Robotic drive system for facilitating therapy of neuvascular

Abstract

A robotic surgical system for treating a neurovasculature of a patient includes 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 a vessel of the patient. The robotic drive system includes a cartridge having at least a first set of rollers and at least a second set of rollers and a controller operatively coupled to the cartridge. The first set of rollers is configured to engage a proximal control element of a support catheter, and the second set of rollers is configured to engage a proximal extension of a navigation catheter. The controller is configured to control the first set of rollers and the second set of rollers to determine an amount of linear translation of the support conduit and an amount of linear translation of the navigation conduit. Related apparatus, systems, and methods are provided.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority under 35 USC §119(e) to U.S. Provisional Patent Application Serial No. 63 / 346,733, filed on May 27, 2022. That disclosure is hereby incorporated by reference in its entirety. Technical Field

[0003] The present disclosure relates generally to the field of catheter surgery systems, and more particularly to robotic systems and methods for automatically moving an elongated medical device configured to be advanced into the neurovasculature to treat intracranial pathologies, such as occlusions in acute ischemic stroke, ICAD, aneurysms, and other intracranial pathologies. Background Art

[0004] Interventions are performed via catheter-based systems to treat a variety of vascular diseases, including neurovascular interventions. Vascular stenosis or intracranial atherosclerotic disease (ICAD) can be treated by intravascular implantation of a scaffolding device (e.g., a stent), usually in combination with balloon angioplasty, to increase the inner diameter or cross-sectional area of ​​the vessel lumen. Other vascular defects include aneurysms, in which a bulge or gas bubble protrudes from a vessel in a radial direction, which, if left untreated, may continue to expand until it ruptures, resulting in bleeding from the vessel. In addition, occlusions in intracranial vessels, or sudden blockage of adequate blood flow to a portion of the brain, leading to acute ischemic stroke (AIS), can be treated intravascularly, such as by delivery of a large-bore catheter for aspiration embolization and / or delivery of a retrievable stent device to help remove the clot.

[0005] Treatment of the cerebral vasculature is particularly challenging, in part due to the tortuosity of the vasculature and the small size of the vessels. In addition, there is a high risk of stroke and thromboembolic complications due to the release of thrombotic material 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 path of the ICA is divided into four segments - the carotid, petrosal, cavernous, and cerebral segments. In the anterior circulation, the consistently tortuous carotid ends are locked into their position by bony elements. The carotid artery enters the petrous bone and is locked into a set of turns (tum) as it is encased in the bone. The cavernous carotid is an artery that passes through the cavernous sinus of the venous bed and, although flexible, is locked as it exits the cavernous sinus by another bony element that surrounds and secures its entrance into the cranial cavity. Due to these bony fixation points, the tortuosity of the petrous carotid and above it is relatively consistent. The carotid siphon S (see Figure 1B) is the S-shaped portion of the terminal part of the internal carotid artery. The carotid siphon S begins at the posterior bend of the cavernous internal carotid artery and ends at the internal carotid bifurcation where it divides into the anterior and middle cerebral arteries. The ophthalmic artery arises from the cerebral ICA, which represents a common point for catheter hang-ups when entering the anterior circulation. These catheter hang-up points can significantly increase the amount of time required to gain access to the cerebral vasculature. When the procedure involves restoring cerebral blood perfusion, the increased time and difficulty in navigating the catheter system is a significant disadvantage with serious consequences.

[0006] Robotic control systems allow clinicians to deliver a variety of surgical tools to locations within a patient's body. Robotic control systems are needed for the delivery of neurointerventional catheter systems to aid in navigating catheter systems to distal sites in the brain, particularly for catheters that are designed to navigate challenging brain anatomy while also improving the delivery of suction to distal sites. Summary of the invention

[0007] In one aspect, a robotic surgery system for treating a patient's neurovascular system is provided. The system includes a guide sheath having a sheath body having at least one lumen extending between a proximal region and a distal region, the distal region defining a distal opening from the at least one lumen; and a hub connected to the proximal region of the sheath body. The system includes a catheter system including a support catheter having a distal lumen portion having an outer diameter sized to be positioned within at least one lumen of the guide sheath, the distal lumen portion being connected to a proximal control element adjacent to a proximal opening of a single lumen from the distal lumen portion in the proximal region; and a navigation catheter having a guidewire lumen; a distal end region tapering from an outer diameter sized to fill a single lumen of the support catheter to a distal end defining an opening from the guidewire lumen; and a proximal extension. The system includes a robotic drive system configured to drive the catheter system within a patient's blood vessel. The robot 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 a support catheter, and the second set of rollers is configured to engage a proximal extension of a navigation catheter. The second set of rollers is located proximal to the first set of rollers. The system includes a controller operatively coupled to the cassette. The controller is configured to control the first and second sets of rollers to determine a linear translation of the support catheter and a linear translation of the navigation catheter.

[0008] The system can also include a guide wire and a third group of rollers located proximal to the second group of rollers, the third group of rollers being configured to engage the guide wire. The spacing of the third group of rollers can be designed to allow the navigation catheter to move in full range by the second group 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 groups of rollers can be configured to adapt to different outer diameters. The spacing between the rollers in the first group of rollers can be closer than the spacing between the rollers in the second group of rollers. The first group of rollers can be located proximal to the working lumen of the guide sheath and deviate from the axis of the working lumen of the guide sheath.

[0009] The system may also include a suction system operatively coupled to the controller. The suction system may be configured to apply static or periodic suction. Periodic suction may be applied using a spring-operated pressure relief valve or a solenoid valve. The suction system may be manually actuated or actuated by software running on the controller. The guide sheath may be coupled to the robot drive system by fixing the hub to the box via at least one connector and / or a cavity within the box. At least one connector may be configured to rotate the guide sheath around the longitudinal axis of the sheath body. At least one of the first and second groups of rollers may be configured to change the linear translation, angle, or both. The first and second groups of rollers may be configured to be driven in unison. Due to mechanical linkage, the first and second groups of rollers may be driven in unison.

[0010] The system may include one or more markers on the support catheter and / or one or more markers on the navigation catheter. The controller may be programmed to detect one or more markers on the support catheter and one or more markers on the navigation catheter to assess the extension of the support catheter relative to the navigation catheter. The controller may be programmed to detect one or more markers on the support catheter and one or more markers on the navigation catheter to assess the total advancement distance. The system may include one or more flow sensors and one or more pressure sensors. The system may also include an oscillating input configured to cause the support catheter to follow one or more retraction and one or more advancement modes. The oscillating input may be programmable by the user. The oscillating input may initiate the following modes: a short retraction of the support catheter, withdrawing 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 the advancement of the support catheter, advancing the distal opening from the second position to the first position. This mode may start after a period of static suction through the support catheter.

[0011] In a related aspect, a method for performing robotic surgery on a patient in a neurovascular system is provided. The method includes coupling a catheter system to a robotic drive system, the robotic drive system being operatively coupled to a controller operable by an operator's input, the robotic drive system having a plurality of rollers movable in response to the operator's input. The catheter system includes a support catheter having a distal lumen portion having a distal opening and a proximal opening, a single lumen extending between the proximal opening and the distal opening; and a proximal control element having no lumen, the proximal control element being coupled to the distal lumen portion near the proximal opening; and a navigation catheter including a guidewire lumen; an outer diameter sized to fill a single lumen of the support catheter; a distal end region; and a proximal extension. The navigation catheter can be axially positioned by the single lumen of the support catheter so that the distal end region of the navigation catheter can extend from the distal opening of the distal lumen portion of the support catheter. A support catheter that positions a navigation catheter within a single lumen is capable of navigating to a vessel distal to the petrous portion of the internal carotid artery. The method includes coupling a proximal control element of the support catheter to a first set of rollers among a plurality of rollers; coupling a proximal extension of the navigation catheter to a second set of rollers among the plurality of rollers, the second set of rollers being located 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 operator input.

[0012] In a related aspect, a robotically controlled surgical system for removing a clot from a patient is provided. The system includes a guide sheath having at least one working lumen; a catheter system including a catheter having a distal lumen portion, the outer diameter of the distal lumen portion being sized to be positioned within the working lumen, the distal lumen portion being coupled at a proximal region to a proximal control element adjacent to a proximal opening of a single lumen from the distal lumen portion. The guide sheath is operatively coupled to a suction system for performing a suction function on the clot through a continuous lumen formed by 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 interventional device. The system includes a remote control station for controlling the instrument drive system and the suction system.

[0013] In a related aspect, a robotic catheter system is provided, comprising a controller including a master input device configured to be operated by a surgeon located remote from a patient, an instrument driver in communication with the controller, the instrument driver having 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 located within the housing, the motors responsive to control signals generated at least in part by movement of the master input device for actuating movement of the catheter drive elements and the catheter interface relative to the housing. The system includes a catheter having a proximal ribbon coupled to a distal lumen portion having a single working lumen, the proximal ribbon operatively coupled to the catheter interface, the catheter being axially movable relative to a guide sheath such that movement of the catheter is controllable by the master input device. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] These and other aspects will now be described in detail with reference to the following drawings. In general, the drawings are not drawn absolutely to scale or comparatively, but are intended to be illustrative. In addition, the relative placement of features and elements may be modified for clarity of illustration.

[0015] Figure 1A A patient having a catheter system inserted using a robotic drive system is shown;

[0016] Figure 1B Shows Figure 1A Patients with a catheter system inserted at a level distal to the siphon segment of the carotid artery;

[0017] Figure 2 is a schematic block diagram of a robotic system for catheter surgery;

[0018] Figure 3A is an exploded view of the catheter system;

[0019] Figure 3B yes Figure 3A Assembly drawing of the catheter system;

[0020] Figure 3C It is taken along circle CC Figure 3A Detailed view of the distal region of the navigation catheter in FIG;

[0021] Figure 4A Is installed Figure 3A-3B Schematic diagram of a robotic drive system for a catheter system;

[0022] Figure 4B Is installed Figure 3A-3B A schematic diagram of a catheter system in a robot drive system and nested in a catheter with a larger outer diameter;

[0023] Figure 4Cis a schematic diagram of a robotic drive system configured to provide independent movement of a guide catheter relative to other components of a catheter system;

[0024] Figure 5 is an example of a user interface;

[0025] Fig. 6A is a side view of an embodiment of a set of rollers for accommodating different outer diameters of a single component driven by a robotic drive system;

[0026] Figure 6B yes Fig. 6A A top plan view of the middle roller;

[0027] Figure 6C yes Fig. 6A A perspective bottom view of the middle roller;

[0028] Fig.6D yes Fig. 6A A cross-sectional view of an embodiment of a set of rollers.

[0029] It should be understood that the drawings are for illustration purposes only and are not drawn to scale. It should be understood that the devices described herein may include features that are not necessarily shown in every drawing. DETAILED DESCRIPTION

[0030] Figure 1A-1B Shown is a patient 5 and a robotic surgical system 10 that includes a distal vascular access system 100 driven by a robotic drive system 600 into the intracranial vasculature. Figure 1B A distal access system 100 is shown having an introducer sheath 400 positioned within an internal carotid artery, a catheter 200 extending out of a distal opening of the introducer sheath 400, and a navigation catheter 300 extending out of the distal opening of the catheter 200 and positioned at least partially distal to the carotid siphon segment. The robotic surgical system 10 enables safe and rapid neurovascular access. The procedures performed by the robotic surgical system 10 can be varied, including diagnostic procedures as well as therapeutic procedures, such as clot removal, angioplasty, stent placement, AV malformation treatment, aneurysm treatment, etc. The distal access system 100 is particularly suitable for aspiration at an embolic site through the catheter 200 or delivery of an interventional device through the catheter 200 for intracranial surgery.

[0031] Figure 2is a schematic block diagram of a robotic surgical system 10. Some components of the robotic surgical system 10 are located next to the patient, while other components may be remote from the patient. As used herein, "remote" may mean outside the fluoro field but in the same room as the patient, or may mean outside the same room as the patient. An operator that is remote and outside the same room as the patient need not be in the same building, and may be remote from the hospital where the patient is located.

[0032] The 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 by an operator (e.g., a physician) on the patient side (i.e., locally) and / or remotely controlled using a control station 700. The control station 700 being remote from the patient reduces radiation exposure to the operator manipulating the control station 700 because the operator can remain well outside the fluoroscopic field and / or behind radiation shielding. The control station 700 also provides a physical advantage to the operator because the operator does not need to wear a protective mask, such as a lead apron, and can sit while operating the control station 700, rather than standing next to the operating table 7 during surgery.

[0033] The robotic surgical system 10 may also include one or more other medical systems 800, including a suction system 805, (one or more) imaging systems 810, contrast injection 815, and other medical systems used during a particular procedure. The other medical systems 800 may be, for example, Figure 2 The individual systems 800 may be combined with one or more medical systems in the robotic drive system 600. For example, the robotic drive system 600 may have an integrated contrast injection, imaging, or aspiration system. Other medical systems 800 may include various patient monitoring including blood pressure, heart rate, carotid ultrasound, etc. Figures 3A-3C , Figure 4A-4B and Figure 5 Each of the various components is described in more detail.

[0034] The robotic drive system 600 may include various drive mechanisms that cause independent movement of components and / or other components (e.g., guidewires) of the distal access system 100. The movement may include advancement and retraction of components. The movement may also include rotation of components. The robotic drive system 600 may include a base console 601 and a box 605 capable of cooperating with the console 601. The base console 601 may include a controller 610 having a user interface with one or more inputs 612 and one or more outputs 614, and one or more sensors 625. The box 605 may include a plurality of roller groups 615 and a plurality of connectors 620. The use of the term "roller" is not intended to exclude other types of manipulation mechanisms. For example, a pad system, teeth, a screw drive, a mobile clamp, a clamp, a gripper, or other mechanisms may be used to advance and / or retract components, which are configured to grasp, release, push, pull, twist, turn, and / or otherwise achieve the feeding movement of each component relative to the patient in one or more directions.

[0035] Base console 601 can be a durable component supported by an articulated arm 603 located on a support as known in the art. Arm 603 can be locked to an infinite position relative to the patient so that base console 601 and therefore box 605 are positioned relative to the patient's access site. Articulated arm 603 and related support can be a self-supporting device that can be moved around in an operating room. Articulated arm 603 and related support can also be configured to be clamped on another component (such as the area of ​​the table 7 where the patient is located). Base console 601 can be connected to the area of ​​arm 603, such as once connected, allowing base console 601 to move relative to arm 603 on a track. The movement of base console 601 can be performed manually by the user physically sliding base console 601 along the track of arm 603. The movement of base console 601 relative to arm 603 can also be actuated by the user through an electronic input on console 601 or arm 603.

[0036] Base console 601 is configured to be operably connected to box 605, and box 605 can be disposable items manufactured for single use. Box 605 and console 601 can be connected together when in use, and use arm 603 to position relative to patient 5 on table 7. For example, base console 601 can be positioned above patient 5, adjacent to the area where the catheter system enters the access site of the patient. The connection between base console 601 and box 605 can be varied. Usually, the connection realizes the electronic and mechanical linkage between the two, so that box 605 can be controlled by base console 601. Base console 601 can be combined with one or more motors and gears, which are connected to the drive roller 615 in box 605. The connection of the motor in base console 601 and the roller 615 in box 605 can also be realized by magnet. For example, base console 601 may include a motor configured to rotate the magnet in base console 601. The base console magnet can rotate the corresponding magnet in box roller 615. The use of magnets can provide an interface with minimal surface features that will need to be cleaned between surgeries. The base console 601 can be covered by a disposable sheath 607 that is designed to be penetrated by or receive one or more connectors 620 of the box 605 through an opening formed in the disposable sheath 607. The sheath 607 maintains a sterile environment while still allowing a connection between the base console 601 and the box 605. The box 605 can incorporate one or more covers, windows, doors that can be opened to allow installation of catheter components with the aid of a plurality of rollers 615 and connectors 620 and latched closed after insertion.

[0037] One or more inputs 612 may be used to manipulate the arm 603, thereby manipulating the position of the console 601 relative to the patient 5. The one or more inputs 612 may also be used to adjust the position of the console 601 (and therefore the cassette 605) relative to the arm 603, as described above. For example, the console 601 may be coupled to a rail system of the arm 603 so that the console 601 and its attached cassette 605 may be incrementally slid forward and backward relative to the patient 5. In other embodiments, the cassette 605 may be moved relative to the console 601 after coupling. Incremental movement may be adjusted, for example, to place a component within an access vessel, change the angle of the robotic drive system 600 relative to the table 7, or make other adjustments.

[0038] One or more inputs 612 may also include inputs configured to set various parameters of the surgery before remotely performing surgical control. One or more inputs 612 do not need to be actual physical buttons and may be located on a touch screen or other type of display device that allows a user next to the robot to start one or more functions of the robot drive system 600. In some embodiments, one or more inputs 612 of the robot drive system 600 may include a scanner configured to scan a 2D barcode, a 3D barcode, a QR code, an image-based code, an optically readable code, or other codes known in the art. For example, any of the various components of the box 605 or used on the patient may include a product label having a code configured to be scanned, and the patient may have a hospital wristband with a code configured to be scanned. One or more inputs 612 may be used to control the manipulation of the catheter system components (including the guidewire 500), such as by activating the roller 615 for manipulation.

[0039] The robotic drive system 600 may include a sheath holder 622 to, for example, assist in supporting the guide sheath 400 relative to the console 601 or the box 605. The sheath holder 622 may be a semi-rigid tube or a slit sleeve that can be advanced over at least a portion of the guide sheath 400 (e.g., a section of the sheath body 420 that is located outside the patient's body that would otherwise be unsupported). The sheath holder 622 may include a telescoping or foldable tube section that may be shortened or lengthened during use while providing columnar support for the body 420 of the guide sheath 400. The sheath holder 622 may prevent the body 420 from buckling when the robotic drive system 600 advances and retracts components such as the catheters 200, 300 relative to the body 420. For example, when the console 601 and the box 605 are moved by the arm 603, the sheath holder 622 may slide within a guide rail within the box 605. A sheath retainer 622 located above the guide sheath 400 can be secured to the patient at the introducer sheath at the entrance to the femoral artery to prevent the guide sheath 400 from buckling between the insertion site in the patient and the robot. The sheath retainer 622 supports the guide sheath 400 while still 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 markings that can be used to monitor the position of the sheath retainer 622 within the cassette 605 via optical monitoring features on the console 601 or arm 603.

[0040] One or more of the multiple cavities and / or connectors 620 on the cartridge 605 can couple the guide sheath 400 to the cartridge 605. A first connector 620 can secure the proximal end of the guide sheath 400 to a connector within a cavity in the cartridge 605 and also secure the robotic drive system 600 to the guide sheath 400. Another cavity or connector 620 can include one or more gears configured to mate with teeth on a collar on the guide sheath 400 so that the guide sheath 400 can rotate about its longitudinal axis A. As will be described in more detail below, the proximal end of the guide sheath 400 can include a y-connector or hub 434 having a rotary connector (referred to herein as a rotary hemostasis valve or RHV) that provides access to the working lumen of the guide sheath and also allows the guide sheath 400 to rotate. Even if the y-connector remains fixed within a cartridge cavity or pocket, the guide sheath 400 can be rotated by a gear collar mounted distal to the hub. The y-connector may be releasably secured within the cartridge 605 by a connector or cavity, which may be a clamp, snap or other feature.

[0041] The plurality of rollers 615 may also be used to engage one or more components to the cartridge 605, and to linearly translate and / or rotate components of the distal access system 100 relative to the longitudinal axis A. The cartridge 605 may have more than a single set of drive rollers 615. As will be described below in conjunction with Figure 4A-4B As discussed in more detail, the first set of rollers 615 can be configured to engage with the catheter 200, in particular, the proximal control element 230 of the catheter 200. The second set of rollers 615 can be configured to engage with the navigation catheter 300, in particular, 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 positioned proximal to the first set of rollers 615. The cartridge 605 can include additional roller sets 615, for example, proximal to the first and second sets of rollers 615, to engage with another region of the guidewire or one or more catheters. The drive roller set 615 can include a first roller and a second roller spaced closely together to allow a component of the system to be located between them and contact the outer surface of the component with sufficient force to provide movement of the component when the roller set 615 is rotated. The roller set 615 can be composed of two rollers, but, as described above, any of a variety of transmission mechanisms are contemplated herein to advance and retract the driven component.

