Hub sensing through sterile barrier in robotic catheter assembly

Abstract

A robotic drive system comprising: a hub configured to adjust an axial position of the interventional device; a driven magnet connected with the hub; a hub adapter configured to move in at least one direction based on an input provided by a user of the robotic control system; a driving magnet connected with the hub adapter and configured to be connected with the driven magnet such that the driven magnet moves in response to movement of the driving magnet; and a sensor connected with the hub or the hub adapter and configured to measure a magnitude of a magnetic field on the sensor from one or both of the driving magnet and the driven magnet.

Description

Technical Field

[0001] The present application relates to neurovascular surgery and, more particularly, to catheter assemblies and robotic control systems for neurovascular access. Background Art

[0002] A variety of neurovascular procedures can be performed via neurovascular access, including thrombectomy, diagnostic angiography, embolic coil deployment, and stent placement. However, the delivery of neurovascular care is limited or delayed by multiple challenges. For example, there are not enough trained interventionalists and medical centers to meet the current demand for neurovascular intervention. Neurovascular intervention is difficult and places complex demands on the surgeon's dexterity. The surgeon must use two hands to precisely control three to four coaxial catheters while managing the fluoroscopic system and patient positioning. Long, tortuous anatomical structures require delicate and accurate manipulation. Due to the storage and release of energy caused by the frictional interaction between the coaxial axes and the patient's vasculature, inadvertent catheter movement can occur. Achieving the supra-aortic access necessary to reach the neurovascular system is challenging, particularly for a type III arch. Once supra-aortic access is achieved, adapting the system for neurovascular treatment is time-consuming and requires removing the guidewire and access catheter and adding the surgical catheter (and possibly one or more additional catheters) to the stack.

[0003] Therefore, there remains a need for a supra-aortic access and neurovascular site access system that addresses some or all of these challenges and increases the availability of neurovascular surgery. Preferably, the system is additionally capable of driving devices more distally through supra-aortic access to complete surgery in intracranial vessels. Summary of the Invention

[0004] Disclosed herein are embodiments of a robotic control system for interventional therapy. Some embodiments of the robotic control system disclosed herein can use a hub adapter to move a hub on the sterile side of a sterile barrier, wherein one or more interventional devices are connected to the hub. In some embodiments, a magnetic field can be generated between the hub adapter and the hub so that the hub adapter causes movement of the hub due to movement of the magnetic field between the hub and the hub. In some embodiments, a magnetic connection can be used in any embodiment of the robotic control system disclosed herein so that movement of the 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 insertion and / or withdrawal direction of the interventional device relative to the port entering the patient's body). The magnetic force between the hub adapter and the hub of some embodiments is elastic.

[0005] In some embodiments, one or more sensors can measure the magnetic field strength and / or direction of the magnetic connection between the hub and the hub adapter. The magnetic field strength and / or direction can be used to determine relative displacement of the hub and the hub adapter, disengagement of the hub from the hub adapter, and / or axial load acting on the hub.

[0006] In some embodiments, one or more sensors of some embodiments of the systems disclosed herein can be used to observe, measure, and characterize the relative displacement of the hub relative to the corresponding hub adapter. 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 the hub adapter can be characterized by changes in magnetic field strength and / or direction detected by the magnetometer. In some embodiments, information on the magnetic field strength and / or direction generated by the magnet opposite to the magnetometer can be used to measure the vertical or horizontal displacement of the hub relative to the hub adapter. In addition, in some embodiments, the magnetic field strength and / or direction data can be used to calculate the force acting on the hub based on the magnetic connection and / or a separate external force acting on the hub.

[0007] 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 of the embodiments disclosed herein, the system may include: 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 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 the hub adapter and configured to measure the magnitude of a magnetic field on the sensor.

[0008] Any embodiments of the methods, apparatus, and systems disclosed herein may include one or more of the following steps, features, components, and / or details of the additional embodiments, and include any combination of any of the other steps, features, components, and / or details of any other embodiments disclosed herein: 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 at least one direction.wherein the driven magnet biases the hub to maintain approximate alignment with the hub adapter in at least one direction when the hub adapter moves in at least one direction; wherein the sensor is a magnetometer; wherein the robotic control system is configured to determine a relative distance between the hub adapter and the hub in at least one direction based on a magnitude of a magnetic field measured on the sensor when the hub is at least partially offset from the hub adapter in at least one direction; wherein the robotic control system is configured to provide a warning when the relative distance reaches or exceeds a threshold; wherein the robotic control system is configured to determine a magnitude of a net external force acting on the hub in at least one direction based on a magnitude of a magnetic field measured on the sensor; wherein the robotic control system is configured to provide a warning ... The robotic control system is configured to determine a relative distance between the hub adapter and the hub in at least one direction based on a magnitude of a magnetic field measured by a sensor when the hub is at least partially deviated from the hub adapter in one direction, and / or wherein the robotic 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 partially on the relative distance between the hub adapter and the hub in at least one direction when the hub is deviated from the hub adapter in at least one direction; wherein the robotic control system is configured to provide an alarm when the external force in at least one direction reaches or exceeds a threshold value; wherein the robotic control system is configured to automatically perform a corrective action when the external force in at least one direction reaches or exceeds a threshold value; wherein the corrective action comprises stopping any hub or hub any movement of the adapter, stopping any movement of the 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 direct the user to perform an operation that would reduce the external force; wherein the hub is connected to the hub adapter across the sterile barrier; wherein the hub is on the sterile side of the sterile barrier and the hub adapter is on the non-sterile side of the sterile barrier; wherein the sensor is connected to the hub adapter; wherein the interventional device is a guide catheter, a surgical catheter, an access catheter, or a guidewire; wherein the interventional device is an aspiration catheter, an embolization deployment catheter, a stent deployment catheter, a shunt deployment catheter, a diagnostic angiography catheter, a stent retrieval catheter, a a catheter, a clot retriever, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, or an ablation catheter; further comprising a microcontroller electrically connected to the sensor; further comprising a second hub configured to adjust the axial position of a second interventional device; a second driven magnet connected 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 connected to the second hub adapter and configured to connect to the second driven magnet so that the second driven magnet moves in response to movement of the second drive magnet; a second sensor connected to the second hub or the second hub adapter and configured to measure the magnitude of the second magnetic field; and / or wherein the hub adapter is connected to the drive belt.

[0009] Also disclosed herein are embodiments of a method for controlling movement of an interventional device through a sterile barrier, the method comprising: magnetically connecting a hub on a sterile side of the sterile barrier to a hub adapter on a non-sterile side of the sterile barrier such that 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 biasing the hub via a magnetic connection to maintain alignment 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 a measurement of a magnetic field from a magnetic connection on a sensor connected to the hub or the hub adapter when the hub deviates from the hub adapter in at least one direction.

[0010] Any embodiments of the methods, devices, and systems disclosed herein may include one or more of the following steps, features, components, and / or details of the additional embodiments, and include any combination of any of the other steps, features, components, and / or details in any other embodiments disclosed herein: wherein the first interventional device is a guide catheter, a surgical catheter, an access catheter, or a guidewire; wherein determining the distance between the hub and the hub adapter includes measuring the magnitude of the magnetic field on the sensor in at least one direction when the hub deviates from the hub adapter in at least one direction; further including determining the magnitude of the external force acting on the hub in at least one direction when the hub deviates from the hub adapter in at least one direction; wherein the sterile barrier does not include any discontinuity between the hub and the hub adapter; including magnetically connecting 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 so that the second hub moves in response to movement of the second hub adapter; including The invention also provides a method of moving the second hub in at least one direction by moving the second hub adapter in at least one direction, while biasing the second hub to maintain alignment with the second hub adapter in at least one direction by a magnetic connection 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 a measurement of a magnetic field from a magnetic connection on a sensor connected to the second hub or the second hub adapter when the second hub deviates from the second hub adapter in at least one direction; comparing the distance between the hub and the hub adapter with the second distance between the second hub and the second hub adapter; comparing the magnitude and / or direction of the second external force applied to the second hub with the magnitude and / or direction of the external force applied to the hub; and / or determining a 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 with the magnitude and / or direction of the external force applied to the hub.

[0011] Some embodiments disclosed herein relate to robotic control systems.

[0012] Also disclosed herein are embodiments of a robotic control system comprising a hub configured to adjust an 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 magnetically couple with the driven magnet in an operable 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 the hub adapter and configured to measure the magnitude of a magnetic field on the sensor.

[0013] In any embodiment of the robotic control system or method of using the robotic control system disclosed herein, a second hub may be included, which is configured to adjust the axial position of a second interventional device; a second driven magnet connected 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 connected to the second hub adapter and configured to connect to the second driven magnet so that the second driven magnet moves in response to movement of the second drive magnet; and a second sensor connected to the second hub or the second hub adapter and configured to measure the magnitude of the second magnetic field.

[0014] In any embodiments 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 spur rack, and each hub adapter can have a motor having a pinion configured to move along the linear spur rack. The first hub adapter can be configured to move in at least one axial direction on the rack and pinion linear actuator in response to input provided by a user of the robotic control system. In some embodiments, any hub adapter can be connected to a drive belt and can be configured to move in an axial direction using the drive belt.

[0015] Any embodiment of the apparatus, system and / or method disclosed herein may include one or more of the following steps, features, components and / or details of the additional embodiments, and include any combination of any of the other features, components, details and / or steps of any other embodiments disclosed herein: 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 at least one direction.wherein the driven magnet biases the hub to maintain approximate alignment with the hub adapter in at least one direction when the hub adapter moves in at least one direction; wherein the sensor is a magnetometer; wherein the sensor is an inductive sensor; wherein the robotic control system is configured to determine a relative distance between the hub adapter and the hub in at least one direction based on a magnitude of a magnetic field measured on the sensor when the hub is at least partially offset from the hub adapter in at least one direction; wherein the robotic control system is configured to provide a warning when the relative distance reaches or exceeds a threshold; wherein the robotic control system is configured to increase the intensity of the warning as the relative distance increases; wherein the robotic control system is configured to provide a warning by increasing the intensity of the warning provided by the robotic control system. wherein the robot control system is configured to increase the size of a warning sign displayed by the system, by increasing the hue or opacity of the warning sign, by changing the color of the warning sign, and / or by increasing the volume level of an audible warning or changing the pitch of an audible warning; wherein the robot control system is configured to determine the magnitude of a net external force acting on the hub in at least one direction based on the magnitude of the magnetic field measured by the sensor; wherein 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; wherein the robot control system is configured to automatically perform a corrective action when the net external force in at least one direction reaches or exceeds a threshold value; wherein the corrective action includes stopping any movement of the hub or the hub adapter, stopping the hub or any movement of the hub adapter in any direction that would increase the net external force, unloading one or more conduits 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 direct the user to perform an operation that would reduce the net external force on the hub; wherein the corrective action comprises moving the hub adapter in a direction that reduces the net external force acting on the hub; wherein the robotic control system is configured to determine a relative distance between the hub adapter and the hub in at least one direction based on a magnitude of a magnetic field measured by a sensor when the hub is at least partially deflected from the hub adapter in at least one direction, and / or wherein the robotic control system is configured to determine a relative distance between the hub adapter and the hub in at least one direction based on a magnitude of a magnetic field measured by a sensor when the hub is at least partially deflected from the hub adapter in at least one direction When the hub adapter is offset from the hub adapter, the magnitude of the net external force acting on the hub in at least one direction is determined at least in part based on the relative distance between the hub adapter and the hub in at least one direction; wherein the hub is connected to the hub adapter across the sterile barrier; wherein the hub is located on the sterile side of the sterile barrier and the hub adapter is located on the non-sterile side of the sterile barrier; wherein the sensor is connected to the hub adapter; wherein the interventional device is a guide catheter, a surgical catheter, an access catheter or a guidewire; and / or wherein the interventional device is an aspiration catheter, an embolization deployment catheter, a stent deployment catheter, a shunt deployment catheter, a diagnostic angiography catheter, a stent retrieval catheter, a clot retriever, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, or an ablation catheter.

[0016] Any embodiment of the apparatus, system and / or method disclosed herein may include one or more of the following steps, features, components and / or details of the additional embodiments, and include any combination of any of the other features, components, details and / or steps in any other embodiment disclosed herein: wherein the robotic control system or method of using the robotic control system further includes a microcontroller electrically connected to the sensor; wherein the robotic control system or method of using the robotic control system further includes a data processor configured to receive data from the sensor and determine the relative displacement of the hub relative to the hub adapter and / or the net external force acting on the hub based on the data from the sensor; wherein the system is configured to determine the relative displacement of the hub relative to the hub adapter and the direction of the displacement of the hub relative to the hub adapter; wherein the system is configured to determine whether the hub has contacted and is pushing against another adjacent hub, for example, but not limited to, whether the hub has contacted and is pushing against another adjacent hub, and / or may determine whether the hub is magnetically tethered to the hub adapter based on the determined displacement between the hub and the hub adapter and / or the determined force acting on the hub; wherein the sensor is used to determine whether the hub is correctly positioned and oriented relative to the hub adapter during the initial setup process of the robotic control system; wherein the robotic control system or method of using the robotic control system further includes at least three hub adapters wherein the robotic control system or method of using a robotic control system further comprises at least four hub adapters each having a magnet and four corresponding hubs, wherein each of the four hub adapters has a sensor configured to measure the magnitude of the magnetic field on the sensor from the magnet of each corresponding hub; wherein the robotic control system or method of using a robotic control system further comprises at least four hub adapters each having a magnet and four corresponding hubs, wherein each of the four hub adapters has a sensor configured to measure the magnitude of the magnetic field on the sensor from the magnet of each corresponding hub; wherein the robotic control system or method of using a robotic control system further comprises a controller configured to perform a control function to cause at least movement of the hub adapters based on a force pattern derived from data on the magnitude of the magnetic field generated by the sensors; wherein the robotic control system or method of using a robotic control system further comprises a controller configured to perform a control function to cause at least movement of the hub adapters based on a force pattern derived from data on the magnitude of the magnetic field generated by the sensors to reduce a net force acting on the hubs; wherein the robotic control system or method of using a robotic control system further comprises a controller configured to perform a control function to cause at least movement of the hub adapters based on a force pattern derived from data on the magnitude of the magnetic field generated by the sensors to reduce a net force acting on the hubs; wherein the robotic control system is configured to determine that the range of motion of the anti-buckling component of the robotic control system is approaching an out-of-range position or that the range of motion of the anti-buckling component is being exceeded; wherein the hub adapters are further configured to move in at least one direction based on a command automatically generated by the controller of the robotic control system;wherein the robotic control system or method of using the robotic control system further comprises an additional magnet coupled to the hub, wherein the additional magnet is configured to generate a magnetic field, and wherein the sensor is coupled to the hub adapter and configured to measure the magnitude of the magnetic field generated by the additional magnet; and / or wherein the driven magnet is an annular magnet having an opening extending axially through its center, and the driving magnet is an annular magnet having an opening extending axially through its center.

[0017] Also disclosed herein are embodiments of a robotic control system that may include: a hub configured to adjust the axial position of an interventional device; a hub adapter configured to move distally or proximally in an axial direction 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 and configured to measure the magnitude and direction of a 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 method of using the robotic control system may further include a drive magnet coupled to the hub adapter and a driven magnet coupled to the hub, wherein the drive magnet is configured to magnetically couple with the driven magnet in an operable state of the robotic control system such that the hub and driven magnet move distally or proximally in an axial direction in response to movement of the hub adapter and the drive magnet. In any embodiments disclosed herein, any magnet, including any magnet positioned and configured to be sensed by the sensor, may be an annular magnet.

[0018] Any embodiment of the apparatus, system and / or method disclosed herein may include one or more of the following steps, features, components and / or details of the additional embodiments, and include any combination of any of the other features, components, details and / or steps of any other embodiments disclosed herein: wherein the robotic control system further comprises a drive magnet coupled to the hub adapter and a driven magnet coupled to the hub, wherein the drive magnet is configured to magnetically couple with the driven magnet in an operable state of the robotic control system such that the hub and the driven magnet move distally or proximally in an axial direction in response to movement of the hub adapter and the drive magnet; wherein when the hub adapter moves in the axial direction, the driven magnet biases the hub to maintain substantial alignment with the hub adapter in the axial direction; wherein one of the one or more magnets is an annular magnet; wherein the sensor is a magnetometer; wherein the sensor is an inductive sensor; wherein the robotic control system is configured to provide a warning when the magnitude of the displacement reaches or exceeds a threshold; wherein the robotic control system is configured to increase the intensity of the warning as the magnitude of the displacement increases; wherein the robotic control system is configured to provide a warning by increasing the size of a warning sign displayed by the robotic control system, by increasing the intensity of the warning sign wherein 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 a magnitude of a magnetic field measured by the sensor; wherein 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; wherein the robot control system is configured to automatically perform a corrective action when the net external force in at least one direction reaches or exceeds a threshold value; wherein the corrective action comprises stopping any movement of the hub or hub adapter; Moving, 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 direct the user to perform actions that would reduce the net external force on the hub; wherein the corrective action comprises moving the hub adapter in a direction that reduces the net external force acting on the hub; wherein the hub is connected to the hub adapter across a sterile barrier; and / or wherein the hub is on the sterile side of the sterile barrier and the hub adapter is on the non-sterile side of the sterile barrier; wherein the sensor is connected to the hub adapter.

[0019] Any embodiment of the devices, systems and / or methods disclosed herein may include one or more of the following steps, features, components and / or details of the additional embodiments, and include any combination of any of the other features, components, details and / or steps in any other embodiment disclosed herein: wherein the interventional device is a guide catheter, a surgical catheter, an access catheter, or a guidewire; wherein the interventional device is an aspiration catheter, an embolization deployment catheter, a stent deployment catheter, a shunt deployment catheter, a diagnostic angiography catheter, a stent retrieval catheter, a clot retriever, a balloon catheter, a catheter to facilitate percutaneous valve repair or replacement, or an ablation catheter; wherein the robotic control system further includes a microcontroller electrically connected to the sensor; wherein the hub The 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; wherein the track is a linear spur rack and each hub adapter has a motor having a pinion configured to move along the linear spur rack; wherein the hub adapter is configured to move in at least one axial direction on the rack and pinion linear actuator in response to input provided by a user of the robotic control system; wherein the robotic control system further includes a data processor configured to receive data from the sensor and determine a relative displacement of the hub relative to the hub adapter and / or an action acting on the hub based on the data from the sensor a net external force; wherein the system is configured to determine whether the hub has contacted and is pushing against another adjacent hub; for example, whether the hub has contacted and is pushing against another hub, and / or whether the hub is magnetically tethered 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; wherein the sensor is used to determine whether the hub is correctly positioned and oriented relative to the hub adapter during an initial setup process of the robotic control system; wherein the robotic control system includes at least three hub adapters, each having a magnet and three corresponding hubs, wherein each of the three hub adapters has a sensor configured to measure the magnitude of the magnetic field on the sensor from the magnet of each corresponding hub wherein the robotic control system includes at least four hub adapters, each having a magnet and four corresponding hubs, wherein each of the four hub adapters has a sensor configured to measure a magnitude of a magnetic field on the sensor from the magnet of each corresponding hub; wherein the robotic control system includes a controller configured to perform a control function to cause at least movement of the hub adapters based on a force pattern derived from data on the magnitude of the magnetic field generated by the sensors; wherein the robotic control system includes a controller configured to perform a control function to cause at least movement of the hub adapters based on a force pattern derived from data on the magnitude of the magnetic field generated by the sensors to reduce a net force acting on the hubs;wherein the robotic control system is configured to determine that the range of motion of the anti-buckling component of the robotic control system is approaching an out-of-range position or that the range of motion of the anti-buckling component is being exceeded; and / or wherein the hub adapter is further configured to move in at least one direction based on a command automatically generated by a controller of the robotic control system.

[0020] In any embodiments disclosed herein, 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 connected 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 connected to the second hub adapter and configured to connect to the second driven magnet such that the second driven magnet moves in response to movement of the second drive magnet; and a second sensor connected to the second hub or the second hub adapter and configured to measure the magnitude of the second magnetic field.

[0021] Also disclosed herein are embodiments of a robotic control system comprising: a hub configured to adjust an axial position of an interventional device; a driven magnet coupled to the hub; a hub adapter configured to move distally or proximally in an axial direction based at least on input provided by a user of the robotic control system; a drive magnet coupled to the hub adapter and configured to couple to 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, the sensor 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 an axial direction based on the magnitude of the magnetic field measured by the sensor. In some embodiments, the robotic control system can be 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 value that is a predetermined percentage of the separation force.

[0022] Any embodiment of the apparatus, system and / or method disclosed herein may include one or more of the following steps, features, components and / or details of the additional embodiments, and include any combination of any other features, components, details and / or steps of any other embodiments disclosed herein: wherein the driving 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; wherein the driven magnet biases the hub to maintain approximate alignment with the hub adapter in the axial direction when the hub adapter moves in the axial direction; wherein the sensor is a magnetometer; wherein the robotic control system is configured to increase the intensity of the warning when the net external force acting on the hub in the axial direction increases; wherein the robotic control system is configured to increase the intensity of the warning by increasing the size of a warning sign displayed by the robotic control system, by increasing the hue or opacity of the warning sign, by changing the color of the warning sign, and / or by increasing the volume level of an audible warning or changing the pitch of an audible warning; wherein the robotic control system Configured to automatically perform a corrective action when the magnitude of the net external force acting on the hub in the axial direction reaches or exceeds a threshold; wherein 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 will 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 direct the user to perform an operation that will reduce the net external force on the hub; wherein the corrective action includes moving the hub adapter in a direction that reduces the net external force acting on the hub; wherein the robotic control system is configured to hinder movement of the hub adapter in a direction that will increase the net external force acting on the hub when the net external force acting on the hub reaches a threshold; wherein the threshold is at least 70% of the separation force between the hub and the hub adapter; wherein the threshold is at least 80% of the separation force between the hub and the hub adapter; wherein the hub is connected to the hub adapter across a sterile barrier; and / or wherein the hub is located on the sterile side of the sterile barrier and the hub adapter is located on the non-sterile side of the sterile barrier.

[0023] In any embodiments 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 connected to the second hub; a second hub adapter configured to move in an axial direction based on input provided by a user of the robotic control system; a second drive magnet connected to the second hub adapter and configured to connect to the second driven magnet such that the second driven magnet moves in response to movement of the second drive magnet; and a second sensor connected to the second hub or the second hub adapter and configured to measure the magnitude of the second magnetic field.

[0024] Any embodiment of the apparatus, system and / or method disclosed herein may include one or more of the following steps, features, components and / or details of the additional embodiments, and include any combination of any of the other features, components, details and / or steps in any other embodiment disclosed herein: wherein the hub adapter is configured to move proximally or distally along a 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; wherein the track is a linear spur rack and each hub adapter has a motor having a pinion configured to move along the linear spur rack; wherein the system is configured to determine whether a hub has contacted and is pushing against another adjacent hub; for example, whether a hub has contacted and is pushing against another adjacent hub, and / or may be based on the hub and hub adapter. a determined displacement between the hubs and / or a determined force acting on the hubs to determine whether the hubs are magnetically tethered to the hub adapter; wherein the robotic control system or the method using the robotic control system further comprises at least three hub adapters, each having a magnet and three corresponding hubs, wherein each of the three hub adapters has a sensor configured to measure the magnitude of the magnetic field from the magnet of each corresponding hub on the sensor; wherein the robotic control system or the method using the robotic control system further comprises a controller configured to perform a control function to at least cause movement of the hub adapters based on a force pattern derived from data on the magnitude of the magnetic field generated by the sensors, thereby reducing the net force acting on the hubs; and / or wherein the driven magnet is an annular magnet having an opening axially through its center, and the driving magnet is an annular magnet having an opening axially through its center.

