Hub detection through sterile barrier in robotic catheter assembly

Abstract

The robotic drive system includes a hub configured to adjust the axial position of the interventional device, a driven magnet coupled to the hub, a hub adapter configured to move in at least one direction based on input provided by a user of the robotic control system, a drive magnet coupled to the hub adapter and configured to couple with the driven magnet such that the driven magnet moves in response to movement of the drive magnet, and a sensor coupled to the hub or hub adapter and configured to measure a magnitude of a magnetic field above the sensor from one or both of the drive magnet and the driven magnet.

Description

[Technical Field]

[0001] This application relates to neurovascular procedures, and more particularly to catheter assemblies and robotic control systems for neurovascular site access. [Background technology]

[0002] A variety of neurovascular procedures, including thrombectomy, diagnostic angiography, embolization coil deployment, and stent placement, can be accomplished via transvascular access. However, the delivery of neurovascular care is limited or delayed by a variety of challenges. For example, there are not enough trained interventionalists and centers to meet the current demand for neurointerventions. Neurointerventions are difficult, with complex setup requirements and demands on the surgeon's dexterity. Using both hands, the surgeon must exercise precise control over three to four coaxial catheters, as well as manage the fluoroscopy system and patient position. Long, tortuous anatomy requires delicate and precise manipulation. Inadvertent catheter movement can occur due to the storage and release of energy caused by frictional interactions between the coaxial shaft and the patient's vasculature. Supra-aortic access, required to reach the neurovasculature, is difficult to achieve, especially in type III arches. Once supra-aortic access is achieved, adapting the system for neurovascular treatment is time-consuming, requiring removal of the guidewire and access catheter and addition of the treatment catheter (and possibly one or more additional catheters) to the stack.

[0003] Thus, a need remains for a supra-aortic access and neurovascular site access system that addresses some or all of these challenges and improves the availability of neurovascular procedures. Preferably, the system would additionally be capable of driving devices further distally through the supra-aortic access to achieve procedures in intracranial vessels. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent Application Serial No. 18 / 524,879 [Patent Document 2] U.S. Patent No. 11,259,821 [Patent Document 3] U.S. Patent Application No. 63 / 256,743 [Patent Document 4] U.S. Patent Application Serial No. 17 / 527,393 [Patent Document 5] U.S. Patent Application Serial No. 17 / 879,614 [Non-patent literature]

[0005] [Non-Patent Document 1] Rafii-Tari et al., Objective Assessment of Endovascular Navigation Skills with Force Sensing, Annals of Biomedical Engineering 2017 Summary of the Invention [Means for solving the problem]

[0006] Disclosed herein are embodiments of a robotic control system for interventional procedures. Some embodiments of the robotic control system disclosed herein can use a hub adapter to move a hub positioned on the sterile side of a sterile barrier, with one or more interventional devices coupled to the hub. In some embodiments, a magnetic field can be generated between the hub adapter and the hub, such that movement of the hub adapter results in movement of the hub as a result of the magnetic field between the hubs. In some embodiments, a magnetic coupling can be used in any embodiment of the robotic control system disclosed herein, such that movement of a drive device on the non-sterile side of the sterile barrier can cause movement of at least one device on the sterile side of the sterile barrier in any desired direction of movement (e.g., in the direction of insertion and / or withdrawal of an interventional device relative to an entry port into a patient's body). The magnetic force between the hub adapter and the hub in some embodiments is elastic.

[0007] In some embodiments, one or more sensors can measure the magnetic field strength and / or direction of the magnetic coupling between the hub and the hub adapter, which can be used to determine the relative displacement of the hub from the hub adapter, the separation of the hub from the hub adapter, and / or the axial load acting on the hub.

[0008] In some embodiments, the relative displacement of the hub with respect to the corresponding hub adapter can be observed, measured, and characterized using one or more sensors of some embodiments of the systems disclosed herein. For example, some embodiments can include a magnetometer device in the hub adapter or the hub, and a corresponding magnet in the other of the hub adapter and the hub. The relative displacement of the hub and hub adapter can be characterized by changes in magnetic field strength and / or direction detected by the magnetometer. Magnetic field strength and / or direction information generated by a magnet on the opposite side of the magnetometer can be used in some embodiments to measure either vertical or horizontal displacement of the hub with respect to the hub adapter. Additionally, in some embodiments, magnetic field strength and / or direction data can be used to calculate forces acting on the hub from the magnetic coupling and / or separate external forces acting on the hub.

[0009] Disclosed herein are embodiments of a robotic control system for interventional procedures (also referred to herein as a robotic system for interventional procedures). In any embodiment disclosed herein, the system may include a hub that may be configured to adjust the axial position of an interventional device, a driven magnet coupled to the hub, a hub adapter configured to move in at least one direction based on input provided by a user of the robotic control system, a drive magnet coupled to the hub adapter and configured to couple with the driven magnet such that the driven magnet moves in response to movement of the drive magnet, and a sensor coupled to the hub or hub adapter, the sensor configured to measure a magnitude of a magnetic field above the sensor.

[0010] Any of the embodiments of the methods, devices, and systems disclosed herein can include, in additional embodiments, one or more of the following steps, features, components, and / or details, in any combination with any of the other steps, features, components, and / or details of any other embodiments disclosed herein: the drive magnet and the driven magnet magnetically couple the hub adapter to the hub when the hub is within a predetermined distance of the hub adapter in at least one direction; the driven magnet biases the hub to stay approximately aligned with the hub adapter in at least one direction as the hub adapter moves in the at least one direction; the sensor is a magnetometer; the robotic control system is configured to determine a relative distance in at least one direction between the hub adapter and the hub when the hub is at least partially offset from the hub adapter in the at least one direction based on the measured magnitude of the magnetic field above the sensor; and the robotic control system is configured to determine the relative distance in at least one direction between the hub adapter and the hub when the hub is at least partially offset from the hub adapter in the at least one direction. the robot control system is configured to determine a magnitude of a net external force acting on the hub in at least one direction based on the measured magnitude of the magnetic field above the sensor; the robot control system is configured to determine a relative distance in at least one direction between the hub adapter and the hub when the hub is at least partially offset from the hub adapter in at least one direction based on the measured magnitude of the magnetic field above the sensor, and / or the robot control system is configured to determine a magnitude of a net external force acting on the hub in at least one direction based at least in part on the relative distance in at least one direction between the hub adapter and the hub when the hub is offset from the hub adapter in at least one direction; the robot control system is configured to provide an alert when the external force in at least one direction reaches or exceeds a threshold;The robotic control system is configured to automatically implement corrective actions when the external force in at least one direction reaches or exceeds a threshold value; the corrective actions include stopping any movement of any hub or hub adapter, stopping any movement of any hub or hub adapter in any direction that would increase the external force, unloading one or more catheters or other devices to reduce the external force, providing information to a user of the system to assist the user in reducing the external force, and / or providing specific instructions to the user to instruct the user on maneuvers that will reduce the external force; the hub is coupled to the hub adapter across the sterile barrier; the hub is positioned on a sterile side of the sterile barrier and the hub adapter is positioned on a non-sterile side of the sterile barrier; a sensor is coupled to the hub adapter; the interventional device is a guide catheter, a procedure catheter, an access catheter, or a guidewire; the interventional device is a suction catheter, an embolic extension ... an open catheter, a stent deployment catheter, a flow diverter 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, or an ablation catheter; further comprising: a second hub configured to adjust an axial position of a second interventional device; a second driven magnet coupled to the second hub; a second hub adapter configured to move in at least one direction based on input provided by a user of the robotic control system; a second drive magnet coupled to the second hub adapter, the second drive magnet configured to couple with the second driven magnet such that the second driven magnet moves in response to movement of the second drive magnet; and a second sensor coupled to the second hub or the second hub adapter, the second sensor configured to measure a magnitude of the second magnetic field; and / or the hub adapter coupled to a drive belt;

[0011] Also disclosed herein are embodiments of a method for controlling movement of an interventional device through a sterile barrier, the method including the steps of magnetically coupling a hub on a sterile side of the sterile barrier to a hub adapter on a non-sterile side of the sterile barrier, wherein the hub moves in response to movement of the hub adapter; moving the hub in at least one direction by moving the hub adapter in at least one direction while the hub is biased by the magnetic coupling to remain aligned with the hub adapter in at least one direction; and determining a distance between the hub and the hub adapter and / or an external force applied to the hub based on measurements of a magnetic field from the magnetic coupling on a sensor coupled to the hub or the hub adapter when the hub is offset in at least one direction from the hub adapter.

[0012] Any of the embodiments of the methods, devices, and systems disclosed herein can include, in additional embodiments, one or more of the following steps, features, components, and / or details, in any combination with any of the other steps, features, components, and / or details of any other embodiment disclosed herein: the first interventional device is a guide catheter, a treatment catheter, an access catheter, or a guidewire; determining the distance between the hub and the hub adapter when the hub is offset in at least one direction from the hub adapter includes measuring a magnitude in at least one direction of a magnetic field above the sensor; further including determining a magnitude of an external force acting on the hub in at least one direction when the hub is offset in at least one direction from the hub adapter; the sterile barrier does not include a discontinuity between the hub and the hub adapter; and magnetically coupling a second hub on a sterile side of the sterile barrier with a second hub adapter on a non-sterile side of the sterile barrier. the second hub is adapted to move in response to movement of the second hub adapter; moving the second hub in at least one direction by moving the second hub adapter in at least one direction while the second hub is biased to remain aligned with the second hub adapter in at least one direction by a magnetic coupling between the second hub adapter and the second hub; determining a second distance between the second hub and the second hub adapter and / or a second external force applied to the second hub based on measurements of a magnetic field from the magnetic coupling on a sensor coupled to the second hub or the second hub adapter when the second hub is offset in at least one direction from the second hub adapter; comparing the distance between the hub and the hub adapter and the second distance between the second hub and the second hub adapter; comparing a magnitude and / or direction of the second external force applied to the second hub with a magnitude and / or direction of the external force applied to the hub;and / or determining the condition of the hub and / or the second hub based on a comparison of the magnitude and / or direction of the second external force applied to the second hub and the magnitude and / or direction of the external force applied to the hub;

[0013] Some embodiments disclosed herein are directed to a robotic control system. In any embodiment disclosed herein,

[0014] Also disclosed herein are embodiments of a robotic control system that includes a hub configured to adjust the axial position of an interventional device, a driven magnet coupled to the hub, a hub adapter configured to move in at least one direction based on input provided by a user of the robotic control system, a drive magnet coupled to the hub adapter, the drive magnet configured to be magnetically coupled to the driven magnet in an operative state of the robotic control system such that the driven magnet moves in response to movement of the drive magnet, and a sensor coupled to the hub or hub adapter, the sensor configured to measure a magnitude of a magnetic field above the sensor.

[0015] In any embodiment of the robotic control system or method of using the robotic control system disclosed herein, the robotic control system may include a second hub configured to adjust the axial position of a second interventional device; a second driven magnet coupled to the second hub; a second hub adapter configured to move in at least one direction based on input provided by a user of the robotic control system; a second drive magnet coupled to the second hub adapter, the second drive magnet configured to couple with the second driven magnet such that the second driven magnet moves in response to movement of the second drive magnet; and a second sensor coupled to the second hub or the second hub adapter, the second sensor configured to measure a magnitude of the second magnetic field.

[0016] In any embodiment of the robotic control system or method of using a robotic control system disclosed herein, the hub adapter can be configured to move proximally or distally along the track in response to input provided by a user of the robotic control system and / or based on commands automatically generated by a controller of the robotic control system. In some embodiments, the track can be a linear straight gear rack, and each hub adapter can have a motor with a pinion gear configured to move along the linear straight gear rack. The first hub adapter can be configured to move in at least one axis on a rack-and-pinion linear actuator in response to input provided by a user of the robotic control system. In some embodiments, any of the hub adapters can be coupled to a drive belt and configured to move axially using the drive belt.

[0017] Any embodiment of the devices, systems, and / or methods disclosed herein can, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other features, components, details, and / or steps of any other embodiment disclosed herein: the drive magnet and the driven magnet magnetically couple the hub adapter to the hub when the hub is within a predetermined distance of the hub adapter in at least one direction; the driven magnet biases the hub to stay approximately aligned with the hub adapter in at least one direction when the hub adapter moves in the at least one direction; the sensor is a magnetometer; the sensor is an inductance sensor; the robotic control system is configured to determine a relative distance in at least one direction between the hub adapter and the hub when the hub is at least partially offset from the hub adapter in the at least one direction based on the measured magnitude of the magnetic field above the sensor; the robot control system is configured to provide a warning when the relative distance reaches or exceeds a threshold value; the robot control system is configured to increase the intensity of the warning when the relative distance increases; the robot control system is configured to increase the intensity of the warning by increasing the size of a warning symbol displayed by the robot control system, by increasing the hue or opacity of the warning symbol, by changing the color of the warning symbol, and / or by increasing the volume level or changing the pitch of an audible warning; the robot control system is configured to determine a magnitude of a net external force acting on the hub in at least one direction based on the measured magnitude of the magnetic field above the sensor; the robot control system is configured to provide an alert when the net external force in at least one direction reaches or exceeds a threshold value; the robot control system is configured to automatically implement corrective action when the net external force in at least one direction reaches or exceeds a threshold value;the corrective action includes stopping any movement of the hub or hub adapter, stopping any movement of the hub or hub adapter in any direction that would increase the net external force, unloading one or more catheters or other devices to reduce the net external force on the hub, providing information to a user of the system to assist the user in reducing the net external force on the hub, and / or providing specific instructions to the user to instruct the user on a maneuver that will reduce the net external force on the hub; the corrective action includes moving the hub adapter in a direction that reduces the net external force acting on the hub; the robotic control system is configured to determine a relative distance in at least one direction between the hub adapter and the hub when the hub is at least partially offset from the hub adapter in at least one direction based on the measured magnitude of the magnetic field above the sensor, and / or is configured to determine a magnitude of a net external force acting on the hub in at least one direction based at least in part on a relative distance in at least one direction between the hub adapter and the hub when the hub is offset from the hub adapter in at least one direction; the hub is coupled to the hub adapter across a sterile barrier; the hub is positioned on a sterile side of the sterile barrier and the hub adapter is positioned on a non-sterile side of the sterile barrier; the sensor is coupled to the hub adapter; the interventional device is a guide catheter, a procedure catheter, an access catheter, or a guidewire; and / or the interventional device is an aspiration catheter, an embolism deployment catheter, a stent deployment catheter, a flow diverter 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, or an ablation catheter;

[0018] Any embodiment of the device, system, and / or method disclosed herein can, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other features, components, details, and / or steps of any other embodiment disclosed herein: the robotic control system or method of using the robotic control system further includes a microcontroller electronically coupled to the sensor; the robotic control system or method of using the robotic control system further includes a data processor, the data processor configured to receive data from the sensor and determine a relative displacement of the hub with respect to the hub adapter and / or a net external force acting on the hub based on the data from the sensor; the system configured to determine a relative displacement of the hub with respect to the hub adapter and a direction of displacement of the hub with respect to the hub adapter; the system configured to determine whether the hub is contacting and pushing against another adjacent hub, for example, but not limited to, whether the hub is contacting and pushing another hub and / or whether the hub is magnetically coupled to the hub adapter can be determined based on the determined displacement between the hub and the hub adapter and / or the determined force acting on the hub; the sensor is used to determine whether the hub is correctly positioned and oriented with respect to the hub adapter during an initial setup procedure of the robot control system; the robot control system or a method of using a robot control system further includes at least three hub adapters each having a magnet and three corresponding hubs, each of the three hub adapters having a sensor, the sensor configured to measure a magnitude of a magnetic field above the sensor from the respective magnet of the corresponding hub; the robot control system or a method of using a robot control system further includes at least four hub adapters each having a magnet and four corresponding hubs, each of the four hub adapters having a sensor, the sensor configured to measure a magnitude of a magnetic field above the sensor from the respective magnet of the corresponding hub;The robot control system or the method of using the robot control system further includes a controller, the controller configured to execute a control function to cause movement of at least the hub adapter based on a force pattern derived from the data of the magnitude of the magnetic field generated by the sensor; the robot control system or the method of using the robot control system further includes a controller, the controller configured to execute a control function to cause movement of at least the hub adapter to reduce a net force acting on the hub based on the force pattern derived from the data of the magnitude of the magnetic field generated by the sensor; the robot control system or the method of using the robot control system further includes a controller, the controller configured to execute a control function to cause movement of at least the hub adapter to reduce a net force acting on the hub based on the force pattern derived from the data of the magnitude of the magnetic field generated by the sensor; the robot control system is ... or is configured to determine that the range of motion of the anti-buckling component has been exceeded; the hub adapter is further configured to move in at least one direction based on commands automatically generated by a controller of the robotic control system; the robotic control system or method of using the robotic control system further includes an additional magnet coupled to the hub, the additional magnet configured to generate a magnetic field, and a sensor coupled to the hub adapter and configured to measure the magnitude of the magnetic field generated by the additional magnet; and / or the driven magnet is a ring magnet having an opening axially through its center and the driving magnet is a ring magnet having an opening axially through its center;

[0019] Also disclosed herein are embodiments of a robotic control system that can include a hub configured to adjust the axial position of an interventional device, a hub adapter configured to move axially distally or proximally based at least on input provided by a user of the robotic control system, one or more magnets coupled to at least the hub, and a sensor coupled to the hub or the hub adapter configured to measure the magnitude and direction of the magnetic field of one of the one or more magnets such that the robotic control system can determine the magnitude and direction of displacement of the hub relative to the hub adapter. In some embodiments, the robotic control system or a method of using the robotic control system can further include a drive magnet coupled to the hub adapter and a driven magnet coupled to the hub, the drive magnet configured to magnetically couple with the driven magnet when the robotic control system is operative such that the hub and driven magnet move axially distally or proximally in response to movement of the hub adapter and drive magnet. In any of the embodiments disclosed herein, any of the magnets (including any magnets positioned and configured to be sensed by the sensor) can be ring magnets.

[0020] Any embodiment of the devices, systems, and / or methods disclosed herein can, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other features, components, details, and / or steps of any other embodiment disclosed herein: the robotic control system further includes a drive magnet coupled to the hub adapter and a driven magnet coupled to the hub, the drive magnet configured to magnetically couple with the driven magnet in an operative state of the robotic control system, such that the hub and driven magnet move axially distally or proximally in response to movement of the hub adapter and the drive magnet; the driven magnet biases the hub to remain approximately axially aligned with the hub adapter as the hub adapter moves axially; one of the one or more magnets is a ring magnet; the sensor is a magnetometer; the sensor is an inductance sensor; and the robotic control system detects when the magnitude of the displacement reaches a threshold. the robot control system is configured to provide a warning when a threshold value is reached or exceeded; the robot control system is configured to increase the intensity of the warning when the magnitude of the displacement increases; the robot control system is configured to increase the intensity of the warning by increasing the size of a warning symbol displayed by the robot control system, by increasing the hue or opacity of the warning symbol, by changing the color of the warning symbol, and / or by increasing the volume level or changing the pitch of an audible warning; the robot control system is configured to determine a magnitude of a net external force acting on the hub in at least one direction based on the measured magnitude of the magnetic field above the sensor; the robot control system is configured to provide an alert when the net external force in at least one direction reaches or exceeds the threshold value; the robot control system is configured to automatically implement corrective action when the net external force in at least one direction reaches or exceeds the threshold value;The corrective action includes stopping any movement of the hub or hub adapter, stopping any movement of the hub or hub adapter in any direction that would increase the net external force, unloading one or more catheters or other devices to reduce the net external force on the hub, providing information to a user of the system to assist the user in reducing the net external force on the hub, and / or providing specific instructions to the user to instruct the user on a maneuver that will reduce the net external force on the hub; the corrective action includes moving the hub adapter in a direction that reduces the net external force acting on the hub; the hub is coupled to the hub adapter across the sterile barrier; and / or the hub is positioned on the sterile side of the sterile barrier and the hub adapter is positioned on the non-sterile side of the sterile barrier; a sensor is coupled to the hub adapter;

[0021] Any embodiment of the devices, systems, and / or methods disclosed herein can, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other features, components, details, and / or steps of any other embodiment disclosed herein: the interventional device is a guide catheter, a procedure catheter, an access catheter, or a guidewire; the interventional device is an aspiration catheter, an embolism deployment catheter, a stent deployment catheter, a flow diverter 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, or an ablation catheter; the robotic control system further includes a microcontroller electronically coupled to the sensor; and the hub adapter is responsive to inputs provided by a user of the robotic control system and / or commands generated automatically by a controller of the robotic control system. the track is configured to move proximally or distally along the track based on a drive signal; the track is a linear straight gear rack, and each hub adapter has a motor with a pinion gear configured to move along the linear straight gear rack; the hub adapter is configured to move axially on the rack and pinion linear actuator in response to input provided by a user of the robotic control system; the robotic control system further includes a data processor configured to receive data from the sensor and determine a relative displacement of the hub with respect to the hub adapter and / or a net external force acting on the hub based on the data from the sensor; the system configured to determine whether the hub is contacting and pushing against another adjacent hub; for example, whether the hub is contacting and pushing against another hub and / or whether the hub is magnetically coupled to the hub adapter can be determined based on the determined displacement between the hub and the hub adapter and / or the determined force acting on the hub;The sensors are used to determine whether the hubs are correctly positioned and oriented relative to the hub adapters during an initial setup procedure of the robotic control system; the robotic control system includes at least three hub adapters each having a magnet and three corresponding hubs, each of the three hub adapters having a sensor, the sensor configured to measure a magnitude of a magnetic field above the sensor from the respective magnet of the corresponding hub; the robotic control system includes at least four hub adapters each having a magnet and four corresponding hubs, each of the four hub adapters having a sensor, the sensor configured to measure a magnitude of a magnetic field above the sensor from the respective magnet of the corresponding hub; the robotic control system includes a controller, the controller is configured to determine the magnitude of the magnetic field generated by the sensors. the robotic control system includes a controller configured to execute a control function to cause movement of at least the hub adapter based on a force pattern derived from the data of the magnitude of the magnetic field generated by the sensor to reduce a net force acting on the hub; the robotic control system is configured to determine that a range of motion of an anti-buckling component of the robotic control system is approaching a position outside of the range or that the range of motion of the anti-buckling component has been exceeded; and / or the hub adapter is further configured to move in at least one direction based on commands automatically generated by the controller of the robotic control system;

[0022] In any embodiment disclosed herein, the robotic control system may further include a second hub configured to adjust the axial position of the second interventional device, a second driven magnet coupled to the second hub, a second hub adapter configured to move in at least one direction based on input provided by a user of the robotic control system, a second drive magnet coupled to the second hub adapter, the second drive magnet configured to couple with the second driven magnet such that the second driven magnet moves in response to movement of the second drive magnet, and a second sensor coupled to the second hub or the second hub adapter, the second sensor configured to measure a magnitude of the second magnetic field.

[0023] Also disclosed herein are embodiments of a robotic control system that includes a hub configured to adjust the axial position of an interventional device, a driven magnet coupled to the hub, a hub adapter configured to move axially distally or proximally based at least on input provided by a user of the robotic control system, a drive magnet coupled to the hub adapter, the drive magnet configured to couple with the driven magnet coupled to the hub such that the driven magnet moves in response to movement of the drive magnet, a sensor coupled to the hub adapter configured to measure a magnitude of a magnetic field from the magnet coupled to the hub, and a controller configured to determine a magnitude of a net external force acting on the hub in the axial direction based on the measured magnitude of the magnetic field on the sensor. In some embodiments, the robotic control system can be configured to output a warning to a user of the robotic control system when the magnitude of the net external force acting on the hub in the axial direction reaches a threshold that is a predetermined percentage of the breakage force.

[0024] Any embodiment of the device, system, and / or method disclosed herein can, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other features, components, details, and / or steps of any other embodiment disclosed herein: the drive magnet and the driven magnet magnetically couple the hub adapter to the hub when the hub is within a predetermined distance of the hub adapter in the axial direction; the driven magnet biases the hub to remain approximately axially aligned with the hub adapter as the hub adapter moves axially; the sensor is a magnetometer; the robotic control system is configured to increase the intensity of the warning when the magnitude of the net external force acting on the hub in the axial direction increases; the robotic control system is configured to increase the intensity of the warning when the magnitude of the net external force acting on the hub in the axial direction increases; or ... size of the warning symbol displayed by the robotic control system, or to increase the color tone or opacity of the warning symbol. , increasing the intensity of the warning by changing the color of the warning symbol and / or increasing the volume level or changing the pitch of the audible warning; the robotic control system is configured to automatically implement corrective actions when the magnitude of the net external force acting on the hub in the axial direction reaches or exceeds a threshold; the corrective actions include stopping any movement of the hub or hub adapter, stopping any movement of the hub or hub adapter in any direction that would increase the net external force, unloading one or more catheters or other devices to reduce the net external force on the hub, providing information to a user of the system to assist the user in reducing the net external force on the hub, and / or providing specific instructions to the user to instruct the user on a maneuver that will reduce the net external force on the hub; the corrective action includes moving the hub adapter in a direction that reduces the net external force acting on the hub;The robotic control system is configured to impede movement of the hub adapter in a direction that would increase the net external force acting on the hub if the net external force acting on the hub reaches a threshold; the threshold is at least 70% of the break force between the hub and the hub adapter; the threshold is at least 80% of the break force between the hub and the hub adapter; the hub is coupled to the hub adapter across a sterile barrier; and / or the hub is positioned on a sterile side of the sterile barrier and the hub adapter is positioned on a non-sterile side of the sterile barrier;

[0025] In any embodiment disclosed herein, the robotic control system or method of using the robotic control system may further include a second hub configured to adjust the axial position of a second interventional device, a second driven magnet coupled to the second hub, a second hub adapter configured to move axially based on input provided by a user of the robotic control system, a second drive magnet coupled to the second hub adapter, the second drive magnet configured to couple with the second driven magnet such that the second driven magnet moves in response to movement of the second drive magnet, and a second sensor coupled to the second hub or the second hub adapter, the second sensor configured to measure a magnitude of the second magnetic field.

[0026] Any embodiment of the devices, systems, and / or methods disclosed herein can, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other features, components, details, and / or steps of any other embodiment disclosed herein: the hub adapter is configured to move proximally or distally along the track in response to input provided by a user of the robotic control system and / or based on commands automatically generated by a controller of the robotic control system; the track is a linear straight gear rack, and each hub adapter has a motor with a pinion gear configured to move along the linear straight gear rack; the system is configured to determine if a hub is contacting and pushing another adjacent hub, e.g., whether a hub is contacting and pushing another hub and / or whether a hub is moving in a direction opposite to the hub adapter; whether the driven magnet is magnetically coupled to the hub adapter can be determined based on a determined displacement between the hub and the hub adapter and / or a determined force acting on the hub; the robot control system or a method of using a robot control system further includes at least three hub adapters, each having a magnet, and three corresponding hubs, each of the three hub adapters having a sensor, the sensor configured to measure a magnetic field magnitude above the sensor from the respective magnet of the corresponding hub; the robot control system or a method of using a robot control system further includes a controller, the controller configured to perform a control function to cause movement of at least the hub adapter to reduce the net force acting on the hub based on a force pattern derived from the magnetic field magnitude data generated by the sensors; and / or the driven magnet is a ring magnet having an opening axially through its center, and the driving magnet is a ring magnet having an opening axially through its center.

[0027] Also disclosed herein are embodiments of methods for controlling movement of an interventional device through a sterile barrier. In some embodiments, a method for controlling movement of an interventional device through a sterile barrier can include magnetically coupling a hub on a sterile side of the sterile barrier to a hub adapter on a non-sterile side of the sterile barrier, wherein the hub moves in response to movement of the hub adapter; moving the hub in at least one direction by moving the hub adapter in at least one direction while the hub is biased by the magnetic coupling to remain aligned with the hub adapter in at least one direction; and determining a distance between the hub and the hub adapter and / or an external force applied to the hub when the hub is offset in at least one direction from the hub adapter based on measurements of a magnetic field from the magnetic coupling on a sensor coupled to the hub or the hub adapter.

