System and method for performing robotic and manual vascular surgery

Abstract

A system for performing vascular surgery includes a robotic drive system and one or more hub assemblies operably connected to the robotic drive system, each of the one or more hub assemblies including a mount, a hub removably connected to the mount, and an interventional device connected to the hub. For each of the one or more hub assemblies, the mount is configured to be driven by a robotic drive system into a patient's vasculature, the hub is configured to be disengaged from the mount when the interventional device is located within the patient's vasculature, and the hub is configured to be disengaged from the mount when the interventional device is located within the patient's vasculature. And the hub is configured such that when the hub is detached from the mount, the hub is manually manipulated to navigate the interventional device to a vascular position.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] Any and all applications for which foreign and domestic priority claims are identified in the Application Data Sheet filed with this application are hereby incorporated by reference pursuant to 37 CFR § 1.57. This application claims priority to U.S. Provisional Patent Application No. 63 / 434,040, filed December 20, 2022, entitled “METHOD OF PERFORMING A ROBOTIC AND MANUAL NEUROVASCULAR PROCEDURE,” the entire contents of which are incorporated herein by reference for all purposes and made a part of this specification. Background Art Technical Field

[0003] The present application relates to vascular surgery, and more particularly, to systems and methods for performing robotic and manual vascular surgery.

[0004] Description of Related Technology

[0005] A variety of neurovascular procedures can be performed via transvascular access, including thrombectomy, diagnostic angiography, embolic coil deployment, and stent placement. However, the delivery of neurovascular care is limited or delayed by multiple challenges. For example, there are not enough trained interventionalists and medical centers to meet the current demand for neurointerventions. Neurointerventions are difficult and place complex demands on the surgeon's dexterity. The surgeon must use both hands to precisely control three to four coaxial catheters while managing the fluoroscopy system and patient positioning.

[0006] Long, tortuous anatomies require delicate, accurate manipulation. Inadvertent catheter movement can occur due to the storage and release of energy caused by frictional interaction between the concentric shaft and the patient's vasculature. Achieving aortic arch access, necessary to reach the neurovasculature, is challenging, particularly for a Type III arch. Once aortic arch access is achieved, adapting the system for neurovascular treatment is time consuming and requires removal of the guidewire and access catheter and adding the surgical catheter (and possibly one or more additional catheters) to the stack.

[0007] Therefore, there remains a need for an aortic arch access and neurovascular site access system that addresses some or all of these challenges and increases the availability of neurovascular procedures. Preferably, the system is additionally capable of driving devices more distally through aortic arch access to perform procedures in intracranial vessels. Summary of the Invention

[0008] The present invention provides a method for performing neurovascular surgery. The method includes providing a multi-catheter assembly comprising a first subset of interventional devices and a second subset of interventional devices detachably connectable to the first subset of interventional devices, connecting the first subset of interventional devices to a robotic drive system, and robotically driving the multi-catheter assembly to achieve aortic arch access when the second subset of interventional devices is connected to the first subset of interventional devices. The method also includes detaching the second subset of interventional devices from the first subset of interventional devices, manually driving the second subset of interventional devices to a neurovascular site, and performing the neurovascular surgery using the second subset of interventional devices.

[0009] The first subset of interventional devices may include an access catheter. Connecting the first subset of interventional devices to the drive system may include magnetically connecting the access catheter hub to a first drive magnet. The first subset of interventional devices may include a guidewire. The second subset of interventional devices may include a surgical catheter and a guide catheter. The neurovascular procedure may include a neurovascular thrombectomy procedure. The surgical catheter may be detachably connected to the access catheter or the access catheter hub via a Luer lock or a hemostatic valve. Detaching the second subset of interventional devices from the first subset of interventional devices may include detaching the surgical catheter from the access catheter or the access catheter hub. The guide catheter may be detachably connected to the surgical catheter via a Luer lock or a hemostatic valve. The method may include detaching the surgical catheter from the guide catheter. The method may include proximally removing the access catheter before performing the neurovascular procedure using the surgical catheter. The second subset of interventional devices may include a guidewire. The surgical catheter may be an aspiration catheter. The surgical catheter may be an embolization deployment catheter. The surgical catheter may be a stent deployment catheter. The surgical catheter may be a shunt deployment catheter. The surgical catheter may be a diagnostic angiography catheter. The surgical catheter may be a stent retriever catheter. The surgical catheter may be a clot retriever. The surgical catheter may be a balloon catheter. The surgical catheter may be a catheter that facilitates percutaneous valve repair or replacement. The surgical catheter may be an ablation catheter.

[0010] A system for performing vascular surgery is also provided. The system includes a robotic drive system and one or more hub assemblies. The one or more hub assemblies are operably connected to the robotic drive system. Each of the one or more hub assemblies includes a mounting member, a hub, and an interventional device. The hub is removably connected to the mounting member. The interventional device is connected to the hub. For each of the one or more hub assemblies, the mounting member is configured to be driven by the robotic drive system to drive the interventional device into the patient's vascular system. For each of the one or more hub assemblies, the hub is configured to be separated from the mounting member when the interventional device is located in the patient's vascular system. For each of the one or more hub assemblies, the hub is configured to be manually operated to navigate the interventional device to a vascular location when the hub is separated from the mounting member.

[0011] The robotic drive system may further include a drive platform and one or more hub adapters that move axially on the drive platform. Each of the one or more hub assemblies may be positioned to move axially along the drive platform and may be magnetically connected to the corresponding one or more hub adapters. The mounting members of the one or more hub assemblies may be configured to magnetically connect to a corresponding one of the one or more hub adapters. The interventional devices of at least one or more hub assemblies may be configured to perform vascular surgery. The vascular surgery may include neurovascular thrombectomy. The one or more hub assemblies may include a first hub assembly, a second hub assembly, a third hub assembly, and a fourth hub assembly. The interventional devices of the one or more hub assemblies may be coaxially nested. The one or more hub assemblies may include one or more access catheter hub assemblies with access catheters, guidewire hub assemblies with guidewires, surgical catheter hub assemblies with surgical catheters, and guide hub assemblies with guide catheters. At least one of the one or more hub assemblies may be configured to accept additional interventional devices therethrough.

[0012] A method for performing vascular surgery is also provided. The method includes connecting a plurality of hub assemblies to a robotic drive system, the plurality of hub assemblies including a first hub assembly and a second hub assembly, the first hub assembly including a first mounting member, a first hub removably connected to the first mounting member and a first interventional device connected to the first hub, and a second hub assembly including a second mounting member, a second hub removably connected to the second mounting member and a second interventional device connected to the second hub. The method includes robotically driving the first hub assembly and the second hub assembly to drive the first interventional device and the second interventional device into the patient's vascular system, and when the second interventional device is located in the patient's vascular system, detaching the second mounting member from the second hub.

[0013] Robotically driving the first and second hub assemblies to drive the first and second interventional devices into the patient's vascular system may include driving the first and second interventional devices to achieve aortic arch access. The method may further include manually driving the second hub to drive the second interventional device to the vascular location while the second hub is detached from the second mounting member. The method may further include inserting a third interventional device through the lumen of the second interventional device and manually driving the third interventional device into the patient's vascular system. The method may further include using the third interventional device to perform a vascular procedure. The vascular procedure may be a neurovascular thrombectomy procedure. The third interventional device may be a stent retriever or a stent retriever catheter. The first interventional device may be a guide catheter, and the second interventional device may be configured to extend a surgical catheter within the lumen of a surgical catheter. While the surgical catheter is within the lumen of the guide catheter and while the first hub is connected to the first mounting member, the second hub may be detached from the second mounting member. Connecting the plurality of hub assemblies to the robotic drive system may include magnetically connecting the first mounting member to the first hub adapter through a sterile barrier and magnetically connecting the second hub adapter to the second mounting member through the sterile barrier. The first interventional device may be a surgical catheter and the second interventional device may be a guide catheter, wherein the surgical catheter may be positioned within a lumen of the guide catheter when the first hub assembly and the second hub assembly are actuated, wherein the method further comprises withdrawing the surgical catheter from the lumen of the guide catheter before the second hub is separated from the second mounting member. The method may further comprise inserting a third interventional device through the lumen of the guide catheter while the second hub is separated from the first hub and manually actuating the third interventional device into the patient's vascular system.

[0014] A system for performing vascular surgery includes a robotic drive system and a multi-catheter assembly. The multi-catheter assembly includes a first subset of interventional devices and a second subset of interventional devices. The first subset of interventional devices is connected to the robotic drive system and the second subset of interventional devices is removably connected to the first subset of interventional devices. The multi-catheter assembly is configured to be driven by the robotic drive system to drive the interventional devices into the patient's vascular system when the second subset of interventional devices is connected to the first subset of interventional devices. The second subset of interventional devices is configured to be manually driven to a vascular location when the second subset of interventional devices is separated from the first subset of interventional devices.

[0015] The second subset of interventional devices can be configured to perform vascular surgery. The vascular surgery may include neurovascular thrombectomy. The first subset of interventional devices can be coaxially nested with the second subset of interventional devices. The first subset of interventional devices can include an access catheter and a guidewire. The second subset of interventional devices can include a surgical catheter and a guide catheter. The guide catheter or guide catheter hub can be detachably connected to the surgical catheter by a Luer lock or a hemostatic valve. The second subset of interventional devices can be separated from the first subset of interventional devices by separating the surgical catheter from the guide catheter or the guide catheter hub. The guide catheter can be removably separated from the surgical catheter by a Luer lock or a hemostatic valve. The surgical catheter can be an aspiration catheter. The surgical catheter can be an embolization deployment catheter. The surgical catheter can be a stent deployment catheter, a shunt deployment catheter, a stent retriever catheter, a clot retriever, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, an ablation catheter and / or a coil delivery catheter. The first subset of interventional devices can be magnetically connected to the drive system.

[0016] A method for performing vascular surgery is also provided. The method includes providing a multi-catheter assembly, connecting a first subset of interventional devices to a robotic drive system; robotically driving the multi-catheter assembly to achieve aortic arch access while a second subset of interventional devices is connected to the first subset of interventional devices; detaching the second subset of interventional devices from the first subset of interventional devices; manually driving the second subset of interventional devices to a surgical site; and performing the vascular surgery using the second subset of interventional devices. The multi-catheter assembly includes a first subset of interventional devices and a second subset of interventional devices. The second subset of interventional devices is removably connected to the first subset of interventional devices.

[0017] The first subset of interventional devices may include an access catheter. Connecting the first subset of interventional devices to the drive system may include magnetically connecting the access catheter hub to a first drive magnet. The first subset of interventional devices may include a guidewire. The second subset of interventional devices may include a surgical catheter and a guide catheter. The vascular procedure may include a neurovascular thrombectomy procedure. The surgical catheter may be removably connected to the access catheter or the access catheter hub via a Luer lock or a hemostatic valve. Detaching the second subset of interventional devices from the first subset of interventional devices may include detaching the surgical catheter from the access catheter or the access catheter hub. The guide catheter may be removably connected to the surgical catheter via a Luer lock or a hemostatic valve. The method may include proximally removing the access catheter prior to performing the neurovascular procedure using the surgical catheter. The second subset of interventional devices may include a guidewire. The surgical catheter may be an aspiration catheter, an embolization deployment catheter, a stent deployment catheter, a shunt deployment catheter, a diagnostic angiography catheter, a stent retriever catheter, a clot retriever, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, an ablation catheter, and / or a coil delivery catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1is a schematic perspective view of an interventional setup with an imaging system, a patient support table and a robotic drive system according to the present invention.

[0019] Figure 2 is a longitudinal cross section showing the concentric relationship between a guidewire with two degrees of freedom, an access catheter with three degrees of freedom, and a guiding catheter with one degree of freedom.

[0020] Figure 3A Schematic diagram of an exploded view of the interventional device hub separated from the support platform by a sterile barrier.

[0021] Figures 3B to 3F An alternative sterile barrier is shown in the form of a transport tray having one or more storage channels for carrying interventional devices.

[0022] Figures 3G to 3K An embodiment of an alternative sterile barrier having a raised drive surface is shown.

[0023] Figure 3L and Figure 3M Describes the Figures 3G to 3K Example of a hub used with a sterile barrier.

[0024] Figure 4 is a schematic elevational cross section through a hub adapter with a driving magnet separated from an interventional device hub and a driven magnet by a sterile barrier.

[0025] Figure 5A and Figure 5B A three- and four-interventional device assembly is schematically shown.

[0026] Figure 6 is a perspective view of the support table.

[0027] Figure 7 Here is a close-up view of the engine drive end of the support table.

[0028] Figure 8 is an elevation cross section through the engine and belt drive assembly.

[0029] Figure 9 It is a close-up view of the pulley end of the support table.

[0030] Figure 10 It is a vertical cross section through the pulley.

[0031] Figure 11 is throughout, for example Figure 5A and Figure 5B Elevated cross-sections of the distal portions of those catheters shown in .

[0032] Figure 12A and Figure 12B A force sensor integrated into the side wall of a catheter is schematically shown.

[0033] Figure 13A and Figure 13B A sensor for measuring the spring force of the magnetic connection between the hub and the corresponding trolley is schematically shown.

[0034] Figure 14 A dual encoder torque sensor for use with the catheter of the present disclosure is schematically shown.

[0035] Figure 15 A clot capture and visualization device is shown that may be integrated into the hub and / or connected to the aspiration line.

[0036] 16A to 16C Exemplary control mechanisms for steering interventional devices driven by respective hubs are shown.

[0037] Figure 17 Shown is a schematic side elevation view of an interventional device assembly for use in aortic arch access and neurointerventional procedures.

[0038] 18A to 18E Depicted is an example sequence of steps for introducing a catheter assembly configured to achieve aortic arch access and neurovascular site access.

[0039] Figure 19 An embodiment of a mechanical coupling between a driver component and a driven machine component is schematically shown.

[0040] 20A to 20C An example sequence of steps for priming a catheter assembly in a stacked configuration is depicted.

[0041] Figures 21A to 21B An example sequence of steps for priming a catheter assembly in a stacked configuration is depicted.

[0042] Figure 22 Describes the use Figures 21A to 21B An example test system for the priming process depicted in FIG.

[0043] Figure 23A An example of a catheter assembly is shown.

[0044] Figure 23B An example of a catheter assembly after a priming procedure is shown.

[0045] Figure 23C An example of a catheter assembly is shown after a priming procedure involving relative movement between adjacent catheters.

[0046] Figures 23D to 23F Shown Figures 23A to 23C Example catheter assembly.

[0047] Figure 24 Depicted is a schematic diagram of the control system.

[0048] Figure 25 Depicted is a side view of an interventional device assembly for aortic arch access and neurovascular procedures.

[0049] Figure 26A A perspective view of the hybrid system is shown.

[0050] Figure 26B A perspective view of the hybrid system is shown. DETAILED DESCRIPTION

[0051] In certain embodiments, a system is provided for advancing aortic arch access by advancing a guide catheter from the femoral or radial artery into the ostium of one of the great vessels at the top of the aortic arch. The surgeon can then take the interventional device via the robotically placed guide catheter and advance it into the cerebral vasculature.

[0052] In some embodiments, the system can additionally be configured to robotically gain intracranial vascular access and perform aspiration thrombectomy or other neurovascular procedures.

[0053] The drive platform can be located above or to the side of the patient and is configured to axially advance, retract, and in some cases rotate and / or laterally deflect two or three or more different (e.g., concentrically or side-by-side oriented) intravascular devices. The hub can move along a path along the surface of the drive platform to advance or retract the interventional device as needed. Each hub can also contain a mechanism to rotate or deflect the device as desired and be connected to a fluid delivery tube (not shown) of the type conventionally attached to a catheter hub. Each hub can be in electrical communication with an electronic control system via a hardwired connection, an RF wireless connection, or a combination of both.

[0054] Each hub is independently movable across the surface of a sterile field barrier membrane carried by a drive table. Each hub is releasably magnetically connected to a unique drive trolley on the table side of the sterile field barrier. The drive system independently moves each hub proximally or distally across the barrier surface to move the corresponding interventional device proximally or distally within the patient's vasculature.

[0055] The pulley on the drive stage that is magnetically connected to the hub to provide linear motion actuation is universal. The catheter / guidewire functionality is provided based on what is included in the hub and shaft design. This allows the system to be flexibly configured to perform a wide range of surgeries using a variety of interventional devices on the same drive stage. In addition, the interventional devices and methods disclosed herein can be easily adapted for use with a variety of other drive systems (e.g., any of a variety of robotic surgical drive systems).

[0056] Figure 1 is a schematic perspective view of an interventional device 10 having a patient support table 12 for supporting a patient 14. An imaging system 16 may be provided along with a robotic interventional device drive system 18 according to the present disclosure.

[0057] The drive system 18 may include a support platform 20 for supporting, for example, a guidewire hub 26, an access catheter hub 28, and a guide catheter hub 30. In the context of this document, the term "access" catheter may be any catheter having a lumen with at least one distal or laterally facing distal opening that can be used to aspirate thrombus, provide a passage for additional devices to be advanced therethrough or along, or infuse saline or contrast or therapeutic agents.

[0058] Depending on the desired clinical procedure, more or fewer interventional device hubs may be provided. For example, in certain embodiments, a diagnostic angiography procedure may be performed using only the guidewire hub 26 and access catheter hub 28 for driving a guidewire and an access catheter (in the form of a diagnostic angiography catheter). A plurality of interventional devices 22 extend between the support table 20 and a femoral access point 24 on the patient 14 (in the example shown). Depending on the desired procedure, access may be achieved by percutaneous or open access into any of a variety of arteries or veins, such as the femoral artery or radial artery. Although disclosed herein primarily in the context of neurovascular access and surgery, the robotic drive system and associated interventional devices can be readily configured for a wide variety of additional medical interventions in the peripheral and coronary arterial and venous vascular systems, the gastrointestinal system, the lymphatic system, cerebrospinal fluid cavities or spaces (e.g., the spinal canal, ventricles, and subarachnoid space), the pulmonary airways, treatment sites reached via transureteral or urethral or fallopian tube navigation, or other hollow organs or structures in the body (e.g., in intracardiac or structural heart applications, such as valve repair or replacement, or in any endovascular procedure).

[0059] A display 23 (e.g., for viewing fluoroscopic images, catheter data (e.g., fiber Bragg grating fiber sensor data or other force or shape sensing data), or other patient data) can be carried by the support table 20 and / or the patient support 12. Alternatively, the physician input / output interface including the display 23 can be remote from the patient, such as behind radiation shielding, in a different room from the patient, or in a different facility from the patient.

[0060] In the example shown, a guidewire hub 26 is carried by the support table 20 and is movable along the table to advance a guidewire into and out of the patient 14. An access catheter hub 28 is also carried by the support table 20 and is movable along the table to advance an access catheter into and out of the patient 14. The access catheter hub can also be configured to rotate the access catheter in response to operation of a rotation control and can also be configured to laterally deflect a deflectable portion of the access catheter in response to operation of a deflection control.

[0061] Figure 2 is a longitudinal cross section schematically illustrating the kinematic relationship between a guidewire 27 having two degrees of freedom (axial and rotational), an access catheter 29 having three degrees of freedom (axial, rotational, and lateral deflection), and a guide catheter 31 having one degree of freedom (axial).

[0062] refer to Figure 3A The support platform 20 includes drive mechanism components, described in more detail below, to independently drive the guidewire hub 26, the access catheter hub 28, and the guide catheter hub 30. An anti-buckling feature 34 can be provided in the proximal anti-buckling region for resisting buckling of the portion of the interventional device that spans the distance between the support platform 20 and the femoral artery access point 24. The anti-buckling feature 34 can include a plurality of concentric, telescopically extending and collapsible tubes through which the interventional device extends.

[0063] Alternatively, the proximal section of one or more device shafts can be configured to have enhanced rigidity to reduce buckling during compression. For example, the proximal reinforced segment can extend from the hub to a distance of at least about 5 cm or 10 cm toward the distal end, but typically no more than about 120 cm or 100 cm, to support the device between the hub and the entry point 24 on the patient. Reinforcement can be achieved by using a metal or polymer tube or by embedding at least one or two or more axially extending elements into the wall of the device shaft, such as a long wire or ribbon. In some embodiments, the extension element can be hollow and prevent wear, buckling or damage at the input and output of the hub. In some embodiments, the hollow extension element can be a hollow and flexible covering layer attached to the hub. The hollow extension element (for example, a hollow and flexible covering layer) can cover a portion of the device shaft when passing through the hub. In some embodiments where the hollow extension element is a covering layer, a coating can be attached to a portion of the hub so that passing the catheter device through the hub 26, 28 or 30 also allows the catheter device to pass through the covering layer. In some embodiments, an anti-buckling device can be mounted on or around the device shaft to avoid misalignment or insertion angle errors between hubs or between the hub and the insertion point. The anti-buckling device can be a laser-cut hypotube, a spring, a telescoping tube, a split tube with tension, etc.

[0064] In some embodiments, multiple deflection sensors can be placed along the length of the catheter to identify buckling. Buckling can be identified by sensing that the hub is advanced distally without movement of the distal tip of the catheter or interventional device. In some embodiments, buckling can be detected by sensing that energy loading has occurred between the catheter shafts (e.g., due to friction).

[0065] Alternatively, a thin tubular reinforcement structure can be embedded in the device wall or continue on the outside of the device wall, such as a tubular polymer extrusion or a section of hypotube. Alternatively, a removable reinforcement mandrel can be placed in the lumen in the proximal section of the device and removed from the proximal end after the hub is advanced distally toward the patient access position to prevent buckling of the proximal shaft during distal advancement of the hub. Alternatively, the proximal section of one or more device shafts can be configured as a tubular hypotube, which can be machined (e.g., with a laser) so that its mechanical properties vary along its length. The proximal section can be formed of stainless steel, nitinol and / or cobalt-chromium alloy, optionally in combination with a polymer component that can provide lubricity and hydraulic sealing. In some embodiments, the proximal section can be formed of a polymer, such as polyetheretherketone (PEEK). Alternatively, the wall thickness or diameter of the interventional device can be increased in the anti-buckling region.

[0066] In certain embodiments, a device shaft having a high degree of stiffness (e.g., axial and torsional) can provide improved motion transfer from the proximal end of the device shaft to the distal end of the device shaft. For example, the device shaft can be more responsive to motion applied at the proximal end. Such an embodiment may be advantageous for robotic actuation without tactile feedback to the user.

[0067] In some embodiments, a flexible covering can be applied to the device shaft and / or hub to reduce friction between the device shaft and / or hub and the second device shaft as the second device shaft passes through the device shaft and / or hub and the second device shaft.

[0068] The interventional device hub can be separated from the support table 20 by a sterile barrier 32. The sterile barrier 32 may comprise a thin plastic film, such as polyethylene terephthalate (PET), polyethylene terephthalate glycol copolymer (PETG), polyethylene terephthalate glycol (PETE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), low-density polyethylene (LDPE), polypropylene (PP), polystyrene (PS) or styrene. This allows the support table 20 and the associated drive system to be located on the non-sterile (lower) side of the sterile barrier 32. The guidewire hub 26, entry catheter hub 28, guide catheter hub 30 and the associated interventional device are all on the sterile (upper) side of the sterile barrier 32. The sterile barrier is preferably waterproof and can also be used as a tray used in the packaging of the interventional device, which will be discussed further below. The interventional device can be provided separately or as a coaxial preassembled kit that is transported and stored in a tray and packaged in sterile packaging.