[0025] Also disclosed herein are embodiments of methods for controlling movement of an interventional device through a sterile barrier. In some embodiments, the method for controlling movement of an interventional device through a sterile barrier may include: magnetically connecting a hub on a sterile side of the sterile barrier to a hub adapter on a non-sterile side of the sterile barrier so that 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 biasing the hub to maintain alignment with the hub adapter in at least one direction via a magnetic connection; and determining a distance between the hub and the hub adapter and / or a net external force applied to the hub based on a measurement of a magnetic field from a sensor connected to the hub or the hub adapter when the hub deviates from the hub adapter in at least one direction.

[0026] Any embodiments of the methods, devices, and systems disclosed herein may include one or more of the following steps, features, components, and / or details of the additional embodiments, and include any combination of any of the other steps, features, components, and / or details of any other embodiments disclosed herein: wherein the first interventional device is a guide catheter, a surgical catheter, an access catheter, or a guidewire; wherein, when the hub deviates from the hub adapter in at least one direction, determining the distance between the hub and the hub adapter includes measuring a magnitude in at least one direction of a magnetic field on the sensor; wherein the robotic control system and method of using the robotic control system further include determining a magnitude of an external force acting on the hub in at least one direction when the hub deviates from the hub adapter in at least one direction; wherein there is no The bacterial barrier does not include any discontinuity between the hub and the hub adapter; includes comparing the distance between the hub and the hub adapter with a second distance between the second hub and the second hub adapter; wherein the robotic control system or the method using the robotic control system also includes comparing the magnitude and / or direction of a second net external force applied to the second hub with the magnitude and / or direction of the net external force applied to the hub; wherein the robotic control system or the method using the robotic control system includes determining the condition of the hub and / or the second hub based on the 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 wherein the robotic control system or the method using the robotic control system also includes moving the hub adapter in at least one direction along a linear rack gear.

[0027] Any embodiments of the methods of controlling movement of an interventional device through a sterile barrier disclosed herein may also include magnetically connecting 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 such that 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 biasing the second hub to maintain alignment with the second hub adapter in at least one direction via a magnetic connection 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 a measurement of a magnetic field from a magnetic connection on a sensor connected to the second hub or the second hub adapter when the second hub deviates from the second hub adapter in at least one direction.

[0028] Also disclosed herein are embodiments of a method for controlling movement of an interventional device through a sterile barrier, which may include: magnetically connecting a hub on a sterile side of the sterile barrier to a hub adapter on a non-sterile side of the sterile barrier such that 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 biasing the hub via a magnetic connection to maintain alignment 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 a measurement of a magnetic field from a magnetic connection on a sensor connected to the hub or the hub adapter when the hub deviates from the hub adapter in at least one direction.

[0029] Any embodiments of the methods, apparatus, and systems disclosed herein may include one or more of the following steps, features, components, and / or details of the additional embodiments, and include any combination of any of the other steps, features, components, and / or details in any other embodiments disclosed herein: wherein the robotic control system or the method 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 value comprising a predetermined percentage of the disengagement force; wherein the threshold value is at least 70% of the separation force between the hub and the hub adapter; wherein the threshold value is at least 80% of the separation force between the hub and the hub adapter; wherein the robotic control system or the method using the robotic control system further includes, when the net external force acting on the hub reaches the threshold value, hindering movement of the hub adapter in a direction that will increase the net external force acting on the hub; wherein the robotic control system or the method using the robotic control system further includes, when at least one When the net external force in a direction reaches or exceeds a threshold value, a corrective action is automatically performed; 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 will 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 guide the user in performing an operation that will reduce the net external force on the hub; wherein the corrective action includes moving the hub adapter in a direction that reduces the net external force acting on the hub; wherein an interventional device is connected to the hub, and the interventional device is a guide catheter, a surgical catheter, an access catheter or a guidewire; and / or wherein the interventional device is connected to the hub, and the interventional device is an aspiration catheter, an embolization deployment catheter, a stent deployment catheter, a shunt deployment catheter, a diagnostic angiography catheter, a stent retrieval catheter, a clot retriever, a balloon catheter, a catheter for facilitating percutaneous valve repair or replacement, or an ablation catheter.

[0030] Also disclosed herein are embodiments of a method for controlling movement of an interventional device through a sterile barrier, the method comprising: 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 such that, in an operable state, the hub moves in response to movement of the hub adapter; 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 based on 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 reaches a threshold value that includes a predetermined percentage of a separation force in at least one direction. In some embodiments, the method for controlling movement of an interventional device through a sterile barrier may further comprise: obstructing 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 a threshold value. In some embodiments, the method for controlling movement of an interventional device through a sterile barrier may further comprise: outputting a warning to a user of a robotic control system when the magnitude of the net external force acting on the hub in at least one direction reaches a threshold value.

[0031] In any embodiments disclosed herein, the threshold value can be 70% or at least 70% of the separation force between the hub and the hub adapter. In any embodiments disclosed herein, the threshold value can be 80% or at least 80% of the separation force between the hub and the hub adapter, or 85% or at least 85% of the separation force between the hub and the hub adapter, or 90% or at least 90% of the separation force between the hub and the hub adapter, or any value within any of the foregoing ranges.

[0032] Also disclosed herein are embodiments of methods for performing neurovascular surgery. In some embodiments, embodiments of methods for performing neurovascular surgery may include controlling movement of an interventional device through a sterile barrier as described in any embodiment of controlling movement of an interventional device through a sterile barrier disclosed herein, wherein the hub is an access catheter hub having an access catheter. In some embodiments, the method for performing neurovascular surgery may further include: connecting 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 achieve supra-aortic vascular access; removing the access catheter and the access catheter hub from the hub adapter; and connecting a surgical catheter hub having a surgical catheter to the hub adapter. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 is a schematic perspective view of an interventional setup with an imaging system, a patient support table, and a robotic drive system according to the present disclosure.

[0034] Figure 2is a longitudinal cross section showing the concentric relationship between a guidewire with two degrees of freedom, an access catheter with three degrees of freedom, and a guiding catheter with one degree of freedom.

[0035] Figure 3A Schematic diagram of an exploded view of the interventional device hub separated from the support platform by a sterile barrier.

[0036] Figures 3B to 3F An alternative sterile barrier is shown in the form of a transport tray having one or more storage channels for carrying interventional devices.

[0037] Figures 3G to 3K An embodiment of an alternative sterile barrier having a raised drive surface is shown.

[0038] Figure 3L and Figure 3M Describes the Figures 3G to 3K Example of a hub used with a sterile barrier.

[0039] Figure 4 is a schematic elevational cross section through a hub adapter with a driving magnet separated from the interventional device hub and driven magnet by a sterile barrier.

[0040] Figure 5A and Figure 5B A three- and four-interventional device assembly is schematically shown.

[0041] Figure 6 is a perspective view of the support table.

[0042] Figure 7 Here is a close-up view of the engine drive end of the support table.

[0043] Figure 8 is an elevation cross section through the engine and belt drive assembly.

[0044] Figure 9 It is a close-up view of the pulley end of the support table.

[0045] Figure 10 It is a vertical cross section through the pulley.

[0046] Figure 11 is throughout, for example Figure 5A and Figure 5B Elevated cross-sections of the distal portions of those catheters shown in .

[0047] Figure 12A and Figure 12B A force sensor integrated into the side wall of a catheter is schematically shown.

[0048] Figure 13A and Figure 13BA sensor for measuring the spring force of the magnetic connection between a hub and a corresponding hub adapter is schematically shown.

[0049] Figure 14 A dual encoder torque sensor for use with the catheter of the present disclosure is schematically shown.

[0050] Figure 15 A clot capture and visualization device is shown that may be integrated into the hub and / or connected to the aspiration line.

[0051] 16A to 16C Exemplary control mechanisms for steering interventional devices driven by respective hubs are shown.

[0052] Figure 17 Shown is a schematic side elevation view of an interventional device assembly for supra-aortic access and neurointerventional procedures.

[0053] 18A to 18E Depicted is an example sequence of steps for introducing a catheter assembly configured to achieve supra-aortic access and neurovascular site access.

[0054] Figure 19 An embodiment of the mechanical coupling between the driving member and the driven member is shown schematically.

[0055] 20A to 20C An example sequence of steps for priming a catheter assembly in a stacked configuration is depicted.

[0056] Figures 21A to 21B An example sequence of steps for priming a catheter assembly in a stacked configuration is depicted.

[0057] Figure 22 Describes the use Figures 21A to 21B An example test system for the priming process depicted in FIG.

[0058] Figure 23A An example of a catheter assembly is shown.

[0059] Figure 23B An example of a catheter assembly after a priming procedure is shown.

[0060] Figure 23C An example of a catheter assembly is shown after a priming procedure involving relative movement between adjacent catheters.

[0061] Figures 23D to 23F Shown Figures 23A to 23C Example of a catheter assembly

[0062] Figure 24 is a schematic representation of a hub and hub adapter having one or more magnets to magnetically connect the hub and hub adapter.

[0063] Figure 25 Shown is a schematic representation of a hypothetical system with a spring located between a hub and a hub adapter.

[0064] Figure 26A An exemplary embodiment of a portion of a robotic control system having multiple magnetically coupled hub adapters and hubs is shown, wherein an interventional device is coupled to one or more of the hubs.

[0065] Figure 26B An exemplary embodiment of magnetically connecting a hub adapter and a hub is shown, and a range of different forces that may be applied to the hub and hub adapter are also schematically illustrated.

[0066] Figure 27 Shown is a wiring schematic that may be used with any of the embodiments of the robotic control system disclosed herein.

[0067] Figure 28 Depicted is a schematic diagram of the control system.

[0068] Figure 29A Shown are embodiments of magnets that may be used with any of the embodiments of the robotic control systems disclosed herein.

[0069] Figure 29B Another embodiment of a magnet that can be used with any of the embodiments of the robotic control systems disclosed herein is shown.

[0070] Figure 30A Shown is a portion of an embodiment of a drive stage having one or more rack and pinion actuators that can be used with any of the embodiments of the robotic control systems disclosed herein.

[0071] Figure 30B Shows Figure 30A An enlarged view of an embodiment of a rack and pinion actuator of an embodiment of the drive stage is shown, which can be used with any of the embodiments of the robotic control systems disclosed herein. DETAILED DESCRIPTION

[0072] In certain embodiments, a system is provided for advancing a guide catheter from the femoral or radial artery into the ostium of one of the great vessels at the top of the aortic arch, thereby achieving supra-aortic access. The surgeon can then take the interventional device via the robotically placed guide catheter and advance it into the cerebral vasculature.

[0073] In some embodiments, the system can additionally be configured to robotically gain intracranial vascular access and perform aspiration thrombectomy or other neurovascular procedures.

[0074] The drive platform is located above or to one side of the patient and is configured to axially advance, retract, and in some cases rotate and / or laterally deflect two or three or more different (e.g., concentrically or side-by-side oriented) intravascular devices. One or more hubs can be used as instrument connectors connected to corresponding interventional devices. The hub can move along a path along the surface of the drive platform to advance or retract the interventional device as needed. Each hub can also contain a mechanism for rotating or deflecting the device as desired and is connected to a fluid delivery tube (not shown) of the type conventionally attached to the catheter hub. Each hub can be in electrical communication with an electronic control system via a hard-wired connection, an RF wireless connection, or a combination of the two.

[0075] Each hub is independently movable across the surface of a sterile field barrier membrane carried by a drive table. Each hub is releasably magnetically connected to a unique hub adapter (also known as a pulley or drive pulley) 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 the corresponding interventional device proximally or distally within the patient's vascular system.

[0076] The hub adapter on the drive stage that magnetically connects to the hub to provide linear motion actuation is universal. The catheter / guidewire functionality is provided based on what is included in the hub and shaft design. This allows the system to be flexibly configured to perform a wide range of surgeries using a variety of interventional devices on the same drive stage. In addition, the interventional devices and methods disclosed herein can be easily adapted for use with a variety of other drive systems (e.g., any of a variety of robotic surgical drive systems).

[0077] Figure 1 is a schematic perspective view of an interventional device 10 having a patient support table 12 for supporting a patient 14. An imaging system 16 may be provided along with a robotic interventional device drive system 18 according to the present disclosure.

[0078] The drive system 18 may include a support platform 20 for supporting, for example, a guidewire hub 26, an access catheter hub 28, and a guide catheter hub 30. In the context of this document, the term "access" catheter may be any catheter having a lumen with at least one distal opening facing distally or laterally that can be used to aspirate thrombus, provide a passage for additional devices to be advanced through or along it, or infuse saline or contrast or therapeutic agents.

[0079] Depending on the desired clinical procedure, more or fewer interventional device hubs may be provided. For example, in certain embodiments, a diagnostic angiography procedure may be performed using only the guidewire hub 26 and access catheter hub 28 for driving a guidewire and an access catheter (in the form of a diagnostic angiography catheter). A plurality of interventional devices 22 extend between the support table 20 and a femoral access point 24 on the patient 14 (in the example shown). Depending on the desired procedure, access may be achieved by percutaneous or open access into any of a variety of arteries or veins, such as the femoral artery or radial artery. Although disclosed herein primarily in the context of neurovascular access and surgery, the robotic drive systems and associated interventional devices can be readily configured for a wide variety of additional medical interventions in the peripheral and coronary arterial and venous vascular systems, the gastrointestinal system, the lymphatic system, cerebrospinal fluid cavities or spaces (e.g., the spinal canal, ventricles, and subarachnoid space), the pulmonary airways, treatment sites reached via transureteral or urethral or fallopian tube navigation, or other hollow organs or structures in the body (e.g., in intracardiac or structural heart applications, such as valve repair or replacement, or in any endovascular procedure).

[0080] A display 23 (e.g., for viewing fluoroscopic images, catheter data (e.g., fiber Bragg grating fiber sensor data or other force or shape sensing data), or other patient data) can be carried by the support table 20 and / or the patient support 12. Alternatively, the physician input / output interface including the display 23 can be remote from the patient, such as behind radiation shielding, in a different room from the patient, or in a different facility from the patient.

[0081] In the example shown, a guidewire hub 26 is carried by the support table 20 and is movable along the table to advance a guidewire into and out of the patient 14. An access catheter hub 28 is also carried by the support table 20 and is movable along the table to advance an access catheter into and out of the patient 14. The access catheter hub can also be configured to rotate the access catheter in response to operation of a rotation control and can also be configured to laterally deflect a deflectable portion of the access catheter in response to operation of a deflection control.

[0082] Figure 2 is a longitudinal cross section schematically illustrating the kinematic relationship between a guidewire 27 having two degrees of freedom (axial and rotational), an access catheter 29 having three degrees of freedom (axial, rotational, and lateral deflection), and a guide catheter 31 having one degree of freedom (axial).

[0083] refer to Figure 3AThe support platform 20 includes a drive mechanism, described in more detail below, to independently drive the guidewire hub 26, the access catheter hub 28, and the guide catheter hub 30. An anti-buckling feature 34 can be provided in the proximal anti-buckling region for resisting buckling of the portion of the interventional device that spans the distance between the support platform 20 and the femoral artery access point 24. The anti-buckling feature 34 can include a plurality of concentric, telescopically extending and collapsible tubes through which the interventional device extends.

[0084] Alternatively, the proximal section of one or more device shafts can be configured to have enhanced rigidity to reduce buckling during compression. For example, the proximal reinforced segment can extend from the hub to a distance of at least about 5 cm or 10 cm toward the distal end, but typically no more than about 120 cm or 100 cm, to support the device between the hub and the entry point 24 on the patient. Reinforcement can be achieved by using a metal or polymer tube or by embedding at least one or two or more axially extending elements into the wall of the device shaft, such as a long wire or ribbon. In some embodiments, the extension element can be hollow and prevent wear, buckling or damage at the input and output of the hub. In some embodiments, the hollow extension element can be a hollow and flexible covering layer attached to the hub. The hollow extension element (for example, a hollow and flexible covering layer) can cover a portion of the device shaft when passing through the hub. In some embodiments where the hollow extension element is a covering layer, a coating can be attached to a portion of the hub so that passing the catheter device through the hub 26, 28 or 30 also allows the catheter device to pass through the covering layer. In some embodiments, an anti-buckling device can be mounted on or around the device shaft to avoid misalignment or insertion angle errors between hubs or between the hub and the insertion point. The anti-buckling device can be a laser-cut hypotube, a spring, a telescoping tube, a split tube with tension, etc.

[0085] In some embodiments, multiple deflection sensors can be placed along the length of the catheter to identify buckling. Buckling can be identified by sensing that the hub is advanced distally without movement of the distal tip of the catheter or interventional device. In some embodiments, buckling can be detected by sensing that energy loading has occurred between the catheter shafts (e.g., due to friction).

[0086] Alternatively, a thin tubular reinforcement structure can be embedded in the device wall or continue on the outside of the device wall, such as a tubular polymer extrusion or a section of hypotube. Alternatively, a removable reinforcement mandrel can be placed in the lumen in the proximal section of the device and removed from the proximal end after the hub is advanced distally toward the patient access position to prevent buckling of the proximal shaft during distal advancement of the hub. Alternatively, the proximal section of one or more device shafts can be configured as a tubular hypotube, which can be machined (e.g., with a laser) so that its mechanical properties vary along its length. The proximal section can be formed of stainless steel, nitinol and / or cobalt-chromium alloy, optionally in combination with a polymer component that can provide lubricity and hydraulic sealing. In some embodiments, the proximal section can be formed of a polymer, such as polyetheretherketone (PEEK). Alternatively, the wall thickness or diameter of the interventional device can be increased in the anti-buckling region.

[0087] In certain embodiments, a device shaft having a high degree of stiffness (e.g., axial and torsional) can provide improved motion transfer from the proximal end of the device shaft to the distal end of the device shaft. For example, the device shaft can be more responsive to motion applied at the proximal end. Such an embodiment may be advantageous for robotic actuation without tactile feedback to the user.

[0088] In some embodiments, a flexible covering can be applied to the device shaft and / or hub to reduce friction between the device shaft and / or hub and the second device shaft as the second device shaft passes through the device shaft and / or hub and the second device shaft.

[0089] The interventional device hub can be separated from the support table 20 by a sterile barrier 32. The sterile barrier 32 may comprise a thin plastic film, such as polyethylene terephthalate (PET), polyethylene terephthalate glycol copolymer (PETG), polyethylene terephthalate glycol (PETE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), low-density polyethylene (LDPE), polypropylene (PP), polystyrene (PS) or styrene. This allows the support table 20 and the associated drive system to be located on the non-sterile (lower) side of the sterile barrier 32. The guidewire hub 26, entry catheter hub 28, guide catheter hub 30 and the associated interventional device are all on the sterile (upper) side of the sterile barrier 32. The sterile barrier is preferably waterproof and can also be used as a tray used in the packaging of the interventional device, which will be discussed further below. The interventional device can be provided separately or as a coaxial preassembled kit, which is transported and stored in a tray and packaged in sterile packaging.

[0090] Figures 3B to 3FSchematic diagram of an optional sterile barrier and a transport tray. The optional sterile barrier is placed on the support table during interventional procedures in a dual-function sterile barrier format, with the transport tray having one or more storage channels for carrying sterile interventional devices. The sterile barrier can also serve as a sterile work surface for preparing catheters or other devices during the procedure.

[0091] refer to Figure 3B and Figure 3C , a sterile barrier 32 in the form of a pre-formed tray is shown for mounting the elongated support table 20. In use, the elongated support table 20 will be positioned below the sterile barrier 32. The sterile barrier 32 extends between a proximal end 100 and a distal end 102 and includes an upper support surface 104 for supporting an interventional device hub. In one embodiment, in a linear drive configuration, the support surface 104 has an axial length that is greater than the length of the intended interventional device.

[0092] The length of the support surface 104 will typically be at least about 100 centimeters, and in the range of about 100 centimeters to about 2.7 meters. Shorter lengths may be used in systems configured to propel a drive connector along an arcuate path. In some embodiments, two or more support surfaces may be used instead of a single support surface 104. The two or more support surfaces may have a combined length of 100 centimeters to about 2.7 meters. The width of the linear drive table is preferably no more than about 30 centimeters to about 80 centimeters.

[0093] At least a first channel 106 may be provided that extends axially for at least a portion of the length of the support platform 20. In the embodiment shown, the first channel 106 extends the entire length of the support platform 20. Preferably, the first channel 106 has sufficient length to accommodate the interventional device and has sufficient width and depth to accommodate the corresponding hub (e.g., by providing lateral support to prevent the hub from moving out when force is applied to the hub). The first channel 106 is defined within the base 108, the outer side wall 110, and the inner side wall 111 to form an upward-facing concave shape. Optionally, a second channel 112 may be provided. The second channel 112 may be located on the same side of the upper support surface 104 or on the opposite side as the first channel 106. Two or three or more additional recesses (e.g., additional channels or holes) may be provided to accommodate additional medical devices or supplies useful during the interventional procedure, as well as to collect fluids and serve as a wash basin for catheters and related equipment.

[0094] refer to Figure 3D, guide catheter hub 30 is shown positioned on upper support surface 104 and magnetically connected to a corresponding connector housing a drive magnet, the connector being positioned beneath sterile barrier 32. Access catheter hub 28 and access catheter 29, as well as guidewire hub 26 and guidewire 27 are shown positioned within first channel 106, e.g., prior to introduction through guide catheter 31 or after removal from guide catheter 31.

[0095] The interventional devices can be located within the channel 106 and enclosed within the sterile barrier for transport. At the clinical location, the upper panel of the sterile barrier can be removed, or the tubular sterile barrier packaging can be opened and axially removed from the support table 20 and sterile barrier assembly 32, exposing the sterile top side of the sterile barrier tray and any included interventional devices. The interventional devices can be carried individually in the channel or preassembled into an access assembly or surgical assembly, which will be discussed in additional detail below.

[0096] Figures 3D to 3F A support table is shown with a sterile barrier in place and Figure 3E In the present invention, the interventional device is configured in the entry assembly for aortic access after the entry assembly is connected to the corresponding hub adapter below the sterile barrier. The entry assembly can be preassembled, wherein the guide wire is fully advanced through the entry catheter, and the entry catheter is fully advanced through the guide catheter. In the embodiment where the entry catheter or other catheters are preformed (i.e., pre-bent or not straight), the guide wire and / or outer catheter can be positioned so that the relatively hard part does not overlap with the harder part of the bend of the preformed catheter, for example, to avoid creep or straightening of the preformed catheter and / or to introduce the bend into other straight catheters. The entry assembly can be lifted out of the channel 106 and positioned on the support surface 104 for connecting to the corresponding drive magnet and being introduced into the patient's body. The guide catheter hub 30 is the most distal hub. The entry catheter hub 28 is located at the proximal end of the guide catheter hub so that the entry catheter 29 can extend distally through the guide catheter. The guidewire hub 26 is located at the most proximal end so as to allow the guidewire 27 to advance through the entry catheter 29 and the guide catheter 31.

[0097] Figure 3F The surgical assembly is shown after being introduced through a guide catheter 31 for achieving supra-aortic access. In this embodiment, the guide catheter 31 is retained at the distal-most end of the interventional device. A first surgical catheter 120 and a corresponding hub 122 are shown extending through the guide catheter 31. An optional second surgical catheter 124 and a corresponding hub 126 are shown extending through the first surgical catheter 120. A guidewire 27 extends through at least a portion of the second surgical catheter 124 in a rapid exchange version thereof, or through the entire length of the second surgical catheter 124 in an over-the-wire embodiment.

[0098] If combined Figure 17 Discussed in more detail, multiple catheter stacks can be utilized to achieve access and endovascular surgery without the need to replace catheters. This can be done in manually or robotically driven surgeries. In one example, the guide catheter 31 can include a catheter having an inner diameter of at least about 0.08 inches, and in one embodiment, an inner diameter of about 0.088 inches. The first surgical catheter 120 can include a catheter having an inner diameter of about 0.065 inches to about 0.075 inches, and in one embodiment, the catheter 120 has an inner diameter of about 0.071 inches. The second surgical catheter 124 can be an access catheter having an OD size that allows advancement through the first surgical catheter 120. The second surgical catheter can be steerable, having a deflection control 2908 configured to laterally deflect the distal end of the catheter. The second surgical (access) catheter can also have a lumen, the size of which allows a guide wire of appropriate size to remain inside the second surgical catheter while angiographic injection is performed through the second surgical catheter.