[0028] Any of the embodiments of the methods, devices, and systems disclosed herein can include, in additional embodiments, one or more of the following steps, features, components, and / or details, in any combination with any of the other steps, features, components, and / or details of any other embodiment disclosed herein: the first interventional device is a guide catheter, a treatment catheter, an access catheter, or a guidewire; determining a distance between the hub and the hub adapter when the hub is offset in at least one direction from the hub adapter includes measuring a magnitude in at least one direction of a magnetic field above the sensor; the robotic control system or method of using a robotic control system includes determining a magnitude of an external force acting on the hub in at least one direction when the hub is offset in at least one direction from the hub adapter. the sterility barrier does not include a discontinuity between the hub and the hub adapter; comparing a distance between the hub and the hub adapter and a second distance between the second hub and the second hub adapter; the robotic control system or method of using a robotic control system further includes comparing a magnitude and / or direction of a second net external force applied to the second hub with a magnitude and / or direction of a net external force applied to the hub; the robotic control system or method of using a robotic control system further includes determining a condition of the hub and / or the second hub based on a comparison of the magnitude and / or direction of the second net external force applied to the second hub with the magnitude and / or direction of the net external force applied to the hub; and / or the robotic control system or method of using a robotic control system further includes moving the hub adapter in at least one direction along a linear rack gear.

[0029] Any embodiment of the method of controlling movement of an interventional device through a sterile barrier disclosed herein may further include magnetically coupling a second hub on the sterile side of the sterile barrier to a second hub adapter on the non-sterile side of the sterile barrier, wherein the second hub moves in response to movement of the second hub adapter; moving the second hub in at least one direction by moving the second hub adapter in at least one direction while the second hub is biased to remain aligned with the second hub adapter in at least one direction by the magnetic coupling between the second hub adapter and the second hub; and / or determining a second distance between the second hub and the second hub adapter and / or a second net external force applied to the second hub based on measurements of a magnetic field from the magnetic coupling on a sensor coupled to the second hub or the second hub adapter when the second hub is offset in at least one direction from the second hub adapter.

[0030] Also disclosed herein are embodiments of methods for controlling movement of an interventional device through a sterile barrier that may include magnetically coupling a hub on a sterile side of the sterile barrier to a hub adapter on a non-sterile side of the sterile barrier, wherein the hub moves in response to movement of the hub adapter; moving the hub in at least one direction by moving the hub adapter in at least one direction along a linear rack gear while the hub is biased by the magnetic coupling to remain aligned with the hub adapter in at least one direction; and determining a distance between the hub and the hub adapter and / or an external force applied to the hub when the hub is offset in at least one direction from the hub adapter based on measurements of a magnetic field from the magnetic coupling on a sensor coupled to the hub or the hub adapter.

[0031] Any of the embodiments of the methods, devices, and systems disclosed herein can, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other steps, features, components, and / or details of any other embodiment disclosed herein: the robotic control system or method of using the robotic control system further includes outputting a warning when the magnitude of the net external force acting on the hub in the axial direction reaches a threshold comprising a predetermined percentage of the breakage force; the threshold is at least 70% of the breakage force between the hub and the hub adapter; the threshold is at least 80% of the breakage force between the hub and the hub adapter; the robotic control system or method of using the robotic control system further includes, when the net external force acting on the hub reaches the threshold, impeding movement of the hub adapter in a direction that would increase the net external force acting on the hub; The system or method of using the robotic control system further includes automatically implementing a corrective action when the net external force in at least one direction reaches or exceeds a threshold value; the corrective action includes stopping any movement of the hub or hub adapter, stopping any movement of the hub or hub adapter in any direction that would increase the net external force, unloading one or more catheters or other devices to reduce the net external force on the hub, providing information to a user of the system to assist the user in reducing the net external force on the hub, and / or providing specific instructions to the user to instruct the user on a maneuver that will reduce the net external force on the hub; the corrective action includes moving the hub adapter in a direction that reduces the net external force acting on the hub; an interventional device is coupled to the hub, and the interventional device is a guide catheter, a procedure catheter, an access catheter, or a guidewire;and / or an interventional device is coupled to the hub, the interventional device being an aspiration catheter, an embolism deployment catheter, a stent deployment catheter, a flow diverter deployment catheter, a diagnostic angiography catheter, a stent retriever catheter, a clot retrieval catheter, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, or an ablation catheter;

[0032] Also disclosed herein are embodiments of a method for controlling movement of an interventional device through a sterile barrier that can include magnetically coupling a hub on a sterile side of the sterile barrier to a hub adapter on a non-sterile side of the sterile barrier, wherein, in an operative state, the hub moves in response to movement of the hub adapter; moving the hub in at least one direction by moving the hub adapter in at least one direction while the hub is magnetically coupled to the hub adapter; measuring a magnitude of a magnetic field from a magnet coupled to the hub using a magnetic field sensor coupled to the hub adapter; determining a magnitude of a net external force acting on the hub from the magnitude of the magnetic field from the magnet coupled to the hub; and outputting a warning to a user of a robotic control system when the magnitude of the net external force acting on the hub in the at least one direction reaches a threshold comprising a predetermined percentage of the breakage force. In some embodiments, the method for controlling movement of an interventional device through a sterile barrier can further include impeding movement of the hub adapter in a direction that would increase the net external force acting on the hub when the net external force acting on the hub reaches the threshold. In some embodiments, the method for controlling movement of an interventional device through a sterile barrier may further include outputting a warning to a user of the robotic control system when the magnitude of the net external force acting on the hub in at least one direction reaches a threshold value.

[0033] In any embodiment disclosed herein, the threshold can be 70% or at least 70% of the break force between the hub and the hub adapter, 80% or at least 80% of the break force between the hub and the hub adapter, 85% or at least 85%, or 90% or at least 90% of the break force between the hub and the hub adapter, or any value within any of the foregoing ranges.

[0034] Also disclosed herein are embodiments of methods of performing a neurovascular procedure. In some embodiments, the method embodiments of performing a neurovascular procedure can include controlling movement of an interventional device through a sterile barrier, as described in any embodiment of the method of controlling movement of an interventional device through a sterile barrier disclosed herein, and the hub is an access catheter hub having an access catheter. In some embodiments, the method of performing a neurovascular procedure can further include coupling the access catheter hub to a hub adapter, the hub adapter being movably carried by a support table; driving the access catheter in response to movement of the hub adapter along the support table until the access catheter is positioned to provide supra-aortic vascular access; removing the access catheter and access catheter hub from the hub adapter; and coupling the treatment catheter hub having the treatment catheter to the hub adapter. [Brief explanation of the drawings]

[0035] [Figure 1] FIG. 1 is a schematic perspective view of an interventional setup having an imaging system, a patient support table, and a robotic drive system according to the present disclosure. [Figure 2] FIG. 1 is a longitudinal cross-sectional view showing the concentric relationship between a guidewire with two degrees of freedom, an access catheter with three degrees of freedom, and a guide catheter with one degree of freedom. [Figure 3A] FIG. 1 is an exploded schematic view of an interventional device hub separated from a support table by a sterile barrier. [Figure 3B] FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3C] FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3D] FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3E] FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3F] FIG. 10 shows an alternative sterility barrier in the form of a shipping tray having one or more storage channels for carrying interventional devices. [Figure 3G] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3H] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3I] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3J] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3K] 10A-10C show alternative sterility barrier embodiments having convex drive surfaces. [Figure 3L] 3A-3K depict examples of hubs that may be used with the sterility barriers of FIGS. 3G-3K. [Figure 3M] 3A-3K depict examples of hubs that may be used with the sterility barriers of FIGS. 3G-3K. [Figure 4] FIG. 1 is a schematic elevational cross-section through a hub adapter having a drive magnet separated from an interventional device hub and driven magnet by a sterile barrier. [Figure 5A] FIG. 10 is a diagram illustrating a schematic of an interventional device assembly having three interventional devices. [Figure 5B] FIG. 10 is a diagram illustrating a schematic diagram of an interventional device assembly having four interventional devices. [Figure 6] FIG. [Figure 7] FIG. 10 is a close-up view of the motor-driven end of the support table. [Figure 8] 1 is an elevational section through the motor and belt drive assembly. [Figure 9] FIG. 10 is a close-up view of the pulley end of the support table. [Figure 10] This is an elevational section through a belt pulley. [Figure 11] FIG. 5C is a side cross-sectional view through a distal portion of a catheter such as either of the catheters shown in FIGS. 5A and 5B. [Figure 12A] FIG. 10 is a diagram illustrating a schematic of a force sensor integrated into the sidewall of a catheter. [Figure 12B] FIG. 10 is a diagram illustrating a schematic of a force sensor integrated into the sidewall of a catheter. [Figure 13A] 10A and 10B are schematic diagrams illustrating sensors for measuring elastic forces in a magnetic coupling between a hub and a corresponding hub adapter. [Figure 13B] 10A and 10B are schematic diagrams illustrating sensors for measuring elastic forces in a magnetic coupling between a hub and a corresponding hub adapter. [Figure 14] FIG. 10 schematically illustrates a dual-encoder torque sensor for use with a catheter of the present disclosure. [Figure 15] FIG. 10 illustrates a clot capture and visualization device that may be integrated into the hub and / or connected to a suction line. [Figure 16A] 10A-10C illustrate exemplary control mechanisms for operating interventional devices driven by respective hubs. [Figure 16B]10A-10C illustrate exemplary control mechanisms for operating interventional devices driven by respective hubs. [Figure 16C] 10A-10C illustrate exemplary control mechanisms for operating interventional devices driven by respective hubs. [Figure 17] FIG. 1 is a side schematic view of an interventional device assembly for supra-aortic access and neurointerventional procedures. [Figure 18A] 1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 18B] 1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 18C] 1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 18D] 1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 18E] 1A-1C depict an exemplary sequence of steps for introducing a catheter assembly configured to provide supra-aortic access and neurovascular site access. [Figure 19] 1A-1C are diagrams illustrating schematically embodiments of mechanical couplings between a driving mechanism and a driven mechanism. [Figure 20A] 1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 20B] 1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 20C] 1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 21A] 1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 21B] 1A-1C depict an exemplary sequence of steps for priming a catheter assembly in a stacked configuration. [Figure 22] FIG. 21B depicts an exemplary test system for the priming process depicted in FIGS. 21A-21B. [Figure 23A] 1A-1C illustrate examples of catheter assemblies. [Figure 23B] 1A-1C illustrate an example of a catheter assembly after a priming procedure. [Figure 23C] 1 is an example of a catheter assembly after a priming procedure involving relative movement between adjacent catheters. [Figure 23D] 23A-23C illustrate the exemplary catheter assembly of FIG. [Figure 23E] 23A-23C illustrate the exemplary catheter assembly of FIG. [Figure 23F] 23A-23C illustrate the exemplary catheter assembly of FIG. [Figure 24] 1 is a schematic diagram of a hub and hub adapter having one or more magnets for magnetically coupling the hub and hub adapter. [Figure 25] FIG. 1 is a schematic diagram of a hypothetical system having a spring positioned between a hub and a hub adapter. [Figure 26A] FIG. 1 illustrates an exemplary embodiment of a portion of a robotic control system having multiple magnetically coupled hub adapters and hubs, with an interventional device coupled to one or more of the hubs. [Figure 26B] 1A-1C illustrate an exemplary embodiment of a magnetically coupled hub adapter and hub, and also schematically illustrate a wide variety of different forces that may be applied to the hub and hub adapter. [Figure 27]FIG. 1 is a wiring schematic diagram that may be used by any embodiment of the robotic control system disclosed herein. [Figure 28] FIG. 1 is a schematic diagram of a control system. [Figure 29A] 1A-1C illustrate embodiments of magnets that may be used by any embodiment of the robotic control system disclosed herein. [Figure 29B] FIG. 10 illustrates another embodiment of a magnet that may be used by any embodiment of the robotic control system disclosed herein. [Figure 30A] FIG. 1 illustrates a portion of an embodiment of a drive table having one or more rack and pinion actuators that may be used by any embodiment of the robotic control system disclosed herein. [Figure 30B] FIG. 30B is a close-up view of an embodiment of a rack and pinion actuator of the drive table embodiment shown in FIG. 30A that may be used by any embodiment of the robotic control system disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0036] In certain embodiments, a system is provided for advancing a guide catheter from femoral or radial artery access into the ostium of one of the great vessels above the aortic arch, thereby achieving supra-aortic access. The surgeon can then take over and advance an interventional device into the cerebral vasculature via the robotically placed guide catheter.

[0037] In some implementations, the system can additionally be configured to robotically obtain intracranial vascular access and to perform aspiration thrombectomy or other neurovascular procedures.

[0038] The drive table can be positioned on or near the patient and configured to axially advance, retract, and in some cases rotate and / or laterally deflect two, three, or more different (e.g., concentrically or side-by-side oriented) intravascular devices. One or more hubs can act as instrument couplers that can be coupled to corresponding interventional devices. The hubs can move along paths along the surface of the drive table to advance or retract the interventional devices as desired. Each hub can also contain mechanisms for rotating or deflecting the device as desired and is connected to fluid delivery tubing (not shown) of the type conventionally attached to catheter hubs. Each hub can be in electrical communication with an electronic control system via either a hardwired connection, an RF wireless connection, or a combination of both.

[0039] Each hub is independently movable across the surface of a sterile field barrier membrane carried by a drive table. Each hub is releasably magnetically coupled to a unique hub adapter (also called a carriage or drive carriage) on the table side of the sterile field barrier. The drive system independently moves each hub proximally or distally across the surface of the barrier to move a corresponding interventional device proximally or distally within the patient's vasculature.

[0040] The hub adapter on the drive table, which magnetically couples with the hub to provide linear motion actuation, is universal. Catheter / guidewire functionality is provided based on what is contained in the hub and shaft design. This allows for flexibility in configuring the system to perform a wide range of procedures using a wide variety of interventional devices on the same drive table. Additionally, the interventional devices and methods disclosed herein can be easily adapted for use with any of a wide variety of other drive systems (e.g., any of a wide variety of robotic surgical drive systems).

[0041] 1 is a schematic perspective view of an interventional setup 10 having a patient support table 12 for supporting a patient 14. An imaging system 16 can be provided along with a robotic interventional device drive system 18 according to the present disclosure.

[0042] Drive system 18 can include, for example, a support table 20 for supporting a guidewire hub 26, an access catheter hub 28, and a guide catheter hub 30. In the present context, the term "access" catheter can be any catheter having a lumen with at least one distally or laterally facing distal opening that can be utilized to aspirate thrombus, to provide access for additional devices to be advanced therethrough, or to inject saline or contrast media or therapeutic agents.

[0043] 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 a guidewire hub 26 and an access catheter hub 28 for driving a guidewire and an access catheter (in the form of a diagnostic angiography catheter), respectively. Multiple interventional devices 22 extend between the support table 20 and (in the illustrated example) a femoral access point 24 on the patient 14. Depending on the desired procedure, access may be achieved by percutaneous or cut-down access to any of various arteries or veins, such as the femoral or radial arteries. Although disclosed herein primarily in the context of neurovascular access and procedures, the robotic drive systems and associated interventional devices can be readily adapted for use in a wide variety of additional medical interventions, such as in the peripheral and coronary arterial and venous vasculature, the gastrointestinal system, the lymphatic system, cerebrospinal fluid lumens or spaces (e.g., the spinal canal, ventricles, and subarachnoid space), the pulmonary airways, treatment sites reached via transurethral or urethral or tubal navigation, or in other hollow organs or structures within the body (e.g., in intracardiac or structural cardiac applications such as valve repair or replacement, or in any endoluminal procedure).

[0044] For example, a display 23 for viewing fluoroscopic images, catheter data (e.g., fiber Bragg grating optical fiber sensor data or other force or shape sensing data), or other patient data, etc., may be carried by support table 20 and / or patient support 12. Alternatively, the physician input / output interface including display 23 may be remote from the patient, e.g., behind radiation shielding, in a different room than the patient, or in a different facility than the patient.

[0045] In the illustrated example, 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 to laterally deflect a deflectable portion of the access catheter in response to operation of a deflection control.

[0046] FIG. 2 is a longitudinal cross-sectional view that schematically illustrates the motion relationships 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).

[0047] 3A, support table 20 includes a drive mechanism, described in more detail below, for independently driving guidewire hub 26, access catheter hub 28, and guide catheter hub 30. Anti-buckling features 34 can be provided in the proximal anti-buckling zone to resist buckling of the portion of the interventional device spanning the distance between support table 20 and femoral artery access point 24. Anti-buckling features 34 can include a plurality of concentric, telescoping, axially extendable and collapsible tubes through which the interventional device extends.

[0048] Alternatively, one or more proximal segments of the device shaft can be configured with enhanced stiffness to reduce buckling under compression. For example, a proximal reinforced segment can extend distally from the hub for a distance of at least about 5 or 10 centimeters, but typically no more than about 120 or 100 centimeters, to support the device between the hub and access point 24 on the patient. Reinforcement can be achieved by using metal or polymer tubing or by embedding at least one or two or more axially extending elements, such as elongated wires or ribbons, into the wall of the device shaft. In some implementations, the extending elements are hollow and can protect against wear, buckling, or damage at the input and output of the hub. In some embodiments, the hollow extending elements can be hollow flexible coatings attached to the hub. The hollow extending elements (e.g., hollow flexible coatings) can cover a portion of the device shaft when threaded through the hub. In some embodiments where the hollow extending element is a coating, the coating can be attached to a portion of the hub such that passing the catheter device through the hub 26, 28, or 30 also passes the catheter device through the coating. In some implementations, an anti-buckling device can be placed on or around or surrounding 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 laser-cut hypotube, a spring, telescoping tubing, tensioned split tubing, or the like.

[0049] In some implementations, multiple deflection sensors can be placed along the catheter length to identify buckling. Identifying buckling can be performed by detecting distal advancement of the hub while the distal tip of the catheter or interventional device is not being moved. In some implementations, buckling can be detected by detecting an energy load (e.g., due to friction) between the catheter shaft.

[0050] Alternatively, a thin tubular stiffening structure can be embedded within or carried on the exterior of the device wall, such as a tubular polymer extrusion or length of hypotube. Alternatively, a removable stiffening mandrel can be placed within the lumen in the proximal segment of the device and removed proximally following distal advancement of the hub toward the patient access site to prevent buckling of the proximal shaft during distal advancement of the hub. Alternatively, one or more proximal segments of the device shaft can be constructed as a tubular hypotube, which can be machined (e.g., by laser) so that its mechanical properties vary along its length. This proximal segment can be formed from stainless steel, nitinol, and / or cobalt-chromium alloy, optionally in combination with a polymer component capable of providing lubricity and hydraulic sealing. In some embodiments, this proximal segment can be formed from a polymer such as polyetheretherketone (PEEK). Alternatively, the wall thickness or diameter of the interventional device can be increased in the anti-buckling zone.

[0051] In certain embodiments, a device shaft having a high degree of stiffness (e.g., axially and torsionally) can provide improved transmission of motion 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 embodiments can be advantageous for robotic actuation in the absence of tactile feedback to the user.

[0052] In some embodiments, a flexible coating can be applied to the device shaft and / or hub to reduce frictional forces between the device shaft and / or hub and a second device shaft as the second device shaft passes through it.

[0053] The interventional device hub can be separated from the support table 20 by a sterile barrier 32. The sterile barrier 32 can comprise a thin plastic film, such as polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG), polyethylene terephthalate (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 associated drive systems to reside on the non-sterile side (below) of the sterile barrier 32. The guidewire hub 26, access catheter hub 28, guide catheter hub 30, and associated interventional devices are all on the sterile side (above) of the sterile barrier 32. The sterile barrier is preferably waterproof and can also serve as a tray used in packaging the interventional devices (discussed further below). The interventional devices can be provided individually or as a coaxially pre-assembled kit, which is shipped and stored in a tray and enclosed in sterile packaging.

[0054] 3B-3F schematically illustrate an alternative sterile barrier in the form of a dual-function sterile barrier for placement on a support table during an interventional procedure and a shipping tray with one or more storage channels for carrying sterile interventional devices. The sterile barrier can also act as a sterile work surface for preparing catheters or other devices during the procedure.

[0055] 3B and 3C, a sterility barrier 32 is shown in the form of a pre-shaped tray to fit over the elongated support table 20. In use, the elongated support table 20 is positioned below the sterility barrier 32. The sterility 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 implementation, the support surface 104 has an axial length greater than the length of the intended interventional device in a linear drive configuration.

[0056] The length of the support surface 104 will typically be at least about 100 centimeters and will be in the range of about 100 centimeters to about 2.7 meters. Shorter lengths can be utilized in systems configured to advance the drive coupler along an arcuate path. In some embodiments, two or more support surfaces can be used in place of a single support surface 104. The two or more support surfaces can have a combined length between 100 centimeters and about 2.7 meters. The width of the linear drive table is preferably no more than about 30 centimeters to about 80 centimeters.

[0057] At least a first channel 106 may be provided, extending axially for at least a portion of the length of the support table 20. In the illustrated implementation, the first channel 106 extends the entire length of the support table 20. Preferably, the first channel 106 has a length sufficient to hold an interventional device and a width and depth sufficient to hold a corresponding hub (e.g., by providing lateral support to prevent dislodgement of the hub when force is applied to the hub). The first channel 106 is defined in the floor 108, the outer sidewall 110, and the inner sidewall 111 and forms an upwardly facing concave surface. Optionally, a second channel 112 may be provided. The second channel 112 may be positioned on the same or opposite side of the upper support surface 104 from the first channel 106. Two, three or more additional recesses, such as additional channels or wells, can be provided to hold additional medical devices or supplies that may be useful during the interventional procedure, as well as to collect fluids and act as washing reservoirs for the catheter and related devices.

[0058] 3D, guide catheter hub 30 is shown positioned on upper support surface 104 and magnetically coupled to a corresponding coupler holding a drive magnet positioned below sterile barrier 32. Access catheter hub 28 and access catheter 29, as well as guidewire hub 26 and guidewire 27, are shown to reside within first channel 106, e.g., prior to introduction through guide catheter 31 or following removal from guide catheter 31.

[0059] An interventional device can be positioned in the channel 106 and enclosed within a sterile barrier for shipping. At the clinical site, 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 32 assembly, exposing the sterile top side of the sterile barrier tray and any contained interventional device. The interventional device can be carried separately in the channel or pre-assembled into an access or treatment assembly, which are discussed in additional detail below.

[0060] Figures 3D-3F illustrate the support table with the sterile barrier in place, and Figure 3E illustrates the interventional devices configured into the access assembly for aortic access following coupling of the access assembly to a corresponding hub adapter below the sterile barrier. The access assembly can be pre-assembled with the guidewire fully advanced through the access catheter and the access catheter fully advanced through the guide catheter. In embodiments where the access catheter or other catheters are pre-shaped (i.e., not pre-curved or straight), the guidewire and / or outer catheter can be positioned so that the relatively stiff sections do not overlap the curved, stiffer sections of the pre-shaped catheter, for example, to avoid creep or straightening of the pre-shaped catheter and / or to avoid introducing a curvature into an otherwise straight catheter. The access assembly can be lifted from the channel 106 and positioned on the support surface 104 for coupling to the respective drive magnets and introduction into the patient. The guide catheter hub 30 is the distal-most hub. Access catheter hub 28 is positioned proximally to the guide catheter hub to allow access catheter 29 to extend distally through the guide catheter. Guidewire hub 26 is positioned proximally most to allow guidewire 27 to be advanced through access catheter 29 and guide catheter 31.

[0061] The treatment assembly is illustrated in FIG. 3F following its introduction through the guide catheter 31 used to achieve supra-aortic access. In this implementation, the guide catheter 31 remains the most distal of the interventional devices. A first treatment catheter 120 and corresponding hub 122 are shown extending through the guide catheter 31. An optional second treatment catheter 124 and corresponding hub 126 are shown extending through the first treatment catheter 120. A guidewire 27 extends through at least a portion of the second treatment catheter 124 in a rapid exchange version of the second treatment catheter 124, or through the entire length of the second treatment catheter 124 in an over-the-wire implementation.

[0062] As discussed in more detail in connection with FIG. 17 , a multi-catheter stack can be utilized to achieve both access and endovascular procedures without the need for catheter exchange. This can be accomplished with either manually or robotically driven procedures. 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 implementation, an inner diameter of about 0.088 inches. The first treatment catheter 120 can include a catheter having an inner diameter in the range of about 0.065 inches to about 0.075 inches, and in one implementation, the catheter 120 has an inner diameter of about 0.071 inches. The second treatment catheter 124 can be an access catheter with an OD sized to allow advancement through the first treatment catheter 120. The second treatment catheter can be steerable and include a deflection control 2908 configured to laterally deflect the distal end of the catheter. The second treatment (access) catheter can also have an inner lumen that is sized to allow an appropriately sized guidewire to remain inside the second treatment catheter while contrast injection is performed through the second treatment catheter.

[0063] In certain embodiments, catheter 31 can be a "large bore" access or guide catheter having a diameter of at least about 0.075 or at least about 0.080 inches. Catheter 120 can be an aspiration catheter having a diameter in the range of about 0.060 inches to about 0.075 inches. Catheter 124 can be a steerable catheter with a deflectable distal tip having a diameter in the range of about 0.025 inches to about 0.050 inches. Guidewire 27 can have a diameter in the range of about 0.014 inches 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.

[0064] In one commercial implementation, a pre-assembled access assembly (guide catheter, access catheter, and guidewire) can be carried in a first channel on the sterile barrier tray, and a pre-assembled treatment assembly (one or two treatment catheters and guidewire) can be carried in the same or a different second channel on the sterile barrier tray. One, two, or more additional catheters or interventional tools can also be provided, depending on potential needs during the interventional procedure.

[0065] 3G-3K illustrate an alternative sterility barrier embodiment having a convex drive surface (e.g., a convex crowned road drive surface). FIG. 3G is a cross-sectional view of sterility barrier 232. Sterility barrier 232 includes a convex upper support surface 204. Fluid channels 205 and 207 are positioned laterally and below support surface 204 for self-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 sterility barrier.

[0066] 3I, 3J, and 3K illustrate a cross-sectional perspective view, a cross-sectional view, and a top cross-sectional view, respectively, of the proximal end of sterility barrier 232. As shown in FIGS. 3I-3K, sterility barrier 232 can include a trough 240 in communication with fluid channels 205 and 207. Trough 240 can receive fluid from channels 205 and 207 (e.g., during an interventional procedure). Trough 240 can be positioned at least partially below fluid channels 205 and 207 such that fluid in channels 205 and 207 flows into trough 240. In certain embodiments, fluid channels 205 and 207 can be angled relative to a horizontal plane (e.g., can descend from the end of the channel farthest from trough 240 into trough 240) such that fluid in channels 205 and 207 is directed toward trough 240. For example, channels 205 and 207 may increase in depth from the ends of the channels farthest from trough 240 to trough 240. Alternatively, sterility barrier 232 and / or support table may be positioned at an angle relative to a horizontal plane during part or all of the interventional procedure, such that the ends of channels 205 and 207 farthest from trough 240 are positioned higher than trough 240. For example, sterility barrier 232 and / or support table may be constructed or positioned in an angled arrangement such that the ends of sterility barrier 232 and / or support table opposite trough 240 are positioned higher than trough 240.Alternatively or additionally, the drive mechanism may be capable of temporarily tilting the sterile barrier 232 and / or support table (e.g., by lifting the end of the sterile barrier and / or support table opposite the trough 240 or by lowering the end of the sterile barrier 232 and / or support table on which the trough 240 is positioned) so that the end of the sterile barrier 232 and / or support table opposite the trough 240 is positioned higher than the trough 240, allowing the fluid in the channels 205 and 207 to flow into the trough 240.