[0042] Reference again Figure 2, the controller 610 of the robotic drive system 600 communicates with a control station 700, which is configured to enable an operator to remotely control one or more functions of the robotic drive system 600. The movement of the catheter 200, 300 achieved by the plurality of rollers 615 can be controlled by the controller 610 of the robotic drive system 600, which is in electronic communication with the control station 700, as will be described in more detail below. The controller 610 of the robotic drive system 600 allows components to be driven directly at the location of the patient. For example, a technician may be stationed next to the patient and be responsible for performing certain procedures by directly operating the robotic drive system 600 using one or more inputs 612.

[0043] The technician may initially use the controller 610 of the robot drive system 600 during the first stage of the operation on the patient, and then turn to the controller 710 of the control station 700 to perform another part of the operation. During the operation, if the user requires, the initial advancement stage of the catheter system components can be manually performed by the operator until the components reach a specific advancement amount. The manual advancement amount can depend on the user's preference and the operation to be performed. For example, for carotid or anterior circulation surgery, the end of the guide sheath 400 can be advanced to the common carotid artery, the cervical ICA, or the more distal segment of the ICA, or for posterior circulation surgery, the end of the guide sheath 400 can be advanced to the subclavian artery or vertebral artery. The catheter system including the catheter 200 and the navigation catheter 300 can be manually advanced to the desired distance through the guide sheath 400 before being latched into the box 605, for example, until the distal end of the guide sheath 400. The guide wire can be further inserted before being latched into the box 605, for example, until and across the target treatment site. The user may then activate or load components into the cartridge 605 so that the drive system 600 can move the components.

[0044] The controller 610 of the robotic drive system 600 may also communicate with a control station 700 that is remote from the patient, so that the doctor may cause the robotic drive system 600 to perform certain other functions through communication between the controller 710 of the control station 700 and the controller 610 of the robotic drive system 600. The controller 610 of the robotic drive system 600 may also communicate with one or more sensors 625 of the robotic drive system 600. The one or more sensors 625 may sense any of a variety of conditions associated with the robotic drive system 600, the distal access system 100, and / or the patient 5. For example, the one or more sensors 625 may sense blood flow or pressure through one or more catheters.

[0045] The control station 700 may be located in the same room as the robotic drive system 600, or may be physically remote from the robotic drive system 600 and the patient 5, such as in a different room. For example, the patient 5 may be in an operating room, and the control station 700 may be located in a separate control room associated with the operating room, or in a room completely remote from the building where the patient 5 is located.

[0046] The control station 700 may be a computing system 705, including but not limited to a desktop computer, a laptop computer, a tablet computer, or other processing device. The computing system 705 of the control station 700 may include a controller 710, a communication port 715, and a user interface 720, the user interface including at least one input 725 and at least one display 730. The user interface 720 may include a graphical user interface (GUI).

[0047] The controller 710 of the computing system 705 may include at least one processor and a memory device. The memory device may be configured to receive and store user input data and data acquired during use of the robot drive system 600. The memory device may include any type of memory capable of storing data and transmitting the data to one or more other components (e.g., a processor) of the system 10. 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 may run software that initiates the action of the robot drive system 600 with or without any user input. The controller 710 may synchronize the movement of one or more components, such as by driving a plurality of rollers 615 at the same speed to achieve simultaneous advancement of two catheters 200, 300 as a catheter assembly. The controller 710 may run software that is programmed to detect / sense various markers on the components in order to assess the relative extension of the components and / or the total distance of advancement, and / or the speed of advancement or withdrawal. For example, the controller 710 can determine the amount of linear translation of one or more components (e.g., catheter 200, catheter 300), such as by sensing one or more marks on the components by the sensor 625 of the robotic drive system 600 or by the rotation of multiple rollers 615. For example, the linear translation of one or more components containing radial marks or magnets can be detected by optical sensors or Hall sensors, respectively, and controlled by a programmable logic control system or software. The roller movement can be controlled by a servo motor, while the rotation is controlled by a programmable logic control system. The controller 710 software can be programmed to drive multiple rollers 615 at a specific relative speed or extension relative to one or more components, depending on the position of the component being advanced in the anatomical structure. The controller 710 software may include blockage detection based on flow sensing performed by one or more sensors 625 of the robotic drive system 600 through the catheter. 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 for the entire system 10 (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 status, data, etc.). The controller 610 of the robot drive system 600 and the controller 710 of the control station 700 can be different controllers that communicate, where one controller (610 or 710) is a master controller and the other controller is a slave controller. In other words, when the control information from one controller conflicts with the second controller, the master controller has priority, so that the two controllers 610, 710 operate according to a master / slave configuration.

[0048] One or both controllers 610 and / or 710 can display the status of components of the robotic display system. For example, if a component of the distal access system 100 is not loaded and / or latched in the associated cartridge position, the controller can display a red light and can switch to a green light when properly loaded and / or latched. User interface features of the system will be described in more detail below.

[0049] The communication port 715 is configured to communicate with a corresponding one of the robotic 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 hard-wired connection, which is configured to receive and / or send information to the robotic drive system 600. The communication port 715 can alternatively or additionally include a wireless communication port so that information can be fed between the control station 700 and the robotic drive system 600 through a wireless link, such as to display the information in real time on the display 730. For example, the display can display the loading and latching status of all components of the distal access system 100 in the relevant positions in the box 605. When all components are loaded and latched, the display can also display a status identifier, such as one or more words (e.g., "READY"). The display can also prompt the order in which the components are loaded 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 cellular phone system, and can also use encoding or authentication to verify the source of the received information. The wireless connection may also be any of a variety of proprietary wireless connection protocols.

[0050] At least one input 725 may include a touch screen, one or more joysticks, rollers, buttons, sliders, foot pedals, microphones, voice commands, and / or other inputs. The input 725 is configured to cause one or more of the various components to be advanced, withdrawn, and / or rotated by driving the rollers 615 of the robot drive system 600, and the various components include one or more guide sheaths, catheters, microcatheters, guidewires, or other components. The input 725 may include an emergency button, a speed control button, or a slider, or other inputs designed to achieve a specific movement or action of one or more components. The input 725 may move multiple rollers, such as in at least one degree of freedom. For example, the first and second groups of rollers 615 may be moved in response to an operator input, thereby advancing the catheter 200, 300, and / or the guide sheath 400 in the distal and proximal directions.

[0051] The user interface 720 may include one or more displays 730 configured to display information about the patient, the component, and / or the procedure. The user interface 720 may be a graphical user interface (GUI) (see Figure 5). The GUI can display image data (e.g., X-ray images, MRI images, CT images, ultrasound images, etc.), patient vital signs (e.g., blood pressure, heart rate, heart rhythm, etc.), patient medical history (e.g., age, weight, medical history), component data (e.g., catheter length, aperture, etc.), treatment assessment data (e.g., suction pressure, suction cycles, etc.), and any other information useful for the surgery being performed. The same information can be displayed on an additional user interface display at the patient table. This allows a technician in the same room as the patient on the operating table to see the same information as an operator away from the patient and the operating table. As described above, the displayed information can be coordinated with the input to provide better guidance to the user. These and other aspects will be described in more detail below.

[0052] Aspects of the subject matter described herein 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 implementations may include implementations in one or more computer programs that can be executed and / or interpreted on a programmable system that includes at least one programmable processor, which can be special purpose or general purpose, coupled to receive signals, data, and instructions from a storage system, at least one input device, and at least one output device, and to transmit signals, data, and instructions to a storage system, at least one input device, and at least one output device.

[0053] These computer programs (also referred to as programs, software, software applications, or code) include machine instructions for a programmable processor and may be implemented in high-level procedural and / or object-oriented programming languages ​​and / or assembly / machine languages. As used herein, the term "machine-readable medium" refers to any computer program product, apparatus, and / or device (e.g., a disk, an optical disk, a memory, a programmable logic device (PLD)) for providing 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 for providing machine instructions and / or data to a programmable processor.

[0054] Each component of the robotic surgical system 10 , including the catheter system 100 and the robotic drive system 600 , will be described in more detail below.

[0055] Catheter system components

[0056] The robotic drive system 600 of the surgical system 10 can be used to deliver one or more catheters, catheter systems and / or devices designed to be delivered by catheters or catheter systems. As previously described, the surgery performed by the surgical system 10 can be different, including diagnostic surgery and therapeutic surgery, such as clot removal, angioplasty, stent placement, AV malformation treatment, aneurysm treatment, etc. In some embodiments, the catheter system described herein can be used to treat acute ischemic stroke (AIS). The system described herein provides fast and simple access to distal target anatomical structures, particularly to the tortuous anatomical structures of the cerebral vasculature at a single manipulation point. Rapid exchange, single-point manipulation allows the robotic drive system to be used with multi-component catheter systems, which would otherwise be impossible due to their overall length creating an unsuitably large footprint in an operating room.

[0057] Medical methods, devices and systems described herein allow for navigation of complex, tortuous anatomical structures, for example, to deliver intracranial medical devices. The extreme flexibility and deliverability of the distal access catheter system described herein allow the catheter to take on the shape of a tortuous anatomical structure, rather than applying a straightening force to create a new anatomical structure. The distal access catheter system described herein can pass through a tortuous loop while maintaining the natural curvature of the anatomical structure therein, thereby reducing the risk of vascular straightening. The distal access catheter system described herein can therefore create a safe conduit (conduit) through the neurovascular system, maintaining the natural tortuosity of the anatomical structure, so that other catheters pass through (e.g., a larger aperture suction catheter, a support catheter for a stent, or a shunt delivery, etc.).

[0058] Although some specific embodiments are described herein that specifically relate to accessing neurovasculature anatomy to apply aspiration or treat AIS, the systems and methods described herein should not be limited thereto and may also be applicable to other procedures mentioned elsewhere herein. The catheter systems described herein can be used to deliver working devices to a target vessel of a coronary anatomy or other vasculature anatomy. When the phrase "distal access catheter" or "aspiration catheter" is used herein, the catheter can be used for aspiration, to deliver fluids to a treatment site, or as a support catheter, or to provide distal access to a conduit that facilitates and guides the delivery or exchange of other devices, such as a guidewire or interventional device, such as a stent retriever, stent, shunt, coil, balloon, and other devices.

[0059] The devices and systems described herein are related to, and may be used in combination or alternatively with, the devices and systems described in the following patents, publications, and applications: U.S. Patent No. 10,327,790, filed August 3, 2012; U.S. Patent No. 9,561,345, filed December 19, 2014; U.S. Patent No. 9,820,761, filed February 4, 2016; U.S. Publication No. 2018 / 0193042, filed January 9, 2018; U.S. Publication No. 2018 / 0361114, filed January 19, 2018; U.S. Publication No. 2019 / 0351182, filed May 16, 2019; U.S. Patent No. 11,400,255, filed November 14, 2019; and U.S. Publication No. 2020 / 0289136, filed June 2, 2020. The disclosures of each of these publications and applications are incorporated herein by reference in their entirety.

[0060] Figure 3A-3B An embodiment of a distal access system 100 is shown that includes a catheter assembly 150 that is configured to be advanced using a robotic drive system 600. The catheter assembly 150 may include a first catheter 200 and a second catheter 300 that is configured to be positioned inside the first catheter 200. The first catheter 200 may be referred to herein as a distal catheter or outer catheter. The second catheter 300 may be referred to herein as a navigation catheter or inner catheter. Figure 3A is an exploded view of system 100, Figure 3B yes Figure 3A An assembly diagram of system 100 is shown. Figure 3C It is taken along circle CC Figure 3A Detailed view of the navigation catheter 300 of the catheter assembly 150 of the catheter assembly 150. System 100 can provide quick and simple access to distal target anatomical structures, particularly the tortuous anatomical structures of the cerebral vasculature. As will be described in more detail below, all silk threads and catheter manipulations can be performed at or in the immediate vicinity of a single rotary hemostatic valve (RHV), or more than a single RHV co-located in the same device or in the immediate vicinity. Manipulation can be performed due to the robot drive system 600, and can also be performed by manual manipulation of the operator at the patient side. The process described herein can relate to a combination of manual operator manipulation and robot drive system manipulation.

[0061] System 100 may include one or more catheter assemblies 150, each of which has a first catheter 200 and an inner navigation catheter 300. The first catheter 200 may be an aspiration catheter designed to be sealed with the catheter extending therethrough, or an access catheter designed to be unsealed. The first catheter 200 does not require sealing and may be used as a support catheter for another component. The catheter assembly 150 is configured to be advanced by accessing a guide sheath 400. The catheter 200 is configured to be received by the guide sheath 400 and is designed to have excellent transportability. The catheter 200 may be a spined catheter, which, when assembled in the guide sheath, provides a gradual increase in the inner diameter (step-up) with the lumen of the guide sheath 400. The navigation catheter 300 inserted through the lumen 223 of the catheter 200 may be used to deliver the catheter 200. The flexibility and transportability of the first catheter 200 allow the catheter 200 to present the shape of a tortuous anatomical structure when advancing, and avoid applying a straightening force to the anatomical structure. The first catheter 200 is able to do this even with the navigation catheter 300 extending through its lumen. Thus, the flexibility and deliverability of the navigation catheter 300 is comparable to or better than the flexibility and deliverability of the distal lumen portion 222 of the first catheter 200, as both are configured to reach the middle cerebral artery (MCA) circulation without straightening the curvature of the anatomy along the way.

[0062] System 100 can be a distal access system that can create a variable length from the entry point of a percutaneous arteriotomy (e.g., the femoral artery or other entry point) to the target control point of the distal catheter. Conventional distal access systems for neurointerventions typically include a long guide sheath or guide catheter that is placed through a shorter "introducer" sheath (e.g., 11-30 cm in length) at the groin. Long guide sheaths are typically located in the ICA to support neurovascular interventions, including stroke embolectomy (sometimes referred to as "thrombectomy"). For added support, these can be advanced until the end of the bony petrous bone and rarely into the cavernous or clinoid or supraclinoid end of the ICA when possible. In order to reach targets in the M1 or M2 distribution using a mechanical thrombectomy device (e.g., a device for manual aspiration thrombectomy (MAT), stent retriever (SR), aspiration first pass technology (ADAPT), and "Solumbra" (aspiration + SR)), an additional catheter can be inserted through the long guide catheter. These catheters are typically large bore aspiration catheters, for example, can be 130 cm or longer 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 measured from the access point (typically the common femoral artery) as considered by the system. In addition, the system described herein can be inserted through a single rotary hemostasis valve (RHV) 434 on the introducer sheath 400 or more than one RHV (e.g., a dual-ended RHV) co-located in the same device.

[0063] Still refer to Figure 3A-3B , the distal access system 100 may include an access guide sheath 400 having a body 402 through which a working lumen extends from a proximal hemostasis valve 434 coupled to a proximal region 403 of the body 402 to a distal opening 408 at a distal region. The working lumen is configured to receive a catheter 200 therethrough such that the distal end of the catheter 200 may extend beyond the distal end of the sheath 400 through the distal opening 408. The guide sheath 400 may be used to deliver any of the catheters described herein and various working devices known in the art. For example, the working device may be configured to provide thrombus treatment and may include a large-bore catheter, aspiration embolectomy (sometimes referred to as thrombectomy), an advanced catheter, a wire, a balloon, a retrievable structure (e.g., a retrievable stent with a coil tip "stent retriever"), a stent, and a shunt.

[0064] The sheath body 402 may extend from a proximal bifurcated or rotating hemostatic valve (RHV) 434 at the proximal region 403 to a distal region 407 of the body 402. The proximal RHV 434 may include one or more cavities molded into the connector body to connect to the working lumen 405 of the body 402 of the guide sheath 400. The working lumen may receive the catheter 200 and / or any of a variety of working devices for delivery to the target anatomical structure. The RHV 434 may be constructed of a thick-walled polymer tube or a reinforced polymer tube. The RHV 434 allows the device to be introduced into the vasculature through the guide sheath 400 while preventing or minimizing blood loss and preventing the introduction of air into the guide sheath 400. The RHV 434 may be integral with the guide sheath 400, or the guide sheath 400 may terminate in a female Luer adapter at the proximal end to which a separate hemostatic valve component (e.g., a passive sealing valve, a Tuohy-Borst valve, or a RHV) may be attached. The RHV 434 can have an adjustable opening that opens sufficiently large to allow removal of a device with an adhered clot on the distal opening 408 without causing the clot to fall out at the RHV 434 during removal. Alternatively, the RHV 434 can be removable, such as when removing the device from the sheath 400, to prevent the clot from falling out at the RHV 434. The RHV 434 can be a dual RHV or a multi-head RHV.

[0065] RHV 434 can form a Y-type connector on the proximal region 403 of sheath 400, so that the first port of RHV434 can be used to insert the working catheter into the working lumen of sheath 400, and the second port entering arm 412 can be used for other purposes. For example, a syringe or other device can be connected to arm 412 through connector 432 to deliver forward instillation, a flushing line for contrast agent or saline injection through the body 402, with or without a distal opening 408 and entering the target anatomical structure catheter. 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 conventional or locked syringe, a handheld aspirator, a hospital aspirator, etc., which is configured to aspirate through the working lumen. In an embodiment, the vacuum source is a locking syringe (e.g., a VacLok syringe) attached to a flow controller. Before the embolectomy step of the operation, the operator can pull the plunger on the syringe back to the locked position while closing the connection to the flow line. 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 introducer sheath 400. A single shared suction source is sufficient to provide suction throughout the entire system 100, even if multiple suction catheters 200 are nested within each other through the working lumen of the introducer sheath 400. The arm 412 can also allow the introducer sheath 400 to be flushed with saline or radiopaque contrast media during surgery. The working lumen can extend from the distal opening 408 to a working proximal port of the proximal region 403 of the sheath body 402.

[0066] Contrast agent (e.g., from contrast agent injection system 815) can be injected into the blood vessel through the guide sheath 400 to visualize the occlusion site through angiography. For example, the guide sheath 400 can be positioned so that at least a portion is located within the carotid artery. Once positioned at this position, contrast agent can be injected through the sheath 400. Contrast agent can also be injected through one or more catheters inserted through the guide sheath 400. Before inserting the device, a baseline angiogram can be obtained, such as in anterior / posterior (AP) and / or lateral view, to evaluate the occlusion site using fluoroscopic visualization (e.g., part of the imaging system 810) by injecting contrast agent through the sheath 400. As the catheter system is advanced, fluoroscopic visualization can continue, and subsequent angiograms can be captured periodically and particularly after each attempt to retrieve the embolus to evaluate reperfusion. The baseline angiogram image can be superimposed, such as using digital subtraction angiography, so that the vasculature and / or occlusion site can be seen as the catheter system is advanced. Once the catheter assembly 150 is advanced into position (positioning will be described in more detail below), the navigation catheter 300 can be withdrawn and removed from the system. In some embodiments, for example, for treating occlusions by aspiration embolectomy, a vacuum source (e.g., a pump) can be connected to the sheath 400 and activated to direct aspiration to the distal end of the catheter 200. The aspiration can be applied for a period of time (e.g., between about 30 seconds and about 3 minutes, preferably about 2 minutes) to allow the capture and engulfment of emboli in the catheter 200. The flow rate of the aspiration can vary, and in one example, can be between about 25 inches of mercury (inHg) (12.279psi) and about 28inHg (13.752psi). In some embodiments, before applying vacuum to the blood vessel, the pump is allowed to run to gradually establish a vacuum outside the patient's body for a first period of time, for example, by switching the 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 blood vessel, allowing a vacuum to be gradually established through the system. After a period of aspiration is applied to the catheter, the catheter 200 can be slowly withdrawn. Once free flow is achieved, as can be observed by the continued collection of fluid within the vessel, the suction source can be disconnected from the sheath 400 and a confirmatory angiogram can be performed. Angiography can be performed by injecting contrast media through the suction catheter 200 still positioned through the working lumen of the sheath 400. Angiography can also be performed through the guide sheath 400 after the suction catheter 200 has been completely removed from the guide sheath 400.

[0067] Aspiration may be performed by aspiration system 805, contrast media injected by contrast media injection system 815, and angiography performed by imaging system 810, each of which is performed at control station 700 (see Figure 2 ) under the control of ).