[0099] In certain embodiments, catheter 31 can be a "large bore" access or guide catheter having a diameter of at least about 0.075 inches or at least about 0.080 inches. Catheter 120 can be an aspiration catheter having a diameter of about 0.060 to about 0.075 inches. Catheter 124 can be a steerable catheter having a deflectable distal tip having a diameter of about 0.025 inches to about 0.050 inches. Guidewire 27 can have a diameter of about 0.014 to about 0.020 inches. In one example, catheter 31 can have a diameter of about 0.088 inches, catheter 120 can have a diameter of about 0.071 inches, catheter 124 can have a diameter of about 0.035 inches, and guidewire 27 can have a diameter of about 0.018 inches.

[0100] In one commercial implementation, a preassembled access assembly (a guide catheter, an access catheter, and a guidewire) can be carried in a first channel on a sterile barrier tray, and a preassembled surgical assembly (one or two surgical catheters and a guidewire) can be carried in the same or a different second channel on the sterile barrier tray. One or two or more additional catheters or interventional tools can also be provided, depending on potential needs during the interventional procedure.

[0101] Figures 3G to 3K An embodiment of an alternative sterile barrier having a convex driving surface (eg, a convex, crowned road-like driving surface) is shown. Figure 3G2 is a cross-sectional view of sterile barrier 232. Sterile barrier 232 includes a raised upper support surface 204. Fluid channels 205 and 207 are located laterally and below support surface 204 for automatically clearing or draining fluid from support surface 204 (e.g., during an interventional procedure). Fluid channels 205 and 207 can extend axially for at least a portion of the length of the sterile barrier.

[0102] Figure 3I 、 Figure 3J and Figure 3K A perspective cross-sectional view, a cross-sectional view, and a top cross-sectional view of the proximal end of the sterile barrier 232 are shown, respectively. Figures 3I to 3K As shown, the sterile barrier 232 can include a groove 240 in communication with the fluid channels 205 and 207. The groove 240 can receive fluid from the channels 205 and 207 (e.g., during an interventional procedure). The groove 240 can be at least partially located below the fluid channels 205 and 207 so that the fluid in the channels 205 and 207 flows into the groove 240. In some embodiments, the fluid channels 205 and 207 can be angled relative to the horizontal plane (e.g., can descend from the end of the channel farthest from the groove 240 to the groove 240) so that the fluid in the channels 205 and 207 is directed to the groove 240. For example, the depth of the channels 205 and 207 can increase from the end of the channel farthest from the groove 240 to the groove 240. Alternatively, during a portion or all of the interventional procedure, sterile barrier 232 and / or the support table can be positioned at an angle relative to the horizontal plane such that the ends of channels 205 and 207 furthest from slot 240 are positioned above slot 240. For example, sterile barrier 232 and / or the support table can be constructed or arranged at an angle such that the ends of sterile barrier 232 and / or the support table opposite slot 240 are positioned above slot 240. Alternatively or additionally, the drive mechanism can temporarily tilt sterile barrier 232 and / or the support table such that the ends of sterile barrier 232 and / or the support table opposite slot 240 are positioned above slot 240 (e.g., by raising the ends of sterile barrier 232 and / or the support table opposite slot 240 or lowering the ends of sterile barrier 232 and / or the support table at slot 240), thereby allowing fluid within channels 205 and 207 to flow into slot 240.

[0103] The tank 240 may include a drain hole 242. The tank 240 may be shaped, sized, and / or configured in other ways as desired so that the fluid in the tank 240 drains into the drain hole 242. The drain hole 242 may include a pipe, a barbed fitting, and / or an on-off valve for removing the fluid from the tank 240. Figures 3I to 3KAs shown, the trough 240 can be located at the proximal end of the sterile barrier 232. In an alternative embodiment, the trough 240 can be located at the distal end of the sterile barrier 232. In some embodiments, the sterile barrier 232 can include a first trough 240 at the proximal end and a second trough 240 at the distal end. In some embodiments, the trough 240 can also serve as a wash basin.

[0104] The first channel 206 can extend axially for at least a portion of the length of the sterile barrier 232. The channel 206 can have sufficient length to accommodate the interventional device and sufficient width and depth to accommodate the corresponding hub (e.g., by providing support to prevent the hub from being dislodged when force is applied to the hub). Optionally, a second channel 212 can be provided. The second channel 212 can be located on the same side of the upper support surface 204 as the first channel 206 or on the opposite side. Figure 3G Channel 212 is shown on the opposite side of support surface 204 from channel 206 . Figure 3H is a cross-sectional view illustrating an alternative embodiment of sterile barrier 232 in which channel 212 is on the same side of support surface 204 as channel 206 .

[0105] like Figure 3G and Figure 3H As shown, channels 206 and 212 can have generally triangular, wedge-shaped, or other angled cross-sections to accommodate the hub at an angle relative to the horizontal plane. Accommodating the hub at an angle relative to the horizontal plane can allow for a smaller width of the sterile barrier 232.

[0106] Two or three or more additional recesses (eg, additional channels or holes) may be provided to accommodate additional medical devices or supplies that may be useful during the interventional procedure, as well as to collect fluids and serve as wash basins for catheters and related equipment.

[0107] In some embodiments, the sterile barrier 232 can include one or more structural ribs 236. The sterile barrier 232 can also include one or more frame support protrusions 228 and 238.

[0108] exist Figure 3G In the embodiment of the sterile barrier 232 shown, the width x1 can be 14 inches, approximately 14 inches, 12 inches to 16 inches, 10 inches to 18 inches, or any other suitable width. Figure 3HIn the illustrated embodiment of sterile barrier 232, width x1 can be 15 in, approximately 15 in, 13 in to 17 in, 11 in to 19 in, or any other suitable width. Height y1 of support surface 204 can be 0.125 in, approximately 0.125 in, 0.1 in to 0.15 in, or any other suitable height. In some embodiments, support surface 204 can be recessed from top surface 233 of sterile barrier 232. Height y2 between the bottom and top surfaces 233 of support surface 204 can be 0.5 in, approximately 0.5 in, 0.25 in to 0.75 in, or any other suitable height. Width x2 from the lateral edge of channel 205 to the lateral edge of channel 207 can be 5 in, approximately 5 in, 4 in to 6 in, or any other suitable width. Width x3 of support surface 204 can be 4 in, approximately 4 in, 3 in to 5 in, or any other suitable width. The height y3 of channel 206 and / or channel 212 can be 1.5 in, approximately 1.5 in, 1 in to 2 in, or any other suitable height. The width x4 of channel 206 and / or channel 212 can be 3 in, approximately 3 in, 2 in to 4 in, or any other suitable width. Channel 206 and / or channel 212 can be defined by an arc angle α of 90°, approximately 90°, 80° to 100°, or any other suitable angle, and a radius of curvature of 0.125 in, approximately 0.125 in, 0.1 in to 0.15 in, or any other suitable radius of curvature. In certain embodiments, an arc angle α of 90° or approximately 90° can be used to accommodate a hub having a rectangular or substantially rectangular cross-section. Support surface 204 can be defined by a radius of curvature of 13 in, approximately 13 in, 11 in to 15 in, or any other suitable radius of curvature. Channel 205 and / or channel 207 may be defined by a radius of curvature of 0.25 in, approximately 0.25 in, 0.15 in to 0.35 in, or any other suitable radius of curvature.

[0109] Figure 3L and Figure 3M Describes how Figures 3G to 3KThe example size of the hub 250 used together with the sterile barrier 232 shown in FIG. Hub 250 can be any hub of this article. In certain embodiments, hub 250 can have a width w1 of 3.75 in, approximately 3.75 in, 3.25 in to 4.25 in, or any other suitable width. Hub 250 can have a height h1 of 1.5 in, approximately 1.5 in, 1.25 in to 1.75 in, or any other suitable height. Alternatively, hub 250 can have a height h2 of 2 in, approximately 2 in, 1.75 in to 2.25 in, or any other suitable height. In some embodiments, hub 250 can have a length L1 of 2.5 in, approximately 2.5 in, 2 in to 3 in, or any other suitable length. Alternatively, hub 250 can have a length L2 of 4 in, approximately 4 in, 3.5 in to 4.75 in, or any other suitable length.

[0110] In some embodiments, the top surface of the support table can include surface features that generally correspond to the surface features of sterile barrier 232. For example, the support table can include a raised surface configured to correspond to the shape, size, and location of support surface 204 and / or one or more recessed portions configured to correspond to the shape, size, and location of channels 205 and 207.

[0111] In an alternative embodiment, the planar support surface (e.g., support surface 104 of sterile barrier 32) can be positioned at an angle to the horizontal plane to facilitate drainage of fluid. In some embodiments, the sterile barrier and / or support table can be positioned at an angle relative to the horizontal plane to facilitate drainage of fluid during a portion or the entirety of the interventional procedure. For example, the sterile barrier and / or support table can be constructed or arranged to be arranged at an angle (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate drainage of fluid. Alternatively or additionally, the drive mechanism can temporarily tilt the sterile barrier and / or support table (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate drainage of fluid. For example, the drive mechanism may raise or lower a lateral side of the sterile barrier and / or support table, a proximal end of the sterile barrier and / or support table, and / or a distal end of the sterile barrier and / or support table.

[0112] In certain embodiments, the support surface (e.g., support surface 104 of sterile barrier 32) can be positioned in a vertical configuration, rather than, for example, Figures 3A to 3FFor example, the support surface 104 can be positioned at approximately 90 degrees (or any other suitable angle) to the horizontal plane (e.g., relative to Figures 3A to 3F 104 is rotated 90 degrees about the long axis of the support surface 104). The vertical configuration can also provide easier physician interaction with the drive system 18. The vertical configuration can also provide the lower shaft of the catheter being advanced closer to the patient without increasing the standoff height of the drive system 18.

[0113] In some embodiments, the drive system 18 can be positioned at an angle relative to the horizontal plane during part or all of the interventional procedure to facilitate fluid drainage. For example, the drive system 18 can be configured or arranged in an angled arrangement (e.g., such that one lateral side of the planar support surface is higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate fluid drainage. Alternatively or additionally, the drive mechanism can temporarily tilt the drive system 18 (e.g., such that one lateral side of the drive system 18 is higher than the other lateral side of the drive system 18, the proximal end is higher than the distal end, or the distal end is positioned higher than the proximal end) to facilitate fluid drainage. For example, the drive mechanism can raise or lower a lateral side of the system 18, the proximal end of the drive system 18, and / or the distal end of the drive system 18. In some embodiments, the drive system 18 can be angled so that it extends at an angle away from the axis point 24 (e.g., such that the proximal end is higher than the distal end), for example, to provide clearance for the patient's foot.

[0114] refer to Figure 4 , hub 36 can represent any hub previously described. Hub 36 includes a housing 38 extending between a proximal end 40 and a distal end 42. An interventional device 44, which can be any interventional device disclosed herein, extends distally from hub 36 and into patient 14 (not shown). Hub adapter 48 acts as a shuttle, proximally or distally advancing along a track in response to operator commands or controller manipulation.

[0115] 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., but not limited to, a linear track) in response to operator commands or controller manipulations. For example, but not limited to, any of the robotic control systems and / or methods 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 following description.

[0116] Figure 30AShown is a portion of an embodiment of a drive stage having one or more rack and pinion actuators that can be used with any of the embodiments of the robotic control systems disclosed herein. Figure 30B Shows Figure 30A An enlarged view of an embodiment of a rack and pinion actuator of an embodiment of the drive stage is shown, which can be used with any of the embodiments of the robotic control systems disclosed herein.

[0117] 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 proximally and / or distally in an axial direction relative to the drive stage 4002 via a linear actuator. In some embodiments, such as in the illustrated embodiment, the linear actuator for one or more or all of the hub adapters can be or include a rack and pinion linear actuator. In some embodiments, one or more hub adapters can be configured to move in response to input provided by a user of the robotic control system and / or in response to automatic commands of the robotic control system.

[0118] Figure 30B An embodiment of a hub adapter 4012 is shown, which can be any hub adapter described herein. Figure 30B Some embodiments of rack and pinion linear actuators may have a rack (or spur gear) 4032 and a pinion 4038 connected to the shaft of the motor 4030 on the hub adapter 4012. For example, but not limited to, reference Figure 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 pinion configured to engage with the rack 4032. For example, the first hub adapter 4012a can have a pinion 4038a connected to the shaft of the motor 4030a. The second hub adapter 4012b can have a pinion 4038b connected to the shaft of the motor 4030b. In this configuration, any or all of the hub adapters can have their own unique motor and pinion to allow independent movement of each hub adapter.

[0119] refer to Figure 30A and Figure 30BIn some embodiments of the robotic control system, the hub adapter can be connected to and move axially along the guide rails or linear guides 4014a and / or the guide rails or linear guides 4014b. When moved by the linear actuator, the linear guides 4014a and / or the linear guides 4014b can guide and / or constrain the hub adapter to move axially (e.g., proximally and distally) along a linear path. In any embodiment, the hub adapter (or any combination of hub adapters) can be configured to move in an axial direction relative to the drive stage 4002 using a belt drive system, multiple wheels, a threaded screw system, a ball screw system, a rack and pinion system, or any other suitable drive system or combination thereof.

[0120] Alternatively, in some embodiments, Figure 30B The hub adapter 4012 (which can be any of the hub adapters described herein) can have a plurality of wheels (e.g., low friction wheels) that are configured to move along one or more guide rails of the drive table 4002. In some embodiments, one side of the hub adapter 4012 can be spring-loaded to facilitate connection with the guide rails. In any embodiments disclosed herein, the table supporting the rails and / or the rails themselves can also be configured to move in a proximal or distal axial direction. Additionally, in some embodiments, the drive table 4002 can be a foldable drive table having two parts connected by a hinge or joint that can be folded together.

[0121] In any embodiments disclosed herein, the first hub adapter 4012a can be distal to the second hub adapter 4012b, the second hub adapter 4012b can be distal to the third hub adapter, and the third hub adapter can be distal to the fourth hub adapter. In any embodiments, the second hub adapter 4012b can be axially aligned with the first hub adapter 4012a such that when the first hub and the second hub are connected to the first hub adapter 4012a and the second hub adapter 4012b, respectively, the first interventional device connected to the first hub and the second interventional device connected to the second hub are coaxially aligned. 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 hub, the second hub, the third hub, and the fourth hub are connected (e.g., magnetically) to the first hub adapter, the second hub, the third hub, and the fourth hub, respectively, the first interventional device connected to the first hub, the second interventional device connected to the second hub, the third hub, and the fourth interventional device connected to the fourth hub are coaxially aligned with the first interventional device connected to 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.

[0122] In addition to what has been described above, any embodiments of the robotic control systems and / or methods of controlling movement of interventional devices 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, filed on November 30, 2023, entitled “ROTATABLE DRIVE TABLE,” which application and all rack and pinion systems, components, features, and / or details are hereby incorporated by reference in their entirety as if fully and expressly set forth herein.

[0123] Any embodiment of the robotic control system and / or method of controlling movement of an interventional device disclosed herein may have any combination of a rack and pinion actuator system or device, a belt drive system or device, or other linear motion systems or devices configured to move one or more hub adapters and / or hubs proximally or distally along a linear track in response to operator commands or controller manipulations. In addition, but without limitation, any and all embodiments of the 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, filed on November 30, 2023, entitled “ROTATABLE DRIVE TABLE,” may be used with and included in any embodiment of the robotic control system disclosed herein, and said application is hereby incorporated by reference in its entirety as if fully and expressly set forth herein.

[0124] In some embodiments, the hub adapter 48 can include at least one drive magnet 67 configured to connect to a driven magnet 69 carried by the hub 36. This provides a magnetic connection between the drive magnet 67 and the driven magnet 69 through the sterile barrier, so that the hub 36 moves on top of the sterile barrier 32 in response to movement of the hub adapter 48 outside the sterile field. The movement of the hub adapter is driven by a drive system carried by the support table and is described in additional detail below. The hub adapter can serve as a robotic drive for the interventional device connected thereto.

[0125] In order to reduce friction in the system, the hub 36 can be equipped with at least a first roller 53 and a second roller 55, which can be in the form of wheels or rotatable balls or drums. The rollers separate the sterile barrier from the surface of the driven magnet 69 by at least about 0.02 cm (about 0.008 inches), and generally do not exceed about 0.08 cm (about 0.03 inches). In some embodiments, the gap is in the range of about 0.03 cm (about 0.010 inches) to about 0.041 cm (about 0.016 inches). The gap between the driving magnet 67 and the driven magnet 69 is generally no more than about 0.38 cm (about 0.15 inches), and in some embodiments no more than about 0.254 cm (about 0.10 inches), for example, in the range of about 0.216 cm (about 0.085 inches) to about 0.229 cm (about 0.090 inches). The hub adapter 48 may similarly be equipped with at least a first hub adapter roller 59 and a second hub adapter roller 63, which may be positioned relative to the corresponding first roller 53 and second roller 55, as shown in FIG. Figure 4 shown.

[0126] refer to Figure 6 , shows an example of a low-profile linear drive support table 20. The support table 20 includes an elongated frame 51 extending between a proximal end 52 and a distal end 54. At least one support table support 56 is provided to stabilize the support table 20 relative to a patient (not shown). The support 56 may include one or more legs, or preferably, an articulated arm configured to allow the frame 51 to be moved and positioned above or near the patient.

[0127] Figure 7 The example of the linear drive table 20 shown includes three different drives. However, depending on the desired clinical performance, two drives or four or more drives (e.g., up to eight drives) can be included. A first drive pulley 58 is engaged with a first drive belt 60. A first hub adapter bracket 61 is fixed to the first drive belt 60 so that rotation of the first drive pulley 58 causes the first drive belt 60 to rotate through an elongated closed loop path. Depending on the direction of rotation of the drive pulley 58, the first hub adapter bracket 61 can be advanced in the proximal or distal direction along the longitudinal axis of the support table 20. In the embodiment shown, the drive pulley 58 is provided with surface structures, such as a plurality of drive pulley teeth 62, for engaging with complementary teeth on the first drive belt 60.

[0128] The second drive pulley 64 can be engaged with a second drive belt 66 configured to axially move a second hub adapter bracket 68 along an axial path on the support table 20. The third drive pulley 70 can be configured to drive a third drive belt 72 to axially advance a third hub adapter bracket 73 along the support table 20. Each hub adapter bracket can be equipped with the previously discussed but not Figure 7 , to form a connector for magnetically connecting to a corresponding driven magnet within the hub of the interventional device, as already discussed.

[0129] Figure 8 Shown is a detailed view of an embodiment of a drive system. Drive support 74 can be carried by frame 51 for supporting the drive assembly. Second drive pulley 64 is shown in a vertical cross section as being rotationally driven by engine 75 via rotatable shaft 76. Rotatable shaft 76 can be rotatably carried by support 74 via first bearing 78, shaft connection 80 and second bearing 79. Engine 75 can be stabilized by engine bracket 82 connected to drive support 74 and / or frame 51. The belt drive assembly for the first drive belt 60 and the third drive belt 72 can be similarly constructed and is not described in detail herein. In some embodiments, the drive system described herein can be a foldable rack and pinion drive stage system. In such an embodiment, engine 75 can be attached to a pulley and move with the pulley.

[0130] refer to Figure 9 and Figure 10 Each of the first, second, and third drive belts extends around a corresponding first idler pulley 84, second idler pulley 86, and third idler pulley 88. Each idler pulley can be equipped with a corresponding tension bracket 90, which is configured to adjust the idler pulley in the proximal or distal direction to adjust the tension of the corresponding belt. Therefore, each tension bracket 90 is equipped with a tension adjustment member 92, such as a rotatable screw.

[0131] like Figure 10 As shown, for example, the second idler gear 86 may be carried by a rotatable shaft 94 that is rotatably fixed relative to the mounting bracket via a first bearing 96 and a second bearing 98 .

[0132] Any catheter (e.g. Figure 5A 、 Figure 5B or Figure 11 The catheter (shown) typically comprises an elongated tubular body extending between a proximal end and a distal functional end. The length and diameter of the tubular body depend on the desired application. For example, lengths of about 90 cm to about 195 cm or longer are typically used for femoral access percutaneous transluminal coronary applications. Intracranial or other applications may require different catheter shaft lengths depending on the vascular access site.

[0133] Any of the catheters disclosed herein can be equipped with a beveled distal tip. Figure 11, the distal catheter tip 1150 includes a tubular body 1152 including a pusher section 1154, a marker band 1156, and a proximal section 1158. An inner tubular liner 1160 can extend throughout the entire length of the distal catheter tip 1150 and can include dip-coated or extruded PTFE or other lubricating material.

[0134] Reinforcement elements 1162 (eg, braid and / or spring coils) are embedded in an outer sheath 1164, which can extend the entire length of the catheter.

[0135] The pusher segment 1154 terminates distally in an inclined surface 1166 to provide a front sidewall portion 1168 having a length measured between the distal end 130 of the marker band 1156 and the distal tip 1172. In some embodiments, the entire distal tip can have a shape that prevents the tip from becoming stuck in the arterial bifurcation region. The rear sidewall portion 1174 of the pusher segment 1154, in the illustrated embodiment, has an axial length that is approximately equal to the axial length of the front sidewall portion 1168, as measured approximately 180 degrees around the catheter from the front sidewall portion 1168. The axial length of the front sidewall portion 1168 can be from about 0.1 mm to about 5 mm, and is typically from about 1 mm to 3 mm. The rear sidewall portion 1174 can be equal to the axial length of the front sidewall portion 1168 or at least about 0.1 mm or 0.5 mm or 1 mm or 2 mm or less shorter than the axial length of the front sidewall portion 1168, depending on the desired performance.

[0136] The inclined surface 1166 is inclined at an angle A of about 45 degrees to about 80 degrees to the longitudinal axis of the catheter. For some embodiments, the angle is about 55 degrees to about 65 degrees to the longitudinal axis of the catheter. In one embodiment, the angle A is about 60 degrees. One result of an angle A of less than 90 degrees is an elongation of the major axis of the region of the distal port, which increases the surface area of ​​the port and can enhance clot aspiration or retention. The area of ​​the inclined port is typically at least about 105% and no more than about 130% of the surface area of ​​a circular port (angle A of 90 degrees), in some embodiments, about 110% to about 125%, and in one example, about 115% of the area of ​​a corresponding circular port (angle A of 90 degrees).

[0137] In the illustrated embodiment, the axial length of the advancement section remains constant around the circumference of the catheter, such that the inclined surface 1166 is generally parallel to the distal surface 1176 of the marker band 1156. The marker band 1156 has a proximal surface that is generally transverse to the longitudinal axis of the catheter, resulting in an internal elevation view of the marker band 1156 having a right-angled trapezoidal configuration. The short sidewall 1178 is rotationally aligned with the rear sidewall portion 1174 and has an axial length of approximately 0.2 mm to approximately 4 mm, and typically is approximately 0.5 mm to approximately 2 mm. The opposing long sidewall 1180 is rotationally aligned with the front sidewall portion 1168. The long sidewall 1180 of the marker band 1156 is typically at least about 10% or 20% longer than the short sidewall 1178, and may be at least about 50%, 70%, 90%, or more longer than the short sidewall 1178, depending on the desired performance. Typically, the long sidewalls 1180 will have a length of at least about 0.5 mm or 1 mm and less than about 5 mm or 4 mm.

[0138] The marker band can be a continuous annular structure or can have at least one, and optionally two or three or more, axially extending slits throughout its entire length. The slits can be located on the short sidewall 1178 or the long sidewall 1180, or between the two, depending on the desired bending characteristics. The marker band can comprise any of a variety of radiopaque materials, such as a platinum / iridium alloy, and preferably has a wall thickness not exceeding about 0.003 inches, and in one embodiment about 0.001 inches.