[0069] Figures 3B to 3F Schematically illustrated is an optional sterile barrier and a transport tray, which serves as a dual-function sterile barrier placed on a support table during an interventional procedure. The transport tray has one or more storage channels for carrying sterile interventional devices. The sterile barrier can also serve as a sterile work surface for preparing catheters or other devices during the procedure.

[0070] refer to Figure 3B and Figure 3C , a sterile barrier 32 in the form of a pre-formed tray is shown for mounting the elongated support table 20. In use, the elongated support table 20 will be positioned below the sterile barrier 32. The sterile barrier 32 extends between a proximal end 100 and a distal end 102 and includes an upper support surface 104 for supporting an interventional device hub. In one embodiment, in a linear drive configuration, the support surface 104 has an axial length that is greater than the length of the intended interventional device.

[0071] The length of the support surface 104 will typically be at least about 100 centimeters, and in the range of about 100 centimeters to about 2.7 meters. Shorter lengths may be used in systems configured to propel a drive connector along an arcuate path. In some embodiments, two or more support surfaces may be used instead of a single support surface 104. The two or more support surfaces may have a combined length of 100 centimeters to about 2.7 meters. The width of the linear drive table is preferably no more than about 30 centimeters to about 80 centimeters.

[0072] At least a first channel 106 may be provided that extends axially for at least a portion of the length of the support platform 20. In the embodiment shown, the first channel 106 extends the entire length of the support platform 20. Preferably, the first channel 106 has sufficient length to accommodate the interventional device and has sufficient width and depth to accommodate the corresponding hub (e.g., by providing lateral support to prevent the hub from moving out when force is applied to the hub). The first channel 106 is defined within the base 108, the outer side wall 110, and the inner side wall 111 to form an upward-facing concave shape. Optionally, a second channel 112 may be provided. The second channel 112 may be located on the same side of the upper support surface 104 or on the opposite side as the first channel 106. Two or three or more additional recesses (e.g., additional channels or holes) may be provided to accommodate additional medical devices or supplies useful during the interventional procedure, as well as to collect fluids and serve as a wash basin for catheters and related equipment.

[0073] refer to Figure 3D , guide catheter hub 30 is shown positioned on upper support surface 104 and magnetically connected to a corresponding connector housing a drive magnet, which connector is positioned below sterile barrier 32. Access catheter hub 28 and access catheter 29, as well as guidewire hub 26 and guidewire 27 are shown positioned within first channel 106, e.g., prior to introduction through guide catheter 31 or after removal from guide catheter 31.

[0074] The interventional devices can be located within the channel 106 and enclosed within the sterile barrier for transport. At the clinical location, the upper panel of the sterile barrier can be removed, or the tubular sterile barrier packaging can be opened and axially removed from the support table 20 and sterile barrier assembly 32, exposing the sterile top side of the sterile barrier tray and any included interventional devices. The interventional devices can be carried individually in the channel or preassembled into an access assembly or surgical assembly, which will be discussed in additional detail below.

[0075] Figures 3D to 3F A support table is shown with a sterile barrier in place and Figure 3EIn the present invention, the interventional device is configured in the entry assembly for entering the aortic arch after the entry assembly is connected to the corresponding pulley below the sterile barrier. The entry assembly can be preassembled, wherein the guide wire is fully advanced through the entry catheter, and the entry catheter is fully advanced through the guiding catheter in turn. In the entry catheter or other conduits are preformed (i.e., pre-bent or not straight) embodiments, the guide wire and / or outer conduit can be positioned so that the relatively hard part does not overlap with the harder part of the bend of the preformed conduit, for example, to avoid creep or straightening of the preformed conduit and / or to introduce the bend into other straight conduits. The entry assembly can be lifted out of channel 106 and positioned on support surface 104, for being connected to corresponding drive magnets and being introduced into the patient's body. The guiding catheter hub 30 is the most distal hub. The entry catheter hub 28 is located at the proximal end of the guiding catheter hub so that the entry catheter 29 can extend distally by the guiding catheter. The guide wire hub 26 is located at the most proximal end so as to allow the guide wire 27 to advance through the entry catheter 29 and the guiding catheter 31.

[0076] Figure 3F The surgical assembly is shown after being introduced through a guide catheter 31 for achieving aortic arch access. In this embodiment, the guide catheter 31 is retained at the distal-most end of the interventional device. A first surgical catheter 120 and a corresponding hub 122 are shown extending through the guide catheter 31. An optional second surgical catheter 124 and a corresponding hub 126 are shown extending through the first surgical catheter 120. A guidewire 27 extends through at least a portion of the second surgical catheter 124 in a rapid exchange version thereof, or through the entire length of the second surgical catheter 124 in an over-the-wire embodiment.

[0077] If combined Figure 17 Discussed in more detail, multiple catheter stacks can be utilized to achieve access and endovascular procedures without the need to change catheters. This can be accomplished in manual or robotically driven surgery. In one example, the guide catheter 31 can include a catheter having an inner diameter of at least about 0.08 inches, and in one embodiment, an inner diameter of about 0.088 inches. The first surgical catheter 120 can include a catheter having an inner diameter of about 0.065 inches to about 0.075 inches, and in one embodiment, the first surgical catheter 120 has an inner diameter of about 0.071 inches. The second surgical catheter 124 can be an access catheter having an OD size that allows advancement through the first surgical catheter 120. The second surgical catheter can be steerable having a deflection control 2908 configured to laterally deflect the distal end of the catheter. The second surgical (access) catheter can also have a lumen sized to allow a guidewire of appropriate size to remain inside the second surgical catheter while angiographic injection is performed through the second surgical catheter.

[0078] In certain embodiments, catheter 31 can be a "large bore" access or guide catheter having a diameter of at least about 0.075 inches or at least about 0.080 inches. Catheter 120 can be an aspiration catheter having a diameter of about 0.060 to about 0.075 inches. Catheter 124 can be a steerable catheter having a deflectable distal tip having a diameter of about 0.025 inches to about 0.050 inches. Guidewire 27 can have a diameter of about 0.014 to about 0.020 inches. In one example, catheter 31 can have a diameter of about 0.088 inches, catheter 120 can have a diameter of about 0.071 inches, catheter 124 can have a diameter of about 0.035 inches, and guidewire 27 can have a diameter of about 0.018 inches.

[0079] In one commercial implementation, a preassembled access assembly (a guide catheter, an access catheter, and a guidewire) can be carried in a first channel on a sterile barrier tray, and a preassembled surgical assembly (one or two surgical catheters and a guidewire) can be carried in the same or a different second channel on the sterile barrier tray. One or two or more additional catheters or interventional tools can also be provided, depending on potential needs during the interventional procedure.

[0080] Figures 3G to 3K An embodiment of an alternative sterile barrier having a convex driving surface (eg, a convex, crowned road-like driving surface) is shown. Figure 3G 2 is a cross-sectional view of sterile barrier 232. Sterile barrier 232 includes a raised upper support surface 204. Fluid channels 205 and 207 are located laterally and below support surface 204 for automatically clearing or draining fluid from support surface 204 (e.g., during an interventional procedure). Fluid channels 205 and 207 can extend axially for at least a portion of the length of the sterile barrier.

[0081] Figure 3I 、 Figure 3J and Figure 3K A perspective cross-sectional view, a cross-sectional view, and a top cross-sectional view of the proximal end of the sterile barrier 232 are shown, respectively. Figures 3I to 3KAs shown, the sterile barrier 232 can include a groove 240 in communication with the fluid channels 205 and 207. The groove 240 can receive fluid from the channels 205 and 207 (e.g., during an interventional procedure). The groove 240 can be at least partially located below the fluid channels 205 and 207 so that the fluid in the channels 205 and 207 flows into the groove 240. In some embodiments, the fluid channels 205 and 207 can be angled relative to the horizontal plane (e.g., can descend from the end of the channel farthest from the groove 240 to the groove 240) so that the fluid in the channels 205 and 207 is directed to the groove 240. For example, the depth of the channels 205 and 207 can increase from the end of the channel farthest from the groove 240 to the groove 240. Alternatively, during a portion or all of the interventional procedure, sterile barrier 232 and / or the support table can be positioned at an angle relative to the horizontal plane such that the ends of channels 205 and 207 furthest from slot 240 are positioned above slot 240. For example, sterile barrier 232 and / or the support table can be constructed or arranged at an angle such that the ends of sterile barrier 232 and / or the support table opposite slot 240 are positioned above slot 240. Alternatively or additionally, the drive mechanism can temporarily tilt sterile barrier 232 and / or the support table such that the ends of sterile barrier 232 and / or the support table opposite slot 240 are positioned above slot 240 (e.g., by raising the ends of sterile barrier 232 and / or the support table opposite slot 240 or lowering the ends of sterile barrier 232 and / or the support table at slot 240), thereby allowing fluid within channels 205 and 207 to flow into slot 240.

[0082] The tank 240 may include a drain hole 242. The tank 240 may be shaped, sized, and / or configured in other ways as desired so that the fluid in the tank 240 drains into the drain hole 242. The drain hole 242 may include a pipe, a barbed fitting, and / or an on-off valve for removing the fluid from the tank 240. Figures 3I to 3K As shown, the trough 240 can be located at the proximal end of the sterile barrier 232. In an alternative embodiment, the trough 240 can be located at the distal end of the sterile barrier 232. In some embodiments, the sterile barrier 232 can include a first trough 240 at the proximal end and a second trough 240 at the distal end. In some embodiments, the trough 240 can also serve as a wash basin.

[0083] The first channel 206 can extend axially for at least a portion of the length of the sterile barrier 232. The channel 206 can have sufficient length to accommodate the interventional device and sufficient width and depth to accommodate the corresponding hub (e.g., by providing support to prevent the hub from being dislodged when force is applied to the hub). Optionally, a second channel 212 can be provided. The second channel 212 can be located on the same side of the upper support surface 204 as the first channel 206 or on the opposite side. Figure 3GChannel 212 is shown on the opposite side of support surface 204 from channel 206 . Figure 3H is a cross-sectional view illustrating an alternative embodiment of sterile barrier 232 in which channel 212 is on the same side of support surface 204 as channel 206 .

[0084] like Figure 3G and Figure 3H As shown, channels 206 and 212 can have generally triangular, wedge-shaped or other angled cross-sections to accommodate the hub at an angle relative to the horizontal plane. Accommodating the hub at an angle relative to the horizontal plane can allow for a smaller width of the sterile barrier 232.

[0085] Two or three or more additional recesses (eg, additional channels or holes) may be provided to accommodate additional medical devices or supplies that may be useful during the interventional procedure, as well as to collect fluids and serve as wash basins for catheters and related equipment.

[0086] In some embodiments, the sterile barrier 232 can include one or more structural ribs 236. The sterile barrier 232 can also include one or more frame support protrusions 228 and 238.

[0087] exist Figure 3G In the embodiment of the sterile barrier 232 shown, the width x1 can be 14 inches, approximately 14 inches, 12 inches to 16 inches, 10 inches to 18 inches, or any other suitable width. Figure 3HIn the illustrated embodiment of sterile barrier 232, width x1 can be 15 in, approximately 15 in, 13 in to 17 in, 11 in to 19 in, or any other suitable width. Height y1 of support surface 204 can be 0.125 in, approximately 0.125 in, 0.1 in to 0.15 in, or any other suitable height. In some embodiments, support surface 204 can be recessed from top surface 233 of sterile barrier 232. Height y2 between the bottom and top surfaces 233 of support surface 204 can be 0.5 in, approximately 0.5 in, 0.25 in to 0.75 in, or any other suitable height. Width x2 from the lateral edge of channel 205 to the lateral edge of channel 207 can be 5 in, approximately 5 in, 4 in to 6 in, or any other suitable width. Width x3 of support surface 204 can be 4 in, approximately 4 in, 3 in to 5 in, or any other suitable width. The height y3 of channel 206 and / or channel 212 can be 1.5 in, approximately 1.5 in, 1 in to 2 in, or any other suitable height. The width x4 of channel 206 and / or channel 212 can be 3 in, approximately 3 in, 2 in to 4 in, or any other suitable width. Channel 206 and / or channel 212 can be defined by an arc angle α of 90°, approximately 90°, 80° to 100°, or any other suitable angle, and a radius of curvature of 0.125 in, approximately 0.125 in, 0.1 in to 0.15 in, or any other suitable radius of curvature. In certain embodiments, an arc angle α of 90° or approximately 90° can be used to accommodate a hub with a rectangular or substantially rectangular cross-section. Support surface 204 can be defined by a radius of curvature of 13 in, approximately 13 in, 11 in to 15 in, or any other suitable radius of curvature. Channel 205 and / or channel 207 may be defined by a radius of curvature of 0.25 in, approximately 0.25 in, 0.15 in to 0.35 in, or any other suitable radius of curvature.

[0088] Figure 3L and Figure 3M Describes how Figures 3G to 3KThe example dimensions of the hub 250 used together with the sterile barrier 232 shown in FIG. The hub 250 can be any hub described herein. In certain embodiments, the hub 250 can have a width w1 of 3.75 in, approximately 3.75 in, 3.25 in to 4.25 in, or any other suitable width. The hub 250 can have a height h1 of 1.5 in, approximately 1.5 in, 1.25 in to 1.75 in, or any other suitable height. Alternatively, the hub 250 can have a height h2 of 2 in, approximately 2 in, 1.75 in to 2.25 in, or any other suitable height. In some embodiments, the hub 250 can have a length L1 of 2.5 in, approximately 2.5 in, 2 in to 3 in, or any other suitable length. Alternatively, the hub 250 can have a length L2 of 4 in, approximately 4 in, 3.5 in to 4.75 in, or any other suitable length.

[0089] In some embodiments, the top surface of the support table can include surface features that generally correspond to the surface features of the sterile barrier 232. For example, the support table can include a raised surface configured to correspond to the shape, size, and location of the support surface 204 and / or one or more recessed portions configured to correspond to the shape, size, and location of the channels 205 and 207.

[0090] In an alternative embodiment, the planar support surface (e.g., support surface 104 of sterile barrier 32) can be positioned at an angle to the horizontal plane to facilitate drainage of fluid. In some embodiments, the sterile barrier and / or support table can be positioned at an angle relative to the horizontal plane to facilitate drainage of fluid during a portion or the entirety of the interventional procedure. For example, the sterile barrier and / or support table can be constructed or arranged to be arranged at an angle (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate drainage of fluid. Alternatively or additionally, the drive mechanism can temporarily tilt the sterile barrier and / or support table (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate drainage of fluid. For example, the drive mechanism may raise or lower a lateral side of the sterile barrier and / or support table, a proximal end of the sterile barrier and / or support table, and / or a distal end of the sterile barrier and / or support table.

[0091] In certain embodiments, the support surface (e.g., support surface 104 of sterile barrier 32) can be positioned in a vertical configuration, rather than, for example, Figures 3A to 3FFor example, the support surface 104 can be positioned at approximately 90 degrees (or any other suitable angle) to the horizontal plane (e.g., relative to Figures 3A to 3F 104 is rotated 90 degrees about the long axis of the support surface 104). The vertical configuration can also provide easier physician interaction with the drive system 18. The vertical configuration can also provide the lower shaft of the catheter being advanced closer to the patient without increasing the standoff height of the drive system 18.

[0092] In some embodiments, the drive system 18 can be positioned at an angle relative to the horizontal plane during part or all of the interventional procedure to facilitate fluid drainage. For example, the drive system 18 can be configured or arranged in an angled arrangement (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate fluid drainage. Alternatively or additionally, the drive mechanism components can temporarily tilt the drive system 18 (e.g., such that one lateral side of the drive system 18 is higher than the other lateral side of the drive system 18, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate fluid drainage. For example, the drive mechanism components can raise or lower a lateral side of the system 18, the proximal end of the drive system 18, and / or the distal end of the drive system 18. In some embodiments, the drive system 18 can be angled so that it extends at an angle away from the axis point 24 (e.g., such that the proximal end is higher than the distal end), for example, to provide clearance for the patient's foot.

[0093] refer to Figure 4 , the hub 36 can represent any hub described previously. The hub 36 includes a housing 38 extending between a proximal end 40 and a distal end 42. An interventional device 44, which can be any interventional device disclosed herein, extends distally from the hub 36 and enters the patient 14 (not shown). A hub adapter 48 or pulley acts as a shuttle by advancing proximally or distally along a track in response to operator instructions or controller operation. The hub adapter 48 includes at least one drive magnet 67 configured to be connected to a driven magnet 69 carried by the hub 36. This provides a magnetic connection between the drive magnet 67 and the driven magnet 69 through the sterile barrier, so that the hub 36 moves on top of the sterile barrier 32 in response to the movement of the hub adapter 48 outside the sterile area. The movement of the hub adapter is driven by a drive system carried by the support table and is described in additional detail below. The hub adapter can serve as a robotic drive for the interventional device connected thereto.

[0094] In order to reduce friction in the system, the hub 36 can be equipped with at least a first roller 53 and a second roller 55, which can be in the form of wheels or rotatable balls or drums. The rollers separate the sterile barrier from the surface of the driven magnet 69 by at least about 0.02 cm (about 0.008 inches), and generally do not exceed about 0.08 cm (about 0.03 inches). In some embodiments, the gap is in the range of about 0.03 cm (about 0.010 inches) to about 0.041 cm (about 0.016 inches). The gap between the driving magnet 67 and the driven magnet 69 is generally no more than about 0.38 cm (about 0.15 inches), and in some embodiments no more than about 0.254 cm (about 0.10 inches), for example, in the range of about 0.216 cm (about 0.085 inches) to about 0.229 cm (about 0.090 inches). The hub adapter 48 may similarly be equipped with at least a first hub adapter roller 59 and a second hub adapter roller 63, which may be positioned relative to the corresponding first roller 53 and second roller 55, as shown in FIG. Figure 4 shown.

[0095] refer to Figure 6 , schematically illustrates one example of a low-profile linear drive support table 20. The support table 20 includes an elongated frame 51 extending between a proximal end 52 and a distal end 54. At least one support table support 56 is provided to stabilize the support table 20 relative to a patient (not shown). The support 56 may include one or more legs, or preferably, an articulated arm configured to allow the frame 51 to be moved and positioned above or near the patient.

[0096] Figure 7 The example of the linear drive table 20 shown includes three different drives. However, depending on the desired clinical performance, two drives or four or more drives (e.g., up to eight drives) can be included. A first drive pulley 58 is engaged with a first drive belt 60. A first pulley bracket 61 is fixed to the first drive belt 60 so that rotation of the first drive pulley 58 causes the first drive belt 60 to rotate through an elongated closed loop path. Depending on the direction of rotation of the drive pulley 58, the first pulley bracket 61 can be advanced in the proximal or distal direction along the longitudinal axis of the support table 20. In the embodiment shown, the drive pulley 58 is provided with a surface structure, such as a plurality of drive pulley teeth 62, for engaging with complementary teeth on the first drive belt 60.

[0097] The second drive pulley 64 can be engaged with a second drive belt 66 configured to axially move a second trolley bracket 68 along an axial path on the support table 20. The third drive pulley 70 can be configured to drive a third drive belt 72 to axially advance a third trolley bracket 73 along the support table 20. Each trolley bracket can be equipped with the previously discussed but not Figure 7 , to form a connector for magnetically connecting to a corresponding driven magnet within the hub of the interventional device, as already discussed.

[0098] Figure 8 Schematically shows a detailed view of the drive system. Drive support 74 can be carried by frame 51 for supporting the drive assembly. Second drive pulley 64 is shown in a vertical cross section as being driven by motor 75 via rotatable shaft 76. Rotatable shaft 76 can be rotatably carried by support 74 via first bearing 78, shaft connection 80 and second bearing 79. Motor 75 can be stabilized by motor bracket 82 connected to drive support 74 and / or frame 51. The belt drive assembly for the first drive belt 60 and the third drive belt 72 can be similarly constructed and will not be described in detail herein. In some embodiments, the drive system described herein can be a foldable rack and pinion drive stage system. In such an embodiment, motor 75 can be attached to a pulley and move with the pulley.

[0099] refer to Figure 9 and Figure 10 Each of the first, second, and third drive belts extends around a corresponding first idler pulley 84, second idler pulley 86, and third idler pulley 88. Each idler pulley can be equipped with a corresponding tension bracket 90, which is configured to adjust the idler pulley in the proximal or distal direction to adjust the tension of the corresponding belt. Therefore, each tension bracket 90 is equipped with a tension adjustment member 92, such as a rotatable screw.

[0100] like Figure 10 As shown, for example, the second idler gear 86 may be carried by a rotatable shaft 94 that is rotatably fixed relative to the mounting bracket via a first bearing 96 and a second bearing 98 .

[0101] Any catheter (e.g. Figure 5A 、 Figure 5B or Figure 11 The catheter (shown in Figure 1) typically comprises an elongated tubular body extending between a proximal end and a distal functional end. The length and diameter of the tubular body depend on the desired application. For example, lengths of about 90 cm to about 195 cm or longer are typically used for femoral access percutaneous transluminal coronary applications. Intracranial or other applications may require different catheter shaft lengths depending on the vascular access site.

[0102] Any of the catheters disclosed herein can be equipped with a beveled distal tip. Figure 11, the distal catheter tip 1150 includes a tubular body 1152 including a pusher section 1154, a marker band 1156, and a proximal section 1158. An inner tubular liner 1160 can extend throughout the entire length of the distal catheter tip 1150 and can include dip-coated or extruded PTFE or other lubricating material.

[0103] Reinforcement elements 1162 (eg, braid and / or spring coils) are embedded in an outer sheath 1164, which can extend the entire length of the catheter.

[0104] The pusher section 1154 terminates distally in an inclined surface 1166 to provide a front sidewall portion 1168 having a length measured between the distal end 130 of the marker band 1156 and the distal tip 1172. In some embodiments, the entire distal tip can have a shape that prevents the tip from becoming stuck in the arterial bifurcation region. The rear sidewall portion 1174 of the pusher section 1154, in the illustrated embodiment, has an axial length that is approximately equal to the axial length of the front sidewall portion 1168, as measured approximately 180 degrees around the catheter from the front sidewall portion 1168. The axial length of the front sidewall portion 1168 can be from about 0.1 mm to about 5 mm, and is typically from about 1 mm to 3 mm. The rear sidewall portion 1174 can be equal to the axial length of the front sidewall portion 1168 or at least about 0.1 mm or 0.5 mm or 1 mm or 2 mm or less shorter than the axial length of the front sidewall portion 1168, depending on the desired performance.

[0105] The inclined surface 1166 is inclined at an angle A of about 45 degrees to about 80 degrees to the longitudinal axis of the catheter. For some embodiments, the angle is about 55 degrees to about 65 degrees to the longitudinal axis of the catheter. In one embodiment, the angle A is about 60 degrees. One result of an angle A of less than 90 degrees is an elongation of the major axis of the region of the distal port, which increases the surface area of ​​the port and can enhance clot aspiration or retention. The area of ​​the inclined port is typically at least about 105% and no more than about 130% of the surface area of ​​a circular port (angle A of 90 degrees), in some embodiments, about 110% to about 125%, and in one example, about 115% of the area of ​​a corresponding circular port (angle A of 90 degrees).