[0068] The vacuum source can increase the level of suction when the flow rate is slow and decrease the level of suction when the flow rate increases. In this way, when the catheter is blocked or partially blocked, the force is greatest, but when there is free flow, the force is reduced to a minimum level to ensure that distal embolism is prevented but the volume of blood aspirated is limited. In this way, the system can optimize embolic aspiration while limiting the volume of blood aspirated. When the flow in the catheter 200 is occluded or restricted, the pump can generate a higher level of vacuum. In this example, the suction force can be configured to be detected (e.g., by one or more sensors 625 (see Figure 2 )) rises when it reaches a higher vacuum. The vacuum source can include a vacuum gauge, or the vacuum gauge can be incorporated into the proximal end of the RHV or Luer connector or guide sheath 400. In a further embodiment, the robotic drive system 600 can be combined with one or more sensors 625, which are configured to evaluate the status of one or more functions of the system, such as flow rate, blockage, vacuum level, etc., to automatically adjust the parameters of the system. Various controls of the system described herein can be performed by an operator at the control station 700 or manually at the operating table 7, or a combination of both.

[0069] In an embodiment, the guide sheath 400 includes one or more radiopaque markers 411. The radiopaque marker 411 can be disposed near the distal opening 408. For example, a pair of radiopaque bands can be provided. The radiopaque marker 411 or any marking of the system component can be swaged, painted, embedded or otherwise disposed in or on the body. In some embodiments, the radiopaque marker comprises a barium polymer, a tungsten polymer blend, a tungsten-filled or platinum-filled marker that maintains the flexibility of the device and improves the transition along the length of the component and its kink resistance. In some embodiments, the radiopaque marker is a tungsten-filled PEBAX or polyurethane that is heat welded to the component.

[0070] The guide sheath marker 411 is shown in the figure as a ring around the circumference of one or more regions of the body 402. However, the marker 411 can have other shapes or create various patterns that provide guidance to the operator about the location of the distal opening 408 within the blood vessel. Therefore, the operator can visualize the location 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 guided toward the target anatomical structure to which the catheter 200 will be delivered. For example, (one or more) non-transmissive markers 411 allow the body 402 of the guide sheath 400 to rotate at an anatomical access point (e.g., the patient's groin) so that the distal opening provides access to the ICA through (one or more) subsequent working devices (e.g., catheters and wires advanced to the ICA). In some embodiments, (one or more) non-transmissive markers 411 include platinum, gold, tantalum, tungsten, or any other material visible under x-ray fluoroscopy. Any of the various components of the system described herein can be combined with non-transmissive markers.

[0071] Still refer to Figure 3A-3B , the catheter 200 may include a relatively flexible distal lumen portion 222, which is connected to a harder anti-kink proximal extension or proximal control element 230. The term "control element" used herein may refer to a proximal region configured to push and move in the distal direction and pull and move in the proximal direction. The control element may be pushed and pulled manually by an operator, or may be pushed and pulled by a robot drive system 600 described elsewhere herein. The control element described herein may 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 may be a hollow or tubular element. The proximal control element 230 may also be solid and have no inner lumen, such as a solid rod, a ribbon, or other solid linear element connected to a tab 234 or other types of components at the proximal end. Typically, the proximal control element described herein is configured to move its corresponding component (which may be attached to or integrated with the component) through the lumen in a bidirectional manner.

[0072] A single inner lumen 223 extends through the lumen portion 222 between the proximal and distal ends of the lumen portion 222. In some embodiments, a proximal opening 242 into the lumen 223 can be located near where the proximal control element 230 couples with the distal lumen portion 222. In other embodiments, the proximal opening 242 into the lumen 223 is located in the proximal region of the catheter 200. A distal opening 231 from the lumen 223 can be located near or at the distal-most end 215 of the lumen portion 222. The inner lumen 223 of the catheter 200 can have a first inner diameter, while the working lumen 405 of the introducer sheath 400 can have a second, larger 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 fluidly connected and continuous with the working lumen of the sheath 400 so that fluid can flow into and out of the system 100, such as by applying suction from a vacuum source coupled proximally to the system 100. The combination of the sheath 400 and the catheter 200 can be in continuous communication with the blood flow at the proximal end during suction as the catheter 200 is advanced and withdrawn.

[0073] The distal lumen portion 222 of the catheter 200 can have a plurality of radiopaque markers 224. A first radiopaque marker 224a can be located near the distal-most end 215 to aid in navigation and proper positioning of the distal-most end 215 under fluoroscopy. Additionally, the proximal region of the catheter 200 can have one or more proximal radiopaque markers 224b such that the overlap region 348 can be visualized as the relationship between the radiopaque marker 411 on the guide sheath 400 and the radiopaque marker 224b on the catheter 200. The proximal region of the catheter 200 can also have one or more radiopaque markers to provide visualization, for example, near the proximal opening 242 of the single lumen 223 of the entry catheter 200, as will be described in more detail below. In an embodiment, the two radiopaque markers (marker 224a near the distal-most end 215 and the more proximal marker 224b) are different to minimize confusion in fluoroscopic images, for example, the catheter proximal marker 224b can be a single band, while the marker 411 on the guide sheath 400 can be a double band, and any markers on the working device delivered through the distal access system can have other types of bands or markers. The radiopaque markers 224 of the distal lumen portion 222, especially radiopaque markers near the distal region of the extremely tortuous anatomical structure to navigate, can be relatively flexible so that they do not affect the overall flexibility of the distal lumen portion 222 near the distal region. The radiopaque markers 224 can be tungsten-filled or platinum-filled markers, which are relatively flexible compared to other types of radiopaque markers used in devices where flexibility is not of paramount importance. In some embodiments, the radiopaque marker can be a tungsten-filled PEBAX band with a Shore 35D durometer.

[0074] The proximal control element 230 may include one or more markings 232 to indicate overlap between the distal lumen portion 222 of the catheter 200 and the sheath body 402 and overlap between the distal lumen portion 222 of the catheter 200 and other interventional devices that may extend through the distal lumen portion 222. At least a first marking may be an RHV proximity marking positioned such that when the marking is aligned with the sheath proximal hemostasis valve 434 during insertion of the catheter 200 through the introducer sheath 400, the catheter 200 is positioned in the most distal position with a minimum overlap length required to form a seal between the catheter 200 and the working lumen. At least a second marking 232 may be a Fluoro-saver marking that may be positioned on the control element 230 and located a distance away from the most distal end 215 of the distal lumen portion 222. In some embodiments, the marking 232 may be positioned about 100 cm away from the most distal end 215 of the distal lumen portion 222.

[0075] The one or more sensors 625 of the robotic drive system 600 may sense various markers to provide information regarding the relative extension of various components and the position of the components within the anatomy based on the total extension achieved.

[0076] Although navigation catheter 300 is described herein with reference to catheter 200, it can be used to advance other catheters and is not intended to limit its use. For example, navigation catheter 300 can be used to deliver a 5MAX reperfusion catheter (Penumbra, Inc., Alameda, CA), a REACT aspiration catheter (Medtronic), or a Sophia Plus aspiration catheter (Terumo) for clot removal in a patient suffering from acute ischemic stroke; or other reperfusion catheters known in the art. Thus, when a catheter is described as having a proximal control element, the catheter can be a full-length catheter, and proximal control element 230 can simply be a proximal tubular portion of the guide tube.

[0077] Still refer to Figure 3A-3B as well as Figure 3C, the navigation catheter 300 may include a non-expandable flexible elongated body 360 connected to a proximal extension 366. Like the catheter 200, the navigation catheter 300 may be configured for a rapid exchange method. The flexible elongated body 360 may also be configured for an over-the-wire method, and may be a tubular portion with a guidewire lumen 368, which extends the entire length of the navigation catheter 300. In this embodiment, the navigation catheter 300 may have a proximal opening from the lumen 368, which is configured to remain outside the patient's body during use. Alternatively, the tubular portion may have a proximal opening, which is positioned so that the proximal opening remains in the patient's body during use. The lumen 368 for the guidewire may extend a limited distance (e.g., 5cm-25cm) to the proximal opening from the distal opening of the navigation catheter. The proximal extension 366 may be a proximal element that is coupled to the distal tubular portion 360 and extends proximally therefrom. The proximal opening from the tubular portion 360 can be located near the location 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, the length of which extends to the proximal opening near the proximal terminal end of the navigation catheter 300 (i.e., outside the patient's body). The Luer connector 364 can be coupled to the proximal extension 366 at the proximal region so that tools such as guide wires can be advanced through the lumen 368 of the navigation catheter 300. A syringe or other component can be coupled to the Luer connector 364 to evacuate and / or inject fluid through the lumen 368. The syringe coupled to the Luer connector 364 can also be used to close the lumen of the navigation catheter 300 to maximize the piston effect described elsewhere herein.

[0078] The configuration of the proximal extension 366 of the navigation catheter 300 can be varied. In some embodiments, the proximal extension 366 is only a proximal extension of the flexible elongated body 360, which has no significant changes in structure, but has significant changes in flexibility. For example, the proximal extension 366 transitions from the very flexible distal region of the navigation catheter 300 toward the less flexible proximal region of the navigation catheter 300. The proximal extension 366 provides a relatively hard proximal end, which is suitable for manipulating and twisting the more distal region of the navigation catheter 300. In other embodiments, the proximal extension 366 is a hypotube. The hypotube can be exposed or can be coated with a polymer. In further embodiments, the proximal extension 366 can be a tubular polymer portion reinforced by a wound ribbon or braid. The proximal extension 366 can have the same outer diameter as the flexible elongated body, or can have a smaller outer diameter such as the flexible elongated body.

[0079] The proximal extension 366 need not include a lumen. For example, the proximal extension 366 can be a solid rod, ribbon, or wire without a lumen extending therethrough, which is coupled to the tubular elongated body 360. When the proximal extension 366 is described herein as having a lumen, it should be understood that the proximal extension 366 can also be solid and without a lumen. The proximal extension 366 is typically less flexible than the elongated body 360 and can transition to even harder toward the proximal end of the proximal extension 366. Therefore, the navigation catheter 300 can have an extremely soft and flexible distal region 346 that transitions proximally to a hard proximal extension 366 that is well suited for pushing and / or twisting the distal elongated body 360.

[0080] The elongated body 360 can be received within and extend through the inner lumen 223 of the distal lumen portion 222 of the catheter 200 (see Figure 3B ). The elongated body 360 or tubular portion may have an outer diameter. The tubular portion of the navigation catheter 300 may have an outer diameter having at least one snug 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 snug point may be no greater than about 0.015 inches (0.381 mm), or may be no greater than about 0.010 inches (0.254 mm), for example, from about 0.003 inches (0.0762 mm) up to about 0.012 inches (0.3048 mm), preferably about 0.005 inches (0.127 mm) to about 0.010 inches (0.254 mm), and more preferably about 0.007 inches (0.1778 mm) to about 0.009 inches (0.2286 mm). At least one point of close contact of this tubular portion can be a point along the length of the tubular portion. The length of at least one point of close contact of this tubular portion can be at least about 5cm until about 50cm, including for example at least about 6cm, at least about 7cm, at least about 8cm, at least about 9cm, at least about 10cm, at least about 11cm or at least about 12cm until about 50cm. This length need not be uniform, so that the length need not be close along its entire length. For example, the close contact point area can include ridges, grooves, slits or other surface features.

[0081] As will be described in more detail below, the navigation catheter 300 may also include a distal region 346 located distal to at least one abutment point of the tubular portion. The distal region 346 may have a length and taper along at least a portion of the length. The distal region 346 of the navigation catheter 300 may extend beyond the distal end of the catheter 200, such as Figure 3BAs shown. The proximal extension 366 or proximal extension of the navigation catheter 300 is coupled to the proximal region of the elongated body 360 and extends proximally therefrom. The proximal extension 366 can be less flexible than the elongated body 360 and is configured to enable the elongated body 360 of the navigation catheter 300 to move bidirectionally within the lumen portion 222 of the catheter 200, and to enable the catheter assembly 150 to move as a whole. The elongated body 360 can be inserted through the inner lumen 223 of the lumen portion 222 in a coaxial manner. 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.

[0082] The overall length (e.g., from the proximal end to the distal-most end 325) of the navigation catheter 300 can vary, but is generally long enough to extend through the support catheter 200 plus at least a distance beyond the distal end of the support catheter 200, while at least a length of the proximal extension 366 remains outside the proximal end of the introducer sheath 400 and outside the patient's body. In some embodiments, the overall length of the navigation catheter 300 is about 145 to about 150 cm, and has a working length of about 140 cm to about 145 cm from the proximal protrusion or hub to the distal-most end 325. The length of the elongated body 360 can be at least as long as the lumen portion 222 of the catheter 200, although the elongated body 360 can be shorter than the lumen portion 222, as long as at least a minimum length remains within the lumen portion 222 when the distal portion of the elongated body 360 extends to the distal end of the lumen portion 222 to form an abutment point or abutment area with the catheter. In some embodiments, when the distal region 346 is in its optimal advancement configuration, the minimum length of the elongated body 360 that remains within the lumen portion 222 is 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 up to about 50 cm. In some embodiments, the shaft length of the distal lumen portion 222 can be about 35 cm up to about 75 cm and shorter than the working length of the introducer sheath, and the insertion 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 up to about 85 cm.

[0083] The length of the elongated body 360 can allow the distal end of the elongated body 360 to reach cerebrovascular targets or occlusions within, for example, segments of the internal carotid artery, including the neck (C1), petrous (C2), foramen rupture (C3), cavernous (C4), clinoid (C5), ocular (C6), and communicating (C7) segments of the internal carotid artery (ICA) and branches of these segments, including the M1 or M2 segments of the middle cerebral artery (MCA), the anterior cerebral artery (ACA), the anterior temporal branch (ATB), and / or the posterior cerebral artery (PCA). The distal region of the elongated body 360 can reach these distal target locations, while the proximal region of the elongated body 360 remains proximal or below the level of a severe bend along the insertion path. For example, the entry location of the catheter system can be located in the femoral artery, and the target occlusion location can be located distal to the right common carotid artery, such as within the M1 segment of the right middle cerebral artery. The proximal region of the elongated body 360 (where it transitions to the proximal extension 366) can be maintained within a vessel proximal to severely tortuous anatomical structures, such as the carotid siphon, the right common carotid artery, the brachiocephalic trunk, the take-off from the aortic arch into the brachiocephalic artery, and the aortic arch as it transitions from the descending aorta. This avoids the insertion of a stiffer proximal extension 366 or the material transition between the stiffer proximal extension 366 and the elongated body 360 presenting a turn in the aortic arch or a turn from the brachiocephalic artery take-off of the aortic arch, both of which can be very severe. The length of the distal lumen portion 222 described herein may also be applicable to the elongated body 360 of a navigation catheter.

[0084] The proximal extension 366 may also have a variable length. In some embodiments, the proximal extension 366 is about 90 cm up to about 95 cm. The distal portion extending distally to the distal end of the lumen portion 222 may include a distal region 346 that extends beyond the length of the distal end of the lumen portion 222 during use of the navigation catheter 300. The distal region 346 of the elongated body 360 is configured to extend distally from the distal end of the lumen portion 222 during advancement of the catheter 200 through the tortuous anatomical structure of the cerebral blood vessels, which will be described in more detail below. The proximal extension 366 coupled to the elongated body 360 and extending proximally from the elongated body 360 can be aligned approximately side by side with the proximal control element 230 of the catheter 200. The arrangement between the elongated body 360 and the lumen portion 222 can be maintained while the catheter 200 passes through a tortuous anatomical structure to reach a target location for treatment in a distal vessel, and maintaining the arrangement between the elongated body 360 and the lumen portion 222 helps prevent the distal end of the catheter 200 from getting stuck in a tortuous branch vessel, as will be described in more detail below.

[0085] 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 region 346 tapers from the uniform outer diameter. The outer diameter of the elongated body 360 can include a step-down at a certain location along its length, for example, a step-down in outer diameter at a proximal 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 (e.g., at least 10 cm of its length, preferably at least 15 cm of its length) can be no more than about 0.015 inches (0.381 mm), for example, within a range of about 0.003 inches-0.015 inches (0.0762 mm-0.381 mm) or between 0.006 inches-0.010 inches (0.1524 mm-0.254 mm). Thus, the gap between the catheter 200 and the slender body 360 can result in a space on the opposite side that is not more than about 0.008 inches (0.2032 mm), or may not exceed about 0.005 inches (0.127 mm), for example, from about 0.001 inches up to about 0.006 inches (0.0254 mm-0.1524 mm), preferably about 0.002 inches to about 0.005 inches (0.0508 mm-0.127 mm), and more preferably about 0.003 inches to about 0.005 inches (0.0762 mm-0.0508 mm).

[0086] The navigation catheter 300 has a relatively large outer diameter and a relatively small inner diameter, particularly when the guidewire extends into or through the lumen of the navigation catheter 300. The lumen of the navigation catheter 300 is substantially filled with a guidewire and / or a liquid that forms a closed system with the catheter 200. The navigation catheter 300 substantially fills or substantially occludes the catheter 200, thereby forming a piston arrangement in the catheter lumen. Withdrawing the occluded navigation catheter 300 through the catheter lumen will form an internal vacuum in the catheter 200, just like a plunger in a syringe barrel. The internal vacuum formed in the distal region of the catheter 200 can draw and / or draw through the distal end 215 of the catheter 200 located at or near the embolic surface. As described above, before the navigation catheter 300 is withdrawn from the catheter lumen, a syringe or flush can be connected to the Luer connector 364. The syringe connected to the Luer connector 364 of the navigation catheter 300 closes the system and maximizes the piston effect during withdrawal. The internal vacuum can begin to clear clot material proximal to the embolism, or draw the embolism itself to the distal end of the catheter, even before external suction is applied at the proximal RHV of the base sheath. In addition, the catheter system can store energy or force when being advanced through tortuous neuroanatomy, for example, stored in the compression of the catheter 200 before withdrawing the navigation catheter 300. The extreme tortuosity of the intracerebral vasculature, particularly around the bony structures of the skull, can require greater force to traverse, coupled with the sharp transition in size between vessels to reach the occlusion site, such as the aorta and 1-3 mm sized target vessels, which can result in stored force or energy in the catheter. Withdrawing the navigation catheter 300 can release this stored energy, resulting in distally directed movement of the distal catheter portion 222. For example, when treating an embolism by aspiration thrombectomy, the distally directed movement of the distal catheter portion 222 can be utilized. The distal catheter portion 222 may be allowed to move toward the obstruction (i.e., the operator and / or robotic system 600 releases the grip on the catheter) to atraumatically nest, seat, and / or embed the distal end 215 of the catheter 200 into the proximal side of the obstruction to optimally position the catheter 200 relative to the obstruction. By creating an initial internal vacuum within the distal region of the catheter 200, either alone or in combination with distally directed movement of the distal catheter portion 222, withdrawing the navigation catheter 300 through the catheter lumen may enable a more successful one-pass embolectomy.

[0087] During use of the system, various movements of the catheter 200 and / or the navigation catheter 300, such as withdrawing the navigation catheter to achieve a piston effect, can be performed manually by an operator located at the operating table 7, or by a robotic drive system 600, such as controlled by an operator at the 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 from about 4 cm per second to about 165 cm per second. In some embodiments, the withdrawal speed is selected so that the piston is arranged to generate suction pressure at the distal region of the catheter 200 that remains in place at the occlusion. For example, the catheter system 150 can be assembled so that the tapered distal region 346 of the navigation catheter 300 extends distally 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, thereby generating a piston arrangement. The length of the piston arrangement can be at least about 10 cm of the catheter length. The length can be about 4 mm to about 75 cm. The assembled catheter system can be advanced together toward the occlusion site in the cerebral vessel (either by a clip connecting the two components or by two roller sets synchronized to advance them simultaneously). The syringe can be coupled to the Luer connector 364 of the navigation catheter 300 before it is withdrawn from the catheter lumen. The syringe closes the lumen, and thus, the system 150 maximizes the piston effect when withdrawing the navigation catheter 300. The navigation catheter 300 can then be withdrawn at a selected speed (e.g., from 20-25 cm per second to about 160 cm per second) using the robotic drive system 600.

