiopaque marker band 344b can be found at the proximal end of the tapered distal end region 346. The proximal radiopaque marker band 344b can have a proximal edge, a distal edge, and a width between the proximal and distal edges. This provides information to the operator and / or the robotic drive system 600 regarding the optimal extension of the distal end region 346 relative to the distal end of the lumen portion 222, minimizing the lip of this distal end of the lumen portion 222 for advancing through tortuous anatomical structures. When in the advancing configuration, the proximal edge of the radiopaque marker band 344b can be substantially aligned with the distal end of the distal catheter portion 222 such that the radiopaque marker band 344b remains outside the lumen 223 of the distal catheter portion 222.At least a portion of the radiopaque marker band 344b can be disposed at a snag point, or at a point of the navigation catheter 200 where the outer diameter is about 0.010 inches (0.254 mm) or less, preferably about 0.006 inches to 0.008 inches (0.152 mm to 0.203 mm) smaller than the inner diameter of the catheter 300 disposed therein. At least one snag point of the tubular portion 360 can be disposed proximal to the distal end region 346 and can be at a location where the taper of the distal end region 346 substantially terminates. This enables a complete extension of the tapered distal end region 346 outside the distal end of the catheter 200 and a snag point substantially aligned from the lumen 223 of the distal catheter portion 222 into the distal opening 231, thereby minimizing any distal-facing lip that can be formed by the catheter 200. The snag point can be disposed along at least a portion of the length of the outer diameter of the tubular portion 360 having a length of at least about 5 cm to about 10 cm, and the outer diameter can be substantially uniform or non-uniform.

[0097] The distal end region 346 can have a constant taper from a larger outer diameter of the elongated body 360 (e.g., the distal end of the marker 344b) to a second, smaller outer diameter at the most distal end (e.g., the proximal end of the marker 344a). In other embodiments, for example, where the distal end region 346 is not necessarily tapered and has an overall change in flexibility along its length, the second radiopaque marker 344b can be disposed to indicate a region where the relative flexibility of the elongated body 360 (or the distal end region 346 of the elongated body 360) and the distal end of the lumen portion 222 is substantially the same. The marker material can be a platinum / iridium band, tungsten, platinum, or tantalum-impregnated polymer, or other radiopaque marker that does not affect the flexibility of the distal end region 346 and the elongated body 360. In some embodiments, the radiopaque marker is an extruded PEBAX loaded with tungsten for radiopacity.

[0098] The distal marker 344a near the most distal end 325 of the navigation catheter 300 can be distinguished from the distal marker 224a on the catheter 200 by its characteristic appearance under fluoroscopy and by simply moving the non-invasive navigation catheter 300 back and forth to understand the relationship and positioning of the navigation catheter 300 relative to the catheter 200. A second marker 344b on the navigation catheter 300 proximal to the most distal tip marker 344a can delineate the taper of the distal end region 346, i.e., the outer diameter of the navigation catheter 300 has a size sufficient to reduce the "lip" of the transition between the navigation catheter 300 and the catheter 200 into which it is inserted and configured to be delivered. The marker serves to position the navigation catheter 200 relative to the distal end 215 of the aspiration catheter 300 such that the tip 215 of the catheter 200 is aligned with the taper of the navigation catheter 300 and optimal alignment is facilitated. In some embodiments, the proximal marker band can be about 2.0 mm wide and the distal marker band can be about 2.5 mm wide to provide distinguishable information regarding the distal end region 346.

[0099] The relationship between the distal tip marker 224 of the aspiration catheter 200 and the taper marker 344b of the navigation catheter 300 (i.e., the proximal marker or proximal end of the distal taper marker if only one marker is incorporated to identify the start of the taper) is at or preferably immediately proximal to the taper marker 344b of the navigation catheter 300 and is identifiable in a tandem marker system. The paired elements 224, 344b are in a "tip-to-taper" position. The relative extension between the navigation catheter 300 and the catheter 200 can be adjusted when inserting the system into the RHV. However, the relative extension can change as it advances through the sheath or guide catheter. When the system exits the guide catheter, the aspiration catheter 200 and the navigation catheter 300 can be adjusted so that the tip-to-taper position is assumed when the system crosses the often tortuous proximal blood vessel (e.g., the internal carotid artery in the neck) towards a more distal target. The system of the aspiration catheter 200 and the navigation catheter 300 can be locked in their relative extension so that the juxtaposition of the navigation catheter 300 and the aspiration catheter 200 is maintained. When the aspiration catheter 200 is visualized within or slightly beyond the distal end of the sheath, the navigation catheter 300 can be adjusted to assume an appropriate position relative to the catheter before advancement resumes. The optimal relative extension between the distal marker 224 of the catheter 200 and the taper marker 344b on the navigation catheter 300 is maintained through as many anatomical structures as possible, maximizing the delivery ability of the navigation catheter 300 to navigate both tortuosities and avoid collateral branches such as the ophthalmic artery. When the desired site is reached, the navigation catheter 300 can be left fixed and the aspiration catheter 200 advanced over the navigation catheter 300 towards the thrombus without crossing the thrombus with the catheter 200. Alternatively, as described elsewhere in this specification, the navigation catheter 300 can be withdrawn proximally and the catheter 200 can ride on the momentum of the force accumulated distally towards the thrombus.The retrieval step of the navigation catheter 300 can be performed manually by an operator directly at the patient's location, or via the control station 700 directly or via the robotic drive system 600, or automatically via the robotic drive system 600.

[0100] The catheter 200 and the navigation catheter 300 (with or without a guide wire) can be advanced as a single unit through both turns of the carotid siphon. Both turns can be traversed in a single smooth passage to a target within the cerebral vasculature without stepwise adjustment of their relative extension and without relying on conventional stepwise advancement techniques using conventional microcatheters. The catheter 200 having the navigation catheter 300 extending therethrough enables the operator to advance simultaneously (via the robotic drive system 600) from the first bend of the siphon through the second bend beyond the terminal cavernous carotid artery and into the ACA and MCA at the same relative position. Importantly, the advancement of the two components can be performed in a single smooth movement through both bends.

[0101] The navigation catheter 300 can be juxtaposed to the catheter 200 that provides an optimal relative elongation between two components for a single smooth advancement. The navigation catheter 300 can be positioned through the lumen of the catheter 200 such that its distal end region 346 extends just beyond the most distal end 215 of the catheter 200. The distal end region 346 of the navigation catheter 300 eliminates a gradual transition between the inner member and the outer catheter 200, thereby avoiding the problem of snagging on the branched blood vessels within the vascular region such that the catheter 200 can easily traverse the multiple angled turns of the carotid siphon. The optimal relative elongation can be, for example, the distal end region 346 of the elongated body 360 that extends immediately distal to the most distal end 215 of the catheter 200. The length of the distal end region 346 that extends distally relative to the most distal end 215 of the catheter 200 during advancement can be from 0.5 cm to about 4 cm. This juxtaposition can mechanically engage with the mechanical element by the operator holding the two components together and / or by the two components that are fixedly held by the robotic drive system 600.

[0102] The mechanical elements can include a coupling mechanism 250, such as a clip, clamp, C-shaped element, or other connector, configured to receive the proximal portions of the catheters 200, 300. The coupling mechanism 250 can be configured to snap fit together with the proximal extension 366 by an interference fit such that a first level of force is required to insert the proximal extension 366 into the clip of the tab 234 and a second, greater level of force is required to remove the proximal extension 366 from the clip of the tab 234. However, when the proximal extension 366 is inserted into the coupling mechanism 250, the navigation catheter 300 and the catheter 200 can still be adjusted slidably relative to each other along the longitudinal axis of the system. The amount of force required to slidably adjust the relative position of the two components can be such that inadvertent adjustment is avoided and the relative position can be maintained during use, but can be adjusted during conscious change. The configuration of the connection between the proximal extension 366 of the navigation catheter 300 and the proximal control element 230 of the catheter 200 can vary. However, generally, the connection is configured to be relatively user-friendly (e.g., enabling use with one hand), reversible, and adjustable while still providing sufficient holding force between the two elements in a way that weaves the proximal ends of the components (e.g., preventing the proximal control element 230 and the proximal extension 366 from twisting and entangling with each other). The coupling mechanism 250 configured to prevent entanglement and assist in the weaving of the proximal portions can be integrated with the tabs or can be a separate mechanism disposed along their proximal end regions.

[0103] The component can be advanced over a pre-positioned guidewire 500 or without a guidewire, together with the guidewire 500. In some embodiments, the guidewire 500 can be pre-assembled with the navigation catheter 300 and the catheter 200 such that the guidewire 500 extends through the lumen 368 of the navigation catheter 300, which is loaded through the lumen 223 of the catheter 200, all prior to insertion into the patient. The pre-assembled components can be simultaneously inserted into the sheath 400 and advanced together through and past the turn of the carotid siphon. The guidewire 500 is disposed within the lumen 368 of the navigation catheter 300 and can be stopped proximal to the tapered distal end region 346 or proximal to the distal tip 325 for potential use if the navigation catheter 300 without a guidewire does not reach the target position. For example, the distal tip of the guidewire can be disposed approximately 5 cm to approximately 40 cm proximal, or approximately 20 cm to approximately 30 cm proximal, to the distal end region 346 of the navigation catheter 300. At this position, the guidewire 500 does not interfere with the performance or function of the navigation catheter. The guidewire 500 can be disposed within the lumen 368 of the navigation catheter 300 such that the distal end of the guidewire 500 is within the navigation catheter 300 during the step of advancing the assembled system of the device together and can extend distally out of the distal opening 326 of the navigation catheter 300 when needed for navigation. In one example, the rescue guidewire has the distal end of the guidewire disposed approximately 0 cm to approximately 40 cm proximal, or approximately 5 cm to approximately 35 cm proximal, or approximately 7 cm to approximately 30 cm, preferably approximately 10 cm proximal to the distal end of the navigation catheter, within the lumen of the navigation catheter. The guidewire 500 at this stop position can provide additional support to the proximal portion of the system without affecting the flexibility and performance of the distal portion of the system.