[0067] The trough 240 can include a drain hole 242. The trough 240 can be shaped, sized, and / or otherwise configured to allow fluid in the trough 240 to empty into the drain hole 242. The drain hole 242 can include tubing, a barb fitting, and / or an on-off valve for removal of fluid from the trough 240. As shown in FIGS. 3I-3K, the trough 240 can be positioned at the proximal end of the sterility barrier 232. In an alternative embodiment, the trough 240 can be positioned at the distal end of the sterility barrier 232. In some embodiments, the sterility 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 be used as a washing reservoir.

[0068] The first channel 206 can extend axially for at least a portion of the length of the sterility barrier 232. The channel 206 can have a length sufficient to hold an interventional device and a width and depth sufficient to hold a corresponding hub (e.g., by providing support to prevent the hub from dislodging when force is applied to the hub). Optionally, a second channel 212 can be provided. The second channel 212 can be positioned on the same or opposite side of the upper support surface 204 from the first channel 206. FIG. 3G illustrates the channel 212 positioned on the opposite side of the support surface 204 from the channel 206. FIG. 3H is a cross-sectional view illustrating an alternative embodiment of the sterility barrier 232 in which the channel 212 is on the same side of the support surface 204 as the channel 206.

[0069] 3G and 3H, channels 206 and 212 can have a generally triangular, wedge-shaped, or otherwise angled cross-section to hold the hub at an angle relative to the horizontal plane. Holding the hub at an angle relative to the horizontal plane can allow for a smaller width of sterility barrier 232.

[0070] Two, three or more additional recesses, such as additional channels or wells, can be provided to hold additional medical devices or supplies that may be useful during the interventional procedure, as well as to collect fluids and act as washing reservoirs for the catheter and related devices.

[0071] In some embodiments, the sterility barrier 232 can include one or more structural ribs 236. The sterility barrier 232 can further include one or more frame support bosses 228 and 238.

[0072] In the embodiment of the sterility barrier 232 shown in FIG. 3G, the width x1 can be 14 inches wide, approximately 14 inches wide, between 12 inches and 16 inches wide, between 10 inches and 18 inches wide, or any other suitable width. In the embodiment of the sterility barrier 232 shown in FIG. 3H, the width x1 can be 15 inches wide, approximately 15 inches wide, between 13 inches and 17 inches wide, between 11 inches and 19 inches wide, or any other suitable width. The height y1 of the support surface 204 can be 0.125 inches high, approximately 0.125 inches high, between 0.1 inches and 0.15 inches high, or any other suitable height. In some embodiments, the support surface 204 can be recessed from the top surface 233 of the sterility barrier 232. The height y2 between the bottom and top surface 233 of support surface 204 can be 0.5 inches high, approximately 0.5 inches high, between 0.25 inches and 0.75 inches high, or any other suitable height. The width x2 from the lateral edge of channel 205 to the lateral edge of channel 207 can be 5 inches wide, approximately 5 inches wide, between 4 inches and 6 inches wide, or any other suitable width. The width x3 of support surface 204 can be 4 inches wide, approximately 4 inches wide, between 3 inches and 5 inches wide, or any other suitable width. The height y3 of channel 206 and / or channel 212 can be 1.5 inches high, approximately 1.5 inches high, between 1 inch and 2 inches high, or any other suitable height. The width x4 of channel 206 and / or channel 212 can be 3 inches wide, approximately 3 inches wide, between 2 inches and 4 inches wide, or any other suitable width. Channel 206 and / or channel 212 can be defined by an arc angle α of 90°, an arc angle α of approximately 90°, an arc angle α of between 80° and 100°, or any other suitable angle, and by a radius of curvature of 0.125 inches, a radius of curvature of approximately 0.125 inches, a radius of curvature between 0.1 inches and 0.15 inches, or any other suitable radius of curvature.In certain embodiments, an arc angle α of 90° or approximately 90° can be used to hold a hub having a rectangular or generally rectangular cross-section. Support surface 204 can be defined by a radius of curvature of 13 inches, approximately 13 inches, between 11 and 15 inches, or any other suitable radius of curvature. Channel 205 and / or channel 207 can be defined by a radius of curvature of 0.25 inches, approximately 0.25 inches, between 0.15 and 0.35 inches, or any other suitable radius of curvature.

[0073] 3L and 3M depict exemplary dimensions of a hub 250 that may be used with the sterility barrier 232 as shown in FIGS. 3G-3K. The hub 250 can be any of the hubs described herein. In certain embodiments, the hub 250 can have a width w1 of 3.75 inches, a width w1 of approximately 3.75 inches, a width w1 of between 3.25 inches and 4.25 inches, or any other suitable width. The hub 250 can have a height h1 of 1.5 inches, a height h1 of approximately 1.5 inches, a height h1 of between 1.25 inches and 1.75 inches, or any other suitable height. Alternatively, the hub 250 can have a height h2 of 2 inches, a height h2 of approximately 2 inches, a height h2 of between 1.75 inches and 2.25 inches, or any other suitable height. In some embodiments, the hub 250 can have a length L1 of 2.5 inches, a length L1 of approximately 2.5 inches, a length L1 of between 2 and 3 inches, or any other suitable length. Alternatively, the hub 250 can have a length L2 of 4 inches, a length L2 of approximately 4 inches, a length L2 of between 3.25 and 4.75 inches, or any other suitable length.

[0074] In some embodiments, the upper surface of the support table can include surface features that generally correspond to those of the sterility barrier 232. For example, the support table can include a convex surface configured to correspond to the shape, size, and location of the support surface 204 and / or one or more recesses configured to correspond to the shape, size, and location of the channels 205 and 207.

[0075] In alternative embodiments, the planar support surface (e.g., support surface 104 of sterility barrier 32) can be positioned at an angle relative to the horizontal plane to facilitate drainage of fluids. In some embodiments, the sterility barrier and / or support table can be positioned at an angle relative to the horizontal plane to facilitate drainage of fluids during part or all of an interventional procedure. For example, the sterility barrier and / or support table can be constructed or positioned in an angled arrangement to facilitate drainage of fluids (e.g., one lateral side of the planar support surface is positioned 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 higher than the proximal end). Alternatively or additionally, the drive mechanism may temporarily tilt the sterile barrier and / or support table (e.g., so that one lateral side of the planar support surface is positioned higher than the other lateral side of the planar support surface, so that the proximal end is higher than the distal end, or so that the distal end is higher than the proximal end) to facilitate fluid drainage. For example, the drive mechanism may raise or lower one lateral side of the sterile barrier and / or support table, the proximal end of the sterile barrier and / or support table, and / or the distal end of the sterile barrier and / or support table.

[0076] In certain embodiments, the support surface (e.g., support surface 104 of sterile barrier 32) can be positioned in a vertical configuration rather than the horizontal configuration shown in, for example, FIGS. 3A-3F. For example, support surface 104 can be positioned approximately 90 degrees (or any other suitable angle) from the horizontal plane (e.g., rotated 90 degrees about the long axis of support surface 104 relative to the embodiment shown in FIGS. 3A-3F). The vertical configuration can provide easier interaction with drive system 18 by the physician. Also, the vertical configuration can provide a lower axis of catheter travel closer to the patient without adding standoff height to drive system 18.

[0077] In some embodiments, drive system 18 can be positioned at an angle relative to a horizontal plane to facilitate fluid drainage during part or all of an interventional procedure. For example, drive system 18 can be constructed or positioned in an angled arrangement (e.g., one lateral side of the planar support surface is positioned 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 higher than the proximal end) to facilitate fluid drainage. Alternatively or additionally, the drive mechanism can temporarily tilt drive system 18 to facilitate fluid drainage (e.g., one lateral side of drive system 18 is positioned higher than the other lateral side of drive system 18, the proximal end is higher than the distal end, or the distal end is higher than the proximal end). For example, the drive mechanism can raise or lower one 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 access point 24 (e.g., so that the proximal end is higher than the distal end), for example, to allow clearance for the patient's feet.

[0078] 4, the hub 36 can represent any of the hubs previously described. 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 of the interventional devices disclosed herein, extends distally from the hub 36 into the patient 14 (not shown). The hub adapter 48 acts as a shuttle by advancing proximally or distally along a track in response to operator commands or controller manipulations.

[0079] In any of the robotic control system embodiments disclosed herein, any of the hub adapter embodiments disclosed herein can be configured to move proximally or distally along a track (e.g., without limitation, a linear track) in response to an operator command or controller operation. For example, without limitation, any of the robotic control system and / or method of controlling movement of an interventional device through a sterile barrier disclosed herein can have one or more rack-and-pinion linear devices, including any of the rack-and-pinion devices, components, and / or features disclosed in the description below.

[0080] Figure 30A shows a portion of an embodiment of a drive table having one or more rack and pinion actuators that may be used by any embodiment of the robotic control system disclosed herein. Figure 30B shows a close-up view of an embodiment of a rack and pinion actuator of the embodiment of the drive table shown in Figure 30A that may be used by any embodiment of the robotic control system disclosed herein.

[0081] In some embodiments, one or more of the first hub adapter 4012a, the second hub adapter 4012b, the third hub adapter (not shown), and the fourth hub adapter (not shown) can be configured to move axially proximally and / or distally relative to the drive table 4002 via linear actuators. In some embodiments, as in the illustrated embodiment, the linear actuators for one or more or all of the hub adapters can be or include rack and pinion linear actuators. In some embodiments, one or more hub adapters can be configured to move in response to inputs provided by a user of the robotic control system and / or in response to automated commands of the robotic control system.

[0082] FIG. 30B shows an embodiment of a hub adapter 4012, which can be any of the hub adapters described herein. Referring to FIG. 30B, some embodiments of the rack and pinion linear actuator can have a rack (or straight gear) 4032 and a pinion gear 4038 coupled to the shaft of the motor 4030 on the hub adapter 4012. For example, without limitation, referring to FIG. 30A, the first hub adapter 4012a, the second hub adapter 4012b, the third hub adapter (not shown), the fourth hub adapter (not shown), and / or any other hub adapter of the robotic control system, or any combination of the foregoing hub adapters, can have a motor and a pinion gear configured to engage the rack 4032. For example, the first hub adapter 4012a can have a pinion gear 4038a coupled to the shaft of the motor 4030a. The second hub adapter 4012b can have a pinion gear 4038b coupled to the shaft of the motor 4030b. In this configuration, any one or all of the hub adapters can have their own unique motor and pinion gear to allow for independent movement of each hub adapter.

[0083] 30A and 30B , in some embodiments of the robotic control system, the hub adapter is coupled to and capable of axial movement along rails or linear guides 4014 a and / or rails or linear guides 4014 b. The linear guides 4014 a and / or linear guides 4014 b can guide and / or constrain the hub adapter to move axially (e.g., proximally and distally) along a linear path when moved by a linear actuator. In any embodiment, the hub adapter (or any combination of hub adapters) can be configured to move axially relative to the drive table 4002 using a belt drive system, multiple wheels, a lead screw system, a ball screw system, a rack and pinion system, or any other suitable drive system or combination thereof.

[0084] Alternatively, in some embodiments, the hub adapter 4012 of FIG. 30B (which can be any of the hub adapters described herein) can have multiple wheels (e.g., low-friction wheels) configured to move along one or more rails of the drive table 4002. In some embodiments, one side of the hub adapter 4012 can be spring-loaded to facilitate coupling with the rail. In any embodiment disclosed herein, the table supporting the rail and / or the rail itself can also be configured to move axially in the proximal or distal direction. Additionally, in some embodiments, the drive table 4002 can be a foldable drive table having two segments connected at a hinge or joint that can be folded together.

[0085] In any embodiment disclosed herein, the first hub adapter 4012a can be distal to the second hub adapter 4012b, which can be distal to the third hub adapter, which can be distal to the fourth hub adapter. In any embodiment, the second hub adapter 4012b can be axially aligned with the first hub adapter 4012a such that a first interventional device coupled with the first hub and a second interventional device coupled with the second hub are coaxially aligned when the first and second hubs are coupled with the first and second hub adapters 4012a, 4012b, respectively. Additionally, in some embodiments, the third hub adapter 4012 and the fourth hub adapter 4012 can be axially aligned with the first hub adapter 4012a such that when the first, second, third, and fourth hubs are coupled (e.g., magnetically coupled) with the first, second, third, and fourth hub adapters, respectively, the first interventional device coupled with the first hub, the second interventional device coupled with the second hub, the third interventional device coupled with the third hub, and the fourth interventional device coupled with the fourth hub are coaxially aligned with the first interventional device coupled with the first hub. As described herein, the first interventional device, the second interventional device, the third interventional device, and the fourth interventional device can be arranged in a concentric stack.

[0086] In addition to what is described above, any embodiment of the robotic control system and / or method of controlling movement of an interventional device disclosed herein may have any of the rack and pinion systems, components, and / or any features or details thereof disclosed in U.S. patent application Ser. No. 18 / 524,879, entitled "ROTATABLE DRIVE TABLE," filed November 30, 2023, which application, and all of its rack and pinion systems, components, features, and / or details, are hereby incorporated by reference in their entirety as if fully and explicitly set forth herein.

[0087] Any embodiment of the robotic control system and / or method for controlling movement of an interventional device disclosed herein can include any combination of rack-and-pinion actuator systems or devices, belt drive systems or devices, or other linear movement systems or devices configured to move one or more hub adapters and / or hubs proximally or distally along a linear track in response to an operator command or controller operation. Additionally, without limitation, any and all embodiments of a drive table with or without systems, components, and features associated with a rack-and-pinion drive system disclosed in U.S. patent application Ser. No. 18 / 524,879, entitled "ROTATABLE DRIVE TABLE," filed November 30, 2023, can be used with and included within any of the embodiments of the robotic control system disclosed herein, and are hereby incorporated by reference in their entirety as if fully and explicitly set forth herein.

[0088] In some embodiments, the hub adapter 48 can include at least one drive magnet 67 configured to couple with a driven magnet 69 carried by the hub 36. This provides a magnetic coupling between the drive magnet 67 and the driven magnet 69 through the sterile barrier such that the hub 36 is moved across the top of the sterile barrier 32 in response to movement of the hub adapter 48 outside the sterile field. 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 act as a robotic drive for an interventional device coupled to it.

[0089] To reduce friction within the system, hub 36 can be provided with at least first and second rollers 53 and 55, which can be in the form of wheels, rotatable balls, or drums. The rollers space the sterility barrier from the surface of driven magnet 69 by at least about 0.008 inches, and typically about 0.03 inches or less. In some implementations, the space is within a range of about 0.010 inches to about 0.016 inches. The space between drive magnet 67 and driven magnet 69 is typically about 0.15 inches or less, and in some implementations, about 0.10 inches or less, such as within a range of about 0.085 inches to about 0.090 inches. The hub adapter 48 may likewise be provided with at least a first hub adapter roller 59 and a second hub adapter roller 63, which may be positioned opposite the respective first roller 53 and second roller 55, as shown in FIG. 4.

[0090] Referring to Figure 6, one example of a low-profile linear drive support table 20 is illustrated. 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 for stabilizing the support table 20 relative to a patient (not shown). The support 56 may include one or more legs, or preferably articulating arms, that are configured to allow movement and positioning of the frame 51 on or adjacent to the patient.

[0091] One example of the linear drive table 20 shown in FIG. 7 includes three individual drives. However, two drives or four or more drives (e.g., up to eight drives) can be included depending on the desired clinical performance. A first drive pulley 58 is engaged with a first drive belt 60. A first hub adapter bracket 61 is fixed to the first drive belt 60 such that rotation of the first drive pulley 58 causes rotation of the first drive belt 60 through an elongated closed-loop path. The first hub adapter bracket 61 can be advanced proximally or distally along the longitudinal axis of the support table 20 depending on the direction of rotation of the drive pulley 58. In the illustrated implementation, the drive pulley 58 is provided with surface structure, such as a plurality of drive pulley teeth 62, for engaging complementary teeth on the first drive belt 60.

[0092] The second drive pulley 64 can be engaged with a second drive belt 66, which is configured to axially move a second hub adapter bracket 68 along an axial path over the support table 20. The third drive pulley 70 can be configured to drive a third drive belt 72 to axially advance a third hub adapter bracket 73 along the support table 20. Each of the hub adapter brackets can be provided with a drive magnet assembly, not shown in FIG. 7 but previously discussed, to form a coupler for magnetically coupling to a corresponding driven magnet in the hub of an interventional device as discussed.

[0093] A detailed view of an embodiment of the drive system is shown in FIG. 8 . A drive support 74 can be carried by the frame 51 for supporting the drive assembly. The second drive pulley 64 is shown in elevational section as being rotationally driven by a motor 75 via a rotatable shaft 76. The rotatable shaft 76 can be rotatably carried by the support 74 via a first bearing 78, a shaft coupling 80, and a second bearing 79. The motor 75 can be stabilized by a motor bracket 82 connected to the drive support 74 and / or the frame 51. The belt drive assemblies for the first drive belt 60 and the third drive belt 72 can be similarly constructed and will not be further detailed herein. In some embodiments, the drive system described herein can be a foldable rack-and-pinion drive table system. In such an embodiment, the motor 75 can be attached to the carriage and move with the carriage.

[0094] 9 and 10, each of the first, second, and third drive belts extends around a corresponding first idler pulley 84, a second idler pulley 86, and a third idler pulley 88. Each idler pulley may be provided with a corresponding tensioning bracket 90 configured to adjust the idler pulley proximally or distally to adjust the tension of the respective belt. Accordingly, each tensioning bracket 90 is provided with a tensioning adjustment portion 92, such as a rotatable screw or the like.

[0095] As seen in FIG. 10 , the second idler pulley 86 may be carried, for example, by a rotatable shaft 94 that is rotatably fixed relative to the mounting bracket by a first bearing 96 and a second bearing 98.

[0096] For example, any of the catheters illustrated in Figures 5A, 5B, or 11 generally include an elongated tubular body extending between a proximal end and a distal working end. The length and diameter of the tubular body depend on the desired application. For example, lengths in the area of ​​about 90 centimeters to about 195 centimeters or more are typical for use in percutaneous transluminal coronary applications with femoral access. Intracranial or other applications may require different catheter shaft lengths depending on the vascular access site.

[0097] Any of the catheters disclosed herein can be provided with a beveled distal tip. Referring to Figure 11, a distal catheter tip 1150 includes a tubular body 1152, which includes an advancement segment 1154, a marker band 1156, and a proximal segment 1158. An inner tubular liner 1160 can extend throughout the length of the distal catheter tip 1150 and can include dip-coated or extruded PTFE or other lubricious material.

[0098] A reinforcing element 1162, such as a braid and / or spring coils, is embedded within an outer jacket 1164, which may extend the entire length of the catheter.

[0099] The advancing segment 1154 terminates distally in an angled surface 1166 and provides a leading sidewall portion 1168 having a length measured between the distal end 130 of the marker band 1156 and a distal tip 1172. In some embodiments, the entire distal tip can be shaped to avoid snagging of the tip in the area of ​​an arterial bifurcation. The trailing sidewall portion 1174 of the advancing segment 1154 has an axial length that, in the illustrated embodiment, is approximately equal to the axial length of the leading sidewall portion 1168 as measured approximately 180 degrees around the catheter from the leading sidewall portion 1168. The leading sidewall portion 1168 can have an axial length in the range of about 0.1 millimeter to about 5 millimeters, and typically in the range of about 1 millimeter to 3 millimeters. The trailing sidewall portion 1174 can be equal to or at least about 0.1 or 0.5 or 1 millimeter or 2 millimeters or more shorter than the axial length of the leading sidewall portion 1168 depending on the desired performance.

[0100] The angled surface 1166 is inclined at an angle A ranging from about 45 degrees to about 80 degrees from the longitudinal axis of the catheter. For certain implementations, the angle is ranging from about 55 degrees to about 65 degrees from the longitudinal axis of the catheter. In one implementation, angle A is about 60 degrees. One result of an angle A less than 90 degrees is that the major axis of the distal port area is lengthened, which can increase the surface area of ​​the port and enhance clot aspiration or retention. Compared to the surface area of ​​a circular port (where angle A is 90 degrees), the area of ​​the angled port is generally at least about 105 percent and not more than about 130 percent, and in some implementations, is in the range of about 110 percent to about 125 percent, and in one example, is about 115 percent of the area of ​​the corresponding circular port (where angle A is 90 degrees).

[0101] In the illustrated embodiment, the axial length of the advancement segment is substantially constant around the circumference of the catheter, such that the angled surface 1166 is approximately parallel to the distal surface 1176 of the marker band 1156. The marker band 1156 has a proximal surface that is approximately transverse to the longitudinal axis of the catheter, creating a right-angled trapezoidal configuration for the marker band 1156 in side view. The short sidewall portion 1178 is rotationally aligned with the trailing sidewall portion 1174 and has an axial length in the range of about 0.2 millimeters to about 4 millimeters, with an axial length of about 0.5 millimeters to about 2 millimeters being typical. The opposing long sidewall portion 1180 is rotationally aligned with the leading sidewall portion 1168. The long sidewall 1180 of the marker band 1156 is generally at least about 10 or 20 percent longer than the short sidewall 1178, and depending on the desired performance, can be at least about 50 or 70 or 90 percent longer than the short sidewall 1178. Generally, the long sidewall 1180 will have a length of at least about 0.5 millimeters or 1 millimeter and less than about 5 millimeters or less than 4 millimeters.

[0102] 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 length. The slits can be located on or between the short sidewall 1178 or the long sidewall 1180 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 the wall thickness is preferably about 0.003 inches or less, and in one implementation, about 0.001 inches.

[0103] The fluoroscopic appearance of the marker bands can be unique or individual for each catheter size or type when multiple catheters are utilized, such that the marker bands can be distinguishable from one another by a software algorithm. Distinguishing the marker bands of multiple catheters can be advantageous when multiple catheters are used together, for example, in a multi-catheter assembly or stack as described herein. In some embodiments, the marker bands of the catheters can be configured to allow a software algorithm to detect catheter tip movement.

[0104] The marker band zone of the assembled catheter can have a relatively high bending stiffness and high crush strength (e.g., at least about 50 percent or at least about 100 percent less than the proximal segment 1158, but not more than about 200 percent less than the proximal segment 1158). The high crush strength can provide radial support to the adjacent advancement segment 1154, particularly to the leading sidewall portion 1168, and promote the distal tip 1172 to function as an atraumatic bumper during transluminal advancement and resist collapse under vacuum. The proximal segment 1158 preferably has a lower bending stiffness than the marker band zone, and the advancement segment 1154 preferably has an even lower bending stiffness and crush strength than the proximal segment 1158.

[0105] The advancement segment 1154 can include a distal extension of an outer tubular jacket 1164 and optionally an inner liner 1160 without any other internal support structure distal to the marker band 1156. The outer jacket 1164 can include an extruded polyurethane such as Tecothane®. The advancement segment 1154 can have a bending stiffness and radial crush stiffness that are about 50 percent or less, and in some implementations about 25 percent or less, 15 percent or less, or 5 percent or less, than the corresponding values ​​of the proximal segment 1158.

[0106] The catheter can further include an axial tension element or support, such as a ribbon or one or more filaments or fibers, to increase tension resistance and / or affect bending characteristics in the distal zone. The tension support can include one or more axially extending monostrand or multistrand filaments. One or more tension elements 1182 can be axially positioned inside the catheter wall near the distal end of the catheter. The one or more tension elements 1182 can function as tension supports and resist tip dislodgement or stretching of the catheter wall under tension (e.g., when the catheter is retracted proximally through a twisted outer catheter or tortuous or narrowed vasculature).

[0107] At least one of the one or more tension elements 1182 can extend proximally along the length of the catheter wall from within about 1.0 centimeter of the distal end of the catheter, to less than about 10 centimeters from the distal end of the catheter, to less than about 20 centimeters from the distal end of the catheter, to less than about 30 centimeters from the distal end of the catheter, to less than about 40 centimeters from the distal end of the catheter, or to less than about 50 centimeters from the distal end of the catheter.

[0108] 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.

[0109] At least one of the one or more tension elements 1182 can extend over at least about the most distal 50 centimeters of the length of the catheter, at least about the most distal 40 centimeters of the length of the catheter, at least about the most distal 30 centimeters or 20 centimeters or 10 centimeters of the length of the catheter.

[0110] In some implementations, the tension element extends proximally from the distal end of the catheter along the length of the coil 24, terminating proximally within about 5 centimeters or 2 centimeters or less on either side of the transition between the distal coil and the proximal braid. The tension element can terminate at the transition without overlapping the braid.

[0111] One or more tension elements 1182 can be located near or radially outside the inner liner 1160. One or more tension elements 1182 can be located near or radially inside the braid and / or coil. One or more tension elements 1182 can be carried between the inner liner 1160 and the helical coil and can be secured to the surface of the inner liner or other underlying layer by adhesive before the addition of the next outer adjacent layer, such as a coil. Preferably, the tension elements 1182 are secured to the marker band 1156 by adhesive or mechanical interference. In one implementation, the tension elements 1182 extend distally over and beyond the marker band on a first (e.g., inner) surface of the marker band, then wrap around the distal end of the marker band, extend along a second (e.g., outer) surface in either or both a proximal angled direction or a circumferential direction, and completely wrap around the marker band.

[0112] When two or more tension elements 1182 or filament bundles are circumferentially spaced apart within the catheter wall, the tension elements 1182 can be positioned in a radially symmetric manner. For example, the angle between two tension elements 1182 relative to the radial center of the catheter can be approximately 180 degrees. Alternatively, depending on the desired clinical performance (e.g., flexibility, trackability), the tension elements 1182 can be positioned in a radially asymmetric manner. The angle between any two tension elements 1182 relative to the radial center of the catheter can be less than or equal to approximately 180 degrees, less than or equal to approximately 165 degrees, less than or equal to approximately 135 degrees, less than or equal to approximately 120 degrees, less than or equal to approximately 90 degrees, less than or equal to approximately 45 degrees, or less than or equal to approximately 15 degrees.

[0113] The one or more tension elements 1182 can include materials such as Vectran®, Kevlar®, Polyester®, Spectra®, Dyneema®, Meta-Para-Aramide®, or any combination thereof. At least one of the one or more tension elements 1182 can include a single fiber or a multi-fiber bundle, and the fiber or bundle can have a round or rectangular (e.g., ribbon) cross-section. The terms fiber or filament do not convey composition; they can include any of a variety of high tensile strength polymers, metals, or alloys, depending on design considerations such as the desired tensile fracture limit and wall thickness. The cross-sectional dimension of the one or more tension elements 1182, as measured radially, can be approximately 2 percent or less, 5 percent or less, 8 percent or less, 15 percent or less, or 20 percent or less of that of the catheter 10.

[0114] The cross-sectional dimension of one or more tension elements 1182, when measured radially, can be about 0.03 millimeters (about 0.001 inches) or less, about 0.0508 millimeters (about 0.002 inches) or less, about 0.1 millimeters (about 0.004 inches) or less, about 0.15 millimeters (about 0.006 inches) or less, about 0.2 millimeters (about 0.008 inches) or less, or about 0.38 millimeters (about 0.015 inches) or less.

[0115] The one or more tensioning elements 1182 can increase the tensile strength of the distal zone of the catheter before failure under tension (e.g., marker band detachment) to at least about 1 lb, at least about 2 lb, at least about 3 lb, at least about 4 lb, at least about 5 lb, at least about 6 lb, at least about 7 lb, at least about 8 lb, or at least about 10 lb or more.

[0116] Depending on the desired data, any of a variety of sensors can be provided on either the catheter, the hub, the hub adapter, or the table. For example, in some implementations, it may be desirable to measure axial tension or compression applied to the catheter, such as along a force-sensing zone. The distal end of the catheter would be made of a similar construction as shown in FIG. 11 with a helical coil distal section. However, instead of using a single helical coil of nitinol wire, first conductor 140 and second conductor 142 are wound into intertwined helical coils and are electrically isolated from each other, for example, by the plastic / resin of the tubular body. See FIG. 12A. Each coil is in electrical communication with the proximal hub by a unique electrical conductor, such as a conductive trace or a proximal extension of the wire.