[0106] In the illustrated embodiment, the axial length of the advancement section remains constant around the circumference of the catheter, such that the inclined surface 1166 is generally parallel to the distal surface 1176 of the marker band 1156. The marker band 1156 has a proximal surface that is generally transverse to the longitudinal axis of the catheter, resulting in an internal elevation view of the marker band 1156 having a right-angled trapezoidal configuration. The short sidewall 1178 is rotationally aligned with the rear sidewall portion 1174 and has an axial length of approximately 0.2 mm to approximately 4 mm, and typically is approximately 0.5 mm to approximately 2 mm. The opposing long sidewall 1180 is rotationally aligned with the front sidewall portion 1168. The long sidewall 1180 of the marker band 1156 is typically at least about 10% or 20% longer than the short sidewall 1178, and may be at least about 50%, 70%, 90%, or more longer than the short sidewall 1178, depending on the desired performance. Typically, the long sidewalls 1180 will have a length of at least about 0.5 mm or 1 mm and less than about 5 mm or 4 mm.

[0107] The marker band can be a continuous annular structure or can have at least one, and optionally two or three or more, axially extending slits throughout its entire length. The slits can be located on the short sidewall 1178 or the long sidewall 1180, or between the two, depending on the desired bending characteristics. The marker band can comprise any of a variety of radiopaque materials, such as a platinum / iridium alloy, and preferably has a wall thickness not exceeding about 0.003 inches, and in one embodiment about 0.001 inches.

[0108] When using multiple catheters, the perspective appearance of the marker band can be unique or different for each catheter size or type, so that the marker bands can be distinguished from each other by a software algorithm. When using multiple catheters together, such as in a multi-catheter assembly or stack as described herein, it may be advantageous to distinguish the marker bands of multiple catheters. In some embodiments, the marker band of the catheter can be configured to enable a software algorithm to detect movement of the catheter tip.

[0109] The marker band region of the assembled catheter can have a relatively high bending stiffness and a high crush strength, for example, at least about 50% less than the proximal segment 1158 or at least about 100% less, but typically no more than about 200% less than the proximal segment 1158. The high crush strength can provide radial support for the adjacent pusher segment 1154, and in particular for the anterior sidewall portion 1168, to facilitate the distal tip 1172 functioning as an atraumatic buffer during transluminal advancement and to prevent collapse under vacuum. The proximal segment 1158 preferably has a lower bending stiffness than the marker band region, and the pusher segment 1154 preferably has an even lower bending stiffness and crush strength than the proximal segment 1158.

[0110] The advancement segment 1154 can include an outer tubular sheath 1164 and an optional distal extension of the inner liner 1160, without other internal support structures distal to the marker band 1156. The outer sheath 1164 can include an extruded polyurethane, such as Tecothane®. The advancement segment 1154 can have a bending stiffness and a radial crush stiffness that are no more than about 50%, and in some embodiments no more than about 25%, 15%, or 5%, or less, of the corresponding values ​​of the proximal segment 1158.

[0111] The catheter can also include an axial tension element or support, such as a ribbon or one or more filaments or fibers, for increasing tension resistance and / or affecting bending properties in the distal region. The tension support can include one or more axially extending single or multiple filaments. One or more tension elements 1182 can be placed axially within the catheter wall near the distal end of the catheter. One or more tension elements 1182 can serve as tension supports and prevent the tip of the catheter wall from detaching or extending when under tension (for example, when the catheter is retracted proximally through a kinked outer catheter or a tortuous or narrowed vascular system).

[0112] At least one of the one or more tension elements 1182 can extend proximally along the length of the catheter wall from within approximately 1.0 centimeters of the distal end of the catheter to less than approximately 10 centimeters of the distal end of the catheter, less than approximately 20 centimeters of the distal end of the catheter, less than approximately 30 centimeters of the distal end of the catheter, less than approximately 40 centimeters of the distal end of the catheter, or less than approximately 50 centimeters of the distal end of the catheter.

[0113] One or more tension elements 1182 can have a length greater than or equal to about 40 centimeters, greater than or equal to about 30 centimeters, greater than or equal to about 20 centimeters, greater than or equal to about 10 centimeters, or greater than or equal to about 5 centimeters.

[0114] At least one of the one or more tension elements 1182 can extend at least approximately up to 50 centimeters of the length of the catheter, extend at least approximately up to 40 centimeters of the length of the catheter, extend at least approximately up to 30 centimeters or 20 centimeters or 10 centimeters of the length of the catheter.

[0115] In some embodiments, the tensile element extends proximally from the distal end of the catheter along the length of the coil 24 and terminates proximally about 5 cm or 2 cm or less on either side of the transition between the distal coil and the proximal braid. The tensile element may terminate at the transition without overlapping the braid.

[0116] One or more tensioning elements 1182 can be placed adjacent to or radially outside of the liner 1160. One or more tensioning elements 1182 can be placed adjacent to or radially inside of the braid and / or coil. One or more tensioning elements 1182 can be carried between the liner 1160 and the helical coil and can be secured to the liner or other underlying surface by an adhesive prior to adding the next outer adjacent layer (e.g., coil). Preferably, the tensioning elements 1182 are secured to the marker band 1156, for example, by an adhesive or by mechanical interference. In one embodiment, the tensioning element 1182 extends distally beyond the marker band on a first (e.g., inner) surface of the marker band, then wraps around the distal end of the marker band and extends along a second (e.g., outer) surface in one or both of a proximal oblique or circumferential direction to completely wrap around the marker band.

[0117] When more than one tensile element 1182 or filament bundle is circumferentially spaced apart in the catheter wall, the tensile elements 1182 can be placed in a radially symmetrical manner. For example, the angle between two tensile elements 1182 relative to the radial center of the catheter can be about 180 degrees. Alternatively, depending on the desired clinical performance (e.g., flexibility, trackability), the tensile elements 1182 can be placed in a radially asymmetric manner. The angle between any two tensile elements 1182 relative to the radial center of the catheter can be less than about 180 degrees, less than or equal to about 165 degrees, less than or equal to about 135 degrees, less than or equal to about 120 degrees, less than or equal to about 90 degrees, less than or equal to about 45 degrees, or less than or equal to about 15 degrees.

[0118] The one or more tensile elements 1182 may comprise materials such as Vectran®, Kevlar®, Polyester®, Spectra®, Dyneema®, Meta-Para-Aramide®, or any combination thereof. At least one of the one or more tensile elements 1182 may comprise a single fiber or a multi-fiber bundle, and the fibers or bundles may have a circular or rectangular (e.g., ribbon) cross-section. The terms fiber or filament do not convey composition, and they may comprise any of a variety of high tensile strength polymers, metals, or alloys, depending on design considerations such as the desired tensile failure limit and wall thickness. The cross-sectional dimension of the one or more tensile elements 1182 measured in the radial direction may not exceed approximately 2%, 5%, 8%, 15%, or 20% of the cross-sectional dimension of the catheter 10.

[0119] The cross-sectional dimension of one or more tension elements 1182 measured in the radial direction may be no more than about 0.03 mm (about 0.001 inch), no more than about 0.0508 mm (about 0.002 inch), no more than about 0.1 mm (about 0.004 inch), no more than about 0.15 mm (about 0.006 inch), no more than about 0.2 mm (about 0.008 inch), or about 0.38 mm (about 0.015 inch).

[0120] One or more tensioning elements 1182 can increase the tensile strength of the distal region of the catheter to at least about 1 pound, at least about 2 pounds, at least about 3 pounds, at least about 4 pounds, at least about 5 pounds, at least about 6 pounds, at least about 7 pounds, at least about 8 pounds, or at least about 10 pounds or more before failing under tension (e.g., the marker band detaches).

[0121] Depending on the desired data, any of a variety of sensors may be provided on any of the catheter, hub, pulley, or table. For example, in some embodiments, it may be desirable to measure, for example, axial tension or compression applied to the catheter along the force sensing region. The distal end of the catheter will be manufactured to have a Figure 11 , and has a helical coil distal portion. However, unlike a single helical coil using a nitinol wire, the first conductor 140 and the second conductor 142 are wound into helical coils that are wound around each other and are electrically insulated from each other, for example, by the plastic / resin of the tubular body. Figure 12A Each coil is in electrical communication with the proximal hub via a unique electrical conductor (eg, a conductive line of wire or a proximal extension).

[0122] This construction of two electrically isolated spiral coils creates a capacitor. This is roughly equivalent to two Nitinol plates with a plastic layer between them, such as Figure 12B As shown. The capacitance is inversely proportional to the distance between the filaments. The only variable that would change would be d, the distance between the plates. If an axial compressive force is applied to the catheter, the filaments (e.g., conductor 140 and conductor 142) will move closer together, thereby increasing the capacitance. If an axial tensile force is applied, the filaments will move further apart, decreasing the capacitance. This capacitance can be measured at the proximal end of the catheter, giving a measure of the force at the spiral capacitor. Although referred to as a capacitor, the sensor measures the electrical interaction between the two coils of wire. There may be a measurable change in inductance or other resulting change due to the applied axial force.

[0123] At least a first helical capacitor may have at least one, five, ten, or more complete rotations per filament. The capacitor may be located within 5 cm, 10 cm, or 20 cm of the distal-most end of the catheter body to sense the force experienced at the distal end. At least a second capacitor may be provided within 5 cm, 10 cm, or 20 cm of the proximal-most end of the catheter body to sense the force experienced at the proximal end of the catheter.

[0124] It may also be desirable to use the natural elasticity (compliance) of the magnetic connection to measure the elastic force across the magnetic connection between the hub and the corresponding pulley to measure the force applied to the hub. The magnetic connection between the hub and the pulley creates a spring. When a force is applied to the hub, the hub will move a small amount relative to the pulley. See Figure 13A In robotics, this is called a series elastic actuator. This property can be used to measure the force applied from the sled to the hub. To measure the force, the relative distance between the hub and the sled is determined ( Figure 13A dx) and characterizes some effective spring constant k between the two components. Figure 13B .

[0125] Relative distance can be measured in a variety of different ways. One method for measuring the relative distance between the hub and the pulley is a magnetic sensor (e.g., a Hall effect sensor between the hub and the pulley). A magnet is mounted to the hub or the pulley, and a corresponding magnetic sensor is mounted on the other device (the pulley or the hub). The magnetic sensor can be a Hall effect sensor, a magnetoresistive sensor, or another type of magnetic field sensor. Typically, multiple sensors can be used to increase the reliability of the measurement. This reduces noise and reduces interference from external magnetic fields.

[0126] Other non-contact distance sensors may also be used. These include optical sensors, inductive sensors, and capacitive sensors. The optical sensor will preferably be configured in a manner to avoid the accumulation of blood or other fluids in the interface between the hub and the pulley. In some embodiments, for example, a wireless (i.e., inductive) power supply may be used to convert movement and / or transmit information across the sterile barrier between the drive pulley and the hub.

[0127] The magnetic connection between the hub and the pulley has a shear or axial fracture threshold, which can be approximately 300 grams or 1000 grams or greater. The processor can be configured to compare the axial force applied to the catheter with a preset axial trigger force, which, if applied to the catheter, is perceived as creating a risk to the patient. If the trigger force is reached, the processor can be configured to generate a response to the physician (e.g., visual, auditory, or tactile feedback), and / or intervene and shut down further advancement of the catheter until repositioning is achieved. An override function can be provided so that the physician can choose to continue advancing the catheter at a force above the trigger force if the physician determines that an increase in force is justified.

[0128] In some embodiments, active real-time or near real-time force sensing can be used for each interventional device (or group of interventional devices) to detect energy storage of compression, tension and / or rotational shear due to friction between the interventional devices. Energy storage can be mitigated by the user (e.g., using push / pull techniques on one or more interventional devices) to reduce the risk of inadvertent, uninstructed movement caused by energy release. In some embodiments, force sensing data can be used by the system described herein to detect energy storage and provide a warning to the user (e.g., if the amount of stored energy exceeds a threshold). In some embodiments, the drive system can automatically adjust the interventional device (e.g., by axial movement of the interventional device if the amount of stored energy exceeds a threshold) to mitigate energy storage.

[0129] Force and / or torque sensing optical fibers (e.g., fiber Bragg grating (FBG) sensors) can be built into the sidewall of the catheter to measure forces and / or torques at various locations along the axis of the catheter, or alternatively can be integrated into the guidewire. The fiber measures axial strain, which can be converted into axial force or torque (when helically wound). At least a first FBG sensor can be integrated into a distal sensing region, a proximal sensing region, and / or an intermediate sensing region on the catheter or guidewire to measure forces and / or torques near the sensor.

[0130] It may also be desirable to understand the three-dimensional configuration of a catheter or guidewire during and / or after transvascular placement. Shape sensing fibers, such as arrays of FBG fibers, are used to sense the shape of catheters and guidewires. By using multiple force sensing fibers at known distances from one another, the shape along the length of the catheter / guidewire can be determined. In some embodiments, the shape along the length of the catheter / guidewire can be determined using RSIP fluorescence image processing.

[0131] Resistive strain gauges can be integrated into the body of a catheter or guidewire to measure force or torque, for example at the distal tip and / or proximal end of the device.

[0132] The measurement of the force and / or torque applied to the catheter or guidewire shaft can be used to determine the applied force and / or torque above a safety threshold. When the applied force and / or torque exceeds the safety threshold, a warning can be provided to the user. The applied force and / or torque measurement can also be used to provide feedback related to better catheter operation and control. The applied force and / or torque measurement can also be used with processed fluoroscopic imaging information to determine or characterize distal tip motion.

[0133] The absolute position of the hub (and corresponding catheter) along the length of the table can be determined in a variety of ways. For example, a non-contact magnetic sensor can be configured to measure the position of the hub directly through a sterile barrier. The same type of sensor can also be configured to measure the position of the pulley. Each hub can have at least one magnet attached to it. The robotic table will have a linear array of corresponding magnetic sensors that pass through the entire length of the table. The processor can be configured to determine the position of the magnet along the length of the linear sensor array and display the axial position information to the physician.

[0134] Alternatively, the above purpose can be accomplished using a non-contact inductive sensor to directly measure the position of the hub through a sterile barrier. Each hub or trolley can be equipped with an inductive "target" therein. The robotic table can be equipped with an inductive sensing array over the entire working length of the table. As another option, an absolute linear encoder can be used to directly measure the linear position of the hub or trolley. The encoder can use any of a variety of different technologies, including optical, magnetic, inductive, and capacitive methods.

[0135] In one embodiment, a passive (no electrical connection) target coil can be carried by each hub. A linear printed circuit board (PCB) can run the entire working length of the table (e.g., at least about 1.5 meters to about 1.9 meters) and is configured to detect an interrogator signal that excites a return signal from the passive coil. The PCB is configured to identify the return signal and its location.

[0136] The axial position of the trolley can be determined using a multi-turn rotary encoder to measure the rotational position of the pulley, which is directly related to the linear position of the trolley. Alternatively, direct measurement of the trolley position can be accomplished by counting the number of steps a stepper motor is commanded to measure the rotational position of the pulley, which is directly related to the linear position of the trolley.

[0137] The position of the catheter and guidewire within the anatomical structure can also be determined by processing fluoroscopic images with machine vision, for example to determine distal tip position, distal tip orientation and / or guidewire shape. Comparing the distal tip position or movement, or lack thereof, with the commanded or actual proximal catheter or guidewire movement at the hub can be used to detect loss of relative motion, which can indicate device shaft buckling, prolapse, kinking, or similar consequences (e.g., along the length of the device shaft inside the body (e.g., in the aorta) or outside the body between hubs). Processing can be performed in real time to provide position / orientation data at up to 30 Hz, although this technology can only provide data when fluoroscopic imaging is turned on. In some embodiments, machine vision algorithms can be used to generate and recommend optimal catheter maneuvers to approach or reach anatomical landmarks, similar to driver assistance. Machine vision algorithms can utilize the data to automatically drive the catheter based on the anatomical structure presented by the fluoroscopic examination.

[0138] A dual encoder torque sensor can be used to determine the proximal torque applied to a catheter or guidewire shaft. Figure 14 , the first encoder 144 and the second encoder 146 can be axially spaced apart along the shaft 148 to measure the angular difference over the length of the flexible catheter / tube. Since the catheter / tube has a known torsional stiffness, the angular difference is interpolated as the torque. When torque is applied to the shaft, the slightly flexible portion of the shaft will twist. The difference between the angles measured by the encoders (dθ) tells us the torque. T = k dθ, where k is the torsional stiffness.

[0139] Confirming the absence of bubbles in the fluid line can also be accomplished using a bubble sensor, particularly in situations where the physician is remote from the patient. This can be accomplished using a non-contact ultrasonic sensor that measures the intensity and Doppler shift of reflected ultrasound passing through the sidewalls of the fluid conduit to detect bubbles and measure fluid flow rate or fluid level. The ultrasonic or optical sensor can be located near the incoming fluid flow path within the hub, or in the supply line leading to the hub. To detect the presence of bubbles in an infusion line (formed of an ultrasonically or optically transmissive material), the sensor can include a signal source on a first side of the flow path and a receiver on a second side of the flow path to detect bubbles by measuring the transmission of liquid through the tube. Alternatively, due to the relatively high echogenicity of bubbles, the reflected ultrasonic signal can be detected from the same side of the flow path as the source.

[0140] Preferably, the bubble removal system is automatically activated when a bubble is detected in the line. The processor can be configured to activate a valve located in the flow path downstream of the bubble detector when a bubble is detected. The valve diverts a column of fluid from the flow path to the patient and into a reservoir. When bubbles are no longer detected in the flow path, and after the volume of fluid in the flow path between the detector and the valve has passed through the valve, the valve can be activated to reconnect the fluid source to the patient through the flow path. In other embodiments, the bubble removal system can include a pump and control system upstream of the bubble detector for removing bubbles in the line. The processor can be configured to activate the pump when a bubble is detected to reverse the flow of fluid and purge the bubbles into a waste reservoir before bubble-free forward flow is reestablished.

[0141] Furthermore, it is desirable for the physician to be able to view the aspirated clot at a location within the sterile field, and preferably as close to the patient as possible for fluid management purposes. This can be accomplished by providing a clot retrieval device mounted on the hub, or by providing a clot retrieval device mounted in the aspiration line away from the hub in the direction of the pump. Figure 15One example of a clot retrieval device 370 may include a body 380 enclosing a chamber 381 in communication with the first port 310 and the second port 320 .

[0142] In some embodiments, the body 380 includes a housing having a top portion 382 and a bottom portion 384. The body 380 can include a filter 330 positioned between the top portion 382 and the bottom portion 384 in the chamber 381. In some examples, the first port 310 is configured to connect to a first end of a first tube 340 that is fluidly connected to a proximal end of the aspiration catheter.

[0143] In an embodiment configured for connection downstream from the hub, the first tube 340 includes a connector 342 at a second end of the first tube 340 that is configured to engage or mate with a corresponding connector on the hub or in communication with the hub. The first port 310 communicates directly with a chamber on the upstream (e.g., top side) of the filter, and the second port 320 communicates directly with a chamber on the downstream (e.g., bottom side) of the filter to facilitate direct visualization of material captured on the upstream side of the filter.

[0144] In embodiments configured for remote operation, any of a variety of sensors may be provided to detect clots passing through the aspiration line and / or trapped in the filter, such as optical sensors, pressure sensors, flow rate sensors, ultrasonic sensors, or other sensors known in the art.

[0145] In some embodiments, the second port 320 is configured to connect to a first end of a second tube 350, which is fluidly connected to a suction source (e.g., a pump). In some embodiments, the second tube 350 includes a connector 352 at a second end of the second tube 350 that is configured to engage or mate with a corresponding connector on the pump.

[0146] In some examples, the system 300 can include a switching valve 360, such as a clamp. The clamp can be located between the filter 330 and the patient, such as on the first tube 340, to allow the user to engage the clamp and provide flow control by isolating the patient from the clot retrieval device 370. Closing the valve 360 ​​and operating a remote vacuum pump (not shown) causes the canister associated with the vacuum pump and chamber 381 to reach the same low pressure. Due to the short distance and small linear volume of the lumen between the chamber 381 and the distal end of the catheter, a sharp negative pressure spike is quickly experienced at the distal end of the catheter after opening the valve 360. Additional details are disclosed in U.S. Patent No. 11,259,821, entitled "Aspiration System with Accelerated Response," issued to Buck et al. on March 1, 2022, the entire contents of which are hereby expressly incorporated herein by reference. In some embodiments, the vacuum can be circulated to the clot to recover the clot. The vacuum can be automatically and robotically controlled to remove the clot.

[0147] The body 380 can have a top surface that is spaced apart from the bottom surface by a tubular sidewall. In the embodiment shown, the top and bottom surfaces are substantially circular and are spaced apart by a cylindrical sidewall. The top surface can have a diameter that is at least about three times, or five times or more, than the axial length of the sidewall (transverse to the top and bottom surfaces) to produce a generally disc-shaped housing. Preferably, at least a portion of the top wall is optically transparent to improve visualization of the clot after it is captured in the clot recovery device 370. Additional details can be found in U.S. Patent Application No. 63 / 256,743, the entire contents of which are incorporated herein by reference.

[0148] In some examples, the body 380 can include a flush port (not shown) configured to allow an optically transparent medium, such as air, saline, or other fluid, to be injected into the chamber 381 to clear the optical path between the window and the filter, thereby improving visualization of the clot once it is trapped in the filter 330.

[0149] The foregoing represents certain specific embodiments of a drive stage and associated components and catheters. A wide variety of different drive stage configurations can be manufactured for supporting and axially advancing and retracting two, three, four, or more drive magnet assemblies to robotically drive interventional devices, fluidic components, and electrical umbilical components for transmitting electrical signals and fluids to a catheter hub, as will be understood by those skilled in the art in light of the disclosure herein. Additional details can be found in U.S. Patent Application No. 17 / 527,393, the entire contents of which are hereby incorporated by reference herein.

[0150] Although the foregoing describes a robotically driven interventional device and a manually driven interventional device, the device may be manually driven, robotically driven, or a combination of manually and robotically driven interventional devices, as will be understood by those skilled in the art in view of the disclosure herein.

[0151] 16A to 16C An example control mechanism 2200 is shown for manipulating interventional devices driven by (or otherwise associated with) a respective hub. For example, each hub can be manipulated and / or otherwise moved using at least one control mounted in the control mechanism 2200. Each control can be adapted to move a unique hub-associated interventional device during an interventional procedure.

[0152] like Figure 16A As shown, the control mechanism 2200 can include a first control 2202, a second control 2204, a third control 2206, and a fourth control 2208. More or fewer controls can be provided depending on the desired interventional device configuration. Each control 2202 to 2208 is movably carried on a shaft 2210, which is connected to a distal support 2212 and a proximal support 2214. The controls 2202 to 2208 can be advanced distally or retracted proximally on the shaft 2210, as indicated by arrows 2218 and 2216. In addition, each control 2202 to 2208 can also rotate about the shaft 2210, as indicated by arrows 2220. Each control movement can trigger a corresponding movement in a corresponding pulley on the support table, which in turn can drive movement of the corresponding hub, as already discussed.

[0153] The control mechanism 2200 can be located on or near a patient support table having a set of hubs and catheter / interventional devices. In some embodiments, the control mechanism 2200 can be located remotely from the support table, such as behind a radiation shield or in a different room or geographical location in a telemedicine embodiment.

[0154] Each control member 2202 to 2208 can correspond to a hub and / or a combination of a hub and an interventional device and drive its movement. For example, the control member 2202 can be configured to drive the hub 30 ( Figure 3F ) to move an interventional device, such as a 0.088 inch guide catheter corresponding to hub 30. Similarly, control 2204 can be configured to drive hub 28 (122) to move an interventional device, such as a 0.071 inch surgical catheter. Control 2206 can be configured to drive hub 126 to move an interventional device, such as a steerable access catheter. Control 2208 can be configured to drive hub 26 to axially and rotationally move an interventional device, such as a guidewire.