[0139] When using multiple catheters, the perspective appearance of the marker band can be unique or different for each catheter size or type, so that the marker band can be distinguished from each other by a software algorithm. When using multiple catheters together, for example, in a multi-catheter assembly or stacking as herein, it may be advantageous to distinguish the marker bands of multiple catheters. In some embodiments, the marker band of a catheter can be configured to enable a software algorithm to detect the motion of the catheter tip.

[0140] The marker band region of the assembled catheter can have a relatively high bending stiffness and a high crush strength, for example, at least about 50% less than the proximal segment 1158 or at least about 100% less, but typically no more than about 200% less than the proximal segment 1158. The high crush strength can provide radial support for the adjacent pusher segment 1154, and in particular for the anterior sidewall portion 1168, to facilitate the distal tip 1172 functioning as an atraumatic buffer during transluminal advancement and to prevent collapse under vacuum. The proximal segment 1158 preferably has a lower bending stiffness than the marker band region, and the pusher segment 1154 preferably has an even lower bending stiffness and crush strength than the proximal segment 1158.

[0141] The advancement segment 1154 can include an outer tubular sheath 1164 and an optional distal extension of the inner liner 1160, without other internal support structures distal to the marker band 1156. The outer sheath 1164 can include an extruded polyurethane, such as Tecothane®. The advancement segment 1154 can have a bending stiffness and a radial crush stiffness that are no more than about 50%, and in some embodiments no more than about 25%, 15%, or 5%, or less, of the corresponding values ​​of the proximal segment 1158.

[0142] The catheter can also include an axial tension element or support, such as a ribbon or one or more filaments or fibers, for increasing tension resistance and / or affecting bending properties in the distal region. The tension support can include one or more axially extending single or multiple filaments. One or more tension elements 1182 can be placed axially within the catheter wall near the distal end of the catheter. One or more tension elements 1182 can serve as tension supports and prevent the tip of the catheter wall from detaching or extending when under tension (for example, when the catheter is retracted proximally through a kinked outer catheter or a tortuous or narrowed vascular system).

[0143] At least one of the one or more tension elements 1182 can extend proximally along the length of the catheter wall from within approximately 1.0 centimeters of the distal end of the catheter to less than approximately 10 centimeters of the distal end of the catheter, less than approximately 20 centimeters of the distal end of the catheter, less than approximately 30 centimeters of the distal end of the catheter, less than approximately 40 centimeters of the distal end of the catheter, or less than approximately 50 centimeters of the distal end of the catheter.

[0144] 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.

[0145] At least one of the one or more tension elements 1182 can extend at least approximately up to 50 centimeters of the length of the catheter, extend at least approximately up to 40 centimeters of the length of the catheter, extend at least approximately up to 30 centimeters or 20 centimeters or 10 centimeters of the length of the catheter.

[0146] In some embodiments, the tensile element extends proximally from the distal end of the catheter along the length of the coil 24 and terminates proximally about 5 cm or 2 cm or less on either side of the transition between the distal coil and the proximal braid. The tensile element may terminate at the transition without overlapping the braid.

[0147] One or more tensioning elements 1182 can be placed adjacent to or radially outside of the liner layer 1160. One or more tensioning elements 1182 can be placed adjacent to or radially inside of the braid and / or coil. One or more tensioning elements 1182 can be carried between the liner layer 1160 and the helical coil and can be secured to the liner layer or other underlying surface by an adhesive prior to adding the next outer adjacent layer (e.g., coil). Preferably, the tensioning elements 1182 are secured to the marker band 1156, for example, by an adhesive or by mechanical interference. In one embodiment, the tensioning element 1182 extends distally beyond the marker band on a first (e.g., inner) surface of the marker band, then wraps around the distal end of the marker band and extends along a second (e.g., outer) surface in one or both of a proximal oblique or circumferential direction to completely wrap around the marker band.

[0148] When more than one tensile element 1182 or filament bundle is circumferentially spaced apart in the catheter wall, the tensile elements 1182 can be placed in a radially symmetrical manner. For example, the angle between two tensile elements 1182 relative to the radial center of the catheter can be about 180 degrees. Alternatively, depending on the desired clinical performance (e.g., flexibility, trackability), the tensile elements 1182 can be placed in a radially asymmetric manner. The angle between any two tensile elements 1182 relative to the radial center of the catheter can be less than about 180 degrees, less than or equal to about 165 degrees, less than or equal to about 135 degrees, less than or equal to about 120 degrees, less than or equal to about 90 degrees, less than or equal to about 45 degrees, or less than or equal to about 15 degrees.

[0149] The one or more tensile elements 1182 may comprise materials such as Vectran®, Kevlar®, Polyester®, Spectra®, Dyneema®, Meta-Para-Aramide®, or any combination thereof. At least one of the one or more tensile elements 1182 may comprise a single fiber or a multi-fiber bundle, and the fibers or bundles may have a circular or rectangular (e.g., ribbon) cross-section. The terms fiber or filament do not convey composition, and they may comprise any of a variety of high tensile strength polymers, metals, or alloys, depending on design considerations such as the desired tensile failure limit and wall thickness. The cross-sectional dimension of the one or more tensile elements 1182 measured in the radial direction may not exceed approximately 2%, 5%, 8%, 15%, or 20% of the cross-sectional dimension of the catheter 10.

[0150] The cross-sectional dimension of one or more tension elements 1182 measured in the radial direction may be no more than about 0.03 mm (about 0.001 inch), no more than about 0.0508 mm (about 0.002 inch), no more than about 0.1 mm (about 0.004 inch), no more than about 0.15 mm (about 0.006 inch), no more than about 0.2 mm (about 0.008 inch), or about 0.38 mm (about 0.015 inch).

[0151] One or more tensioning elements 1182 can increase the tensile strength of the distal region of the catheter to at least about 1 pound, at least about 2 pounds, at least about 3 pounds, at least about 4 pounds, at least about 5 pounds, at least about 6 pounds, at least about 7 pounds, at least about 8 pounds, or at least about 10 pounds or more before failing under tension (e.g., the marker band detaches).

[0152] Depending on the desired data, any of a variety of sensors may be provided on any of the catheter, hub, hub adapter, or table. For example, in some embodiments, it may be desirable to measure, for example, axial tension or compression applied to the catheter along the force sensing region. The distal end of the catheter will be manufactured to have, for example, Figure 11 , and has a helical coil distal portion. However, unlike a single helical coil using a nitinol wire, the first conductor 140 and the second conductor 142 are wound into helical coils that are wound around each other and are electrically insulated from each other, for example, by the plastic / resin of the tubular body. Figure 12A Each coil is in electrical communication with the proximal hub via a unique electrical conductor (eg, a conductive line of wire or a proximal extension).

[0153] This construction of two electrically isolated spiral coils creates a capacitor. This is roughly equivalent to two Nitinol plates with a plastic layer between them, such as Figure 12B As shown. The capacitance is inversely proportional to the distance between the filaments. The only variable that would change would be d, the distance between the plates. If an axial compressive force is applied to the catheter, the filaments (e.g., conductor 140 and conductor 142) will move closer together, thereby increasing the capacitance. If an axial tensile force is applied, the filaments will move further apart, decreasing the capacitance. This capacitance can be measured at the proximal end of the catheter, giving a measure of the force at the spiral capacitor. Although referred to as a capacitor, the sensor measures the electrical interaction between the two coils of wire. There may be a measurable change in inductance or other resulting change due to the applied axial force.

[0154] At least a first helical capacitor may have at least one, five, ten, or more complete rotations per filament. The capacitor may be located within 5 cm, 10 cm, or 20 cm of the distal-most end of the catheter body to sense the force experienced at the distal end. At least a second capacitor may be provided within 5 cm, 10 cm, or 20 cm of the proximal-most end of the catheter body to sense the force experienced at the proximal end of the catheter.

[0155] It may also be desirable to use the natural elasticity (compliance) of the magnetic connection to measure the elastic force across the magnetic connection between the hub and the corresponding hub adapter to measure the force applied to the hub. The magnetic connection between the hub and the 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 Figure 13A In robotics, this is called a series elastic actuator. This property can be used to measure the force applied from the hub adapter to the hub. To measure the force, the relative distance between the hub and the hub adapter is determined ( Figure 13A dx) and characterizes some effective spring constant k between the two components. Figure 13B .

[0156] Relative distance can be measured in a number of different ways. One method for measuring the relative distance between the hub and the hub adapter is a magnetic sensor (e.g., a Hall effect sensor between the hub and the hub adapter). A magnet is mounted to the hub or the hub adapter, and a corresponding magnetic sensor is mounted on the other device (the hub adapter or the hub). The magnetic sensor can be a Hall effect sensor, a magnetoresistive sensor, or another type of magnetic field sensor. Often, multiple sensors can be used to increase the reliability of the measurement. This reduces noise and reduces interference from external magnetic fields. Additional details about the magnetic sensor are provided in the following sections. Figures 24 to 27 described.

[0157] Other non-contact distance sensors may also be used. These include optical sensors, inductive sensors, and capacitive sensors. The optical sensor will preferably be configured in a manner that avoids the accumulation of blood or other fluids in the interface between the hub adapter. In some embodiments, for example, a wireless (i.e., inductive) power source may be used to convert motion and / or transmit information across the sterile barrier between the drive hub adapter and the hub.

[0158] In some embodiments, the magnetic connection between the hub and the hub adapter has a shear or axial fracture threshold, which can be about 300 grams or 1000 grams or 1300 grams or greater. The processor can be configured to compare the axial force applied to the catheter with a preset axial trigger force, which, if applied to the catheter, is perceived as creating a risk to the patient. If the trigger force is reached, the processor can be configured to generate a response to the physician (e.g., visual, auditory, or tactile feedback), and / or intervene and shut down further advancement of the catheter until repositioning is achieved. An override function can be provided so that the physician can choose to continue advancing the catheter at a force above the trigger force if the physician deems an increase in force is justified.

[0159] Force and / or torque sensing optical fibers (e.g., fiber Bragg grating (FBG) sensors) can be built into the sidewall of the catheter to measure forces and / or torques at various locations along the axis of the catheter, or alternatively can be integrated into the guidewire. The fiber measures axial strain, which can be converted into axial force or torque (when helically wound). At least a first FBG sensor can be integrated into a distal sensing region, a proximal sensing region, and / or an intermediate sensing region on the catheter or guidewire to measure forces and / or torques near the sensor.

[0160] It may also be desirable to understand the three-dimensional configuration of a catheter or guidewire during and / or after transvascular placement. Shape sensing fibers, such as arrays of FBG fibers, are used to sense the shape of catheters and guidewires. By using multiple force sensing fibers at known distances from one another, the shape along the length of the catheter / guidewire can be determined.

[0161] Resistive strain gauges can be integrated into the body of a catheter or guidewire to measure force or torque, for example at the distal tip and / or proximal end of the device.

[0162] The measurement of the force and / or torque applied to the catheter or guidewire shaft can be used to determine the applied force and / or torque above a safety threshold. When the applied force and / or torque exceeds the safety threshold, a warning can be provided to the user. The applied force and / or torque measurement can also be used to provide feedback related to better catheter operation and control. The applied force and / or torque measurement can also be used with processed fluoroscopic imaging information to determine or characterize distal tip motion.

[0163] In some embodiments, a force and / or torque sensor can be incorporated into the hub to indicate the force or torque 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 six-axis force / torque sensor). 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, the entire contents of which are hereby incorporated by reference herein, can be incorporated into the hub and / or hub adapter.

[0164] The absolute position of the hub (and corresponding catheter) along the length of the table can be determined in a variety of ways. For example, a non-contact magnetic sensor can be configured to measure the position of the hub directly through a sterile barrier. The same type of sensor can also be configured to measure the position of the hub adapter. Each hub can have at least one magnet attached to it. In some embodiments, the robotic table can have a linear array of corresponding magnetic sensors that pass through the entire length of the table. The processor can be configured to determine the position of the magnet along the length of the linear sensor array and display the axial position information to the physician.

[0165] Alternatively, the above purpose can be accomplished using a non-contact inductive sensor to directly measure the position of the hub through a sterile barrier. Each hub or hub adapter can be equipped with an inductive "target" therein. The robotic table can be equipped with an inductive sensing array over the entire working length of the table. As another option, an absolute linear encoder can be used to directly measure the linear position of the hub or hub adapter. The encoder can use any of a variety of different technologies, including optical, magnetic, inductive, and capacitive methods.

[0166] In one embodiment, a passive (no electrical connection) target coil can be carried by each hub. A linear printed circuit board (PCB) can run the entire working length of the table (e.g., at least about 1.5 meters to about 1.9 meters) and is configured to detect an interrogator signal that excites a return signal from the passive coil. The PCB is configured to identify the return signal and its location.

[0167] 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 is directly related to the linear position of the hub adapter. Alternatively, direct measurement of the hub adapter position can be accomplished by recording the number of steps commanding a stepper motor to measure the rotational position of the pulley, which is directly related to the linear position of the hub adapter.

[0168] The position of the catheter and guidewire within the anatomical structure can also be determined by processing fluoroscopic images with machine vision, for example to determine distal tip position, distal tip orientation and / or guidewire shape. Comparing the distal tip position or movement, or lack thereof, with the commanded or actual proximal catheter or guidewire movement at the hub can be used to detect loss of relative motion, which can indicate device shaft buckling, prolapse, kinking, or similar consequences (e.g., along the length of the device shaft inside the body (e.g., in the aorta) or outside the body between hubs). Processing can be performed in real time to provide position / orientation data at up to 30 Hz, although this technology can only provide data when fluoroscopic imaging is turned on. In some embodiments, machine vision algorithms can be used to generate and recommend optimal catheter maneuvers to approach or reach anatomical landmarks, similar to driver assistance. Machine vision algorithms can utilize the data to automatically drive the catheter based on the anatomical structure presented by the fluoroscopic examination.

[0169] A dual encoder torque sensor can be used to determine the proximal torque applied to a catheter or guidewire shaft. Figure 14 , the first encoder 144 and the second encoder 146 can be axially spaced apart along the shaft 148 to measure the angular difference over the length of the flexible catheter / tube. Since the catheter / tube has a known torsional stiffness, the angular difference is interpolated as the torque. When torque is applied to the shaft, the slightly flexible portion of the shaft will twist. The difference between the angles measured by the encoders (dθ) tells us the torque. T = k dθ, where k is the torsional stiffness.

[0170] Confirming the absence of bubbles in the fluid line can also be accomplished using a bubble sensor, particularly in situations where the physician is remote from the patient. This can be accomplished using a non-contact ultrasonic sensor that measures the intensity and Doppler shift of reflected ultrasound passing through the sidewalls of the fluid conduit to detect bubbles and measure fluid flow rate or fluid level. The ultrasonic or optical sensor can be located near the incoming fluid flow path within the hub, or in the supply line leading to the hub. To detect the presence of bubbles in an infusion line (formed of an ultrasonically or optically transmissive material), the sensor can include a signal source on a first side of the flow path and a receiver on a second side of the flow path to detect bubbles by measuring the transmission of liquid through the tube. Alternatively, due to the relatively high echogenicity of bubbles, the reflected ultrasonic signal can be detected from the same side of the flow path as the source.

[0171] Preferably, the bubble removal system is automatically activated upon detection of an air bubble in the line. The processor can be configured to activate a valve located in the flow path downstream of the bubble detector upon detection of a bubble. The valve diverts a column of fluid from the flow path to the patient and into a reservoir. When bubbles are no longer detected in the flow path, and after the volume of fluid in the flow path between the detector and the valve has passed through the valve, the valve can be activated to reconnect the fluid source to the patient through the flow path. In other embodiments, the bubble removal system can include a pump and control system upstream of the bubble detector for removing air bubbles in the line. The processor can be configured to activate the pump upon detection of a bubble to reverse the flow of fluid and purge the bubbles into a waste reservoir before reestablishing bubble-free forward flow.

[0172] Furthermore, it is desirable for the physician to be able to view the aspirated clot at a location within the sterile field, and preferably as close to the patient as possible for fluid management purposes. This can be accomplished by providing a clot retrieval device mounted on the hub, or by providing a clot retrieval device mounted in the aspiration line away from the hub in the direction of the pump. Figure 15 One example of a clot retrieval device 370 may include a body 380 enclosing a chamber 381 in communication with the first port 310 and the second port 320 .

[0173] In some embodiments, the body 380 includes a housing having a top portion 382 and a bottom portion 384. The body 380 can include a filter 330 positioned between the top portion 382 and the bottom portion 384 in the chamber 381. In some examples, the first port 310 is configured to connect to a first end of a first tube 340 that is fluidly connected to a proximal end of the aspiration catheter.

[0174] In an embodiment configured for connection downstream from the hub, the first tube 340 includes a connector 342 at a second end of the first tube 340 that is configured to engage or mate with a corresponding connector on the hub or in communication with the hub. The first port 310 communicates directly with a chamber on the upstream (e.g., top side) of the filter, and the second port 320 communicates directly with a chamber on the downstream (e.g., bottom side) of the filter to facilitate direct visualization of material captured on the upstream side of the filter.

[0175] In embodiments configured for remote operation, any of a variety of sensors may be provided to detect clots passing through the aspiration line and / or trapped in the filter, such as optical sensors, pressure sensors, flow rate sensors, ultrasonic sensors, or other sensors known in the art.

[0176] In some embodiments, the second port 320 is configured to connect to a first end of a second tube 350, which is fluidly connected to a suction source (e.g., a pump). In some embodiments, the second tube 350 includes a connector 352 at a second end of the second tube 350 that is configured to engage or mate with a corresponding connector on the pump.

[0177] In some examples, the system 300 can include a switching valve 360, such as a clamp 360. The clamp 360 can be located between the filter 330 and the patient, such as on the first tube 340, to allow the user to engage the clamp and provide flow control by isolating the patient from the clot retrieval device 370. Closing the valve 360 ​​and operating a remote vacuum pump (not shown) causes the canister associated with the vacuum pump and chamber 381 to reach the same low pressure. Due to the short distance and small linear volume of the lumen between the chamber 381 and the distal end of the catheter, a sharp negative pressure spike is quickly experienced at the distal end of the catheter after opening the valve 360. Additional details are disclosed in U.S. Patent No. 11,259,821, entitled "Aspiration System with Accelerated Response," issued to Buck et al. on March 1, 2022, the entire contents of which are hereby expressly incorporated herein by reference. In some embodiments, the vacuum can be circulated to the clot to recover the clot. The vacuum can be automatically and robotically controlled to remove the clot.

[0178] The body 380 can have a top surface that is spaced apart from the bottom surface by a tubular sidewall. In the embodiment shown, the top and bottom surfaces are substantially circular and are spaced apart by a cylindrical sidewall. The top surface can have a diameter that is at least about three times, or five times or more, than the axial length of the sidewall (transverse to the top and bottom surfaces) to produce a generally disc-shaped housing. Preferably, at least a portion of the top wall is optically transparent to improve visualization of the clot after it is captured in the clot recovery device 370. Additional details can be found in U.S. Patent Application No. 63 / 256,743, the entire contents of which are incorporated herein by reference.

[0179] In some examples, the body 380 can include a flush port (not shown) configured to allow an optically transparent medium, such as air, saline, or other fluid, to be injected into the chamber 381 to clear the optical path between the window and the filter, thereby improving visualization of the clot once it is trapped in the filter 330.

[0180] The foregoing represents certain specific embodiments of a drive stage and associated components and catheters. A wide variety of different drive stage configurations can be manufactured for supporting and axially advancing and retracting two, three, four, or more drive magnet assemblies to robotically drive interventional devices, fluidic components, and electrical umbilical components for transmitting electrical signals and fluids to a catheter hub, as will be understood by those skilled in the art in light of the disclosure herein. Additional details can be found in U.S. Patent Application No. 17 / 527,393, the entire contents of which are hereby incorporated by reference herein.

[0181] Although the foregoing describes robotically driven interventional devices and manually driven interventional devices, the device can be manually driven, robotically driven, or a combination of manually and robotically driven interventional devices, as will be understood by those skilled in the art in view of the disclosure herein.

[0182] 16A to 16C An example control mechanism 2200 is shown for manipulating interventional devices driven by (or otherwise associated with) a respective hub. For example, each hub can be manipulated and / or otherwise moved using at least one control mounted in the control mechanism 2200. Each control can be adapted to move a unique hub-associated interventional device during an interventional procedure.

[0183] like Figure 16A As shown, the control mechanism 2200 includes a first control 2202, a second control 2204, a third control 2206, and a fourth control 2208. More or fewer controls may be provided depending on the desired interventional device configuration. Each control 2202 to 2208 is movably carried on a shaft 2210, which is connected to a distal support 2212 and a proximal support 2214. The controls 2202 to 2208 can be advanced distally or retracted proximally on the shaft 2210, as indicated by arrows 2218 and 2216. In addition, each control 2202 to 2208 can also rotate about the shaft 2210, as indicated by arrows 2220. Each control movement can trigger a corresponding movement in a corresponding hub adapter on the support platform, which in turn can drive movement of the corresponding hub, as already discussed.

[0184] The control mechanism 2200 can be located on or near a patient support table having a set of hubs and catheter / interventional devices. In some embodiments, the control mechanism 2200 can be located remotely from the support table, such as behind a radiation shield or in a different room or geographical location in telemedicine embodiments.

[0185] Each control member 2202 to 2208 can correspond to a hub and / or a combination of a hub and an interventional device and drive its movement. For example, the control member 2202 can be configured to drive the hub 30 ( Figure 3F ) to move an interventional device, such as a 0.088 inch guide catheter corresponding to hub 30. Similarly, control 2204 can be configured to drive hub 28 (122) to move an interventional device, such as a 0.071 inch surgical catheter. Control 2206 can be configured to drive hub 126 to move an interventional device, such as a steerable access catheter. Control 2208 can be configured to drive hub 26 to axially and rotationally move an interventional device, such as a guidewire.

[0186] Figure 16B An example of manually manipulating a control 2202 on a control mechanism 2200 is shown. In operation, if a user 2230 moves the control 2202 axially and distally along the axis 2210, as indicated by arrow 2232, the corresponding connected hub and / or interventional device can responsively move in the same direction by the same or proportional amount. If the user 2230 rotates the control 2202 about the axis 2210 and advances the control proximally, as indicated by arrow 2234, the corresponding connected interventional device will correspondingly rotationally and proximally move by the same or proportional amount. If the user 2230 rotationally moves the control 2202 about the axis 2210, as indicated by arrow 2236 or arrow 2238, the corresponding connected hub will rotationally drive the corresponding interventional device in the same direction and / or by the same or proportional amount.

[0187] Other axes and degrees of freedom can be defined to enable movement of the control member 2202 that can be translated into movement of the hub and / or interventional device. For example, the control member can be equipped with one or more deflection controls configured to activate lateral deflection in a deflection region on a corresponding interventional device.

[0188] Axial movement of the control can be configured to move the connected hub on a 1: 1 basis or on a non-1: 1 scaled basis. For example, if the user 2230 advances the control 2022 distally along the shaft 2210 by approximately 5 mm, the corresponding hub can correspondingly move 5 mm in the distal direction.

[0189] If the user 2230 rotates the control 2022 about its rotational axis by 5 degrees, the connected hub will rotate the corresponding interventional device on a 1: 1 basis or on a non-1: 1 scaled basis. The amount of scaling can be selected to reduce or increase the distance the hub and / or interventional device moves and the amount of rotation in response to the control movement.

[0190] In some embodiments, a scaling factor can be used to determine the amount of scaling described herein. The scaling factor can be applied to one or both of translational and rotational movement. In some embodiments, a first scaling factor is selected for translational movement, and a second scaling factor, different from the first scaling factor, is selected for rotational movement. For a given proximal or distal operation of a control member, the axial scaling factor can drive proximal catheter movement at a faster rate than distal catheter movement.

[0191] The rotational scaling factor may be 1:1, while the axial scaling factor may cause the hub to move a greater distance than the control member, such that hub travel relative to control member travel is at least about 2:1 or 5:1 or 10:1 or greater, depending on the desired axial length of the control assembly.