[0104] The use of the navigation catheter 300 having a tapered distal end region 346 enables the delivery of catheters such as large-bore aspiration catheters, and further the catheters described herein having a full-length "over-the-wire" catheter or a proximal extension. The navigation catheter 300 is specifically designed to be able to deliver the catheter 200 without the need for a guide wire. This ability to deliver the catheter 300 without a guide wire (or with the guide wire disposed within the lumen 368 of the navigation catheter 200 and stopped proximal to the distal opening 326 for potential use proximal and / or distal to the tapered distal end region 346) without passing through a plug is based in part on the smooth transition between the outer diameter of the navigation catheter 300 and the catheter 200, as well as the smooth transition in flexibility between the two. When the navigation catheter 300 is bent in an arc greater than 180 degrees, the flexibility and flexibility create a smooth arc without severe bending or twisting of the catheter geometry. Thus, the navigation catheter 300 seeks out larger lumens, in contrast to where most of the blood flow goes towards smaller branched arteries. The distal end region 346 of the navigation catheter 300 can facilitate a strong preference for finding larger blood vessels during advancement into the distal vasculature. This tendency to stay within the main channel allows for the advancement of a large-bore catheter without using a guide wire. The tendency to follow the main channels of blood flow is consistent with the pathophysiology of acute ischemic stroke, where major emboli follow these same paths and tend to block and occlude the antegrade blood flow. Similarly, these main channels are often ideal for the placement of access catheters because these conduit arteries allow smaller catheters to pass through to specific target arteries for therapeutic intervention.

[0105] Standard neurovascular interventions, and nearly all endovascular interventions, are based on the concept that a guidewire guides a catheter to a target location. Guidewires are typically preformed and often find collateral branches at off-target locations where the guidewire converges or deviates, causing time-consuming nuisances during the intervention and often requiring repeated repositioning of the guidewire by the operator to overcome. Further, this tendency for the guidewire to enter a collateral can be dangerous. Guidewires are typically 0.014 inches to 0.018 inches (0.356 mm to 0.457 mm) in neuroanatomical structures, find small branches corresponding to this size, and can often cause trauma, resulting in small bleeding or incisions and occlusions. In sensitive areas such as the brain, these events can be devastating. The tendency for guidewires to bunch and deviate can also cause the tip of the guidewire, which can be advanced alone or as part of a triaxial system to create an incision plane and traumatize small blood vessels. Guidewires are also designed to cross emboli, mainly for the purpose of providing support to secure the guidewire and deliver a catheter over the guidewire. However, crossing an embolus with a guidewire can increase the risk of expelling embolic debris that migrates distally to the occlusion site.

[0106] In contrast, the navigation catheter 300 described herein preferentially remains in the larger lumen of the conduit vessel. In the context of stroke treatment, emboli are propelled to specific anatomical structures due to the blood flow drawn by the arterial system into the anatomical structure of the brain. The navigation catheter 300 tends to cross emboli that are moved from positions such as the heart or the etiology of the carotid artery, along the same path as the path taken by the emboli. The navigation catheter 300 is delivered to the largest lumen within the anatomical structure, even in view of the highly tortuous anatomical structures and curves being navigated. The navigation catheter 300 can preferentially take the larger lumen at the bifurcation while following the flow of the maximum blood flow, thereby maintaining the general direction and angle of the parent vessel. Looking at the standard anatomical structures found in the cerebrovascular system, the circle of Willis is supplied by two vertebral arteries and two carotid canal arteries. Since these four arteries are access points to the brain anatomical structure, the path of the navigation catheter 300 can be identified and has been verified in a standard brain anatomical structure model.

[0107] In the anterior circulation where the catheter arterial entry point for intracranial vascular treatment is the internal carotid artery (ICA), the navigation catheter can guide a large-diameter catheter to the M1 segment of the middle cerebral artery (MCA) that bypasses the anterior communicating artery (ACA) and the anterior temporal branch (ATB). The very flexible nature of the navigation catheter 300, combined with the distal flexibility of most brain catheters, is combined to enable delivery through severe tortuosity. Regardless of the tortuous nature of the arterial path, the navigation catheter 300 tends to navigate turns and deliver from the parent artery to the largest descendants, for example, from the ICA to the M1 segment of the MCA. The M2-level branching of M1 can be variable, but is often seen to have two main M2 branches (superior and inferior) and can be seen to branch "equally" or "unequally" depending on the anatomical structure that can vary significantly between patients. When the M2 branches have similar sizes and angles, the navigation catheter 300 can take one of the two branches. If the target for catheter placement is not at the preferred angle or size of the artery, the navigation catheter 300 can be curved (e.g., via shaping of the flexible distal tip), induced, or a guidewire may be used.

[0108] In some anatomical structures where the size of the M2 bifurcation is "uniform", reciprocating motion can help select one bifurcation and then the other while still avoiding the need or use of a guidewire or a curved distal tip of the navigation catheter. The reciprocating motion can enable the navigation catheter to be directed to either M2 bifurcation. The navigation catheter, even if initially straight, achieves some curvature that helps guide it into the branched blood vessel. Thus, if the operator encounters an M2 bifurcation and wants to insert a cannula into either of the equally divided bifurcations, it is possible to select either bifurcation using the navigation catheter without a guidewire.

[0109] Therefore, the major channels such as the ICA, middle cerebral artery, and its branches in the anterior circulation are, of course, favorable routes for the described navigation catheter and subsequence large-caliber catheter delivery (by access from the ICA). A similar phenomenon can occur in the posterior circulation, which is accessed via the vertebral arteries arising from the left and right subclavian arteries. The navigation catheter takes this major channel in this circulation by crossing through the vertebral artery to the basilar artery and the major branches at the base of the brain, namely the posterior cerebral artery and the superior cerebellar artery during the posterior circulation.

[0110] Navigation using a navigation catheter can provide maximum deliverability with minimal vascular trauma. The blunt end of a large-bore catheter tends to take a greater curve when rounding a blood vessel when pushed by the operator, so the catheter can cause a "shaving" effect on the curved blood vessel. This blunt end can shave or "shave" a larger curve while increasing the risk of incision along the anatomical plane within the layers or in large-sized arteries or veins (see, e.g., Catheter Cardiovasc.Interv. 2014 Feb;83(2):211-20). A navigation catheter can help minimize the edges of these catheters. Positioning the navigation catheter within the lumen of the large-bore catheter so that the taper marker of the navigation catheter is optimally aligned with the distal tip marker of the catheter minimizes the edges and thereby eliminates "shaving" when the large-bore catheter advances through a turn in the blood vessel. This is particularly useful for the anatomical structure of the brain. Treatment of stroke is typically required in the distal region of the carotid siphon, particularly in the distal region of the extraction of the ophthalmic artery from the greater curve of the severe tortuosity of the final turn "S turn" of the carotid siphon, and the "pre-genus" of the carotid siphon is typically seen as part of the terminal internal carotid artery (ICA). The details of the navigation catheter in the proper alignment (the "taper from tip" position indicated by the distal tip marker) within the large-bore catheter with respect to the taper marker of the navigation catheter maximize the possibility of avoiding shaving and hang-up of the ophthalmic artery during manual advancement of the catheter system. The taper marker of the navigation catheter can be placed at or beyond the takeoff of the ophthalmic artery to minimize these adverse effects and allow the large-bore catheter to pass through the ophthalmic artery without incidence. In the relatively straight segment that is common after passing through the siphon, the large-bore catheter can still advance over the navigation catheter that still functions as a guiding element to the target.The transition between the navigation catheter and the distal edge of the large-bore catheter is not significant, particularly as compared to the step changes present in typical microcatheters or guidewires that do not prevent hang-ups at bifurcations such as the ophthalmic artery. The navigation catheter enables the movement of the large-bore catheter to the surface of the thrombus without using a microcatheter or guidewire and without crossing and / or fragmenting the thrombus.

[0111] Robot drive system FIG. 4A is a schematic view of a robotic drive system 600 having a proximal end of a catheter system 150 and a guide sheath 400 disposed within a cassette 605. As described above with respect to FIG. 2, the robotic drive system 600 can include a base console 601 and a cassette 605 that is matingly engageable with the console 601. The robotic drive system 600 can include a controller 610 having one or more input portions 612, output portions 614, and sensors 625. The cassette 605 can include a set of rollers 615 or other type of operating mechanism and a plurality of connectors 620. The guide sheath 400 can be engaged by at least a first connector 620 in the form of a rotary gear. A sheath retainer sleeve 622 (shown in FIG. 2) can be advanced over the guide sheath 400 and connected to a patient access sheath introducer (not shown). The sheath retainer sleeve 622 is slidably attached to the cassette 605 to provide support when the guide sheath 400 is advanced, retracted, or rotated by movement of the cassette 605 and / or arm 603, or advancement of components of the catheter system 150 through the guide sheath 400. The guide sheath 400 can be slidably moved within the sheath retainer. The guide sheath 400 can move within the sheath retainer sleeve 622 through a slit extending along the length of the sheath retainer. The sheath retainer sleeve 622 can include a collapsible portion or a plurality of tubes that slide relative to each other to shorten and lengthen telescopically as the guide sheath 400 is inserted and retracted. The telescoping or collapsible tube provides support to prevent buckling or bending during the procedure.