[0117] This construction of dual, electrically isolated helical coils creates a capacitor, roughly equivalent to two plates of Nitinol with a plastic layer between them, as shown in FIG. 12B. Capacitance is inversely proportional to the distance between the wires. The only variable that will vary is d (the distance between the plates). When an axial compressive force is applied to the catheter, the wires (e.g., conductors 140 and 142) will move closer together, thus increasing the capacitance. When an axial tensile force is applied, the wires will move further apart, decreasing the capacitance. This capacitance can be measured at the proximal end of the catheter, providing a measure of the force on the helical capacitor. Although called a capacitor, the sensor is measuring the electrical interaction between the two coils of wire. There can be a measurable change in inductance or other resulting change due to the applied axial force.

[0118] At least a first helical capacitor can have at least one, five, ten, or more complete turns of each wire. The capacitor can be positioned within the distal-most 5, 10, or 20 centimeters of the catheter body to sense forces experienced at the distal end. At least a second capacitor can be provided within the proximal-most 5, 10, or 20 centimeters of the catheter body to sense forces experienced at the proximal end of the catheter.

[0119] It may also be desirable to measure the elastic force across the magnetic coupling between the hub and the corresponding hub adapter, using the magnetic coupling's natural springiness (compliance) to measure the force applied to the hub. The magnetic coupling between the hub and hub adapter creates a spring. When a force is applied to the hub, the hub will move a small amount relative to the hub adapter. See FIG. 13A. In robotics, this is called a series elastic actuator. This property can be used to measure the force applied to the hub from the hub adapter. To measure the force, the relative distance between the hub and hub adapter (dx shown in FIG. 13A) is determined to characterize some effective spring constant k between the two components. See FIG. 13B.

[0120] The relative distance can be measured in several different ways. One method for measuring the relative distance between the hub and hub adapter is a magnetic sensor (e.g., a Hall Effect sensor between the hub and hub adapter). A magnet is attached to either the hub or the hub adapter, and a corresponding magnetic sensor is attached to the other device (hub adapter or hub). The magnetic sensor can be a Hall Effect sensor, a magnetoresistive sensor, or another type of magnetic field sensor. Generally, multiple sensors can be used to increase the reliability of the measurement. This reduces noise and reduces interference from external magnetic fields. Additional details regarding magnetic sensors are described with respect to FIGS. 24-27.

[0121] Other non-contact distance sensors can also be used. These include optical, inductive, and capacitive sensors. Optical sensors will preferably be configured in a manner that avoids the accumulation of blood or other fluids at the interface between the hub and hub adapter. In some implementations, for example, wireless (i.e., inductive) power can be used to transduce movement and / or transfer information across the sterile barrier between the hub adapter and the hub.

[0122] In some embodiments, the magnetic coupling between the hub and hub adapter has a shear or axial break threshold, which can be approximately 300 grams, 1000 grams, or 1300 grams, or greater. The processor can be configured to compare the axial force applied to the catheter to a preset axial trigger force that, if applied to the catheter, is perceived to create a risk to the patient. If the trigger force is reached, the processor can be configured to generate a response, such as visual, auditory, or tactile feedback to the physician, and / or to slow and stop further advancement of the catheter until a reset is achieved. An override feature can be provided so that the physician can choose to continue advancing the catheter at a force higher than the trigger force in situations where the physician believes incremental force is justified.

[0123] Force and / or torque sensing optical fibers (e.g., fiber Bragg grating (FBG) sensors) can be incorporated into the catheter sidewall or, alternatively, integrated into the guidewire to measure force and / or torque at various locations along the catheter shaft. The fiber measures axial strain, which (when helically wound) can be converted to axial force or torque. At least a first FBG sensor can be integrated into a distal, proximal, and / or intermediate sensing zone on the catheter or guidewire to measure force and / or torque in the vicinity of the sensor.

[0124] It may also be desirable to understand the three-dimensional configuration of a catheter or guidewire during and / or following transvascular placement. Shape-sensing optical 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 each other, the shape along the length of the catheter / guidewire can be determined.

[0125] Resistive strain gauges can be integrated into the body of the catheter or guidewire to measure force or torque, such as at the distal tip and / or proximal end of the device.

[0126] Measurements of the force and / or torque applied to the catheter or guidewire shaft can be used to determine 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. Measurements of the applied force and / or torque can also be used to provide feedback related to better catheter manipulation and control. Measurements of the applied force and / or torque can also be used in conjunction with processed fluoroscopic imaging information to determine or characterize distal tip motion.

[0127] In some embodiments, a force and / or torque sensor can be incorporated into the hub to indicate the force or torque being applied to the proximal end of the catheter or guidewire shaft. In some embodiments, the sensor can be a multi-axis force / torque sensor (e.g., a 6-axis force / torque transducer). In some embodiments, the configuration described in Rafii-Tari et al., Objective Assessment of Endovascular Navigation Skills with Force Sensing, Annals of Biomedical Engineering 2017 (incorporated herein by reference in its entirety) can be incorporated into the hub and / or hub adapter.

[0128] 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 the sterile barrier. The same type of sensor can also be configured to measure the position of the hub adapter. Each hub can have at least one magnet attached to it. In some embodiments, the robotic table can have a corresponding linear array of magnetic sensors spanning the length of the table. A processor can be configured to determine the location of the magnet along the length of the linear sensor array and display the axial position information to the physician.

[0129] Alternatively, the foregoing can be accomplished using a non-contact inductive sensor to directly measure the position of the hub through the sterile barrier. Each hub or hub adapter can be provided with an inductive "target" therein. The robot table can be provided with an inductive sensing array throughout the working length of the table. As a further alternative, an absolute linear encoder can be used to directly measure the linear position of the hub or hub adapter. The encoder can use any of a variety of different technologies, including optical, magnetic, inductive, and capacitive methods.

[0130] In one implementation, 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) configured to ping an interrogator signal that stimulates a return signal from the passive coil. The PCB is configured to identify the return signal and its location.

[0131] The axial position of the hub adapter can be determined using a multi-turn rotary encoder to measure the rotational position of the pulley, which directly correlates to the linear position of the hub adapter. Direct measurement of the hub adapter location can alternatively be achieved by recording the number of steps commanded to a stepper motor to measure the rotational position of the pulley, which directly correlates to the linear position of the hub adapter.

[0132] The location of the catheter and guidewire within the anatomy 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 distal tip position or movement, or lack thereof, to 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 device shaft length inside the body (e.g., in the aorta) or outside the body between the hubs). Processing can be done in real time to provide position / orientation data at up to 30 Hz, although this technique will only provide data while fluoroscopic imaging is turned on. In some embodiments, machine vision algorithms can be used to generate and suggest optimal catheter maneuvers to access or reach anatomical landmarks, similar to driver assistance. Machine vision algorithms can utilize the data to automatically navigate the catheter according to the anatomy presented by fluoroscopy.

[0133] The proximal torque applied to a catheter or guidewire shaft can be determined using a dual-encoder torque sensor. Referring to FIG. 14, a first encoder 144 and a second encoder 146 can be spaced axially along a shaft 148 to measure the difference in angle over the length of a flexible catheter / tube. The difference in angle is interpolated as torque because the catheter / tube has a known torsional stiffness. 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) gives the torque: T=k*dθ, where k is the torsional stiffness.

[0134] Ensuring the absence of bubbles in the fluid line can also be achieved using a bubble sensor, especially when the physician is remote from the patient. This can be achieved using a non-contact ultrasonic sensor that measures the intensity and Doppler shift of reflected ultrasound through the sidewall of the fluid tubing to detect bubbles and measure fluid flow rate or level. An ultrasonic or optical sensor can be positioned adjacent to the inflow fluid flow path in the hub or in the supply line leading to the hub. To detect the presence of air bubbles in an infusion line (which is formed from an ultrasonically or optically transparent 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 measure transmission through the liquid passing through the tubing to detect bubbles. Alternatively, the reflected ultrasound signal can be detected from the same side of the flow path as the source due to the relatively high echogenicity of bubbles.

[0135] Preferably, the bubble removal system is automatically activated upon detection of an in-line bubble. The processor can be configured to activate a valve positioned in the flow path downstream of the bubble detector upon detection of a bubble. The valve diverts the column of fluid from the flow path to the patient into the reservoir. Once bubbles are no longer detected in the flow path, and after a 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 source of fluid 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 removal of in-line bubbles. The processor can be configured to activate the pump upon detection of a bubble to reverse fluid flow and remove the bubble into the waste reservoir before reestablishing forward, bubble-free flow.

[0136] Additionally, it may be desirable for the physician to be able to view the aspirated clot at a predetermined location within the sterile field, and preferably as close to the patient as practical for fluid management purposes. This can be accomplished by providing a clot retrieval device mounted on the hub or mounted in the aspiration line leading away from the hub toward the pump. Referring to FIG. 15 , one example of a clot retrieval device 370 can include a body portion 380 enclosing a chamber 381 that communicates with a first port 310 and a second port 320.

[0137] In some embodiments, body 380 includes a housing having a top portion 382 and a bottom portion 384. Body 380 can include filter 330, which is positioned within chamber 381 between top portion 382 and bottom portion 384. In some examples, first port 310 is configured to connect to a first end of first tubing 340 that is fluidly connected to the proximal end of the suction catheter.

[0138] In embodiments configured to be connected downstream from a hub, first tube 340 includes connector 342 positioned at a second end of first tube 340 that is configured to engage or mate with a corresponding connector on or in communication with the hub. First port 310 is in direct communication with the chamber upstream (e.g., top side) of the filter, and second port 320 is in direct communication with the chamber downstream (e.g., bottom side) of the filter, facilitating direct visualization of captured material on the upstream side of the filter.

[0139] In implementations configured for remote operation, any of a variety of sensors may be provided to detect clots passing through the suction line and / or trapped in the filter, such as, for example, optical sensors, pressure sensors, flow sensors, ultrasonic sensors, or others known in the art.

[0140] In some embodiments, the second port 320 is configured to connect to a first end of a second tube 350 that is fluidly connected to a suction source (e.g., a pump). In some embodiments, the second tube 350 includes a connector 352 positioned at the second end of the second tube 350 that is configured to engage or mate with a corresponding connector on the pump.

[0141] In some examples, system 300 can include an on-off valve 360, such as clamp 360. Clamp 360 can be positioned between filter 330 and the patient (e.g., on first tube 340) to allow a user to engage the clamp and to provide flow control by isolating the patient from clot retrieval device 370. Closing valve 360 ​​and operating a remote vacuum pump (not shown) causes the vacuum pump and the canister associated with chamber 381 to reach the same low pressure. Due to the short lumen distance and small line volume between chamber 381 and the distal end of the catheter, a sharp negative pressure spike is experienced at the distal end of the catheter quickly following the opening of valve 360. Additional details are disclosed in U.S. Patent No. 11,259,821, entitled "Aspiration System with Accelerated Response," issued March 1, 2022 to Buck et al., the entire contents of which are expressly incorporated herein by reference. In some embodiments, a vacuum can be circulated over the clot to retrieve it. The vacuum can be automatically and robotically controlled to remove the clot.

[0142] The body portion 380 can have a top surface spaced apart from a bottom surface by a tubular sidewall. In the illustrated implementation, the top and bottom surfaces are substantially circular and spaced apart by a cylindrical sidewall. The top surface can have a diameter at least about three or five or more times the axial length (transverse to the top and bottom surfaces) of the sidewall to create a generally disk-shaped housing. Preferably, at least a portion of the top wall is optically transparent to improve clot visualization once the clot is trapped within the clot retrieval 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.

[0143] In some examples, the main body portion 380 can include a flush port (not shown) configured to allow injection of an optically transparent medium (e.g., air, saline, or other fluid) into the chamber 381 to clear the optical path between the window and the filter for improved clot visualization once the clot is trapped in the filter 330.

[0144] The foregoing represent certain specific implementations of drive tables and associated components and catheters. As those skilled in the art will recognize in light of the disclosure herein, a wide variety of different drive table configurations can be made to support and axially advance and retract two, three, four, or more drive magnet assemblies for robotically driving interventional devices, fluidic elements, and electrical umbilical elements for transmitting electrical signals and fluids to the catheter hub. Additional details can be found in U.S. Patent Application Serial No. 17 / 527,393, which is incorporated herein by reference in its entirety.

[0145] Although the foregoing describes robotically driven and manually driven interventional devices, the devices can be manually driven, robotically driven, or a combination of both manually and robotically driven interventional devices, as will be recognized by those of ordinary skill in the art in light of the disclosure herein.

[0146] 16A-16C illustrate an exemplary control mechanism 2200 for manipulating an interventional device driven by (or otherwise associated with) a respective hub. For example, each hub can be manipulated and / or otherwise moved using at least one controller located within the control mechanism 2200. Each controller can be adapted to move its own hub and associated interventional device during an interventional procedure.

[0147] 16A, the control mechanism 2200 includes a first control unit 2202, a second control unit 2204, a third control unit 2206, and a fourth control unit 2208. More or fewer controls may be provided depending on the intended interventional device configuration. Each control unit 2202-2208 is movably carried on a shaft 2210, which is coupled to a distal bracket 2212 and a proximal bracket 2214. The control units 2202-2208 can be advanced distally or retracted proximally on the shaft 2210, as indicated by arrow 2218 and arrow 2216. Additionally, each control unit 2202-2208 can also be rotated about the shaft 2210, as indicated by arrow 2220. Movement of each control can trigger a responsive movement in a corresponding hub adapter on the support table, which can drive movement of the corresponding hub, as discussed.

[0148] The control mechanism 2200 can be positioned on or near a patient support table with a set of hubs and catheter / interventional devices. In some implementations, the control mechanism 2200 can be positioned remotely from the support table, such as behind a radiation shield in a telemedicine implementation, or in a different room or geographic location.

[0149] Each controller 2202-2208 can correspond to and drive the movement of a hub and / or a combination of a hub and an interventional device. For example, controller 2202 can be configured to drive hub 30 (FIG. 3F) to move an interventional device, such as a 0.088-inch guide catheter, corresponding to hub 30. Similarly, controller 2204 can be configured to drive hub 28 (122) to move an interventional device, such as a 0.071-inch treatment catheter. Controller 2206 can be configured to drive hub 126 to move an interventional device, such as a steerable access catheter. Controller 2208 can be configured to drive hub 26 to move an interventional device, such as a guidewire, axially and rotationally.

[0150] 16B illustrates an example of manually manipulating the control 2202 on the control mechanism 2200. In operation, when a user 2230 moves the control 2202 axially and distally along the shaft 2210, as indicated by arrow 2232, a corresponding coupled hub and / or interventional device can responsively move in the same direction by the same or scaled amount. When a user 2230 rotates the control 2202 about the shaft 2210 and advances the control proximally, as indicated by arrow 2234, a corresponding coupled interventional device will responsively move rotationally and proximally by the same or scaled amount. When a user 2230 moves the control 2202 rotationally about the shaft 2210, as indicated by arrow 2236 or arrow 2238, a corresponding coupled hub will rotationally drive a corresponding interventional device in the same direction and / or by the same or scaled amount.

[0151] Other axes and degrees of freedom can be defined to enable the control unit 2202 to perform movements that can be translated into movements of the hub and / or interventional device. For example, the control mechanism can be provided with one or more deflection controls configured to initiate lateral deflection within a deflection zone on a corresponding interventional device.

[0152] Axial movement of the control can be configured to move the coupled 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 approximately 5 millimeters, the corresponding hub can move distally 5 millimeters in response.

[0153] If the user 2230 rotates the control 2022 by 5 degrees about its axis of rotation, the coupled hub will rotate the corresponding interventional device on a 1:1 basis or on a non-1:1 scaled basis. The scaled amount can be selected to reduce or increase the distance and amount of rotation that the hub and / or interventional device travels in accordance with the control movement.

[0154] In some implementations, the scaled amounts described herein can be determined using a scale factor. The scale factor can be applied to one or both of the translational and rotational movements. In some implementations, a first scale factor is selected for the translational movement, and a second scale factor, different from the first scale factor, is selected for the rotational movement. The axial scaling factor can drive proximal catheter movement at a faster rate than distal catheter movement for a given proximal or distal manipulation of the control.

[0155] The rotational scale factor can be 1:1, while the axial scale factor can move the hub a greater distance than the control travel, such that the hub travel to control travel ratio is at least about 2:1, or 5:1, or 10:1, or more, depending on the desired axial length of the control assembly.

[0156] The control mechanism 2200 can be configured to allow the clinician to adjust the scale factor for different parts of the procedure. For example, distal advancement of the treatment catheter and access catheter through the guide catheter and to the selected ostium can desirably be achieved in a "fast" mode, while more distal travel into the neurovasculature can desirably be achieved in a slower mode by actuation of the speed control.

[0157] In another implementation, one or more controls can be configured to incrementally drive the advancement or retraction rate of a corresponding hub and associated catheter. For example, the distal control 2202 can drive a guide catheter. Small distal movements of the control 2202 can advance the guide catheter distally at a slow rate, while advancing the control 2202 distally a greater distance increases the rate of distal travel of the guide catheter.

[0158] Controlling the speed of the corresponding hub, either axially or both axially and rotationally, can enhance the overall speed of the procedure. For example, advancement of various devices from the femoral access point to the aortic arch can desirably be achieved at a faster rate than more distal navigation closer to the treatment site. Also, proximal retraction of various devices (guidewires, access catheters, and treatment catheters, among others) can desirably be achieved at a relatively higher rate than distal advancement.

[0159] FIG. 16C illustrates another example of manually manipulating controls on the control mechanism 2200 to move the hub and / or other interventional devices. In some implementations, 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, the user 2230 moves the control 2204 and the control 2206 in combination (e.g., sequentially, simultaneously), such as to simultaneously move a 0.088 guide catheter and a 0.071 suction catheter as a unit. Exemplary movement of the control 2204 can include axial proximal movement in the direction indicated by arrow 2250. Sequentially or simultaneously, the user 2230 can move the control 2206 axially in either of the directions indicated by arrows 2254 and 2256 and simultaneously move the control 2206 rotationally in either of the directions indicated by arrows 2258 and 2260.

[0160] In some implementations, each control mechanism 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 implementations, the color coding of the controls can also be applied to the hub and / or interventional device, allowing the user to visually match a particular hub / device with a particular control.

[0161] In some implementations, other control operations besides translational and rotational movements can be performed using the controllers 2202-2208. For example, the controllers 2202-2208 can be configured to drive shape and / or stiffness changes of the corresponding interventional device. The controllers 2202-2208 can be switched between different operating modes. For example, the controllers 2202-2208 can be switched between movements driven by acceleration and velocity and movements reflecting actual linear displacement or rotation.

[0162] In some implementations, the control mechanism 2200 can be provided with a visual display or other indicator of the relative position of the controls, which can correspond to the relative position of the interventional device. Such a display can depict any or all movement directions, commands, movement percentages performed, and / or hub and / or catheter indicators to show which devices are controlled by a particular control. In some implementations, the display can depict the applied force or resistance encountered by the catheter, or other measurements being detected or observed by a particular hub or interventional component.

[0163] In some implementations, the control mechanism 2200 can include a haptic component to provide haptic feedback to a user operating the controller. For example, if the controller 2202 is triggering catheter movement and the catheter detects a large force at the tip, the controller 2202 can generate haptic feedback to indicate to the user to stop or reverse the movement that was performed. In some implementations, haptic feedback can be generated in the controller to indicate to the user to use the controller to slow or speed up the movement. In some implementations, haptics can provide feedback regarding the accumulation of large torsional strains that may precede a sharp rotation or the accumulation of large axial forces that may be a precursor to catheter buckling.

[0164] The systems described herein can compare actual fluoroscopic image positions with input displacements from a controller. A static fluoroscopic image of the patient can be captured, in which the patient's vasculature is indexed relative to bony landmarks or one or more implanted soft tissue fiducial markers. A real-time fluoroscopic image can then be displayed as an overlay, aligned with the static image by fiducial marker registration. Visual observation of the compatibility of real-time movement with the static image, aided by detected force data, can help confirm proper navigation of the associated catheter or guidewire. The systems described herein can also display a comparison of the input proximal mechanical translation of the catheter or guidewire and the resulting distal tip output motion, or lack thereof. Loss of relative motion at the distal tip can indicate shaft buckling, prolapse, kinking, or similar consequences, either inside or outside the body. Such a comparison can be beneficial when shaft buckling, prolapse, kinking, or similar consequences occur outside the current fluoroscopic field of view.

[0165] 17 illustrates a side schematic view of a multi-catheter interventional device assembly 2900 for combined supra-aortic and / or neurovascular site access and treatment (e.g., aspiration) as described herein. The multi-catheter assembly 2900 can be configured for either manual or robotic procedures.

[0166] Interventional device assembly 2900 includes an insertion or access catheter 2902, a treatment catheter 2904, and a guide catheter 2906. Other components are possible, including, but not limited to, one or more guidewires (e.g., optional guidewire 2907), one or more guide catheters, an access sheath and / or one or more other treatment catheters, and / or associated catheter (control) hubs. In some embodiments, assembly 2900 can also be configured with an optional deflection control 2908 for controlling the deflection of one or more catheters of assembly 2900.

[0167] In operation, the multi-catheter assembly 2900 can be used without the need to replace hub components. For example, in a previously disclosed two-stage procedure, the first stage to achieve supra-aortic access involves mounting the access catheter, guide catheter, and guidewire to a support table. Once supra-aortic access is obtained, the access catheter and guidewire are typically removed from the guide catheter. A second catheter assembly is then introduced through the guide catheter after attaching a new guidewire hub and procedure catheter hub to corresponding drive hub adapters on the support table.

[0168] The single multi-catheter assembly 2900 of FIG. 17 is configured to be operated without the need to remove hubs and catheters and without the addition of additional assemblies and / or hubs. Thus, the multi-component access and treatment configuration of assembly 2900 can utilize guidewire 2907, which is manufactured to function as both an access guidewire and a navigation guidewire, allowing for sufficient access and support to, and navigation of, a specific distal treatment site. In a non-limiting example configured for robotic implementation, the catheter assembly can include a guidewire hub (e.g., guidewire hub 2909 or guidewire hub 26 positioned on the drive table and to the right of catheter 2902), an insertion or access catheter hub 2910, a treatment catheter hub 2912, a guide catheter hub 2914, and corresponding catheters. In certain embodiments, one or more of the hubs can include or be coupled to a hemostasis valve (e.g., a rotary hemostasis valve) to accommodate the introduction of an interventional device therethrough. Additional details regarding hemostasis valves are contained in U.S. Patent Application No. 17 / 879,614, entitled "Multi Catheter System With Integrated Fluidics Management," filed August 2, 2022, which is expressly incorporated herein in its entirety.

[0169] Once access is achieved above the aortic arch, the insertion or access catheter 2902 (associated with the insertion catheter hub 2910) can be placed near the carotid ostium, and the remainder or subset of the catheter assembly can be guided more distally toward a particular site (e.g., clot site, surgical site, treatment site, etc.).

[0170] In some embodiments, additional smaller treatment catheters may be used at the site. As used herein with respect to catheter assembly 2900, in a robotic configuration of assembly 2900, catheter 2906 may function as a guide catheter. Catheter 2904 may function as a treatment (e.g., suction) catheter. In some embodiments, catheter 2906 may function to perform suction in addition to functioning as a guide catheter, instead of or in addition to catheter 2904. Access catheter 2902 may have a distal deflection zone and may function to access a desired ostium. Those skilled in the art will recognize from FIGS. 18A-18E that either manual or robotic manipulation of a multi-catheter stack is contemplated herein.

[0171] In some embodiments, catheter assembly 2900 (or other combined catheter assemblies described herein) can be driven to a predetermined location as a unit, but each catheter (or guidewire) component can instead be actuated and driven to the same or different locations independently of one another.

[0172] In a non-limiting example, catheter assembly 2900 can be used for a diagnostic angiography procedure. In some embodiments, assembly 2900 can include only guidewire 2907 and access catheter 2902 (in the form of a diagnostic angiography catheter) for performing the diagnostic angiography procedure, or only guidewire 2907 and access catheter 2902 can be utilized during the procedure. Alternatively, guide catheter 2906 and treatment catheter 2904 can be retracted proximally to expose the distal end of access catheter 2902 (e.g., several centimeters of the distal end of the access catheter) to perform a diagnostic angiography.

[0173] 17, guide catheter 2906, treatment catheter 2904, access catheter 2902, and guidewire 2907 can be arranged concentrically. In certain embodiments, guide catheter 2906 can be a "large bore" guide or access catheter having a diameter of at least about 0.075 or at least about 0.080 inches. Treatment catheter 2904 can be an aspiration catheter having a diameter in the range of about 0.060 inches to about 0.075 inches. Access catheter 2902 can be a steerable catheter with a deflectable distal tip having a diameter in the range of about 0.025 inches to about 0.050 inches. Guidewire 2907 can have a diameter in the range of about 0.014 inches to about 0.020 inches. In one example, the guide catheter 2906 can have a diameter of approximately 0.088 inches, the treatment catheter 2904 can have a diameter of approximately 0.071 inches, the access catheter 2902 can have a diameter of approximately 0.035 inches, and the guidewire 2907 can have a diameter of approximately 0.018 inches.

[0174] 18A-18E depict an exemplary sequence of steps for introducing, either manually or robotically, a multi-catheter assembly configured to provide access to a blood clot. 18A-18E can be described using the interventional device assembly of FIG. 17. Other combinations of catheters can be substituted for the interventional device assembly, as one of ordinary skill in the art would recognize in light of the disclosure herein.

[0175] Referring to FIG. 18A , a three catheter interventional device assembly 2900 is shown being driven through an introducer sheath 3002, through an iliac artery 3004, and into the descending aorta. Next, the access catheter 2902, the treatment 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 in FIG. 18B . Here, the distal end of the guide catheter 2906 can be placed below the aortic arch 3006, and the treatment catheter 2904, the access catheter 2902 (positioned within the treatment catheter 2904 and not visible in FIG. 18B ), and the guidewire 2907 can be driven (e.g., simultaneously or separately) into the ostium. In some embodiments, the access catheter 2902 is advanced out of the treatment catheter 2904 and the guide catheter 2906, engaging the ostium first. 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 positioned within the desired ostium, the treatment catheter 2904 and / or guide catheter 2906 can be advanced into (and, in some embodiments, beyond) the ostium, using the support of the access catheter 2902 and / or guidewire 2907 to navigate through the aorta and into the ostium. In the embodiment shown in FIG. 18B , the treatment catheter 2904 has been advanced into the ostium, while the guide catheter 2906 remains indwelling below the aortic arch 3006.

[0176] 18C, the guidewire 2907 can be advanced distally, and the radiopacity of the guidewire 2907 can be used to confirm under fluoroscopic imaging that access through the desired ostium has been achieved. The guidewire 2907 engages the origin of the brachiocephalic trunk 3014. The guidewire 2907 is then advanced to the petrous segment 3018 of the internal carotid artery 3016.

[0177] 18D, guide catheter 2906 and treatment catheter 2904 (positioned within guide catheter 2906 and not visible in FIG. 18D) are both advanced (e.g., simultaneously or sequentially) over guidewire 2907 and over insertion or access catheter 2902 (positioned within treatment catheter 2904 and not visible in FIG. 18D), while access catheter 2902 remains at the ostium for support. Guidewire 2907 can be advanced further beyond cone segment 3018 to the site of clot 3020, such as the M1 segment.