[0155] Figure 16BAn example of manually manipulating a control 2202 on a control mechanism member 2200 is shown. In operation, if a user 2230 moves the control 2202 axially and distally along the axis 2210, as indicated by arrow 2232, the corresponding connected hub and / or interventional device can responsively move in the same direction by the same or proportional amount. If the user 2230 rotates the control 2202 about the axis 2210 and advances the control proximally, as indicated by arrow 2234, the corresponding connected interventional device will correspondingly rotationally and proximally move by the same or proportional amount. If the user 2230 rotationally moves the control 2202 about the axis 2210, as indicated by arrow 2236 or arrow 2238, the corresponding connected hub will rotationally drive the corresponding interventional device in the same direction and / or by the same or proportional amount.

[0156] Other axes and degrees of freedom can be defined to enable movement of the control member 2202 that can be translated into movement of the hub and / or interventional device. For example, the control member can be equipped with one or more deflection controls configured to activate lateral deflection in a deflection region on a corresponding interventional device.

[0157] Axial movement of the control can be configured to move the connected hub on a 1: 1 basis or on a non-1: 1 scaled basis. For example, if the user 2230 advances the control 2022 distally along the shaft 2210 by approximately 5 mm, the corresponding hub can correspondingly move 5 mm in the distal direction.

[0158] If the user 2230 rotates the control 2022 about its rotational axis by 5 degrees, the connected hub will rotate the corresponding interventional device on a 1: 1 basis or on a non-1: 1 scaled basis. The amount of scaling can be selected to reduce or increase the distance the hub and / or interventional device moves and the amount of rotation in response to the control movement.

[0159] In some embodiments, a scaling factor can be used to determine the amount of scaling described herein. The scaling factor can be applied to one or both of translational and rotational movement. In some embodiments, a first scaling factor is selected for translational movement, and a second scaling factor, different from the first scaling factor, is selected for rotational movement. For a given proximal or distal operation of a control member, the axial scaling factor can drive proximal catheter movement at a faster rate than distal catheter movement.

[0160] The rotational scaling factor may be 1:1, while the axial scaling factor may cause the hub to move a greater distance than the control member, such that hub travel relative to control member travel is at least about 2:1 or 5:1 or 10:1 or greater, depending on the desired axial length of the control assembly.

[0161] The control mechanism 2200 can be configured to enable the clinician to adjust the scale factor for different parts of the procedure. For example, advancement of the surgical catheter and access catheter through the guide catheter and to the distal end of the selected port may be ideally accomplished in a "fast" mode. However, advancement more distally into the neurovascular system may be ideally accomplished in a relatively slow mode through speed-controlled actuation.

[0162] In another embodiment, one or more controls can be configured to gradually drive the advancement or retraction rate of the corresponding hub and associated catheter. For example, distal control 2202 can drive a guide catheter. Slight distal movement of control 2202 can advance the guide catheter distally at a slower rate, while advancing control 2202 distally over a greater distance increases the rate of distal travel of the guide catheter.

[0163] Controlling the speed of the corresponding hubs axially or axially and rotationally can increase the overall speed of the procedure. For example, advancement of various devices from a femoral access point to the aortic arch can be ideally accomplished at a faster rate than distal navigation closer to the treatment site. Furthermore, proximal retraction of various devices, particularly guidewires, access catheters, and surgical catheters, can be ideally accomplished at a relatively higher speed than distal advancement.

[0164] Figure 16C Another example of manually operating controls on control mechanism member 2200 to move a hub and / or other interventional device is shown. In some embodiments, two or more controls 2202-2208 can be moved in combination to trigger movement of one or more hubs and / or associated interventional devices. In the depicted example, user 2230 moves control member 2204 and control member 2206 in combination (e.g., sequentially, simultaneously) to simultaneously move a 0.088 guide catheter and a 0.071 aspiration catheter as an assembly. Example movement of control member 2204 can include axial proximal movement in the direction indicated by arrow 2250. Sequentially or simultaneously, user 2230 can move control member 2206 axially in either direction indicated by arrows 2254 and 2256, while also rotationally moving control member 2206 in either direction indicated by arrows 2258 and 2260.

[0165] In some embodiments, each control member and / or additional controls (not shown) can be color-coded, shape-coded, tactilely coded, or otherwise coded to indicate to the user 2230 which color is configured to move which hub or interventional device. In some embodiments, control color coding can also be applied to the hubs and / or interventional devices so that the user can visually match a particular hub / device with a particular control.

[0166] In some embodiments, controls 2202-2208 can be used to perform other control operations besides translational and rotational movement. For example, controls 2202-2208 can be configured to drive a shape change and / or a stiffness change of a corresponding interventional device. Controls 2202-2208 can be switched between different operating modes. For example, controls 2202-2208 can be switched between movement driven by acceleration and velocity and movement reflecting actual linear displacement or rotation.

[0167] In some embodiments, the control mechanism 2200 can be equipped with a visual display or other indicator of the relative position of the control members, which can correspond to the relative position of the interventional devices. Such a display can depict any or all movement directions, instructions, percentages of movement performed, and / or hub and / or catheter indicators to indicate which device is controlled by a particular control member. In some embodiments, the display can depict the applied force or resistance encountered by the catheter or other measurement detected or observed by a particular hub or interventional component.

[0168] In some embodiments, the control member 2200 can include a haptic component to provide tactile feedback to the user operating the control. For example, if the control 2202 triggers movement of the catheter and the catheter detects a large force at the tip, the control 2202 can generate tactile feedback to indicate to the user to stop or reverse the ongoing movement. In some embodiments, tactile feedback can be generated at the control to indicate to the user to slow down or speed up the movement using the control. In some embodiments, haptics can provide feedback on the accumulation of large torsional strains that may precede a sudden rotation, or can provide feedback on the accumulation of large axial forces that may be a prelude to catheter buckling.

[0169] The system described herein can compare the actual perspective image position with the input displacement from the controller. A static perspective image of the patient can be captured, in which the patient's vascular system is indicated relative to bone landmarks or one or more implanted soft tissue fiducial markers. The real-time perspective image can then be displayed as an overlay, aligned with the static image by registration of the fiducial markers. By visually observing the consistency of the real-time movement with the static image, assisted by the detected force data, it can help confirm the correct navigation of the associated catheter or guidewire. The system described herein can also display a comparison of the input proximal mechanical translation of the catheter or guidewire and the resulting output motion of the distal tip or its lack thereof. The loss of relative motion at the distal tip can indicate shaft buckling, prolapse, kinking, or similar results inside or outside the body. Such a comparison may be beneficial when shaft buckling, prolapse, kinking, or similar results appear outside the current perspective view.

[0170] Figure 17A schematic side elevation view of a multi-catheter interventional device assembly 2900 for combined aortic arch access and / or neurovascular site access and surgery (eg, aspiration), as described herein, is shown. Multi-catheter assembly 2900 can be configured for manual or robotic surgery.

[0171] The interventional device assembly 2900 includes an insertion or access catheter 2902, a surgical catheter 2904, and a guide catheter 2906. Other components may include, but are not limited to, one or more guidewires (e.g., optional guidewire 2907), one or more guidewire catheters, an access sheath, and / or one or more other surgical catheters and / or associated catheter (control) hubs. In some embodiments, the assembly 2900 may also be configured with an optional deflection control 2908 for controlling the deflection of one or more interventional devices (e.g., catheters, microcatheters, or wires such as guidewires or hollow wires) of the assembly 2900.

[0172] In operation, the multi-catheter assembly 2900 can be used without having to replace the hub assembly. For example, in the two-stage procedure previously disclosed, the first stage for achieving aortic arch access includes installing the access catheter, guide catheter, and guidewire onto the support table. When aortic arch access is achieved, the access catheter and guidewire are typically removed from the guide catheter. Then, after attaching a new guidewire hub and surgical catheter hub to the corresponding drive pulleys on the support table, the second catheter assembly is introduced over the guidewire catheter.

[0173] Figure 17 Single multi-catheter assembly 2900 is configured to operate when hub and catheter do not have to be removed and do not increase extra assembly and / or hub.Therefore, the multi-assembly entry and surgical configuration of assembly 2900 can utilize the guidewire 2907 that is manufactured to be used as entry guidewire and navigation guidewire, to allow enough entry and support, and navigate to specific distal treatment site.In the non-limiting example that is configured to be used for robot embodiment, catheter assembly can include guidewire hub (for example, be positioned at guidewire hub 2909 or guidewire hub 26 on the drive platform and on catheter 2902 right), insert or enter catheter hub 2910, surgical catheter hub 2912, guide catheter hub 2914 and corresponding catheter.In certain embodiments, one or more hubs can include hemostatic valve (for example, rotation hemostatic valve) or be connected thereto, to adapt to interventional device by introducing therein. Additional details regarding hemostatic valves are included in U.S. patent application serial number 17 / 879,614, filed on August 2, 2022, entitled “Multi Catheter System With Integrated Fluidics Management,” which is hereby incorporated by reference in its entirety.

[0174] Once access above the aortic arch is complete, the insertion or access catheter 2902 (associated with the insertion catheter hub 2910) can be parked near the carotid ostium and the remainder or subset of the catheter assembly can be directed more distally to a specific site (e.g., a clot site, a surgical site, a procedure site, etc.).

[0175] In some embodiments, other smaller surgical catheters may also be added and used at the site. As used in the catheter assembly 2900 herein, in the robotic configuration of the assembly 2900, the catheter 2906 may be used as a guide catheter. The catheter 2904 may be used as a surgical (e.g., suction) catheter. In some embodiments, instead of or in addition to the catheter 2904, the catheter 2906 may also function to perform suction in addition to functioning as a guide catheter. The entry catheter 2902 may have a distal deflection region and may be used to enter the desired port. One skilled in the art will appreciate the advantages of the present invention. 18A to 18E It is understood that manual or robotic operation of multiple catheter stacks is contemplated herein. In some embodiments, the guidewire 2907 can have a distal deflection region and can be used to access a desired port.

[0176] In some embodiments, catheter assembly 2900 (or other combined catheter assemblies described herein) can be driven to a certain position as an assembly. However, each catheter (or guidewire) assembly can be operated and driven to the same or different positions independently of each other.

[0177] In a non-limiting example, catheter assembly 2900 can be used for a diagnostic angiography procedure. In some embodiments, assembly 2900 can include only a guidewire 2907 and an access catheter 2902 (in the form of a diagnostic angiography catheter) for performing a diagnostic angiography procedure, or only a guidewire 2907 and an access catheter 2902 can be used during a procedure. Optionally, guide catheter 2906 and surgical catheter 2904 can be retracted proximally to expose the distal end of access catheter 2902 (e.g., a few centimeters of the distal end of the access catheter) for performing a diagnostic angiography procedure. A diagnostic angiography procedure can be performed at any point during the procedure. In some embodiments, interventional devices (e.g., catheter and guidewire) can be spaced sufficiently apart to allow for angiographic injections to be performed in parallel, around, or within other interventional devices.

[0178] like Figure 17As shown, guide catheter 2906, surgical catheter 2904, access catheter 2902, and guidewire 2907 can be arranged concentrically. In certain embodiments, guide catheter 2906 can be a "large bore" guide catheter or access catheter having an inner diameter of at least about 0.075 inches or at least about 0.080 inches in diameter. Surgical catheter 2904 can be an aspiration catheter having an inner diameter of about 0.060 inches to about 0.075 inches. Access catheter 2902 can be a steerable catheter having a deflectable distal tip having an inner diameter of about 0.025 inches to about 0.050 inches. Guidewire 2907 can have a diameter of about 0.014 inches to about 0.020 inches. In one example, guide catheter 2906 can have an inner diameter of approximately 0.088 inches, surgical catheter 2904 can have an inner diameter of approximately 0.071 inches, access catheter 2902 can have an inner diameter of approximately 0.035 inches, and guidewire 2907 can have a diameter of approximately 0.018 inches.

[0179] 18A to 18E Depicted is an exemplary sequence of steps for introducing a multi-catheter assembly configured to manually or robotically achieve access directly to a clot. 18A to 18E Can be used Figure 17 Other combinations of catheters may be substituted for the interventional device assembly, as will be understood by those skilled in the art in light of the disclosure herein.

[0180] refer to Figure 18A , the three-catheter interventional device assembly 2900 is shown as being driven through the introducer sheath 3002, up through the iliac arteries 3004 and into the descending aorta. In some embodiments, the three-catheter interventional device assembly can be driven through the introducer sheath, up through the femoral artery and into the descending aorta. Next, the access catheter 2902, the surgical catheter 2904 (e.g., 0.071 inches) and the guide catheter 2906 (e.g., 0.088 inches) are tracked to the aortic arch 3006, as shown. Figure 18B Here, the distal end of the guide catheter 2906 can be parked below the aortic arch 3006, and the surgical catheter 2904, the access catheter 2902 (located within the surgical catheter 2904, and Figure 18Bostium (not visible in the figure) and guidewire 2907 can be driven into the ostium (e.g., simultaneously or separately). In some embodiments, the access catheter 2902 is pushed out of the surgical catheter 2904 and the guide catheter 2906 to first engage the ostium. After the distal end of the access catheter 2902 is positioned within the desired ostium, the guidewire 2907 can be advanced distally into the ostium to secure access. After the access catheter 2902 and guidewire 2907 are located within the desired ostium, the surgical catheter 2904 and / or guidewire 2906 can be advanced into the ostium (and in some embodiments, beyond the ostium) while using the support of the access catheter 2902 and / or guidewire 2907 to maneuver through the aorta and into the ostium. Figure 18B In the embodiment shown, the surgical catheter 2904 has been advanced into the ostium, while the guide catheter 2906 has been maintained below the aortic arch 3006.

[0181] refer to Figure 18C , guidewire 2907 can be advanced distally, and the radiopacity of guidewire 2907 can be used to confirm under fluoroscopic imaging that access through the desired ostium has been achieved. Guidewire 2907 engages the origin of the brachiocephalic artery 3014. Guidewire 2907 is then advanced proximal to the petrous segment 3018 of the internal carotid artery 3016 (e.g., proximally or distally above or adjacent to petrous segment 3018).

[0182] refer to Figure 18D , guide catheter 2906 and surgical catheter 2904 (located within guide catheter 2906 and Figure 18D (not visible in FIG) over the guidewire 2907 and into the catheter 2902 (located within the surgical catheter 2904 and Figure 18D The guidewire 2907 can be further advanced through the rock segment 3018 to the site of the clot 3020, such as the M1 segment.

[0183] refer to Figure 18E , guide catheter 2906 and surgical catheter 2904 (located within guide catheter 2906 and Figure 18E 3020) are advanced (e.g., simultaneously or sequentially) to position the distal tip of surgical catheter 2904 at the surgical site, such as on the surface of clot 3020. Guidewire 2907 and access catheter 2902 (located within surgical catheter 2904 and Figure 18E2906) and aspiration of the clot 3020 is initiated through the surgical catheter 2904. That is, the guidewire 2907 and the access catheter 2902 are retracted proximally to allow aspiration through the surgical catheter 2904. After aspiration of the clot, the surgical catheter 2904 and the guide catheter 2906 can be removed (e.g., simultaneously or sequentially). For example, in some embodiments, the surgical catheter 2904 can be removed before the guide catheter 2906 is removed.

[0184] The catheter assembly 2900 can be used to perform neurovascular procedures, such as 18A to 18E As shown. For example, the neurovascular procedure can be a neurovascular thrombectomy. The steps of the procedure can include providing an assembly comprising at least a guidewire, an access catheter, a guide catheter, and a surgical catheter. For example, catheter assembly 2900 comprises a guidewire 2907, an access (e.g., insertion) catheter 2902, a guide catheter 2906, and at least one surgical catheter 2904. The surgical catheter 2904 can include an aspiration catheter, an embolization deployment catheter, a stent deployment catheter, a shunt deployment catheter, a diagnostic angiography catheter, a stent retriever catheter, a clot retrieval catheter, a balloon catheter, a catheter to facilitate percutaneous valve repair or replacement, an ablation catheter, and / or an RF ablation catheter or guidewire.

[0185] The neurovascular procedure may also include the steps of connecting the assembly to a non-robotic or robotic actuation system and actuating the assembly to achieve aortic arch access. The steps may also include actuating a subset of the assembly to the neurovascular site and performing the neurovascular procedure using the subset of the assembly. The subset of the assembly may include a guidewire, a guide catheter, and a surgical catheter.

[0186] Each of the guidewire 2907, access catheter 2902, guide catheter 2906, and surgical catheter 2904 is configured to be regulated by a corresponding hub. For example, the guidewire 2907 can include (or be connected to) a hub mounted on one of the tray assemblies described herein. Similarly, the access catheter 2902 can be connected to a catheter hub 2910. The guide catheter 2906 can be connected to a guide catheter hub 2914. The surgical catheter 2904 can be connected to a surgical catheter hub 2912.

[0187] Typically, the connection of the components can include magnetically connecting the first hub 2909 on the guidewire 2907 to the first drive magnet, magnetically connecting the second hub 2910 on the access catheter 2902 to the second drive magnet, magnetically connecting the third hub 2912 on the surgical catheter 2904 to the third drive magnet, and magnetically connecting the fourth hub 2914 on the guide catheter 2906 to the fourth drive magnet. Typically, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are each independently and movably carried by the drive station, as described by the tray assembly and control member described herein. In some embodiments, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are connected (e.g., connected to their respective catheter hubs) through a sterile barrier (e.g., a sterile and fluid barrier) and are independently and movably carried by a drive station having multiple driven magnets. In some embodiments, two or more drive magnets may be bolted or otherwise connected together to move as an assembly in response to commands from a single controller bolted to or otherwise connected to one of the drive magnets.

[0188] In some embodiments, the step of performing the neurovascular procedure can include driving the assembly in response to movement of each of the hub adapters along the support table until the assembly is positioned to achieve aortic arch vascular access. The hub adapter can include, for example, a connector / pulley that acts as a shuttle by being propelled proximally or distally along a track in response to operator commands. The hub adapters described herein can each include at least one drive magnet configured to connect to a driven magnet carried by a corresponding hub. This provides a magnetic connection between the drive magnet and the driven magnet through the sterile barrier so that the corresponding hub moves into the top of the sterile barrier in response to movement of the hub adapter outside the sterile field (e.g., Figure 4 ). Movement of the hub adapter is driven by a drive system carried by a support platform on which the guidewire hub 2909, guide catheter hub 2914, surgical catheter hub 2912, and access catheter hub 2910 are mounted.

[0189] The steps may also include driving a subset of the components in response to movement of each of the hub adapters along the support table until the subset of components is positioned to perform a neurovascular procedure at the neurovascular treatment site. The subset of components may include a guidewire 2907, a guide catheter 2906, and a surgical catheter 2904.

[0190] In some embodiments, the guidewire 2907, guide catheter 2906, and surgical catheter 2904 are passed as an assembly (relative to the guidewire 2907) and over (relative to the guide catheter 2906 and surgical catheter 2904) at least a portion of the length of the entry (e.g., insertion) catheter 2902 after aortic arch access is achieved.

[0191] In some embodiments, catheter assembly 2900 can be part of a robotically controlled system for achieving aortic arch access and neurovascular treatment site access, such as 18A to 18E As shown. In some embodiments, catheter assembly 2900 can be part of a manually controlled system for achieving aortic arch access and neurovascular treatment site access. In some embodiments, catheter assembly 2900 can be part of a hybrid control system (having manual and robotic components) for achieving aortic arch access and neurovascular treatment site access. For example, in such a hybrid system, aortic arch access can be robotically driven, while neurovascular site access and embolectomy or other procedures can be manual. Alternatively, in such a hybrid system, aortic arch access can be manual, while neurovascular site access can be robotically achieved. In addition, in such a hybrid system, any one or more of the guidewire, access catheter, guide catheter, or surgical catheter can be robotically driven or manually operated.

[0192] In some embodiments, the user can manually control the interventional device with one hand or manually control the interventional device with both hands. The robotic control system can automatically remove other interventional devices that are consistent with the manually controlled interventional device. In some embodiments, the robotically controlled interventional device can be controlled by a second user. In some embodiments, the robotically controlled interventional device can be controlled by the same user who manually controls the catheter. For example, in some embodiments, the controller for the robotically controlled interventional device can be located on or adjacent to the interventional device or its corresponding hub so that the user can manipulate the controller with one hand while manually manipulating another interventional device. In some embodiments, the robotically controlled interventional device can be controlled by the user without using his hands. For example, the user can control the robotically controlled interventional device with his feet (e.g., via a foot pedal).

[0193] During a procedure, in some embodiments, one or more robotically-driven interventional devices can be interchanged with one or more manually-driven interventional devices. For example, one or more robotically-driven interventional devices can be used before the start of a procedure, then removed and replaced with one or more manually-driven interventional devices during later steps of the procedure. In some embodiments, the manually-driven interventional devices can be longer than traditional manually-controlled interventional devices to interface with the robotically-driven interventional devices. In some embodiments, during a procedure, one or more robotically-controlled catheters can be left in place, and one or more robotically-controlled interventional devices can be inserted and manipulated through the robotically-controlled catheters. For example, in some embodiments, a manually-controlled aspiration catheter can be inserted into catheter assembly 2900 (e.g., via robotically-controlled guide catheter 2906) in place of robotically-controlled access catheter 2902 and / or robotically-controlled surgical catheter 2904. The manually-controlled aspiration catheter can have a smaller diameter than robotically-controlled access catheter 2902 or robotically-controlled surgical catheter 2904.

[0194] In some embodiments, a stent, shunt, stent retriever, stent retriever delivery microcatheter, coil, microcatheter, balloon, guidewire, and / or any other suitable device can be manually or robotically inserted into a patient through an entry point (e.g., a femoral or iliac entry point). A stent, shunt, stent retriever, stent retriever delivery microcatheter, coil, microcatheter, balloon, guidewire, and / or any other suitable device can be manually or robotically inserted into a patient through a guide catheter (e.g., guide catheter 2906). Guide catheter 2906 and / or any other interventional device described herein can be manually or robotically inserted into a patient through an entry point (e.g., a femoral or iliac entry point).

[0195] In some embodiments, a stent, shunt, stent retriever, stent retriever delivery microcatheter, coil, microcatheter, balloon, guidewire, and / or any other suitable device can be manually or robotically inserted into a patient and navigated upward through the descending aorta to a target site in the patient's vasculature. In some embodiments, a stent, shunt, stent retriever, stent retriever delivery microcatheter, coil, microcatheter, balloon, guidewire, and / or any other suitable device can be manually or robotically inserted into a patient through an entry point (e.g., a femoral or iliac entry point) and then robotically navigated upward through the descending aorta to a target site. In some embodiments, a stent, shunt, stent retriever, stent retriever delivery microcatheter, coil, microcatheter, balloon, guidewire, and / or any other suitable device can be manually inserted into a patient through an entry point (e.g., a femoral or iliac entry point) and then manually navigated upward through the descending aorta to a target site. Accordingly, a stent, shunt, stent retriever, stent retriever delivery microcatheter, coil, microcatheter, balloon, guidewire, and / or any other suitable device may be inserted through the robotically or manually inserted and controlled guide catheter 2906. In some procedures, a user may simultaneously control the robotically controlled interventional device with one hand (e.g., using the left hand to move or actuate a switch on the hub) and manually manipulate the interventional device or devices with the other hand (e.g., the right hand).