[0112] The plurality of rollers 615 within the cassette 605 operate the various components of the distal access system 100 when those components are loaded and latched within the cassette 605. The rollers 615 are arranged to optimally operate each component. For example, a roller that operates an outer component can be arranged toward the distal side of the cassette 605, a roller that operates an intermediate component can be arranged more proximally, and a roller that operates an inner component can be arranged even more proximally toward the proximal side of the cassette 605. The roller 615 associated with the innermost component is arranged at the proximal end of the cassette 605. In some cases, multiple sets of rollers 615 can operate a single component. For example, a first set of rollers 615a can operate a first region of the catheter 200 (e.g., the body 222 of the catheter 200 within the roller 615a shown in FIG. 4A), and a second set of rollers 615b can operate a second region of the same catheter 200 (e.g., the smaller diameter proximal control element 230 of the catheter 200 within the roller 615b shown in FIG. 4A). The set of rollers that controls the movement of a component can depend on the extent of the component's extension. For example, the first set of rollers 615a can operate the catheter 200 when the body 222 of the catheter 200 is drawn proximal to the hub 434 of the guide sheath 400 and is disposed outside the hub. The second set of rollers 615b can operate the catheter 200 when the body 222 of the catheter 200 has advanced distally and is disposed completely inside the hub 434 of the guide sheath 400. The second set of rollers 625b can control the forward and backward movement of the catheter 200 when the first set of rollers 615a is no longer in contact with the catheter.

[0113] In some cases, the roller 615 can be aligned with the longitudinal axis A. In other cases, the roller 615 can be offset at an angle from the longitudinal access A, preferably at an angle of 45 degrees or less. Further, some of the rollers can be arranged out of plane at an angle and also relative to most of the rollers on the cassette 605. The number, positioning, and angle of the rollers (i.e., on-axis, angled, out-of-plane) can be configured to optimize the forward and backward movement of each component throughout the movement range of each component. In one example, referring further to FIG. 4A, the cassette 605 can include a first set of rollers 615a located near the connector 620 such that the first set of rollers 615a are positioned proximal to the guide sheath hub 434. This first set of rollers 615a can be aligned such that the component driven through the roller 615a is aligned with the longitudinal axis A. The cassette 605 can include a second set of rollers 615b positioned proximal to the first set of rollers 615a. The second set of rollers 615b can be offset at a constant angle from the longitudinal axis A. The second set of rollers 615b can be out of plane with respect to the rollers 615a such that the component coupled to the roller 615b does not contact the roller 615a. Alternatively, when the roller 615b is actuated, the roller 615a can bounce back or otherwise disengage so as not to impede the movement of the inner component. A third set of rollers 615c can be arranged proximal to the first set of rollers 615a. However, unlike the second set of rollers 615b, the third set of rollers 615c can be aligned with both the first set of rollers 615a and the longitudinal axis A. FIG. 4A shows a fourth set of rollers 615d arranged proximal to the third set of rollers 615c and aligned with the longitudinal axis.

[0114] With further reference to FIG. 4A, the first catheter 200 can be inserted through the working lumen of the guide sheath 400 such that the distal end 215 of the first catheter 200 extends beyond the distal opening 408 of the guide sheath 400. The first catheter 200 can be received through a first set of rollers 615a located proximal to the hub 434 of the guide sheath 400. A second set of rollers 615b, located proximal to the first rollers 615a and offset with respect to the longitudinal axis A, can engage the proximal control element 230 of the first catheter 200. The first catheter 200 can have a navigation catheter 300 extending through its single lumen such that the distal end region 346 extends distally beyond the distal end 215 of the first catheter 200. A third set of rollers 615c can engage the proximal extension 366 of the navigation catheter 300. A fourth set of rollers 615d can engage a guide wire 500 extending through the navigation catheter 300. The rollers 615d can also include means for rotating the guide wire and advancing and retracting the guide wire.

[0115] The rollers can include a soft elastomer capable of engaging different diameters of components, such as thermoplastic elastomers such as Santoprene, silicone, urethane foam, neoprene, etc.

[0116] The number and arrangement of roller sets can vary depending on whether the catheter system being used includes one, two, three, four or more components and / or has multiple diameters. The roller sets need not engage each component of the catheter system. In other words, the number of components being advanced and the number of roller sets can be different. In the example shown in FIG. 4A, the catheter system includes a first catheter 200, a navigation catheter 300 extending through the first catheter 200, and a guide wire 500 extending through the navigation catheter 300. The distal section 222 of the first catheter 200 can be engaged by a first roller set 615a, and the proximal section 230 of the first catheter 200 can be engaged by a second roller set 615b. The first roller set 615a can be aligned with the longitudinal axis A, and the second roller set 615b can be arranged at an angle to the longitudinal axis A. The navigation catheter 300 can be engaged by a third roller set 615c located proximal to the first and second roller sets 615a, 615b. The guide wire 500 can be engaged by a fourth roller set 615d arranged proximal to the third roller set 615c near the proximal end region of the cassette 605. In this example, the system includes three components, each having at least one dedicated roller set. However, the catheter 200 and the navigation catheter 300 need not include their own dedicated roller sets. For example, a single roller set can move both components. In one embodiment, the catheter 200 and the navigation catheter 300 can be clipped or otherwise joined together so that they are advanced / retracted together by a single roller set. In another embodiment, the roller sets can be physically joined to advance two components. Thus, multiple components joined together can be moved by the robotic system 600 using a single roller set when a single component is moved.

[0117] The same roller can be used to advance the multiple components of the catheter assembly 150. Referring again to FIG. 4A, in the initial state of advancement, the large-diameter distal lumen portion 222 of the catheter 200 can be engaged by the first set of rollers 615a, and the proximal portion 230 of the catheter 200 can be engaged by the second set of rollers 615b. When the proximal end of the large-diameter distal lumen portion 222 of the catheter 200 advances inside the RHV 434 of the guide sheath 400, in the second stage of advancement, the advancement of the catheter 200 can be driven through the proximal control element 230 of the catheter 200. The advancement of the catheter 200 can be driven by the second set of rollers 615b engaged with the proximal control element 230, and the robotic drive system 600 transmits the drive of the catheter 200 to that set of rollers 615b instead of the first set of rollers 615a. The first set of rollers 615a can engage and control the movement of the inner navigation catheter 300 while the second out-of-plane set of rollers 615b, which is still engaged with the proximal element 230, continues to control the movement of the catheter 200. Alternatively, the third set of rollers 615c engaged with the inner navigation catheter 300 can continue to control and drive its movement. Any of the various combinations are contemplated herein.

[0118] The movement of the catheter 200 does not require a plurality of rollers of the robotic drive system 600. Rather, the robotic drive system 600 can be configured to operate the catheter 200 with only a single set of rollers that engage the catheter 200, for example, the proximal element 230. The catheter 200 can first be inserted into the guide sheath 400 and manually advanced until the entire lumen portion 222 enters the RHV 434 of the sheath 400. The proximal element 230 can then be inserted between the rollers 615b to enable the robotic drive system 600 to control the movement of the catheter 200. In this embodiment, the robotic drive system 600 can include only one set of rollers 615b for the catheter 200 instead of the two sets 615a, 615b as shown in FIG. 4A. FIG. 4A shows a set of rollers 615b arranged at an angle with respect to the longitudinal axis A, but the dedicated set of rollers for the catheter can be aligned with the longitudinal axis A since the rollers do not need to be out of plane from the rest of the cassette rollers.

[0119] In one embodiment, the catheter system includes two catheters 200 sized to allow one catheter to be nested within the other. For example, the first catheter can have a larger 0.088-inch ID, and the second catheter can have a 0.070-inch ID sized to be inserted within the ID of the first catheter. The first and second catheters can be driven simultaneously when the respective larger diameter portions (distal lumen portions 222) of the first and second catheters extend outside the guide sheath 400. The first catheter having the larger ID can first be driven to a target region within a blood vessel, with the 0.070-inch second catheter pre-loaded therein and moved along with the first catheter actively driven by a set of rollers. Thereafter, if the smaller second catheter is required for treatment, the larger first catheter can be removed from the rollers, and the proximal control element 230 of the second catheter can be inserted into the rollers and driven directly. Once the first and second catheters are both inserted through their respective material transition sections between the proximal control element 230 and the distal lumen portion 222, a second set of rollers can be used to control each of the first and second catheters independently.

[0120] FIG. 4B shows a robotic drive system 600 configured to manipulate nested distal access catheters 200a, 200b. The first catheter 200a can include a distal lumen portion 222a and a proximal control element 230a. The second catheter 200b extending through the first catheter 200a can also include a distal lumen portion 222b and a proximal control element 230b. The navigation catheter 300 can extend through the second catheter 200b, and the guidewire 500 can extend through the navigation catheter 300. A first set of rollers 615a can drive the proximal control element 230a of the first catheter 200a. A second set of rollers 615b can drive the proximal control element 230b of the second catheter 200b nested within the first catheter 200a. The second catheter 200b can be physically clipped to the navigation catheter 300 such that, as described elsewhere herein, the two are moved as a single unit by a single set of rollers. Alternatively, the system 600 can include a third set of rollers 615c that drive the proximal extension 366 of the navigation catheter 300. Yet another set of rollers 615d can drive the guidewire 500. Depending on whether the catheter and the navigation catheter 300 are clipped together and moved as a unit, the system includes more components than roller sets. If the navigation catheter 300 and the guidewire 500 are shown extending along the longitudinal axis A and engaging their respective roller sets, one or both of the guidewire 500 and the navigation catheter 300 can also be offset from the axis A and engage different roller sets such that they exit the cassette 605 at an angle, as opposed to passing immediately behind or through the proximal end of the cassette 605.