[0192] Control mechanism 2200 can be configured to enable the clinician to adjust the scaling factor for different parts of the procedure. For example, advancement of the surgical catheter and access catheter through the guide catheter and distal to the selected port may be ideally accomplished in a "fast" mode. However, advancement further distally into the neurovascular system may be ideally accomplished in a relatively slow mode using speed-controlled actuation.

[0193] In another embodiment, one or more controls can be configured to gradually drive the advancement or retraction rate of the corresponding hub and associated catheter. For example, distal control 2202 can drive a guide catheter. Slight distal movement of control 2202 can advance the guide catheter distally at a slower rate, while advancing control 2202 distally over a greater distance increases the rate of distal travel of the guide catheter.

[0194] Controlling the speed of the corresponding hubs axially or axially and rotationally can increase the overall speed of the procedure. For example, advancement of various devices from a femoral access point to the aortic arch can be ideally accomplished at a faster rate than distal navigation closer to the treatment site. Furthermore, proximal retraction of various devices, particularly guidewires, access catheters, and surgical catheters, can be ideally accomplished at a relatively higher speed than distal advancement.

[0195] Figure 16CAnother example of manually operating controls on control mechanism 2200 to move a hub and / or other interventional devices is shown. In some embodiments, two or more controls 2202-2208 can be moved in combination to trigger movement of one or more hubs and / or associated interventional devices. In the depicted example, user 2230 moves control 2204 and control 2206 in combination (e.g., sequentially, simultaneously) to simultaneously move a 0.088 guide catheter and a 0.071 aspiration catheter as an assembly. Example movement of control 2204 can include axial proximal movement in the direction indicated by arrow 2250. Sequentially or simultaneously, user 2230 can move control 2206 axially in either direction indicated by arrows 2254 and 2256, while also rotationally moving control 2206 in either direction indicated by arrows 2258 and 2260.

[0196] In some embodiments, 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 embodiments, control color coding can also be applied to the hubs and / or interventional devices so that the user can visually match a particular hub / device with a particular control.

[0197] In some embodiments, controls 2202-2208 can be used to perform other control operations besides translational and rotational movement. For example, controls 2202-2208 can be configured to drive a shape change and / or a stiffness change of a corresponding interventional device. Controls 2202-2208 can be switched between different operating modes. For example, controls 2202-2208 can be switched between movement driven by acceleration and velocity and movement reflecting actual linear displacement or rotation.

[0198] In some embodiments, the control mechanism 2200 can be equipped with a visual display or other indicator of the relative position of the control members, which can correspond to the relative position of the interventional devices. Such a display can depict any or all movement directions, instructions, percentages of movement performed, and / or hub and / or catheter indicators to indicate which device is controlled by a particular control member. In some embodiments, the display can depict the applied force or resistance encountered by the catheter or other measurement detected or observed by a particular hub or interventional component.

[0199] In some embodiments, the control mechanism 2200 can include a haptic component to provide tactile feedback to the user operating the control. For example, if the control 2202 triggers movement of the catheter and the catheter detects a large force at the tip, the control 2202 can generate tactile feedback to indicate to the user to stop or reverse the ongoing movement. In some embodiments, tactile feedback can be generated at the control to indicate to the user to slow down or speed up the movement using the control. In some embodiments, haptics can provide feedback on the accumulation of large torsional strains that may precede a sudden rotation, or can provide feedback on the accumulation of large axial forces that may be a prelude to catheter buckling.

[0200] The system described herein can compare the actual perspective image position with the input displacement from the controller. A static perspective image of the patient can be captured, in which the patient's vascular system is indicated relative to bone landmarks or one or more implanted soft tissue fiducial markers. The real-time perspective image can then be displayed as an overlay, aligned with the static image by registration of the fiducial markers. By visually observing the consistency of the real-time movement with the static image, assisted by the detected force data, it can help confirm the correct navigation of the associated catheter or guidewire. The system described herein can also display a comparison of the input proximal mechanical translation of the catheter or guidewire and the resulting output motion of the distal tip or its lack thereof. The loss of relative motion at the distal tip can indicate shaft buckling, prolapse, kinking, or similar results inside or outside the body. Such a comparison may be beneficial when shaft buckling, prolapse, kinking, or similar results appear outside the current perspective view.

[0201] Figure 17 A schematic side elevation view of a multi-catheter interventional device assembly 2900 for combined supra-aortic access and / or neurovascular site access and surgery (eg, aspiration), as described herein, is shown. Multi-catheter assembly 2900 can be configured for manual or robotic surgery.

[0202] The interventional device assembly 2900 includes an insertion or access catheter 2902, a surgical catheter 2904, and a guide catheter 2906. Other components may include, but are not limited to, one or more guidewires (e.g., optional guidewire 2907), one or more guidewire catheters, an access sheath, and / or one or more other surgical catheters and / or associated catheter (control) hubs. In some embodiments, the assembly 2900 may also be configured with an optional deflection control 2908 for controlling the deflection of one or more catheters of the assembly 2900.

[0203] In operation, the multi-catheter assembly 2900 can be used without having to replace the hub assembly. For example, in the two-stage procedure previously disclosed, the first stage for achieving supra-aortic access includes installing the access catheter, guide catheter, and guidewire onto the support table. When supra-aortic access is achieved, the access catheter and guidewire are typically removed from the guide catheter. Then, after attaching a new guidewire hub and surgical catheter hub to the corresponding drive hub adapters on the support table, the second catheter assembly is introduced over the guidewire catheter.

[0204] Figure 17 Single multi-catheter assembly 2900 is configured to operate when hub and catheter do not have to be removed and do not increase extra assembly and / or hub.Therefore, the multi-assembly entry and surgical configuration of assembly 2900 can utilize the guidewire 2907 that is manufactured to be used as entry guidewire and navigation guidewire, to allow enough entry and support, and navigate to specific distal treatment site.In the non-limiting example that is configured to be used for robot embodiment, catheter assembly can include guidewire hub (for example, be positioned at guidewire hub 2909 or guidewire hub 26 on the drive platform and on catheter 2902 right), insert or enter catheter hub 2910, surgical catheter hub 2912, guide catheter hub 2914 and corresponding catheter.In certain embodiments, one or more hubs can include hemostatic valve (for example, rotation hemostatic valve) or be connected thereto, to adapt to interventional device by introducing therein. Additional details regarding hemostatic valves are included in U.S. patent application Ser. No. 17 / 879,614, filed on August 2, 2022, entitled “Multi Catheter System With Integrated Fluidics Management,” which is hereby incorporated by reference in its entirety.

[0205] Once access above the aortic arch is complete, the insertion or access catheter 2902 (associated with the insertion catheter hub 2910) can be parked near the carotid ostium and the remainder or subset of the catheter assembly can be directed more distally to a specific site (e.g., a clot site, a surgical site, a procedure site, etc.).

[0206] In some embodiments, other smaller surgical catheters may also be added and used at the site. As used in the catheter assembly 2900 herein, in the robotic configuration of the assembly 2900, the catheter 2906 may be used as a guide catheter. The catheter 2904 may be used as a surgical (e.g., suction) catheter. In some embodiments, instead of or in addition to the catheter 2904, the catheter 2906 may also function to perform suction in addition to functioning as a guide catheter. The entry catheter 2902 may have a distal deflection region and may be used to enter the desired port. One skilled in the art will appreciate the advantages of the catheter 2906. 18A to 18EIt is understood that manual or robotic manipulation of multi-catheter stacks is contemplated herein.

[0207] In some embodiments, catheter assembly 2900 (or other combined catheter assemblies described herein) can be driven to a certain position as an assembly. However, each catheter (or guidewire) assembly can be operated and driven to the same or different positions independently of each other.

[0208] In a non-limiting example, the catheter assembly 2900 can be used for a diagnostic angiography procedure. In some embodiments, the assembly 2900 can include only a guidewire 2907 and an access catheter 2902 (in the form of a diagnostic angiography catheter) for performing a diagnostic angiography procedure, or only the guidewire 2907 and access catheter 2902 can be used during the procedure. Optionally, the guide catheter 2906 and the surgical catheter 2904 can be retracted proximally to expose the distal end of the access catheter 2902 (e.g., a few centimeters of the distal end of the access catheter) for performing a diagnostic angiography procedure.

[0209] like Figure 17 As shown, guide catheter 2906, surgical catheter 2904, access catheter 2902, and guidewire 2907 can be arranged concentrically. In certain embodiments, guide catheter 2906 can be a "large bore" guide catheter or access catheter having a diameter of at least about 0.075 inches or at least about 0.080 inches. Surgical catheter 2904 can be an aspiration catheter having a diameter of about 0.060 inches to about 0.075 inches. Access catheter 2902 can be a steerable catheter having a deflectable distal tip having a diameter of about 0.025 inches to about 0.050 inches. Guidewire 2907 can have a diameter of about 0.014 inches to about 0.020 inches. In one example, guide catheter 2906 may have a diameter of approximately 0.088 inches, surgical catheter 2904 may have a diameter of approximately 0.071 inches, access catheter 2902 may have a diameter of approximately 0.035 inches, and guidewire 2907 may have a diameter of approximately 0.018 inches.

[0210] 18A to 18E Depicted is an exemplary sequence of steps for introducing a multi-catheter assembly configured to achieve direct access to a clot, either manually or robotically. 18A to 18E Can be used Figure 17 Other combinations of catheters may be substituted for the interventional device assembly, as will be understood by those skilled in the art in light of the disclosure herein.

[0211] refer to Figure 18A, the three-catheter interventional device assembly 2900 is shown as being driven through the introducer sheath 3002, up through the iliac arteries 3004 and into the descending aorta. Next, the access catheter 2902, the surgical catheter 2904 (e.g., 0.071 inches), and the guide catheter 2906 (e.g., 0.088 inches) are tracked to the aortic arch 3006, as shown. Figure 18B Here, the distal end of the guide catheter 2906 can be parked below the aortic arch 3006, and the surgical catheter 2904, the access catheter 2902 (located within the surgical catheter 2904, and Figure 18B ostium (not visible in the figure) and guidewire 2907 can be driven into the ostium (e.g., simultaneously or separately). In some embodiments, the access catheter 2902 is pushed out of the surgical catheter 2904 and the guide catheter 2906 to first engage the ostium. After the distal end of the access catheter 2902 is positioned within the desired ostium, the guidewire 2907 can be advanced distally into the ostium to secure access. After the access catheter 2902 and guidewire 2907 are located within the desired ostium, the surgical catheter 2904 and / or guidewire 2906 can be advanced into the ostium (and in some embodiments, beyond the ostium) while using the support of the access catheter 2902 and / or guidewire 2907 to maneuver through the aorta and into the ostium. Figure 18B In the embodiment shown, the surgical catheter 2904 has been advanced into the ostium, while the guide catheter 2906 has been maintained below the aortic arch 3006.

[0212] refer to Figure 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 artery 3014. The guidewire 2907 is then advanced superiorly to the petrous segment 3018 of the internal carotid artery 3016.

[0213] refer to Figure 18D , guide catheter 2906 and surgical catheter 2904 (located within guide catheter 2906 and Figure 18D (not visible in FIG) over the guidewire 2907 and into the catheter 2902 (located within the surgical catheter 2904 and Figure 18D The guidewire 2907 can be further advanced through the rock segment 3018 to the site of the clot 3020, such as the M1 segment.

[0214] refer to Figure 18E , guide catheter 2906 and surgical catheter 2904 (located within guide catheter 2906 and Figure 18E3020) are advanced (e.g., simultaneously or sequentially) to position the distal tip of surgical catheter 2904 at the surgical site, such as on the surface of clot 3020. Guidewire 2907 and access catheter 2902 (located within surgical catheter 2904 and Figure 18E 2906) and aspiration of the clot 3020 is initiated through the surgical catheter 2904. That is, the guidewire 2907 and the access catheter 2902 are retracted proximally to allow aspiration through the surgical catheter 2904. After aspiration of the clot, the surgical catheter 2904 and the guide catheter 2906 can be removed (e.g., simultaneously or sequentially). For example, in some embodiments, the surgical catheter 2904 can be removed before the guide catheter 2906 is removed.

[0215] The catheter assembly 2900 can be used to perform neurovascular procedures, such as 18A to 18E As shown. For example, the neurovascular procedure can be a neurovascular thrombectomy. The steps of the procedure can include providing an assembly comprising at least a guidewire, an access catheter, a guide catheter, and a surgical catheter. For example, catheter assembly 2900 comprises a guidewire 2907, an access (e.g., insertion) catheter 2902, a guide catheter 2906, and at least one surgical catheter 2904. The surgical catheter 2904 can include an aspiration catheter, an embolization deployment catheter, a stent deployment catheter, a shunt deployment catheter, a diagnostic angiography catheter, a stent retrieval catheter, a clot retrieval catheter, a balloon catheter, a catheter to facilitate percutaneous valve repair or replacement, an ablation catheter, and / or an RF ablation catheter or guidewire.

[0216] The neurovascular procedure may also include the steps of connecting the assembly to a non-robotic or robotic drive system and driving the assembly to achieve supra-aortic access. The steps may also include driving a subset of the assembly to the neurovascular site and performing the neurovascular procedure using the subset of the assembly. The subset of the assembly may include a guidewire, a guide catheter, and a surgical catheter.

[0217] Each of the guidewire 2907, access catheter 2902, guide catheter 2906, and surgical catheter 2904 is configured to be regulated by a corresponding hub. For example, the guidewire 2907 can include (or be connected to) a hub mounted on one of the tray assemblies described herein. Similarly, the access catheter 2902 can be connected to a catheter hub 2910. The guide catheter 2906 can be connected to a guide catheter hub 2914. The surgical catheter 2904 can be connected to a surgical catheter hub 2912.

[0218] Typically, the connection of the components can include magnetically connecting the first hub 2909 on the guidewire 2907 to the first drive magnet, magnetically connecting the second hub 2910 on the access catheter 2902 to the second drive magnet, magnetically connecting the third hub 2912 on the surgical catheter 2904 to the third drive magnet, and magnetically connecting the fourth hub 2914 on the guide catheter 2906 to the fourth drive magnet. Typically, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are each independently and movably carried by the drive station, as described by the tray assembly and control member described herein. In some embodiments, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are connected (e.g., connected to their respective catheter hubs) through a sterile barrier (e.g., a sterile and fluid barrier) and are independently and movably carried by a drive station having multiple driven magnets. In some embodiments, two or more drive magnets may be bolted or otherwise connected together to move as an assembly in response to commands from a single controller bolted to or otherwise connected to one of the drive magnets.

[0219] In some embodiments, the step of performing the neurovascular procedure can include driving the assembly in response to movement of each of the hub adapters along the support table until the assembly is positioned to achieve supra-aortic vascular access. The hub adapters can include, for example, a connector / hub adapter that acts as a shuttle by being propelled proximally or distally along a track in response to operator commands. The hub adapters described herein can each include at least one drive magnet configured to connect to a driven magnet carried by a corresponding hub. This provides a magnetic connection between the drive magnet and the driven magnet through the sterile barrier so that the corresponding hub moves into the top of the sterile barrier in response to movement of the hub adapter outside the sterile field (e.g., Figure 4 ). Movement of the hub adapter is driven by a drive system carried by a support platform on which the guidewire hub 2909, guide catheter hub 2914, surgical catheter hub 2912, and access catheter hub 2910 are mounted.

[0220] The steps may also include driving a subset of the components in response to movement of each of the hub adapters along the support table until the subset of components is positioned to perform a neurovascular procedure at the neurovascular treatment site. The subset of components may include a guidewire 2907, a guide catheter 2906, and a surgical catheter 2904.

[0221] In some embodiments, the guidewire 2907, guide catheter 2906, and surgical catheter 2904 are passed as an assembly (relative to the guidewire 2907) and over (relative to the guide catheter 2906 and surgical catheter 2904) at least a portion of the length of the entry (e.g., insertion) catheter 2902 after access over the aorta is achieved.

[0222] In some embodiments, catheter assembly 2900 can be part of a robotically controlled system for achieving supra-aortic access and neurovascular treatment site access, such as 18A to 18E As shown. 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 (having manual and robotic components) for achieving supra-aortic access and neurovascular treatment site access. For example, in such a hybrid system, supra-aortic access can be robotically driven, while neurovascular site access and embolectomy or other procedures can be manual. Alternatively, in such a hybrid system, supra-aortic access can be manual, while 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 surgical catheter can be robotically driven or manually operated.

[0223] The example robotic control system can include at least a guidewire hub (e.g., guidewire hub 2909) configured to adjust each of the axial position and the rotational position of the guidewire 2907. The robotic control system can also include an access catheter hub 2910 configured to adjust the axial and rotational movement of the access catheter 2902. The robotic control system can also include a guide catheter hub 2914 configured to control the axial movement of the guide catheter 2906. The robotic control system can also include a surgical catheter hub 2912 configured to adjust the axial position and the rotational position of the surgical catheter 2904.

[0224] In some embodiments, the surgical catheter hub 2912 is also configured to laterally deflect the distal deflection region of the surgical catheter 2904 .

[0225] In some embodiments, the guidewire hub 2909 is configured to connect to the guidewire hub adapter by magnetically connecting the guidewire hub to the first drive magnet. The access catheter hub 2910 is configured to connect to the access catheter hub adapter by magnetically connecting the access catheter hub 2910 to the second drive magnet. The surgical catheter hub 2912 is configured to connect to the surgical catheter hub adapter by magnetically connecting the surgical catheter hub 2912 to the third drive magnet. The guide catheter hub 2914 is configured to connect to the guide catheter hub adapter by magnetically connecting the guide catheter hub 2914 to the fourth drive magnet. In some embodiments, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are independently and movably carried by the drive platform.

[0226] In some embodiments, the robotic control system includes a first driven magnet on the guidewire hub 2909. The first driven magnet can be configured to cooperate with the first drive magnet such that the first driven magnet is configured to move in response to movement of the first drive magnet. In some embodiments, the first drive magnet is configured to move through a barrier to the outside of the sterile field separated from the first driven magnet while the first driven magnet is within the sterile field. In some embodiments, the position of the first driven magnet can move in response to operation of a surgical drive control on a console associated with the drive table. References above Figure 4 The interaction of the driving and driven magnets is described in detail.

[0227] In some embodiments, the robotic control system includes a second driven magnet on the entry catheter hub 2910. The second driven magnet can be configured to cooperate with the second drive magnet such that the second driven magnet is configured to move in response to movement of the second drive magnet. In some embodiments, the second drive magnet is configured to move outside the sterile field separated from the second driven magnet through a barrier when the second driven magnet is within the sterile field.

[0228] In some embodiments, the robotic control system includes a third driven magnet on the surgical catheter hub 2912. The third driven magnet can be configured to cooperate with the third drive magnet such that the third driven magnet is configured to move in response to movement of the third drive magnet. In some embodiments, the third drive magnet is configured to move outside the sterile field separated from the third driven magnet through a barrier when the third driven magnet is within the sterile field.

[0229] In some embodiments, the robotic control system includes a fourth driven magnet on the guide catheter hub 2914. The fourth driven magnet can be configured to cooperate with the fourth drive magnet so that the fourth driven magnet is configured to move in response to the movement of the fourth drive magnet. In some embodiments, the fourth drive magnet is configured to move to the outside of the sterile area separated from the fourth driven magnet through a barrier when the fourth driven magnet is within the sterile area. In some embodiments, there can be more than four driven magnets and corresponding catheter hubs for controlling additional catheters.

[0230] In some embodiments, the devices described herein (e.g., hubs, hub adapters, interventional devices, and / or trays) can be used in robotically driven surgery. For example, in robotically driven surgery, one or more interventional devices can be driven through the vascular system and reach the surgical site. Robotically driving such a device can include engaging an electromechanical assembly controlled by user input. In some embodiments, a user can provide input at a control system that interfaces with one or more hubs and hub adapters.

[0231] In some embodiments, the hubs, hub adapters, interventional devices, and trays described herein can be used during non-robotic (e.g., manually driven) surgery. Manually driving such a device can include manually engaging the hub to affect movement of the interventional device.

[0232] In some embodiments, the devices described herein can be used to implement methods for performing intracranial surgery at an intracranial site. The methods for performing intracranial surgery can include any of the same steps as those described herein for performing neurovascular surgery. The methods can be performed robotically, manually, or a hybrid combination of the two.

[0233] While the foregoing describes a magnetic connection of the hub to the drive magnet, in other embodiments, any interventional device and / or hub can be mechanically connected to the drive system. Any method described herein may include the step of mechanically connecting one or more interventional devices (e.g., guidewire 2907, access catheter 2902, surgical catheter 2904, and / or guide catheter 2906) and / or one or more hubs (e.g., guidewire hub 2909, access catheter hub 2910, surgical catheter hub 2912, and / or guide catheter hub 2914) to one or more drive mechanisms.

[0234] Figure 19A mechanical connection mechanism 1654 is shown between the driver member 1650 and the driven member 1652. The driver member 1650 and the driven member 1652 can have any features or functions that are the same or similar to the driver magnet 67 and the driven magnet 69, respectively, unless otherwise described herein. The driver member 1650 can be part of or connected to a hub adapter (e.g., hub adapter 48). The driven member 1652 can be part of or connected to a hub (e.g., hub 36, guidewire hub 2909, access catheter hub 2910, surgical catheter hub 2912, or guide catheter hub 2914). In some cases, the mechanical connection mechanism 1654 can include a structural support member (e.g., a support rod or support strut) that extends laterally through the seal in the sterile barrier 1632. As the drive mechanism 1650 and the driven mechanism 1652 are advanced and / or retracted as described herein, the seal can allow the structural support to be advanced along the length of the sterile barrier 1632 while still maintaining a seal with the structural support to maintain the sterile field. For example, the seal can include a tongue and groove closure mechanism along the sterile barrier 1632 that is configured to close on either side of the structural support while allowing the structural support to pass through the sterile barrier 1632 and maintain the seal against the structural support as the structural support is advanced along the length of the sterile barrier 1632.

[0235] In some embodiments, the structural support can extend through an elongated self-closing seal (e.g., shaped like a duckbill valve) between two adjacent mating edges of a flexible material that extends along the shaft. As the structural support is advanced along the shaft between the mating edges, the mating edges can allow the structural support to advance and then be biased back into sealing engagement with each other when the structural support passes any given point along the shaft.

[0236] In some embodiments, the drive mechanism can be a spline drive shaft (e.g., a non-sterile spline drive shaft). Mechanical connection 1654 can include a pulley in a plate used as a sterile barrier 1632 and a sterile spline shaft configured to be connected to a driven member 1652. Driven member 1652 can be a sterile pulley that receives a sterile spline shaft from a sterile barrier. In some embodiments, one or more spline drive shafts can engage and rotate the corresponding pulleys used as a sterile barrier in the plate. Each hub can have a sterile pulley that is configured to receive a sterile spline shaft from a sterile barrier plate. The rotation of the spline drive shaft can rotate the pulley in the sterile barrier plate, which can then rotate the sterile pulley in the hub via a sterile spline shaft.

[0237] Those skilled in the art will appreciate that any of the embodiments described herein may be modified to incorporate mechanical connection mechanisms, such as Figure 19 shown.

[0238] The interventional devices described herein can be provided individually, or at least some of the interventional devices can be provided in a preassembled (e.g., nested or stacked) configuration. For example, the interventional devices can be provided in a concentric nested or stacked configuration in the form of an interventional device assembly (e.g., interventional device assembly 2900). If provided individually, each catheter (and in some embodiments, each corresponding catheter hub) can be unpacked and pre-filled to remove air from its inner lumen, for example, by flushing the catheter (and in some embodiments, flushing the corresponding catheter hub) to remove air by displacing the air with a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent). After pre-filling, the interventional devices can be manually assembled into a stacked configuration so that they are ready to be introduced into the body for surgical use, for example, via an introducer sheath.