[0196] In some embodiments described herein, force sensing can be used to detect energy storage. In some embodiments, a robotic control system can use force sensing of energy storage and accompanying control algorithms to actively compensate for energy storage in a robotically controlled interventional device while a user manually advances other interventional devices.

[0197] In certain embodiments, any manually driven or robotically driven catheter can be connected to one or more fluid and / or vacuum sources to provide fluid (e.g., saline, contrast agent, liquid medication, etc.) or to evacuate the catheter. In certain embodiments, any fluid and / or vacuum source can be operated manually or robotically (e.g., automatically). For example, in certain embodiments, one or more manually driven catheters can be connected to a robotically operated fluidics system. In certain embodiments, one or more robotically driven catheters can be connected to a manually operated fluidics system. In certain embodiments, an interventional device assembly (e.g., interventional device assembly 2900) can be connected to a fluidics system that is both manually operated and robotically operated. In certain embodiments, a single fluidics system or fluidics machine can simultaneously manage fluidics injection and aspiration into a catheter that is both robotically driven and manually manipulated.

[0198] Additional details regarding the fluidics system are disclosed in U.S. patent application Ser. No. 17 / 879,614, filed on August 2, 2022, entitled “MultiCatheter System With Integrated Fluidics Management,” which is hereby incorporated by reference in its entirety.

[0199] The example robotic control system can include at least a guidewire hub (e.g., guidewire hub 2909) configured to adjust each of the axial position and the rotational position of the guidewire 2907. The robotic control system can also include an access catheter hub 2910 configured to adjust the axial and rotational movement of the access catheter 2902. The robotic control system can also include a guide catheter hub 2914 configured to control the axial movement of the guide catheter 2906. In some embodiments, the robotic control system can control the rotational movement of the guide catheter 2906. The robotic control system can also include a surgical catheter hub 2912 configured to adjust the axial position and the rotational position of the surgical catheter 2904.

[0200] In some embodiments, the surgical catheter hub 2912 is also configured to laterally deflect the distal deflection region of the surgical catheter 2904 .

[0201] In some embodiments, the guidewire hub 2909 is configured to connect to the guidewire hub adapter by magnetically connecting the guidewire hub to the first drive magnet. The access catheter hub 2910 is configured to connect to the access catheter hub adapter by magnetically connecting the access catheter hub 2910 to the second drive magnet. The surgical catheter hub 2912 is configured to connect to the surgical catheter hub adapter by magnetically connecting the surgical catheter hub 2912 to the third drive magnet. The guide catheter hub 2914 is configured to connect to the guide catheter hub adapter by magnetically connecting the guide catheter hub 2914 to the fourth drive magnet. In some embodiments, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are independently and movably carried by the drive platform.

[0202] In some embodiments, the robotic control system includes a first driven magnet on the guidewire hub 2909. The first driven magnet can be configured to cooperate with the first drive magnet such that the first driven magnet is configured to move in response to movement of the first drive magnet. In some embodiments, the first drive magnet is configured to move through a barrier to the outside of the sterile field separated from the first driven magnet while the first driven magnet is within the sterile field. In some embodiments, the position of the first driven magnet can move in response to operation of a surgical drive control on a console associated with the drive table. References above Figure 4The interaction of the driving and driven magnets is described in detail.

[0203] In some embodiments, the robotic control system includes a second driven magnet on the entry catheter hub 2910. The second driven magnet can be configured to cooperate with the second drive magnet such that the second driven magnet is configured to move in response to movement of the second drive magnet. In some embodiments, the second drive magnet is configured to move outside the sterile field separated from the second driven magnet through a barrier when the second driven magnet is within the sterile field.

[0204] In some embodiments, the robotic control system includes a third driven magnet on the surgical catheter hub 2912. The third driven magnet can be configured to cooperate with the third drive magnet such that the third driven magnet is configured to move in response to movement of the third drive magnet. In some embodiments, the third drive magnet is configured to move outside the sterile field separated from the third driven magnet through a barrier when the third driven magnet is within the sterile field.

[0205] In some embodiments, the robotic control system includes a fourth driven magnet on the guide catheter hub 2914. The fourth driven magnet can be configured to cooperate with the fourth drive magnet so that the fourth driven magnet is configured to move in response to the movement of the fourth drive magnet. In some embodiments, the fourth drive magnet is configured to move to the outside of the sterile area separated from the fourth driven magnet through a barrier when the fourth driven magnet is within the sterile area. In some embodiments, there can be more than four driven magnets and corresponding catheter hubs for controlling additional catheters.

[0206] In some embodiments, the devices described herein (e.g., hubs, hub adapters, interventional devices, and / or trays) can be used in robotically driven surgery. For example, in robotically driven surgery, one or more interventional devices can be driven through the vascular system and reach the surgical site. Robotic driving of such devices can include engaging electromechanical components controlled by user input. In some embodiments, a user can provide input at a control system that interfaces with one or more hubs and hub adapters.

[0207] In some embodiments, the hubs, hub adapters, interventional devices, and trays described herein can be used during non-robotic (e.g., manually driven) surgery. Manually driving such a device can include manually engaging the hub to affect movement of the interventional device.

[0208] In some embodiments, the devices described herein can be used to implement methods for performing intracranial surgery at an intracranial site. The methods for performing intracranial surgery can include any of the same steps as those described herein for performing neurovascular surgery. The methods can be performed robotically, manually, or a hybrid combination of the two.

[0209] While the foregoing describes a magnetic connection of the hub to the drive magnet, in other embodiments, any interventional device and / or hub can be mechanically connected to the drive system. Any method described herein may include the step of mechanically connecting one or more interventional devices (e.g., guidewire 2907, access catheter 2902, surgical catheter 2904, and / or guide catheter 2906) and / or one or more hubs (e.g., guidewire hub 2909, access catheter hub 2910, surgical catheter hub 2912, and / or guide catheter hub 2914) to one or more drive mechanism components.

[0210] Figure 19 A mechanical connection mechanism 1654 is shown between a driver mechanism 1650 and a driven mechanism member 1652. The driver mechanism 1650 and the driven mechanism member 1652 can have any features or functions that are identical or similar to the drive magnet 67 and the driven magnet 69, respectively, unless otherwise described herein. The driver mechanism 1650 can be a part of or connected to a hub adapter (e.g., hub adapter 48). The driven mechanism member 1652 can be a part of or connected to a hub (e.g., hub 36, guidewire hub 2909, access catheter hub 2910, surgical catheter hub 2912, or guide catheter hub 2914). In some cases, the mechanical connection mechanism 1654 can include a structural support member (e.g., a support rod or support strut) that extends laterally through the seal in the sterile barrier 1632. As the driver member 1650 and the follower member 1652 are advanced and / or retracted as described herein, the seal can allow the structural support to be advanced along the length of the sterile barrier 1632 while still maintaining a seal with the structural support to maintain the sterile field. For example, the seal can include a tongue and groove closure mechanism along the sterile barrier 1632 that is configured to close on either side of the structural support while allowing the structural support to pass through the sterile barrier 1632 and maintain the seal against the structural support as the structural support is advanced along the length of the sterile barrier 1632.

[0211] In some embodiments, the structural support can extend through an elongated self-closing seal (e.g., shaped like a duckbill valve) between two adjacent mating edges of a flexible material that extends along the shaft. As the structural support is advanced along the shaft between the mating edges, the mating edges can allow the structural support to advance and then be biased back into sealing engagement with each other when the structural support passes any given point along the shaft.

[0212] In some embodiments, the drive mechanism component can be a spline drive shaft (e.g., a non-sterile spline drive shaft). Mechanical connection mechanism component 1654 can include a pulley in the plate used as sterile barrier 1632 and a sterile spline shaft configured to be connected to a driven mechanism component 1652. Driven mechanism component 1652 can be a sterile pulley that receives a sterile spline shaft from a sterile barrier. In some embodiments, one or more spline drive shafts can engage and rotate the corresponding pulleys used as sterile barrier in the plate. Each hub can have a sterile pulley that is configured to receive the sterile spline shaft from a sterile barrier plate. The rotation of the spline drive shaft can rotate the pulley in the sterile barrier plate, and the sterile barrier plate can rotate the sterile pulley in the hub via a sterile spline shaft.

[0213] Those skilled in the art will appreciate that any of the embodiments described herein may be modified to incorporate mechanical connectors, such as Figure 19 shown.

[0214] In some embodiments, the interventional devices described herein (e.g., insertion or access catheter 2902, surgical catheter 2904, guide catheter 2906, and / or guidewire 2907) can be manually driven, robotically driven, or a combination of manually driven and robotically driven, as will be understood by those skilled in the art. For example, the procedures described herein can be performed with an interventional device that manually drives an interventional device assembly (e.g., interventional device assembly 2900), an interventional device that robotically drives an interventional device assembly, or an interventional device that can both manually and robotically drive an interventional device assembly.

[0215] In some embodiments, a first subset of interventional devices of an interventional device assembly (e.g., interventional device assembly 2900) are robotically driven during a surgical procedure, and a second subset of interventional devices are manually driven during a surgical procedure. In certain embodiments, one or more interventional devices of an interventional device assembly (e.g., interventional device assembly 2900) can be robotically driven during a portion of a surgical procedure and manually driven during another portion of a surgical procedure.

[0216] For example, in some embodiments, the second subset of interventional devices can be removably connected to the robotically driven first subset of interventional devices. During part of a neurovascular procedure, while the second subset of interventional devices is connected to the first subset of interventional devices, the second subset of interventional devices can be driven by the first subset of interventional devices. During another part of the neurovascular procedure, one or more interventional devices of the second subset of interventional devices can be detached from the first subset of interventional devices and manually driven.

[0217] Figure 25A side view of a multi-catheter interventional device assembly 2900a for combined aortic arch access and / or neurovascular access site and procedure (eg, aspiration) as described herein is depicted. The interventional device assembly 2900a may include any of the same or similar features or functionality as the interventional device assembly 2900.

[0218] The interventional device assembly 2900a includes a robotically driven subgroup 2916 of the interventional device and a manually driven subgroup 2918 of the interventional device. The manually driven subgroup 2918 can be removably connected to the robotically driven subgroup 2916 via one or more connecting mechanisms 2920a and 2920b. The one or more connecting mechanisms 2920a and 2920b can be Luer locks, hemostatic valves, fasteners, complementary threaded connection members, and / or other suitable connecting mechanisms.

[0219] In some embodiments, the interventional devices of the manually-driven subgroup 2918 can be robotically driven when connected to the robotically-driven subgroup 2916, and can be manually driven when detached from the robotically-driven subgroup 2916. In other words, the interventional devices of the manually-driven subgroup 2918 can be connected to one or more interventional devices of the robotically-driven subgroup 2916 such that movement of the one or more interventional devices of the robotically-driven subgroup 2916 results in corresponding movement of the interventional devices of the manually-driven subgroup 2918.

[0220] In some embodiments, when connected as described above, the relative positions of the interventional devices of the manually driven subgroup 2918 can be fixed relative to at least one interventional device of the robotically driven subgroup 2916, so that movement of at least one interventional device of the robotically driven subgroup 2916 can drive the interventional devices of the manually driven subgroup 2918 without changing the relative positions.

[0221] In some embodiments, when the manually driven subgroup 2918 is separated from the robotically driven subgroup 291, the interventional devices of the manually driven subgroup 2918 and the interventional devices of the robotically driven subgroup 2916 can be driven independently of each other. The interventional devices of the manually driven subgroup 2918 can be driven manually while the interventional devices of the robotically driven subgroup 2916 can be driven robotically.

[0222] like Figure 25As shown, in some embodiments, interventional device assembly 2900a includes an insertion or access catheter 2905, a surgical catheter 2904, a guide catheter 2906, and a guidewire 2907. Other components may also include, but are not limited to, one or more guide catheters, access sheaths, and / or one or more other surgical catheters and / or associated catheter (control) hubs. In some embodiments, assembly 2900a may also be configured with an optional deflection control for controlling the deflection of one or more catheters of assembly 2900a.

[0223] In some embodiments, the robotically driven subassembly 2916 may include an access catheter 2902 and a guidewire 2907. The interventional device assembly 2900a may include a guidewire hub 2909 and an insertion or access catheter hub 2910. As described herein, the guidewire hub 2909 and the access catheter 2910 may be used to robotically drive the guidewire 2907 and the access catheter 2902, respectively, during neurovascular surgery. In some embodiments, as described herein with reference to FIG. 26A to FIG. 26B , the hubs of assembly 2900a (eg, guidewire hub 2909 and access catheter hub 2910) may be replaced by a hub assembly having a removable hub movably connected to a mount.

[0224] In some embodiments, manually driven subgroup 2918 may include surgical catheter 2904 and guide catheter 2906 .

[0225] In some embodiments, the surgical catheter 2904 can be removably connected to the robotically operated drive subassembly 2916 via a connecting mechanism 2920a. For example, the surgical catheter 2904 can be removably connected directly to the access catheter 2902 or the access catheter hub 2910 via the connecting mechanism 2920a. In some embodiments, the connecting mechanism 2920a can be a Luer lock, a hemostatic valve, a fastener, a complementary threaded connection member, and / or other suitable connecting mechanism.

[0226] In some embodiments, the guide catheter 2906 can be removably connected to the robotically operated drive subassembly 2916 via a connecting mechanism 2920b. In some embodiments, the guide catheter 2906 can be directly removably connected to the access catheter hub 2910 via the connecting mechanism 2920b. In other embodiments, when the surgical catheter 2904 is removably connected to the robotically operated drive subassembly 2916, the guide catheter 2906 can be indirectly removably connected to the robotically operated drive subassembly 2916 via a removable connection of the surgical catheter 2904 or the connecting mechanism 2920a. In some embodiments, the connecting mechanism 2920b can be a Luer lock, a hemostatic valve, a fastener, a complementary threaded connection member, and / or other suitable connecting mechanism.

[0227] In some embodiments, the surgical catheter 2904 and the guide catheter 2906 can be simultaneously removably connected to the robotically driven subassembly 2916 via a single connector (eg, connector 2920a or connector 2920b).

[0228] In some embodiments, when surgical catheter 2904 and guide catheter 2906 are connected to the robotically operated actuated subassembly, access catheter 2902 can extend distally beyond surgical catheter 2904 and guide catheter 2906 and surgical catheter 2904 can extend distally beyond guide catheter 2906, as shown. Figure 25 shown.

[0229] As described herein, when connected as described above, the relative positions of the interventional devices of the manually driven subset 2918 can be fixed relative to the interventional devices of the robotically driven subset 2916. For example, when the surgical catheter 2904 and / or the guide catheter 2906 are connected (e.g., directly or indirectly) to the access catheter 2902, the relative positions of the surgical catheter 2904 and / or the guide catheter 2906 can be fixed relative to the access catheter 2902 when the access catheter 2902 is robotically driven.

[0230] In some embodiments, the interventional devices of the manually driven subset 2918 (e.g., surgical catheter 2904 or guide catheter 2906) can be individually detached from the robotically driven subset 2916. For example, in some embodiments, guide catheter 2906 can be detached from the robotically driven subset 2916 while surgical catheter 2904 remains connected to the robotically driven subset 2916, or vice versa. In some embodiments, the interventional devices of the manually driven subset 2918 (e.g., surgical catheter 2904 or guide catheter 2906) can be manually driven together or individually.

[0231] As described herein, interventional device assembly 2900a can be used to perform vascular surgery (e.g., neurovascular surgery). In some embodiments, interventional device assembly 2900a can be robotically driven to achieve aortic arch access, while manually driven subassembly 2918 can be connected to robotically driven subassembly 2916.

[0232] Once access is complete above the aortic arch, the interventional device assembly 2900a can be robotically driven to position the guidewire 2907 and / or access catheter 2902 to provide access to a specific site (e.g., a clot site, a surgical site, a procedure, etc.), with the manually driven subassembly 2918 connected to the robotically driven subassembly 2916. For example, in some embodiments, the interventional device assembly 2900a can be robotically driven to position the guidewire 2907 and / or access catheter 2902 at the distal neck / flap portion of the anatomy. In some embodiments (e.g., in a procedure to remove a clot in the middle cerebral artery), the interventional device assembly 2900a can be robotically driven such that the guidewire 2907 and / or access catheter 2902 extends to the middle cerebral artery.

[0233] After the guidewire 2907 and / or access catheter 2902 are in position to provide access to a particular site, the surgical catheter 2904 and / or guide catheter 2906 can be separated from the robotically driven subassembly 2916.

[0234] After separation, surgical catheter 2904 and / or guide catheter 2906 can be manually advanced toward the specific site (e.g., a clot site, a surgical site, a surgical site, etc.). For example, when the specific site is a clot site, surgical catheter 2904 and / or guide catheter 2906 can be manually advanced to traverse one side of the clot.

[0235] In some embodiments, when the distal end is located in the patient's neck (i.e., proximal to the intracranial vessels), surgical catheter 2904 and / or guide catheter 2906 can be separated from robotically driven subassembly 2916. Surgical catheter 2904 and / or guide catheter 2906 can then be manually advanced into the patient's intracranial vessels. In some embodiments, surgical catheter 2904 and / or guide catheter 2906 can be robotically driven within the carotid artery. Surgical catheter 2904 and / or guide catheter 2906 can then be manually driven distally beyond the carotid artery.

[0236] In some embodiments, only surgical catheter 2904 is advanced to a specific location. In some embodiments, both surgical catheter 2904 and guide catheter 2906 are advanced to a specific location. Surgical catheter 2904 and guide catheter 2906 can be manually advanced to a specific location together or separately.

[0237] After the surgical catheter 2904 and the guide catheter 2906 are advanced to a specific location, treatment is performed, such as aspiration of a clot. In some embodiments, other interventional devices (e.g., a smaller surgical catheter) may also be added or used at a specific location (e.g., an additional aspiration catheter, a stent retriever, etc.).

[0238] In some embodiments, after surgical catheter 2904 and / or guide catheter 2906 are advanced to a specific location, one or more robotically driven interventional devices (e.g., guidewire 2907 and / or access catheter 2902) can be removed from surgical catheter 2904 and / or guide catheter 2906. Removal can provide a larger cross-sectional lumen area for clot extraction and / or delivery of additional devices. In some embodiments, for example, surgical catheter 2904 can also be removed, and guide catheter 2906 can be used as a surgical catheter to remove the clot. In other embodiments, surgical catheter 2904 can be removed and guide catheter 2906 can be used to deliver additional devices.

[0239] In other embodiments, when the robotically driven guidewire 2907, the robotically driven access catheter 2902, the manually driven surgical catheter 2904, and the manually driven guide catheter 2906 are referenced Figure 25 As depicted, any interventional device or subset of interventional devices can be robotically driven and any interventional device or subset of interventional devices can be manually driven. For example, in some embodiments, a manually driven guidewire 2907 can be used with a robotically driven access catheter 2902, a manually driven surgical catheter 2904, and a manually driven guide catheter 2906.

[0240] In certain embodiments, guide catheter 2906 and surgical catheter 2904 can be robotically driven and access catheter 2902 and guidewire 2907 can be manually driven. For example, robotically driven subgroup 2916 can include surgical catheter 2904 and manually driven subgroup 2918 can include access catheter 2902 and guidewire 2907. In those embodiments, guide catheter 2906 and surgical catheter 2904 can be connected to a robotically controlled guide catheter hub and a robotically controlled surgical catheter hub, respectively.

[0241] In some embodiments, access catheter 2902 can be removably connected to robotically operated drive subassembly 2916 via a connector (e.g., connector 2920a or 2920b). For example, access catheter 2902 can be removably connected to a surgical catheter hub via a connector. In some embodiments, guidewire 2907 can be removably connected to robotically operated drive subassembly 2916 via a connector. For example, in some embodiments, guidewire 2907 can be removably connected to a surgical catheter hub via a connector. In some embodiments, guidewire 2907 can be indirectly removably connected to robotically operated drive subassembly 2916 via a removable connection of access catheter 2902 or a connector of 2902.

[0242] In some embodiments, the manually driven subgroup 2918 (e.g., a guide catheter and / or surgical catheter) may not be connected to the robotically driven subgroup 2916. For example, in certain embodiments, the robotically driven subgroup 2916 may be robotically driven within the patient's vasculature, and one or more interventional devices may be manually inserted and advanced within the robotically driven subgroup 2916 without being connected to the robotically driven subgroup 2916.

[0243] Any combination of interventional devices can be part of both manually-driven subset 2918 and robotically-driven subset 2916. For example, one of the interventional devices (e.g., catheter 2906, catheter 2904, catheter 2902, or guidewire 2907) can be part of robotically-driven subset 2916, and the remaining interventional devices can be part of manually-driven subset 2918 (with one or more of manually-driven subset 2918 being directly or indirectly connected to robotically-driven subset 2916). Alternatively, one of the interventional devices (e.g., catheter 2906, catheter 2904, catheter 2902, or guidewire 2907) can be part of manually-driven subset 2918 (with one or more of manually-driven subset 2918 being directly or indirectly connected to robotically-driven subset 2916), and the remaining interventional devices can be part of robotically-driven subset 2916.

[0244] In certain embodiments, each of access catheter 2902, surgical catheter 2904, guide catheter 2906, and guidewire 2907 can be part of a robotically driven subset 2916. In those embodiments, access catheter 2902, guidewire 2907, surgical catheter 2904, and guide catheter 2906 can be robotically driven.

[0245] In certain embodiments, the guide catheter 2906 can be advanced to a desired location within the vessel (within the desired ostium as described herein) and maintained in that location (or not further advanced distally beyond that location) to allow one or more additional interventional devices to be driven through the guide catheter 2906 further distally into the vascular system. In some embodiments, the guide catheter 2906 remains in the same location throughout the entire procedure or during a critical portion of the procedure. In those embodiments, it is desirable for the guide catheter 2906 to be robotically driven within the vessel to the desired location. In those embodiments, one or more additional interventional devices can be driven manually or robotically through the guide catheter 2906.

[0246] When the catheter 2902, surgical catheter 2904, guide catheter 2906 and guide wire 2907 are entered, refer to Figure 25While depicted, other interventional devices may be used additionally and / or alternatively during the procedure. The devices may be part of the robotically operated actuated subgroup 2916 or the manually actuated subgroup 2918. For example, in certain embodiments, one or more robotically operated actuated interventional devices may be removed from the interventional device assembly, and one or more manually actuated interventional devices may be inserted into the interventional device assembly.

[0247] In some embodiments, additional interventional devices (e.g., stent retrievers, embolic coils, aneurysm coils, coil delivery catheters, and / or occlusive devices) can be inserted within access catheter 2902, surgical catheter 2904, and / or guide catheter 2906 and manually controlled. In some embodiments, the surgical catheter can be a coil delivery catheter. In some embodiments, one or more interventional devices (e.g., access catheter 2902 and guidewire 2907) can be removed from the interventional device assembly prior to inserting the additional interventional devices. For example, in a stroke situation, a stent retriever and / or stent retriever microcatheter can be manually positioned through surgical catheter 2904 and / or guide catheter 2906 to remove a clot, e.g., if aspiration of the clot is difficult.

[0248] Additionally, when the guidewire 2907, access catheter 2902, surgical catheter 2904, and guide catheter 2906 are referenced Figure 25 While described, in other embodiments, only a subset of the devices may be used during a neurovascular procedure. For example, a neurovascular procedure (or at least a portion of the procedure) may be performed without guidewire 2907. In some embodiments, only insertion or access catheter 2902 and guidewire 2907 may be used during the procedure (or at least a portion of the procedure). In some embodiments, only guide catheter 2906 and insertion or access catheter 2902 may be used during the procedure (or at least a portion of the procedure).