[0121] Catheters 200a, 200b can first be advanced until their lumen portions 222a, 222b enter the RHV 434 and until their proximal elements 230a, 230b are inserted into their respective rollers 615a, 615b. The initial advancement can be performed manually by the user or by a set of rollers. For example, as shown in FIG. 4A, an additional set of rollers may be included that are located immediately proximal to the RHV 434 of the guide sheath 400. The additional roller set can be used to drive nested components such as catheter 200a nested within catheter 200b. Once the proximal end of the large-diameter distal lumen portion 222a has advanced inside the RHV 434 of the guide sheath 400 (manually or via an additional roller set), the advancement of catheter 200a can be driven by engaging the proximal control element 230a of catheter 200a with the roller set 615a. The small-diameter proximal control element 230b can be manually transferred to the second set of rollers 615b, and the robotic drive system 600 transfers the drive of catheter 200b to that set of rollers 615b rather than the first set of rollers. Alternatively, the outer catheter 200a can incorporate a slit that allows the distal lumen portion 222a to ride laterally over the inner navigation catheter 300. This arrangement eliminates the need for a set of rollers immediately proximal to the hub 434 of the guide sheath 400.

[0122] The rollers of the navigation catheter 300 can be physically coupled to the rollers of the proximal control element of the catheter in which the navigation catheter 300 is present. For example, FIGS. 4A and 4C show a roller 615b engaged with the proximal control element 230 of the catheter 200, and is physically coupled to a roller 615c engaged with the navigation catheter 300. FIG. 4B shows a roller 615b engaged with the proximal control element 230b of a second catheter 200b that is physically coupled to a roller 615c engaged with the navigation catheter 300. The physical link mechanism enables the catheter 200 to move simultaneously and synchronously with its navigation catheter 300 when the rollers are driven together. The link mechanism can be via a clip or other mechanical mechanism that joins the rollers. The rollers of the drive system 600 need not be synchronized to advance the two components simultaneously. As described elsewhere herein, the catheter 200 can be mechanically clipped to the navigation catheter 300 as described above so that they can be advanced simultaneously using a single set of rollers.

[0123] The catheter system described herein can be advanced without using a guidewire, but the robotic drive system can include an additional set of rollers 615d (see FIGS. 4A - 4C) for engaging the guidewire 500. The additional set of rollers 615d, if used, can be positioned further proximally along the cassette 605 so as to engage the guidewire 500. The position of the guidewire rollers 615d enables the full range of motion of the navigation catheter 300. The additional set of rollers 615 can also be used to engage intervention devices such as stent retrievers, stents, aneurysm coils, flow diverter delivery systems, and the like.

[0124] The configuration of the rollers 615 can be changed. Each roller 615 can include a friction element or a tire attached to a central shaft or axle. The rollers are configured to grip the components of the catheter system 150 without damaging the components such that when the roller 615 rotates, the element moves. The rollers can rotate in two directions to move the element forward and backward. At least one of the rollers of a set of rollers can have a shaft that is driven to rotate by a motor within the cassette 605 or the console 601. Thereby, using a set of rollers, a catheter body engaged between the set of rollers can be moved relative to the cassette 605. One of the rollers of a set of rollers can be actively driven by a motor that rotates the shaft, and the other roller of the set of rollers can passively rotate its shaft without being actively driven. Each set of rollers 615 can have at least one tire driven by a motor and a passive tire that rotates without being driven by a motor.

[0125] The tires can be made of an elastomeric material that is somewhat sticky to assist in engagement with the catheter body to bias the catheter body in a particular direction. The rollers can include a soft elastomer such as a thermoplastic elastomer such as Santoprene, silicone, urethane foam, neoprene, etc. The material and configuration of the tires can be non-traumatic so as to avoid damage to the catheter body when the catheter body is sandwiched between a set of rollers. In some embodiments, the material of the tires can be a compressible elastomer such that a set of rollers can accommodate different outer diameters therebetween. In some embodiments, one or more of the rollers 615 can include a compressible sleeve that allows one or more catheters to pass therethrough when in an open state or secures one or more catheters (or guide wires 500) when in a closed state.

[0126] The cassette 605 can include two sets of rollers for engaging a single catheter having different diameters along its length. For example, the first pair of rollers 615a can engage the larger-dimension distal lumen portion 222, and the second pair of rollers 615b can engage the smaller-dimension proximal control element 230. A flexible elastomer can be configured to engage different diameters of the catheter. Alternatively, the cassette can have a dedicated set of rollers configured to engage the catheter 200 and automatically adjust to different dimensions along the length of the catheter as the catheter advances into and out of the patient. One or both of the rollers of a set of rollers can have two different diameters, and the roller can be moved relative to the outer surface (e.g., up and down or left and right) of the catheter to align the diameter change with the corresponding region of the catheter. FIGS. 6A-6D are various views of an embodiment of a set of rollers 615 having a first tire 630a and a second tire 630b adjacent to each other, whereby their inward-facing surfaces are spaced apart. The inward-facing surfaces can have a geometry that creates gaps of various sizes between the tires 630a, 630b. The upper region 632a of the first tire 630a and the corresponding upper region 632b of the second tire 630b can define a first space therebetween corresponding to the shape of at least a portion of the catheter, such as a semi-cylindrical space. This semi-cylindrical space can have an inner diameter that accommodates the outer diameter of the distal lumen portion 222 of the catheter. The lower region 636a of the first tire 630a and the corresponding lower region 636b of the second tire 630b can define a second space corresponding to the shape of at least another portion of the catheter. The second space can have a smaller diameter compared to the first space so as to engage the smaller-dimension proximal control element 230 of the catheter 200.

[0127] A set of rollers 615 can also be spring-biased to accommodate different outer diameters. The catheter 200 can include a distal lumen portion 222 of a larger dimension and a proximal control element 230 of a smaller dimension. The set of rollers 615 can be configured to move away from each other so as to engage and drive the distal lumen portion 222 during a first stage of engagement. Then, when the distal lumen portion 222 is fully inserted through the hub 434, the rollers 615 can bounce back towards each other, such that the rollers 615 can engage and drive the proximal control element 230 during a second engagement stage. As described elsewhere herein, the proximal control element 230 of the catheter 200 can be a hypotube, ribbon, or wire and can have a significantly smaller outer diameter compared to the distal lumen portion 222 of the catheter 200. As an example, the distal lumen portion 222 of the catheter 200 can have an outer diameter sized to be inserted through a sheath of 6-8Fr, such as 0.080 inches to about 0.105 inches. The proximal control element 230 of the same catheter can have a much smaller outer diameter, such as about 0.014 inches to 0.022 inches. Similarly, the inner navigation catheter 300 can undergo a change in outer diameter from a larger outer diameter at a more distal location (e.g., about 0.080 inches) to a smaller outer diameter at a more proximal location (e.g., a smaller size on the order of about 0.062 inches to about 0.022 inches) along its length. Catheters driven by a robotic drive system can also be of different sizes and thus can have different outer diameters. The robotic drive system can be used with smaller catheters (e.g., 3Fr) and larger catheters (e.g., 8Fr). It is useful for a supply drive mechanism to accommodate these different catheter sizes while still providing an appropriate grip. The set of rollers 615 can automatically adjust their spacing so as to accommodate the larger outer diameter of the distal region of the catheter 200 and the smaller outer diameter of the proximal region of the catheter 200.Similarly, if the inner navigation catheter 300 has a varying outer diameter along its length (e.g., incorporating a proximal drop in outer diameter), a set of rollers 615 configured to engage and drive the navigation catheter 300 can automatically adjust their spacing to accommodate the dimensional changes as the catheter 300 is further advanced into the patient.

[0128] Suction system As described with respect to FIG. 2 above, the robotic drive system 600 can communicate with one or more other medical systems 800, such as a suction system 805, or can have a suction system integrated within the robot. Suction can be automatically turned on, off, up, down, and / or circulated faster or slower in response to treatment stages or events that cause changes in suction. The system 600 that senses pressure and / or flow in the arm 412 of the sheath RHV434 can include one or more sensors 625. The sensor 625 can be aligned with a suction tube connected to a pump or canister of the suction system 805. A proximal pressure transducer can be placed at this location, and a distal pressure transducer can be placed near the distal opening of the catheter 200 (e.g., about 1 - 5 cm from the opening). The distal pressure transducer can be configured to read arterial pressure, and the proximal pressure transducer can be configured to read vacuum pressure. A blood clot that is clogged at the distal end of the catheter 200 or slowly progresses through the lumen of the catheter is detected. The in-line pressure transducer can also be designed to detect when the fluid chamber on the exhaust side of the suction cycle is filled. A low positive or zero pressure at the proximal transducer can activate the software of the control system 700 to indicate to the operator that the fluid chamber requires filling.

[0129] In some embodiments, the aspiration system 805 can include a vacuum source coupled to the catheter system via a vacuum line. The vacuum source can be configured to vary. The vacuum source can be an active aspiration source such as an aspiration pump, a regular or lock syringe, a handheld aspirator, a hospital suction, etc., configured to aspirate aspiration through the working lumen of the base sheath. As described above, the RHV of the base sheath can be sealed and aspiration can be initiated through the side arm of the RHV. The side arm of the RHV can be coupled to any of a variety of vacuum sources. In a preferred embodiment, the vacuum source is an aspiration pump such as a Gomco 405 tabletop aspirator (Allied Healthcare Products, Inc. (St. Louis, Missouri)). The aspiration pump can incorporate a programmable pump motor such as a motor controlled by pulse width modulation, a brushless motor and a controller, or a similar controllable motor. Alternatively, a controllable valve can be used to perform the periodic aspiration described herein. In another embodiment, the vacuum source is a lock syringe such as a VacLok type syringe.