[0239] Assembling the devices into a stacked configuration may include inserting the interventional devices individually into each other in order of size. For example, an interventional device having the second largest diameter may be inserted into the lumen of an interventional device having the largest diameter. An interventional device having the third largest diameter may then be inserted into the lumen of an interventional device having the second largest diameter, and so on.

[0240] For example, by Figure 17 , can be assembled by first inserting the distal end of catheter 2904 through hub 2914 and into catheter 2906. Catheter 2904 can be advanced through catheter 2906 until the distal tip of catheter 2904 is flush with or extends beyond the distal tip of catheter 2906, and / or until catheter 2904 can no longer be inserted. Then, the distal end of catheter 2902 can be inserted through hub 2912 and into catheter 2904. Catheter 2902 can be advanced through catheter 2904 until the distal tip of catheter 2902 is flush with or extends beyond the distal tip of catheter 2904, and / or until catheter 2902 can no longer be inserted. Then, the distal end of guidewire 2907 can be inserted through hub 2910 and into catheter 2902. The guidewire 2907 may be advanced through the catheter 2902 until the distal tip of the guidewire 2907 is flush with or extends beyond the distal tip of the catheter 2902 and / or until the guidewire 2907 cannot be inserted any further.

[0241] Embodiments in which two or more interventional devices are packaged together as a single assembly in an assembled (e.g., nested or stacked) configuration can provide efficient unpacking and preparation prior to use, and provide efficient assembly within a robotic control system. The interventional devices can be pre-installed to their respective hubs prior to packaging. In certain embodiments, two or three or more interventional devices can be packaged in a fully nested (i.e., fully axially inserted) configuration or an almost fully nested configuration. In a fully nested configuration, each interventional device is inserted as far as possible into the adjacent distal hub and interventional device. Such a fully nested configuration can minimize the total length of the interventional device assembly and minimize the size of the packaging required to accommodate the interventional device assembly.

[0242] In some embodiments, interventional device can also be sterilized before packaging, while in assembly configuration, for example, using ethylene oxide gas.In some embodiments, before sterilizing with ethylene oxide gas, interventional device can be packaged in assembly configuration.For the interventional device of nested or stacked configuration, ethylene oxide gas can be provided in the space (for example, the annular lumen between the outer diameter of the first interventional device and the inner diameter of the second interventional device nested in the second interventional device) between adjacent interventional devices for sterilization.In some embodiments, interventional device assembly can be packaged in a thermoformed tray and sealed with HDPE (for example, Tyvek®) lid. The interventional device assembly can be unpacked by removing (for example, opening or peeling off) lid by the user in a non-sterile area. Then, the user in the sterile area can remove the interventional device assembly and place it on the sterile working surface of, for example, a robot-driven table, as described herein.

[0243] Packaging the interventional devices in an assembled configuration and sterilized state can reduce the time associated with unpacking and assembling individual interventional devices and facilitate efficient connection to a robotic drive system. Each interventional device and hub combination can also be packaged with fluidic connectors for connecting to a fluid source and / or vacuum source. In some embodiments, each hub or hemostatic valve connected to the hub can include a fluidic connector.

[0244] After unpacking the interventional device assembly (e.g., after positioning the interventional device assembly on the robotic drive station), priming can be performed while the devices are concentrically nested or stacked. This is preferably done in each fluid lumen, e.g., the annular lumen between catheter 2906 and catheter 2904, and between each additional concentric interventional device in the concentric stack. In some embodiments, the fluid lumen can include a lumen between the distal hub and the proximal interventional device, e.g., the lumen between hub 2914 and catheter 2904. In some embodiments, priming can be performed while the devices are still in sterile packaging.

[0245] The fluidics connector can be connected to a fluidics system for delivering saline and contrast media to conduit and providing suction. In some embodiments, the fluidics connector can be delivered to the outside of the sterile area for being connected to the fluidics system. After being connected, the fluidics system can carry out a series of pre-fills to rinse each conduit of the interventional device assembly with fluid (for example, saline, contrast media, or a mixture of saline and contrast media). A series of pre-fills can also include flushing each corresponding conduit hub with fluid. Fluid can be removed by the fluidics system before pre-filling or removed by gas. In some embodiments, the vacuum source of the fluidics system can also be used for evacuating air from each conduit while flushing with fluid. In certain embodiments, the tip of the conduit can be placed in the container of fluid (for example, saline, contrast media, or a mixture of saline and contrast media) during pre-filling so that when applying a vacuum source, the fluid in the container rather than air is aspirated by the tip of the conduit. In other embodiments, the tip of the conduit can be closed (for example, using a plug) so that when applying a vacuum source, air can not be aspirated from the tip of the conduit. In certain embodiments, the priming process can be automated such that a user can provide a single command, and each catheter (and in some embodiments, each corresponding catheter hub) can be primed sequentially or simultaneously (e.g., as by 20A to 20C described).

[0246] Additional details regarding the fluidics system are described in U.S. patent application Ser. No. 17 / 879,614, filed on August 2, 2022, entitled “MultiCatheter System With Integrated Fluidics Management,” which is hereby expressly incorporated herein in its entirety.

[0247] When the cross-sectional lumen area available for flow is reduced, for example, when a second interventional device (e.g., a catheter or guidewire) is extended within the lumen of a first interventional device, the fluid resistance within the lumen can be greater. For example, the amount of fluid resistance can be affected by the length narrowing of the cross section due to the depth of axial insertion of the second interventional device within the first interventional device. A second interventional device that extends partially through the lumen of the first interventional device will provide a smaller length narrowing of the cross section and, therefore, may result in a lower fluid resistance within the lumen of the first catheter than would be the case if the second interventional device were fully extended through the lumen of the first interventional device. Thus, fluid resistance can be reduced by at least partially reducing the depth to which the second interventional device is axially inserted (i.e., axially overlapped) into a lumen through which fluid is injected (e.g., the length of the second interventional device into its concentrically adjacent lumen).

[0248] In some embodiments, at certain insertion depths of the second interventional device within the first interventional device (e.g., when the second interventional device is at or near a maximum insertion depth within the first interventional device), the size of the fluid pathway between the devices (e.g., the annular lumen between the first interventional device and the second interventional device) can result in a higher than desired amount of fluid resistance during the priming process. In some embodiments, the insertion depth of the second interventional device within the first interventional device can be reduced to reduce the pressure required to prime the catheter and reduce internal interference.

[0249] In some embodiments, the catheter in the interventional device assembly can be separated from other interventional devices for prefilling, to reduce the pressure required for prefilling catheter and to reduce internal interference. By making the interventional device retract to the proximal end in the lumen of catheter, the catheter to be prefilled can be separated from the interventional device in the lumen of catheter. For example, the interventional device in the lumen of catheter to be prefilled can be retracted to the proximal end as far as possible from the catheter to be prefilled, while still maintaining a nested or stacked relationship (for example, at least about 2cm or 5cm or more axial overlap), so as to minimize the pressure required for prefilling catheter and minimize internal interference. In other words, catheter can be separated from the interventional device more proximal, for prefilling, while the distal tip of the adjacent proximal interventional device is still located in the lumen of catheter. Remaining at least some distal tips of the adjacent proximal interventional device in the lumen of catheter can allow to more easily reinsert and advance the proximal interventional device after prefilling.

[0250] In some embodiments, the axial overlap can be from about 2 cm to about 20 cm, from about 2 cm to 10 cm, from about 2 cm to 5 cm, from about 5 cm to 20 cm, from about 5 cm to 10 cm, or any other suitable range. In some embodiments, the axial overlap can be at least about 2 cm, at least about 5 cm, at least about 10 cm, at least about 20 cm, no more than 2 cm, no more than 5 cm, no more than 10 cm, no more than 20 cm, about 2 cm, about 5 cm, about 10 cm, about 20 cm, or any other suitable amount.

[0251] In some embodiments, the robotically driven stage can be programmed to retract the internal interventional device proximally from the catheter to be primed as much as possible while still maintaining a nested or stacked relationship. In other embodiments, the robotically driven stage can be programmed to separate the internal device from the catheter to be primed to a distance sufficient to optimize the length of the unobstructed lumen and result in an amount of fluid resistance below a threshold. After the catheter to be primed is separated from the other interventional devices, the catheter can be primed by flushing the catheter with a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent).

[0252] After the catheter is primed, it can be returned to the initial position and the next catheter of the interventional device assembly can be separated from the other interventional devices within its lumen for primed. This sequence can be repeated for each catheter of the interventional device assembly. In other embodiments, after the catheter is primed, it can be advanced to a ready or driven position to begin insertion into the patient. Although the foregoing describes the separation of the catheter to be primed by retraction of the inner interventional device, the outer catheter can also be separated from the inner interventional device by axially advancing the outer catheter distally relative to the inner interventional device. 20A to 20C , an example of the precharging process is described.

[0253] Figure 20A The interventional device assembly 2900 is depicted assembled in a concentrically stacked and axially compressed configuration. Figure 20A As shown, the interventional devices can be completely nested within each other. This can be the configuration after the device assembly 2900 is unpacked and placed on the robotic drive table. A series of priming can be initiated by axially advancing the catheter 2906 and hub 2914 distally relative to the catheter 2904, hub 2912, catheter 2902, hub 2910, guidewire 2907 and hub 2909, for example, as far as possible while maintaining the distal tip of the catheter 2904 within the lumen of the catheter 2906, as shown. Figure 20B As shown, or advanced to a distance that will result in the desired amount of fluid resistance for priming. In some embodiments, the catheter 2906 is advanced in response to a control signal from a control system. The catheter 2906 can then be primed by introducing a priming fluid using a fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. The priming catheter 2906 may include a priming hub 2914. For example, in certain embodiments, the hub 2914 or a hemostatic valve connected thereto may include a fluidics connector to receive the priming fluid from the fluidics system. After priming, the catheter 2906 can be returned to its initial position (e.g., a fully axially compressed configuration), as shown. Figure 20A In some embodiments, the catheter 2906 is returned to its initial position in response to a control signal from the control system.

[0254] After catheter 2906 is primed and returned to its initial position, catheter 2904 and hub 2912 can be advanced distally axially relative to catheter 2902, hub 2910, guidewire 2907, and hub 2909 (also advancing catheter 2906 and hub 2914 axially distally without changing or minimally changing their relative positions relative to catheter 2904), e.g., as far as possible while maintaining the distal tip of catheter 2902 within the lumen of catheter 2904, as shown. Figure 20CAs shown, or is advanced to a distance that will result in the desired amount of fluid resistance for priming. In some embodiments, catheter 2904 and catheter 2906 are advanced in response to a control signal from a control system. Catheter 2904 can then be primed by introducing a priming fluid using a fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. The priming catheter 2904 may include a priming hub 2912. For example, in certain embodiments, the hub 2912 or a hemostatic valve connected thereto may include a fluidics connector to receive the priming fluid from the fluidics system. After priming, catheter 2904 and catheter 2906 can be returned to their initial positions (e.g., a fully axially compressed configuration), as shown. Figure 20A In some embodiments, conduit 2904 and conduit 2906 are returned to their initial positions in response to a control signal from a control system.

[0255] After catheter 2904 is primed and returned to its initial position, catheter 2902 and hub 2910 can be axially advanced distally relative to guidewire 2907 and hub 2909 (also axially advancing catheter 2906, hub 2914, catheter 2904, and hub 2912 distally without changing or minimally changing their relative positions relative to catheter 2902), for example, as far as possible while maintaining the distal tip of guidewire 2907 within the lumen of catheter 2902, or to a distance that will result in the desired amount of fluid resistance for priming. In some embodiments, catheter 2902, catheter 2904, and catheter 2906 are advanced in response to a control signal from a control system. Catheter 2902 can then be primed by introducing a priming fluid using a fluidics system. In some embodiments, the priming fluid is introduced in response to a control signal from a control system. Priming catheter 2902 may include priming hub 2910. For example, in some embodiments, hub 2910 or a hemostatic valve connected thereto may include a fluidic connection to receive priming fluid from the fluidic system. After priming, catheter 2902 and catheters 2904 and 2906 may be returned to Figure 20A 2902, 2904, and 2906 are shown in their initial positions (eg, fully axially compressed configuration). In some embodiments, conduit 2902, conduit 2904, and conduit 2906 are returned to their initial positions in response to a control signal from a control system.

[0256] In some embodiments, by 20A to 20C The described priming procedure can be performed in response to a single control signal from a control system. In other embodiments, the various steps of the priming procedure can be performed in response to unique control signals. In some embodiments, the priming of each unique interventional device can be performed in response to a unique control signal.

[0257] In an alternative embodiment, each of the catheters can be distally separated from each other simultaneously for priming. For example, catheter 2902 can be distally separated from guidewire 2907 while maintaining the distal tip of guidewire 2907 within the lumen of catheter 2902, catheter 2904 can be distally separated from catheter 2902 while maintaining the distal tip of catheter 2902 within the lumen of catheter 2904, and catheter 2906 can be distally separated from catheter 2904 while maintaining the distal tip of catheter 2904 within the lumen of catheter 2906. However, as shown by 20A to 20C In the described embodiments, only one set of adjacent hubs is separated at a time, which can provide a smaller overall assembly length at any given time, which can allow for use with smaller robotic drive systems. Although separation of the outer catheters from their inner interventional devices is described as axially advancing the catheters distally relative to their inner interventional devices, separation can include proximally retracting the inner interventional devices from the outer catheters.

[0258] In an alternative embodiment, one or more of catheters 2902, 2904, and 2906 can be advanced to a ready or actuated position to initiate insertion into a patient after priming (e.g., before priming a subsequent catheter). In such an embodiment, the catheters can be advanced to the ready or actuated position without returning to their initial positions after priming.

[0259] As described above, in some embodiments, the catheters 2902, 2904, and 2906 can be assembled prior to flushing the catheter. Figure 17 The concentric stack shown is oriented to remove air by displacing it with a fluid (e.g., saline contrast or a mixture of saline and contrast). This is preferably done in each fluid lumen, e.g., the annular lumen between catheter 2906 and catheter 2904, and between each of the additional concentric interventional devices in the concentric stack. Infusing fluid (e.g., saline, contrast, or a mixture of saline and contrast) under pressure can displace substantially all of the air, but may retain some small bubbles that adhere to the inner wall of the outer catheter (e.g., guide catheter 2906), the outer wall of the inner catheter (e.g., surgical catheter 2904), or both.

[0260] When fluid is introduced into the proximal end of the annular lumen under pressure (for example, introduced into the hub of the outer catheter or the hemostatic valve connected thereto), the inner catheter can move relative to the outer catheter to destroy the holding force between the microbubble and the adjacent wall, and allow the bubble to be brought downstream and discharged or removed via suction through the distal opening of the cavity. The catheter can move axially, rotationally, or axially and rotationally relative to each other. In certain embodiments, the catheter can move back and forth axially, rotationally, or axially and rotationally relative to each other. In some embodiments, the catheter can move back and forth, axially, rotationally, or reciprocatingly axially and rotationally. In other embodiments, the catheter can rotate continuously or rotate in a constant direction.

[0261] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating over a stroke length of about 1 mm to about 250 mm, about 10 mm to about 250 mm, about 5 mm to about 125 mm, about 25 mm to about 125 mm, about 10 mm to about 50 mm, about 15 mm to about 30 mm, about 5 mm to about 30 mm, about 15 mm to about 25 mm, about 20 mm to about 40 mm, or any other suitable range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating over a stroke length of at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, at least 30 mm, at least 50 mm, no more than 10 mm, no more than 20 mm, no more than 25 mm, no more than 30 mm, no more than 50 mm, no more than 125 mm, no more than 150 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 50 mm, or any other suitable stroke length.

[0262] In some embodiments, the first conduit reciprocates relative to an adjacent conduit or guidewire, for example, axially reciprocates with a reciprocating frequency of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, no more than 0.5 Hz, no more than 1 Hz, no more than 2 Hz, no more than 5 Hz, no more than 10 Hz, no more than 25 Hz, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency range.

[0263] In one embodiment, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, axially reciprocating over a stroke length of about 0.5 inches to about 10 inches, or axially reciprocating over a stroke length of about 1 inch to about 5 inches at a reciprocating frequency of no more than about 5 cycles / second or two cycles / second or less.

[0264] In some embodiments, the first catheter is reciprocated relative to an adjacent catheter or guidewire, for example, at an angle of about 5 degrees to about 180 degrees, about 5 degrees to about 360 degrees, about 15 degrees to about 180 degrees, about 15 degrees to about 150 degrees, about 15 degrees to about 120 degrees, about 15 degrees to about 90 degrees, about 15 degrees to about 60 degrees, about 15 degrees to about 30 degrees, about 30 degrees to about 180 degrees, about 30 degrees to about 150 degrees, about 30 degrees to about 120 degrees, about 30 degrees to about 90 degrees, about 15 degrees to about 60 degrees, about 15 degrees to about 30 degrees, about 30 degrees to about 180 degrees, about 30 degrees to about 150 degrees, about 30 degrees to about 120 degrees, about 30 degrees to about 150 degrees. The device may be rotatably reciprocated about an angle of rotation / stroke of about 90 degrees, about 30 degrees to about 60 degrees, about 60 degrees to about 180 degrees, about 60 degrees to about 150 degrees, about 60 degrees to about 120 degrees, about 60 degrees to about 90 degrees, about 90 degrees to about 180 degrees, about 90 degrees to about 150 degrees, about 90 degrees to about 120 degrees, about 120 degrees to about 180 degrees, about 120 degrees to about 150 degrees, about 150 degrees to about 180 degrees, or any other suitable range of rotation angles / strokes. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire, for example, rotationally reciprocating with a rotational angle / stroke of at least 5 degrees, at least 15 degrees, at least 30 degrees, at least 60 degrees, at least 90 degrees, at least 120 degrees, at least 150 degrees, at least 180 degrees, at least 360 degrees, no more than 5 degrees, no more than 15 degrees, no more than 30 degrees, no more than 60 degrees, no more than 90 degrees, no more than 120 degrees, no more than 150 degrees, no more than 180 degrees, no more than 360 degrees, about 5 degrees, about 15 degrees, about 30 degrees, about 60 degrees, about 90 degrees, about 120 degrees, about 150 degrees, about 180 degrees, about 360 degrees, or any other suitable angle.

[0265] In some embodiments, the first conduit reciprocates relative to an adjacent conduit or guidewire, for example, with a reciprocating frequency of about 0.5 Hz to about 1 Hz, about 1 Hz to about 5 Hz, about 1 Hz to about 10 Hz, about 1 Hz to about 25 Hz, about 5 Hz to about 10 Hz, about 10 Hz to about 25 Hz, or any other suitable frequency range. In some embodiments, the first conduit reciprocates relative to an adjacent conduit or guidewire, for example, with a reciprocating frequency of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, no more than 0.5 Hz, no more than 1 Hz, no more than 2 Hz, no more than 5 Hz, no more than 10 Hz, no more than 25 Hz, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz, or any other suitable frequency range.

[0266] In some embodiments, the first catheter is reciprocated relative to an adjacent catheter or guidewire for a reciprocating number of times within a range of 1 to 200, 1 to 100, 1 to 50, 1 to 25, 1 to 15, 1 to 10, 1 to 5, 5 to 25, 5 to 15, 5 to 10, or any other suitable range. In some embodiments, the first catheter is reciprocated relative to an adjacent catheter or guidewire for at least 1 back-and-forth, at least 2 back-and-forth, at least 5 back-and-forth, at least 10 back-and-forth, at least 15 back-and-forth, at least 25 back-and-forth, at least 50 back-and-forth, no more than 5 back-and-forth, no more than 10 back-and-forth, no more than 15 back-and-forth, no more than 25 back-and-forth, no more than 50 back-and-forth, no more than 100 back-and-forth, no more than 200 back-and-forth, about 1 back-and-forth, about 2 back-and-forth, about 5 back-and-forth, about 10 back-and-forth, about 25 back-and-forth, about 50 back-and-forth, about 100 back-and-forth, about 200 back-and-forth, or any other suitable number of reciprocating movements. A reciprocating movement can include moving (axially or rotationally) from a first position to a second position and then returning to the first position from the second position.

[0267] In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire over a length of time from about 1 second to about 60 seconds, from about 1 second to about 45 seconds, from about 1 second to about 30 seconds, from about 1 second to about 20 seconds, from about 1 second to about 15 seconds, from about 1 second to about 10 seconds, from about 5 seconds to about 45 seconds, from about 5 seconds to about 30 seconds, from about 5 seconds to about 20 seconds, from about 5 seconds to about 15 seconds, from about 5 seconds to about 10 seconds, from about 10 seconds to about 30 seconds, from about 10 seconds to about 20 seconds, or any other suitable range. In some embodiments, the first catheter reciprocates relative to an adjacent catheter or guidewire for a period of at least 1 second, at least 5 seconds, at least 10 seconds, at least 15 seconds, at least 20 seconds, at least 30 seconds, at least 45 seconds, at least 60 seconds, no more than 5 seconds, no more than 10 seconds, no more than 15 seconds, no more than 20 seconds, no more than 30 seconds, no more than 45 seconds, no more than 60 seconds, about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 30 seconds, about 45 seconds, about 60 seconds, or any other suitable period of time.

[0268] The reciprocating movement of adjacent catheters to destroy microbubbles can be accomplished by manually grasping the corresponding catheter hubs and manually moving the catheters axially or rotationally relative to each other while delivering a pressurized fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent). Alternatively, for example 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 hub 2914 and hub 2912) to achieve relative movement between adjacent catheters to destroy and expel microbubbles, such as in response to user activation of a flush control. For example, in certain embodiments, two adjacent interventional devices can be moved relative to each other in response to a control signal from a control system. In certain embodiments, the delivery of the pressurized fluid can be performed in response to a control signal from a control system.

[0269] The reciprocating movement of adjacent conduits can generate a shear force that removes bubbles. For example, the relative movement of the inner and outer surfaces of adjacent conduits can increase the fluid shear rate between adjacent conduits during pre-filling compared to a static surface. In some embodiments, shear force can be increased by increasing the flow rate of a solution (e.g., saline, contrast agent, or a mixture of saline and contrast agent) provided by a fluidics system. In certain embodiments, the flow rate and relative movement between adjacent conduits are controlled to remove bubbles.

[0270] In some embodiments, after each catheter is primed with the fluidics system, an ultrasonic bubble detector can be used to confirm that the catheter is substantially free of bubbles. For example, an ultrasound chip (e.g., mounted within a hub adjacent to the catheter receiving lumen) can be extended along the length of the catheter to confirm that no bubbles remain in the system.

[0271] pass Figures 21A to 21B An example of a priming procedure involving reciprocating movement of adjacent catheters is described.

[0272] Figure 21A The interventional device assembly 2900 is depicted assembled in a concentric stacked configuration. Figure 21A As shown, the interventional devices can be completely nested within each other. This can be the configuration after the device assembly 2900 is unpacked and placed on the robotic drive table. Alternatively, the individual interventional devices of the device assembly 2900 can be assembled into the device assembly 2900 on the drive table.

[0273] A series of priming can be initiated by priming catheter 2906. In some embodiments, catheter 2906 can be primed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of catheter 2906 while causing axial, rotational, or axial and rotational reciprocating movement of catheter 2906 and / or hub 2914 relative to catheter 2904. The priming catheter 2906 can include a priming hub 2914. For example, in certain embodiments, hub 2914 or a hemostatic valve connected thereto can include a fluidic connector to receive priming fluid from a fluidic system. In certain embodiments, catheter 2906 and / or hub 2914 can be positioned along the longitudinal axis of catheter 2906 (e.g., at Figure 21A location and Figure 21B The axial and / or rotational reciprocating motion of the conduit 2906 and / or hub 2914 can be performed manually or by a robotically driven stage. The reciprocating motion can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0274] In some embodiments, priming of the catheter 2906 can be performed by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) under pressure into the lumen of the catheter 2906 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of the catheter 2904 and / or hub 2912 relative to the catheter 2906. The axial and / or rotational reciprocating movement of the catheter 2904 and / or hub 2912 can be performed manually or by a robotic drive stage. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0275] In some embodiments, priming of catheter 2906 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of catheter 2906 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of catheter 2906 (and / or hub 2914) and catheter 2904 (and / or hub 2912) relative to each other. The reciprocating movement can be caused in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0276] In some embodiments, after priming the catheter 2906, the catheter 2906 can be returned to the Figure 21A In other embodiments, after priming the catheter 2906, the catheter 2906 can be advanced to a ready or actuated position to begin insertion into the patient.