[0249] When the guide wire 2907, the access catheter 2902, the surgical catheter 2904 and the guide catheter 2906 are referenced Figure 25 While described, other combinations of interventional devices may be used in a partially robotically driven or partially manually driven assembly of the interventional device. For example, a thrombectomy catheter or access sheath may be used in place of guide catheter 2906. In embodiments where a thrombectomy catheter is used in place of guide catheter 2906, surgical catheter 2904 may be a smaller thrombectomy catheter. In those embodiments (or other embodiments), access catheter 2902 may be a microcatheter and guidewire 2907 may be a microwire.

[0250] In certain embodiments, during surgery, one or more additional interventional devices, which may be a combination of manually driven and / or robotically driven interventional devices, may be added to the interventional device assembly 2900. In certain embodiments, as described herein, during surgery, one or more interventional devices may be removed from the interventional device assembly 2900 and, in some embodiments, may be replaced with other interventional devices.

[0251] For example, in certain embodiments, a stent retriever can replace guidewire 2907. The stent retriever can be connected to hub 2909 or an optional drive member (e.g., an additional hub that can replace hub 2909). The stent retriever can be manually driven or robotically driven.

[0252] In some embodiments, the microcatheter can replace insertion or access catheter 2902. Alternatively, the microcatheter can be inserted through insertion or access catheter 2902. The microcatheter can be connected to hub 2910 or an optional drive member (e.g., an additional hub that can replace hub 2909). The microcatheter can be manually driven or robotically driven.

[0253] Other interventional devices including coils, wires, implants (stents, shunts, intracranial devices), etc., may also be attached to the interventional device assembly during surgery. Any of these devices can be manually or robotically driven.

[0254] In some embodiments, as Figure 25 As shown, when a manually driven subgroup 2918 of detachably connected interventional devices is provided, one or more manually driven interventional devices may not be connected to the robotically operated interventional device at the start of the surgery, but may be introduced during the surgery. For example, in some embodiments, the surgery may begin using one or more robotically operated interventional devices (e.g., components of the robotically operated interventional device). Some time after the start of the surgery, the one or more manually driven interventional devices may be introduced (e.g., via the one or more robotically operated interventional devices). The one or more manually driven interventional devices may at least initially be manually manipulated. After introduction, the one or more manually driven interventional devices may be connected to the one or more robotically operated interventional devices and robotically driven via the one or more robotically operated interventional devices. In other embodiments, the one or more manually driven interventional devices may not be connected to the robotically operated interventional device and may instead remain independently manually movable.

[0255] In some embodiments, as Figure 25As shown, when a manually actuated subset 2918 of detachably connected interventional devices is provided, one or more interventional devices can be operated in a manually actuated mode without detaching the interventional device from the hub. In some embodiments, any of the robotically actuated interventional devices described herein can be selectively operated in a manual mode. In addition, the hub can be removed from the hub assembly and manually manipulated. For example, in some embodiments, an actuator (e.g., a button or switch 2921) can be operated to allow manual movement of the interventional device or its associated hub. The actuator can be located on the hub, on the interventional device, on a drive platform, or otherwise adjacent to the interventional device assembly 2900 or 2900a. In certain embodiments, for the actuator. Additionally or alternatively, resistance sensing can be used to determine whether a user is attempting to manually move the interventional device or hub, and if the resistance sensor detects a value exceeding a threshold, manual movement of the interventional device and / or hub can be permitted.

[0256] In certain embodiments, one or more interventional devices and / or hubs can be robotically operated by a controller that is located so as to allow the user to manually move the other interventional devices while operating the controller. For example, one or more hubs can include a controller (e.g., a joystick or toggle switch 2922) that can be operated by a user with one hand (left or right) to cause robotically driven movement of the corresponding interventional device, while the user manually manipulates another interventional device with the other hand (left or right). Such a configuration can allow the user to robotically control the interventional device while being located close enough to manually control the other interventional devices (e.g., rather than robotically controlling the interventional device from a console remote from the patient). Such a configuration can also provide redundancy to allow robotic control of the interventional device in the event that communication with the remote console is interrupted.

[0257] In certain embodiments, one or more interventional devices (e.g., within the robotically driven subgroup 2916 and the manually driven subgroup 2918) can be transitioned from robotically driven to manually driven during a procedure. In certain embodiments, one or more interventional devices can be transitioned from manually driven to robotically driven during a procedure. For example, one or more interventional devices that are initially part of the robotically driven subgroup 2916 can be transitioned to being part of the manually driven subgroup 2918. Thus, one or more interventional devices can be robotically driven during initialization and transitioned to manual control after the one or more interventional devices are initially positioned. Additionally and / or alternatively, one or more interventional devices that are initially part of the manually driven subgroup 2918 can be transitioned to being part of the robotically driven subgroup 2916. Thus, one or more interventional devices can be manually driven during initialization and transitioned to robotic control after the one or more interventional devices are initially positioned. In some embodiments, a procedure can transition from a fully robotic procedure to a fully manual procedure, or vice versa.

[0258] In some embodiments, one or more interventional devices can be transitioned from robotically driven to manually driven by physically decoupling the interventional device from the robotic drive system. The interventional device can be decoupled from the robotic drive system while portions of the interventional device remain within the patient's blood vessel.

[0259] One or more detached interventional devices can provide different work surfaces. For example, one or more interventional devices can be detached from the drive table and moved to a different work surface (e.g., onto the patient's leg). Detaching and moving the interventional devices can advantageously provide greater ergonomic support for the physician and / or provide the physician with control in a more natural position and / or facilitate the same surgical procedures routinely performed by the physician.

[0260] In certain embodiments, detaching one or more interventional devices can also advantageously allow for the deployment of additional and / or alternative interventional devices (e.g., stent retrievers, embolic coils, aneurysm coils, and / or occlusive devices) through the detached interventional device for manual actuation at a location offset from other components on the drive table (e.g., if there is insufficient workspace on the drive table). For example, in certain embodiments, the robotically actuated guidewire 2907 and the robotically actuated access catheter 2902 can be removed from the robotically actuated surgical catheter 2904 and the robotically actuated guide catheter 2906. In some embodiments, the robotically actuated surgical catheter 2904 and the robotically actuated guide catheter 2906 can be detached from the robotically actuated table for manual use and positioned on a different work surface. One or more additional interventional devices can then be advanced into the vessel through the surgical catheter 2904 and the guide catheter 2906 to a location offset from the location of the withdrawn guidewire 2907 and access catheter 2902.

[0261] In certain embodiments, detaching one or more interventional devices may advantageously allow for alternative mechanisms for driving the interventional devices in the event of a failure of the robotic drive system.

[0262] An embodiment of an interventional device assembly wherein the interventional device can be separated from the robotic drive stage is shown in FIG. Figures 26A to 26B middle.

[0263] Certain embodiments of the hubs described herein, such as hub 36, include a housing (such as housing 38) for connecting to an interventional device herein, components (such as rollers 53 and 55) for direct connection and movement along a drive stage 2610, and magnets for magnetically connecting to a hub adapter through a sterile barrier. In other embodiments, such as FIG. 26A to FIG. 2 8B, a first subassembly or hub configured to connect to or house an interventional device (e.g., first subassembly or hub 2638A, first subassembly or 2638B, first subassembly or 2638C, first subassembly or 2638D) can be removably connected to a second subassembly or mount (e.g., second subassembly or mount 2640A, second subassembly or mount 2640B, second subassembly or mount 2640C, second subassembly or mount 2640D) configured to pass through the sterile field barrier and magnetically connect to the hub adapter and move along the drive stage 2610. Such a hub and mount can together form a hub assembly (e.g., hub assembly 2636A, hub assembly 2636B, hub assembly 2636C, hub assembly 2636D). In some embodiments, the mount can be a magnetic drive member, an axial drive member, a disk, a slider, a shuttle, or a gantry.

[0264] One or more hubs 2638A-D can include a valve, such as a hemostatic valve, to allow an interventional device to be advanced therethrough. For example, in certain embodiments, hub 2638A can include a hemostatic valve to allow one or more interventional devices connected to hubs 2638B-D to be advanced therethrough, thereby facilitating concentric placement of the interventional devices.

[0265] Figures 26A to 26B A plurality of hub assemblies are shown, each hub assembly being connected to a respective interventional device. The plurality of hub assemblies may include a first hub assembly 2636A having a first hub 2368A and a first mounting member 2640A, a second hub assembly 2636B having a second hub 2368B and a second mounting member 2640B, a third hub assembly 2636C having a third hub 2368C and a third mounting member 2640C, and a fourth hub assembly 2636D having a fourth hub 2368D and a fourth mounting member 2640D.

[0266] In certain embodiments, the first hub 2638A can be connected to a guide catheter. In certain embodiments, the second hub 2368B can be connected to a surgical catheter. In certain embodiments, the third hub 2368C can be connected to an access catheter. In certain embodiments, the fourth hub 2368D can be connected to a guide wire.

[0267] For example, such hub assemblies 2636A-D can allow hubs 2638A-D to be removed from mounts 2640A-D so that a different hub can be connected to the same mounts 2640A-D. In some embodiments, a manually driven interventional device can be connected to the same mounts 2640A-D so that it can be robotically driven. In other embodiments, mounts 2640A-D can initially have no interventional device connected thereto, and manually driven interventional devices can be connected to mounts 2640A-D so that they can be robotically driven. Such an arrangement can allow hubs 2638A-D to be replaced with different hubs having different interventional devices connected thereto without disrupting the magnetic connection with the hub adapter. For example, such an arrangement can allow hub 2638C connected to an access catheter to be removed from mounts 2640C and replaced with a hub connected to a surgical catheter without disrupting the magnetic connection with the hub adapter.

[0268] In some embodiments, the hub 2638A-D can be removed from the first mount 2640A-D and connected to a second mount 2640A-D that is distal to or adjacent to the first mount, for example, to provide a different set or arrangement of interventional devices for a portion of the surgery compared to the pre-operative portion.

[0269] For example, in some embodiments, an access assembly of an interventional device can be connected to a drive platform 2610 for a first portion of a medical procedure, and a surgical catheter of the interventional device can be connected to the drive platform 2610 for a second portion of the medical procedure. In some embodiments, a hub 2638A connected to a guide catheter can be connected to a mount 2640A, a hub 2638B connected to an insertion or access catheter (e.g., a 5 French insertion or access catheter) can be connected to a mount 2640B, and a hub 2638C connected to a guidewire (e.g., a 0.035 diameter guidewire) can be connected to a mount 2640C and used to complete aortic arch access. When aortic arch access is completed, mount 2640D can be free of a hub. After aortic arch access is completed, hubs 2638B and 2638C can be removed. Thus, a hub connected to a surgical catheter can be connected to mounting member 2640B, a hub connected to an insertion or access catheter (e.g., an access catheter having an inner diameter of 0.035 in) can be connected to mounting member 2640C, and a hub connected to a guidewire (e.g., a microwire having a diameter of 0.014 in) can be connected to mounting member 2640D, and a procedure, such as aspiration of a clot, can be performed.

[0270] In some embodiments, such as when performing thrombectomy in a distal moderate vessel occlusion (DMVO), it may not be possible to reach the clot with certain surgical catheters, such as a surgical catheter having an inner diameter of 0.071 inches. In those embodiments, a catheter having a smaller outer diameter can be used to reach and aspirate the clot. For example, when the initial deployment of the interventional device includes a first hub 2638A connected to a guide catheter, a second hub 2638B connected to a surgical catheter, a third hub 2638C connected to an access catheter (e.g., a 5 Fr insertion or access catheter), and a fourth hub 2638D connected to a guidewire, hub 2638C can be removed and replaced with a hub connected to a smaller catheter (e.g., a 0.035 inch inner diameter catheter) to navigate to (e.g., through the access catheter) and aspirate the clot. In other embodiments, the smaller catheter can be manually navigated to the clot.

[0271] In some embodiments, hub assemblies 2636A-D can be configured to have hubs 2638A-D connected to mounts 2640A-D (e.g., to provide more working space along drive table 2610) to allow hubs 2638A-D to be removed from mounts 2640A-D to facilitate surgical procedures. For example, as described herein, in some embodiments, an access catheter and / or guidewire can be withdrawn from a surgical catheter prior to aspiration using the surgical catheter. In some embodiments, hub 2638C of the access catheter and / or hub 2638D of the guidewire can be removed from their respective mounts 2640C and 2640D before, after, or simultaneously with withdrawal of the access catheter and / or guidewire from the surgical catheter prior to aspiration using the surgical catheter. In some embodiments, hub 2638A of the guide catheter and hub 2638B of the surgical catheter can remain connected to their respective mounts. In other embodiments, the surgical catheter's hub 2638B or both the surgical catheter hub 2638B and the guide catheter hub 2638A can be separated from their respective connected mounts 2640A and 2640B prior to using the surgical catheter for aspiration.

[0272] In some embodiments, hub assemblies 2636A-D can be removed from mounts 2640A-D by a more distal hub assembly to facilitate access for inserting one or more manually inserted devices. For example, in some embodiments, after initial deployment of an interventional device, including a first hub 2638A connected to a guide catheter, a second hub 2638B connected to a surgical catheter, a third hub 2638C connected to an access catheter, and a fourth hub 2638D connected to a guidewire, hubs 2638B, 2638C, and 2638D can be removed. Following removal, a stent can be manually navigated through the guide catheter for tandem lesion placement. In some such embodiments, the stent is navigated through the guide catheter while hub 2638A is connected to mount 2640A. In other embodiments, hub 2638A is removed from mount 2640A while the guide catheter is positioned within the patient's vessel, and the stent is then navigated through the guide catheter.

[0273] Optionally, one or more hub assemblies 2636A-D can be moved closer to the proximal end of the drive station 2610 to withdraw its corresponding interventional device to facilitate a path for inserting one or more manual devices through a more distal hub assembly.

[0274] In some embodiments, the hub assembly 2636A-D can allow the hub 2638A-D to be removed from the mount 2640A-D so that the hub 2638A-D can be used separately from the mount 2640A-D (e.g., in a manual procedure). Such an arrangement can allow the hub 2638A-D to be removed from the magnetically driven mount 2640A-D so that the hub 2638A-D can be used manually during a medical procedure (e.g., by a user manually manipulating the advancement, retraction, and / or rotation of the hub 2638A-D and its connected interventional device).

[0275] In some embodiments, the interventional device may be robotically driven for one part of the procedure and manually driven for another part of the procedure. Figure 26A As shown, in some embodiments, during at least a portion of the procedure, one or more hubs 2638A-D can be connected or physically coupled to corresponding mounts 2640A-D. As further shown in FIG. 26A , interventional devices can be arranged in a stacked or nested manner.

[0276] In some embodiments, during portions of a procedure, a subset of the multiple interventional devices may be manually driven by decoupling one or more hubs 2638A-D from their respective mounts 2640A-D. For example, Figure 26B Depicted are hub 2638A connected to mount 2640A, hub 2638B separate from mount 2640B, hub 2638C separate from mount 2640C, and hub 2638D separate from mount 2640D.

[0277] In certain embodiments, during a first portion of the procedure, a plurality of interventional devices can be robotically driven to a desired location in the patient's vascular system (e.g., via connections between their respective hubs 2638A-D and robotically driven mounts 2640A-D). Thus, all or a subset of the interventional devices can be detached from their respective mounts 2640A-D via their respective hubs 2638A-D, disconnected from the robotic drive system, while a portion of the interventional devices are positioned in the patient's vascular system. For example, in certain embodiments, a plurality of interventional devices can be robotically driven to achieve aortic arch access. After aortic arch access is complete, all or a subset of the interventional devices can be detached from their respective mounts 2640A-D via their respective hubs 2638A-D, disconnected from the robotic drive system, and additional surgical steps can be performed manually.

[0278] For example, in certain embodiments, a hub assembly 2636A having a hub 2638A connected to a guide catheter 2906, a hub assembly 2636B having a hub 2638B connected to a surgical catheter 2904, a hub assembly 2636C having a hub 2638C connected to an access catheter 2902, and a hub assembly 2636D having a hub 2638D connected to a guidewire 2907 can be driven until aortic arch access is complete and the guide catheter 2906 is positioned within the desired ostium. Thus, one or more hubs 2638B, 2638C, and 2638D can be disconnected from their respective mountings 2640B, 2640C, 2640D, allowing one or more surgical catheters 2904, access catheters 2902, and guidewires 2907 to be used to manually perform additional steps of the procedure, such as when the aortic arch is accessed. Figure 26B For example, one or more surgical catheters 2904, access catheter 2902, and guidewire 2907 can be manually advanced more distally toward the anatomical location. In other embodiments, for example, access catheter 2902 and guidewire 2907 can be withdrawn from the surgical catheter before or after hub 2638B is disconnected from its mounting 2640B, and one or more additional manually inserted interventional devices, such as a stent retriever and / or a stent retriever delivery microcatheter, can be inserted into the surgical catheter to manually perform additional steps of the procedure.

[0279] In other embodiments, the hub 2638A can be individually disconnected from the mounting member 2640A (e.g., after withdrawing the surgical catheter 2904, access catheter 2902, and guidewire 2907 from the guide catheter 2906) or alternatively, via separation of the hub 2638B from the mounting member 2640B (or via separation of additional hubs from their respective mounting members) for manually performing additional surgical steps (e.g., via manually manipulating the hub 2638A and / or via inserting additional manual interventional devices through the hub 2368A and the guide catheter 2906).

[0280] like Figure 26B Further described, one or more interventional devices can remain in a stacked or nested configuration after being disconnected. Portions of the interventional devices can remain within the vascular system and / or within the lumen of an adjacent vascular system while disconnected from the robotic control system.

[0281] The hubs 2638A-2638D can include surfaces configured to be simultaneously supported and manipulated by the corresponding mounting members 2640A-2640D and / or by a human operator. Thus, when one or more hubs 2638A-2638D are disconnected from the corresponding one or more mounting members 2640A-2640D, the corresponding one or more interventional devices can be positioned or moved within the patient's body via manual manipulation of the hubs 2638A-2638D (e.g., via a user grasping, rotating, and / or axially moving the hubs).

[0282] In some embodiments, as Figure 26A As shown, each hub 2638A-C can be in fluid communication with a corresponding mount 2640A-C via a conduit 2642A-C. Each mount 2640A-C can be in communication with a fluid system that can provide fluid (e.g., saline, contrast media, and / or therapeutic agents) and / or vacuum. Conduits 2642A-C can connect a conduit connected to a hub 2638A-C to the fluidics system to provide fluid or vacuum to the conduit.

[0283] In some embodiments, the conduits 2642A-C can remain connected to their respective hubs 2638A-C during manual control. In some embodiments, the conduits 2642A-C can be of sufficient length to advantageously provide the physician with flexibility to manually control the hubs 2638A-C away from the respective mounts 2640A-C. In some embodiments, monitoring and reducing bubbles and / or cavitation within the fluid system can be difficult with longer conduits 2642A-C. The conduits 2642A-C can be between 6 inches and 24 inches in length. For example, the conduits 2642 can be 6 inches, 7 inches, 8 inches, 9 inches, 10 inches, 11 inches, 12 inches, 13 inches, 14 inches, 15 inches, 16 inches, 17 inches, 18 inches, 19 inches, 20 inches, 21 inches, 22 inches, 23 inches, or 24 inches, or any intermediate length. In such an embodiment, the catheters 2642A-C may be long enough to enable a physician to manually control one or more hubs 2638A-C away from the corresponding mounts 2640A-C while monitoring and reducing air bubbles.

[0284] In some embodiments, one or more of the catheters 2642A-C can be separated from their corresponding hubs 2638A-C. In some such embodiments, the hub 2638 can be connected to the fluid dynamics system using an alternative connection (e.g., an alternative catheter or tube set). In some embodiments, the hubs 2638A-C can be fluidically connected to a second fluid source. For example, the hubs 2638A-C can be fluidically connected to a saline and / or contrast agent bag or other fluid source. In some embodiments, the second fluid source can be a gravity-fed or pressurized fluid bag. In some embodiments, the hubs 2638A-C can be connected to a vacuum source, such as a syringe for suction. In some embodiments, the fluids can be connected via a T-connector. The T-connector can be in fluid communication with the saline and / or contrast agent bag and / or the suction source. For example, the T-connector can fluidically connect one or more separate interventional devices to a syringe.

[0285] In some embodiments, one or more hubs 2638A-D can remain connected to their corresponding mounts 2640A-D throughout the procedure. This can advantageously allow a physician to maintain a connection between an interventional device, whose hubs remain connected to their corresponding mounts, and a fluidics system (e.g., via catheter 2642A) throughout the procedure. This can be advantageous during a procedure in which an interventional device can be robotically driven to a specific location, and further movement of the interventional device is undesirable during the remainder of the procedure. For example, in some embodiments, a hub 2638A connected to a guide catheter 2906 can be driven to achieve aortic arch access. Further distal movement of the guide catheter may not be desired during the procedure. In such an embodiment, hub 2638A can remain robotically operatively connected to mount 2640A for the duration of the procedure. This can advantageously allow a physician to maintain a connection between a guide catheter 2906 and a fluidics system (e.g., via catheter 2642A) throughout the procedure.

[0286] like Figures 26A to 26B As shown, in certain embodiments, the interventional device assembly 2600 can include multiple hub assemblies. In some embodiments, the multiple hub assemblies can include a first hub assembly 2636A, a second hub assembly 2636B, a third hub assembly 2636C, and a fourth hub assembly 2636D. Each of the multiple hub assemblies can include a corresponding first subassembly or hub 2638A-D, a corresponding second subassembly or mount 2640A-D, and one or more anti-buckling devices 2602, 2604, 2606, and 2607, which can be in the form of telescoping tubes. The one or more anti-buckling devices 2602, 2604, 2606, and 2607 can provide support for one or more interventional devices extending between the one or more hub assemblies.

[0287] In some embodiments, the first anti-buckling device 2606 can extend from the hub 2638A of the first hub assembly 2636A to a distal support at a distal portion of the drive platform 2610 having a support surface 2612. The first anti-buckling device 2606 is removably connected to the distal support to allow for detachment of the first anti-buckling device prior to detaching the hub 2638A from the mount 2640A of the first hub assembly 2636A.

[0288] The second anti-buckling device 2604 can extend between the hub 2638B and the hub 2638A of the second hub assembly 2636B and can be removably connected to the hub 2638A. In some embodiments, if it is necessary to separate the hub 2638A from its mounting member 2640A, but it is not necessary to separate the hub 2638B from its mounting member 2640B, the second anti-buckling device 2604 can be separated from the hub 2638A before separating the hub 2638A from its mounting member 2640A. In other embodiments, if both the hub 2638A and the hub 2638B are separated from their respective mounting members, the second anti-buckling device 2604 can remain connected to the hub 2638A. In some embodiments, if the hub 2638A is also not separated from its mounting member 2640A (e.g., Figure 26B ), the second anti-buckling device 2604 may be separated from the hub 2638A before separating the hub 2638B from the mounting member 2640B. Figure 26B The second anti-buckling device 2604 is shown retracted and / or separated from the hub 2638B. The hub 2638B can be separated from its mounting member 2640B while the surgical catheter 2904 is located within the guide catheter 2906.