[0130] The material aspirated from the catheter system can be collected within a proximal vacuum cannister connected to the vacuum line. In some embodiments, the proximal vacuum cannister itself can be a vacuum source such as the barrel of a lock syringe. In other embodiments, the proximal vacuum cannister is coupled to the vacuum source via tubing.

[0131] During a procedure where the distal tip of the catheter 200 is near or on the surface of an occlusion, the operator can open the connection to the vacuum source of the aspiration system 805 (e.g., an aspiration syringe). This allows for maximum communication of the suction force applied through the working lumen of the sheath 400 and any catheter extending through the sheath 400, which communicates with the blood vessel at its distal end. In another embodiment, the arm 412 can be connected to the vacuum source of the aspiration system 805, such as a pump. The vacuum source can provide a periodic level of suction force, e.g., repeating suction force from a high level of vacuum to a low level of vacuum, or from a high level of vacuum to no vacuum, or from a high level of vacuum to positive pressure, at one or more set frequencies. The periodic suction mode can provide a jackhammer-type force to the occlusion and enhance the ability to aspirate the occlusion through the catheter. One effect of these forces is to fatigue and break up occlusions that are often taken into the catheter, and to mobilize the slow, progressive movement of thrombotic material along the length of the catheter, especially when static suction cannot do so. Another effect of the periodic force is to change the frictional pattern, resist the connection between the blood clot and the vessel wall, relax the blood clot, and propel the blood clot towards the vacuum source.

[0132] A periodic suction force can be enabled by using one or more valves disposed between a vacuum source and a catheter system. The valve can control the opening and closing between the vacuum source, the catheter tip, and the external environment that provides a pressure differential. When the valve is opened, the valve can establish an open continuity between the vacuum source, the catheter tip, and the external environment (e.g., air). Temporarily closing the valve with respect to the external environment (e.g., manually, mechanically, or via software programming in a pump or a controller of a robotic system) can enable the vacuum source to establish a vacuum at the catheter tip, and then opening the valve with respect to the external environment can reduce the vacuum at the catheter tip in a controlled manner. Repeatedly opening and closing the valve creates a periodic pressure profile at the catheter tip. Changes in the operation of the valve produce different periodic suction solenoid valves, spring-actuated pressure relief valves, electronically controlled valves, manual or mechanical valves, programmable pump motor controllers, etc. In one embodiment, the periodic suction is applied only when a clogged or restricted flow is detected in the suction line via either a low flow or a high vacuum, and at other times, the vacuum source returns to a low level of flow or turns off. This configuration may be controlled by the user or may be automatically controlled via a feedback loop to the vacuum source.

[0133] Periodic suction can include high-speed pressure cycles, for example, from 1 Hz to 100 Hz. The cycles can be executed over a long period of time at a single frequency, multiple frequencies, a dynamic array of frequencies, or a recipe. A pressure cycling mechanism, such as a solenoid valve within or near the vacuum line to the catheter, operates in conjunction with the suction pump to apply rapid oscillations of pressure. These pressure oscillations or cycles improve the blood clot removal ability of the suction catheter and generally, the pressure loss is minimized, so the pressure oscillation device is most effective when the distance between the pressure oscillation device and the catheter tip is minimized. The periodic suction system can be easily incorporated into the current suction thrombectomy system without the need to replace the entire vacuum pump assembly or an existing vacuum pump assembly, since it hinges around an independent pressure oscillation mechanism.

[0134] In one embodiment, the cycling frequency can be from 1 Hz to 50 Hz, more preferably from 2 Hz to 10 Hz. In one embodiment, the periodic pressure profile includes a high-speed “burst” of higher frequency cycles within a frequency range (e.g., about 10 Hz) followed by a section of static suction or low-speed “recovery” frequency cycles within a frequency range (e.g., about 3 Hz). The static or slow cycle profile following the period of the higher frequency cycles allows the pressure to build up to the maximum operating pressure after the pressure has degraded during the high-speed cycles. In the case of a manual system, the suction cycles can include cycling between -23.8 inHg and 0 inHg at 1 Hz, cycling between -22 inHg and 0 inHg at 2 Hz, and cycling between -18.9 inHg and -5.0 inHg at 6.3 Hz. The cycling can be in the range of 1 Hz to 3 Hz, or 1 Hz to 6 Hz, or 1 Hz to 10 Hz, or 1 Hz to 50 Hz. Generally, the cycling can be at a frequency less than that which increases the risk of damaging the blood vessel wall or increasing bleeding or thermal tissue damage. The low-frequency mechanical perturbation should not exceed the local elastic limit.

[0135] The cycling profile can vary. The cycle suction time can be about 100 - 260 ms. The total suction time for both suction and relaxation of the cycle can be about 6 - 8 seconds. The time per cycle of relaxation between suctions can be about 40 - 70 ms. The static suction between suction cycles can be about 2 - 4 seconds.

[0136] If coking occurs and the operator determines that it is necessary to withdraw the coked catheter, the operator can switch to static full pressure suction. Generally, a corked or restricted flow state occlusion where the occluded portion outside the lumen may fragment due to catheter movement to form a plug is withdrawn by the catheter under static suction, preferably at maximum force, to compress and hold the plug during catheter removal. As another example, the surgeon can apply periodic suction to aspirate the occlusion. The periodic suction can be continued as long as the surgeon desires to aspirate the plug aspirated through the lumen. In one embodiment, it may be preferable to apply periodic suction while the movement of the catheter is decreasing. The aspirated occlusion can be completely discharged under periodic suction (i.e., transparent to the proximal cannister or syringe). The aspirated occlusion can be completely discharged under static suction. The aspirated occlusion can be at least partially discharged using cyclic suction and at least partially discharged using static suction before being finally withdrawn with the catheter. The suction force can be shifted in real time during the procedure between static suction and periodic suction. Different cycle frequencies and amplitudes can be executed depending on the diameter of the catheter used, the position of the suction valve / pressure release / pressure change mechanism, and the degree to which the pressure is released or changed to create different movements of the plug. The operator can switch from periodic suction to static suction at any time if it is observed that there is no flow and the catheter is being withdrawn to remove a plugged plug.

[0137] The operator can initiate the suction of the suction system 805 by tapping a button or icon on the user interface 720 of the control station 700 (alternatively, the operator of the operating table 7 can directly initiate the suction on the user interface of the robot drive system 600), which will be described in more detail below. Alternatively, there may be a separate controller 610 for the control system for the suction system 805 and for the robot drive system 600. One or both of the control systems may also be connected to the remote control system 700 and can be remotely operated by the remote control system. The operator can have the option to select the type of suction applied (e.g., static, periodic). Selecting periodic suction can also prompt the user to select the cycling frequency (e.g., increase or decrease). When suction is initiated by the user, the software operating on the controller 710 can perform checks on the system pressure and flow rate. If no flow through one or more of the catheters 200 is detected and the vacuum pressure exceeds the threshold pressure, the suction pump can be turned on (manually by the operator making a selection on the GUI 720 or automatically by the software operating on the controller 710). The software operating on the controller 710 can continue to monitor the system pressure until the desired vacuum pressure is reached. When the desired vacuum pressure is reached and there is no flow between the catheter 200 and the vacuum chamber of the suction system 805, the system can open the valve between the catheter 200 and the vacuum chamber. Flow detected while the valve between the vacuum chamber and the catheter 200 is closed indicates a leak in the system and an error message can be displayed on the GUI 720. While the valve is open between the catheter 200 and the vacuum chamber, the system can monitor the pressure and flow rate to evaluate whether the parameters are within the specified operating range. Excessively high flow rates and / or pressures outside the specified operating range indicate that no blood clots are being suctioned and rather only blood is being suctioned from the patient, which is a safety risk or there is a system leak.When only blood is being aspirated from the patient, the software running on the controller 710 can automatically close the valve between the catheter 200 and the vacuum chamber and be programmed to display an error message on the GUI 720. The error message can provide information suggesting that the operator advance the catheter 200 more distally within the patient's body. The operator can use one or more input portions 725 on the GUI to advance the catheter 200, as a result of which one or more sets of rollers 715 drive the catheter 200 a distance distally. In the case of a system leak, an error message can be displayed instructing the operator to check the system connections.

[0138] High vacuum pressure at the proximal transducer in combination with low flow rate identified by the distal transducer may indicate a cork plug of blood clot passing through the catheter 200 or an unduly slow passage of the blood clot. This can also indicate that aspiration was initiated by the operator prior to withdrawal of the inner navigation catheter 300. The software operating on the controller 710 is programmed to display an error message after a period of high vacuum pressure / low flow rate conditions (e.g., after 30 seconds to about 2 - 3 minutes). This allows sufficient time for the blood clot to pass through the catheter 200 before generating the error message. The error message can provide the operator with additional instructions such as a reminder to check for the presence of the inner navigation catheter 300, a recommendation to switch to periodic aspiration (if currently stationary), or removal of the catheter 200 to flush out the corked blood clot.

[0139] Low vacuum pressure at the proximal transducer may indicate no system leak or blood clot aspiration. The software operating on the controller 710 can be programmed to close the valve to the catheter 200 and display an error message instructing the operator to confirm that the aspiration system 805 is properly connected and that there are no leaks.