[0277] In some embodiments, after catheter 2906 is prefilled, catheter 2904 can be prefilled. Prefilling catheter 2904 can include a prefilling hub 2912. For example, in certain embodiments, hub 2912 or a hemostatic valve connected thereto can include a fluidic connector to receive a prefill fluid from a fluidics system. In some embodiments, catheter 2904 can be prefilled by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) under pressure into the lumen of catheter 2904 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of catheter 2904 and / or hub 2912 relative to catheter 2902. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0278] In some embodiments, priming of the catheter 2904 can be performed by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) under pressure into the lumen of the catheter 2904 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of the catheter 2902 and / or hub 2910 relative to the catheter 2904. The axial and / or rotational reciprocating movement of the catheter 2902 and / or hub 2910 can be performed manually or by a robotic drive stage. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0279] In some embodiments, priming of catheter 2904 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of catheter 2904 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of catheter 2904 (and / or hub 2912) and catheter 2902 (and / or hub 2910) relative to each other. The reciprocating movement can be caused in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0280] In some embodiments, after priming the catheter 2904, the catheter 2904 can be returned to the Figure 21A In some embodiments, after priming catheter 2904, catheter 2904 can be advanced to a ready or actuated position to begin insertion into the patient.

[0281] In some embodiments, after catheter 2904 is pre-filled, catheter 2902 can be pre-filled. Pre-filled catheter 2902 can include a pre-filled hub 2910. For example, in certain embodiments, hub 2910 or a hemostatic valve connected thereto can include a fluidic connector to receive a pre-filled fluid from a fluidic system. In some embodiments, catheter 2902 can be pre-filled by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) into the lumen of catheter 2902 under pressure while causing axial, rotational, or axial and rotational reciprocating movement of catheter 2902 and / or hub 2910 relative to guidewire 2907. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of fluid under pressure can be performed in response to a control signal from a control system.

[0282] In some embodiments, priming of the catheter 2902 can be performed by introducing a fluid (e.g., saline, a contrast agent, or a mixture of saline and a contrast agent) under pressure into the lumen of the catheter 2902 while simultaneously causing axial, rotational, or axial and rotational reciprocating movement of the guidewire 2907 and / or hub 2909 relative to the catheter 2902. The axial and / or rotational reciprocating movement of the guidewire 2907 and / or hub 2909 can be performed manually or by a robotic drive station. The reciprocating movement can be generated in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0283] In some embodiments, priming of the catheter 2902 can be performed by introducing a fluid (e.g., saline, contrast agent, or a mixture of saline and contrast agent) under pressure into the lumen of the catheter 2902 while simultaneously causing the catheter 2902 (and / or hub 2910) and the guidewire 2907 (and / or hub 2909) to reciprocate axially, rotationally, or both axially and rotationally relative to each other. The reciprocating movement can be caused in response to a control signal from a control system. The introduction of the fluid under pressure can be performed in response to a control signal from a control system.

[0284] In some embodiments, after priming the catheter 2902, the catheter 2902 can be returned to the Figure 21A In other embodiments, after priming the catheter 2902, the catheter 2902 can be advanced to a ready or actuated position to begin insertion into the patient.

[0285] In some embodiments, by Figure 21A and Figure 21BThe described priming procedure can be performed in response to a single control signal from a control system. In other embodiments, the various steps of the priming procedure can be performed in response to unique control signals. In some embodiments, priming of a unique interventional device can be performed in response to a unique control signal.

[0286] In this article through Figure 21A and Figure 21B In the series of priming described, the catheters are primed sequentially, starting with catheter 2906, followed by catheter 2904, and then catheter 2902. However, it is contemplated that the catheters may be primed in any order. The catheters may be primed as described above. Figure 21A and Figure 21B Alternatively, two or more catheters, or each catheter, may be primed in parallel.

[0287] In certain embodiments, the priming of the catheter may include reducing the depth of axial insertion (i.e., axial overlap) of the second interventional device into the lumen of the first interventional device through which the fluid is injected (e.g., the length of the second interventional device into its concentrically adjacent lumen), such as by 20A to 20C As described, and also during priming, relative reciprocating movement is generated axially, rotationally, or axially and rotationally between the first interventional device and the second interventional device, such as by Figure 21A and Figure 21B described.

[0288] In some embodiments, priming of the catheter can include vibrating at least a portion of the catheter and / or its associated hub (when included). For example, the vibration can be induced by a motor integrated into the hub of the catheter, or by a separate motor or vibration source placed on the catheter during priming. In some embodiments, at least a portion of the support platform on which the catheter and / or its associated hub is placed can be vibrated during priming of any one or more catheters to help remove air and / or air microbubbles. Such vibration can be performed by a motor.

[0289] Example

[0290] Additional embodiments are disclosed in more detail in the examples below, which are not intended to limit the scope of the claims in any way.

[0291] Figure 22Figure 2 is a diagram of a test system for testing bubble removal between concentrically stacked catheters. The test system includes an inner catheter 2108 positioned within the lumen of concentrically stacked outer catheters 2106. Outer catheter 2106 is connected to a rotary hemostasis valve 2104. Hemostasis valve 2104 is connected to a syringe 2102 so that fluid injected using the syringe will flow through the lumen between inner catheter 2108 and outer catheter 2106. In the test system, inner catheter 2108 has a diameter of approximately 0.071 inches. Outer catheter 2106 has a diameter of approximately 0.088 inches. Outer catheter 2106 is transparent to allow observation of bubbles within the lumen. The distal end of outer catheter 2108 allows a small volume of fluid to exit the outer catheter. Figure 23A is a photograph showing catheter 2106 and catheter 2108 in a concentric stack prior to injection of fluid. Figure 23D It is the diagram.

[0292] Example 1

[0293] In a first embodiment, syringe 2102 is used to inject water at a constant pressure of approximately 150 psi through hemostasis valve 2104 without moving catheter 2106 or catheter 2108. Figure 23B This is a photograph showing the conduit 2106 and the conduit 2108 after water is injected. Figure 23E is its diagram. Figure 23B As shown, there is an air bubble in the lumen between catheter 2106 and catheter 2108.

[0294] Example 2

[0295] In the second embodiment, a syringe 2102 is used to inject water at a constant pressure of about 150 psi through a hemostatic valve 2104. Shortly after the water injection begins, an axial reciprocating motion of the inner catheter 2108 is performed for about 10 seconds. The reciprocating motion is performed at a frequency of about 1 Hz (or less) and a stroke length of about 20 mm (or more). Figure 23C is a photograph showing catheter 2106 and catheter 2108 after axial reciprocating movement. Figure 23F is its diagram. Figure 23C As shown, the lumen between catheter 2106 and catheter 2108 is substantially free of air bubbles.

[0296] Example 3

[0297] In a third embodiment, an outer conduit with a diameter of approximately 0.071 inches and an inner conduit with a diameter of approximately 0.035 inches were used in a test system 2100, rather than the outer conduit 2106 and inner conduit 2108 described in Examples 1 and 2. A syringe 2102 was used to inject water at a constant pressure of approximately 150 psi through a hemostatic valve 2104 connected to the outer conduit. Shortly after the water injection began, the inner conduit was axially reciprocated for approximately 10 seconds. The reciprocating motion was performed at a frequency of approximately 1 Hz (or lower) and a stroke length of approximately 20 mm (or more). After the axial reciprocating motion, the lumen between the outer conduit and the inner conduit was found to be substantially free of bubbles by visual inspection.

[0298] control system

[0299] Figure 28 A schematic diagram of an example of a control system 4000 is shown that can be used to electronically control the systems and components described herein and / or perform the methods described herein. The control system 4000 can be configured to automatically adjust various motors, hub adapters, hubs, interventional devices, fluidics components (e.g., valves, pumps, etc.), and / or any other components described herein in response to command input by an operator (e.g., a physician). In response to the operator's command input, the control system 4000 can automatically cause a series of response events to occur.

[0300] In certain embodiments, the control system 4000 may include one or more processors 4002. The one or more processors 4002 may be configured to automatically adjust various system components described herein in response to operator command input, for example, using one or more controls 4004 of the control system 4000. Figure 28 4004. However, any suitable number of controls may be provided to correspond to the various functions of the systems described herein. For example, in certain embodiments, each interventional device may have its own unique control 4004 or a set of controls 4004 that may control various functions of the interventional device (e.g., axial movement, rotational movement, fluid supply (e.g., saline, contrast agent, etc.), aspiration, etc.).

[0301] In certain embodiments, one or more controls 4004 can control a priming function of one or more interventional devices. For example, one or more controls 4004 can be operated to cause the interventional device to perform a priming procedure, such as by 20A to 20CFor example, one or more controls 4004 can be operated to cause one or more interventional devices to move axially relative to one or more other interventional devices (e.g., by causing a corresponding hub and / or hub adapter to move axially). One or more controls 4004 can be operated to cause fluid to be introduced into a lumen of an interventional device, thereby priming the interventional device.

[0302] In certain embodiments, one or more controls 4004 can be operated to cause the interventional device to undergo a priming procedure, such as by Figures 21A to 21B For example, one or more controls 4004 can be operated to cause one or more interventional devices to reciprocate (e.g., axially and / or rotationally) relative to one or more other interventional devices (e.g., by reciprocating corresponding hubs and / or hub adapters). One or more controls 4004 can be operated to cause fluid to be introduced into the lumen of the interventional device to prime the interventional device (e.g., during relative reciprocation).

[0303] The processor 4002 can receive signals from one or more controllers 4004 and, in response, initiate corresponding actions in the components of the system herein. For example, the processor 4002 can be configured to generate output signals that cause the corresponding actions to be performed by the components herein.

[0304] Although the foregoing describes robotically driven interventional devices and manually driven interventional devices, these devices can be manually driven, robotically driven, or any combination of manually and robotically driven interventional devices, as will be understood by those skilled in the art in light of the disclosure herein.

[0305] The foregoing describes one specific embodiment of a robotic control system. A variety of different robotic control system configurations can be made for supporting and axially advancing and retracting two, three, four, or more components to robotically drive an interventional device, as will be understood by those skilled in the art in light of the disclosure herein.

[0306] Although the foregoing describes an interventional device driven by a drive stage, other suitable robotic drive systems or mechanisms may be used to drive the interventional device, as will be understood by those skilled in the art in view of the disclosure herein.

[0307] Various systems and methods are described herein primarily in the context of neurovascular access or surgery (e.g., neurothrombectomy). However, the catheters, systems (e.g., drive systems), and methods disclosed herein can be readily adapted for use in any of a wide variety of other diagnostic and therapeutic applications throughout the body, particularly including endovascular procedures, such as those in the peripheral vascular system (e.g., deep vein thrombosis), the central vascular system (pulmonary embolism), and the coronary vascular system, as well as procedures in other hollow organs or tubular structures in the body.

[0308] In any embodiments disclosed herein, the robotic drive system may further include a magnet (also referred to herein as a driven magnet) on each of the one or more hubs, including but not limited to on the guidewire hub, on the entry catheter hub, and on the guide catheter hub. Each of the driven magnets can be configured to cooperate with a corresponding drive magnet located on each of the one or more hub adapters. In some embodiments, the system can be configured so that the driven magnet moves in response to the movement of the corresponding drive magnet. In some embodiments, the system can be configured to have a magnet on one of the hub and the hub adapter, and an iron object on the other of the hub and the hub adapter. In some embodiments, the drive magnets can each be independently carried by the support table for axial movement. In some embodiments, but not limited to, the drive magnet can be located outside the sterile field, separated from the drive magnet by a barrier, and the driven magnet can be located within the sterile field. The barrier can include a tray made of a thin polymer film or a film of any non-ferromagnetic material or other material.

[0309] In any embodiment disclosed herein, one or more or each of the magnets may 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 may be a rare earth magnet, a neodymium magnet, an anisotropic ferrite magnet, or other magnet. In any embodiment disclosed herein, one or more or each of the magnets may include a rare earth magnetic material, a neodymium magnetic material, an anisotropic ferrite, or other material.

[0310] In some implementations, one or more of the hubs and / or hub adapters disclosed herein may have one or more magnets that can be used in conjunction with a magnetic field sensor to provide information to a user of the system regarding the position of the hub relative to the corresponding hub adapter, information regarding the forces applied to the hub, and other information. More details on this are provided below.

[0311] Force and joint sensors: In some embodiments, any hub or small circular element 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, surgical catheter hub 2912, and guide catheter hub 2914) and / or hub adapter (e.g., hub adapter 48) can include any of a variety of sensors to measure parameters associated with the hub, instruments connected to the hub, etc. Such parameters can include, for example, but not limited to, the force applied to the hub and / or the displacement of the hub relative to its corresponding hub adapter. In some embodiments, the parameters can include the magnitude and / or direction of the magnetic field.

[0312] The robotic control system can use these parameters to determine the state or condition of one or more of the hub, hub adapter, hub / hub adapter pair, interventional device, and / or robotic control system, or to determine the occurrence of an event during a procedure. For example, as described herein, the parameters can be used to determine displacement or separation between the hub and the hub adapter, excessive forces on the interventional device and / or hub, excessive forces (e.g., friction) between the interventional devices, excessive energy storage in the interventional device, etc. In some embodiments, the parameters of multiple hubs, hub adapters, hub / hub adapter pairs, and / or interventional devices can be compared to determine the state or condition of one or more of the hub, hub adapter, hub / hub adapter pair, interventional device, and / or robotic control system, or to determine the occurrence of an event during a procedure.

[0313] 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, y, and z directions). In some embodiments, the magnetic field measurements can be used to determine the magnitude and / or direction of the displacement of the hub relative to the corresponding hub adapter (e.g., based on the measured magnetic field vector or a change in the measured magnetic field vector).

[0314] In some embodiments, one or more magnetic field sensors can be used to measure the magnetic field strength of the magnetic connection between the hub and the corresponding hub adapter. In some embodiments, one or more magnetic field sensors can be located on the hub or the hub adapter and can be 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 the hub adapter (i.e., the other component that does not have a magnetic field sensor). For example, but not limited to, the magnetic field sensor can be located on any one or all of the hub adapters, and the magnet that generates the magnetic field sensed by the magnetic field sensor can be located at a certain position on any one or all of the corresponding hubs (e.g., a position aligned with the position of the magnetic field sensor) so that when the hub is in a desired position aligned with the hub adapter, the magnetic field of the magnet will be sensed by the magnetic field sensor. In any embodiment of the robotic control system disclosed herein, the magnet that generates the magnetic field sensed by the magnetic field sensor can be a magnet that is different from the driving magnet and different from the driven magnet. In some embodiments, the magnet that generates the magnetic field sensed by the magnetic field sensor can also be used for other purposes, such as, but not limited to, transmitting axial force from one or more hub adapters to the corresponding hub.

[0315] In any of the embodiments disclosed herein, the magnet that generates the magnetic field sensed by the magnetic field sensor may be a disk-shaped magnet (for example, but not limited to, Figure 29A 8006 shown in FIG), cylindrical magnets, annular magnets (such as but not limited to, Figure 29B ), or any other suitable type of magnet. Ring-shaped magnets are also referred to herein as annular magnets. In some embodiments, one or more magnets (e.g., annular magnets) that generate a magnetic field sensed by a magnetic field sensor may have an opening or hole through its center in the axial direction and a circular shape at the periphery of the magnet. In any embodiments disclosed herein, the driving magnet of at least one hub adapter and the driven magnet of the corresponding hub may be annular magnets. In any embodiments disclosed herein, the driving magnet of each hub adapter and the driven magnet of the corresponding hub of the robotic control system may be annular magnets.

[0316] In certain embodiments with a ring magnet, when the ring magnet passes by a magnetic field sensor (e.g., from above), the ring magnet can provide additional information about the magnet's position relative to the sensor. In certain embodiments with a ring magnet, the ring magnet can be magnetized radially or concentrically. For example, but not limited to, the magnet's north pole can be located at the innermost portion of the ring magnet, and the ring magnet's north pole can be surrounded by a south pole, so that the outermost perimeter of the ring magnet can be a south pole. Conversely, in some embodiments of the ring magnet, the magnet's south pole can be located at the innermost portion of the ring magnet, and the ring magnet's south pole can be surrounded by a north pole, so that the outermost perimeter of the ring magnet can be a north pole. Knowing the polarity of the ring magnet allows for the collection of additional information not provided by a solid cross-section magnet. For example, the system can be configured to collect polarity information to obtain additional information about the magnet's position relative to the sensor. For example, in such an embodiment, when the ring magnet passes by a magnetic field sensor (e.g., from above), the magnetic field sensor can detect the orientation of the magnetic field. Knowing the polarity of the ring magnet, this information can be used to determine the magnet's position relative to the sensor. In some embodiments, orientation information can be used along with magnetic field strength information to determine the position of the magnet relative to the sensor. In other embodiments, the ring magnet can have a selectable magnetization direction that can provide information about the magnetic field orientation to the magnetic field sensor, which can be used to determine the position of the magnet relative to the sensor. For example, in some embodiments, the ring magnet can be magnetized radially. In some embodiments, other magnets, such as disk magnets, can have a magnetization direction that provides information about the magnetic field orientation to the magnetic field sensor, which can be used to determine the position of the magnet relative to the sensor.

[0317] In any embodiments disclosed herein, the hub and the corresponding hub adapter can each have a magnet, each magnet being configured to attract a magnet of the other of the hub and the hub adapter. Alternatively, in any embodiments disclosed herein, the hub or the corresponding hub adapter can have a magnet, and the other of the hub and the hub adapter can have a ferromagnetic object configured to magnetically connect with the magnet.

[0318] In any embodiment, one or more sensors can be used to measure the magnetic field strength between the magnets of the hub and hub adapter pair, or between the magnets and a ferromagnetic object. In some embodiments, the magnetic field magnitude (or magnetic field vector magnitude) of the magnetic field between each magnet of the hub and hub adapter pair, or between the magnets and the ferromagnetic object, can be measured in a baseline position to determine and establish a baseline magnitude (or baseline vector magnitude) of the magnetic force between the hub and hub adapter for each hub and hub adapter pair. For example, but not limited to, when the hub and hub adapter are in a baseline position, such as when the hub and hub adapter are aligned in the axial direction, the baseline magnitude (or baseline vector magnitude) can be the magnitude (or set of baseline vector magnitudes) of the magnetic field of the hub and hub adapter pair. In some embodiments, the baseline position can be the position of the hub and hub adapter when the hub and hub adapter are magnetically connected to each other and no external forces other than the magnetic connection force (or, in some embodiments, when no other significant external forces are acting on the hub or hub adapter). The baseline magnitude (or set of baseline vector magnitudes) can be the highest value of the magnetic field strength for each pair.

[0319] In some embodiments, the system can be configured to determine or roughly estimate the displacement of the hub relative to the 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 the baseline magnitude (or baseline vector size group) of the magnetic connection force (i.e., baseline magnitude minus actual magnetic field magnitude, referred to herein as ΔF). In some embodiments, empirical data can be collected regarding the difference between the actual magnetic connection force magnitude (or vector magnitude) and the baseline magnitude (or baseline vector size group) of the magnetic connection force within a range of displacement positions. In some embodiments, these values ​​can be stored in a lookup table. This information can be used to determine the position or displacement of the hub adapter relative to the corresponding hub (i.e., ΔP value) based on the ΔF value.

[0320] In some embodiments, the system can be configured to have a lookup table of data that represents the displacement values ​​between the corresponding hub and hub adapter relative to the difference between the corresponding magnetic connection force magnitudes (or vector magnitudes). The lookup table can also have data related to the baseline magnitude (or set of baseline vector magnitudes) of the magnetic connection force. In some embodiments, the lookup table can be based on empirical data for hub and hub adapter pairs, the empirical data being derived from actual measurements of the displacement between the corresponding hub and hub adapter relative to the difference between the corresponding magnetic connection force magnitudes (or vector magnitudes) and the baseline magnitude (or set of baseline vector magnitudes) of the magnetic connection force.

[0321] In some embodiments, the mapping of magnetic field vector data to displacement is not disturbed by friction between the hub and the sterile barrier.

[0322] In some embodiments, the system can be configured to determine or roughly estimate the external force applied to the hub. For example, but not limited to, the external force can be determined based on the difference between the measured magnetic force magnitude (or vector magnitude) between the hub and the hub adapter and the baseline magnitude (or baseline vector size group). Thus, 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 measured difference and the baseline magnetic field vector). Therefore, as mentioned above, in some embodiments, 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 the measured change in the magnetic field vector).

[0323] 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 no hub is connected to the hub adapter. The system can be configured to determine that the hub is connected 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 baseline vector magnitude group). In some embodiments, the system can be configured to determine or roughly estimate the displacement of the hub relative to the hub's baseline position (referred to herein as ΔP or offset distance) or the external force applied to the hub based at least in part on the hub adapter baseline magnetic field magnitude (or baseline vector magnitude group), 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 baseline vector magnitude group). In other embodiments, a hub baseline magnetic magnitude (or baseline vector magnitude group) can be determined when the hub is not connected to the hub adapter, and the hub baseline magnetic magnitude can be used in the same or similar manner as the hub adapter baseline magnetic field magnitude (or hub adapter baseline vector magnitude group). The data from the sensor can be used to determine other characteristics of the system, such as whether the hub has contacted and is pushing against the other hub and / or whether the hub is magnetically tethered to the hub adapter. For example, whether the hub has contacted and is pushing against the other hub and / or whether the hub is magnetically tethered 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.

[0324] In some embodiments, force measurements and / or magnetic field magnitude and / or direction measurements from one or more sensors can be used to determine that movement of one or more hubs has been impeded or blocked. This may be due to tension in fluid lines or electrical wires connected to the hubs (e.g., a fluid line is stuck or stretched), one or more hubs physically contacting another hub or object (e.g., a hub pushing another hub), a malfunctioning condition of the hub, forces acting on an interventional device connected to the hub, and / or other physical impediments to movement of the hub.

[0325] In some embodiments, force measurements and / or magnetic field magnitude and / or direction measurements from one or more sensors may be used to determine that the range of motion of an anti-buckling component (e.g., any anti-buckling component disclosed herein) is approaching a point where the range of motion is out of range or is being exceeded.

[0326] In some embodiments, force measurements and / or magnetic field magnitude and / or direction measurements from one or more sensors may be used to determine that one or more hubs have become detached from a corresponding hub adapter.

[0327] In some embodiments, force measurements and / or magnetic field magnitude and / or direction measurements from one or more sensors can be used to determine that frictional forces inside the body are large or excessive. In any embodiments disclosed herein, the robotic control system can be configured to provide a warning to the user when an abnormal condition (e.g., any abnormal or potentially abnormal condition discussed herein) exists. In some embodiments, the warning can include a visual warning on a graphical user interface or other user interface, an audible warning to the user, tactile feedback, and any combination of the foregoing.

[0328] In some embodiments, active real-time or near real-time force sensing can be used for each interventional device (or a subset of interventional devices) to detect energy storage that may be generated by friction between interventional devices in compression, tension and / or rotational shear. Energy storage can occur in the interventional device, for example, axially due to accumulated friction along the axis of the interventional device. Clinically, this may present various problems. For example, due to accumulated friction along the axis, the desired, commanded motion may not be transmitted to the top of the axis. Moreover, when the friction force is overcome, the stored energy may be released, which may result in significant non-commanded (i.e., unintentional) motion of the axis. In some embodiments, the energy storage can be released by a user performing a corrective action (e.g., using a push / pull technique on one or more interventional devices) to reduce the risk of unintentional, non-commanded motion due to energy release.