[0088] The elongated body 360 may have an overall shape profile from the proximal end to the distal end, which transitions from a first outer diameter having a first length to a tapered outer diameter having a second length. The first length of the first outer diameter region (i.e., the tight fit region between the distal lumen portion 222 and the elongated body 360) may be at least about 5 cm, or 10 cm, up to about 50 cm. In other embodiments, the tight fit region may extend substantially from the proximal protrusion or Luer connector 364 to the tapered distal region 346, which may be up to about 170 cm depending on the length of the navigation catheter 300.

[0089] In some embodiments, the length of the tapered outer diameter of the distal region 346 may be between 1 cm and 4 cm. In other embodiments, the length of the tapered outer diameter may be within a length of 0.5 cm to 5 cm. In yet other embodiments, the length of the tapered outer diameter may be within a length of 2 cm to 3 cm. The distal region 346 of the elongated body 360 may also be shaped to have or not have a tapered portion. When the navigation catheter 300 is inserted through the catheter 200, the distal region 346 is configured to extend beyond the distal end 215 of the lumen portion 222 and extend through the 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.

[0090] As described above, the distal-most end 215 of the lumen portion 222 can be blunt and have no change in outer diameter size, while the distal region 346 can taper, thereby providing an overall slender, tapered geometry of the catheter system. The outer diameter of the elongated body 360 is also close to the inner diameter of the lumen portion 222, so that the gradual increase in the outer diameter from the elongated body 360 to the lumen portion 222 is minimized. Minimizing this gradual increase prevents the lip formed by the distal end of the lumen portion 222 from getting caught on tortuous neurovasculature, such as around the carotid siphon segment near the ophthalmic artery branch, when the distal region 346 is combined with the distal region of the catheter 200 to flex and bend along the vascular anatomy. 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), and the maximum outer diameter of the elongated body 360 can be about 0.048 inches (1.219 mm), so that the difference therebetween 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), and the maximum outer diameter of the elongated body 360 can be about 0.062 inches (1.575 mm), so that the difference therebetween is about 0.008 inches (0.2032 mm). In some embodiments, the inner diameter of the lumen portion 222 can be approximately 0.088 inches (2.235 mm) and the maximum outer diameter of the elongated body 360 can be approximately 0.080 inches (2.032 mm), making the difference therebetween approximately 0.008 inches (0.2032 mm). In some embodiments, the inner diameter of the lumen portion 222 can be approximately 0.072 inches (1.829 mm) and the maximum outer diameter of the elongated body 360 can be approximately 0.070 inches (1.778 mm), making the difference therebetween only two thousandths of an inch (0.002 inches / 0.0508 mm). In other embodiments, the maximum outer diameter of the elongated body 360 can be approximately 0.062 inches (1.575 mm), making the difference therebetween approximately 0.010 inches (0.254 mm). Although the outer diameter of elongate body 360 extends through the lumen of lumen portion 222, lumen portion 222 and elongate body 360 extending therethrough in a coaxial manner are flexible enough to navigate the tortuous anatomy leading to the level of the M1 or M2 artery without kinking or damaging the vessel.

[0091] The dimensions provided herein are approximate, and each dimension may have an engineering tolerance or allowed variation limit. The use of the terms "about", "approximately", or "substantially" is intended to provide such allowed tolerance for the referred dimension. When "about", "approximately", or "substantially" is not used herein with a particular dimension, the dimension need not be exact.

[0092] The length of the tapered distal region 346 can vary. In some embodiments, the length of the distal region 346 can be in the range of about 0.50 cm to about 4.0 cm from the most distal end of the elongated body 360, or in the range of about 1.0 cm to about 3.0 cm. In other embodiments, the length of the distal region 346 is between 2.0 cm and about 2.5 cm. In some embodiments, the length of the distal region 346 varies depending on the inner diameter of the catheter 200 with which the navigation catheter 300 is to be used. For example, 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), the length of the distal region 346 can be shorter (e.g., 1.2 cm), while 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 length of the distal region 346 can be longer (e.g., 2.5 cm). The distal region 346 can be a constant taper from the larger outer diameter of the elongated body 360 to the second smaller outer diameter of the distal terminal. In some embodiments, the constant taper of the distal region 346 can be a taper from about 0.048 inches outer diameter to about 0.031 inches (0.787mm) outer diameter within a length of about 1 cm. In some embodiments, the constant taper of the distal region 346 can be from 0.062 inches (1.575mm) outer diameter to about 0.031 inches (0.787mm) outer diameter within a length of about 2 cm. In yet another embodiment, the constant taper of the distal region 346 can be from 0.080 inches (2.032mm) outer diameter to about 0.031 inches (0.787mm) outer diameter within a length of about 2.5 cm. The length of the constant taper of the distal 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 depending on 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 horizontal. The angle of the taper can be between 2-3 degrees from the centerline of the elongated body 360. The length of the taper of the distal region 346 can be between about 5 mm and 20 mm or between about 20 mm and about 50 mm.

[0093] The lumen 368 of the elongated body 360 of the navigation catheter 300 may have an inner diameter that does not change over the length of the elongated body even in the presence of a taper in the distal region 346. Thus, the inner diameter of the lumen 368 extending through the tubular portion of the navigation catheter 300 may remain uniform, and the wall thickness of the distal region 346 may be reduced to provide a taper. The wall thickness may taper distally along the length of the taper. Thus, the combination of material properties and the wall thickness, angle, and length of the taper may contribute to the overall maximum flexibility of the distal end of the distal region 346. The navigation catheter 300 undergoes a flexible transition from the distal end toward the abutment point, where it achieves an outer diameter that is no more than about 0.010 inches (0.254 mm) different from the inner diameter of the catheter 200.

[0094] The length of the tapered portion can also vary according to the anatomical structure of the target area. The distal region 346 can achieve its soft, non-invasive and flexible characteristics due to material properties rather than due to changes in external dimensions to facilitate intravascular navigation to embolism in tortuous anatomical structures. In addition or alternatively, the distal region 346 of the elongated body 360 can have a flexible transition along its length. The most flexible area of ​​the distal region 346 can be its distal terminal. Move from the distal terminal toward the area proximal to the distal terminal along the length of the distal region 346. For example, the distal region 346 can be formed by a material having a Shore material hardness of no more than 35D or about 62A, and transition to the proximal side to become less flexible near the place where it is formed by a material having a material hardness of no more than 55D and 72D, until the proximal extension 366, which can be a stainless steel hypotube, or a combination of material properties and a tapering shape. The material used to form the various regions of the elongated body 360 can include PEBAX (e.g., PEBAX 25D, 35D, 55D, 69D, 72D) or a mixture of PEBAX (e.g., a mixture of 25D and 35D, 25D and 55D, 25D and 72D, 35D and 55D, 35D and 72D, 55D and 72D, wherein the mixing ratio for each PEBAX durometer can range from 0.1% up to 50%), with a lubricating additive compound, such as silicone or Mobilize (Compounding Solutions, Lewiston, Maine). In some embodiments, the material used to form the regions of the elongated body 360 can be Tecothane 62A. Incorporating the lubricating additive directly into the polymer elongated body means that a separate lubricating liner, such as a PTFE, FEP or HDPE liner, does not need to be incorporated. This allows for a more flexible element that can navigate 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 region 346 can be achieved by a combination of a flexible lubricating material and a tapering shape. For example, the length of the distal region 346 can be kept shorter than 2cm-3cm, but due to the change of the flexible material from the distal end 325 toward a more proximal region at a distance away from the distal end 325, optimal transportability is maintained. In an embodiment, the elongated body 360 is formed by PEBAX (polyether block amide) embedded silicone designed to maintain the highest degree of flexibility. The wall thickness of the distal end of the lumen portion 222 can also be made thin enough to minimize the lip formed by the distal end of the lumen portion 222 relative to the elongated body 360.

[0095] An advantage of the elongated body 360 over a microcatheter is that it can have a relatively large outer diameter that is only 0.003"-0.010" (0.0762mm-0.254mm) less than the inner diameter of the distal lumen portion 222 of the catheter 200 and still remain highly flexible to navigate tortuous anatomical structures. When the clearance between the two components is too tight (e.g., less than about 0.003" (0.0762 mm)), the force required to slide the navigation catheter 300 relative to the catheter 200 may result in damage to one or both components and increase risk to the patient during the procedure. The clearance results in a fit that is too tight and does not provide optimal relative sliding. When the clearance between the two components is too loose (e.g., greater than about 0.010" / 0.254 mm), the distal end of the catheter 200 forms a lip that is prone to snagging on branch vessels during advancement through the tortuous neurovasculature, such as around the carotid siphon segment where the ophthalmic artery branches and the piston effect of the withdrawal of the slender body 360 may be reduced or eliminated.

[0096] The ID / OD gap between the elongated body 360 and the distal lumen portion 222 may be within this size range (e.g., between 0.003"-0.015" (0.0762mm-0.381mm) or 0.006"-0.010" (0.152mm-0.254mm)) along most of its length. For example, from the proximal region to the distal region to the point where the taper of the distal region 346 begins, the elongated body 360 may have a relatively uniform outer diameter between about 0.048" (1.219mm) and about 0.080" (2.032mm). Similarly, from the proximal region to the distal region, the distal lumen portion 222 of the catheter 200 may have a relatively uniform inner diameter between about 0.054" (1.372mm) and about 0.088" (2.235mm). Thus, along most of their lengths, the difference between their respective inner and outer diameters can be within this gap size range, i.e., 0.003" to 0.015" (0.0762mm-0.381mm). The tapered distal region 346 of the elongated body 360 will have a larger gap size relative to the inner diameter of the distal lumen portion 222. However, during use, the tapered distal region 346 is configured to extend distally to the distal end of the catheter 200 so that a region of the elongated body 360 having an outer diameter sized to match the inner diameter of the distal lumen portion 222 is located within the lumen of the catheter 200, so that it can minimize the lip at the distal end of the catheter 200.

[0097] The elongated body 360 can be formed by various materials providing suitable flexibility and lubricity. Example materials include high density polyethylene, 77A PEBAX, 33D PEBAX, 42D PEBAX, 46D PEBAX, 54D PEBAX, 69D PEBAX, 72DPEBAX, 90D PEBAX and mixtures thereof or equivalent stiffness and lubricity materials. In some embodiments, the elongated body 360 is an unreinforced non-torsion catheter having a relatively large outer diameter designed to fill the lumen through which it is inserted, and having a relatively small inner diameter to minimize any gap at the distal end of the device. In other embodiments, at least a portion of the elongated body 360 can be strengthened to improve navigation and torsion (e.g., braided reinforcement layer). The flexibility of the elongated body 360 can be increased toward the distal region 346, so that the distal region of the elongated body 360 is softer, more flexible, and more easily movable (articulate) and flexed than the more proximal region. For example, the more proximal region of the elongated body may have a sufficiently flexible flexion stiffness to navigate tortuous anatomical structures (e.g., the carotid siphon segment) without kinking. If the elongated body 360 has a braided reinforcement layer over at least a portion of its length, the braided reinforcement layer may terminate at a distance proximal to the distal region 346. For example, the distance from the end of the braid to the distal-most end 325 may be about 10 cm to about 15 cm, or about 4 cm to about 10 cm, or about 4 cm to about 15 cm.

[0098] As described above, the elongated body 360 can be generally tubular along at least a portion of its length such that the single lumen 368 extends parallel to the longitudinal axis of the navigation catheter 300 (see Figures 3A-3C). In an embodiment, the size of the single lumen 368 of the elongated body 360 is set to accommodate the guidewire 500, but the use of the navigation catheter 300 generally eliminates the need for a guidewire lead. Preferably, the assembled system does not include a guidewire. The guidewire is designed to be very flexible so that they deflect to navigate the severe turns of the anatomical structure. However, many main guidewires have stiffness and / or an outer diameter small enough along their longitudinal axis so that they can find their own path through the embolism instead of sliding around the embolism. In some cases, these guidewires may cause perforation and / or dissection of the blood vessel itself. Therefore, even if the guidewire can have an outer diameter that is smaller and very flexible at the distal end in its distal end region, the guidewire cannot usually detect the embolism without trauma. The guidewire does not deflect when encountering the dense proximal side of the embolism. Instead, the guidewire will embed and penetrate the embolism. The navigation catheter 300 has softness, a tapered portion and a size setting, which finds and / or creates a sliding space between a portion of the embolism and the vessel wall, instead of penetrating it like a guidewire. The method uses the navigation catheter 300 without a guidewire or with the guidewire 500 resting within the lumen 368 acting as a rescue guidewire to deliver the catheter to a distal region of the brain.

[0099] The guidewire 500 may extend through a single lumen 368 approximately concentrically from the proximal opening to the distal opening 326 at the distal end 325 of the navigation catheter 300. In some embodiments, the proximal opening is located at the proximal end of the navigation catheter 300, so that the navigation catheter 300 is configured for an over-the-wire (OTW) approach. In other embodiments, the proximal opening is a rapid exchange opening through the wall of the navigation catheter 300, so that the navigation catheter 300 is configured for rapid exchange, rather than OTW or in addition to OTW. In this embodiment, the proximal opening extends through the side wall of the elongated body 360 and is located at a distance away from the proximal protrusion or Luer connector 364 and at a distance distal to the proximal extension 366. The proximal opening may be located at a distance of about 10 cm from the distal region 346 to about 20 cm from the distal region 346. In some embodiments, the proximal opening may be located near the region where the elongated body 360 is connected to the proximal extension 366, for example, just distal to the end of the hypotube. In other embodiments, the proximal opening is located further distally, for example, about 10 cm to about 18 cm from the most distal end of the elongated body 360. The proximal opening located closer to the distal region 346 allows the navigation catheter 300 to be removed more easily from the catheter 200, while the guidewire is left in place for a "quick exchange" type of surgery. Rapid exchange can rely on only one person to perform the exchange. The navigation catheter 300 can be easily replaced with another device using the same guidewire that remains in place. The single lumen 368 of the elongated body 360 can be configured to receive a guidewire with a diameter in the range of 0.014" (0.356mm) and 0.018" (0.457mm), or a guidewire in the range of 0.014" and 0.022" (0.356mm-0.559mm). In this embodiment, the inner lumen diameter of the elongated body 360 can be between 0.020" and 0.024" (0.508mm-0.610mm). The guidewire, navigation catheter 300, and catheter 200 can all be coaxially assembled 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 0.019" to about 0.021" (0.483mm-0.533mm). The distal opening from the lumen 368 can have an inner diameter between about 0.018" to about 0.024" (0.457mm-0.610mm).

[0100] The area near the distal region 346 can taper so that the outer diameter tapers over a length of about 1 cm to about 4 cm. In some embodiments, the distal taper is about 2.5 cm in length. In other embodiments, the distal taper is within a length of about 0.5 cm to about 5 cm, or within a length of about 1 cm to 4 cm, or within a length of 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 the smaller outer diameter. The distal region 346 can taper along the distance from a first outer diameter to a second outer diameter, the first outer diameter being at least 1.5 times the second outer diameter. In some embodiments, the distal region 346 tapers from about 0.080" (2.032 mm) to about 0.031" (0.787 mm). In some embodiments, the smaller outer diameter at the distal end of the taper may be about 0.026" (0.66mm) to about 0.040" (1.016mm), and the larger outer diameter proximal to the taper may be about 0.062" (1.575mm) to about 0.080" (2.032mm). In addition, the distal region 346 may be formed of a material having a material hardness (e.g., 62A and 35D), which transitions proximally toward increasingly harder materials having (e.g., 55D and 72D) until the proximal extension 366. The first section of the slender body 360 including the distal region 346 may be formed of a material having a material hardness of 35D and a length of about 10 cm to about 12.5 cm. The first section of the slender body 360 including the distal region 346 may be formed of a material having a material hardness of 62A and a length of about 10 cm to about 12.5 cm. The second section of the elongated body 360 can be formed of a material having a material hardness of 55D and a length of about 5 cm to about 8 cm. The third section of the elongated body 360 can be formed of a material having a material hardness of 72D and a length of about 25 cm to about 35 cm. The three sections can form an insertion length of the elongated body 360 from the location where the proximal extension 366 is coupled to the elongated body 360 to the terminal end of the distal region 346, which can be about 49 cm in length.

[0101] The navigation catheter 300 has a flexible distal embolism detection end portion 346, which has a length ranging from 1 cm to 5 cm, tapering from a proximal outer diameter (e.g., about 1.58 mm-about 2.03 mm) to a distal outer diameter (e.g., about 0.66 mm-about 0.79 mm). The non-invasive end region 346 is preferably radiopaque. The tapered end region 346 has a flexibility that allows it to deflect generally away from the dense embolism toward the vessel wall. Deflection occurs when the navigation catheter encounters resistance to further axial movement from the generally organized or dense embolism within the flexible vessel as it is advanced through the vessel, wherein the flexible vessel inner diameter is about 2-5 mm for emboli located in the MCA and can be up to about 8 mm for emboli located proximal to the MCA (e.g., within the ICA). The end region 346 is arranged to deflect away from the proximal side of the embolism toward the vessel wall, and in some cases, at least partially move below the proximal side of the embolism, so that when additional force is applied to push the embolism detection end portion against the embolism, the embolism detection end portion extends between the obstacle and the vessel wall between about 0 mm and about 3 cm. Conventional catheters and guide wires have a terminal structure that tends to embed in the embolism, rather than detecting the front side of the embolism to find space or deviate from the proximal side. The guide wire has a small outer diameter and a flexible distal end. Although the outer diameter is small and flexible, the guide wire end cannot detect the embolism according to the method provided herein. Instead, the guide wire end structure, especially when used with a microcatheter that provides a guide wire centering effect, causes the guide wire to penetrate and embed or pass through the embolism, which is best avoided in aspiration thrombectomy. The tapered distal end region 346 of the navigation catheter 300 detects the embolism, causing the end to deflect and slide between the proximal side of the embolism and the vessel wall.

[0102] The profile of the distal region of the guidewire is much smaller than that of the distal end region 346 of the navigation catheter. The outer diameter of the guidewire also remains small as it moves proximally along its length compared to the navigation catheter, which expands to an even larger outer diameter when it moves proximally only a few centimeters. In turn, the force per unit area of ​​the guidewire is much higher than that of the navigation catheter. The guidewire used in the neurovascular system (particularly at the level of the MCA) may have an outer diameter of 0.014 inches (0-36 mm) at the distal end, with a contact area of ​​about 1.50 x 10 cm facing the distal end. -4 Square inch (0.100mm 2 The outer diameter of the distal end of the navigation catheter can be about 0.031 inches (0.79 mm), and the inner diameter of the distal end of the navigation catheter can be about 0.021 inches (0.53 mm). If the lumen is filled with a fluid column and / or a guidewire, the distal-facing contact area of ​​the navigation catheter can be about 8.00 x 10 4 Square inch (0.5mm 2For a single annular distal-facing surface without a fluid column or guidewire in the lumen, the distal-facing contact area of ​​the navigation catheter may be approximately 4.20 x 10 -4 Square inch (0.27mm 2 ). Regardless, the force per unit area of ​​a guidewire is significantly greater (i.e., approximately 2 to 5 times) than the force per unit area of ​​a navigation catheter. The force per unit area of ​​a 0.014-inch guidewire at 1 N force is approximately 6700 N / square inch (10 N / mm 2 ), while the force per unit area of ​​the navigation catheter is about 1300N / square inch (2N / mm 2 ) to about 2400N / square inch (4N / mm 2 ). The profile of the guidewire, combined with the force per unit area of ​​the guidewire (and the centering effect provided by the microcatheter), creates a higher risk of embolic penetration than deflection when encountering the proximal side of the embolism. The profile of the navigation catheter, including a larger outer diameter as the distal end, a relatively tapered portion to an even larger outer diameter, and its high flexibility, results in the navigation catheter being unable to penetrate the embolism, but rather deflecting away from the proximal side of the embolism when encountering an embolism within the vessel. The guidewire penetrates the embolism or the vessel wall. In contrast, the navigation catheter detects the embolism and deflects away from the embolism, finding any space and wedging into the final resting point without penetrating the embolism or the vessel wall.