[0140] The arterial pressure at the distal transducer and the high vacuum pressure at the proximal transducer with no flow can indicate a catheter 200 with a cork, where a blood clot has passed through the distal pressure transducer and is moving through the lumen of the catheter 200 with at least some success. The software executed on the controller 710 warns the operator with an error message on the GUI 720 after maintaining a certain period of conditions for successful aspiration of the blood clot, and can recommend switching from static to periodic aspiration or program to remove the catheter 200 from the patient to flush the blood clot. Removal of the catheter 200 can be performed by the robot drive system 600 when the operator activates a specific input 725 on the GUI 720 to retract the catheter 200.

[0141] A moderate flow rate and pressure remaining within the selected operating range (e.g., between artery and maximum vacuum) indicate successful aspiration of the blood clot. If no error state is detected, the software operating on the controller 710 is programmed to automatically close the valve after a specified time limit (e.g., 60 seconds). Aspiration can be restarted by the operator, such as by activating the "Suction On" button or tapping an input on the GUI 720.

[0142] Control System / User Interface The control system 700 of the treatment system 10 can be used by an operator to control one or more of the robot drive system 600, the suction system 805, or other functions. As described above, the control system 700 can include a computing device having a user interface 720 with one or more input units 725 and one or more displays 730. FIG. 5 is an exemplary graphical user interface (GUI) 720 of the control system 700 used by an operator to control various functions of the system 10. The user interface of the robot drive system 600 can be used by an operator to control various functions of the system 10, is shown in FIG. 5, and it should be understood that the GUI features described below with respect to the control system 700 can be reflected in the user interface or controller of the system 600 placed by the patient. When the control of the system 10 is described as being performed by an operator on the control system 700, the operator can also use the user interface of the robot drive system 600 to control the system 10 and does not need to be remote.

[0143] The relative arrangement and configuration of the input units 725 on the GUI 720 can vary. Some of the input units 725 can be physical components configured to be engaged by an operator (e.g., buttons, sliders, dials, joysticks, foot pedals), and other input units 725 can be icons displayed on the screen that are tapped or selected as known in the art.

[0144] Figure 5 shows that the displayed information can be organized into columns for each component. The information can be organized into a guide wire column 5500, a navigation catheter column 5300, a suction catheter column 5200, and a guide sheath column 5400. Each component column can have specific information and / or inputs displayed regarding the function of that component. Each component column can provide an indication of which component the information relates to, such as by being labeled with text, shape, and / or color. For example, the navigation catheter column 500 can be labeled with the word "navigation catheter" or another name that appropriately identifies its components, and can have an icon with a specific color scheme unique to that component. The suction catheter column 5200 can also be labeled with words by identifying its components and displaying icons of different colors unique to that component. Figure 5 shows columns arranged on a display such that the guide wire column 5500 is at the left end and the guide sheath column 5400 is at the right end. The columns can be arranged on the display in any of various orders, and that arrangement can be programmed by an operator during a procedure. In one embodiment, the columns can be arranged on the display in the same order as they are arranged on the patient and roller such that the manipulation of the components on the display reflects the arrangement of the manipulation on the components themselves. With respect to Figure 4A, the guide wire roller 615d is arranged on the rightmost or proximal side of the cassette 605, and the catheter rollers 615a, 615b are arranged on the left or distal side of the navigation catheter roller 615c which is arranged on the left side of the guide wire roller 615d. The sheath manipulator 620 is on the leftmost or distal side. The guide wire column 5500 can be arranged on the display immediately to the right of the navigation catheter column 5300, and the sheath column 5400 can be arranged on the display immediately to the left of the suction catheter column 5200. The operations performed by an operator on a remote control system more intuitively reflect the operations being performed within the cassette 605 for that component.

[0145] Each component column can display a movement output (5505, 5305, 5405) indicating the magnitude of the linear translation of the component relative to the baseline, and, if applicable, an angle output (5510, 5310, 5410) indicating the rotation angle relative to the baseline, and a corresponding reset input. Some components, such as the aspiration catheter, can have additional information displays such as a vacuum pressure output 5215 indicating the vacuum pressure within the catheter or a flow rate output 5220 indicating the flow rate within the catheter. The guide sheath column 5400 can include a movement output 5425 that displays the movement of the guide sheath from the patient's original placement.

[0146] Regarding FIG. 5 further, each component column can also include one or more inputs (5530, 5330, 5230, 5430) for incrementally increasing or decreasing movement and / or angles, etc. Additional inputs include a rotational input 5535, a vibration input section 5540, and a cycle suction input 5545. For example, when the vibration input section 5540 is switched “on”, the catheter 200 can be intermittently advanced and retracted to reduce the occurrence of coking. Another input can include a link input 5565 that joins a set of rollers 615 of the navigation catheter 300 to the suction catheter 200, such that the two components move synchronously. The input can also indicate that there are two components that are mechanically linked, such as by a physical clip, to move synchronously. When the components are clipped together, the operator can switch the input and can alert the operator as to how the components move together during the operation of a particular set of rollers. Each component can include an input that is a toggle switch 5550 configured to move the device distally by toggling the switch forward or proximally by toggling the switch backward. In some cases, the switch 5550 can be a joystick that can be twisted to rotate one or more of the components. The switch 5550 for the suction catheter 200 can further include a button 5555 at the top of the switch 5550 that enables the operator to manually activate “suction on” and / or “suction off” by pressing the button. Alternatively, as described elsewhere in this specification, “suction off” can be automatically initiated, such as by software executed on the controller 710.

[0147] The position and configuration of the switches 5550 of various components can provide the user with information regarding which components of the system are being operated when the switches 5550 are actuated. For example, the first switch 5550 can be of a first color, and the second switch 5550 can be of a second different color. The colors can be coordinated with the colors on the GUI indicating one or more indicators of that component. The position of the joystick on the console can also be coordinated with the position of the indicator on the GUI. The degree of change provided by the switch 5550 during actuation can be selected or programmed by the user according to the incremental change in position desired for each actuation.

[0148] One or more outputs can include warnings for providing the operator with information regarding the state of the robot drive system 600 or other components of the system 10. The warnings can be audible signals, visual signals, and / or tactile signals. The visual signals can include one or more LEDs, icons on a display, or other signals. The audible signals can be one or more beep sounds indicating information to the user. The warnings can be beneficial, such as the speed until forward represented by the frequency of the sound. One or more outputs can also include alarms (audible, visual, and / or tactile signals) that can indicate malfunctions, interruptions in communication between the control system 700 and the robot drive system 600, changes in the patient's condition, etc. The alerts can be cleared by the user, but the alarms continue to be triggered until the problem is resolved. The visual signals can include the display of the state of the components of the robot system. For example, when the components of the distal access system 100 are not loaded and / or latched in the associated cassette position, light of a first color (e.g., red) can be displayed, and when the components are correctly loaded and / or latched, a second color (e.g., green) can be displayed. The visual signals do not have to be colors and can incorporate symbols and / or text providing information regarding loading and / or latching.

[0149] The parameters of the vibration input unit 5540 can be programmed by the user to cause the support catheter to follow one or more retraction and one or more advancement patterns. In one embodiment, activating the vibration input unit 5540 can initiate a pattern such as: 1) a period of static suction while the catheter distal opening is in a first position relative to the occlusion, 2) a short retraction of the catheter to place the distal opening in a second position relative to the occlusion, and 3) an advancement of the catheter to return the distal opening to the first position. The period of static suction can be about 5 seconds of static suction, although this can vary anywhere from 1 second to about 30 seconds. The short retraction of the catheter after static suction can also vary and can include about 1 mm to 50 mm, about 2 mm to 25 mm, about 3 mm to 10 mm, or preferably about 5 mm. The advancement of the catheter to return the distal opening to the first position can also advance the catheter to a position more distal than the first position (e.g., if at least a portion of the occlusion is aspirated) or to a position more proximal than the first position. The preferred advancement is to the position where the distal end of the catheter contacts the occlusion.

[0150] Method of Use The following is an example of the method of using the system described herein to perform a neurovascular procedure using the distal vascular access system 100 and the robotic drive system 600. Examples include performing suction through the catheter 200 and the guide sheath 400 using the suction system 805. Other neurovascular procedures are contemplated, including delivery of a PTA catheter and implantation of expandable tools including coils, stents, or flow diverters.

[0151] In an embodiment of performing a robot-assisted interventional procedure on a patient within the neurovascular system, an introducer sheath and / or a guide sheath, such as guide sheath 400, is used to access the patient's vascular system, for example, at a femoral artery or radial artery access site. A guide wire and a catheter system can be introduced into the patient's vascular system through the sheath. The catheter system 150 can include a support catheter 200 and a navigation catheter 300. The catheter system 150 can be advanced through the sheath 400 as described elsewhere herein. Optionally, the guide wire and catheters 200, 300 of the catheter system 150 can be manually advanced by the user in a first stage, for example, from the access site to the distal end region of the guide sheath 400. The catheter system can then be coupled to a robot drive system 600, such as in a cassette 605. The robot drive system 600 is operably coupled to a controller 610 and / or a remote controller 710 that is operable by an input from an operator. The robot drive system 600 includes a plurality of rollers 615 or other actuator bodies that are movable in response to an operator input. The support catheter 200 includes a distal lumen portion 222 having a distal opening 231 and a proximal opening 242. A single lumen 223 extends between the proximal opening 242 and the distal opening 231. The support catheter 200 also includes a proximal control element 230 coupled to the distal lumen portion 222 near the proximal opening 242. The proximal control element 230 does not have a lumen extending therethrough. The navigation catheter 300 includes a guide wire lumen 368 and an outer diameter sized to fill the lumen 223 of the support catheter 200. The navigation catheter includes a distal tip region 346 and a proximal extension. The distal tip region can taper from the outer diameter to the most distal end that defines an opening from the guide wire lumen 368. The navigation catheter 300 can be axially positioned through the single lumen 223 of the support catheter 200 such that the distal tip region 346 of the navigation catheter 300 can extend from the distal opening 231 of the distal lumen portion 222 of the support catheter 200.The support catheter 200 having the navigation catheter 300 disposed within its single lumen 223 is steerable into vessels distal to the pyramidal portion of the internal carotid artery (ICA).