[0178] 18E , guide catheter 2906 and treatment catheter 2904 (positioned within guide catheter 2906 and not visible in FIG. 18E ) are advanced (e.g., simultaneously or sequentially) to position the distal tip of treatment catheter 2904 at the treatment site (e.g., in front of clot 3020). Guidewire 2907 and access catheter 2902 (positioned within treatment catheter 2904 and not visible in FIG. 18E ) are removed, and aspiration of clot 3020 begins through treatment catheter 2904. That is, guidewire 2907 and access catheter 2902 are retracted proximally to allow aspiration through treatment catheter 2904. After aspiration of the clot, treatment catheter 2904 and guide catheter 2906 can be removed (e.g., simultaneously or sequentially). For example, in some embodiments, treatment catheter 2904 can be removed before removing guide catheter 2906.

[0179] The catheter assembly 2900 can be used to perform a neurovascular procedure, as illustrated in FIGS. 18A-18E. For example, the neurovascular procedure can be a neurovascular thrombectomy. The steps of the procedure can include providing an assembly including at least a guidewire, an access catheter, a guide catheter, and a treatment catheter. For example, the catheter assembly 2900 includes a guidewire 2907, an access (e.g., insertion) catheter 2902, a guide catheter 2906, and at least one treatment catheter 2904. The treatment catheter 2904 can include an aspiration catheter, an embolism deployment catheter, a stent deployment catheter, a flow diverter deployment catheter, a diagnostic angiography catheter, a stent retriever catheter, a clot retrieval catheter, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, an ablation catheter, and / or an RF ablation catheter or guidewire.

[0180] The neurovascular procedure may further include coupling the assemblies to a non-robotic or robotic drive system and driving the assemblies to achieve supra-aortic access. The steps may further include driving a subset of the assemblies to a neurovascular site and performing the neurovascular procedure using the subset of the assemblies. The subset of assemblies may include a guidewire, a guide catheter, and a treatment catheter.

[0181] Each of the guidewire 2907, access catheter 2902, guide catheter 2906, and treatment catheter 2904 is configured to be regulated by a respective hub. For example, the guidewire 2907 can include (or be coupled to) a hub mounted on one of the tray assemblies described herein. Similarly, the access catheter 2902 can be coupled to a catheter hub 2910. The guide catheter 2906 can be coupled to a guide catheter hub 2914. The treatment catheter 2904 can be coupled to a treatment catheter hub 2912.

[0182] Generally, coupling of the assemblies can include magnetically coupling a first hub 2909 on the guidewire 2907 to a first drive magnet, a second hub 2910 on the access catheter 2902 to a second drive magnet, a third hub 2912 on the treatment catheter 2904 to a third drive magnet, and a fourth hub 2914 on the guide catheter 2906 to a fourth drive magnet. Generally, the first, second, third, and fourth drive magnets are each independently movably carried by a drive table, as described with respect to the tray assemblies and controls described herein. In some embodiments, the first, second, third, and fourth drive magnets are coupled (e.g., to their respective catheter hubs) through a sterile barrier (e.g., a sterile barrier and a fluid barrier) and independently movably carried by a drive table having a plurality of driven magnets. In some embodiments, two or more drive magnets can be tethered or otherwise coupled together so that they move as a unit in response to commands from a single controller that is tethered or otherwise coupled to one of the drive magnets.

[0183] In some implementations, performing a neurovascular procedure can include driving the hub adapters in response to movement of each of the hub adapters along the support table until the assemblies are positioned to provide supra-aortic vascular access. The hub adapters can include, for example, a coupler / carriage that acts as a shuttle by advancing proximally or distally along a track in response to an operator command. The hub adapters described herein can each include at least one drive magnet configured to couple with a driven magnet carried by the respective hub. This provides a magnetic coupling between the drive magnet and the driven magnet through the sterile barrier such that the respective hubs are moved across the top of the sterile barrier in response to movement of the hub adapter outside the sterile field (as described in detail in FIG. 4 ). Movement of the hub adapters is driven by a drive system carried by the support table on which the guidewire hub 2909, guide catheter hub 2914, procedure catheter hub 2912, and access catheter hub 2910 are mounted.

[0184] The steps can further include actuating the subset of assemblies in response to respective movement of the hub adapters along the support table until the subset of assemblies is positioned to perform a neurovascular procedure at the neurovascular treatment site. The subset of assemblies can include a guidewire 2907, a guide catheter 2906, and a treatment catheter 2904.

[0185] In some embodiments, the guidewire 2907, guide catheter 2906, and treatment catheter 2904 are advanced as a unit through (with respect to the guidewire 2907) and over (with respect to the guide catheter 2906 and treatment catheter 2904) at least a portion of the length of the access (e.g., insertion) catheter 2902 after supra-aortic access has been achieved.

[0186] In some embodiments, the catheter assembly 2900 can be part of a robotic control system for achieving supra-aortic access and neurovascular treatment site access, as illustrated in FIGS. 18A-18E . In some embodiments, the catheter assembly 2900 can be part of a manually controlled system for achieving supra-aortic access and neurovascular treatment site access. In some embodiments, the catheter assembly 2900 can be part of a hybrid control system (comprising manual and robotic components) for achieving supra-aortic access and neurovascular treatment site access. For example, in such a hybrid system, the supra-aortic access can be robotically driven, while the neurovascular site access and embolectomy or other procedure can be manual. Alternatively, in such a hybrid system, the supra-aortic access can be manual, while the neurovascular site access can be robotically achieved. Furthermore, in such a hybrid system, any one or more of the guidewire, access catheter, guide catheter, or treatment catheter can be robotically driven or manually operated.

[0187] An exemplary robotic control system can include at least a guidewire hub (e.g., guidewire hub 2909) configured to adjust the axial and rotational positions of guidewire 2907. The robotic control system can also include an access catheter hub 2910 configured to adjust the axial and rotational movement of access catheter 2902. The robotic control system can also include a guide catheter hub 2914 configured to control the axial movement of guide catheter 2906. The robotic control system can also include a treatment catheter hub 2912 configured to adjust the axial and rotational position of treatment catheter 2904.

[0188] In some embodiments, the treatment catheter hub 2912 is further configured to laterally deflect a distal deflection zone of the treatment catheter 2904 .

[0189] In some embodiments, guidewire hub 2909 is configured to couple to the guidewire hub adapter by magnetically coupling the guidewire hub to a first drive magnet. Access catheter hub 2910 is configured to couple to the access catheter hub adapter by magnetically coupling the access catheter hub 2910 to a second drive magnet. Treatment catheter hub 2912 is configured to couple to the treatment catheter hub adapter by magnetically coupling the treatment catheter hub 2912 to a third drive magnet. Guide catheter hub 2914 is configured to couple to the guide catheter hub adapter by magnetically coupling the guide catheter hub 2914 to a 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 movably carried by a drive table.

[0190] 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 outside the sterile field separated from the first driven magnet by a barrier, while the first driven magnet is within the sterile field. In some embodiments, the position of the first driven magnet is movable in response to manipulation of a treatment drive control on a control console associated with the drive table. The interaction of the drive magnet and driven magnet is described in detail with respect to FIG. 4 above.

[0191] In some embodiments, the robotic control system includes a second driven magnet on the access 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 by a barrier, while the second driven magnet is within the sterile field.

[0192] In some embodiments, the robotic control system includes a third driven magnet on the treatment 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 by a barrier, while the third driven magnet is within the sterile field.

[0193] 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, such that the fourth driven magnet is configured to move in response to movement of the fourth drive magnet. In some embodiments, the fourth drive magnet is configured to move outside the sterile field separated from the fourth driven magnet by a barrier, while the fourth driven magnet is within the sterile field. In some embodiments, there can be more than four driven magnets and corresponding catheter hubs for control of additional catheters.

[0194] In some embodiments, the devices described herein (e.g., hubs, hub adapters, interventional devices, and / or trays) can be used during robotically driven procedures. For example, in a robotically driven procedure, one or more of the interventional devices can be driven through the vasculature to a treatment site. Robotically driving such devices can include engaging electromechanical components controlled by user input. In some implementations, a user can provide input at a control system that interfaces with one or more hubs and hub adapters.

[0195] In some embodiments, the hubs, hub adapters, interventional devices, and trays described herein can be used during non-robotic (e.g., manually driven) procedures. Manually driving such devices can include manually engaging the hub to affect movement of the interventional device.

[0196] In some embodiments, the devices described herein can be used to perform a method of performing an intracranial procedure at an intracranial site. The method of performing an intracranial procedure can include any of the same steps described herein for performing a neurovascular procedure. The procedure can be performed robotically, manually, or a hybrid combination of both.

[0197] While the foregoing describes magnetic coupling of the hub to the drive magnet, in other embodiments, any of the interventional devices and / or hubs can be mechanically coupled to the drive system. Any of the methods described herein can include mechanically coupling one or more interventional devices (e.g., guidewire 2907, access catheter 2902, treatment catheter 2904, and / or guide catheter 2906) and / or one or more hubs (e.g., guidewire hub 2909, access catheter hub 2910, treatment catheter hub 2912, and / or guide catheter hub 2914) to one or more drive mechanisms.

[0198] 19 illustrates a mechanical linkage 1654 between the drive mechanism 1650 and the driven mechanism 1652. The drive mechanism 1650 and the driven mechanism 1652 can have any of the same or similar features or functionality as the drive magnet 67 and the driven magnet 69, respectively, unless otherwise described herein. The drive mechanism 1650 can be part of or coupled to a hub adapter (e.g., hub adapter 48). The driven mechanism 1652 can be part of or coupled to a hub (e.g., hub 36, guidewire hub 2909, access catheter hub 2910, procedure catheter hub 2912, or guide catheter hub 2914). In some cases, the mechanical linkage 1654 can include structural support (e.g., a support rod or support strut) extending transversely through a seal in the sterile barrier 1632. 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 a sterile field when the drive mechanism 1650 and driven mechanism 1652 are advanced and / or retracted, as described herein. 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 passage of the structural support through the sterile barrier 1632 and maintaining a seal against the structural support as the structural support is advanced along the length of the sterile barrier 1632.

[0199] In some embodiments, the structural support can extend through an elongated self-closing seal between two adjacent joining edges (e.g., similar in shape to duckbill valves) of flexible material extending along an axis. As the structural support advances along the axis between the joining edges, the joining edges can allow the structural support to advance and then be biased back into sealing engagement with one another as the structural support passes any given point along the axis.

[0200] In some embodiments, the drive mechanism can be a splined drive shaft (e.g., a non-sterile splined drive shaft). The mechanical linkage 1654 can include a pulley in the plate that serves as the sterile barrier 1632 and a sterile splined shaft configured to couple to the driven mechanism 1652. The driven mechanism 1652 can be a sterile pulley that receives the sterile splined shaft from the sterile barrier. In some embodiments, one or more splined drive shafts can engage and turn corresponding pulleys in the plate that serves as the sterile barrier. Each hub can have a sterile pulley configured to receive the sterile splined shaft from the sterile barrier plate. Rotation of the splined drive shaft can turn a pulley in the sterile barrier plate, which can turn a sterile pulley in the hub via the sterile splined shaft.

[0201] It will be understood by those skilled in the art that any embodiment as described herein may be modified to incorporate a mechanical linkage, for example, as shown in FIG. 19.

[0202] The interventional devices described herein can be provided individually, or at least some of the interventional devices can be provided in a pre-assembled (e.g., nested or stacked) configuration. For example, the interventional devices can be provided in the form of an interventional device assembly (e.g., interventional device assembly 2900) in a concentric nested or stacked configuration. If provided individually, each catheter (and, in some embodiments, each corresponding catheter hub) can be unpackaged and primed, e.g., by flushing the catheter (and, in some embodiments, the corresponding catheter hub) to remove air from its inner lumen and replacing it with a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium). After priming, the interventional devices can be manually assembled into a stacked configuration, e.g., through an introducer sheath, so that they are ready for introduction into the body for a surgical procedure.

[0203] Assembling the devices into a stacked configuration can include inserting the interventional devices individually into one another in order of size. For example, the interventional device with the second largest diameter can be inserted into the lumen of the interventional device with the largest diameter. Then, the interventional device with the third largest diameter can be inserted into the interventional device with the second largest diameter, and so on.

[0204] 17 , assembly can be performed 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 cannot be inserted further. The distal end of catheter 2902 can then 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 cannot be inserted further. The distal end of guidewire 2907 can then be inserted through hub 2910 and into catheter 2902. Guidewire 2907 can be advanced through catheter 2902 until the distal tip of guidewire 2907 is flush with or extends beyond the distal tip of catheter 2902 and / or until guidewire 2907 cannot be inserted any further.

[0205] Embodiments in which two or more of the interventional devices are packaged together as a single unit in an assembled (e.g., nested or stacked) configuration can provide efficient unpackaging and preparation before use, as well as efficient assembly within a robotic control system. The interventional devices can be pre-loaded onto their respective hubs before packaging. In certain embodiments, two, three, or more interventional devices can be packaged in a fully nested (i.e., fully axially inserted) or nearly 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.

[0206] In some embodiments, the interventional device can also be sterilized while in the assembled configuration prior to packaging, e.g., using ethylene oxide gas. In some embodiments, the interventional device can be packaged while in the assembled configuration prior to sterilization with ethylene oxide gas. For interventional devices in a nested or stacked configuration, ethylene oxide gas can be provided in the space between adjacent interventional devices (e.g., the annular lumen between the outer diameter of a first interventional device nested within a second interventional device and the inner diameter of the second interventional device) for sterilization. In some embodiments, the interventional device assembly can be packaged in a thermoformed tray and sealed with an HDPE (e.g., Tyvek®) lid. The interventional device assembly can be unpackaged by a user in a non-sterile field by removing (e.g., opening or peeling) the lid. A user in a sterile field can then remove the interventional device assembly and place it on a sterile work surface, e.g., of a robot-driven table, as described herein.

[0207] Packaging the interventional devices in an assembled configuration and in a sterile state can reduce the time associated with unpackaging and assembling individual interventional devices and facilitate efficient connection to a robotic drive system. Each interventional device and hub combination can be further packaged with fluidic connections for connecting to a fluid and / or vacuum source. In some embodiments, each hub or a hemostasis valve connected to the hub can include the fluidic connections.

[0208] After the interventional device assembly is unpackaged (e.g., after the interventional device assembly is positioned on a robotically driven table), priming can be performed while the devices are concentrically nested or stacked. This is preferably accomplished within each fluid lumen, such as, for example, the annular lumen between catheter 2906 and catheter 2904, and between each additional concentric interventional device in the concentric stack. In certain embodiments, the fluid lumen can include the lumen between the distal hub and the proximal interventional device, such as, for example, the lumen between hub 2914 and catheter 2904. In certain embodiments, priming can be performed while the devices are still in sterile packaging.

[0209] The fluidics connections can be connected to a fluidics system for delivering saline and contrast medium to the catheters and for providing suction. In some embodiments, the fluidics connections can be threaded outside the sterile field for connection to the fluidics system. Once connected, the fluidics system can perform a priming sequence to flush each catheter of the interventional device assembly with a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium). The priming sequence can also include flushing each corresponding catheter hub with the fluid. The fluid can be degassed or degassed by the fluidics system before priming. In some embodiments, a vacuum source of the fluidics system can also be used to evacuate air from each catheter during fluid flushing. In certain embodiments, the tip of the catheter can be placed into a container of fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) during priming, such that the fluid (but not air) in the container is aspirated through the tip of the catheter when the vacuum source is applied. In other embodiments, the tip of the catheter can be plugged (e.g., using a plug) to prevent air from being drawn from the tip of the catheter when the vacuum source is applied. In certain embodiments, the priming process can be automated so that the user can provide a single command and each catheter (and, in some embodiments, each corresponding catheter hub) can be primed sequentially (e.g., as described with respect to Figures 20A-20C) or simultaneously.

[0210] Additional details regarding the fluidics system are disclosed in U.S. Patent Application No. 17 / 879,614, entitled "Multi Catheter System With Integrated Fluidics Management," filed August 2, 2022, which is expressly incorporated herein in its entirety.

[0211] When there is a reduction in the lumen cross-sectional area for flow, for example, when a second interventional device (e.g., a catheter or guidewire) extends into the lumen of a first interventional device, the fluid resistance in the lumen may be greater. The amount of fluid resistance may be affected by the length of the cross-sectional constriction, for example, due to the depth of axial insertion of the second interventional device within the first interventional device. A second interventional device extending partially through the lumen of the first interventional device will provide a smaller length of cross-sectional constriction and may therefore result in lower fluid resistance in the lumen of the first catheter than if the second interventional device had extended completely through the lumen of the first interventional device. Thus, fluid resistance can be reduced at least in part by reducing the depth of axial insertion (i.e., axial overlap) of the second interventional device into the lumen through which fluid will be injected (e.g., the length of the second interventional device into its concentrically adjacent lumen).

[0212] In some embodiments, when a certain depth of insertion of a second interventional device within a first interventional device is exceeded (e.g., when the second interventional device is at or near its maximum insertion depth within the first interventional device), the size of the fluid channel between the devices (e.g., the annular lumen between the first and second interventional devices) may lead to a higher than desirable amount of fluid resistance during the priming procedure. In some embodiments, the depth of insertion of the second interventional device within the first interventional device can be reduced to reduce the pressure required to prime the catheter and to reduce internal interference.

[0213] In some embodiments, catheters in an interventional device assembly can be separated from other interventional devices for priming to reduce the pressure required to prime the catheter and to reduce internal interference. The catheter being primed can be separated from the interventional device in the catheter's lumen by retracting the interventional device proximally within the catheter's lumen. For example, the interventional device in the lumen of the priming catheter can be retracted as proximally as possible from the priming catheter while still maintaining a nested or stacked relationship (e.g., at least about 2 cm or 5 cm or more of axial overlap) to minimize the pressure required to prime the catheter and to minimize internal interference. In other words, a catheter can be separated from a more proximal interventional device for priming while the distal tip of the adjacent proximal interventional device is still positioned within the catheter's lumen. Maintaining at least some of the distal tips of the adjacent proximal interventional devices within the catheter's lumen can allow for easier reinsertion and advancement of the proximal interventional device after priming.

[0214] In some embodiments, the axial overlap can be between about 2 cm and about 20 cm, between about 2 cm and 10 cm, between about 2 cm and 5 cm, between about 5 cm and 20 cm, between about 5 cm and 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, 2 cm or less, 5 cm or less, 10 cm or less, 20 cm or less, about 2 cm, about 5 cm, about 10 cm, about 20 cm, or any other suitable amount.

[0215] In some embodiments, the robotic drive table can be programmed to retract the inner interventional device as proximally as possible from the catheter being primed while still maintaining the nested or stacked relationship. In other embodiments, the robotic drive table can be programmed to separate the inner device from the catheter being primed 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 being primed is separated from the other interventional devices, the catheter can be primed by flushing it with a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium, etc.).

[0216] After a catheter is primed, it can be returned to its initial position, and the next catheter in the interventional device assembly can be separated from the other interventional devices in its lumen for priming. This sequence can be repeated for each catheter in the interventional device assembly. In other embodiments, after a catheter is primed, it can be advanced to a ready or actuated position to begin insertion into the patient. While the foregoing describes separating the catheter to be primed by retracting the inner interventional device, the outer catheter can also be separated from the inner interventional device by advancing the outer catheter axially distally relative to the inner interventional device. An example of a priming process is described with reference to FIGS. 20A-20C.

[0217] FIG. 20A depicts interventional device assembly 2900 assembled in an axially compressed configuration in a concentric stack. As shown in FIG. 20A , the interventional devices can be fully nested within one another. This can be the configuration following unpackaging and placement of device assembly 2900 on a robotic table. The priming sequence can begin, for example, as shown in FIG. 20B , by axially advancing catheter 2906 and hub 2914 distally relative to catheter 2904, hub 2912, catheter 2902, hub 2910, guidewire 2907, and hub 2909 as far as possible while maintaining the distal tip of catheter 2904 within the lumen of catheter 2906, or to a distance that will result in a desired amount of fluid resistance for priming. In some embodiments, catheter 2906 is advanced in response to a control signal from a control system. Catheter 2906 can then be primed by introducing a priming fluid using the fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. Priming the catheter 2906 can include priming the hub 2914. For example, in certain embodiments, the hub 2914 or a hemostasis valve coupled thereto can include a fluidic connection for receiving 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 in FIG. 20A . In some embodiments, the catheter 2906 is returned to its initial position in response to a control signal from the control system.

[0218] After catheter 2906 has been primed and returned to its initial position, catheter 2904 and hub 2912 can be axially advanced distally relative to catheter 2902, hub 2910, guidewire 2907, and hub 2909 (and catheter 2906 and hub 2914 can be axially advanced distally without or only minimally changing their relative position with respect to catheter 2904), for example, as shown in FIG. 20C . In some embodiments, catheter 2904 and catheter 2906 are advanced in response to control signals from a control system. Catheter 2904 can then be primed by introducing a priming fluid using the fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from the control system. Priming catheter 2904 can include priming hub 2912. For example, in certain embodiments, hub 2912 or a hemostasis valve coupled thereto can include a fluidic connection for receiving priming fluid from a fluidics system. After priming, catheter 2904 and catheter 2906 can be returned to their initial position (e.g., a fully axially compressed configuration), as shown in FIG. 20A . In some embodiments, catheter 2904 and catheter 2906 are returned to their initial position in response to a control signal from a control system.

[0219] After catheter 2904 has been primed and returned to its initial position, catheter 2902 and hub 2910 can be advanced axially distally relative to guidewire 2907 and hub 2909 (and catheter 2906, hub 2914, catheter 2904, and hub 2912 can be advanced axially distally without or only 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 a desired amount of fluid resistance for priming. In some embodiments, catheter 2902, catheter 2904, and catheter 2906 are advanced in response to control signals from a control system. Catheter 2902 can then be primed by introducing a priming fluid using the fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from the control system. Priming catheter 2902 can include priming hub 2910. For example, in certain embodiments, hub 2910 or a hemostasis valve coupled thereto can include a fluidic connection for receiving priming fluid from a fluidics system. After priming, catheter 2902 and catheters 2904 and 2906 can be returned to their initial positions (e.g., fully axially compressed configurations) shown in FIG. 20A . In some embodiments, catheter 2902, catheter 2904, and catheter 2906 are returned to their initial positions in response to control signals from a control system.

[0220] 20A-20C can be performed in response to a single control signal from a control system. In other embodiments, 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.

[0221] In an alternative embodiment, each of the catheters can be distally separated from one another 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 simultaneously be distally separated from catheter 2904 while maintaining the distal tip of catheter 2904 within the lumen of catheter 2906. However, as described with respect to FIGS. 20A-20C , embodiments in which only one set of adjacent hubs is separated at a time can provide a smaller overall length of the assembly at any particular time, which can enable use with smaller robotic drive systems. Although the separation of the outer catheter from the inner interventional device is described as advancing the catheter axially distally relative to the inner interventional device, the separation can include retracting the inner interventional device proximally from the outer catheter.

[0222] In alternative embodiments, one or more of catheters 2902, 2904, and 2906 can be advanced to a ready or driven position to begin insertion into a patient after priming (e.g., before priming a subsequent catheter). In such embodiments, the catheters can be advanced to the ready or driven position after priming without returning to their initial positions.

[0223] As explained above, in some embodiments, catheters 2902, 2904, and 2906 can be assembled into the concentric stack orientation illustrated in FIG. 17 before flushing the catheters to remove air by replacing it with a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium). This is preferably accomplished within each fluid lumen, such as the annular lumen between catheters 2906 and 2904, and between each additional concentric interventional device in the concentric stack. Infusing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure can replace substantially all of the air, although some small bubbles may remain and may adhere to the inner wall of the outer catheter (e.g., guide catheter 2906), the outer wall of the inner catheter (e.g., treatment catheter 2904), or both.

[0224] While fluid is introduced under pressure into the proximal end of the annular lumen (e.g., into the hub of the outer catheter or a hemostatic valve connected thereto), the inner catheter can be moved relative to the outer catheter, breaking the holding forces between the microbubbles and the adjacent wall and allowing the bubbles to be carried downstream and exit through the distal opening of the lumen or removed via suction. The catheters can be moved axially, rotationally, or both relative to each other. In certain embodiments, the catheters can be reciprocated axially, rotationally, or both relative to each other. In some embodiments, the catheters can be moved axially, rotationally, or both intermittently. In other embodiments, the catheters can be rotated continuously or in a constant direction.

[0225] In some implementations, the first catheter is reciprocated axially relative to an adjacent catheter or guidewire over a stroke length in the range of, for example, 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 implementations, the first catheter is reciprocated axially relative to an adjacent catheter or guidewire over a stroke length of, for example, 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, 10 mm or less, 20 mm or less, 25 mm or less, 30 mm or less, 50 mm or less, 125 mm or less, 150 mm or less, 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.

[0226] In some implementations, the first catheter is reciprocated axially relative to an adjacent catheter or guidewire, e.g., at a reciprocating frequency in the range 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 range of frequencies. In some implementations, the first catheter is reciprocated axially relative to an adjacent catheter or guidewire, e.g., 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, 0.5 Hz or less, 1 Hz or less, 2 Hz or less, 5 Hz or less, 10 Hz or less, 25 Hz or less, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency.

[0227] In one implementation, the first catheter is reciprocated axially relative to an adjacent catheter or guidewire, for example, at a reciprocating frequency of about 5 cycles per second or less, or 2 cycles per second or less, over a stroke length in the range of about 0.5 inches to about 10 inches, or about 1 inch to about 5 inches.

[0228] In some implementations, the first catheter may be oriented at an angle, for example, in the range 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 30 degrees to about 60 degrees, about 60 degrees to about 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 rotational angles per stroke. In some implementations, the first catheter is rotationally moved back and forth relative to an adjacent catheter or guidewire through a rotational angle per stroke of, for example, 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, 5 degrees or less, 15 degrees or less, 30 degrees or less, 60 degrees or less, 90 degrees or less, 120 degrees or less, 150 degrees or less, 180 degrees or less, 360 degrees or less, 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.

[0229] In some implementations, the first catheter is rotationally reciprocated relative to an adjacent catheter or guidewire at a reciprocating frequency in the range 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 range of frequencies, etc. In some implementations, the first catheter is rotationally reciprocated relative to an adjacent catheter or guidewire 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, 0.5 Hz or less, 1 Hz or less, 2 Hz or less, 5 Hz or less, 10 Hz or less, 25 Hz or less, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency, etc.

[0230] In some embodiments, the first catheter is reciprocated relative to an adjacent catheter or guidewire through between 1 and 200, between 1 and 100, between 1 and 50, between 1 and 25, between 1 and 15, between 1 and 10, between 1 and 5, between 5 and 25, between 5 and 15, between 5 and 10, or any other suitable range of reciprocations. In some embodiments, the first catheter is reciprocated relative to an adjacent catheter or guidewire through at least 1 reciprocation, at least 2 reciprocations, at least 5 reciprocations, at least 10 reciprocations, at least 15 reciprocations, at least 25 reciprocations, at least 50 reciprocations, 5 reciprocations or less, 10 reciprocations or less, 15 reciprocations or less, 25 reciprocations or less, 50 reciprocations or less, 100 reciprocations or less, 200 reciprocations or less, about 1 reciprocation, about 2 reciprocations, about 5 reciprocations, about 100 reciprocations, about 200 reciprocations, or any other suitable number. One reciprocating motion can include movement (axially or rotationally) from a first position to a second position, followed by movement from the second position back to the first position.

[0231] In some implementations, the first catheter is reciprocated relative to the adjacent catheter or guidewire for a length of time in the range of about 1 second to about 60 seconds, about 1 second to about 45 seconds, about 1 second to about 30 seconds, about 1 second to about 20 seconds, about 1 second to about 15 seconds, about 1 second to about 10 seconds, about 5 seconds to about 45 seconds, about 5 seconds to about 30 seconds, about 5 seconds to about 20 seconds, about 5 seconds to about 15 seconds, about 5 seconds to about 10 seconds, about 10 seconds to about 30 seconds, about 10 seconds to about 20 seconds, or any other suitable range. In some implementations, the first catheter is reciprocated relative to the adjacent catheter or guidewire for a length of time 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, 5 seconds or less, 10 seconds or less, 15 seconds or less, 20 seconds or less, 30 seconds or less, 45 seconds or less, 60 seconds or less, 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 length of time.