[0103] Advantageously, there is a specially constructed end region to ensure that the end region will deflect relative to the embolism when encountering an embolism, without penetrating the embolism or the vessel wall. The end region will deflect until a path or space is found. This is achieved by having a sufficient degree of flexibility in the all-polymer distal end region, which includes a tapered portion in length so that the end region is easily deflected when contacting the proximal side of the embolism. The flexibility and shape of the tapering end region cause the end region (which will extend from the suction catheter during advancement through the blood vessel) to pass through less or less dense thrombus material organized until the end region encounters the true proximal side of the embolism. The end region then deflects away from the organization or dense part of the embolism, so that, for example, it is wedged between the embolism and the vessel wall. The end region is configured to find the path of least resistance in an atraumatic manner, without being too flexible or prone to buckling so as to fold onto itself and cannot be advanced.

[0104] The distal-most end of the terminal region can have a smooth, relatively rounded shape with a low-friction outer surface, which tends to cause the terminal region to deflect relative to the proximal side of the embolism. The distal end can also be radiopaque, due to the material embedded in the polymer, which is described in more detail below.

[0105] The navigation catheter 300 can be combined with a reinforcement layer. The reinforcement layer can be a coil, a braid, or other type of reinforcement to bridge the components of the navigation catheter 300 with such a flexibility difference. 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 located between the PEBAX inner layer and the outer layer. The reinforcement layer can terminate at a distance proximal to the distal region 346. The distal region 346 can be formed by a material having a hardness of up to about 35D. The first section can be an unreinforced polymer with a length of about 4cm to about 12.5cm without metal reinforcement. The third section of the elongated body 360 located proximal to the first section can include a reinforcement layer and can extend to the unreinforced distal section, a total of about 37cm. The proximal region of the reinforcement layer can overlap with the distal region of the proximal extension 366, so that there is a small overlap of the hypotube and the reinforcement near the transition between the proximal extension 366 and the elongated body 360.

[0106] The inlet port of the surgical guide wire can be positioned at a distance away from the distal end of the elongated body 360. In some embodiments, the inlet / outlet port can be about 18 cm from the distal end, thereby forming a rapid exchange wire inlet / outlet section. The outer diameter of the elongated body 360 in the first two sections can be about 0.080"-0.082" (2.032mm-2.083mm), while the third section proximal to the rapid exchange wire inlet / outlet section can have a gradual decrease in outer diameter, for example, about 0.062"-0.064" (1.575mm-1.626mm).

[0107] In other embodiments, the entire navigation catheter 300 can be a tubular element configured to receive a guidewire through the proximal extension 366 and the elongated body 360. For example, the proximal extension 366 can be a hypotube or a tubular element having a lumen communicating with a lumen 368 extending through the elongated body 360 (as shown in FIG. 1C ). In some embodiments, the proximal extension 366 can be a skived hypotube of stainless steel coated with PTFE. In some embodiments, the proximal extension 366 may be a cut hypotube coupled to the proximal hub or luer connector 364, for example in an over-the-wire version. The proximal extension 366 may extend eccentrically or concentrically to the distal lumen portion 222. The proximal extension 366 may be a stainless steel hypotube. The proximal extension 366 may be a solid metal wire having a circular or elliptical cross-sectional shape. The proximal extension 366 may be a flat wire ribbon having a rectangular cross-sectional shape. The wire ribbon may be bent along an arc into a circular, elliptical, C-shaped, or quarter-circular or other cross-sectional shape. Regardless of whether the lumen extends through the proximal extension 366, the proximal extension 366 may have any of a variety of cross-sectional shapes, including circular, elliptical, C-shaped, D-shaped, or other shape. In some embodiments, the proximal extension 366 is a hypotube having a D-shape such that the side facing inward is flat and the side facing outward is rounded. The rounded side of the proximal extension 366 can be shaped to engage with a corresponding rounded inner surface of the sheath 400. The hypotube can have a lubricious coating, such as PTFE. The hypotube can have an inner diameter of about 0.021" (0.533 mm), an outer diameter of about 0.0275" (0.699 mm), and a total length of about 94 cm, thereby providing The navigation catheter 300 provides a working length of about 143 cm. Including the proximal Luer connector 364, the total length of the navigation catheter 300 can be about 149 cm. In some embodiments, the hypotube can be a tapered portion of about 100 mm in length, starting with a thickness of 0.3 mm on the proximal side and ending with a thickness of 0.10 mm to 0.15 mm. In further embodiments, the elongated body 360 can be a solid element coupled to a proximal extension 366 without a guidewire lumen.

[0108] Figure 3AThe proximal extension 366 shown in FIG. 1 has an outer diameter that is smaller than the outer diameter of the elongated body 360. The outer diameter of the proximal extension 366 need not taper, and may also have the same outer diameter as the outer diameter of the elongated body 360. For example, the proximal extension 366 may incorporate a hypotube or other reinforcing element coated with one or more layers of a polymer, resulting in the proximal extension 366 having substantially the same outer diameter as the elongated body 360.

[0109] At least a portion of the solid elongated body 360, such as the elongated distal region 346, can be formed of or embedded with or attached to a ductile material that is thinned to a smaller size at the distal end. The distal region 346 can be formed into a desired angle or shape, similar to the way a guidewire can be used. The slender body 360 has an extendable length of at least about 1 cm, 3 cm, 5 cm, and at most about 10 cm, 15 cm, or longer. In some embodiments, the extendable length is about 1%, 2%, 5%, 10%, 20%, 25%, 50% or more of the total length of the elongated body 360. In some embodiments, the working length of the navigation catheter 300 is about 140 cm to about 143 cm, and the insertion length of the elongated body 360 is about 49 cm. The insertion length can be a PEBAX portion of about 49.5 cm of the elongated body 360. Therefore, the extendable length of the elongated body 360 can be between about 0.5 cm and about 25 cm or more. The shape change can change with the operator manually shaping the ductile length before inserting the patient, or the distal region 346 can be preformed into a specific angle or bend when manufacturing. Alternatively, the shape change can be a reversible and actuable shape change, so that the distal region 346 forms a shape when the operator activates, so that the distal region 346 can be used in a straight form until the operator expects the shape change. The navigation catheter 300 can also include a forming mandrel (forming mandrel) extending through the lumen of the elongated body 360 so that the physician can shape the distal region 346 into a desired shape when in use. Therefore, the plastic distal region 346 can be incorporated into the elongated body 360 with the guidewire lumen.

[0110] The elongated body 360 may 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 may be combined with a proximal extension 366 that is generally aligned side by side with the proximal extension 230 of the catheter 200. The proximal extension 366 of the elongated body 360 may be coaxial or eccentrically positioned with the elongated body 360. The proximal extension 366 of the elongated body 360 may have a lumen extending therethrough. Alternatively, the portion 366 may be a solid rod or ribbon without a lumen.

[0111] Reference again Figures 3A-3C, like the distal lumen portion 222 of the catheter 200, the elongated body 360 may have one or more radiopaque markers 344 along its length. The size, shape, and location of the one or more markers 344 may vary. One or more markers 344 may be incorporated along one or more portions of the navigation catheter 300, such as an end-to-end marker, an end-to-taper marker, an RHV proximity marker, a fluorescent preservative marker, or other markers that provide various information about the relative position of the navigation catheter 300 and its components. The tubular portion 360 of the navigation catheter 300 may have a radiopaque marker band embedded in or positioned on the wall of the tubular portion 360 near the distal region 346. In some embodiments, such as Figure 3C As best shown, the distal region may have a first radiopaque marker 344a and a second radiopaque marker 344b may be positioned to indicate the boundary between the tapering of the distal 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 may be located at the distal end of the tapered distal region 346 and the second radiopaque marker band 344b may be located at the proximal end of the tapered distal region 346. The proximal radiopaque marker band 344b may have a proximal edge, a distal edge, and a width between the proximal and distal edges. This provides the operator and / or the robotic drive system 600 with information about the optimal extension of the distal region 346 relative to the distal end of the lumen portion 222 to minimize the lip at the distal end of the lumen portion 222 to advance through tortuous anatomical structures. When in the advanced configuration, the proximal edge of the radiopaque marker band 344b can be generally aligned with the distal end of the distal catheter portion 222 such that the radiopaque marker band 344b remains outside of the lumen 223 of the distal catheter portion 222. At least a portion of the radiopaque marker band 344b can be positioned at an abutment point, or a point where the outer diameter of the navigation catheter 300 is no more than about 0.010 inches (0.254 mm), preferably less than about 0.006 inches and 0.008 inches (0.152 mm-0.203 mm) of the inner diameter of the catheter 200 in which it is positioned. At least one abutment point of the tubular portion 360 can be located proximal to the distal region 346 and can be located where the taper of the distal region 346 generally terminates. This allows the tapered distal region 346 to extend completely beyond the distal end of the catheter 200 and the abutment point to be substantially aligned within the distal opening 231 from the lumen 223 of the distal catheter portion 222, thereby minimizing any distally facing lip that may be created by the catheter 200. The abutment point can be located 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 up to about 10 cm, which outer diameter may be substantially uniform or non-uniform.

[0112] The distal region 346 can be 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 terminal (e.g., the proximal end of the marker 344a). In other embodiments, such as where the distal region 346 does not necessarily taper but has an overall flexibility change along its length, the second radiopaque marker 344b can be positioned to indicate an area where the relative flexibility of the elongated body 360 (or the distal region 346 of the elongated body 360) and the distal end of the lumen portion 222 are substantially the same. The marker material can be a platinum / iridium ribbon, tungsten, a platinum or tantalum impregnated polymer, or other radiopaque markers that do not affect the flexibility of the distal region 346 and the elongated body 360. In some embodiments, the radiopaque marker is extruded PEBAX filled with tungsten to achieve radiopacity.

[0113] 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 nudging the atraumatic 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 end marker 344a can define the taper of the distal region 346, i.e., the location of the "lip" where the outer diameter of the navigation catheter 300 is of sufficient size to reduce the transition between the navigation catheter 300 and the catheter 200 through which the navigation catheter 300 is inserted and configured for delivery. The marker helps position the navigation catheter 300 relative to the distal end 215 of the aspiration catheter 200 so that the tip 215 of the catheter 200 is aligned with the taper of the navigation catheter 300 and helps achieve optimal alignment. In some embodiments, the proximal marker band can be approximately 2.0 mm wide and the distal marker band can be approximately 2.5 mm wide to provide discernible information about the distal region 346 .

[0114] The relationship between the distal end marker 224 of the aspiration catheter 200 being located at or ideally just proximal to the taper marker 344b of the navigation catheter 300 (i.e., the proximal end of the proximal marker or distal taper marker if only one marker is incorporated to identify the start of the taper) can be identified by a tandem marker system. The paired elements 224, 344b are in a "tip to taper" position. When the system is inserted into the RHV, the relative extension between the navigation catheter 300 and the catheter 200 can be adjusted. However, the relative extension can change with advancement through the sheath or guide catheter. When the system leaves the guide catheter, the aspiration catheter 200 and the navigation catheter 300 can be adjusted so that the tip to taper position can be presented when the system passes through a generally tortuous proximal vessel (e.g., the internal carotid artery in the neck) toward a more distal target. The system of the aspiration catheter 200 and the navigation catheter 300 can be locked in their relative extensions so as to maintain the juxtaposition of the navigation catheter 300 and the aspiration catheter 200. When the suction catheter is visualized in the distal end of the sheath or even slightly beyond the distal end of the sheath, the navigation catheter 300 can be adjusted to present the appropriate position relative to the catheter before the advancement continues. The best relative extension between the distal marker 224 of the catheter 200 and the tapered portion marker 344b on the navigation catheter 300 can be maintained by as many anatomical structures as possible, so that the delivery capacity of the navigation catheter 300 is maximized, thereby navigating tortuosity and avoiding side branches, such as ophthalmic artery. Once the desired position is reached, the navigation catheter 300 can be kept fixed, and the suction catheter 200 is advanced toward the embolism via the navigation catheter 300, but the catheter 200 is not passed through the embolism. Alternatively, the navigation catheter 300 can be withdrawn proximally, and the catheter 200 is allowed to advance toward the embolism distally by the momentum of the stored force, as described elsewhere herein. The withdrawal step of the navigation catheter 300 can be performed manually by the operator directly at the patient's position, or performed by the control station 700 through the robot drive system 600, or automatically performed by the robot drive system 600.

[0115] The catheter 200 and navigation catheter 300 (with or without a guidewire) can be advanced as a single unit through the two turns of the carotid siphon segment. The two turns can be traversed in a single smooth pass to reach the target in the cerebral vessels without the need to gradually adjust their relative extensions and without relying on conventional step-by-step advancement techniques with conventional microcatheters. The catheter 200 through which the navigation catheter 300 extends allows the operator (via the robotic drive system 600) to advance them consistently from the first bend of the siphon segment through the second bend, beyond the terminal cavernous carotid artery into the ACA and MCA in the same relative position. Importantly, the advancement of the two components can be performed through the two bends in a single smooth move.

[0116] The navigation catheter 300 can be juxtaposed relative to the catheter 200, and the catheter 200 provides the best relative extension between the two components to achieve a single smooth advancement. The navigation catheter 300 can be positioned by the lumen of the catheter 200 so that its distal region 346 extends just beyond the distal end 215 of the catheter 200. The distal region 346 of the navigation catheter 300 eliminates the stepped transition between the inner member and the outer catheter 200, thereby avoiding the problem of getting stuck on the branch vessels in the area of ​​the vascular system, so that the catheter 200 can easily pass through multiple angled turns of the carotid siphon segment. For example, the best relative extension can be that the distal region 346 of the elongated body 360 just extends to the distal end 215 of the catheter 200. During advancement, the length of the distal region 346 extending to the distal end 215 of the catheter 200 can be between 0.5 cm and about 4 cm. This juxtaposition can be a locking engagement with a mechanical element, the two components are held together by an operator, and / or the two components are held fixed by the robot drive system 600.

[0117] The mechanical element may include a coupling feature 250, such as a clip, a clamp, a c-shaped element, or other connector, which is configured to receive the proximal portion of the catheter 200, 300. The coupling feature 250 may be configured to snap together with the proximal extension 366 by an interference fit, so that a first level of force is required to insert the proximal extension 366 into the clip of the protrusion 234, and a second level of greater force is required to remove the proximal extension 366 from the clip of the protrusion 234. However, after the proximal extension 366 is inserted into the coupling feature 250, the navigation catheter 300 and the catheter 200 can still be slidably adjusted relative to each other along the longitudinal axis of the system. The amount of force required to slide the relative position of the two components can be such that accidental adjustment is avoided, and the relative position can be maintained during use, but can be adjusted when intentionally modified. The configuration of the coupling between the proximal extension 366 of the navigation catheter 300 and the proximal control element 230 of the catheter 200 can vary. Typically, however, the coupling is configured to be reversible and adjustable while still providing sufficient retention between the two elements and organizing the proximal ends of the components (e.g., preventing the proximal control element 230 and the proximal extension 366 from twisting and tangling with each other) in a relatively user-friendly manner (e.g., allowing one-handed use). The coupling feature 250 configured to prevent tangling and help organize the proximal portion can be integrated with the protrusion, or can be a separate feature located along its proximal region.

[0118] The components can be advanced together with the guidewire 500, or can be advanced via a pre-positioned guidewire 500, or can be advanced without any guidewire at all. In some embodiments, the guidewire 500 can be preassembled with the navigation catheter 300 and the catheter 200 so that the guidewire 500 extends through the lumen 368 of the navigation catheter 300, and the navigation catheter 300 is loaded through the lumen 223 of the catheter 200, all of which are completed before being inserted into the patient. The preassembled components can be inserted into the sheath 400 at the same time and advanced together through and through the turn of the carotid siphon segment. The guidewire 500 can be located in the lumen 368 of the navigation catheter 300 and parked in the proximal side of the tapering distal region 346 or the proximal side of the distal end 325, so as to potentially be used in the case where the navigation catheter 300 without a guidewire does not reach the target position. For example, the distal end of the guidewire can be positioned at about 5cm to about 40cm or about 20cm to about 30cm near the distal region 346 of the navigation catheter 300. In this position, the guidewire 500 does not interfere with the performance or function of the navigation catheter. The guidewire 500 can be positioned within the lumen 368 of the navigation catheter 300 so that during the step of advancing the assembled device system together, the distal end of the guidewire 500 is located within the navigation catheter 300, and when navigation is required, the distal end of the guidewire 500 can extend from the distal opening 326 of the navigation catheter 300. In one example, the rescue guidewire is parked in the lumen of the navigation catheter, with the distal end of the guidewire about 0 cm to about 40 cm, or about 5 cm to about 35 cm, or about 7 cm to about 30 cm proximal to the distal end of the navigation catheter, preferably about 10 cm proximal to the distal end of the navigation catheter. The guidewire 500 in this parked position can provide additional support for the proximal portion of the system without affecting the flexibility and performance of the distal portion of the system.

[0119] The use of a navigation catheter 300 with a tapered distal region 346 allows for the delivery of large-caliber aspiration catheters, even full-length "over-the-wire" catheters or catheters with proximal extensions (such as the catheters described herein). The navigation catheter 300 is specifically designed so that the catheter 200 can be delivered without the need for a guidewire. This ability to deliver the catheter 200 without a guidewire (or with a guidewire that is located in the lumen 368 of the navigation catheter 300 and parked proximal to the tapered distal region 346 and / or proximal to the distal opening 326 for use) and without passing through an embolism is based in part on the smooth transition between the outer diameter of the navigation catheter 300 and the catheter 200 and the smooth transition of flexibility between the two. When the navigation catheter 300 is bent into an arc greater than 180 degrees, the softness and flexibility form a smooth arc without severe buckling or kinking in the geometry of the catheter. Therefore, the navigation catheter 300 seeks a larger lumen and goes to where most of the blood flow is going, rather than entering a smaller branch artery. The distal region 346 of the navigation catheter 300 can promote a strong preference for finding larger vessels during advancement to distal vessels. This tendency to stay in the main channel allows large-caliber catheters to be advanced without the help of a guidewire. The tendency to follow the main channels of blood flow is consistent with the pathophysiology of acute ischemic stroke, in which major emboli tend to follow these same paths to the point where the emboli are stuck and interrupt forward blood flow. Likewise, these main channels are usually ideal for placing access catheters because these conduit arteries allow smaller catheters to be introduced into specific target arteries for therapeutic intervention.

[0120] Standard neurovascular interventions, and almost all endovascular interventions for that matter, are predicated on the concept that a guidewire will guide the catheter to the target location. Guidewires are typically pre-shaped and will often find side branches that deviate from the target location where they will bunch up or prolapse, causing time-consuming headaches during the intervention that often require the operator to repeatedly redirect the guidewire to overcome. Furthermore, this tendency for the guidewire to enter side branches can be dangerous. Guidewires are typically 0.014” to 0.018” (0.356mm-0.457mm) in the neuroanatomy and will find and often traumatize small branches that accommodate this size, which can result in small hemorrhages or dissections and occlusions. In sensitive areas like the brain, these events can be catastrophic. The tendency for guidewires to bunch up and prolapse can also cause the leading edge of the guidewire, which may be advanced alone or as part of a triaxial system to create a dissection plane and traumatize small vessels. Guidewires are also designed to pass through emboli, with the primary purpose of securing the guidewire to provide support for catheter delivery over the guidewire. However, passing a guidewire across the occlusion increases the risk of embolic fragments being dislodged and traveling distally to the occlusion site.

[0121] In contrast, the navigation catheter 300 described herein tends to stay in the larger lumen of the catheter vessel. In the context of stroke treatment, emboli are driven to certain anatomical structures due to the blood flow drawn by the arterial system in the brain anatomy. The navigation catheter 300 tends to pass through the same path as the embolism will take, especially embolism driven from locations such as the heart or carotid etiology. Even in view of the navigation of very tortuous anatomical structures and bends, the navigation catheter 300 is delivered to the largest lumen in the anatomical structure. The navigation catheter 300 can tend to select the larger lumen at the bifurcation while also following the flow of the maximum blood flow, thereby maintaining the overall direction and angulation of the primary blood vessel. When observing the standard anatomical structures found in the cerebral vasculature, the Willis circle is supplied with blood by two vertebral arteries and two carotid artery catheters. Since these four arteries are access points to the brain anatomy, the path of the navigation catheter 300 can be identified, and the path has been verified in a standard brain anatomy model.