[0152] The method further includes coupling the proximal control element 230 of the support catheter 200 to a first set of rollers 615 of a plurality of rollers 615, and coupling the proximal extension 366 of the navigation catheter 300 to a second set of rollers 615 of the plurality of rollers 615. The second set of rollers 615 is disposed proximal to the first set of rollers 615. The method further includes moving the first and second sets of rollers 615 in at least one degree of freedom in response to operator input.

[0153] The method optionally includes operating the guide sheath 400 with the control system 600 using, for example, a sheath hub housing controllably movable in at least one degree of freedom in response to operator input. FIG. 4C shows an embodiment providing independent movement of the guide sheath 400 relative to other components coupled to the cassette 605. The proximal end of the guide sheath 400, such as RHV 434, can be disposed within a rack 640 having an outer surface arranged to engage the teeth of a small gear or pinion 642. The teeth of the pinion 642 mesh with corresponding features of the outer surface of the rack 640. The rack 640 can float, the pinion 642 is carried on a bearing, and as the pinion 642 rotates, the rack 640 translates axially along the longitudinal axis A. The guide sheath 400 can be manually advanced to a distal position. For example, the tip of the guide sheath 400 can be advanced into the common carotid artery, the cervical ICA, or a more distal portion of the ICA for carotid or anterior circulation procedures, or the subclavian or vertebral artery for posterior circulation procedures. This initial stage of advancement can be manually performed by the operator until a desired position is reached prior to coupling the hub to the rack 640. The sheath can move with the rack 640 for limited axial adjustment of the sheath independent of other components coupled to the cassette 605.

[0154] The distal lumen portion 222 of the catheter 200 having an outer diameter sized to be disposed within the working lumen of the guide sheath 400 advances through the guide sheath 400 coupled to a robotic drive system 600 configured to drive the catheter 200.

[0155] In a method involving aspiration of a blood clot, the guide sheath 400 is operably coupled to an aspiration system 805. The catheter 200 and the navigation catheter 300 can be advanced to the location of the blood clot occlusion. The navigation catheter 300 is removed, and aspiration of the blood clot can be performed through the working lumen of the guide sheath 400 and an adjacent lumen formed from the single lumen of the catheter 200. The control station 700 controls the drive system 600 and the aspiration system 805.

[0156] In related embodiments of a method of using a robotic drive system to perform a procedure, a control signal is generated corresponding to the movement of a master input device. A plurality of drive elements of a device drive unit move in response to the control signal to translate a catheter system operably coupled to the plurality of drive elements. The catheter system has a distal end inserted into a patient's blood vessel. The catheter system includes a support catheter having a distal lumen portion coupled at a proximal end region to a proximal control element adjacent a proximal opening from a single lumen of the distal lumen portion. The proximal control element is engaged by a first drive element. The catheter system further includes a navigation catheter having a guidewire lumen and a distal tip region that tapers from an outer diameter sized to fill a single lumen of the support catheter to a most distal end defining an opening from the guidewire lumen. A proximal extension of the navigation catheter is engaged by a second drive element. The movement of the plurality of drive elements causes a corresponding movement of the catheter system. The control signal moves the individual drive elements of the plurality of drive elements independently of each other to achieve a desired advancement of the catheter system within the blood vessel and a relative extension of the navigation catheter with respect to the support catheter. A further control signal is generated using a master input device. Further drive elements of the device drive unit move in response to the further control signal.

[0157] In a further embodiment, the robotic drive system 600 can be used to perform high-speed movement techniques. A catheter system including the support catheter 200 and the navigation catheter 300 can be inserted using the robotic drive system 600 such that the distal end of the navigation catheter 300 (i.e., extending distally relative to the distal end of the support catheter 200) can be placed from outside the body at a location near the distal end of the sheath 400. The robotic drive system 600 can automatically advance the catheter system relative to the sheath 400 at high robotic control speeds to this position and then automatically stop when reaching the target position near the distal end of the sheath 400. The operator can then use the control system 700 to control the advancement speed of the catheter system 150 outside the sheath 400. The high robotic control speed for advancing the catheter system 150 through the sheath 400 can be at least about 1 cm / sec, preferably at least about 5 cm / sec to about 10 - 15 cm / sec, although other speeds are contemplated.

[0158] The robotic drive system 600 can automatically control the withdrawal of the navigation catheter 300 at high robotic control speeds to generate a piston effect, as described elsewhere herein. The high robotic control speed for the withdrawal of the navigation catheter 300 from the support catheter 200 can be between about 4 cm / sec and about 165 cm / sec, or between about 10 cm / sec and about 75 cm / sec, or between about 20 cm / sec and about 25 cm / sec.

[0159] The robotic drive system 600 can automatically control the withdrawal of the support catheter 200 after the procedure. The high speed of robotic control for withdrawing the support catheter 200 away from the treatment site can be at least about 1 cm / second, preferably at least about 5 cm / second to about 10 - 15 cm / second, although other speeds are also contemplated. If the catheter 200 is corked, the withdrawal of the catheter 200 can be slower (e.g., 10 - 15 cm / second), but if the catheter 200 has completely ingested the blood clot and free flow of blood is observed through the suction tube, the pump is turned off and the catheter can be removed more rapidly (e.g., 15 - 20 cm / second).

[0160] The robotic drive system can be capable of any of a variety of speeds outside of these specified ranges. The user can select the minimum and / or maximum thresholds possible for the system during operation, whether the operation is for forward movement of the system or withdrawal of one or more components. Further, the robotic drive system can incorporate a feedback loop between the drive system and one or more sensors of the system (e.g., a sensor that monitors blood flow through a tube). The feedback can change the forward or reverse speed, including completely stopping all movement. The high-speed forward and reverse of robotic control can have an emergency shut-off, for example, if the sensor senses a problem. For example, a force sensor can be incorporated that can sense one or more resistances of components of the catheter system outside of an acceptable range and sense the automatic shut-off operation of that component driven by the roller 615.

[0161] Material One or more components of the catheter described herein may comprise or be made from a variety of materials, including one or more of metals, metal alloys, polymers, metal-polymer composites, ceramics, hydrophilic polymers, polyacrylamide, polyethers, polyamides, polyethylene, polyurethane, their copolymers, polyvinyl chloride (PVC), PEO, PEO-impregnated polyurethane, such as PEO soft segment polyurethane blended with Hydrothane, Tecophilic polyurethane, Tecothane, Tecoflex, thermoplastic starch, PVP, and combinations thereof, or other suitable materials.

[0162] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steel, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic nitinol, nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22®, UNS:N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N®), nickel-molybdenum alloys (e.g., UNS:N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel alloys such as other nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY®, PHYNOX®), platinum-enriched stainless steel, titanium, combinations thereof, or any other suitable material, and materials described elsewhere in this specification.

[0163] The inner liner material of the catheter described in this specification can include low-friction polymers such as PTFE (polytetrafluoroethylene) or FEP (fluorinated ethylene propylene), PTFE with a polyurethane layer (Tecoflex). The reinforcing layer material of the catheter described in this specification can be incorporated to provide mechanical integrity for applying torque and / or to prevent flattening or twisting, including metals such as stainless steel, nitinol, nitinol blades, helical ribbons, helical wires, cut stainless steel, or rigid polymers such as PEEK. The reinforcing fiber material of the catheter described in this specification can include various high-toughness polymers such as Kevlar, polyester, meta-para-aramid, PEEK, single fibers, multi-fiber bundles, high-tensile-strength polymers, metals, or alloys. The outer jacket material of the catheter described in this specification can provide mechanical integrity and can shrink with various materials such as polyethylene, polyurethane, PEBAX, nylon, and Tecotan. Other coating materials of the catheter described in this specification include parylene, Teflon (registered trademark), silicone, polyimide-polytetrafluoroethylene, etc. The inner liner can further include different surface finishes such as dimples, bumps, ridges, troughs, etc. The surface finish can be arranged randomly, linearly, helically, or using a specific pattern along the length of the catheter. Further, the inner liner can include a mixture of different surface finishes, for example, one part may have depressions and another part may have troughs. Further, the surface finish can be incorporated along the entire length of the catheter or only in parts of the catheter. Also, the inner liner can further include an electrospray layer, by which it is considered that materials can be incorporated into the inner liner. Examples of materials can include low-friction materials as described above.Alternatively, the electrospray or electrospinning layer may incorporate a beneficial agent that becomes coating-free when exposed to pressure from blood or a blood clot. For example, the beneficial agent may be tissue plasminogen activator (tPA) or heparin encapsulated in alginate.

[0164] The cassette is designed for single use, disposable, and may be replaced. The cassette may also be formed from materials configured to be sterilized and reused. The cassette can be formed of plastics such as injection-molded plastic or 3D printed plastic, and is one or more parts that are transparent or translucent. The material of one or more regions of the cassette may be various, including plastics such as polycarbonate, acrylonitrile butadiene styrene (ABS), acrylic, nylon polyamide, polyethylene, polypropylene, polystyrene, and metals such as stainless steel. One or more parts of the cassette can also be machined.