[0289] The third anti-buckling device 2602 can extend between the hub 2638C and the hub 2638B of the third hub assembly 2636C and can be removably connected to the hub 2638B. In some embodiments, if it is necessary to separate the hub 2638B from the mounting member 2640B without separating the hub 2638C from its mounting member 2640C, the third anti-buckling device 2602 can be separated from the hub 2638B before separating the hub 2638B from the mounting member 2640B. In other embodiments, if both the hub 2638B and the hub 2638C are separated from their respective mounting members, the third anti-buckling device 2602 can remain connected to the hub 2638B (e.g., as shown in FIG. 2 ). Figure 26B In some embodiments, the third anti-buckling device 2602 can be separated from the hub 2638B before the hub 2638C is separated from the mounting member 2640C, if the hub 2638B is also not separated from its mounting member 2640B.

[0290] The fourth anti-buckling device 2607 can extend between the hub 2638D and the hub 2638C of the fourth hub assembly 2636D and can be removably connected to the hub 2638C. In some embodiments, if it is necessary to separate the hub 2638C from the mounting member 2640C without separating the hub 2638D from its mounting member 2640D, the fourth anti-buckling device 2607 can be separated from the hub 2638C before separating the hub 2638C from the mounting member 2640C. In other embodiments, if both the hub 2638C and the hub 2638D are separated from their respective mounting members, the fourth anti-buckling device 2607 can remain connected to the hub 2638C (e.g., as in Figure 26B In some embodiments, the anti-buckling device 2607 can be separated from the hub 2638C before the hub 2638D is separated from the mounting member 2640D, if the hub 2638C is not also separated from its mounting member 2640C.

[0291] In certain embodiments, such as FIG. 26A to FIG. 26B As shown, hubs 2638A-D may be removably secured to mounting members 2640A-D using clamp mechanism members 2644A-D.

[0292] In certain embodiments, one or more hub assemblies having a removable hub connected to a mount may be used in an embodiment in which one or more manually operated interventional devices are connected (directly or indirectly) to an adjacent interventional device or an adjacent interventional device hub, e.g., as described with reference to Figure 25 As described. For example, in certain embodiments, one or both of hubs 2910 and 2909 can be a hub assembly having a removable hub connected to a mounting member. In such embodiments, the interventional devices of the manually driven subgroup 2918 can be directly or indirectly connected to the hub, mounting member, and / or interventional device of one of the hub assemblies via one or more connecting mechanisms (e.g., 2920a and 2920b). In such embodiments, manual movement of the interventional device can be provided by separating the hub of the hub assembly from its corresponding mounting member or by separating the interventional device of the manually driven subgroup 2918 from an adjacent hub assembly.

[0293] FIG. 26A to FIG. 26B The interventional device assembly 2600 may have Figure 25 For example, when one or more hubs 2638A-D are separated from their respective mounts 2640A-D, the hubs 2638A-D and their corresponding interventional devices can be manually manipulated to perform the same or similar surgical steps as described with reference to the interventional devices of the manually-actuated subassembly 2918 when separated from the robotically-actuated subassembly 2916, or vice versa.

[0294] In certain embodiments, an interventional device assembly having both robotically driven and manually driven interventional devices can allow the interventional device to be robotically driven to a specific location in the anatomical structure and allow the interventional device to be manually driven beyond a specific location. For example, in some embodiments, one or more interventional devices can be robotically driven to the vicinity of and within the carotid artery. Then, the same or different interventional device can be manually driven distally beyond the carotid artery. In certain embodiments, an interventional device assembly having both robotically driven and manually driven interventional devices can allow multiple doctors and / or technicians to perform neurovascular surgery. For example, a first doctor or technician can robotically drive a robotically driven interventional device while a second doctor or technician can manually drive a manually driven interventional device. In certain embodiments, a remote doctor or technician can perform the robotically driven portion of the surgery while a bedside doctor or technician can perform the manual portion of the surgery.

[0295] Although an interventional device assembly using a robotically operated interventional device and a manually operated interventional device for performing neurovascular procedures is described, the interventional device assembly having a robotically operated interventional device and a manually operated interventional device can be used to perform a variety of interventional procedures. The interventional device assembly having a robotically operated interventional device and a manually operated interventional device described herein can be readily adapted for use in any of a variety of other diagnostic and therapeutic applications throughout the body, including, in particular, endovascular procedures, such as in the peripheral vasculature (e.g., deep vein thrombosis), central vasculature (pulmonary embolism), and coronary vasculature, as well as in other hollow organs or tubular structures in the body.

[0296] The interventional devices described herein can be provided individually, or at least some of the interventional devices can be provided in a preassembled (e.g., nested or stacked) configuration. For example, the interventional devices can be provided in a coaxial nested or stacked configuration in the form of an interventional device assembly (e.g., interventional device assembly 2900). If provided individually, each catheter (and in some embodiments, each corresponding catheter hub) can be unpacked and pre-filled to remove air from its inner lumen, for example, by flushing the catheter (and in some embodiments, flushing the corresponding catheter hub) to remove air by displacing the air with a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent). After pre-filling, the interventional devices can be manually assembled into a stacked configuration so that they are ready to be introduced into the body for surgical use, for example, via an introducer sheath.

[0297] Assembling the devices into a stacked configuration may include inserting the interventional devices individually into each other in order of size. For example, an interventional device having the second largest diameter may be inserted into the lumen of an interventional device having the largest diameter. An interventional device having the third largest diameter may then be inserted into the lumen of an interventional device having the second largest diameter, and so on.

[0298] For example, by Figure 17 , can be assembled by first inserting the distal end of catheter 2904 through hub 2914 and into catheter 2906. Catheter 2904 can be advanced through catheter 2906 until the distal tip of catheter 2904 is flush with or extends beyond the distal tip of catheter 2906, and / or until catheter 2904 can no longer be inserted. Then, the distal end of catheter 2902 can be inserted through hub 2912 and into catheter 2904. Catheter 2902 can be advanced through catheter 2904 until the distal tip of catheter 2902 is flush with or extends beyond the distal tip of catheter 2904, and / or until catheter 2902 can no longer be inserted. Then, the distal end of guidewire 2907 can be inserted through hub 2910 and into catheter 2902. The guidewire 2907 may be advanced through the catheter 2902 until the distal tip of the guidewire 2907 is flush with or extends beyond the distal tip of the catheter 2902 and / or until the guidewire 2907 cannot be inserted any further.

[0299] Embodiments in which two or more interventional devices are packaged together as a single assembly in an assembled (e.g., nested or stacked) configuration can provide efficient unpacking and preparation prior to use, and provide efficient assembly within a robotic control system. The interventional devices can be pre-installed to their respective hubs prior to packaging. In certain embodiments, two or three or more interventional devices can be packaged in a fully nested (i.e., fully axially inserted) configuration or an almost fully nested configuration. In a fully nested configuration, each interventional device is inserted as far as possible into the adjacent distal hub and interventional device. Such a fully nested configuration can minimize the total length of the interventional device assembly and minimize the size of the packaging required to accommodate the interventional device assembly.

[0300] In some embodiments, interventional device can also be sterilized before packaging, while in assembly configuration, for example, using ethylene oxide gas.In some embodiments, before sterilizing with ethylene oxide gas, interventional device can be packaged in assembly configuration.For the interventional device of nested or stacked configuration, ethylene oxide gas can be provided in the space (for example, the annular lumen between the outer diameter of the first interventional device and the inner diameter of the second interventional device nested in the second interventional device) between adjacent interventional devices for sterilization.In some embodiments, interventional device assembly can be packaged in a thermoformed tray and sealed with HDPE (for example, Tyvek®) lid. The interventional device assembly can be unpacked by removing (for example, opening or peeling off) lid by the user in a non-sterile area. Then, the user in the sterile area can remove the interventional device assembly and place it on the sterile working surface of, for example, a robot-driven table, as described herein.

[0301] Packaging the interventional devices in an assembled configuration and sterilized state can reduce the time associated with unpacking and assembling individual interventional devices and facilitate efficient connection to a robotic drive system. Each interventional device and hub combination can also be packaged with fluidic connectors for connecting to a fluid source and / or vacuum source. In some embodiments, each hub or hemostatic valve connected to the hub can include a fluidic connector.

[0302] After unpacking the interventional device assembly (e.g., after positioning the interventional device assembly on the robotic drive stage), priming can be performed while the devices are coaxially nested or stacked. This is preferably done in each fluid lumen, e.g., the annular lumen between catheter 2906 and catheter 2904, and between each additional concentric interventional device in the concentric stack. In some embodiments, the fluid lumen can include a lumen between the distal hub and the proximal interventional device, e.g., the lumen between hub 2914 and catheter 2904. In some embodiments, priming can be performed while the devices are still in sterile packaging.

[0303] The fluidics connector can be connected to a fluidics system for delivering saline and contrast media to conduit and providing suction. In some embodiments, the fluidics connector can be delivered to the outside of the sterile area for connection to the fluidics system. After connection, the fluidics system can carry out a series of pre-fills to rinse each conduit of the interventional device assembly with fluid (for example, saline, contrast media, or a mixture of saline and contrast media). A series of pre-fills can also include flushing each corresponding conduit hub with fluid. Fluid can be removed by the fluidics system before pre-filling or removed by gas. In some embodiments, the vacuum source of the fluidics system can also be used for evacuating air from each conduit while flushing with fluid. In certain embodiments, the tip of the conduit can be placed in the container of fluid (for example, saline, contrast media, or a mixture of saline and contrast media) during pre-filling so that when applying a vacuum source, the fluid in the container rather than air is aspirated by the tip of the conduit. In other embodiments, the tip of the conduit can be closed (for example, using a plug) so that when applying a vacuum source, air can not be aspirated from the tip of the conduit. In certain embodiments, the priming process can be automated such that a user can provide a single command, and each catheter (and in some embodiments, each corresponding catheter hub) can be primed sequentially or simultaneously (e.g., as by 20A to 20C described).

[0304] Additional details regarding the fluidics system are described in U.S. patent application serial number 17 / 879,614, filed on August 2, 2022, entitled “MultiCatheter System With Integrated Fluidics Management,” which is hereby expressly incorporated herein in its entirety.

[0305] When the cross-sectional lumen area available for flow is reduced, for example, when a second interventional device (e.g., a catheter or guidewire) is extended within the lumen of a first interventional device, the fluid resistance within the lumen can be greater. For example, the amount of fluid resistance can be affected by the length narrowing of the cross section due to the depth of axial insertion of the second interventional device within the first interventional device. A second interventional device that extends partially through the lumen of the first interventional device will provide a smaller length narrowing of the cross section and, therefore, may result in a lower fluid resistance within the lumen of the first catheter than would be the case if the second interventional device were fully extended through the lumen of the first interventional device. Thus, fluid resistance can be reduced by at least partially reducing the depth to which the second interventional device is axially inserted (i.e., axially overlapped) into a lumen through which fluid is injected (e.g., the length of the second interventional device into its concentrically adjacent lumen).

[0306] In some embodiments, at certain insertion depths of the second interventional device within the first interventional device (e.g., when the second interventional device is at or near a maximum insertion depth within the first interventional device), the size of the fluid pathway between the devices (e.g., the annular lumen between the first interventional device and the second interventional device) can result in a higher than desired amount of fluid resistance during the priming process. In some embodiments, the insertion depth of the second interventional device within the first interventional device can be reduced to reduce the pressure required to prime the catheter and reduce internal interference.

[0307] In some embodiments, the catheter in the interventional device assembly can be separated from other interventional devices, for pre-filling, to reduce the pressure required for pre-filling catheter and to reduce internal interference. By making the interventional device retract to the proximal end in the lumen of catheter, the catheter to be pre-filled can be separated from the interventional device in the lumen of catheter. For example, the interventional device in the lumen of catheter to be pre-filled can be retracted to the proximal end as far as possible from the catheter to be pre-filled, while still keeping nested or stacked relationship (for example, at least about 2 cm or 5 cm or more axial overlap), so as to minimize the pressure required for pre-filling catheter and minimize internal interference. In other words, catheter can be separated from the interventional device of more proximal end, for pre-filling, and the distal tip of adjacent proximal interventional device is still located in the lumen of catheter simultaneously. At least some distal tips of adjacent proximal interventional devices are maintained in the lumen of catheter and can be allowed to more easily reinsert and advance the proximal interventional device after pre-filling.

[0308] In some embodiments, the axial overlap can be from about 2 cm to about 20 cm, from about 2 cm to 10 cm, from about 2 cm to 5 cm, from about 5 cm to 20 cm, from about 5 cm to 10 cm, or any other suitable range. In some embodiments, the axial overlap can be at least about 2 cm, at least about 5 cm, at least about 10 cm, at least about 20 cm, no more than 2 cm, no more than 5 cm, no more than 10 cm, no more than 20 cm, about 2 cm, about 5 cm, about 10 cm, about 20 cm, or any other suitable amount.

[0309] In some embodiments, the robotically driven stage can be programmed to retract the internal interventional device proximally from the catheter to be primed as much as possible while still maintaining a nested or stacked relationship. In other embodiments, the robotically driven stage can be programmed to separate the internal device from the catheter to be primed to a distance sufficient to optimize the length of the unobstructed lumen and result in an amount of fluid resistance below a threshold. After the catheter to be primed is separated from the other interventional devices, the catheter can be primed by flushing the catheter with a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent).

[0310] After the catheter is primed, it can be returned to the initial position and the next catheter of the interventional device assembly can be separated from the other interventional devices within its lumen for primed. This sequence can be repeated for each catheter of the interventional device assembly. In other embodiments, after the catheter is primed, it can be advanced to a ready or driven position to begin insertion into the patient. Although the foregoing describes the separation of the catheter to be primed by retraction of the inner interventional device, the outer catheter can also be separated from the inner interventional device by axially advancing the outer catheter distally relative to the inner interventional device. 20A to 20C , an example of the precharging process is described.

[0311] Figure 20A The interventional device assembly 2900 is depicted assembled in a concentrically stacked and axially compressed configuration. Figure 20A As shown, the interventional devices can be completely nested within each other. This can be the configuration after the device assembly 2900 is unpacked and placed on the robotic drive table. A series of priming can be initiated by axially advancing the catheter 2906 and hub 2914 distally relative to the catheter 2904, hub 2912, catheter 2902, hub 2910, guidewire 2907 and hub 2909, for example, as far as possible while maintaining the distal tip of the catheter 2904 within the lumen of the catheter 2906, as shown. Figure 20B As shown, or advanced to a distance that will result in the desired amount of fluid resistance for priming. In some embodiments, the catheter 2906 is advanced in response to a control signal from a control system. The catheter 2906 can then be primed by introducing a priming fluid using a fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. The priming catheter 2906 may include a priming hub 2914. For example, in certain embodiments, the hub 2914 or a hemostatic valve connected thereto may include a fluidics connector to receive the priming fluid from the fluidics system. After priming, the catheter 2906 can be returned to its initial position (e.g., a fully axially compressed configuration), as shown. Figure 20A In some embodiments, the catheter 2906 is returned to its initial position in response to a control signal from the control system.

[0312] After catheter 2906 is primed and returned to its initial position, catheter 2904 and hub 2912 can be advanced distally axially relative to catheter 2902, hub 2910, guidewire 2907, and hub 2909 (also advancing catheter 2906 and hub 2914 axially distally without changing or minimally changing their relative positions relative to catheter 2904), e.g., as far as possible while maintaining the distal tip of catheter 2902 within the lumen of catheter 2904, as shown. Figure 20CAs shown, or is advanced to a distance that will result in the desired amount of fluid resistance for priming. In some embodiments, catheter 2904 and catheter 2906 are advanced in response to a control signal from a control system. Catheter 2904 can then be primed by introducing a priming fluid using a fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. The priming catheter 2904 may include a priming hub 2912. For example, in certain embodiments, the hub 2912 or a hemostatic valve connected thereto may include a fluidics connector to receive the priming fluid from the fluidics system. After priming, catheter 2904 and catheter 2906 can be returned to their initial positions (e.g., a fully axially compressed configuration), as shown. Figure 20A In some embodiments, conduit 2904 and conduit 2906 are returned to their initial positions in response to a control signal from a control system.

[0313] After catheter 2904 is primed and returned to its initial position, catheter 2902 and hub 2910 can be axially advanced distally relative to guidewire 2907 and hub 2909 (also axially advancing catheter 2906, hub 2914, catheter 2904, and hub 2912 distally without changing or minimally changing their relative positions relative to catheter 2902), for example, as far as possible while maintaining the distal tip of guidewire 2907 within the lumen of catheter 2902, or to a distance that will result in the desired amount of fluid resistance for priming. In some embodiments, catheter 2902, catheter 2904, and catheter 2906 are advanced in response to a control signal from a control system. Catheter 2902 can then be primed by introducing a priming fluid using a fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. Priming catheter 2902 may include priming hub 2910. For example, in some embodiments, hub 2910 or a hemostatic valve connected thereto may include a fluidic connection to receive priming fluid from the fluidic system. After priming, catheter 2902 and catheters 2904 and 2906 may be returned to Figure 20A 2902, 2904, and 2906 are shown in their initial positions (eg, fully axially compressed configuration). In some embodiments, conduit 2902, conduit 2904, and conduit 2906 are returned to their initial positions in response to a control signal from a control system.

[0314] In some embodiments, by 20A to 20C The described priming procedure can be performed in response to a single control signal from a control system. In other embodiments, the various steps of the priming procedure can be performed in response to unique control signals. In some embodiments, the priming of each unique interventional device can be performed in response to a unique control signal.

[0315] In an alternative embodiment, each of the catheters can be distally separated from each other simultaneously for priming. For example, catheter 2902 can be distally separated from guidewire 2907 while maintaining the distal tip of guidewire 2907 within the lumen of catheter 2902, catheter 2904 can be distally separated from catheter 2902 while maintaining the distal tip of catheter 2902 within the lumen of catheter 2904, and catheter 2906 can be distally separated from catheter 2904 while maintaining the distal tip of catheter 2904 within the lumen of catheter 2906. However, as shown by 20A to 20C In the described embodiments, only one set of adjacent hubs is separated at a time, which can provide a smaller overall assembly length at any given time, which can allow for use with smaller robotic drive systems. Although separation of the outer catheters from their inner interventional devices is described as axially advancing the catheters distally relative to their inner interventional devices, separation can include proximally retracting the inner interventional devices from the outer catheters.

[0316] In an alternative embodiment, one or more of catheters 2902, 2904, and 2906 can be advanced to a ready or actuated position to initiate insertion into a patient after priming (e.g., before priming a subsequent catheter). In such an embodiment, the catheters can be advanced to the ready or actuated position without returning to their initial positions after priming.

[0317] As described above, in some embodiments, the catheters 2902, 2904, and 2906 can be assembled prior to flushing the catheter. Figure 17 The concentric stack shown is oriented to remove air by displacing it with a fluid (e.g., saline contrast or a mixture of saline and contrast). This is preferably done in each fluid lumen, e.g., the annular lumen between catheter 2906 and catheter 2904, and between each of the additional concentric interventional devices in the concentric stack. Infusing fluid (e.g., saline, contrast, or a mixture of saline and contrast) under pressure can displace substantially all of the air, but may retain some small bubbles that adhere to the inner wall of the outer catheter (e.g., guide catheter 2906), the outer wall of the inner catheter (e.g., surgical catheter 2904), or both.

[0318] When fluid is introduced into the proximal end of annular lumen under pressure (for example, be introduced into the hub of outer conduit or be connected in the hemostatic valve thereon), interior conduit can move relative to outer conduit, to destroy the holding power between microbubble and adjacent wall, and allow bubble to be brought downstream and be discharged or be removed via suction by the distal opening of cavity. Conduit can be axially, rotationally or axially and rotationally moved relative to each other. In certain embodiments, conduit can be axially, rotationally or axially and rotationally moved back and forth relative to each other. In some embodiments, conduit can be reciprocating, axially, rotationally or reciprocating axially and rotationally moved. In other embodiments, conduit can rotate continuously or rotate with a constant direction.

[0319] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating over a stroke length of about 1 mm to about 250 mm, about 10 mm to about 250 mm, about 5 mm to about 125 mm, about 25 mm to about 125 mm, about 10 mm to about 50 mm, about 15 mm to about 30 mm, about 5 mm to about 30 mm, about 15 mm to about 25 mm, about 20 mm to about 40 mm, or any other suitable range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating over a stroke length of at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, at least 30 mm, at least 50 mm, no more than 10 mm, no more than 20 mm, no more than 25 mm, no more than 30 mm, no more than 50 mm, no more than 125 mm, no more than 150 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 50 mm, or any other suitable stroke length.

[0320] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating at a reciprocating frequency of about 0.5 Hz to about 1 Hz, about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 25 Hz, about 5 Hz to about 10 Hz, about 10 Hz to about 25 Hz, or any other suitable frequency range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating at a reciprocating frequency of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, no more than 0.5 Hz, no more than 1 Hz, no more than 2 Hz, no more than 5 Hz, no more than 10 Hz, no more than 25 Hz, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency.

[0321] In one embodiment, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating over a stroke length of about 0.5 inches to about 10 inches, or axially reciprocating over a stroke length of about 1 inch to about 5 inches at a reciprocating frequency of no more than about 5 cycles / second or two cycles / second or less.

[0322] In some embodiments, the first catheter is reciprocated relative to an adjacent catheter or guidewire, for example, at an angle of about 5 degrees to about 180 degrees, about 5 degrees to about 360 degrees, about 15 degrees to about 180 degrees, about 15 degrees to about 150 degrees, about 15 degrees to about 120 degrees, about 15 degrees to about 90 degrees, about 15 degrees to about 60 degrees, about 15 degrees to about 30 degrees, about 30 degrees to about 180 degrees, about 30 degrees to about 150 degrees, about 30 degrees to about 120 degrees, about 30 degrees to about 90 degrees, about 15 degrees to about 60 degrees, about 15 degrees to about 30 degrees, about 30 degrees to about 180 degrees, about 30 degrees to about 150 degrees, about 30 degrees to about 120 degrees, about 30 degrees to about 150 degrees. Rotatably reciprocates about an angle of rotation / stroke of about 90 degrees, about 30 degrees to about 60 degrees, about 60 degrees to about 180 degrees, about 60 degrees to about 150 degrees, about 60 degrees to about 120 degrees, about 60 degrees to about 90 degrees, about 90 degrees to about 180 degrees, about 90 degrees to about 150 degrees, about 90 degrees to about 120 degrees, about 120 degrees to about 180 degrees, about 120 degrees to about 150 degrees, about 150 degrees to about 180 degrees, or any other suitable range of rotation angles / strokes. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, rotationally reciprocating with a rotational angle / stroke of at least 5 degrees, at least 15 degrees, at least 30 degrees, at least 60 degrees, at least 90 degrees, at least 120 degrees, at least 150 degrees, at least 180 degrees, at least 360 degrees, no more than 5 degrees, no more than 15 degrees, no more than 30 degrees, no more than 60 degrees, no more than 90 degrees, no more than 120 degrees, no more than 150 degrees, no more than 180 degrees, no more than 360 degrees, about 5 degrees, about 15 degrees, about 30 degrees, about 60 degrees, about 90 degrees, about 120 degrees, about 150 degrees, about 180 degrees, about 360 degrees, or any other suitable angle.

[0323] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, rotationally reciprocating at a reciprocating frequency of about 0.5 Hz to about 1 Hz, about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 25 Hz, about 5 Hz to about 10 Hz, about 10 Hz to about 25 Hz, or any other suitable frequency range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, rotationally reciprocating at a reciprocating frequency of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, no more than 0.5 Hz, no more than 1 Hz, no more than 2 Hz, no more than 5 Hz, no more than 10 Hz, no more than 25 Hz, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency.