[0122] In the anterior circulation, the catheter arterial entry point for cerebrovascular surgery is the internal carotid artery (ICA), and the navigation catheter can bypass the anterior communicating artery (ACA) and the anterior temporal branch (ATB) to guide the large-caliber catheter to the M1 segment of the middle cerebral artery (MCA). The very flexible nature of the navigation catheter 300 combined with the distal flexibility of most brain catheters allows delivery through severe tortuosity. Regardless of the tortuous nature of the arterial course, the navigation catheter 300 tends to navigate the turn and deliver to the largest sub-artery of the primary artery, such as the M1 segment of the ICA to the MCA. The M2 horizontal branch of the M1 can be variable, but it is generally considered to have two main M2 branches (upper and lower), and depending on the anatomical structure (which may vary significantly between patients), it may be considered as "equal" or "unequal" bifurcation. If the caliber of the M2 branch has similar size and angulation, the navigation catheter 300 can take one of the two branches. If the target of catheter placement is not at a favorable angulation or artery size, the navigation catheter 300 may be bent (eg, by shaping a malleable distal tip) and guided, or a guidewire may be used.

[0123] In some anatomical structures where the M2 bifurcations are "evenly" sized, the forward and backward movement can help select one branch and then the other, while still avoiding the need or use of a guidewire or the curved distal end of the navigation catheter. The forward and backward movement can allow the navigation catheter to be guided into either branch of the M2. Even if the navigation catheter is initially straight, some curvature will be achieved, which helps guide the navigation catheter into the branching vessel. Therefore, when the operator encounters an M2 bifurcation and wants to cannulate either branch of the evenly divided bifurcation, either branch can be selected using a guidewire-free navigation catheter.

[0124] Therefore, the major channels in the anterior circulation, such as the ICA, middle cerebral artery, and its tributaries, will naturally become the preferred routes for the described navigation catheters and subsequent large-bore catheter delivery (via access from the ICA). A similar phenomenon may occur in the posterior circulation, which is accessed via the vertebral arteries arising from the right and left subclavian arteries. The navigation catheter will also occupy the major channels in this circulation by crossing the vertebral arteries to reach the basilar artery and its major tributaries (the posterior cerebral artery and superior cerebellar artery in the posterior circulation).

[0125] Navigation using a navigation catheter can provide maximum deliverability and minimal vascular trauma. The catheter may cause a "shaving" effect in curved vessels because the blunt end of the large-bore catheter tends to take a larger bend when rounding the vessel when pushed by the operator. This blunt end may dig or "shave" larger bends with its sharp edge, thereby increasing the risk of dissection along anatomical planes within multiple layers of medium-sized or large-sized arteries or veins (see, e.g., Catheter Cardiovasc. Interv. 2014 February; 83(2): 211-20). Navigation catheters can be used to minimize the edges of these catheters. Positioning the navigation catheter within the lumen of the large-bore catheter so that the tapered portion marker of the navigation catheter is optimally aligned with the distal end marker of the catheter can minimize the edges, thereby eliminating the "shaving" of the large-bore catheter as it is advanced through the bends of the vessel. This is particularly useful for brain anatomy. Stroke treatment is often required in the area distal to the carotid siphon segment, especially the area distal to the origin of the ophthalmic artery with a larger bend that is severely tortuous from the last turn of the carotid siphon segment, the "anterior genu" of the carotid siphon segment, which is generally considered to be part of the terminal internal carotid artery (ICA). The feature of the navigation catheter being properly aligned within the large-bore catheter relative to the taper marker of the navigation catheter (the "end to taper" position indicated by the distal end marker) minimizes the possibility of shaving and hanging on the ophthalmic artery during manual advancement of the catheter system. The taper marker of the navigation catheter can be positioned at or past the origin of the ophthalmic artery to minimize these deleterious effects and allow the large-bore catheter to be smoothly passed through the ophthalmic artery. In the relatively straight section that is common after passing through the siphon segment, the large-bore catheter can be advanced through the navigation catheter, and the navigation catheter can still serve as a guiding element to reach the target. The transition between the distal edge of the navigation catheter and the large bore catheter is not dramatic, especially compared to the step-wise transitions of a typical microcatheter or guidewire that do not prevent hooking up on a branch, such as the ophthalmic artery. The navigation catheter allows the large bore catheter to be manipulated, passed to the embolic surface without the use of a microcatheter or guidewire and without penetrating and / or disrupting the embolism in any way.

[0126] Robot drive system

[0127] Figure 4A600 having the catheter system 150 and the proximal end of the guide sheath 400 mounted within a box 605. Figure 2 As described, the robotic drive system 600 may include a base console 601 and a box 605 capable of cooperating with the console 601. The robotic drive system 600 may include a controller 610 having one or more inputs 612, outputs 614, and sensors 625. The box 605 may include multiple sets of rollers 615 or other types of steering mechanisms and multiple connectors 620. The guide sheath 400 may be engaged by at least one first connector 620 in the form of a rotating gear. A sheath retainer sleeve 622 (such as Figure 2 The guide sheath 400 may be advanced over the guide sheath 400 and connected to an access sheath introducer (also not shown) at the patient. The sheath retainer sleeve 622 may be slidably attached to the box 605 to provide support when the guide sheath 400 is advanced, retracted, or rotated due to movement of the box 605 and / or the arm 603 or advancement of components of the catheter system 150 through the guide sheath 400. The guide sheath 400 may be slidably moved within the sheath retainer. The guide sheath 400 may be moved within the sheath retainer sleeve 622 through a slit extending along the length of the sheath retainer. The sheath retainer sleeve 622 may include a foldable portion, or may include multiple tubes that slide within each other to telescopically shorten and lengthen when the guide sheath 400 is inserted and retracted. The telescopic or (one or more) foldable tubes provide support during surgery to prevent buckling or bowing.

[0128] When the components are loaded and latched into the cartridge 605, a plurality of rollers 615 in the cartridge 605 manipulate the various components of the distal access system 100. The rollers 615 are positioned to optimally manipulate each component. For example, rollers manipulating outer components may be positioned toward the distal side of the cartridge 605, rollers manipulating intermediate components may be positioned more proximally, and rollers manipulating inner components may be positioned even more proximally on the proximal side of the cartridge 605. The rollers 615 associated with the innermost components are positioned at the proximal end of the cartridge 605. In some cases, more than one set of rollers 615 may manipulate a component. For example, a first set of rollers 615a may manipulate a first region of the catheter 200 (e.g., Figure 4A 615a) within the body 222 of the catheter 200, while a second set of rollers 615b may manipulate a second region of the same catheter 200 (e.g., Figure 4A4. The rollers 615a and 615b are shown in the drawing to control the movement of the catheter 200. The rollers 615b are shown in the drawing to control the movement of the catheter 200. The rollers 615a are shown in the drawing to control the movement of the catheter 200. The rollers 615b ...

[0129] In some cases, the rollers 615 can be aligned with the longitudinal axis A. In other cases, the rollers 615 can be offset from the longitudinal axis A and at an angle thereto, preferably at an angle of 45 degrees or less. In addition, some of the rollers can be arranged at an angle and also out of plane from the majority of the rollers on the box 605. The number, positioning, and angling (i.e., on-axis, at an angle, out of plane) of the rollers can be configured to optimize the forward and backward movement of each component throughout the entire range of movement of each component. In the example, and still referring to Figure 4A , the box 605 may include a first group of rollers 615a located near the connector 620, so that the first group of rollers 615a is located proximal to the guide sheath hub 434. The first group of rollers 615a can be aligned so that the components driven by the rollers 615a are aligned with the longitudinal axis A. The box 605 may include a second group of rollers 615b located proximal to the first group of rollers 615a. The second group of rollers 615b can deviate from the longitudinal axis A and be at a certain angle relative to the longitudinal axis A. The second group of rollers 615b can also deviate from the plane of the rollers 615a, so that the components connected to the rollers 615b do not contact the rollers 615a. Alternatively, when the rollers 615b are active, the rollers 615a can be ejected or otherwise disengaged so as not to interfere with the movement of the internal components. The third group of rollers 615c can be located proximal to the first group of rollers 615a. However, unlike the second set of rollers 615b, the third set of rollers 615c can be aligned with the first set of rollers 615a and the longitudinal axis A. Figure 4A A fourth set of rollers 615d is shown, located proximal to the third set of rollers 615c and aligned with the longitudinal axis.

[0130] Still refer to Figure 4A, the first catheter 200 can be inserted through the working lumen of the guide sheath 400 so that the distal end 215 of the first catheter 200 extends through the distal opening 408 of the guide sheath 400. The first catheter 200 can be received by 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 relative 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 so that the distal region 346 extends distal to the distal end 215 of the first catheter 200. The third set of rollers 615c can engage the proximal extension 366 of the navigation catheter 300. The fourth set of rollers 615d can engage the guidewire 500 extending through the navigation catheter 300. The rollers 615d can also include a means for rotating the guidewire and advancing and retracting the guidewire.

[0131] The roller may include a soft elastomer that can engage components of different diameters, such as a thermoplastic elastomer, such as santoprene, silicone, polyurethane foam, neoprene, etc.

[0132] The number and arrangement of roller groups may vary depending on whether the catheter system to be used includes 1, 2, 3, 4 or more components and / or has multiple diameters. The roller groups need not engage every component of the catheter system. In other words, the number of components being advanced and the number of roller groups may vary. Figure 4A In the example shown, the catheter system includes a first catheter 200, a navigation catheter 300 extending through the first catheter 200, and a guidewire 500 extending through the navigation catheter 300. The distal portion 222 of the first catheter 200 can be engaged by a first roller set 615a, and the proximal portion 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 a certain angle to the longitudinal axis A. The navigation catheter 300 can be engaged by a third roller set 6154c located proximal to the first and second roller sets 615a, 615b. The guidewire 500 can be engaged by a fourth roller set 615d located proximal to the third roller set 615c near the proximal region of the box 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 do not need to include their own dedicated roller sets. For example, a single roller set can move two components. In one embodiment, the catheter 200 and the navigation catheter 300 can be clamped together or otherwise coupled together so as to be advanced / retracted together by a single roller set. In another embodiment, the roller set can be physically coupled to advance the two components. Thus, when moving a single component, the robotic system 600 can use a single roller set to move multiple components coupled together.

[0133] The same roller may be used to advance more than one component of the catheter assembly 150. Figure 4A , in the initial state of advancement, the larger diameter distal lumen portion 222 of the catheter 200 may be engaged by the first set of rollers 615a, and the proximal portion 230 of the catheter 200 may be engaged by the second set of rollers 615b. In the second stage of advancement, once the proximal end of the larger diameter distal lumen portion 222 of the catheter 200 is pushed inside the RHV 434 of the guide sheath 400, advancement of the catheter 200 may be driven by the proximal control element 230 of the catheter 200. Advancement of the catheter 200 may be driven by the second set of rollers 615b engaged with the proximal control element 230, and the robotic drive system 600 transmits drive of the catheter 200 to the set of rollers 615b instead of the first set of rollers 615a. The first set of rollers 615a may engage with the inner navigation catheter 300 and control its movement, while the second set of out-of-plane rollers 615b remain engaged with the proximal element 230, continuing to control the movement of the catheter 200. Alternatively, the third set of rollers 615c engaged with the inner navigation catheter 300 may continue to control and drive its movement. Any of the various combinations are contemplated herein.

[0134] Movement of the catheter 200 need not involve multiple rollers of the robotic drive system 600. Instead, the robotic drive system 600 may be configured to manipulate the catheter 200 using a single set of rollers that engages the catheter 200, for example, only the proximal element 230. The catheter 200 may 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 may then be inserted between the rollers 615b to allow the robotic drive system 600 to control movement of the catheter 200. In this embodiment, the robotic drive system 600 may include only one set of rollers 615b for the catheter 200, rather than a plurality of rollers 615b as shown in FIG. Figure 4A Two groups 615a, 615b are shown. Figure 4A Roller set 615b is shown positioned at an angle relative to the longitudinal axis A, however, the catheter's dedicated roller set can be aligned with the longitudinal axis A since the rollers do not need to be out of the plane of the remaining box rollers.

[0135] In an embodiment, the catheter system includes two catheters 200, which are sized to allow one catheter to be nested within the other. For example, the first catheter can be a larger 0.088" ID, while the second catheter can be a 0.070" ID with an outer diameter sized to be inserted into the ID of the first catheter. The first and second catheters can be driven simultaneously when the corresponding larger diameter portions (distal lumen portions 222) of the first and second catheters extend outside of the guide sheath 400. The first catheter with the larger ID can be initially driven to a target area in a blood vessel, where the 0.070" second catheter is preloaded therein and moves with the first catheter actively driven by a set of rollers. Then, if the procedure requires a smaller second catheter, 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 to be driven directly. Once both the first and second catheters are inserted through the corresponding material transition between the proximal control element 230 and the distal lumen portion 222, the second set of rollers can be used to independently control each of the first and second catheters.

[0136] Figure 4B A robotic drive system 600 is shown, which is configured to manipulate nested distal access catheters 200a, 200b. The first catheter 200a may include a distal lumen portion 222a and a proximal control element 230a. The second catheter 200b extending through the first catheter 200a may also include a distal lumen portion 222b and a proximal control element 230b. The navigation catheter 300 may extend through the second catheter 200b, and the guidewire 500 may extend through the navigation catheter 300. The first set of rollers 615a may drive the proximal control element 230a of the first catheter 200a. The second set of rollers 615b may drive the proximal control element 230b of the second catheter 200b nested in the first catheter 200a. The second catheter 200b may be physically clamped together with the navigation catheter 300 so that both are moved as a single unit by a set of rollers, as described elsewhere herein. Alternatively, the system 600 may include a third set of rollers 615c that drives the proximal extension 366 of the navigation catheter 300. Yet another set of rollers 615d may drive the guidewire 500. Depending on whether the catheter and navigation catheter 300 are clamped together and moved as a unit, the system includes more than just a set of rollers. Although the navigation catheter 300 and the guidewire 500 are shown extending along the longitudinal axis A and engaging their respective sets of rollers, one or both of the guidewire 500 and the navigation catheter 300 may also deviate from the axis A and engage with different sets of rollers so that they come out of the box 605 at an angle, rather than directly behind or through the proximal end of the box 605.

[0137] The catheters 200a, 200b may be initially advanced until their lumen portions 222a, 222b enter the RHV 434 and before their proximal elements 230a, 230b are inserted into their respective rollers 615a, 615b. The initial advancement may be performed manually by the user or by a set of rollers. For example, another set of rollers may be included just proximal to the RHV 434 of the introducer sheath 400, similar to Figure 4A . An additional set of rollers can be used to drive nested components, such as catheter 200a nested with catheter 200b. Once the proximal end of the larger diameter distal lumen portion 222a is advanced to the interior of the RHV 434 of the guide sheath 400 (whether manually or by another set of rollers), the advancement of the catheter 200a can be driven by engaging the proximal control element 230a of the catheter 200a with the roller set 615a. The proximal control element 230b of the smaller diameter can be manually transferred to the second set of rollers 615b, and the robot drive system 600 transmits the drive of the catheter 200b to the group of rollers 615b instead of the first group of rollers. Alternatively, the outer catheter 200a can be combined with a slit that allows the distal lumen portion 222a to deviate (ride off) one side of the inner navigation catheter 300. This arrangement eliminates the need for a roller set directly located proximal to the hub 434 of the guide sheath 400.

[0138] The scroll wheel used to navigate catheter 300 can be physically linked to the scroll wheel of the proximal control element of the catheter in which the navigation catheter 300 resides. Figure 4A and 4C Scroll wheel 615 b engaged with proximal control element 230 of catheter 200 is shown physically linked to scroll wheel 615 c engaged with navigation catheter 300 . Figure 4B The roller 615b that is engaged with the proximal control element 230b of the second catheter 200b is shown to be physically linked to the roller 615c that is engaged with the navigation catheter 300. When the rollers are driven together, the physical linkage allows the catheter 200 to move simultaneously and synchronously with its navigation catheter 300. The linkage can be achieved by a clip or other mechanical features connecting the rollers. The rollers of the drive system 600 do not need to be synchronized to advance two components simultaneously. As described elsewhere herein, the catheter 200 can be mechanically clamped to the navigation catheter 300 as described above so that they can be advanced simultaneously using a single roller set.

[0139] Although the catheter system described herein can be advanced without the use of a guidewire, the robotic drive system can include another set of rollers 615d (see Figures 4A-4C) to engage the guidewire 500. The other set of rollers 615d can be positioned further proximally along the box 605 to engage the guidewire 500 (if used). The position of the guidewire rollers 615d allows for a full range of movement of the navigation catheter 300. The other set of rollers 615d can also be used to engage with interventional devices, such as stent retrievers, stents, aneurysm coils, shunt delivery systems, etc.

[0140] The configuration of roller 615 can vary. Each roller 615 can include a friction element or tire mounted on a central axis or axle. The roller is configured to clamp the components of the catheter system 150 without damaging the components so that the components move when the roller 615 rotates. The roller can rotate in two directions to advance and retract the components. At least one roller in a set of rollers can have an axis driven to rotate by a motor in the box 605 or console 601. This allows the use of the set of rollers to drive the catheter body engaged between the set of rollers to move relative to the box 605. One roller in the set of rollers can be actively driven by a motor that rotates the axis, while another roller in the set of rollers can be passively rotated on its axis 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.

[0141] The tire can be made of an elastic material that is a little sticky to help engage with the catheter body, thereby pushing the catheter body in a specific direction. The roller can include a soft elastic body, such as a thermoplastic elastomer, such as santoprene, silicone, polyurethane foam, chloroprene rubber, etc. The material and configuration of the tire can be non-traumatic, to avoid damaging the catheter body when the catheter body is sandwiched between a group of rollers. In some embodiments, the material of the tire can be a compressible elastomer so that the roller group can adapt to the different outer diameters between them. In some embodiments, one or more rollers 615 can include a compressible sleeve that allows one or more catheters to pass through when in an open state, or fixes one or more catheters (or guide wires 500) when in a closed state.

[0142] Box 605 can include two groups of rollers to engage a single catheter with different diameters along its length. For example, a first pair of rollers 615a can engage a larger-sized distal lumen portion 222, and a second pair of rollers 615b can engage a smaller-sized proximal control element 230. Soft elastomers can be configured to engage the different diameters of catheters. Alternatively, box can have a group of special rollers that are configured to engage with catheter 200 and automatically adjust to the different sizes along the catheter length when catheter is advanced into and out of the patient. One or two rollers in a group of rollers can have two different diameters, and (one or more) rollers can move relative to the outer surface of the catheter (e.g., up and down or side to side) to match the change in diameter with the corresponding area of ​​the catheter. Figures 6A-6D615 are various views of an embodiment of a set of rollers having a first tire 630a and a second tire 630b adjacent to each other so that their inwardly facing surfaces are spaced a distance apart. The inwardly facing surfaces may 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 may define a first space between them that corresponds to the shape of at least a portion of the catheter, such as a semi-cylindrical space. The semi-cylindrical space may 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 may define a second space that corresponds to the shape of at least another portion of the catheter. The diameter of the second space may be smaller than the first space so as to engage with the smaller-sized proximal control element 230 of the catheter 200.

[0143] The roller set 615 may also be spring loaded to accommodate different outer diameters. The catheter 200 may include a larger sized distal lumen portion 222 and a smaller sized proximal control element 230. The roller set 615 may 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. Once the distal lumen portion 222 is fully inserted through the hub 434, the rollers 615 may spring back toward each other so that the rollers 615 may engage and drive the proximal control element 230 during a second stage of engagement. As described elsewhere herein, the proximal control element 230 of the catheter 200 may be a hypotube, ribbon, or wire and have a significantly smaller outer diameter than the distal lumen portion 222 of the catheter 200. For example, the distal lumen portion 222 of the catheter 200 may have an outer diameter sized for insertion through a 6-8 Fr sheath, e.g., 0.080" to about 0.105". The proximal control element 230 of the same catheter may have a much smaller outer diameter, e.g., about 0.014"-0.022". Similarly, the outer diameter of the inner navigation catheter 300 can vary along its length, from a larger outer diameter at a more distal location (e.g., about 0.080") to a smaller outer diameter at a more proximal location (e.g., about 0.062" to as small as about 0.022"). The catheters driven by the robotic drive system can also have different sizes and therefore different outer diameters. The robotic drive system can be used for smaller catheters (e.g., 3Fr) as well as larger catheters (e.g., 8Fr). It is useful for the feed drive mechanism to accommodate these different catheter sizes while still providing adequate grip. The set of rollers 615 can automatically adjust their spacing so that they can 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 outer diameter of the inner navigation catheter 300 varies along its length (e.g., in combination with a proximal gradual decrease in outer diameter), the set of rollers 615 engaged with the navigation catheter 300 and configured to drive the navigation catheter 300 can automatically adjust their spacing to accommodate the size change as the catheter 300 is further advanced into the patient's body.