[0232] Reciprocating motion of adjacent catheters to destroy microbubbles can be accomplished manually by grasping the corresponding catheter hubs and manually moving the catheters axially or rotationally relative to one another while delivering pressurized fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium). Alternatively, such as in a robotically driven system, the processor can be configured to robotically drive at least one of two adjacent catheter hubs (e.g., at least one of hubs 2914 and 2912) to effect relative movement between the adjacent catheters, thereby destroying and expelling 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 one another in response to control signals from a control system. In certain embodiments, delivery of pressurized fluid can be performed in response to control signals from the control system.

[0233] The reciprocating motion of adjacent catheters can generate shear forces that dislodge air bubbles. For example, relative movement of the inner and outer surfaces of adjacent catheters can increase the fluid shear rate between adjacent catheters during priming compared to static surfaces. In some embodiments, the shear forces can be increased by increasing the flow rate of the solution (e.g., saline, contrast medium, or a mixture of saline and contrast medium) being provided by the fluidics system. In certain embodiments, both the flow rate and the relative movement between adjacent catheters are controlled to dislodge air bubbles.

[0234] In some embodiments, after each catheter is primed by the fluidics system, an ultrasonic bubble detector can be used to verify that the catheter is substantially free of air bubbles. For example, an ultrasonic tip (e.g., mounted in a hub adjacent to the catheter receiving lumen) can be run along the length of the catheter to verify that no air bubbles remain in the system.

[0235] An example of a priming process involving reciprocating adjacent catheters is described with respect to Figures 21A-21B.

[0236] 21A depicts an interventional device assembly 2900 assembled in a concentric stack configuration. As shown in FIG. 21A, the interventional devices can be fully nested within one another. This can be the configuration following unpackaging and placement of the device assembly 2900 on a 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.

[0237] The priming sequence can begin by priming the catheter 2906. In some embodiments, the catheter 2906 can be primed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of the catheter 2906 while causing reciprocating movement of the catheter 2906 and / or hub 2914 axially, rotationally, or both relative to the catheter 2906. Priming the catheter 2906 can include priming the hub 2914. For example, in certain embodiments, the hub 2914 or a hemostasis valve coupled thereto can include a fluidic connection for receiving priming fluid from the fluidics system. In certain embodiments, the catheter 2906 and / or hub 2914 can be axially agitated back and forth along the longitudinal axis of the catheter 2906 (e.g., between the positions of FIGS. 21A and 21B ). The axial and / or rotational reciprocating movement of the catheter 2906 and / or hub 2914 can be performed manually or by a robotically driven table. The reciprocating movement can occur in response to control signals from a control system. The introduction of fluid under pressure can be performed in response to control signals from the control system.

[0238] In some embodiments, priming of catheter 2906 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2906 while causing reciprocating movement of catheter 2904 and / or hub 2912 axially, rotationally, or both relative to catheter 2906. The axial and / or rotational reciprocating movement of catheter 2904 and / or hub 2912 can be performed manually or by a robotically driven table. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from the control system.

[0239] In some embodiments, priming of catheter 2906 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2906 while causing reciprocating movement of both catheter 2906 (and / or hub 2914) and catheter 2904 (and / or hub 2912) axially, rotationally, or both relative to one another. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from the control system.

[0240] In some embodiments, after priming the catheter 2906, the catheter 2906 can be returned to an initial position, as shown in Figure 21 A. 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.

[0241] In some embodiments, catheter 2904 can be primed after catheter 2906 is primed. Priming catheter 2904 can include priming hub 2912. For example, in certain embodiments, hub 2912 or a hemostasis valve coupled thereto can include a fluidic connection for receiving a priming fluid from a fluidics system. In some embodiments, catheter 2904 can be primed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2904 while causing reciprocating movement of catheter 2904 and / or hub 2912 axially, rotationally, or both relative to catheter 2906. The reciprocating movement can be caused in response to a control signal from a control system. Introducing the fluid under pressure can be performed in response to a control signal from the control system.

[0242] In some embodiments, priming of catheter 2904 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2904 while causing reciprocating movement of catheter 2902 and / or hub 2910 axially, rotationally, or both relative to catheter 2904. The axial and / or rotational reciprocating movement of catheter 2902 and / or hub 2910 can be performed manually or by a robotically driven table. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of fluid under pressure can be performed in response to a control signal from a control system.

[0243] In some embodiments, priming of catheter 2904 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2904 while causing reciprocating movement of both catheter 2904 (and / or hub 2912) and catheter 2902 (and / or hub 2910) axially, rotationally, or both relative to one another. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from the control system.

[0244] In some embodiments, after priming the catheter 2904, the catheter 2904 can be returned to an initial position, as shown in Figure 21 A. In some embodiments, after priming the catheter 2904, the catheter 2904 can be advanced to a ready or actuated position to begin insertion into the patient.

[0245] In some embodiments, catheter 2902 can be primed after catheter 2904 is primed. Priming catheter 2902 can include priming hub 2910. For example, in certain embodiments, hub 2910 or a hemostasis valve coupled thereto can include a fluidic connection for receiving a priming fluid from a fluidics system. In some embodiments, catheter 2902 can be primed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2902 while causing reciprocating movement of catheter 2902 and / or hub 2910 axially, rotationally, or both relative to guidewire 2907. The reciprocating movement can be caused in response to a control signal from a control system. Introducing the fluid under pressure can be performed in response to a control signal from the control system.

[0246] In some embodiments, priming of catheter 2902 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2902 while causing reciprocating movement of guidewire 2907 and / or hub 2909 axially, rotationally, or both relative to catheter 2902. The axial and / or rotational reciprocating movement of guidewire 2907 and / or hub 2909 can be performed manually or by a robotically driven table. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from the control system.

[0247] In some embodiments, priming of catheter 2902 can be performed by introducing a fluid (e.g., saline, contrast medium, or a mixture of saline and contrast medium) under pressure into the lumen of catheter 2902 while causing reciprocating movement of both catheter 2902 (and / or hub 2910) and guidewire 2907 (and / or hub 2909) axially, rotationally, or both relative to one another. The reciprocating movement can be caused in response to a control signal from a control system. The introducing of the fluid under pressure can be performed in response to a control signal from the control system.

[0248] In some embodiments, after priming the catheter 2902, the catheter 2902 can be returned to an initial position, as shown in Figure 21 A. 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.

[0249] 21A and 21B can be performed in response to a single control signal from the control system. In other embodiments, 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.

[0250] 21A and 21B, the catheters are primed in order, starting with catheter 2906, followed by catheter 2904, then catheter 2902. However, it is contemplated that the catheters may be primed in any order. The catheters may be primed serially as described above with respect to FIGS. 21A and 21B. Alternatively, two or more of the catheters, or each of the catheters, may be primed in parallel.

[0251] In certain embodiments, priming the catheter can include reducing the depth of axial insertion (i.e., axial overlap) of a second interventional device into the lumen of a first interventional device through which fluid is to be injected (e.g., the length of the second interventional device into its concentrically adjacent lumen), as described with respect to Figures 20A-20C, and also generating relative reciprocating movement between the first interventional device and the second interventional device, axially, rotationally, or both, during priming, as discussed with respect to Figures 21A and 21B.

[0252] In some implementations, priming a catheter can include vibrating at least a portion of the catheter and / or its associated hub, if included. The vibration can be induced, for example, by an electric motor built into the catheter hub or by a separate electric motor or vibration source placed against the catheter during priming. In some implementations, at least a portion of the support table on which the catheter and / or its associated hub is placed can be vibrated during priming of any one or more catheters to aid in the removal of air and / or air microbubbles. Such vibration can be performed by an electric motor.

[0253] (Example) Additional embodiments are disclosed in more detail in the following examples, which are not intended to limit the scope of the claims in any way.

[0254] FIG. 22 is a diagram of a test system used to detect air bubble removal between concentrically stacked catheters. The test system included an inner catheter 2108 positioned within the internal lumen of an outer catheter 2106 in a concentric stack. The outer catheter 2106 was connected to a rotary hemostatic valve 2104. The hemostatic valve 2104 was connected to a syringe 2102 such that fluid injected using the syringe would flow through the lumen between the inner catheter 2108 and the outer catheter 2106. In the test system, the inner catheter 2108 had a diameter of approximately 0.071 inches. The outer catheter 2106 had a diameter of approximately 0.088 inches. The outer catheter 2106 was clear to allow visualization of bubbles within the lumen. The distal end of the outer catheter 2108 allowed 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 fluid injection, and Figure 23D is an illustration of this.

[0255] Example 1 In a first example, syringe 2102 was 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 is a photograph showing catheter 2106 and catheter 2108 following the injection of water. Figure 23E is an illustration of this. As shown in Figure 23B, a bubble is present in the lumen between catheter 2106 and catheter 2108.

[0256] Example 2 In a second example, the syringe 2102 was used to inject water through the hemostatic valve 2104 at a constant pressure of about 150 psi. Immediately after initiating the water injection, the inner catheter 2108 was axially reciprocated for about 10 seconds. The reciprocation was performed at a frequency of about 1 Hz (or less) and a stroke length of about 20 mm (or more). FIG. 23C is a photograph showing the catheter 2106 and catheter 2108 following the axial reciprocation. FIG. 23F is an illustration thereof. As shown in FIG. 23C, the lumen between the catheter 2106 and catheter 2108 was substantially free of bubbles.

[0257] Example 3 In the third example, instead of the outer catheter 2106 and inner catheter 2108 described with respect to Examples 1 and 2, an outer catheter having a diameter of approximately 0.071 inches and an inner catheter having a diameter of approximately 0.035 inches were used in the test system 2100. 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 catheter. Immediately after initiating the water injection, axial reciprocating motion of the inner catheter was performed for approximately 10 seconds. The reciprocating motion was performed at a frequency of approximately 1 Hz (or less) and a stroke length of approximately 20 mm (or more). Following the axial reciprocating motion, the lumen between the outer and inner catheters was found to be substantially free of bubbles by visual inspection.

[0258] Control System 28 illustrates a schematic diagram of an example control system 4000 that may be used to electronically control the systems and components described herein and / or to implement 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 commands entered by an operator, such as a physician. In response to commands entered by the operator, the control system 4000 can automatically cause a series of responsive events to occur.

[0259] In certain embodiments, the control system 4000 can include one or more processors 4002. The one or more processors 4002 can be configured to automatically adjust various system components described herein in response to commands entered by an operator, for example, using one or more controllers 4004 of the control system 4000. A single controller 4004 is shown in FIG. 28 . However, any suitable number of controllers can be provided to correspond to various functions of the systems described herein. For example, in certain embodiments, each interventional device can have its own unique controller 4004 or set of controllers 4004 that can control various functions of the interventional device (e.g., axial movement, rotational movement, delivery of fluid (e.g., saline, contrast, etc.), suction, etc.).

[0260] In certain embodiments, the one or more controllers 4004 can control a priming function for one or more interventional devices. For example, the one or more controllers 4004 can be operated to cause an interventional device to perform a priming procedure, e.g., as described with reference to FIGS. 20A-20C. For example, the one or more controllers 4004 can be operated to cause axial movement of one or more interventional devices relative to one or more other interventional devices (e.g., by causing axial movement of a corresponding hub and / or hub adapter). The one or more controllers 4004 can be operated to cause introduction of a fluid into a lumen of the interventional device to prime the interventional device.

[0261] In certain embodiments, the one or more controllers 4004 can be operated to cause an interventional device to perform a priming procedure, e.g., as described with reference to Figures 21A-21B. For example, the one or more controllers 4004 can be operated to cause reciprocating movement (e.g., axial and / or rotational reciprocating movement) of one or more interventional devices relative to one or more other interventional devices (e.g., by causing reciprocating movement of corresponding hubs and / or hub adapters). The one or more controllers 4004 can be operated to cause introduction of a fluid into a lumen of the interventional device to prime the interventional device (e.g., during the relative reciprocating movement).

[0262] The processor 4002 can receive signals from one or more controllers 4004 and, in response, initiate corresponding actions in 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 components of the systems described herein.

[0263] Although the foregoing describes robotically driven and manually driven interventional devices, the devices can be manually driven, robotically driven, or any combination of manually and robotically driven interventional devices, as will be recognized by those of ordinary skill in the art in light of the disclosure herein.

[0264] The foregoing represents one specific implementation of a robotic control system. As one of ordinary skill in the art will recognize in light of the disclosure herein, a wide variety of different robotic control system configurations can be created for robotically driving interventional devices, for supporting two, three, four, or more assemblies, and for axial advancement and retraction.

[0265] Although the foregoing describes an interventional device driven by a drive table, other suitable robotic drive systems or mechanisms can be used to drive the interventional device, as will be recognized by those skilled in the art in light of the disclosure herein.

[0266] Although the various systems and methods are described herein primarily in the context of neurovascular access or procedures (e.g., neurothrombectomy), the catheters, systems (e.g., drive systems), and methods disclosed herein can be readily adapted for any of a wide variety of other diagnostic and therapeutic applications throughout the body, including, for example, intravascular procedures in the peripheral vasculature (e.g., deep vein thrombosis), central vasculature (pulmonary embolism), and coronary vasculature, among others, as well as procedures in other hollow organs or tubular structures within the body.

[0267] In any embodiment disclosed herein, the robotic drive system may further include a magnet (also referred to herein as a driven magnet) on one or more of the hubs (including, but not limited to, the guidewire hub, the access catheter hub, and the guide catheter hub). Each of the driven magnets may be configured to cooperate with a corresponding drive magnet positioned on one or more of the hub adapters. In some embodiments, the system may be configured such that the driven magnet moves in response to movement of the corresponding drive magnet. In some embodiments, the system may be configured to have a magnet on one of the hub and the hub adapter and a ferrous object on the other of the hub and the hub adapter. In some embodiments, the drive magnets may be independently axially movably carried by the support table. In some embodiments, without limitation, the drive magnet may be positioned outside the sterile field, separated from the driven magnet by a barrier, and the driven magnet may be positioned within the sterile field. The barrier may include a tray made of a thin polymer film, any film of a non-ferromagnetic material, or the like.

[0268] In any embodiment disclosed herein, one or more or each of the magnets can be a permanent magnet, a rare earth magnet, or a neodymium magnet. In any embodiment disclosed herein, one or more or each of the magnets can be a rare earth magnet, a neodymium magnet, an anisotropic ferrite magnet, or the like. In any embodiment disclosed herein, one or more or each of the magnets can include a rare earth magnetic material, a neodymium magnetic material, an anisotropic ferrite, or the like.

[0269] In some embodiments, one or more of the hubs and / or hub adapters disclosed herein may include one or more magnets that may be used in conjunction with magnetic field sensors to provide information to a user of the system regarding the position of the hub relative to the corresponding hub adapter, information regarding the force being applied to the hub, and other information, more details of which are provided below.

[0270] Force and coupling sensors: In some embodiments, any of the hubs or pucks disclosed herein (e.g., guidewire hub 26, access catheter hub 28, guide catheter hub 30, hub 36, hub 250, guidewire hub 2909, insertion or access catheter hub 2910, procedure catheter hub 2912, and guide catheter hub 2914) and / or hub adapters disclosed herein (e.g., hub adapter 48) can include any of a variety of sensors for measuring parameters associated with the hub, an instrument coupled to the hub, etc. Such parameters can include, for example, but are not limited to, a force applied to the hub and / or a displacement of the hub relative to its corresponding hub adapter. In some embodiments, the parameter can include a magnetic field magnitude and / or a magnetic field direction.

[0271] The parameters can be used by the robotic control system to determine a state or condition of one or more of the hubs, hub adapters, hub / hub adapter pairs, interventional devices, and / or robotic control systems, or the occurrence of an event during a procedure. For example, as described herein, the parameters can be used to determine displacement or disconnection between the hub and hub adapter, excessive forces on the interventional device and / or hub, excessive forces (e.g., frictional forces) between interventional devices, excessive energy storage in the interventional device, etc. In some embodiments, parameters for multiple hubs, hub adapters, hub / hub adapter pairs, and / or interventional devices can be compared to determine a state or condition of one or more of the hubs, hub adapters, hub / hub adapter pairs, interventional devices, and / or robotic control systems, or the occurrence of an event during a procedure.

[0272] In some embodiments, one or more sensors can measure a magnetic field vector. The sensors can measure the magnitude of the magnetic field in one or more directions (e.g., x-direction, y-direction, and z-direction). In some embodiments, the magnetic field measurements can be used to determine the magnitude and / or direction of displacement of the hub from the corresponding hub adapter (e.g., based on the measured magnetic field vector or a change in the measured magnetic field vector).

[0273] In some embodiments, a magnetic field sensor or sensors can be used to measure the magnetic field strength of the magnetic coupling between the hub and each hub adapter. In some embodiments, one or more magnetic field sensors can be positioned on the hub or hub adapter and used to measure the magnetic field strength of a magnet (also referred to herein as a sensor target magnet) on the other of the hub and hub adapter (i.e., the component without the magnetic field sensor). For example, without limitation, a magnetic field sensor can be positioned on any one or all of the hub adapters, and a magnet producing a magnetic field sensed by the magnetic field sensor can be positioned on any one or all of the corresponding hubs in a position (e.g., aligned with the position of the magnetic field sensor) such that the magnetic field will be sensed by the magnetic field sensor when the hub is in a desired position aligned with the hub adapter. In any embodiment of the robotic control system disclosed herein, the magnet producing the magnetic field sensed by the magnetic field sensor can be a different magnet from the drive magnet and can be different from the driven magnet. In some embodiments, the magnets that create the magnetic fields sensed by the magnetic field sensors may also be used for other purposes, such as, but not limited to, transmitting axial forces from one or more of the hub adapters to the corresponding hubs.

[0274] In any embodiment disclosed herein, the magnets that create the magnetic fields sensed by the magnetic field sensors can be disk-shaped magnets (such as, for example, but not limited to, magnet 8006 shown in FIG. 29A ), cylindrically shaped magnets (such as, for example, but not limited to, ring-shaped magnets such as magnet 8006 shown in FIG. 29B ), or any other suitable type of magnet. Ring-shaped magnets are sometimes referred to herein as ring magnets. In some embodiments, one or more of the magnets (e.g., ring magnets) that create the magnetic fields sensed by the magnetic field sensors can have an opening or hole axially through their center and a circular shape at the periphery of the magnet. In any embodiment disclosed herein, the drive magnet of at least one hub adapter and the driven magnet of the corresponding hub can be ring magnets. In any embodiment disclosed herein, the drive magnets of all hub adapters and the driven magnets of the corresponding hubs of a robotic control system can be ring magnets.

[0275] In certain embodiments having a ring magnet, as the ring magnet passes (e.g., passes over) a magnetic field sensor, the ring magnet can provide additional information about the magnet's position relative to the sensor. In certain embodiments having a ring magnet, the ring magnet can be radially or concentrically magnetized. For example, without limitation, the north pole of the magnet can be at the innermost portion of the ring magnet, which can be surrounded by the south pole, such that the outermost periphery of the ring magnet is magnetically south. Conversely, in some embodiments of a ring magnet, the south pole of the magnet can be at the innermost portion of the ring magnet, which can be surrounded by the north pole, such that the outermost periphery of the ring magnet is magnetically north. Thus, by knowing the polarity of the ring magnet, additional information can be gathered that is not provided by magnets with solid cross-sections; for example, a system can be configured to gather polarity information to obtain additional information related to the magnet's position relative to the sensor. For example, in such embodiments, as a ring magnet passes (e.g., passes over) the magnetic field sensor, the magnetic field sensor can detect the orientation of the magnetic field. By knowing the polarity of the ring magnet, this information can be used to determine the position of the magnet relative to the sensor. In some embodiments, the orientation information can be used along with the magnetic field strength information to determine the position of the magnet relative to the sensor. In other embodiments, the ring magnet can have an alternative magnetization orientation that can provide the magnetic field sensor with information about the orientation of the magnetic field that can be used to determine the position of the magnet relative to the sensor. For example, in certain embodiments, the ring magnet can be diametrically magnetized. In certain embodiments, other magnets, such as disk magnets, can have magnetization orientations that provide the magnetic field sensor with information about the orientation of the magnetic field that can be used to determine the position of the magnet relative to the sensor.

[0276] In any embodiment disclosed herein, the hub and each hub adapter may each include a magnet configured to attract the magnet of the other of the hub and hub adapter. Alternatively, in any embodiment disclosed herein, the hub or each hub adapter may include a magnet, and the other of the hub and hub adapter may include a ferromagnetic object configured to magnetically couple with the magnet.

[0277] In any embodiment, one or more sensors can be used to measure the magnetic field strength between the magnets of a hub and hub adapter pair or between the magnet and a ferromagnetic object. In some embodiments, the magnetic field magnitude (or magnetic field vector magnitude) of the magnetic field between each magnet of a hub and hub adapter pair or between the magnet and a ferromagnetic object at a baseline position can be measured to determine and establish a baseline magnitude (or baseline vector magnitude) of the magnetic force between the hub and hub adapter of each hub and hub adapter pair. For example, without limitation, the baseline magnitude (or baseline vector magnitude) can be the magnetic field magnitude (or set of baseline vector magnitudes) of the hub and hub adapter pair when the hub and hub adapter are at a baseline position (e.g., when the hub and hub adapter are axially aligned). In some embodiments, this can be the position of the hub and hub adapter when the hub and hub adapter are magnetically coupled to each other and no external forces other than the magnetic coupling force are acting on the hub or hub adapter (or, in some embodiments, when no other significant external forces are acting). The baseline magnitude (or set of baseline vector magnitudes) can be the highest value of the magnetic field strength of each pair.

[0278] In some embodiments, the system can be configured to determine or estimate the displacement of the hub from a baseline position of the hub (referred to herein as ΔP or offset distance) based on the difference between the actual (e.g., measured) magnetic field magnitude (or vector magnitude) and a baseline magnitude (or set of baseline vector magnitudes) of the magnetic coupling force (i.e., baseline magnitude minus actual magnetic field magnitude, referred to herein as ΔF). In some embodiments, empirical data can be collected that relates to the difference between the actual magnetic coupling force magnitude (or vector magnitude) and the baseline magnitude (or set of baseline vector magnitudes) of the magnetic coupling force at a variety of displacement positions. These values, in some embodiments, can be stored in a lookup table. This information can be used to determine the position or displacement of the hub adapter relative to each hub (i.e., ΔP value) based on the ΔF value.

[0279] In some embodiments, the system can be configured to include a lookup table of data relating displacement values ​​between each hub and hub adapter to the difference between the magnitudes (or vector magnitudes) of the respective magnetic coupling forces. The lookup table can also include data relating to a baseline magnitude (or set of baseline vector magnitudes) of the magnetic coupling forces. In some embodiments, the lookup table can be based on empirical data for hub and hub adapter pairs derived from actual measurements of displacement between each hub and hub adapter to the difference between the magnitude (or vector magnitude) of the respective magnetic coupling forces and the baseline magnitude (or set of baseline vector magnitudes) of the magnetic coupling forces.

[0280] In some embodiments, the mapping of magnetic field vector data to displacement is not perturbed by friction between the hub and the sterile barrier.

[0281] In some embodiments, the system can be configured to determine or estimate an external force applied to the hub. For example, without limitation, the external force can be determined based on the difference between a measured magnetic force magnitude (or vector magnitude) between the hub and the hub adapter and a baseline magnitude (or set of baseline vector magnitudes). From this, some embodiments can be configured to calculate the external force acting on the hub and the displacement ΔP between the hub and the hub adapter. Some embodiments can be configured to calculate the direction of the external force acting on the hub (e.g., based on the difference between the measured magnetic field vector and the baseline magnetic field vector). Thus, as stated, in some embodiments, the magnetic field measurements can be used to determine the magnitude and / or direction of the external force acting on the hub (e.g., based on the measured magnetic field vector or a change in the measured magnetic field vector).

[0282] Additionally or alternatively, in some embodiments, a hub adapter baseline magnetic field value (e.g., magnitude) or magnetic field vector value (e.g., magnetic field vector magnitude) can be determined when the hub is not coupled to the hub adapter. The system can be configured to determine that the hub is coupled to the hub adapter based on the difference between the actual (e.g., measured) magnetic field magnitude (or vector magnitude) and the hub adapter baseline magnetic field magnitude (or set of baseline vector magnitudes). In some embodiments, the system can be configured to determine or estimate the displacement of the hub from its baseline position (referred to herein as ΔP or offset distance) or an external force applied to the hub based at least in part on the hub adapter baseline magnetic field magnitude (or set of baseline vector magnitudes), for example, based on the difference between the actual (e.g., measured) magnetic field magnitude (or vector magnitude) and the hub adapter baseline magnetic field magnitude (or set of baseline vector magnitudes). In other embodiments, the hub baseline magnetic field magnitude (or set of baseline vector magnitudes) can be determined when the hub is not coupled to the hub adapter and can be used in the same or similar manner as the hub adapter baseline magnetic field magnitude (or set of hub adapter baseline vector magnitudes). Data from the sensors can be used to determine other attributes of the system, such as, for example, whether a hub is contacting and pressing against another hub and / or whether the hub is magnetically coupled to a hub adapter. For example, whether a hub is contacting and pressing against another hub and / or whether the hub is magnetically coupled to a hub adapter can be determined based on a determined displacement between the hub and the hub adapter and / or a determined force acting on the hub.

[0283] In some embodiments, force measurements and / or magnetic field magnitude and / or direction measurements from one or more of the sensors can be used to determine that movement of one or more of the hubs has been impeded or prevented, which may be the result of tension in fluid or electrical lines coupled to the hubs (e.g., a fluid line is caught or stretched), one or more of the hubs being in physical contact with another hub or object (e.g., a hub pushing against another hub), poor conditions of the hubs, forces acting on an interventional device coupled to the hubs, and / or other physical impediments to hub movement.

[0284] In some embodiments, force measurements and / or magnetic field magnitude and / or direction measurements from one or more of the sensors can be used to determine that the range of motion of an anti-buckling component (e.g., any of the anti-buckling components disclosed herein) is approaching a position where it is out of range or that the range of motion has been exceeded.

[0285] In some embodiments, force measurements and / or magnetic field magnitude and / or direction measurements from one or more of the sensors can be used to determine that one or more of the hubs has been detached from their respective hub adapters.

[0286] In some embodiments, force measurements and / or magnetic field magnitude and / or direction measurements from one or more of the sensors can be used to determine whether frictional forces within the body are high or excessive. In any embodiment disclosed herein, the robotic control system can be configured to provide a warning to the user when an abnormal condition (e.g., such as any of the abnormal or potentially abnormal conditions discussed herein) exists. In some embodiments, the warning can include a visual alert on a graphical user interface or other user interface, an audible alert to the user, tactile feedback, and any combination of the foregoing.

[0287] In some embodiments, active real-time or near-real-time force sensing is used for each interventional device (or a subset of interventional devices) to detect energy storage in compression, tension, and / or rotational shear, which may be caused by friction between interventional devices. Energy storage can occur within an interventional device, e.g., axially, due to cumulative friction along the shaft of the interventional device. Clinically, this can cause a variety of problems. For example, the desired commanded motion may not be transmitted to the tip of the shaft due to cumulative friction along the shaft. Also, the stored energy may be released when frictional forces are overcome, which may result in significant uncommanded (i.e., inadvertent) movement of the shaft. In some embodiments, energy storage can be mitigated by the user taking corrective action (e.g., using push / pull techniques on one or more of the interventional devices), reducing the risk of inadvertent uncommanded movement due to energy release.