[0324] In some embodiments, the first catheter is reciprocated relative to an adjacent catheter or guidewire for a reciprocating number of times within a range of 1 to 200, 1 to 100, 1 to 50, 1 to 25, 1 to 15, 1 to 10, 1 to 5, 5 to 25, 5 to 15, 5 to 10, or any other suitable range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire for at least 1 back and forth, at least 2 back and forth, at least 5 back and forth, at least 10 back and forth, at least 15 back and forth, at least 25 back and forth, at least 50 back and forth, no more than 5 back and forth, no more than 10 back and forth, no more than 15 back and forth, no more than 25 back and forth, no more than 50 back and forth, no more than 100 back and forth, no more than 200 back and forth, about 1 back and forth, about 2 back and forth, about 5 back and forth, about 10 back and forth, about 25 back and forth, about 50 back and forth, about 100 back and forth, about 200 back and forth, or any other suitable number of reciprocating movements. A reciprocating movement can include moving (axially or rotationally) from a first position to a second position and then returning to the first position from the second position.

[0325] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire over a length of time from about 1 second to about 60 seconds, from about 1 second to about 45 seconds, from about 1 second to about 30 seconds, from about 1 second to about 20 seconds, from about 1 second to about 15 seconds, from about 1 second to about 10 seconds, from about 5 seconds to about 45 seconds, from about 5 seconds to about 30 seconds, from about 5 seconds to about 20 seconds, from about 5 seconds to about 15 seconds, from about 5 seconds to about 10 seconds, from about 10 seconds to about 30 seconds, from about 10 seconds to about 20 seconds, or any other suitable range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire for a period of at least 1 second, at least 5 seconds, at least 10 seconds, at least 15 seconds, at least 20 seconds, at least 30 seconds, at least 45 seconds, at least 60 seconds, no more than 5 seconds, no more than 10 seconds, no more than 15 seconds, no more than 20 seconds, no more than 30 seconds, no more than 45 seconds, no more than 60 seconds, about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 30 seconds, about 45 seconds, about 60 seconds, or any other suitable period of time.

[0326] The reciprocating movement of adjacent catheters to destroy microbubbles can be accomplished by manually grasping the corresponding catheter hubs and manually moving the catheters axially or rotationally relative to each other while delivering a pressurized fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent). Alternatively, in a robotically driven system, for example, the processor can be configured to robotically drive at least one of two adjacent catheter hubs (e.g., at least one of hub 2914 and hub 2912) to achieve relative movement between adjacent catheters to destroy and expel microbubbles, such as in response to user activation of a flush control. For example, in certain embodiments, two adjacent interventional devices can be moved relative to each other in response to a control signal from a control system. In certain embodiments, the delivery of the pressurized fluid can be performed in response to a control signal from a control system.

[0327] The reciprocating movement of adjacent conduits can generate a shear force that removes bubbles. For example, the relative movement of the inner and outer surfaces of adjacent conduits can increase the fluid shear rate between adjacent conduits during pre-filling compared to a static surface. In some embodiments, shear force can be increased by increasing the flow rate of a solution (e.g., saline, contrast agent, or a mixture of saline and contrast agent) provided by a fluidics system. In certain embodiments, the flow rate and relative movement between adjacent conduits are controlled to remove bubbles.

[0328] In some embodiments, after each catheter is primed with the fluidics system, an ultrasonic bubble detector can be used to confirm that the catheter is substantially free of bubbles. For example, an ultrasound chip (e.g., mounted within a hub adjacent to the catheter receiving lumen) can be extended along the length of the catheter to confirm that no bubbles remain in the system.

[0329] pass Figures 21A to 21B An example of a priming procedure involving reciprocating movement of adjacent catheters is described.

[0330] Figure 21A The interventional device assembly 2900 is depicted assembled in a concentric stacked configuration. Figure 21A As shown, the interventional devices can be completely nested within each other. This can be the configuration after the device assembly 2900 is unpacked and placed on the robotic drive table. Alternatively, the individual interventional devices of the device assembly 2900 can be assembled into the device assembly 2900 on the drive table.

[0331] A series of priming can be initiated by priming catheter 2906. In some embodiments, catheter 2906 can be primed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of catheter 2906 while causing axial, rotational, or axial and rotational reciprocating movement of catheter 2906 and / or hub 2914 relative to catheter 2904. The priming catheter 2906 can include a priming hub 2914. For example, in certain embodiments, hub 2914 or a hemostatic valve connected thereto can include a fluidic connector to receive priming fluid from a fluidic system. In certain embodiments, catheter 2906 and / or hub 2914 can be positioned along the longitudinal axis of catheter 2906 (e.g., at Figure 21A location and Figure 21B The axial and / or rotational reciprocating motion of the conduit 2906 and / or hub 2914 can be performed manually or by a robotically driven stage. The reciprocating motion can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0332] In some embodiments, priming of the catheter 2906 can be performed by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) under pressure into the lumen of the catheter 2906 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of the catheter 2904 and / or hub 2912 relative to the catheter 2906. The axial and / or rotational reciprocating movement of the catheter 2904 and / or hub 2912 can be performed manually or by a robotic drive stage. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0333] In some embodiments, priming of catheter 2906 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of catheter 2906 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of catheter 2906 (and / or hub 2914) and catheter 2904 (and / or hub 2912) relative to each other. The reciprocating movement can be caused in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0334] In some embodiments, after priming the catheter 2906, the catheter 2906 can be returned to the Figure 21A In other embodiments, after priming the catheter 2906, the catheter 2906 can be advanced to a ready or actuated position to begin insertion into the patient.

[0335] In some embodiments, after catheter 2906 is prefilled, catheter 2904 can be prefilled. Prefilling catheter 2904 can include a prefilling hub 2912. For example, in certain embodiments, hub 2912 or a hemostatic valve connected thereto can include a fluidic connector to receive a prefill fluid from a fluidics system. In some embodiments, catheter 2904 can be prefilled by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) under pressure into the lumen of catheter 2904 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of catheter 2904 and / or hub 2912 relative to catheter 2902. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0336] In some embodiments, priming of the catheter 2904 can be performed by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) under pressure into the lumen of the catheter 2904 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of the catheter 2902 and / or hub 2910 relative to the catheter 2904. The axial and / or rotational reciprocating movement of the catheter 2902 and / or hub 2910 can be performed manually or by a robotic drive stage. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0337] In some embodiments, priming of catheter 2904 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of catheter 2904 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of catheter 2904 (and / or hub 2912) and catheter 2902 (and / or hub 2910) relative to each other. The reciprocating movement can be caused in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0338] In some embodiments, after priming the catheter 2904, the catheter 2904 can be returned to the Figure 21A In some embodiments, after priming catheter 2904, catheter 2904 can be advanced to a ready or actuated position to begin insertion into the patient.

[0339] In some embodiments, after catheter 2904 is pre-filled, catheter 2902 can be pre-filled. Pre-filled catheter 2902 can include a pre-filled hub 2910. For example, in certain embodiments, hub 2910 or a hemostatic valve connected thereto can include a fluidic connector to receive a pre-filled fluid from a fluidic system. In some embodiments, catheter 2902 can be pre-filled by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) into the lumen of catheter 2902 under pressure while causing axial, rotational, or axial and rotational reciprocating movement of catheter 2902 and / or hub 2910 relative to guidewire 2907. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of fluid under pressure can be performed in response to a control signal from a control system.

[0340] In some embodiments, priming of the catheter 2902 can be performed by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) under pressure into the lumen of the catheter 2902 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of the guidewire 2907 and / or hub 2909 relative to the catheter 2902. The axial and / or rotational reciprocating movement of the guidewire 2907 and / or hub 2909 can be performed manually or by a robotic drive station. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0341] In some embodiments, priming of the catheter 2902 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of the catheter 2902 while simultaneously causing the catheter 2902 (and / or hub 2910) and the guidewire 2907 (and / or hub 2909) to reciprocate axially, rotationally, or both axially and rotationally relative to each other. The reciprocating movement can be caused in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0342] In some embodiments, after priming the catheter 2902, the catheter 2902 can be returned to the Figure 21A In other embodiments, after priming the catheter 2902, the catheter 2902 can be advanced to a ready or actuated position to begin insertion into the patient.

[0343] In some embodiments, by Figure 21A and Figure 21BThe described priming procedure can be performed in response to a single control signal from a control system. In other embodiments, the various steps of the priming procedure can be performed in response to unique control signals. In some embodiments, priming of a unique interventional device can be performed in response to a unique control signal.

[0344] In this article through Figure 21A and Figure 21B In the series of priming described, the catheters are primed sequentially, starting with catheter 2906, followed by catheter 2904, and then catheter 2902. However, it is contemplated that the catheters may be primed in any order. The catheters may be primed as described above. Figure 21A and Figure 21B Alternatively, two or more catheters, or each catheter, may be primed in parallel.

[0345] In certain embodiments, the priming of the catheter may include reducing the depth of axial insertion (i.e., axial overlap) of the second interventional device into the lumen of the first interventional device through which the fluid is injected (e.g., the length of the second interventional device into its concentrically adjacent lumen), such as by 20A to 20C As described, and also during priming, relative reciprocating movement is generated axially, rotationally, or axially and rotationally between the first interventional device and the second interventional device, such as by Figure 21A and Figure 21B described.

[0346] In some embodiments, priming of the catheter can include vibrating at least a portion of the catheter and / or its associated hub (when included). For example, the vibration can be induced by a motor integrated into the hub of the catheter, or by a separate motor or vibration source placed on the catheter during priming. In some embodiments, at least a portion of the support platform on which the catheter and / or its associated hub is placed can be vibrated during priming of any one or more catheters to help remove air and / or air microbubbles. Such vibration can be performed by a motor.

[0347] Example

[0348] Additional embodiments are disclosed in more detail in the examples below, which are not intended to limit the scope of the claims in any way.

[0349] Figure 22Figure 2 is a diagram of a test system for testing bubble removal between concentrically stacked catheters. The test system includes an inner catheter 2108 positioned within the lumen of concentrically stacked outer catheters 2106. Outer catheter 2106 is connected to a rotary hemostasis valve 2104. Hemostasis valve 2104 is connected to a syringe 2102 so that fluid injected using the syringe will flow through the lumen between inner catheter 2108 and outer catheter 2106. In the test system, inner catheter 2108 has a diameter of approximately 0.071 inches. Outer catheter 2106 has a diameter of approximately 0.088 inches. Outer catheter 2106 is transparent to allow observation of bubbles within the lumen. The distal end of outer catheter 2108 allows a small volume of fluid to exit the outer catheter. Figure 23A is a photograph showing catheter 2106 and catheter 2108 in a concentric stack prior to injection of fluid. Figure 23D It is the diagram.

[0350] Example 1

[0351] In a first embodiment, syringe 2102 is used to inject water at a constant pressure of approximately 150 psi through hemostasis valve 2104 without moving catheter 2106 or catheter 2108. Figure 23B This is a photograph showing the conduit 2106 and the conduit 2108 after water is injected. Figure 23E is its diagram. Figure 23B As shown, there is an air bubble in the lumen between catheter 2106 and catheter 2108.

[0352] Example 2

[0353] In the second embodiment, a syringe 2102 is used to inject water at a constant pressure of approximately 150 psi through a hemostatic valve 2104. Shortly after the water injection begins, the inner catheter 2108 is axially reciprocated for approximately 10 seconds. The reciprocating motion is performed at a frequency of approximately 1 Hz (or less) and a stroke length of approximately 20 mm (or more). Figure 23C is a photograph showing catheter 2106 and catheter 2108 after axial reciprocating movement. Figure 23F is its diagram. Figure 23C As shown, the lumen between catheter 2106 and catheter 2108 is substantially free of air bubbles.

[0354] Example 3

[0355] In a third embodiment, an outer conduit with a diameter of approximately 0.071 inches and an inner conduit with a diameter of approximately 0.035 inches were used in a test system 2100, rather than the outer conduit 2106 and inner conduit 2108 described in Examples 1 and 2. A syringe 2102 was used to inject water at a constant pressure of approximately 150 psi through a hemostatic valve 2104 connected to the outer conduit. Shortly after the water injection began, the inner conduit was axially reciprocated for approximately 10 seconds. The reciprocating motion was performed at a frequency of approximately 1 Hz (or lower) and a stroke length of approximately 20 mm (or more). After the axial reciprocating motion, the lumen between the outer conduit and the inner conduit was found to be substantially free of bubbles by visual inspection.

[0356] control system

[0357] Figure 24 A schematic diagram of an example of a control system 4000 is shown that can be used to electronically control the systems and components described herein and / or perform the methods described herein. The control system 4000 can be configured to automatically adjust various motors, hub adapters, hubs, interventional devices, fluidics components (e.g., valves, pumps, etc.), and / or any other components described herein in response to command input by an operator (e.g., a physician). In response to the operator's command input, the control system 4000 can cause a series of response events to occur automatically.

[0358] In certain embodiments, the control system 4000 may include one or more processors 4002. The one or more processors 4002 may be configured to automatically adjust various system components described herein in response to operator command input, for example, using one or more controls 4004 of the control system 4000. Figure 24 4004. However, any suitable number of controls may be provided to correspond to the various functions of the systems described herein. For example, in certain embodiments, each interventional device may have its own unique control 4004 or a set of controls 4004 that may control various functions of the interventional device (e.g., axial movement, rotational movement, fluid supply (e.g., saline, contrast agent, etc.), aspiration, etc.).

[0359] In certain embodiments, one or more controls 4004 can control a priming function of one or more interventional devices. For example, one or more controls 4004 can be operated to cause the interventional device to perform a priming procedure, such as by 20A to 20CFor example, one or more controls 4004 can be operated to cause one or more interventional devices to move axially relative to one or more other interventional devices (e.g., by causing a corresponding hub and / or hub adapter to move axially). One or more controls 4004 can be operated to cause fluid to be introduced into a lumen of an interventional device, thereby priming the interventional device.

[0360] In certain embodiments, one or more controls 4004 can be operated to cause the interventional device to undergo a priming procedure, such as by Figures 21A to 21B For example, one or more controls 4004 can be operated to cause one or more interventional devices to reciprocate (e.g., axially and / or rotationally) relative to one or more other interventional devices (e.g., by reciprocating corresponding hubs and / or hub adapters). One or more controls 4004 can be operated to cause fluid to be introduced into the lumen of the interventional device to prime the interventional device (e.g., during relative reciprocation).

[0361] The processor 4002 can receive signals from one or more controls 4004 and, in response, initiate corresponding actions in the components of the systems described herein. For example, the processor 4002 can be configured to generate output signals that cause responsive actions to be performed by the components described herein.

[0362] Although the foregoing describes robotically driven interventional devices and manually driven interventional devices, these devices can be manually driven, robotically driven, or any combination of manually and robotically driven interventional devices, as will be understood by those skilled in the art in light of the disclosure herein.

[0363] The foregoing describes one specific embodiment of a robotic control system. A variety of different robotic control system structures can be manufactured for supporting and axially advancing and retracting two or three or four or more components to robotically drive an interventional device, as will be understood by those skilled in the art in light of the disclosure herein.

[0364] Although the foregoing describes an interventional device driven by a drive stage, other suitable robotic drive systems or mechanisms may be used to drive the interventional device, as will be understood by those skilled in the art in view of the disclosure herein.

[0365] Various systems and methods are described herein primarily in the context of neurovascular access or surgery (e.g., neurothrombectomy). However, the catheters, systems (e.g., drive systems), and methods disclosed herein can be readily adapted for use in any of a wide variety of other diagnostic and therapeutic applications throughout the body, particularly including endovascular procedures, such as those in the peripheral vascular system (e.g., deep vein thrombosis), the central vascular system (pulmonary embolism), and the coronary vascular system, as well as procedures in other hollow organs or tubular structures in the body.

Claims

1. A system for performing vascular surgery, comprising: Robot drive system; and one or more hub assemblies operably connected to the robotic drive system, each of the one or more hub assemblies comprising: Mounting parts; a hub removably connected to the mount; and an interventional device coupled to the hub; wherein, for each of the one or more hub assemblies: The mounting member is configured to be driven by the robotic drive system to drive the interventional device into the patient's vascular system; The hub is configured to be separated from the mount when the interventional device is located in the patient's vascular system; and The hub is configured to be manually manipulated to navigate the interventional device to a vascular location when the hub is detached from the mount.

2. The system of claim 1, wherein the robotic drive system further comprises a drive stage and one or more hub adapters, the one or more hub adapters being axially movable in the drive stage.

3. The system of claim 2, wherein each of the one or more hub assemblies is positioned to move axially along the drive stage and is magnetically connected to a corresponding one of the one or more hub adapters. 4 . The system of claim 3 , wherein the mount of each of the one or more hub assemblies is configured to magnetically connect to a corresponding one of the one or more hub adapters.

5. The system of claim 1, wherein the interventional device of at least one of the one or more hub assemblies is configured to perform vascular surgery.

6. The system of claim 5, wherein the vascular procedure comprises neurovascular thrombectomy.

7. The system of claim 1, wherein the one or more hub assemblies include a first hub assembly, a second hub assembly, a third hub assembly, and a fourth hub assembly.

8. The system of claim 7, wherein the interventional devices of the one or more hub assemblies are coaxially nested.

9. The system of claim 7, wherein the one or more hub assemblies include one or more of an access catheter hub assembly having an access catheter, a guidewire hub assembly having a guidewire, a surgical catheter hub assembly having a surgical catheter, and a guide catheter hub assembly having a guide catheter.

10. The system of claim 7, wherein at least one of the one or more hub assemblies is configured to accept an additional interventional device therethrough.

11. The system of claim 10, wherein the hub of at least one of the one or more hub assemblies is configured to accept the additional interventional device therethrough.

12. A method of performing vascular surgery, comprising: Connecting a plurality of hub assemblies to the robotic drive system, the plurality of hub assemblies comprising: a first hub assembly comprising a first mount, a first hub removably coupled to the first mount, and a first interventional device coupled to the first hub; and a second hub assembly comprising a second mount, a second hub removably coupled to the second mount, and a second interventional device coupled to the second hub; robotically driving the first hub assembly and the second hub assembly to drive the first interventional device and the second interventional device into the patient's vascular system; and The second hub is separated from the second mount when the second interventional device is located within the patient's vasculature.

13. The method of claim 12, wherein robotically driving the first hub assembly and the second hub assembly to drive the first interventional device and the second interventional device into the patient's vascular system includes driving the first interventional device and the second interventional device to achieve aortic arch access.

14. The method of claim 12, further comprising manually driving the second hub to drive the second interventional device to the vascular location when the second hub is separated from the second mount.

15. The method of claim 12, further comprising inserting a third interventional device through the lumen of the second interventional device and manually driving the third interventional device into the patient's vasculature.

16. The method of claim 15, further comprising performing a vascular procedure using the third interventional device.

17. The method of claim 16, wherein the vascular surgery is neurovascular thrombectomy.

18. The method of claim 16, wherein the third interventional device is a stent retriever or a stent retriever catheter.

19. The method of claim 12, wherein the first interventional device is a guide catheter and the second interventional device is a surgical catheter configured to extend within a lumen of the surgical catheter.

20. The method of claim 19, wherein the separating of the second hub from the second mount is performed while the surgical catheter is within the lumen of the guide catheter and the first hub is connected to the first mount.

21. The method of claim 12, wherein coupling the plurality of hub assemblies with the robotic drive system comprises magnetically coupling the first mount to a first hub adapter through a sterile barrier and magnetically coupling the second mount to a second hub adapter through the sterile barrier.

22. The method of claim 12, wherein the first interventional device is a surgical catheter and the second interventional device is a guide catheter, wherein the surgical catheter is located within a lumen of the guide catheter when the first hub assembly and the second hub assembly are actuated, wherein the method further comprises withdrawing the surgical catheter from the lumen of the guide catheter before separating the second hub from the second mount.

23. The method of claim 22, further comprising inserting a third interventional device through the lumen of the guide catheter and manually driving the third interventional device into the patient's vasculature after separating the second hub from the first hub.

24. A method of performing vascular surgery, comprising: providing a multi-catheter assembly comprising a first subset of interventional devices and a second subset of interventional devices, the second subset of interventional devices being detachably connected to the first subset of interventional devices; connecting the first subset of interventional devices to a robotic drive system; When the second subset of interventional devices is connected to the first subset of interventional devices, robotically driving the multi-catheter assembly to complete aortic arch access; separating the second subset of interventional devices from the first subset of interventional devices; manually driving the second subset of interventional devices to the surgical site; and A vascular procedure is performed using the second subset of interventional devices.

25. The method of claim 24, wherein the first subset of interventional devices comprises an access catheter.

26. The method of claim 25, wherein coupling the first subset of interventional devices to the robotic drive system comprises magnetically coupling a hub of the access catheter to a first drive magnet.

27. The method of claim 25, wherein the first subset of interventional devices comprises guidewires.

28. The method of claim 25, wherein the second subset of interventional devices comprises a surgical catheter and a guide catheter.

29. The method of claim 28, wherein the vascular surgery comprises neurovascular thrombectomy.

30. The method of claim 28, wherein the surgical catheter is detachably connected to the access catheter or the hub of the access catheter via a Luer lock or a hemostatic valve.

31. The method of claim 30, wherein separating the second subset of interventional devices from the first subset of interventional devices comprises separating the surgical catheter from the access catheter or the hub of the access catheter.

32. The method of claim 31 , wherein the guide catheter is detachably connected to the surgical catheter via a Luer lock or a hemostatic valve.

33. The method of claim 32, further comprising decoupling the guide catheter from the surgical catheter.

34. The method of claim 28, further comprising proximally removing the access catheter prior to using the surgical catheter to perform the vascular procedure.

35. The method of claim 28, wherein the second subset of interventional devices comprises guidewires.

36. The method of claim 28, wherein the surgical catheter is a catheter that facilitates percutaneous valve repair or replacement.

37. The method of claim 28, wherein the surgical catheter is an ablation catheter.

38. A system for performing vascular surgery, comprising: Robot drive system; A multi-catheter assembly comprising: a first subset of interventional devices connected to the robotic drive system; and a second subset of interventional devices, the second subset of interventional devices being removably connected to the first subset of interventional devices; wherein the multi-catheter assembly is configured to be robotically driven by the robotic drive system to achieve aortic arch access when the second subset of interventional devices is connected to the first subset of interventional devices; and The second subset of interventional devices is configured to be manually driven to the blood vessel location when the second subset of interventional devices is separated from the first subset of interventional devices.

39. The method of claim 38, wherein the second subset of interventional devices is configured to perform vascular surgery.

40. The method of claim 39, wherein the vascular surgery comprises neurovascular thrombectomy.

41. The method of claim 38, wherein the first subset of interventional devices and the second subset of interventional devices are coaxially nested.

42. The method of claim 38, wherein the first subset of interventional devices comprises an access catheter and a guidewire.

43. The method of claim 42, wherein the second subset of interventional devices comprises a surgical catheter and a guide catheter.

44. The method of claim 43, wherein the surgical catheter is detachably connected to the access catheter or the hub of the access catheter via a Luer lock or a hemostatic valve.

45. The method of claim 44, wherein the second subset of interventional devices is separated from the first subset of interventional devices by separation of the surgical catheter from the access catheter or the hub of the access catheter.

46. ​​The method of claim 43, wherein the guide catheter is detachably connected to the surgical catheter via a Luer lock or a hemostatic valve.

47. The method of claim 38, wherein the first subset of interventional devices is connected to the robotic drive system via a magnetic connection.

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