[0144] Suction system

[0145] As mentioned above about Figure 2As described, the robot 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 in the robot. Suction can be automatically turned on, off, adjusted up, adjusted down and / or cycled faster or slower, depending on the stage of the operation or the event that triggers the suction change. One or more sensors 625 can be included in the system 600 for sensing the pressure and / or flow at the arm 412 of the RHV 434 of the sheath. The sensor 625 can be arranged in line with the suction tube of the pump or tank connected to the suction system 805. The proximal pressure sensor can be positioned at this position, and the distal pressure sensor can be positioned near the distal opening of the catheter 200 (for example, about 1-5cm from the opening). The distal pressure sensor can be arranged to read arterial pressure, and the proximal pressure sensor can be arranged to read vacuum pressure. A clot blocked on the distal end of the catheter 200 or a clot that slowly advances through the catheter lumen will be detected. The in-line pressure sensor can also be designed to detect when the fluid chamber on the discharge side of the suction cycle is filled. A low positive pressure or zero pressure at the proximal sensor may trigger the software of the control system 700 to display a reminder to the operator that the fluid chamber needs to be filled.

[0146] In some embodiments, the suction system 805 can include a vacuum source connected to the catheter system by a vacuum line. The configuration of the vacuum source can vary. The vacuum source can be an active suction source, such as a suction pump, a conventional or locking syringe, a hand-held aspirator, a hospital aspirator, etc., configured to aspirate through the working lumen of the base sheath. As described above, the RHV of the base sheath can be sealed and initiate suction via the side arm of the RHV. The side arm of the RHV can be connected to any one of various vacuum sources. In a preferred embodiment, the vacuum source is a suction pump, such as a Gomco 405 desktop aspirator (United Medical Products, St. Louis, Missouri). The suction pump can be combined with 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 periodic suction as described herein. In another embodiment, the vacuum source is a locking syringe, such as a VacLok type syringe.

[0147] The material aspirated from the catheter system can be collected in a proximal vacuum tank connected to a vacuum line. In some embodiments, the proximal vacuum tank itself can be a vacuum source, such as a barrel of a locking syringe. In other embodiments, the proximal vacuum tank is connected to a vacuum source via a pipe.

[0148] During the procedure, when the distal end of the catheter 200 is close to or located at the occlusion surface, the operator can open the connection to the vacuum source (e.g., a suction syringe) of the suction system 805. This allows the maximum transmission of the suction force applied by the working lumen of the sheath 400 and any catheter extending through the sheath 400, which is in communication with the blood vessel at its distal end. In another embodiment, the arm 412 can be connected to the vacuum source of the suction system 805, such as a pump. The vacuum source can provide a cyclic level of suction force, for example, a suction force that cycles between a high vacuum level and a low vacuum level at one or more frequencies that are set, or a suction force that cycles from a high vacuum level to a no vacuum level, or from a high vacuum level to a positive pressure level. The periodic suction mode can apply a jackhammer type force to the occlusion and increase the ability to suction the occlusion through the catheter. One of the effects of these forces is to fatigue and rupture the occlusion that is usually engulfed by the catheter, and to promote the slow and gradual movement of thrombotic material along the length of the catheter, especially when static suction cannot do this. Another effect of the cyclical forces is to change the frictional state and challenge the connection between the clot and the vessel wall, causing the clot to loosen in order to push the clot toward the vacuum source.

[0149] By using one or more valves between the vacuum source and the catheter system, it is possible to achieve periodic suction force. The valve can control the patency between the vacuum source, the catheter end and the external environment providing the pressure difference. When the valve is opened, the valve can establish open continuity between the vacuum source, the catheter end and the external environment (e.g., air). The valve temporarily closed to the external environment (e.g., manually, mechanically, or by software programming on a pump or in a controller of a robotic system) can allow the vacuum source to establish a vacuum at the catheter end, and the valve subsequently opened to the external environment reduces the vacuum at the catheter end in a controlled manner. Repeatedly opening and closing the valve forms a periodic pressure curve at the catheter end. The change in valve operation produces different periodic suction solenoid valves, spring-operated pressure relief valves, electronically controlled valves, manual or mechanical valves, programmable pump motor controllers, etc. In an embodiment, only when a blocked or restricted flow is detected in the suction line, periodic suction is applied, by low flow or by high vacuum, and at other times, the vacuum source returns to a low flow level, or is closed. This configuration can be controlled by the user, or automatically controlled by the feedback loop of the vacuum source.

[0150] Cyclic aspiration can involve rapid pressure cycling, for example, between 1 Hz and 100 Hz. Cycling can be performed at a single frequency, multiple frequencies, a range of dynamic frequencies or frequency combinations, and for extended time periods. A pressure cycling mechanism, such as a solenoid valve, is located within or near the vacuum line to the catheter and works in conjunction with the aspiration pump to apply rapid pressure oscillations. These pressure oscillations or cycles improve the clot removal capabilities of the aspiration catheter, and in general, the pressure oscillation device is most effective if the distance between the pressure oscillation device and the end of the catheter is minimized because pressure losses are minimized. Because the cyclic aspiration system is centered around an independent pressure oscillation mechanism, it can be easily integrated into current aspiration thrombectomy systems without replacing the entire or existing vacuum pump assembly.

[0151] In an embodiment, the cycle frequency may be between 1 Hz and 50 Hz, more preferably between 2 Hz and 10 Hz. In an embodiment, the cyclic pressure profile includes a rapid "burst" of a higher frequency cycle within the frequency range (e.g., about 10 Hz), followed by a portion of a static suction or slow "recovery" frequency cycle within the frequency range (e.g., about 3 Hz). The static or slow cycle profile after the higher frequency cycle period allows the pressure to be increased to the maximum operating pressure after the pressure deteriorates under high-speed cycles. For a manual system, the suction cycle may 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 cycle may be within the range of between 1 Hz and 3 Hz, or between 1 Hz and 6 Hz, or between 1 Hz and 10 Hz, or between 1 Hz and 50 Hz. Typically, the cycle may be below a frequency that increases damage to the vessel wall or increases the risk of bleeding or thermal tissue damage. Low-frequency mechanical disturbances should not exceed the local elastic limit.

[0152] The cycle profile can vary. The cycle puff time can be about 100-260 milliseconds. The total puff time for the puff and release of the cycle is about 6-8 seconds. The time between puffs and each release cycle is about 40-70 milliseconds. The static puff between puff cycles is about 2-4 seconds.

[0153] Once a blockage occurs and the operator deems it necessary to withdraw the blocked catheter, the operator can switch to static full-pressure suction. Typically, occlusions in a blocked or restricted flow state, where the occluded portion outside the lumen may break and embolize due to catheter movement, are extracted with a catheter under static suction and preferably at maximum force to compress and maintain the embolism during catheter removal. As another example, the surgeon can apply periodic suction to engulf the occlusion. As long as the surgeon wishes to aspirate the engulfed embolism through the lumen, periodic suction can be continued. In an embodiment, periodic suction may be preferably applied during a period of reduced catheter movement. The engulfed occlusion can be completely discharged (i.e., cleared to a proximal can or syringe) under periodic suction. The engulfed occlusion can be completely discharged under static suction. The engulfed occlusion can be at least partially discharged using periodic suction, and at least partially discharged using static suction, and then finally extracted with a catheter. During surgery between static suction and periodic suction, the suction force can be converted in real time. Different cycle frequencies and amplitudes can be performed depending on the diameter of the catheter used, the location of the aspiration valve / pressure release / pressure change mechanism, and the degree to which pressure is released or changed to produce different embolic movement. The operator can switch from cyclic aspiration to static aspiration at any time if no flow is observed and the catheter needs to be withdrawn to remove the obstructing embolus.

[0154] The operator can initiate suction of the suction system 805 by clicking a button or icon on the user interface 720 of the control station 700 (or the operator at the operating table 7 can directly initiate suction on the user interface of the robot drive system 600), which will be described in more detail below. Alternatively, there can be a control system for the suction system 805 and a separate controller 610 for the robot drive system 600. One or both control systems can also be connected to the remote control system 700 and remotely operated by the remote control system 700. The operator has the option of selecting the type of suction applied (e.g., static, cycle). Selecting cyclic suction can also prompt the user to select (e.g., increase or decrease) the cycle frequency. Once the user initiates suction, the software running on the controller 710 can perform a system pressure and flow check. If the flow through one or more catheters 200 is not detected and the vacuum pressure is higher than the threshold pressure, the suction pump can be turned on (manually turned on by the operator selecting on the GUI 720 or automatically turned on by the software running on the controller 710). The software running on the controller 710 can continue to monitor the system pressure until the desired vacuum pressure is reached. Once the desired vacuum pressure is reached and there is no flow between the catheter 200 and the vacuum chamber of the aspiration system 805, the system can open the valve between the catheter 200 and the vacuum chamber. The flow detected when the valve between the vacuum chamber and the catheter 200 is closed indicates that there is a leak in the system, and an error message can be displayed on the GUI 720. When the valve between the catheter 200 and the vacuum chamber is open, the system can monitor the pressure and flow to assess whether the parameters are within the specified operating range. Excessive flow and / or pressure outside the specified operating range indicates that the clot is not aspirated, but only blood is aspirated from the patient, which is a safety risk, or there is a system leak. In the case of only blood being aspirated from the patient, the software running on the controller 710 can be programmed to automatically close the valve between the catheter 200 and the vacuum chamber and display an error message on the GUI 720. The error message can provide information suggesting that the operator advance the catheter 200 further distally in the patient. The operator can advance the catheter 200 using one or more inputs 725 on the GUI, causing one or more sets of rollers 715 to drive the catheter 200 distally a distance. In the event that a system leak exists, an error message may be displayed instructing the operator to check the system connections.

[0155] The high vacuum pressure at the proximal sensor combined with the low flow rate identified by the distal sensor may indicate a clot blockage or that the clot is moving too slowly through the catheter 200. This may also indicate that the operator initiated aspiration before withdrawing the inner navigation catheter 300. The software running on the controller 710 may be programmed to display an error message after a certain period of time (e.g., after 30 seconds to approximately 2-3 minutes) of the high vacuum pressure / low flow condition. This allows a sufficient period of time for the clot to pass through the catheter 200 before triggering the error message. The error message may provide additional instructions to the operator, such as a reminder to check whether the inner navigation catheter 300 is present, a suggestion to switch to periodic aspiration (if currently static), or to remove the catheter 200 to flush out the blocked clot.

[0156] Low vacuum pressure at the proximal sensor may indicate a system leak or no clot aspiration. Software running on the controller 710 may be programmed to close the valve to the catheter 200 and display an error message instructing the operator to check that the aspiration system 805 is properly connected and has no leaks.

[0157] Arterial pressure at the distal sensor and high vacuum pressure at the proximal sensor and no flow may indicate a clogging of the catheter 200, where a clot has successfully traveled past the distal pressure sensor and at least partially through the lumen of the catheter 200. The software running on the controller 710 may be programmed to maintain the condition for a period of time to allow successful clot aspiration before alerting the operator with an error message on the GUI 720 suggesting switching from static aspiration to periodic aspiration or removing the catheter 200 from the patient to flush out the clogging clot. When the operator activates a specific input 725 on the GUI 720 to retract the catheter 200, the robotic drive system 600 may perform the removal of the catheter 200.

[0158] A moderate flow and pressure maintained within a selected operating range (e.g., between arterial and maximum vacuum) indicates successful aspiration of the clot(s). If no error condition is detected, the software running on the controller 710 is programmed to automatically close the valve after a specified time limit (e.g., 60 seconds). The operator can restart aspiration, for example, by activating a "suction on" button or clicking an input on the GUI 720.

[0159] Control system / user interface

[0160] The operator can use the control system 700 of the surgical system 10 to control one or more functions of the robotic drive system 600, the suction system 805, or other functions. As described above, the control system 700 may include a computing device having a user interface 720 having one or more inputs 725 and one or more displays 730. Figure 56 is an example graphical user interface (GUI) 720 of the control system 700 that an operator may use to control various functions of the system 10. It should be understood that an operator may use the user interface of the robotic drive system 600 to control various functions of the system 10, and Figure 5 The GUI features shown in and discussed below with respect to the control system 700 can be mirrored on a user interface or controller of the system 600 where the patient is located. Where control of the system 10 is described as being performed by an operator on the control system 700, the operator can also control the system 10 using the user interface of the robotic drive system 600 without having to be remote.

[0161] The relative arrangement and configuration of inputs 725 on GUI 720 may vary. Some inputs 725 may be physical components (e.g., buttons, sliders, dials, joysticks, foot pedals) configured to be engaged by an operator, while other inputs 725 may be icons displayed on a screen that may be clicked or selected, as is known in the art.

[0162] Figure 5 It is shown that the displayed information can be organized into columns for each component. The information can be organized into a guidewire column 5500, a navigation catheter column 5300, a suction catheter column 5200, and a guide sheath column 5400. Each component column can have certain information and / or inputs displayed in relation to the function of the component. Each component column can provide information related to an indication of what component is associated, such as by marking with text, shape, and / or color. For example, the navigation catheter column 500 can be marked with the word "navigation catheter" or other names suitable for identifying the component, and can have an icon presented in a specific color scheme unique to the component. The suction catheter column 5200 can also be marked with a word identifying the component, and marked by displaying an icon in a different color unique to the component. Figure 5 The columns are shown arranged on the display such that the guidewire column 5500 is at the far left and the guide sheath column 5400 is at the far right. The columns can be arranged on the display in various orders and the arrangement can be programmed by the operator at the time of surgery. In an embodiment, the columns can be arranged on the display in the same order as they are positioned in the patient and the roller so that manipulation of the components on the display reflects the arrangement of manipulations at the components themselves. Figure 4A, the guidewire roller 615d is located at the far right or proximal side of the box 605, the catheter rollers 615a, 615b are located at the left or distal side of the navigation catheter roller 615c, and the navigation catheter roller 615c is located to the left of the guidewire roller 615d. The sheath manipulator 620 is located at the far left or distal side. The guidewire column 5500 can be arranged at the far right on the display, next to the navigation catheter column 5300, and the sheath column 5400 can be arranged at the far left on the display, next to the aspiration catheter column 5200. The manipulation performed by the operator on the remote control system more intuitively reflects the manipulation of the component occurring within the box 605.

[0163] Each component column may display a movement output (5505, 5305, 5405) showing the amount of linear translation of the component relative to a baseline, and an angle output (5510, 5310, 5410) showing the angle of rotation relative to the baseline (if applicable), and a corresponding reset input. Some components (e.g., aspiration catheters) may have additional information displayed, such as a vacuum pressure output 5215 showing the vacuum pressure within the catheter, or a flow rate output 5220 showing the flow rate within the catheter. The guide sheath column 5400 may include a movement output 5425 showing the movement of the guide sheath from its original placement in the patient.

[0164] Still refer to Figure 5 , each component column may also include one or more inputs (5530, 5330, 5230, 5430) to gradually increase or decrease movement and / or angle, etc. Additional inputs include rotation input 5535, oscillation input 5540, and cyclic suction input 5545. For example, switching the oscillation input 5540 to "on" can intermittently retract-advance-retract the catheter 200 to alleviate the occurrence of blockage. Another input may include a link input 5565, which connects the roller group 615 for the navigation catheter 300 to the suction catheter 200 so that the two components are moved synchronously. The input can also indicate that there are two components that are mechanically linked, such as mechanically linked by a physical clip, to move synchronously. When the components are clamped together, the operator can switch the input to ensure that the operator notices how the components will move together when a specific set of rollers moves. Each component may include an input as an input to a toggle switch 5550, which is configured to move the device distally by switching the switch forward, or to move the device proximally by switching the switch backward. In some cases, the switch 5550 can be a joystick that can be twisted to rotate one or more components. The switch 5550 for the suction catheter 200 can also include a button 5555 on the top of the switch 5550, which allows the operator to manually actuate "suction on" and / or "suction off" by pressing the button. Alternatively, "suction off" can be automatically initiated, such as by software running on the controller 710, as described elsewhere herein.

[0165] The position and configuration of the switches 5550 for the various components can provide information to the user as to which component of the system is being manipulated when the switch 5550 is actuated. For example, a first switch 5550 can be a first color, while a second switch 5550 can be a second, different color. The colors can be coordinated with the colors of one or more indicators on the GUI that display the 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 that the switch 5550 provides when actuated can be selected or programmed by the user according to the incremental change in position required for each actuation.

[0166] One or more outputs may include reminders to provide information to the operator about the status of the robot drive system 600 or other components of the system 10. Reminders may be audible, visual, and / or tactile signals. Visual signals may include one or more LEDs, icons on a display, or other signals. Auditory signals may be one or more beeps that indicate information to the user. Reminders may be informational, such as a propulsion speed represented by a sound frequency. One or more outputs may also include alarms (audible, visual, and / or tactile signals) that may indicate a fault, a communication interruption between the control system 700 and the robot drive system 600, a change in patient status, and the like. The user may clear the reminder, and the alarm will continue to be triggered until the problem is resolved. Visual signals may include a display of the status of the robot system components. For example, if a component of the distal access system 100 is not loaded and / or latched in the associated cartridge position, a light of a first color (e.g., red) may be displayed, and once the component is properly loaded and / or latched, a second color (e.g., green) may be displayed. Visual signals do not have to be colors, and may be combined with symbols and / or text to provide information about loading and / or latching.

[0167] The user can program the oscillation input 5540 parameters so that the supporting catheter follows one or more retractions and one or more advancements. In an embodiment, actuating the oscillation input 5540 can initiate the following modes: 1) static suction for a period of time when the distal opening of the catheter 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) advancing the catheter to place the distal opening back to the first position. The static suction period can be about 5 seconds of static suction, although this can vary from 1 second to about 30 seconds. The short retraction of the catheter after static suction can also vary, including about 1mm-50mm, about 2mm-25mm, about 3mm-10mm, or preferably about 5mm. Advancing the catheter to place the distal opening back to the first position can also advance the catheter to a position more distal to the first position (for example, if at least a portion of the occlusion has been engulfed) or more proximal to the first position. The preferred advancement is to advance to a position where the distal end of the catheter contacts the occlusion.

[0168] How to use

[0169] The following is an example of a method of performing a neurovascular procedure using the systems described herein using the distal vascular access system 100 and the robotic drive system 600. An example of performing aspiration using the aspiration system 805 through the catheter 200 and the guide sheath 400 is included. Other neurovascular procedures are also contemplated, including the delivery of a PTA catheter and the implantation of expandable tools including coils, stents, or shunts.

[0170] In an embodiment of a robot-assisted interventional procedure performed on a patient in a neurovascular system, an introducer sheath and / or a guide sheath (e.g., a guide sheath 400) is used to access the patient's vascular system, such as at a femoral or radial artery access site. A guidewire and catheter system can be introduced into the patient's vascular system through the sheath. The catheter system 150 may include a support catheter 200 and a navigation catheter 300. The catheter system 150 may be advanced through the sheath 400, as described elsewhere herein. If necessary, the catheters 200, 300 of the guidewire and catheter system 150 may be manually advanced to the first stage by the user, such as from the access site to the distal region of the guide sheath 400. The catheter system may then be coupled to a robot drive system 600, such as at a box 605. The robot drive system 600 is operatively coupled to a controller 610 and / or a remote controller 710 that can be operated by input from an operator. The robot drive system 600 includes a plurality of rollers 615 or other actuator bodies that can move in response to 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, which is coupled to the distal lumen portion 222 near the proximal opening 242. The proximal control element 230 has no lumen extending therethrough. The navigation catheter 300 includes a guidewire lumen 368 and an outer diameter of the lumen 223 sized to fill the support catheter 200. The navigation catheter includes a distal end region 346 and a proximal extension. The distal end region can taper from an outer diameter to a distal end, thereby defining an opening from the guidewire 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 with the navigation catheter 300 positioned within its single lumen 223 can be navigated to a vessel located distal to the petrous portion of the internal carotid artery (ICA).