[0288] In some embodiments, force patterns derived from magnetic field magnitude information collected by the system can also be used to perform control functions. For example, in some embodiments, force patterns derived from magnetic field magnitude information can be used to perform control functions to compensate for or mitigate energy storage (e.g., in the axial shaft due to cumulative friction along the shaft of the interventional device). For example, in some embodiments, force sensing data can be used by any embodiment of the robotic control 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., using a control algorithm). For example, without limitation, some embodiments of the drive system can automatically adjust the interventional device via axial movement of the interventional device where the amount of stored energy exceeds a threshold to mitigate energy storage.

[0289] In some embodiments, the robotic control system can be configured to execute a control function to mitigate one or more abnormal conditions. For example, some embodiments of the robotic control system can be configured to override user control of one or more hub adapters and prevent further movement of the one or more hub adapters. In some embodiments, the robotic control system can be configured to override user control of one or more hub adapters and move the hub adapters, and consequently, the coupled or tethered hubs (e.g., a first hub), away from another hub with which the first hub is interfering, or to move the first hub in a direction that reduces a force on the first hub or a force on a hub with which the first hub is interfering.

[0290] In some embodiments, the robotic control system may include one or more sensors in the hub adapter and / or the corresponding hub configured to detect whether the hub is coupled with the hub adapter, which may include determining whether the hub is magnetically coupled to and / or aligned with the hub adapter.

[0291] In some embodiments, the robotic control system may have a sensor (such as, but not limited to, a magnetometer positioned in or coupled to the hub adapter) to detect the presence and / or magnitude and / or direction of a magnetic field generated by a magnet positioned in or coupled to the hub. In some embodiments, the robotic control system may have a sensor (such as, but not limited to, a magnetometer positioned in or coupled to the hub) to detect the presence and / or magnitude and / or direction of a magnetic field generated by a magnet positioned in or coupled to the hub adapter. Detection of the presence and / or magnitude and / or direction of the magnetic field may be used to determine whether the hub is magnetically coupled to the hub adapter.

[0292] In some embodiments, the magnitude and / or direction of the magnetic field generated by a magnet positioned in the hub or hub adapter can be measured by a sensor to determine the displacement (i.e., offset distance), if any, between the hub and the hub adapter. In some embodiments, the magnitude and / or direction of the magnetic field generated by a magnet positioned in the hub or hub adapter can be measured by a sensor to determine the magnitude of the force being applied to the hub.

[0293] In some embodiments, the sensor may include an RFID reader positioned on or coupled to one of the hub and the hub adapter and configured to interrogate an RFID tag positioned on or coupled to the other of the hub and the hub adapter to verify that the hub and hub adapter are coupled (e.g., magnetically coupled). For example, in some embodiments, the RFID reader is positioned on or coupled to the hub and the RFID tag is positioned on or coupled to the hub adapter. In some embodiments, the RFID reader is positioned on or coupled to the hub adapter and the RFID tag is positioned on or coupled to the hub. The RFID reader may be used in combination with a magnetic sensor (e.g., a magnetometer) to verify that the magnetic field sensed by the magnetic sensor is from the corresponding hub or hub adapter and not from a different magnetic object.

[0294] Features and benefits of force sensors and / or coupled sensors: Some embodiments of the robotic control systems disclosed herein having one or more force sensors and / or coupling sensors may have at least the following features or may be otherwise configured to perform the following functions:

[0295] In some embodiments, the robotic control system can be configured to measure (e.g., continuously or near-continuously) the magnetic field strength and / or direction between the hub and the hub adapter and provide hub release detection and / or warning to the user. For example, if it is determined that the hub will release from the hub adapter at a particular relative displacement value (also referred to herein as the displacement threshold), the robotic control system can be configured to communicate an alert to the user if the relative displacement between the hub and the hub adapter reaches a particular predetermined percentage of the displacement threshold (e.g., 70% of the displacement threshold, approximately 70% of the displacement threshold, 80% of the displacement threshold, approximately 80% of the displacement threshold, 60% of the displacement threshold, or approximately 60% of the displacement threshold, or less than 60%, to 90% of the displacement threshold, or approximately 90% of the displacement threshold, or more than 90% of the displacement threshold, or any value within any of the foregoing ranges or other suitable predetermined percentage, etc.).

[0296] Alternatively, if it is determined that the hub will release from the hub adapter at a particular relative force value (also referred to herein as a force threshold or breakage force), the robotic control system can be configured to communicate an alert to the user if the net external force acting on the hub reaches a predetermined percentage of the breakage force (e.g., 70% of the breakage force, approximately 70% of the breakage force, 80% of the breakage force, approximately 80% of the breakage force, 60% of the breakage force or approximately 60% of the breakage force or less than 60% to 90% of the breakage force or approximately 90% of the breakage force or more than 90% of the breakage force, or any value within any of the foregoing ranges or other suitable predetermined percentage, etc.).

[0297] In some embodiments, the robot control system can be configured to increase the intensity of an alert to the user (e.g., increase the size of the warning symbol (which can be a triangle, arrow, or any other desired shape), increase the hue or opacity of the warning symbol, change the color of the warning symbol, increase the volume level or change the pitch of the audible warning, and / or provide other levels of warning, etc.) as the relative displacement value or the net external force on the hub increases.

[0298] In some embodiments, the robotic control system can be configured to warn the user about the risk of disengagement between the hub and hub adapter at a lower predetermined percentage of the displacement threshold (e.g., 50% or approximately 50% or less than 50% of the displacement threshold before disengagement) if the hub adapter and / or hub are moving at a higher speed, or at a lower value of the net external force acting on the hub (e.g., 50% of the breakage force, approximately 50% of the breakage force). This can allow more time for the user to react to mitigate the relative displacement or other problem.

[0299] Additionally, in some embodiments, the robotic control system can be configured to impede movement of the hub adapter by increasing the resistive force on the hub adapter and / or by slowing movement of the hub adapter if the relative displacement reaches a threshold value (e.g., 80% or approximately 80% or at least 80% of the displacement threshold, or 70% or approximately 70% or at least 70% of the displacement threshold, or from 60% or approximately 60% or less of the displacement threshold to 90% or approximately 90% or more than 90% of the displacement threshold, or any percentage within any of the foregoing ranges). In some embodiments, the robotic control system can increase such resistive force or further slow movement of the hub adapter, such as if the relative displacement reaches a second threshold value (e.g., 90% or approximately 90% of the total allowable relative displacement before disengaging).

[0300] Similarly, in some embodiments, the robotic control system can be configured to impede movement of the hub adapter by increasing the resistive force on the hub adapter and / or by slowing movement of the hub adapter if the net external force acting on the hub reaches a threshold value (e.g., 80% or approximately 80% of the breakage force, or 70% or approximately 70% of the breakage force, or from 60% or approximately 60% of the breakage force to 90% or approximately 90% of the breakage force or greater than 90% of the breakage force, or any percentage within any of the foregoing ranges). In some embodiments, the robotic control system can increase such resistive force or further slow movement of the hub adapter if the net external force acting on the hub reaches a second threshold value (e.g., 90% or approximately 90% of the breakage force). In some embodiments, the robotic control system can be configured to impede movement of the hub adapter in a direction that would increase the net external force acting on the hub if the net external force acting on the hub reaches a threshold value.

[0301] As mentioned, some embodiments of the robotic control system disclosed herein can be configured to measure (e.g., continuously or near-continuously) the magnetic field strength and / or direction between the hub and the hub adapter and provide a warning of impending hub disengagement. In some embodiments, the robotic control system can be configured to measure (e.g., continuously or near-continuously) the magnetic field strength and / or direction between the hub and the hub adapter and provide an excessive force (e.g., excessive insertion force) warning and / or take other corrective action. For example, corrective action can include preventing further movement of the hub adapter in a direction that would increase the external force on the hub or interventional device, moving the hub adapter in a direction that would reduce the external force on the hub or interventional device, disengaging the hub from the hub adapter, or any other appropriate corrective action. In some embodiments, the robotic control system can recommend to the user a corrective maneuver to reduce the load on one or more hubs.

[0302] In some embodiments, the robotic control system can be configured to communicate an alert to a user if the axial force applied to the hub is greater than 2 N, greater than approximately 2 N, greater than 3 N, greater than approximately 3 N, greater than 5 N, greater than approximately 5 N, greater than 10 N, greater than approximately 10 N, greater than 15 N, greater than approximately 15 N, or any other suitable value.

[0303] Some embodiments of the robotic control system disclosed herein can be configured to measure (e.g., continuously or near-continuously) the magnetic field strength and / or direction between the hub and hub adapter and provide real-time or near-instantaneous force data to a user. In some embodiments, the robotic control system can be configured to measure (e.g., continuously or near-continuously) the magnetic field strength and / or direction between the hub and hub adapter and provide (e.g., real-time or near-instantaneous data) to a user regarding the force exerted on an interventional device (e.g., a catheter or guidewire) coupled to the hub. In some embodiments, the robotic control system can be configured to measure (e.g., continuously or near-continuously) the magnetic field strength between the hub and hub adapter and provide (e.g., real-time or near-instantaneous data) to a user regarding the magnitude of axial torque built up in an interventional device (e.g., a catheter (e.g., an insertion or access catheter) or guidewire) coupled to the hub. In some embodiments, torque can be measured by measuring the change in the magnetic field (e.g., magnetic field magnitude) in a direction perpendicular to the axis of the shaft.

[0304] Some embodiments of the robotic control system disclosed herein having one or more force sensors and / or coupling sensors can have at least the following benefits: In some embodiments, the robotic control system can determine whether a hub is about to detach (i.e., magnetically disengage) from its respective hub adapter, and an appropriate warning can be communicated to a user and / or corrective action can be taken. In some embodiments, the robotic control system can determine whether a hub has detached (i.e., magnetically disengaged) from its respective hub adapter, and an appropriate warning can be communicated to a user and / or corrective action can be taken. In some embodiments, the robotic control system can determine the presence and / or magnitude of an external force on the hub, and an appropriate warning can be communicated to a user and / or corrective action can be taken. In some embodiments, the robotic control system can be configured to determine whether an insertion force acting through the magnetic coupling exceeds a predetermined threshold, and an appropriate warning can be communicated to a user and / or corrective action can be taken.

[0305] Some embodiments of the robotic control system disclosed herein can be configured to detect predetermined patterns associated with undesirable clinical scenarios (e.g., involving one or more hubs / interventional devices) and provide warnings and / or take other corrective action. For example, if a pattern is recognized indicating adjacent interventional device shafts are experiencing simultaneous forces in opposite directions, the system can provide a warning or automatically take corrective action, for example, by unloading either or both interventional devices to reduce energy storage caused by frictional interactions between them.

[0306] As described, in certain embodiments, the robotic control system can be configured to perform magnetic force sensing for multiple hub / hub adapter combinations. In certain embodiments, the robotic control system can analyze (e.g., compare) data (e.g., magnetic field magnitude, magnetic field vector magnitude, force, displacement, force direction, displacement direction, and / or changes in any of the foregoing over time) for multiple hub / hub adapter pairs to determine the status or condition of one or more hub / hub adapter pairs, one or more interventional devices, or the robotic control system, or the occurrence of one or more events during a procedure. For example, if the system determines that a force acting on a first hub (e.g., hub 2914) is the same or similar in magnitude and opposite in direction as a force acting on a second hub (e.g., hub 2912), the system can determine that a large amount of friction exists between an interventional device (e.g., guide catheter 2906) coupled to the first hub and an interventional device (e.g., treatment catheter 2904) coupled to the second hub. As another example, if the system determines that the force on each hub of the interventional device assembly is increasing as the interventional device assembly is inserted more distally into a tortuous vasculature, it can be determined that friction in the vasculature is the source of the additional force on the hub.

[0307] Additionally, in some embodiments, having force and / or displacement data associated with one or more of the hub and hub adapter pairs can provide useful information to assist during equipment setup prior to a procedure. For example, without limitation, in some embodiments, one or more sensors can be configured to determine whether the hub is correctly oriented relative to the hub adapter and provide a warning or other output configured to alert a user that the position and / or orientation of the hub relative to the hub adapter may be incorrect or outside a threshold tolerance range (e.g., from 20% of the displacement threshold, approximately 20% of the displacement threshold, 10% of the displacement threshold, approximately 10%, 10% of the displacement threshold, or approximately 10% or less than 10% of the displacement threshold to 30% of the displacement threshold or approximately 30% of the displacement threshold or greater than 30% of the displacement threshold, or any value within any of the foregoing ranges or other suitable predetermined percentage).

[0308] Additionally, in some embodiments, one or more sensors can be used to determine whether the hub is properly oriented relative to the hub adapter and provide a warning or other output configured to prevent or prevent use of the system before the error condition is corrected. In some embodiments, the robotic control system can be configured to identify to a user or operator which hubs may be outside a range or tolerance in terms of their relative displacement relative to a corresponding hub adapter, their orientation relative to the hub adapter, their pre-procedure setup for net forces acting on the hub, or other parameters. In some embodiments, the robotic control system can be configured to indicate or provide feedback to the user to help them understand the magnitude or degree of misalignment, the direction of the misalignment, the magnitude or degree of the net external force acting on the hub, the direction of the net external force acting on the hub, or other parameters. Additionally, some embodiments of the robotic control system can be configured to assess and provide feedback to a user that the relative displacement, net external force, and / or orientation of the hub with respect to the hub adapter are all within acceptable ranges or values, that the initial setup was completed correctly, and / or that other operating parameters of the robotic control system are within acceptable ranges (e.g., within predetermined ranges or threshold ranges).

[0309] Measurement of the offset between the hub and the hub adapter and the force applied to the hub: As described herein, some embodiments of the robotic control system may include sensors in the hub adapter and / or the hub configured to measure forces being applied to the hub. In some embodiments, and as described herein with respect to some embodiments, the magnetic field vector data may be used to calculate a force acting on the hub from the magnetic coupling between the hub and the hub adapter and / or from separate external forces acting on the hub. In some embodiments, the calculated force may be proportional to (if not equal to) the net resulting force of all external forces acting on the hub.

[0310] Calculating the force being applied to the hub can help prevent the hub from being ripped or disconnected from the hub adapter, which can occur if the hub's movement is constrained or impeded but the hub adapter continues to move relative to the hub.

[0311] In some embodiments, a user may feel resistance to movement of the hub adapter relative to the hub (e.g., via haptic feedback) due to magnetic forces between the hub and hub adapter when the hub and hub adapter are coupled.

[0312] In some embodiments, the sensor (which may be a magnetometer) may continuously (or near-continuously) measure the magnitude and / or direction of the magnetic field (e.g., by measuring the magnetic field vector). In some embodiments, the sensor may provide continuous (or near-continuous) feedback to the user of the amount of offset between the hub adapter and the hub, and / or the magnitude and / or direction of any external force applied to the hub.

[0313] Any embodiment of the robotic control system disclosed herein can include a magnetometer device in the hub adapter or the hub, and can include a magnet (e.g., a rare earth magnet) corresponding to the other of the hub adapter and the hub. The relative displacement of the hub and hub adapter can be characterized based on changes in magnetic field strength detected by the magnetometer. In certain embodiments, data regarding the magnetic field strength and / or direction generated by a magnet on the opposite side of the magnetometer can be used to measure either vertical or horizontal displacement of the hub relative to the hub adapter in some embodiments.

[0314] 24 is a schematic diagram of a portion of a robotic control system 8000 showing a hub (which may be any of the embodiments of a hub disclosed herein, including but not limited to hub 2910) and a hub adapter (which may be any of the embodiments of a hub adapter disclosed herein, including but not limited to hub adapter 8004b). Hub 2910 may include one or more magnets 8006, and hub adapter 8004 may include one or more magnets 8007 to magnetically couple hub 2910 and hub adapter 8004.

[0315] In some embodiments, the magnetic coupling between the hub 2910 and the hub adapter 8004 is elastic. The magnetic field strength data can be used to calculate the elastic force across the magnetic coupling between the hub 2910 and the hub adapter 8004. Due to the elastic nature of the coupling, the magnetic coupling can be modeled as a spring coupling, as shown in FIG. 25, which shows a schematic diagram of a hypothetical system with a spring positioned between the hub 2910 and the hub adapter 8004.

[0316] The relative displacement 8020 between the hub 2910 and the hub adapter 8004 in the z direction (i.e., the proximal-distal or axial direction of movement of the hub) is represented by Δz in Figures 24 and 25. As shown in Figure 24, the relative displacement 8020 between the hub 2910 and the hub adapter 8004 is determined by the force F acting on the hub 2910. hub and / or the force F acting on the hub adapter 8004 adapter It is possible that this is caused by

[0317] In some embodiments, the magnetometer can be configured to measure the magnetic field strength in the direction of the axial movement of the hub 2910 (i.e., parallel to Δz). hub can be characterized by the following formula: F hub = k mag (Δz(B z ))·B z where Δz is the relative displacement of the fixed point on the hub 2910 relative to the fixed point on the hub adapter 8004, and k mag is the effective spring constant between the hub 2910 and the hub adapter 8004, and B z is the magnetic field strength in the direction of axial movement of the hub 2910. In some embodiments, Δz is z is proportional to.

[0318] In part, movement of the hub adapter may result in a relative displacement in the z-direction between the hub and the hub adapter, as described above. This relative displacement may lead to a magnetic coupling force that can move the hub in the z-direction toward the hub adapter. In other cases, an external force may act on the hub and a device attached to the hub, which may result in a relative displacement in the z-direction between the hub and the hub adapter. In those cases, the magnetic coupling force may increase to counteract the external force. However, in those cases where there is an external force applied to the hub, there may be a relative displacement in the z-direction between the hub and the hub adapter due to the external force. In some embodiments, the amount of relative displacement will depend, among other things, on the magnitude of the external force.

[0319] 24 shows a magnet coupled to both the hub 2910 and the hub adapter 8004, it should also be noted that some embodiments of the system can be configured such that only the hub 2910 includes a magnet. The hub adapter 8004 can support a sensor (which, as discussed, can be a magnetometer) and can be configured to be coupled to a hub without having a second magnet in the hub adapter 8004.

[0320] In some embodiments, the hub adapter 8004 and hub 2910 can be configured such that the hub 2910 can withstand a force (e.g., axial) of up to 10 N, up to approximately 10 N, up to 15 N, up to approximately 15 N, up to 20 Newtons, up to approximately 20 N, 10 N to 30 N, approximately 10 N to approximately 30 N, 15 N to 25 N, approximately 15 N to approximately 25 N, or any other suitable force or range of forces before the hub 2910 disengages from the hub adapter 8004.

[0321] Although hub 2910 and hub adapter 8004 are described with respect to Figures 24 and 25, it will be understood by those skilled in the art that any of the hubs described herein (e.g., hub 2909, hub 2912, and hub 2914) and corresponding hub adapters (e.g., hub adapter 8004a, hub adapter 8004c, and hub adapter 8004d, as shown in Figure 26A) can operate in the same or similar manner.

[0322] In some embodiments, different interventional devices and / or different hubs can be configured to disengage from their respective hub adapters at different force magnitudes (e.g., can have different threshold shear forces).

[0323] In any embodiment disclosed herein, the robotic control system may include additional electronic components to accompany the magnetometer, including, but not limited to, a microcontroller (which may be an Arduino-IDE programmable board), a power supply for the magnetometer and other components, a memory storage device, one or more wired or wireless communication devices for communicating with the magnetometer, a display device, and a workstation directly or any other desired components, and / or a data processor configured to receive data from the magnetometer and perform calculations based on the data from the magnetometer.

[0324] Some embodiments of the system may include a processor (e.g., a separate, stand-alone computer) configured to communicate with one or more sensors of the system. The processor may be configured to transmit sensor data from a second processor of the system. In some embodiments, the system may be configured to have only a single processor.

[0325] Some embodiments will be configured to execute programs and include appropriate software for performing at least the functions disclosed herein. For example, without limitation, some embodiments of the systems disclosed herein can be configured to run a noise reduction algorithm, an algorithm configured to determine the position of the hub adapter and / or hub in the z-direction (for any of the hubs and / or hub adapters of the system), an algorithm configured to calculate the relative displacement in the z-direction between the hub and hub adapter based on raw magnetic field vector data (for any of the hubs of the system), an algorithm configured to calculate the external force on the hub (for any of the hubs of the system) (e.g., based on the raw magnetic field vector data), an algorithm configured to calculate the coupling force between the hub and hub adapter (e.g., based on the raw magnetic field vector data), an algorithm configured to provide an alert or warning to a user or others when a threshold or condition (e.g., a relative displacement or external force threshold, etc.) is reached, and / or an algorithm configured to process data and / or data signals into a user-friendly format for display on a graphical user interface. Any embodiment of the systems disclosed herein can have a controller programmed to implement any or any combination of the foregoing algorithms.

[0326] Some embodiments of the robotic control system may include signal boosters and / or noise reduction or elimination components to improve data from the sensors. Additionally, a main computer or computing device may be configured to communicate with each of the sensors (including magnetometers) in the robotic control system and to output such data from the sensors to a user display, memory storage device, and / or other devices.

[0327] In some embodiments, the robotic control system can be configured to provide a warning to the user when the axial torque exceeds a threshold value at the proximal end of one or more interventional devices. In some embodiments, such axial torque can be calculated by collecting data related to the reaction torque applied to the end of the interventional device (e.g., an insertion or access catheter) or motor drive mechanism, using, for example, a torque sensor.

[0328] 26A shows a schematic diagram of an exemplary embodiment of a portion of a robotic control system 8000, showing a guidewire hub 2909, an access catheter hub 2910, a treatment catheter hub 2912, and a guide catheter hub 2914, which are magnetically coupled to multiple hub adapters 8004a, 8004b, 8004c, and 8004d, respectively. As shown in FIG. 26A, the hubs are separated from the hub adapters by a sterile barrier 8044.

[0329] 26A , hub 2910 is coupled to or includes hemostasis valve 8046a and can accommodate the introduction of guidewire 2907 therethrough. Hub 2912 is coupled to or includes hemostasis valve 8046b and can accommodate the introduction of access catheter 2902 and / or guidewire 2907 therethrough. Hub 2914 is coupled to or includes hemostasis valve 8046c and can accommodate the introduction of procedure catheter 2904, access catheter 2902, and / or guidewire 2907 therethrough.

[0330] Any of the hubs of any embodiment disclosed herein (including but not limited to first hub 2909, second hub 2910, third hub 2912, and / or fourth hub 2914 shown in FIG. 26A ) can each have one or more magnets (such as but not limited to magnets 8006a, 8006b, 8006c, and 8006d) associated therewith. In some embodiments, a magnetic field can be generated between the hub adapter and the hub using one or more magnets on each hub and hub adapter pair, and the system is configured such that movement of the hub adapter results in movement of the hub as a result of the magnetic field between the hub and hub. Magnetic coupling can be used in any embodiment of the robotic control system disclosed herein such that movement of a drive device on the non-sterile side of the sterile barrier can cause movement of at least one device on the sterile side of the sterile barrier in any desired direction of movement (e.g., in the direction of insertion and / or withdrawal of an interventional device relative to a port into the patient's body).

[0331] Although four hubs and four hub adapters are shown in Figure 26A, any embodiment of the robotic control system disclosed herein can have one, two, three, five, or more hubs and hub adapters, either paired or unpaired. In other words, some embodiments of the robotic control system disclosed herein can have more hubs than hub adapters.

[0332] In some embodiments, each hub and hub adapter pair can have a sensor. As shown in FIG. 26A , robotic control system 8000 can have multiple sensors 8010a, 8010b, 8010c, and / or 8010d. In any embodiment disclosed herein, the “sensor” of each hub and hub adapter pair can include multiple sensors. For example, without limitation, the multiple sensors can be any combination of the following: one or more magnetic field sensors, one or more magnetic inductance sensors, one or more capacitance sensors, one or more magneto-optical sensors, one or more general force sensors, one or more magnetic force sensors, and / or one or more magnetic load sensors (e.g., a current sensor configured to determine a motor load value of any drive component for the hub adapter, such as, but not limited to, a motor used for a rack and pinion or other linear actuation device). Such sensors can be or include any of the details of any of the sensors disclosed herein or known in the art. In some embodiments, each hub and hub adapter pair, or any of the hub and hub adapter pairs, of any embodiment of the robotic control system disclosed herein can include multiple redundant sensors, such as a magnetic field sensor (e.g., without limitation, a magnetometer) and another secondary sensor. Any of the sensors disclosed herein can be configured to determine one or more of the following parameters, or any combination or all of the following parameters: relative displacement between the hub and the corresponding hub adapter, direction of displacement of the hub relative to the corresponding hub adapter, net force applied to the hub and / or hub adapter, and / or net force vector applied to the hub and / or hub adapter. In some embodiments, the secondary sensor can be any of the sensor types disclosed herein.In some embodiments, a secondary sensor can be used to collect redundant or additional specific data.

[0333] As mentioned, some embodiments of the robotic control system may include an inductance sensor (e.g., an inductance position sensor). In some embodiments of the robotic control system in which a hub and hub adapter pair includes an inductance sensor, the sensor may be positioned on one or the other of the hub and hub adapter and configured to emit an electromagnetic field from a face of the sensor. For example, without limitation, the inductance sensor may be positioned on the hub adapter and may have a major surface configured to face the hub, from which the electromagnetic field may be emitted. A metal target may be positioned at a designated location on the other of the hub and hub adapter (in this non-limiting example, on the hub). The metal target may be configured to disrupt the electromagnetic field, which may be detected by the sensor. In some embodiments, the target metal may have any shape or size suitable for positioning on the hub or hub adapter. In some embodiments, the target metal will be positioned on the hub.

[0334] The positions of the sensor and metal target on the hub and hub adapter will be known. With this information and based on the magnetic field parameters the sensor can detect and collect, the system can determine the existence of an offset between the hub and hub adapter and, if applicable, the relative offset distance between the hub and hub adapter. In any embodiment, the inductance sensor can be shielded or unshielded, can be normally open or normally closed, can be in an NPN configuration (a positively doped semiconductor material positioned between two negatively doped materials) or a PNP configuration (a negatively doped semiconductor material positioned between two positively doped materials), and / or can have any other details or features known in the art or to those skilled in the art. In some embodiments, the inductance sensor can include one or more coils or antennas along with a microcontroller unit and / or other processing electronics.

[0335] As mentioned, in some embodiments, any of sensors 8010a-d may include or be a magnetic sensor (e.g., a magnetometer, etc.). In some embodiments, any of sensors 8010a-d may be configured to measure a wide variety of parameters, including, but not limited to, magnetic field strength and / or direction from one or more magnets (e.g., magnets 8006a-d) of a robotic control system. For example, each sensor 8010a-d may be configured to measure the magnetic field strength and / or direction from a respective magnet 8006a-d in a hub and hub adapter pair of which sensor 8010a-d is a part.

[0336] Each of sensors 8010a-d can be configured to determine the relative displacement or offset between a corresponding pair of hub and hub adapter (e.g., hub 2909 and hub adapter 8004a, hub 2910 and hub adapter 8004b, hub 2912 and hub adapter 8004c, and hub 2914 and hub adapter 8004d). Additionally or alternatively, any of sensors 8010a-d can be configured to determine the magnitude of force being applied to the corresponding hub 2909, 2910, 2912, and 2914 based on the magnetic field strength and / or direction from the respective magnets 8006a-d, as discussed above.

[0337] In some embodiments, any of sensors 8010a-d may be a three-axis magnetometer. In some embodiments, such a magnetometer may be configured to detect magnetic field strength in the x-, y-, and z-directions. In some embodiments, the magnetic field strength and / or direction values ​​may be used to determine relative displacement between corresponding hub and hub adapter pairs (e.g., hub 2909 and hub adapter 8004a, hub 2910 and hub adapter 8004b, hub 2912 and hub adapter 8004c, and hub 2914 and hub adapter 8004d). In some embodiments, the magnetic field strength and / or direction values ​​may be used to determine the force on the magnetic coupling between corresponding hub and hub adapter pairs (e.g., hub 2909 and hub adapter 8004a, hub 2910 and hub adapter 8004b, hub 2912 and hub adapter 8004c, and hub 2914 and hub adapter 8004d). In some embodiments, the magnetic field strength and / or direction values ​​may be used to determine the force acting on the corresponding hub.