[0165] The cassette is individually packaged and may be sterilized by, for example, ethylene oxide or radiation. The catheter system disclosed herein may be packaged together in a single package, and the support / suction catheter and the corresponding navigation catheter are packaged in a coiled tube. The completed package is sterilized using a sterilization method such as ethylene oxide or radiation, labeled, and placed in a box. Instructions for use may also be provided inside the box printed on the label or via an Internet link.

[0166] Embodiments describe a catheter, delivery system, and method for delivering a catheter to a target anatomical structure. However, while some embodiments are particularly described with respect to delivering a catheter to a target vessel of a neurovascular anatomical structure such as a cerebral blood vessel, the embodiments are not so limited and certain embodiments may be applicable to other uses. For example, the catheter can be adapted for delivery to different neuroanatomical structures such as the subclavian, vertebral, carotid canal, etc., as well as to coronary anatomical structures or peripheral vascular anatomical structures. The systems described herein are described as being useful for treating certain conditions or lesions, but the conditions or lesions to be treated may vary and are not intended to be limiting.

[0167] In various embodiments, reference is made to the drawings for explanation. However, certain embodiments can be practiced without one or more of these specific details, or in combination with other known methods and configurations. In the description, numerous specific details such as specific configurations, dimensions, and processes are set forth in order to provide a thorough understanding of the embodiments. In other instances, well-known processes and manufacturing techniques are not described in particular detail so as not to unnecessarily obscure the description. Throughout this specification, references to "one embodiment", "an embodiment", "one implementation", "the implementation", etc. mean that the particular feature, structure, configuration, or characteristic described is included in at least one embodiment or implementation. Thus, the appearances of the phrases "one embodiment", "an embodiment", "one implementation", "the implementation", etc. in various places throughout this specification are not necessarily all referring to the same embodiment or implementation. Further, the particular features, structures, configurations, or characteristics can be combined in any suitable manner in one or more embodiments.

[0168] Throughout the description, the use of relative terms can indicate relative positions or directions. For example, "distal" can indicate a first direction away from a reference point. Similarly, "proximal" can indicate a position in a second direction opposite the first direction. The reference point used herein can be the operator or the insertion site such that the terms "proximal" and "distal" refer to the operator using the device or the insertion site. The region of the device closer to the operator or insertion site can be described herein as "proximal", and the region of the device further away from the operator or insertion site can be described herein as "distal". Similarly, the terms "proximal" and "distal" can also be used herein to refer to the anatomical position of the patient from the perspective of the operator, or from the perspective of the entry point, or along the insertion path from the entry point of the system. Thus, a proximal position can mean a position within the patient close to the entry point of the device along the insertion path towards the target, and a distal position can mean a position within the patient further away from the entry point of the device along the insertion path towards the target position. However, such terms are provided to establish a relative reference frame and are not intended to limit the use or orientation of the catheter and / or delivery system to the specific configurations described in the various embodiments.

[0169] This specification includes many details, but these should not be construed as limitations on the scope of what is claimed or can be claimed, but rather as descriptions of features specific to particular embodiments. The particular features described herein in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, the various features described in the context of a single embodiment can also be implemented separately in multiple embodiments, or in any suitable partial combination. Further, features are described above as acting in a particular combination and may initially be claimed as such, but one or more features from the claimed combination may, in some cases, be excised from the combination, and the claimed combination may be directed to a partial combination or a variation of a partial combination. Similarly, operations are shown in the drawings in a particular order, but this should not be understood as requiring that such operations be performed in the particular order shown, or in a sequential order, or that all of the operations shown be performed, in order to achieve a desirable result. Only some examples and embodiments are disclosed. Variations, modifications, and enhancements to the described examples and embodiments, as well as other embodiments, can be made based on what is disclosed.

[0170] In the foregoing description and claims, phrases such as "at least one" or "one or more" may appear, followed by a list of conjunctive elements or features. The term "and / or" may also appear in a list of two or more elements or features. Such phrases are intended to mean any of the recited elements or features individually or in combination with any of the other recited elements or features, as long as it is not implicitly or explicitly inconsistent with the context in which it is used. For example, the phrases "at least one of A and B", "one or more of A and B", and "A and / or B" are each intended to mean "only A, only B, or both A and B". A similar interpretation is intended for lists containing three or more items. For example, the phrases "at least one of A, B, and C", "one or more of A, B, and C", and "A, B, and / or C" are each intended to mean "only A, only B, only C, A and B, A and C, B and C, or A, B, and C".

[0171] The use of the term "based on" in the foregoing and in the claims is intended to mean "at least in part based on", such that features or elements not recited are also permitted.

Claims

1. A robotic treatment system for treating a patient's neurovascular system, wherein the system is It is a guide sheath, A sheath body having at least one lumen extending between a proximal end region and a distal end region, defining a distal opening from the at least one lumen, A hub coupled to the proximal end region of the sheath body, A guide sheath including, It is a catheter system, A support catheter comprising a distal lumen portion having an outer diameter sized to be positioned within the at least one lumen of the guide sheath, wherein the distal lumen portion is coupled in the proximal end region to a proximal control element adjacent to the proximal opening of the distal lumen portion from a single lumen, A navigation catheter having a guidewire lumen, a distal tip region tapering from an outer diameter sized to fill the single lumen of the support catheter to the distal end defining an opening from the guidewire lumen, and a proximal extension, A catheter system including, A robotic drive system configured to drive the catheter system within a patient's blood vessel, A cassette having at least a first set of rollers and at least a second set of rollers, wherein the first set of rollers is configured to engage with the proximal control element of the support catheter, the second set of rollers is configured to engage with the proximal extension of the navigation catheter, and the second set of rollers is positioned proximal to the first set of rollers, A controller operably coupled to the cassette, configured to control the first set of rollers and the second set of rollers to determine the magnitude of linear translation of the support catheter and the magnitude of linear translation of the navigation catheter, Robot drive system including A robotic treatment system including...

2. The system according to claim 1, further comprising a guidewire and a third set of rollers positioned proximal to the second set of rollers configured to engage with the guidewire, wherein the spacing of the third set of rollers is designed to allow full range of motion of the navigation catheter through the second set of rollers.

3. The system according to claim 1 or 2, wherein the proximal control element of the support catheter is a ribbon, a hypotube, or a solid round wire.

4. The system according to claim 1 or 2, wherein the proximal extension of the navigation catheter is a polymer-coated rigid component.

5. The system according to claim 1 or 2, wherein at least one of the first and second sets of rollers is configured to accommodate different outer diameters.

6. The system according to claim 1 or 2, wherein the rollers in the first set of rollers are spaced closer together than the rollers in the second set of rollers.

7. The system according to claim 1 or 2, wherein the first set of rollers is located proximal to the axis of the guide sheath working lumen and offset from the axis of the guide sheath working lumen.

8. The system according to claim 1 or 2, further comprising a suction system operably coupled to the controller.

9. The system according to claim 8, wherein the suction system is operated manually or by software executed on the controller.

10. The system according to claim 1 or 2, wherein the guide sheath is coupled to the robot drive system by fixing the hub to the cassette via at least one connector and / or cavity in the cassette, and the at least one connector is configured to rotate the guide sheath around the longitudinal axis of the sheath body.

11. The system according to claim 1 or 2, wherein at least one of the first set of rollers and the second set of rollers is configured to change the magnitude, angle, or both of the linear translation.

12. The system according to claim 11, wherein the first set of rollers and the second set of rollers are driven simultaneously by a mechanical link mechanism between the first set of rollers and the second set of rollers to advance the support catheter and the navigation catheter together.

13. The system according to claim 1 or 2, further comprising one or more markers on the support catheter and / or one or more markers on the navigation catheter.

14. The system according to claim 13, wherein the controller is programmed to detect the one or more markers on the support catheter and the one or more markers on the navigation catheter in order to evaluate the extension of the support catheter relative to the navigation catheter.

15. The system according to claim 13, wherein the controller is programmed to detect the one or more markers on the support catheter and the one or more markers on the navigation catheter in order to evaluate the total forward distance.

16. The system according to claim 8, further comprising one or more flow sensors and one or more pressure transducers.

17. The system according to claim 1 or 2, further comprising a vibration input unit configured to cause the support catheter to follow one or more retraction and one or more advancement patterns.

18. The system according to claim 17, wherein the vibration input unit is programmable by the user and / or the vibration input unit initiates a pattern of a short retraction of the support catheter that draws the distal opening of the distal lumen portion from a first position relative to the occlusion to a second position relative to the occlusion, and an advancement of the support catheter that advances the distal opening from the second position toward the first position.

19. The system according to claim 18, wherein the pattern begins after a period of static aspiration through the support catheter.

20. The system according to claim 1, wherein the proximal control element has a second outer diameter smaller than a first outer diameter, and the first set of rollers is configured to automatically adapt to the first and second outer diameters of the support catheter so as the support catheter is moved axially, to engage with the proximal control element and the distal lumen portion of the support catheter.

21. The system according to claim 20, wherein at least one of the first set of rollers and the second set of rollers is arranged to advance the support catheter and the navigation catheter together through the patient's blood vessel.

22. The system according to claim 1, wherein the support catheter is mechanically clipped to the navigation catheter, and at least one of the first set of rollers and the second set of rollers is driven to advance the support catheter and the navigation catheter together through the patient's blood vessel.

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