[0171] The method also includes coupling the proximal control element 230 of the support catheter 200 to a first set of rollers 615 of the 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 located proximal to the first set of rollers 615. The method also includes moving the first and second sets of rollers 615 in at least one degree of freedom in response to an operator input.

[0172] The method optionally includes manipulating the introducer sheath 400 using a control system 600, for example, using a sheath hub housing that is movably controlled in at least one degree of freedom in response to operator input. Figure 4C An embodiment is shown that provides independent movement of the guide sheath 400 relative to other components coupled to the cartridge 605. The proximal end of the guide sheath 400, such as the RHV 434, can be positioned within a rack 640 having an outer surface arranged to engage with teeth on a small-sized gear or pinion 642. The teeth on the pinion 642 mesh with corresponding features on the outer surface of the rack 640. The rack 640 can be floating, and the pinion 642 is carried on bearings so that the rack 640 translates axially along the longitudinal axis A when the pinion 642 rotates. The guide sheath 400 can be manually advanced to a distal position. For example, the tip of the guide sheath 400 can be advanced to the common carotid artery, the cervical ICA, or a more distal portion of the ICA for carotid or anterior circulation surgery, or can be advanced to the subclavian artery or vertebral artery for posterior circulation surgery. This initial advancement stage can be performed manually by the operator before the hub is coupled to the rack 640 until the desired position is reached. The sheath can move with the rack 640 to provide limited axial adjustment of the sheath independent of other components coupled to the cartridge 605 .

[0173] The distal lumen portion 222 of the catheter 200 has an outer diameter sized to be positioned within the working lumen of the introducer sheath 400 , which is advanced through the introducer sheath 400 coupled to a robotic drive system 600 configured to drive the catheter 200 .

[0174] In a method involving clot aspiration, the guide sheath 400 is operatively coupled to the aspiration system 805. The catheter 200 and the navigation catheter 300 can be advanced to the location of the clot occlusion. The navigation catheter 300 can be removed and aspiration of the clot performed through a continuous lumen formed by the working lumen of the guide sheath 400 and the single lumen of the catheter 200. The control station 700 controls the drive system 600 and the aspiration system 805.

[0175] In a related embodiment of a method for performing surgery using a robotic drive system, a control signal corresponding to the movement of a main input device is generated. A plurality of drive elements of an instrument driver move in response to the control signal to translate a catheter system operatively coupled to the plurality of drive elements. The distal end of the catheter system is inserted into a patient's blood vessel. The catheter system includes a support catheter having a distal lumen portion, the distal lumen portion being coupled to a proximal control element in a proximal region, the proximal control element being adjacent to a proximal opening of a single lumen from the distal lumen portion. The proximal control element is engaged by a first drive element. The catheter system also includes a navigation catheter having a guidewire lumen and a distal end region, the distal end region tapering from an outer diameter of a single lumen sized to fill the support catheter to a distal end, the distal end defining an opening from the guidewire lumen. The proximal extension of the navigation catheter is engaged by a second drive element. The movement of the plurality of drive elements results in a corresponding movement of the catheter system. The control signal causes each of the plurality of drive elements to move independently of one another to achieve the desired advancement of the catheter system in the blood vessel and the relative extension of the navigation catheter relative to the support catheter. Another control signal is generated using the primary input device.Another drive element of the instrument driver moves in response to the other control signal.

[0176] In another embodiment, the robotic drive system 600 can be used to perform high-speed operation techniques. A catheter system including a support catheter 200 and a navigation catheter 300 can be inserted so that the distal end of the navigation catheter 300 (i.e., the distal end extending to the distal end of the support catheter 200) can be positioned from outside the body to a position near the distal end of the sheath 400 using the robotic drive system 600. The robotic drive system 600 can automatically advance the catheter system to this position relative to the sheath 400 at a robotically controlled high speed, and then automatically stop once the target position near the distal end of the sheath 400 is reached. The operator can then use the control system 700 to control the advancement speed of the catheter system 150 outside the sheath 400. The robotically controlled high speed of the catheter system 150 advancing through the sheath 400 can be about at least about 1 cm / second, preferably at least about 5 cm / second, up to about 10-15 cm / second, but other speeds can also be considered.

[0177] The robotic drive system 600 can automatically control the withdrawal of the navigation catheter 300 at a robotically controlled high speed to produce a piston effect as described elsewhere herein. The robotically controlled high speed for withdrawing the navigation catheter 300 from the support catheter 200 can be between about 4 cm / sec to about 165 cm / sec, or about 10 cm / sec up to about 75 cm / sec, or about 20 cm / sec to about 25 cm / sec.

[0178] The robotic drive system 600 can automatically control the withdrawal of the support catheter 200 after surgery. The high speed of the robotic control for withdrawing the support catheter 200 from the surgical site can be at least about 1 cm / second, preferably at least about 5 cm / second up to about 10-15 cm / second, but other speeds are also contemplated. If the catheter 200 is blocked, the withdrawal of the catheter 200 may be slower (e.g., 10-15 cm / second), while if the catheter 200 has completely absorbed the clot and blood is observed to flow freely through the suction tube, the pump can be turned off and the catheter can be removed faster (e.g., 15-20 cm / second).

[0179] The robotic drive system is capable of reaching various speeds far beyond these specified ranges. The user can select the minimum and / or maximum thresholds that the system can reach when actuated, whether the actuation is for advancing the system or withdrawing one or more components. In addition, the robotic drive system can be combined with a feedback loop between the drive system and one or more sensors of the system (e.g., sensors that monitor blood flow through the pipeline). Feedback can change the speed of advancement or withdrawal, including completely stopping all movement. Robot-controlled high-speed advancement and withdrawal can have an emergency shutdown, for example, if a sensor detects a problem. For example, a force sensor can be combined that can sense one or more resistances in the catheter system components outside the acceptable range and automatically shut down the movement of the component driven by the roller 615.

[0180] Material

[0181] One or more components of the catheter described herein may include or be made of a variety of materials, including one or more of the following: metals, metal alloys, polymers, metal-polymer composites, ceramics, hydrophilic polymers, polyacrylamides, polyethers, polyamides, polyethylene, polyurethanes, their copolymers, polyvinyl chloride (PVC), PEO, PEO-impregnated polyurethanes, such as hydrogenated ethane, mesophilic polyurethanes, tetrahydrofuran, PEO soft segment polyurethanes blended with Tecoflex, thermoplastic starch, PVP and combinations thereof, or other suitable materials.

[0182] Some examples of suitable metals and metal alloys include: stainless steels, such as 304V, 304L, and 316LV stainless steels; mild steels; nickel-titanium alloys, such as linear elastic and / or superelastic nickel-titanium alloys; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as 625; UNS: N06022, such as UNS: N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g. UNS: R30003, such as etc.); platinum-rich stainless steel; titanium; combinations thereof; and the like; or any other suitable material as described elsewhere herein.

[0183] The inner lining material of the catheter described herein may include a low friction polymer, such as PTFE (polytetrafluoroethylene) or FEP (fluorinated ethylene propylene), PTFE with a polyurethane layer (Tecoflex). The reinforcing layer material of the catheter described herein may be combined to provide mechanical integrity for applying torque and / or prevent flatness or kinking, such as metals including stainless steel, nitinol, nitinol braid, spiral tape, spiral wire, cut stainless steel, etc. Or a rigid polymer such as PEEK. The reinforcing fiber material of the catheter described herein may include various high-strength polymers, such as Kevlar, polyester, meta-para-aramid, PEEK, single fiber, multi-fiber bundle, high tensile strength polymer, metal or alloy, etc. The sheath material of the catheter described herein may provide mechanical integrity and may include a variety of materials, such as polyethylene, polyurethane, PEBAX, nylon, tetrahydrofuran, etc. Other coating materials of the catheter described herein include polyparaxylene, polytetrafluoroethylene, silicone, polyimide-polytetrafluoroethylene, etc. The liner may also include different surface finishes, such as pits, protrusions, ridges, grooves. The surface finish may be randomly arranged, linearly arranged, spirally arranged, or otherwise arranged along the length of the catheter using a particular pattern. It is further contemplated that the liner may include a mix of different surface finishes, for example, one portion may have dimples, another portion may have grooves, etc. In addition, the surface finish may be incorporated along the entire length of the catheter or only in some portions of the catheter. It is also contemplated that the liner may also include an electrosprayed coating, whereby materials may be incorporated into the liner. Examples of materials may include low friction materials as described above. Alternatively, the electrosprayed or electrospun layer may contain a beneficial agent that will break away from the coating when exposed to blood or clot compression, for example, the beneficial agent may be tissue plasminogen activator (tPA) or heparin encapsulated in alginate.

[0184] The box can be designed to be disposable and can be discarded and replaced after use. The box can also be formed of a material configured to be sterilizable and reusable. The box can be formed of plastic, such as injection molded plastic or 3D printed plastic, and one or more parts are transparent or translucent. The material of one or more areas of the box can vary, 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 box can also be processed.

[0185] The boxes can be packaged individually and sterilized, for example, by ethylene oxide or irradiation. The catheter systems disclosed herein can be packaged together in a single package, wherein the support / suction catheter and the corresponding navigation catheter are packaged in a coil tube. The finished package will be sterilized using a sterilization method, such as ethylene oxide or irradiation, and labeled and boxed. Instructions for use can also be provided in the box or through an Internet link printed on the label.

[0186] Embodiments describe catheters and delivery systems and methods for delivering catheters to target anatomical structures. However, although some embodiments are described specifically for delivering catheters to target vessels (e.g., cerebral vessels) of neurovascular anatomical structures, these embodiments are not limited thereto, and certain embodiments may also be applicable to other uses. For example, the catheter may be suitable for delivery to different neuroanatomical structures, such as the subclavian artery, vertebral artery, carotid vessels, and to coronary anatomical structures or peripheral vascular anatomical structures, just to name a few possible applications. Although the system described herein is described as being useful for treating a specific condition or lesion, the condition or lesion treated may vary and is not restrictive.

[0187] In various embodiments, description is made with reference to the accompanying drawings. However, a specific embodiment may be implemented without one or more of these specific details or in combination with other known methods and configurations. In the specification, many specific details, such as specific configurations, sizes and processes, are described to provide a thorough understanding of the embodiments. In other cases, known processes and manufacturing techniques are not particularly described in detail to avoid making the description unclear unnecessarily. Throughout the specification, references to "one embodiment", "an embodiment", "an implementation", "an implementation", etc. mean that the specific features, structures, configurations or characteristics described are included in at least one embodiment or implementation. Therefore, the phrases "one embodiment", "an embodiment", "an implementation", "an implementation", etc. that appear throughout the specification do not necessarily refer to the same embodiment or implementation. In addition, specific features, structures, configurations or characteristics may be combined in any suitable manner in one or more embodiments.

[0188] The use of relative terms throughout the specification may indicate a relative position or direction. For example, "distal" may indicate a first direction away from a reference point. Similarly, "proximal" may indicate a position in a second direction opposite to the first direction. The reference point used herein may be an operator or an insertion site, so that the terms "proximal" and "distal" refer to the operator or insertion site using the device. The area of ​​the device closer to the operator or the insertion site may be described as "proximal" in this article, while the area of ​​the device farther from the operator or the insertion site may be described as "distal" in this article. Similarly, the terms "proximal" and "distal" may 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. In this way, the proximal position may refer to a position in the patient's body that is closer to the entry point of the device along the insertion path toward the target, while the distal position may refer to a position in the patient's body that is farther away from the entry point of the device along the insertion path toward the target position. However, these terms are provided to establish a relative reference system and are not intended to limit the use or orientation of the catheter and / or delivery system to the specific configurations described in various embodiments.

[0189] Although this specification contains many details, these details should not be interpreted as limitations on the scope of protection or the scope that can be claimed, but rather as descriptions of specific features of specific embodiments. Specific features described in the context of separate embodiments in this specification may also be implemented in combination in a single embodiment. On the contrary, the various features described in the context of a single embodiment may also be implemented in multiple embodiments, respectively, or in any suitable sub-combination. In addition, although the features may be described as working in a specific combination, even initially claimed, in some cases, one or more features in the claimed combination may be removed from the combination, and the claimed combination may be directed to a sub-combination or a variation of the sub-combination. Similarly, although operations are depicted in a specific order in the drawings, this should not be understood as requiring the operations to be performed in the specific order shown or in a continuous order, or performing all operations shown to obtain the desired result. Only a few examples and implementations are disclosed. The described examples and implementations and other implementations may be changed, improved, and enhanced based on the disclosed content.

[0190] In the above description and claims, phrases such as "at least one" or "one or more" may appear, followed by a list of combinations of elements or features. The term "and / or" may also appear in a list of two or more elements or features. Unless the context in which it is used implies or is clearly contradictory to it, the phrase is intended to mean any element or feature listed individually, or a combination of any referenced element or feature with any other referenced element or feature. For example, the phrases "at least one of A and B", "one or more of A and B", "A and / or B" are intended to mean "A alone, B alone, or A and B together", respectively. Similar interpretations apply to lists including 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 intended to mean "A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together".

[0191] Use of the term "based on" above and in the claims is intended to mean "based, at least in part, on," such that non-recited features or elements are also allowable.

Claims

1. A robotic surgical system for treating a patient's neurovascular system, the system comprising: A guide sheath, the guide sheath comprising: a sheath body having at least one lumen extending between a proximal region and a distal region defining a distal opening from the at least one lumen; and a hub coupled to the proximal region of the sheath body; A catheter system, the catheter system comprising: a support catheter including a distal lumen portion having an outer diameter sized to be positioned within at least one lumen of the introducer sheath, the distal lumen portion coupled at a proximal region to a proximal control element adjacent a proximal opening of a single lumen from the distal lumen portion; and a navigation catheter having a guidewire lumen, a distal end region tapering from an outer diameter sized to fill a single lumen of the support catheter to a distal-most end defining an opening from the guidewire lumen, and a proximal extension; and A robotic drive system, the robotic drive system being configured to drive the catheter system within a blood vessel of a patient, the robotic drive system comprising: a cassette having at least a first set of rollers configured to engage the proximal control element of the support catheter and at least a second set of rollers configured to engage the proximal extension of the navigation catheter, the second set of rollers being located proximal to the first set of rollers; and A controller is operatively coupled to the cassette, the controller being configured to control the first and second sets of rollers to determine an amount of linear translation of the support catheter and an amount of linear translation of the navigation catheter.

2. The system of claim 1 , further comprising a guidewire and a third set of rollers located proximal to the second set of rollers, the third set of rollers being configured to engage the guidewire, the spacing of the third set of rollers being designed to allow the navigation catheter to move through a full range of motion through the second set of rollers.

3. A system according to claim 1 or claim 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 any one of claims 1 to 3, wherein: The proximal extension of the navigation catheter is a polymer-coated rigid component.

5. The system according to any one of claims 1 to 4, wherein: At least one of the first set of rollers and the second set of rollers is configured to accommodate different outer diameters.

6. The system according to any one of claims 1 to 5, 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 any one of claims 1 to 6, wherein: The first group of rollers is located proximal to the working lumen of the guide sheath and offset from the axis of the working lumen of the guide sheath.

8. The system of any one of claims 1-7, further comprising a suction system operatively connected to the controller.

9. The system according to claim 8, wherein: The suction system is configured to apply static suction or periodic suction.

10. The system according to claim 9, wherein: Periodic suction is applied using a spring-operated pressure relief valve or a solenoid valve.

11. The system according to claim 9, wherein: The suction system is actuated manually or by software running on the controller.

12. The system according to any one of claims 1 to 11, wherein: The introducer sheath is coupled to the robotic drive system by securing the hub to the cartridge via at least one connector and / or a cavity within the cartridge.

13. The system according to claim 12, wherein: The at least one connector is configured to rotate the introducer sheath about a longitudinal axis of the sheath body.

14. The system according to any one of claims 1 to 13, wherein: At least one of the first set of rollers and the second set of rollers is configured to vary the amount of linear translation, the angle, or both.

15. The system according to any one of claims 1 to 14, wherein: The first set of rollers and the second set of rollers are configured to be driven in unison.

16. The system of claim 15, wherein: The first set of rollers and the second set of rollers are driven in unison due to a mechanical linkage.

17. The system of any one of claims 1-16, further comprising one or more markings on the supporting catheter.

18. The system of claim 17, further comprising one or more markings on the navigation catheter.

19. The system of claim 18, wherein: The controller is programmed to detect one or more markers on the support catheter and one or more markers on the navigation catheter to assess the extension of the support catheter relative to the navigation catheter.

20. The system of claim 18, wherein: The controller is programmed to detect one or more markers on the support catheter and one or more markers on the navigation catheter to assess a total advancement distance.

21. The system of claim 8, further comprising one or more flow sensors and one or more pressure sensors.

22. The system of any one of claims 1-21, further comprising an oscillating input configured to cause the support catheter to follow one or more retraction and one or more advancement patterns.

23. The system of claim 22, wherein: The oscillation input can be programmed by the user.

24. The system of claim 22, wherein: The oscillation input initiates a mode of short retraction of the support catheter and advancement of the support catheter, wherein the short retraction of the support catheter withdraws 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 the advancement of the support catheter advances the distal opening from the second position to the first position.

25. The system of claim 24, wherein: The mode begins after a period of static suction through the support catheter.

26. A method for performing robotic surgery on a patient in the neurovasculature, the method comprising: coupling the catheter system to a robotic drive system operatively coupled to a controller operable by operator input, the robotic drive system having a plurality of rollers movable in response to the operator input, the catheter system comprising: A supporting conduit, the supporting conduit comprising: a distal lumen portion having a distal opening and a proximal opening with a single lumen extending between the proximal opening and the distal opening; and a proximal control element having no lumen, the proximal control element being coupled to the distal lumen portion proximate the proximal opening; and A navigation catheter, the navigation catheter comprising: Guidewire lumen; sized to fill an outer diameter of a single lumen of the support catheter; the distal terminal region; and proximal extension, wherein the navigation catheter is axially positionable through a single lumen of the support catheter such that the distal end region of the navigation catheter is extendable from a distal opening of the distal lumen portion of the support catheter, and wherein the support catheter that enables the navigation catheter to be positioned within the single lumen can navigate to a blood vessel distal to the petrous portion of the internal carotid artery; coupling the proximal control element of the support catheter to a first set of rollers of the plurality of rollers; coupling the proximal extension of the navigation catheter to a second set of rollers of the plurality of rollers, the second set of rollers being located proximal to the first set of rollers; and The first and second sets of navigational wheels are moved in at least one degree of freedom in response to operator input.

27. A robotically controlled surgical system for removing a clot from a patient, the system comprising: A guide sheath having at least one working lumen; a catheter system comprising a catheter including a distal lumen portion having an outer diameter sized to be positioned within the working lumen, the distal lumen portion coupled at a proximal region to a proximal control element adjacent a proximal opening of a single lumen from the distal lumen portion; wherein the introducer sheath is operatively coupled to an aspiration system for performing an aspiration function on the clot through a continuous lumen formed by a working lumen of the introducer sheath and a single lumen of the catheter; An instrument drive system for driving the catheter system, wherein the instrument drive system includes a first instrument drive for driving the catheter and a second instrument drive for driving the interventional device; and a remote control station for controlling the instrument drive system and the suction system.

28. A robotic catheter system, comprising: a controller including a primary input device configured to be operated by a physician located remotely from the patient; an instrument driver in communication with the controller, the instrument driver comprising a housing having a catheter interface movable relative to the housing, the catheter interface comprising a plurality of catheter drive elements coupled to respective motors within the housing, the motors responsive to control signals generated at least in part by movement of the master input device for actuating movement of the catheter drive elements and the catheter interface relative to the housing; as well as A catheter having a proximal ribbon coupled to a distal lumen portion having a single working lumen, the proximal ribbon operatively coupled to the catheter hub, the catheter being axially movable relative to a guide sheath such that movement of the catheter can be controlled by the master input device.

Images