[0338] In some embodiments, the magnetometer may have a 16-bit output proportional to the magnetic flux density sensed along the X, Y, and Z axes, and in some embodiments may have a temperature output signal. 2 C and SPI, where sensors 8010a-d are slaves on the bus. In some embodiments, any of sensors 8010a-d can be programmed to have any desired range of duty cycles, for example, but not limited to, from a range of 0.1% to 100%. In some embodiments, any of sensors 8010a-d can be configured to acquire and provide force and / or displacement information to a user only when a certain threshold force and / or displacement is detected by sensor 8010a-d.

[0339] In some embodiments, any of the sensors 8010a-d can be positioned on or coupled to a portion (e.g., a central portion) of the corresponding hub adapter 8004a-d. The corresponding magnet 8006a-d (e.g., a strong magnet or a rare earth magnet, etc.) can be positioned on or coupled to a portion (e.g., a central portion) of the corresponding hub 2909, 2910, 2912, or 2914. In some embodiments, the center or central portion of the magnet 8006a-d can be aligned or approximately aligned with the central portion of the corresponding sensor 8010a-d. The displacement can be determined based on the offset between the central portion of the magnet 8006a-d and the central portion of the corresponding sensor 8010a-d.

[0340] FIG. 26B illustrates an exemplary embodiment of a magnetically coupled hub adapter 8004b and hub 2910, which may be used with any embodiment of a robotic control system disclosed herein, including robotic control system 8000 or portions of the embodiment of a robotic control system shown in FIG. 26A. FIG. 26B schematically illustrates a wide variety of different forces that may be applied to a hub and corresponding hub adapter. In the example shown in FIG. 26B, a wide variety of different forces are shown that may be applied to hub 2910 and hub adapter 8004b. However, it will be recognized by those skilled in the art that any of the same or similar types of forces may be applied to any of the other hubs described herein (e.g., hubs 2909, 2912, and 2914).

[0341] For example, in some arrangements and in some applications, the forces that may act on a hub (e.g., hub 2910 in FIG. 26B) may be greater than or equal to the forces (F) from the body acting on an interventional device (e.g., access catheter 2902 in FIG. 26B) coupled to the hub. body ), forces (F) from a connected catheter (e.g., access catheter 2902 in FIG. 26B) or other interventional device that may act on the hub. catheter ), forces (F) from a distal hemostasis valve (e.g., hemostasis valve 8046b relative to hub 2910) that may act on an interventional device coupled to the hub. THV ), the distal anti-buckling force (F) that may act on the hub and the associated interventional device. anti-buckling ), friction, etc. acting on the hub from the hub bearing or roller in the z direction (F bearing z ), inertial forces, and other resistive forces, forces from the proximal hemostasis valve (e.g., hemostasis valve 8046a relative to hub 2910) acting on the hub (F THV 2 ), proximal anti-buckling forces (F ) that may act on the hub, such as forces from proximal instruments (e.g., from guidewire 2907 relative to hub 2910) passing through the proximal hemostatic valve. anti-buckling 2 ), gravity based on the mass of the hub (Fg ), the force from the magnetic field in the y direction (F magnet y ), and the force from the magnetic field in the z direction (F magnet z ), the force acting in the y direction from the bearing or roller to the hub (F bearing y ), and / or the forces acting on the hub from the electrical and / or fluid lines (F lines ), which can act in the z-direction, y-direction, and / or x-direction, as well as any combination of these directions. catheter can represent the friction force between a device attached to the hub and another device in contact with the device. For example, but not limited to, F catheter F can include frictional forces from the interaction between the catheter and the hub through which it passes, or from the interaction of the treatment catheter and the guide catheter. body can represent the net friction between the walls of the vasculature and the device attached to the hub.

[0342] In some embodiments, an anti-buckling support mechanism (e.g., a telescoping tube, etc.) can be provided. The use of these can result in drag on the catheter or guidewire and / or insertion or retraction forces from rubbing the outer surface of the shaft against the inner surface of the anti-buckling support mechanism. In some embodiments, there can be a distinction as to which part of any anti-buckling system applies an external load to the hub. When the device is loaded in compression and buckles, there can be contact between the device and the inner wall of the anti-buckling component (e.g., in some embodiments, a split tube or telescoping tube). F anti-buckling can represent the force transmitted through the fasteners / interlocking features that attach the anti-buckling component to the device hub and / or the friction between the device and a section of the anti-buckling device (e.g., the wall of a telescoping tube, etc.).

[0343] F retainer can represent the downward holding force that prevents the magnet in the hub adapter from being pulled vertically into the sterile barrier. In a free body diagram, it represents the vertical lift force F from the magnetic coupling. magnet, y The downward retention force can be provided by any suitable retention mechanism (e.g., screws or other fasteners, etc.).

[0344] In some arrangements and in some applications, forces that may act on a hub adapter (e.g., hub adapter 8004b in FIG. 26B) include, but are not limited to, forces from a magnetic field in the y direction (F magnet y ), and the force from the magnetic field in the z direction (F magnet z ), the force exerted by the drive system on the hub adapter (F drive ), and / or gravity from the mass of the hub adapter (F g adapter ) can be included.

[0345] FIG. 27 illustrates a wiring schematic that may be used by any embodiment of the robotic control system 8000 disclosed herein. As described above, some embodiments of the robotic control system 8000 may have four (or more) hubs (e.g., hubs 2909, 2910, 2912, and 2914) and four (or more) paired hub adapters (e.g., hub adapters 8004a, 8004b, 8004c, and 8004d), each having a sensor (e.g., sensors 8010a, 8010b, 8010c, and 8010d) and any of the other components or features disclosed herein. Each sensor 8010a-d may be a magnetometer. Each sensor 8010a-d may be connected to corresponding power and ground wires 8030a-d, as well as to an inter-integrated circuit (IIC) coupled with each sensor 8010a-d and the microcontroller 8038. 2C) communication wires 8032a-d. A signal booster 8040 can be used to increase the amplitude of signals from the sensors 8010a-d through at least the communication wires 8032a-d. Additionally, in some embodiments, the booster can split the I2C signal into a differential I2C signal to reduce noise along long lengths of wiring. A USB or other communication wire 8042 can be coupled to the microcontroller 8038 and provide a communication link with a main controller, computer, input device, or the like.

[0346] It should be noted that a hub is also referred to herein as a puck. Use of the term hub herein is meant to be synonymous with the term puck. Therefore, any use of the terms hub or puck is meant to be used interchangeably and to refer to the same component. It should be noted that a hub adapter is also referred to herein as a carriage. Use of the term hub adapter is meant to be synonymous with the term carriage. Therefore, any use of the terms hub adapter or carriage is meant to be used interchangeably and to refer to the same component.

[0347] While specific embodiments of the present invention have been described, these embodiments are presented by way of example only and are not intended to limit the scope of the present disclosure. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Moreover, various omissions, substitutions, and modifications may be made in the robotic drive systems and methods described herein without departing from the spirit of the present disclosure. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the present disclosure. Accordingly, the scope of the present invention is defined solely by reference to the appended claims.

[0348] It should be understood that features, materials, attributes, or groups described in connection with a particular aspect, embodiment, or example are applicable to any other aspect, embodiment, or example described in this section or elsewhere in this specification, unless inconsistent therewith. All features disclosed in this specification (including any accompanying claims, abstract, and drawings), and / or all steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. Protection is not limited to the details of any foregoing embodiment. Protection extends to any novel or any novel combination of features disclosed in this specification (including any accompanying claims, abstract, and drawings), or to any novel or any novel combination of steps of any method or process so disclosed.

[0349] Moreover, certain features that are described in this disclosure in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation may also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, while features may be described above as acting in a particular combination, one or more features from a claimed combination may, in some cases, be removed from that combination, and the combination may be claimed as any subcombination or a variation of any subcombination.

[0350] Moreover, while operations may be depicted in the figures or described in the specification in a particular order, such operations need not be performed in the particular order shown, or in sequential order, to achieve desirable results, and not all operations need be performed. Other operations not depicted or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Moreover, operations may be rearranged or reordered in other implementations. Those skilled in the art will recognize that in some embodiments, the actual steps performed in the illustrated and / or disclosed processes may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, and others may be added. Moreover, features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which are within the scope of the present disclosure. It should also be understood that the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and that the components and systems described may generally be integrated together in a single product or packaged into multiple products.

[0351] For purposes of this disclosure, certain aspects, advantages, and novel features have been described herein. Not all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, one skilled in the art will recognize that the present disclosure can be embodied or performed in a manner that achieves one advantage or group of advantages as taught herein, without necessarily achieving other advantages as may be taught or suggested herein.

[0352] Conditional language (e.g., "can," "could," "might," or "may," etc.), unless specifically stated otherwise or understood otherwise within the context in which it is used, is generally intended to convey that certain embodiments include certain features, elements, and / or states, while other embodiments do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are somehow required for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps will be included or performed in any particular embodiment, with or without user input or prompting.

[0353] Connecting language (e.g., the phrase "at least one of X, Y, and Z") is understood as generally used to convey that, unless specifically stated otherwise, depending on the context, an item, term, etc. may be either X, Y, or Z. Thus, such connective language is generally not intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0354] As used herein, language of degree (e.g., the terms "approximately," "about," "generally," and "substantially," as used herein) refers to a value, amount, or characteristic that is close to a stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is within 10%, within 5%, within 1%, within 0.1%, and within 0.01% of a stated amount. As another example, in certain embodiments, the terms "generally parallel" and "substantially parallel" refer to a value, amount, or characteristic that deviates from "exactly parallel" by no more than 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degrees. Ranges disclosed herein also encompass any and all overlaps, subranges, and combinations thereof, as well as any specific value within those ranges. Language such as "up to," "at least," "greater than," "less than," and "between" is inclusive of the stated numbers. Numbers and values ​​used herein that are preceded by terms such as "about" or "approximately" are inclusive of the recited number. For example, "approximately 7 mm" includes "7 mm." Numbers and ranges preceded by terms such as "about" or "approximately" should be construed as disclosing the numbers and ranges, regardless of the presence or absence of such terms before the numbers or values, and are intended to support the present application in claiming the numbers, values, and ranges disclosed in this specification and / or claims, regardless of the presence or absence of terms such as "about" or "approximately" before such numbers, values, or ranges; for example, "approximately 2 times to approximately 5 times" also includes the disclosure of a range of "2 times to 5 times." The scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere herein, but can be defined by the claims, as presented in this section or elsewhere herein, or as presented in the future.The language of the claims should be interpreted broadly based on the language used in the claims and should not be limited to the examples described in this specification or during the prosecution process of this application, which examples should be construed as non-exclusive. [Explanation of symbols]

[0355] 10. Intervention Setup 12 Patient Support Table 14 patients 16 Imaging Systems 18 Robotic Intervention Device Drive System 20 Support Table 22 Interventional Devices 23 Display 24 Femoral Artery Access Point 26 Guidewire hub 27 Guidewire 28 Access Catheter Hub 29 Access Catheter 30 Guide Catheter Hub 31 Guide catheter 32 Sterile Barrier 34 Anti-buckling features 36 Hub 38 Housing 40 proximal end 42 distal end 44 Intervention Devices 48 Hub Adapter 51 frames 52 proximal end 53 First Roller 54 distal end 55 Second Roller 56 Support table support 58 First driving pulley 59 First hub adapter roller 60 First drive belt 61 First hub adapter bracket 62 drive pulley teeth 63 Second Hub Adapter Roller 64 Second driving pulley 66 Second drive belt 67 Drive magnet 68 Second Hub Adapter Bracket 69 Driven magnet 70 Third drive pulley 72 Third Drive Belt 73 Third Hub Adapter Bracket 74 Drive unit support 75 motor 76 Rotatable shaft 78 First bearing 79 Second bearing 80 Shaft connection 82 Motor bracket 84 First idler pulley 86 Second idler pulley 88 Third idler pulley 90 Tensioning Bracket 92 Tension adjustment unit 94 Rotatable Shaft 96 First bearing 98 Second bearing 100 proximal end 102 distal end 104 Support surface 106 First Channel 108 floors 110 Outer side wall 111 Inner side wall 112 Second Channel 120 first treatment catheter 122 Hub 124 Second Treatment Catheter 126 Hub 140 First Conductor 142 Second Conductor 144 First Encoder 146 Second Encoder 148 Shaft 204 Upper support surface 205 channels 206 First Channel 207 channels 212 Second Channel 228 Frame support boss 232 Sterile Barrier 233 Upper surface 236 Structural Ribs 238 Frame support boss 240 Trough 242 Drain hole 250 hub 300 System 310 First Port 320 Secondary Port 330 Filter 340 First Tube 342 Connector 350 Second Tube 352 Connector 360 Clamp, Valve 370 Clot Retrieval Device 380 Main body 381 Chamber 382 Upper part 384 Bottom part 1150 Distal catheter tip 1152 Tubular body 1154 forward segment 1156 Marker Band 1158 proximal segment 1160 Inner tubular liner 1162 Reinforcing element 1164 outer jacket 1166 Angled Surface 1168 Leading side wall part 1172 Distal tip 1174 Trailing side wall part 1176 Distal surface 1178 Short side wall 1180 Long side wall 1182 tension element 1632 Sterile Barrier 1650 Drive mechanism 1652 Driven mechanism 1654 Mechanical Linkages 2100 Test System 2102 Syringe 2104 Hemostatic valve 2106 Outer catheter 2108 Inner catheter 2200 Control Mechanism 2202 First control section 2204 Second control section 2206 Third Control Section 2208 Fourth Control Section 2210 Shaft 2212 Distal Bracket 2214 Proximal Bracket 2216 Arrow 2218 Arrow 2220 Arrow 2230 users 2232 Arrow 2234 Arrow 2236 Arrow 2238 Arrow 2250 Arrow 2254 Arrow 2256 Arrow 2258 Arrow 2260 Arrow 2900 Multi-Catheter Interventional Device Assembly 2902 Insertion or access catheters 2904 Treatment catheter 2906 Guide catheter 2907 Guidewire 2908 Deflection control section 2909 Guidewire Hub 2910 Insertion or Access Catheter Hub 2912 Treatment Catheter Hub 2914 Guide Catheter Hub 3002 Introducer sheath 3004 Iliac artery 3006 Aortic arch 3014 Innominate artery 3016 Internal carotid artery 3018 Cone Segment 3020 Blood clot 4000 Control System 4002 processor, driving table 4004 Control section 4012 Hub Adapter 4012a First Hub Adapter 4012b Second Hub Adapter 4014a Rail, Linear Guide 4014b Rail, Linear Guide 4030 motor 4030a motor 4030b motor 4032 Rack, straight gear 4038 Pinion Gear 4038a Pinion Gear 4038b pinion gear 8000 Robot Control System 8004 Hub Adapter 8004a~d Hub Adapter 8006 Magnet 8006a~d Magnets 8007 Magnet 8010a~d Sensor 8020 Relative Displacement 8030a~d Power wires, ground wires 8032a~d Communication Wire 8038 microcontroller 8040 signal booster 8042 USB or other communication wires 8044 Sterile Barrier 8046a~c Hemostatic valve A angle d distance between plates h1 height h2 height L1 length L2 length w1 width x1 width x2 Width from the lateral edge of channel 205 to the lateral edge of channel 207 x3 width of support surface 204 x4 channel 206 and / or channel 212 width y1: the height of the support surface 204 y2: the height between the bottom of the support surface 204 and the top surface 233 y3 Height of channel 206 and / or channel 212 α Arc angle Δz relative displacement

Claims

1. 1. A robot control system, comprising: a hub configured to adjust the axial position of the interventional device; a hub adapter configured to move axially distally or proximally based at least on input provided by a user of the robotic control system; one or more magnets coupled with at least the hub; a sensor coupled to the hub or the hub adapter, the sensor configured to measure the magnitude and direction of the magnetic field of one of the one or more magnets such that the robotic control system can determine the magnitude and direction of displacement of the hub relative to the hub adapter.

2. 2. The robotic control system of claim 1, further comprising a drive magnet coupled to the hub adapter and a driven magnet coupled to the hub, the drive magnet configured to be magnetically coupled with the driven magnet in an operative state of the robotic control system such that the hub and the driven magnet move distally or proximally in the axial direction in response to movement of the hub adapter and the drive magnet.

3. 3. The robotic control system of claim 2, wherein the driven magnet biases the hub to remain approximately aligned with the hub adapter in the axial direction as the hub adapter moves in the axial direction.

4. The robotic control system of claim 1 , wherein at least one of the one or more magnets is a ring magnet.

5. The robotic control system of claim 1 , wherein the sensor is a magnetometer.

6. The robot control system of claim 1 , wherein the sensor is an inductance sensor.

7. The robotic control system of claim 1 , configured to provide an alert when the magnitude of the displacement reaches or exceeds a threshold value.

8. 8. The robotic control system of claim 7, configured to increase the intensity of the warning as the magnitude of the displacement increases.

9. 10. The robotic control system of claim 8, configured to increase the intensity of the warning by increasing the size of a warning symbol displayed by the robotic control system, by increasing the hue or opacity of the warning symbol, by changing the color of the warning symbol, and / or by increasing the volume level or changing the pitch of an audible warning.

10. 10. The robotic control system of claim 1, configured to determine a magnitude of a net external force acting on the hub in at least one direction based on the measured magnitude of the magnetic field above the sensor.

11. 11. The robotic control system of claim 10, configured to provide an alert when the net external force in the at least one direction reaches or exceeds a threshold value.

12. 11. The robotic control system of claim 10, configured to automatically implement corrective action when the net external force in the at least one direction reaches or exceeds a threshold value.

13. 13. The robotic control system of claim 12, wherein the corrective action includes stopping any movement of the hub or the hub adapter, stopping any movement of the hub or the hub adapter in any direction that would increase the net external force, unloading one or more catheters or other devices to reduce the net external force on the hub, providing information to a user of the system to assist the user in reducing the net external force on the hub, and / or providing specific instructions to the user to instruct the user on a maneuver that will reduce the net external force on the hub.

14. 13. The robotic control system of claim 12, wherein the corrective action includes moving the hub adapter in a direction that reduces the net external force acting on the hub.

15. The robotic control system of claim 1 , wherein the hub is coupled to the hub adapter across a sterile barrier.

16. 16. The robotic control system of claim 15, wherein the hub is positioned on a sterile side of the sterile barrier and the hub adapter is positioned on a non-sterile side of the sterile barrier.

17. The robotic control system of claim 1 , wherein the sensor is coupled to the hub adapter.

18. The robotic control system of claim 1 , wherein the interventional device is a guide catheter, a treatment catheter, an access catheter, or a guidewire.

19. 10. The robotic control system of claim 1, wherein the interventional device is an aspiration catheter, an embolism deployment catheter, a stent deployment catheter, a flow diverter deployment catheter, a diagnostic angiography catheter, a stent retriever catheter, a clot retrieval catheter, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, or an ablation catheter.

20. The robotic control system of claim 1 further comprising a microcontroller in electronic communication with the sensor.

21. a second hub configured to adjust the axial position of a second interventional device; a second driven magnet coupled to the second hub; a second hub adapter configured to move in the axial direction based on input provided by a user of the robotic control system; a second drive magnet coupled to the second hub adapter, the second drive magnet configured to couple with the second driven magnet such that the second driven magnet moves in response to movement of the second drive magnet; a second sensor coupled to the second hub or the second hub adapter, the second sensor configured to measure a magnitude of a second magnetic field; The robot control system of claim 1 further comprising:

22. 10. The robotic control system of claim 1, wherein the hub adapter is configured to move proximally or distally along a track in response to the input provided by a user of the robotic control system and / or based on commands automatically generated by a controller of the robotic control system.

23. 23. The robotic control system of claim 22, wherein the track is a linear straight gear rack, and each hub adapter includes a motor having a pinion gear configured to move along the linear straight gear rack.

24. 10. The robotic control system of claim 1, wherein the hub adapter is configured to move in the axial direction on a rack and pinion linear actuator in response to inputs provided by a user of the robotic control system.

25. 10. The robotic control system of claim 1, further comprising a data processor configured to receive data from the sensor and determine a relative displacement of the hub with respect to the hub adapter and / or a net external force acting on the hub based on the data from the sensor.

26. The robotic control system of claim 1 configured to determine if the hub is contacting and pushing against another adjacent hub.

27. 10. The robotic control system of claim 1, wherein the sensor is used to determine whether the hub is correctly positioned and oriented relative to the hub adapter during an initial setup procedure of the robotic control system.

28. 10. The robotic control system of claim 1, comprising at least three hub adapters, each having a magnet, and three corresponding hubs, each of the three hub adapters having a sensor, the sensor configured to measure a magnitude of a magnetic field above the sensor from the magnet of each of the corresponding hubs.

29. 10. The robotic control system of claim 1, comprising at least four hub adapters each having a magnet and four corresponding hubs, each of the four hub adapters having a sensor configured to measure a magnitude of a magnetic field above the sensor from the magnet of each of the corresponding hubs.

30. 10. The robotic control system of claim 1, further comprising a controller configured to perform a control function to cause movement of at least the hub adapter based on a force pattern derived from data of the magnitude of the magnetic field generated by the sensor.

31. 2. The robotic control system of claim 1, further comprising a controller configured to execute a control function to cause movement of at least the hub adapter to reduce a net force acting on the hub based on a force pattern derived from data of the magnitude of the magnetic field generated by the sensor.

32. 10. The robotic control system of claim 1, configured to determine when a range of motion of an anti-buckling component of the robotic control system is approaching an out-of-range position or when the range of motion of the anti-buckling component has been exceeded.

33. 10. The robotic control system of claim 1, wherein the hub adapter is further configured to move in at least one direction based on commands automatically generated by a controller of the robotic control system.

34. 1. A robot control system, comprising: a hub configured to adjust the axial position of the interventional device; a driven magnet coupled to the hub; a hub adapter configured to move axially distally or proximally based at least on input provided by a user of the robotic control system; a drive magnet coupled to the hub adapter, the drive magnet configured to couple with the driven magnet coupled to the hub such that the driven magnet moves in response to movement of the drive magnet; a sensor coupled to the hub adapter configured to measure a magnitude of a magnetic field from a magnet coupled to the hub; a controller configured to determine a magnitude of a net external force acting on the hub in the axial direction based on the measured magnitude of the magnetic field above the sensor; and Including, a robotic control system configured to output a warning to the user of the robotic control system when the magnitude of the net external force acting on the hub in the axial direction reaches a threshold comprising a predetermined percentage of a breakage force.

35. 35. The robotic control system of claim 34, wherein the drive magnet and the driven magnet magnetically couple the hub adapter to the hub when the hub is within a predetermined distance of the hub adapter in the axial direction.

36. 35. The robotic control system of claim 34, wherein the driven magnet biases the hub to remain approximately aligned with the hub adapter in the axial direction as the hub adapter moves in the axial direction.

37. 35. The robotic control system of claim 34, wherein the sensor is a magnetometer.

38. 35. The robotic control system of claim 34, configured to increase the intensity of the warning as the magnitude of the net external force acting on the hub in the axial direction increases.

39. 39. The robotic control system of claim 38, configured to increase the intensity of the warning by increasing the size of a warning symbol displayed by the robotic control system, by increasing the hue or opacity of the warning symbol, by changing the color of the warning symbol, and / or by increasing the volume level or changing the pitch of an audible warning.

40. 35. The robotic control system of claim 34, configured to automatically implement corrective action when the magnitude of the net external force acting on the hub in the axial direction reaches or exceeds the threshold value.

41. 41. The robotic control system of claim 40, wherein the corrective action includes stopping any movement of the hub or the hub adapter, stopping any movement of the hub or the hub adapter in any direction that would increase the net external force, unloading one or more catheters or other devices to reduce the net external force on the hub, providing information to the user of the system to assist the user in reducing the net external force on the hub, and / or providing specific instructions to the user to instruct the user on a maneuver that will reduce the net external force on the hub.

42. 41. The robotic control system of claim 40, wherein the corrective action includes moving the hub adapter in a direction that reduces the net external force acting on the hub.

43. 35. The robotic control system of claim 34, configured to impede movement of the hub adapter in a direction that would increase the net external force acting on the hub if the net external force acting on the hub reaches the threshold.

44. 35. The robotic control system of claim 34, wherein the threshold is at least 70% of the break force between the hub and the hub adapter.

45. 35. The robotic control system of claim 34, wherein the threshold is at least 80% of the break force between the hub and the hub adapter.

46. 35. The robotic control system of claim 34, wherein the hub is coupled to the hub adapter across a sterile barrier.

47. 47. The robotic control system of claim 46, wherein the hub is positioned on a sterile side of the sterile barrier and the hub adapter is positioned on a non-sterile side of the sterile barrier.

48. a second hub configured to adjust the axial position of a second interventional device; a second driven magnet coupled to the second hub; a second hub adapter configured to move in the axial direction based on input provided by a user of the robotic control system; a second drive magnet coupled to the second hub adapter, the second drive magnet configured to couple with the second driven magnet such that the second driven magnet moves in response to movement of the second drive magnet; a second sensor coupled to the second hub or the second hub adapter, the second sensor configured to measure a magnitude of a second magnetic field; 35. The robotic control system of claim 34, further comprising:

49. 35. The robotic control system of claim 34, wherein the hub adapter is configured to move proximally or distally along a track in response to the input provided by the user of the robotic control system and / or based on commands automatically generated by the controller of the robotic control system.

50. 50. The robotic control system of claim 49, wherein the track is a linear straight gear rack, and each hub adapter includes a motor having a pinion gear configured to move along the linear straight gear rack.

51. 35. The robotic control system of claim 34 configured to determine if the hub is contacting and pushing against another adjacent hub.

52. 35. The robotic control system of claim 34, comprising at least three hub adapters, each having a magnet, and three corresponding hubs, each of the three hub adapters having a sensor configured to measure a magnitude of a magnetic field above the sensor from the magnet of each of the corresponding hubs.

53. 35. The robotic control system of claim 34, wherein the controller is configured to execute a control function to cause movement of at least the hub adapter to reduce the net external force acting on the hub based on a force pattern derived from data of the magnitude of the magnetic field generated by the sensor.

54. 35. The robotic control system of claim 34, wherein the driven magnet is a ring magnet having an opening axially through its center, and the drive magnet is a ring magnet having an opening axially through its center.

55. 1. A method for controlling the movement of an interventional device through a sterile barrier, comprising: magnetically coupling a hub on the sterile side of the sterile barrier with a hub adapter on the non-sterile side of the sterile barrier, wherein in an operative state, the hub moves in response to movement of the hub adapter; moving the hub in at least one direction by moving the hub adapter in at least one direction while the hub is magnetically coupled to the hub adapter; measuring a magnetic field magnitude from a magnet coupled to the hub using a magnetic field sensor coupled to the hub adapter; determining a magnitude of a net external force acting on the hub from the magnitude of the magnetic field from the magnet coupled to the hub; outputting a warning to a user of the robotic control system when the magnitude of the net external force acting on the hub in the at least one direction reaches a threshold comprising a predetermined percentage of a breakage force; A method comprising:

56. 56. The method of claim 55, comprising: when the net external force acting on the hub reaches the threshold, impeding movement of the hub adapter in a direction that would increase the net external force acting on the hub.

57. 56. The method of claim 55, comprising outputting a warning to the user of the robotic control system when the magnitude of the net external force acting on the hub in the at least one direction reaches the threshold.

58. 56. The method of claim 55, wherein the threshold is at least 70% of the break force between the hub and the hub adapter.

59. 56. The method of claim 55, wherein the threshold is at least 80% of the break force between the hub and the hub adapter.

60. 10. A robotic control system substantially as hereinbefore described or shown in the accompanying drawings.

61. 10. A method of controlling the movement of an interventional device through a sterile barrier substantially as hereinbefore described or shown in the accompanying drawings.

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