[0329] 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., axially in the shaft due to accumulated friction along the axis 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 (e.g., using a control algorithm) the interventional device. For example, but not limited to, some embodiments of the drive system can automatically adjust the interventional device to release energy storage via axial movement of the interventional device in which the amount of stored energy exceeds a threshold.

[0330] In some embodiments, the robotic control system can be configured to perform control functions to mitigate one or more abnormal conditions. For example, some embodiments of the robotic control system can be configured to override user controls of one or more hub adapters to prevent further movement of the one or more hub adapters. In some embodiments, the robotic control system can be configured to override user controls of one or more hub adapters and move the hub adapters, and thereby move a connected or tethered hub (e.g., a first hub) away from another hub that the first hub interferes with, or move the first hub in a direction that reduces forces on the first hub or on a hub that the first hub interferes with.

[0331] In some embodiments, the robotic control system can have one or more sensors in the hub adapter and / or the corresponding hub that are configured to detect whether the hub is connected to the hub adapter. This can include determining whether the hub is magnetically connected to the hub adapter and / or aligned with the hub adapter.

[0332] In some embodiments, the robotic control system may have a sensor, such as but not limited to a magnetometer, located in or connected to the hub adapter to detect the presence and / or magnitude and / or direction of a magnetic field generated by a magnet located in or connected to the hub adapter. In some embodiments, the robotic control system may have a sensor, such as but not limited to a magnetometer, located in or connected to the hub to detect the presence and / or magnitude and / or direction of a magnetic field generated by a magnet located in or connected 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 tethered to the hub adapter.

[0333] In some embodiments, the magnitude and / or direction of the magnetic field generated by a magnet located in the hub or hub adapter can be measured by a sensor to determine the displacement (i.e., offset distance) between the hub and the hub adapter (if any). In some embodiments, the magnitude and / or direction of the magnetic field generated by a magnet located in the hub or hub adapter can be measured by a sensor to determine the amount of force applied to the hub.

[0334] In some embodiments, the sensor may include an RFID reader that is located on or connected to one of the hub and the hub adapter and is configured to interrogate an RFID tag that is located on or connected to the other of the hub and the hub adapter to verify that the hub and the hub adapter are connected (e.g., magnetically connected). For example, in some embodiments, the RFID reader is located on or connected to the hub, and the RFID tag is located on or connected to the hub adapter. In some embodiments, the RFID reader is located on or connected to the hub adapter, and the RFID tag is located on or connected 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 coming from the corresponding hub or hub adapter and not a different magnetic object.

[0335] Features and benefits of force and / or linkage sensors: Some embodiments of the robotic control systems disclosed herein having one or more force and / or connection sensors may have at least the following features or be configured to perform the following functions.

[0336] In some embodiments, the robotic control system can be configured to (e.g., continuously or nearly continuously) measure the magnetic field strength and / or direction between the hub and the hub adapter and provide hub disconnect sensing and / or warnings to the user. For example, if it is determined that the hub will disconnect from the hub adapter at a specific relative displacement value (also referred to herein as a displacement threshold), the robotic control system can be configured to communicate an alert to the user when the relative displacement between the hub and the hub adapter reaches a specific predetermined percentage of the displacement threshold, such as, for example, 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, approximately 60% of the displacement threshold, or less than 60% to 90% of the displacement threshold, 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 percentages.

[0337] Alternatively, if it is determined that the hub will disconnect from the hub adapter at a particular relative force value (also referred to herein as a force threshold or separation force), the robotic control system can be configured to communicate an alert to the user when the net external force acting on the hub reaches a predetermined percentage of the separation force, such as, for example, 70% of the separation force, approximately 70% of the separation force, 80% of the separation force, approximately 80% of the separation force, 60% of the separation force, or approximately 60% of the separation force or less than 60% to 90% of the separation force or approximately 90% of the separation force or more than 90% of the separation force, or any value within any of the foregoing ranges, or other suitable predetermined percentages.

[0338] In some embodiments, the robotic control system can be configured to increase the intensity of the alert to the user as the relative displacement value or the net external force on the hub increases, such as by increasing the size of the alert symbol (which can be a triangle, arrow, or any other desired shape), increasing the hue or opacity of the alert symbol, changing the color of the alert symbol, increasing the volume level or changing the pitch of an audible warning, and / or providing other alert levels.

[0339] In some embodiments, if the hub adapter and / or hub are moving at a higher speed, the robotic control system can be configured to warn the user of the risk of disconnection between the hub and the 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 disconnection) or a lower value of the net external force acting on the hub (e.g., 50% of the separation force, approximately 50% of the separation force). This can allow the user more time to react to mitigate relative displacement or other problems.

[0340] In addition, in some embodiments, 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 60% or approximately 60% of the displacement threshold or less than 60% to 90% or approximately 90% of the displacement threshold or more than 90% of the displacement threshold, or any percentage within any of the foregoing ranges), the robotic control system can be configured to hinder movement of the hub adapter by increasing resistance on the hub adapter and / or by slowing movement of the hub adapter. In some embodiments, if the relative displacement reaches a second threshold value (e.g., 90% or approximately 90% of the total allowable relative displacement before disconnection), the robotic control system can increase such resistance or further slow movement of the hub adapter, etc.

[0341] Similarly, in some embodiments, if the net external force acting on the hub reaches a threshold value (e.g., 80% or approximately 80% of the separation force, or 70% or approximately 70% of the separation force, or 60% or approximately 60% of the separation force or less than 60% to 90% or approximately 90% of the separation force or more than 90% of the separation force, or any percentage within any of the foregoing ranges), the robotic control system can be configured to hinder movement of the hub adapter by increasing resistance on the hub adapter and / or by slowing movement of the hub adapter. In some embodiments, if the net external force acting on the hub reaches a second threshold value (e.g., 90% or approximately 90% of the separation force), the robotic control system can increase such resistance or further slow movement of the hub adapter, etc. In some embodiments, if the net external force acting on the hub reaches a threshold value, the robotic control system can be configured to hinder movement of the hub adapter in a direction that will increase the net external force acting on the hub.

[0342] As previously described, some embodiments of the robotic control system disclosed herein can be configured to (e.g., continuously or nearly continuously) measure 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 (e.g., continuously or nearly continuously) measure the magnetic field strength and / or direction between the hub and the hub adapter and provide a warning of excessive force (e.g., excessive insertion force) and / or take other corrective actions. For example, the corrective action can include preventing the hub adapter from moving further in a direction that will increase the external force on the hub or interventional device, moving the hub adapter in a direction that will 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 corrective actions to the user to reduce the load on one or more hubs.

[0343] In some embodiments, the robotic control system can be configured to communicate an alert to the user if the axial force applied to the hub is greater than 2N, greater than approximately 2N, greater than 3N, greater than approximately 3N, greater than 5N, greater than approximately 5N, greater than 10N, greater than approximately 10N, greater than 15N, greater than approximately 15N, or any other suitable value.

[0344] Some embodiments of the robotic control system disclosed herein can be configured to (e.g., continuously or nearly continuously) measure the magnetic field strength and / or direction between the hub and the hub adapter and provide real-time or nearly instantaneous force data to a user. In some embodiments, the robotic control system can be configured to (e.g., continuously or nearly continuously) measure the magnetic field strength and / or direction between the hub and the hub adapter and provide data (e.g., real-time or nearly instantaneous data) about the force applied to an interventional device (e.g., a catheter or guidewire) connected to the hub. In some embodiments, the robotic control system can be configured to (e.g., continuously or nearly continuously) measure the magnetic field strength between the hub and the hub adapter and provide data (e.g., real-time or nearly instantaneous data) about the magnitude of the axial torque established in an interventional device (e.g., a catheter (such as an insertion catheter or access catheter) or a guidewire) connected to the hub. In some embodiments, torque can be measured by measuring the change in the magnetic field (e.g., the magnitude of the magnetic field) in a direction perpendicular to the axis of the shaft.

[0345] Some embodiments of the robotic control systems disclosed herein having one or more force and / or connection sensors can have at least the following benefits. In some embodiments, the robotic control system can determine whether the hub is close to being disengaged from the corresponding hub adapter (i.e., magnetically disconnected), so that an appropriate warning can be conveyed to the user and / or corrective action can be taken. In some embodiments, the robotic control system can determine whether the hub has been disengaged from the corresponding hub adapter (i.e., magnetically disconnected), so that an appropriate warning can be conveyed to the 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, so that an appropriate warning can be conveyed to the user and / or corrective action can be taken. In some embodiments, the robotic control system can be configured to determine whether the insertion force acting through the magnetic connection exceeds a predetermined threshold, so that an appropriate warning can be conveyed to the user and / or corrective action can be taken.

[0346] Some embodiments of the robotic control systems disclosed herein can be configured to detect predetermined patterns associated with undesirable clinical conditions (e.g., for one or more hubs / interventional devices) and provide warnings and / or take other corrective actions. For example, if a pattern is identified indicating that adjacent interventional device axes are simultaneously subjected to forces in opposite directions, the system can provide a warning or automatically take corrective action, such as by unloading one or both interventional devices to reduce the energy storage generated by the frictional interaction between them.

[0347] As described, in some embodiments, the robotic control system can be configured to perform magnetic force sensing on multiple hub / hub adapter combinations. In some embodiments, the robotic control system can analyze (e.g., compare) data from multiple hub / hub adapter pairs (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) to determine the state or condition of one or more hub / hub adapter pairs, one or more interventional devices, or the robotic control system, or to determine the occurrence of one or more events during a procedure. For example, if the system determines that the force acting on a first hub (e.g., hub 2914) is of the same or similar magnitude and opposite direction to the force acting on a second hub (e.g., hub 2912), the system can determine that there is a significant amount of friction between the interventional device (e.g., guide catheter 2906) connected to the first hub and the interventional device (e.g., surgical catheter 2904) connected to the second hub. As another example, if the system determines that the force acting on each hub of the interventional device assembly increases as the interventional device assembly is inserted into a more distal and tortuous vasculature, friction in the vasculature can be determined to be the source of the additional force acting on the hubs.

[0348] In addition, in some embodiments, having force and / or displacement data associated with one or more of the hub and hub adapter pair can provide useful information to assist during setup of the device prior to surgery. For example, but not 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., such as 20% of a displacement threshold, approximately 20% of a displacement threshold, 10% of a displacement threshold, approximately 10% of a displacement threshold, 10% of a displacement threshold, or approximately 10% of a displacement threshold, or less than 10% to 30% of a displacement threshold, or approximately 30% of a displacement threshold, or more than 30% of a displacement threshold, or any value within any of the foregoing ranges, or other suitable predetermined percentages).

[0349] Additionally, in some embodiments, one or more sensors can be used to determine whether the hub is correctly oriented relative to the hub adapter and provide a warning or other output configured to hinder or prevent use of the system until the error condition is corrected. In some embodiments, the robotic control system can be configured to identify to a user or operator which hub may be outside a range or tolerance in terms of relative displacement relative to the corresponding hub adapter, orientation relative to the hub adapter, which hub may be outside a pre-operatively set range or tolerance for the net force acting on the hub, or other parameters. In some embodiments, the robotic control system can be configured to indicate to the user or provide feedback to the user to help the user 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. Furthermore, some embodiments of the robotic control system can be configured to assess and provide feedback to the user that the relative displacement, net external force, and / or orientation of the hub relative to the hub adapter are within acceptable ranges or values, that initial setup has been completed correctly, and / or that other operating parameters of the robotic control system are within acceptable ranges (e.g., within predetermined ranges or thresholds).

[0350] Measure the deflection between the hub and the hub adapter and the force applied to the hub: As described herein, some embodiments of the robotic control system can have sensors in the hub adapter and / or the hub that are configured to measure forces applied to the hub. In some embodiments, and as described herein with respect to some embodiments, magnetic field vector data can be used to calculate the forces acting on the hub based on the magnetic connection between the hub and the hub adapter and / or individual external forces acting on the hub. In some embodiments, the calculated force (if not equal to the net resultant force) can be proportional to the net resultant force of all external forces acting on the hub.

[0351] Calculating the force applied to the hub can help prevent the hub from becoming dislodged from the hub adapter or becoming uncoupled from the hub adapter, which can occur if movement of the hub is restricted or impeded but the hub adapter continues to move relative to the hub.

[0352] In some embodiments, when the hub and hub adapter are connected, the user can feel (eg, via tactile feedback) resistance to movement of the hub adapter relative to the hub due to magnetic forces between the hub and hub adapter.

[0353] In some embodiments, the sensor (which may be a magnetometer) can continuously (or nearly continuously) measure the magnitude and / or direction of the magnetic field (e.g., by measuring the magnetic field vector). In some embodiments, the sensor can provide continuous (or nearly continuous) feedback to the user of the offset between the hub adapter and the hub and / or the magnitude and / or direction of any external forces applied to the hub.

[0354] Any embodiment of the robotic control system disclosed herein can include a magnetometer device in the hub adapter or the hub and a corresponding magnet (e.g., a rare earth magnet) in the other of the hub adapter and the hub. Based on the change in magnetic field strength detected by the magnetometer, the relative displacement of the hub and the hub adapter can be characterized. In certain embodiments, data related to the magnetic field strength and / or direction generated by the magnet in opposition to the magnetometer can be used in certain embodiments to measure the vertical or horizontal displacement of the hub relative to the hub adapter.

[0355] Figure 24 8004b.

[0356] In some embodiments, the magnetic connection 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 connection between the hub 2910 and the hub adapter 8004. Due to the elastic nature of the connector, the magnetic connector can be shaped like a spring connector, such as Figure 25 As shown, Figure 25 A schematic representation of a hypothetical system with a spring located between the hub 2910 and the hub adapter 8004 is shown.

[0357] exist Figure 24 and Figure 25 The relative displacement 8020 between the hub 2910 and the hub adapter 8004 in the z direction (i.e., the proximal-distal direction or axial direction of hub movement) is represented by Δz. Figure 24 As shown, the relative displacement 8020 between the hub 2910 and the hub adapter 8004 can be caused by the force acting on the hub 2910. F 毂 and / or forces acting on the hub adapter 8004 F 适配器 cause.

[0358] In some embodiments, the magnetometer can be configured to measure the magnetic field strength in the direction of axial movement of the hub 2910 (ie, parallel to Δz). In some embodiments, the force acting on the hub 2910 F 毂 It can be represented by the following equation:

[0359] where Δz is the relative displacement of a fixed point on the hub 2910 relative to a fixed point on the hub adapter 8004, 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 related to B z Directly proportional.

[0360] As mentioned above, to some extent, movement of the hub adapter can result in relative displacement between the hub and the hub adapter in the z-direction. This relative displacement can result in a magnetic connection force that can cause the hub to move toward the hub adapter in the z-direction. In other cases, external forces can act on the hub and the device attached to the hub, which can result in relative displacement between the hub and the hub adapter along the z-direction. In those cases, the magnetic connection force can be increased to balance the external force. However, in the event that an external force is applied to the hub, there may be relative displacement between the hub and the hub adapter in the z-direction due to the external force. In some embodiments, the amount of relative displacement will depend on factors such as the magnitude of the external force.

[0361] Also note that even if Figure 24 While magnets are shown coupled to the hub 2910 and the hub adapter 8004, some embodiments of the system may be configured such that only the hub 2910 includes a magnet. The hub adapter 8004 may support a sensor (which may be a magnetometer, as discussed) and may be configured to couple to the hub without a second magnet in the hub adapter 8004.

[0362] In some embodiments, the hub adapter 8004 and the hub 2910 can be configured such that the hub 2910 can withstand a force (e.g., in an axial direction) 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 disengaging from the hub adapter 8004.

[0363] Although the reference Figure 24 and 25 Hub 2910 and hub adapter 8004 are described, but those skilled in the art will appreciate that any hub 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 described herein) may be used interchangeably. Figure 26Ashown) can operate in the same or similar manner.

[0364] In some embodiments, different interventional devices and / or different hubs can be configured to detach from corresponding hub adapters with different amounts of force (eg, can have different threshold shear forces).

[0365] In any embodiments disclosed herein, the robotic control system may include additional electronic components along with the magnetometer, including but not limited to a microcontroller (which may be an Arduino-IDE programmable board), a power supply for supporting 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 directly connected to a workstation or any other desired equipment, and / or a data processor configured to receive data from the magnetometer and perform calculations based on the data from the magnetometer.

[0366] Some embodiments of the system can have a processor (e.g., a separate, independent computer) configured to communicate with one or more sensors of the system. The processor can be configured to transmit sensor data from a second processor of the system. In some embodiments, the system can be configured to have only a single processor.

[0367] Some embodiments will be configured to execute programs and have appropriate software to perform at least the functions disclosed herein. For example, but not limited to, some embodiments of the systems disclosed herein can be configured to have and execute a noise reduction algorithm, an algorithm configured to determine the position of the hub adapter and / or hub in the z direction (for any hub and / or hub adapter of the system), an algorithm configured to calculate the relative displacement between the hub and the hub adapter in the z direction based on the raw magnetic field vector data (for any hub of the system), an algorithm configured to calculate the external force on the hub (for any hub of the system, for example, based on the raw magnetic field vector data), an algorithm configured to calculate the connection force between the hub and the hub adapter (for example, based on the raw magnetic field vector data), an algorithm configured to provide an alarm or warning to the user when a threshold or condition (e.g., a relative displacement or external force threshold) 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 system disclosed herein can have a controller programmed to execute any one or any combination of the aforementioned algorithms.

[0368] Some embodiments of the robotic control system may have signal boosters and / or noise reduction or noise suppression components to improve the data from the sensors. Additionally, a host computer or computing device may be configured to communicate with each sensor (including the magnetometer) in the robotic control system and output such data from the sensors to a user display, memory storage device, and / or other device.

[0369] In some embodiments, the robotic control system can be configured to provide a warning to the user when the axial torque at the proximal end of one or more interventional devices is above a threshold value. In some embodiments, such axial torque can be calculated by using a torque sensor to collect data related to the reaction torque on the end of the interventional device (e.g., an insertion member or access catheter) or a motor drive mechanism, as an example.

[0370] Figure 26A A schematic diagram of an exemplary embodiment of a portion of a robotic control system 8000 is shown showing a guidewire hub 2909, an access catheter hub 2910, a surgical catheter hub 2912, and a guide catheter hub 2914 magnetically connected to a plurality of hub adapters 8004a, 8004b, 8004c, and 8004d, respectively. Figure 26A As shown, the hub is separated from the hub adapter by a sterile barrier 8044.

[0371] like Figure 26A As shown, hub 2910 can be connected to or include hemostasis valve 8046a to accommodate the introduction of guidewire 2907 therethrough. Hub 2912 can be connected to or include hemostasis valve 8046b to accommodate the introduction of access catheter 2902 and / or guidewire 2907 therethrough. Hub 2914 can be connected to or include hemostasis valve 8046c to accommodate the introduction of surgical catheter 2904, access catheter 2902, and / or guidewire 2907 therethrough.

[0372] Any hub of any embodiment disclosed herein, including but not limited to Figure 26A The first hub 2909, the second hub 2910, the third hub 2912, and / or the fourth hub 2914 shown can have one or more magnets connected thereto, such as, but not limited to, magnets 8006a, 8006b, 8006c, and 8006d, respectively. In some embodiments, one or more magnets on each hub and hub adapter pair can be used to generate a magnetic field between the hub adapter and the hub, and the system can be configured so that movement of the hub adapter causes the hub to move due to the magnetic field between the hub and the hub. The magnetic connection can be used in any embodiment of the robotic control system disclosed herein so 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 a patient's body).

[0373] Although Figure 26A, four hubs and four hub adapters are shown, but any embodiment of the robotic control system disclosed herein can have one, two, three, five, or more of each of the hubs and hub adapters, whether paired or unpaired. In other words, some embodiments of the robotic control system disclosed herein can have more hubs than hub adapters.

[0374] In some embodiments, each hub and hub adapter pair may have a sensor. Figure 26A As shown, the robotic control system 8000 can have multiple sensors 8010a, 8010b, 8010c, and / or 8010d. In any embodiments disclosed herein, the "sensors" of each pair of hubs and hub adapters can include multiple sensors. For example, but not limited to, the multiple sensors can include any combination of the following: one or more magnetic field sensors, one or more magnetic induction 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 (for example, but not limited to, a current sensor configured to determine the load value of the motor for any drive component of the hub adapter, such as a motor for a rack and pinion or other linear actuator). Such sensors can be sensors that include any details of any sensor disclosed herein or known in the art, or can have any details of any sensor disclosed herein or known in the art. In some embodiments, each hub and hub adapter pair, or any one 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 (for example, but not limited to, a magnetometer) and another secondary sensor. Any sensor disclosed herein can be configured to determine one or more of the following parameters, or any combination of the following parameters, or all of the following parameters: the relative displacement between the hub and the corresponding hub adapter, the direction of the displacement of the hub relative to the corresponding hub adapter, the net force applied to the hub and / or hub adapter, and / or the net force vector applied to the hub and / or hub adapter. In some embodiments, the secondary sensor can be any type of sensor disclosed herein. In some embodiments, auxiliary sensors can be used to collect redundant or additional, unique data.

[0375] As mentioned above, some embodiments of the robotic control system can have an inductive sensor (e.g., an inductive position sensor). In some embodiments of the robotic control system in which a hub and hub adapter pair have an inductive sensor, the sensor can be located on one or the other of the hub and the hub adapter and can be configured to emit an electromagnetic field from a surface of the sensor. For example, but not limited to, the inductive sensor can be located on the hub adapter and can have a major surface configured to face the hub, which can emit a magnetic field. A metal target can be positioned at a specified location on the other of the hub and the hub adapter, in this non-limiting example, the metal target is positioned on the hub. The metal target can be configured to disrupt the electromagnetic field detected by the sensor. In some embodiments, the target metal can have any shape or size suitable for positioning on the hub or the hub adapter. In some embodiments, the target metal will be positioned on the hub.

[0376] The positions of the sensor and the metal target on the hub and hub adapter will be known. Using this information and based on the parameters of the magnetic field that the sensor is able to detect and collect, the system can determine the presence of an offset between the hub and the hub adapter and, if applicable, the relative offset distance between the hub and the hub adapter. In any embodiment, the inductive sensor can be shielded or unshielded, normally open or normally closed, an NPN configuration (a positively doped semiconductor medium is located between two negatively doped materials), or a PNP configuration (a negatively doped semiconductor medium is located between two positively doped materials), and / or have any other details or features known in the industry or to a person of ordinary skill in the art. In some embodiments, the inductive sensor can include one or more coils or antennas and a microcontroller unit and / or other processing electronics.

[0377] As mentioned above, in some embodiments, any of the sensors 8010a to 8010d can include a magnetic sensor or can be a magnetic sensor, such as a magnetometer. In some embodiments, any of the sensors 8010a to 8010d can be configured to measure a range of parameters, including but not limited to the magnetic field strength and / or direction of one or more magnets (e.g., magnets 8006a to 8006d) from the robotic control system. For example, each sensor 8010a to 8010d can be configured to measure the magnetic field strength and / or direction from a corresponding magnet 8006a to 8006d within a hub and hub adapter pair of which the sensors 8010a to 8010d are part.

[0378] Each of the sensors 8010a-8010d can be configured to determine the relative displacement or offset between a corresponding hub and hub adapter pair (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 the sensors 8010a-8010d can be configured to determine the magnitude of the force applied to the corresponding hub 2909, 2910, 2912, and 2914 based on the strength and / or direction of the magnetic field from the corresponding magnet 8006a-8006d, as discussed above.

[0379] In some embodiments, any one of sensors 8010a to 8010d can be a three-axis magnetometer. In some embodiments, such a magnetometer can be configured to detect magnetic field strength in the x, y, and z directions. In some embodiments, magnetic field strength and / or direction values ​​can be used to determine the 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, magnetic field strength and / or direction values ​​can be used to determine the force on the magnetic connection 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, magnetic field strength and / or direction values ​​can be used to determine the force acting on the corresponding hub.

[0380] In some embodiments, the magnetometer may have a 16-bit output proportional to the magnetic flux density sensed along the XYZ axis and, in some embodiments, also a temperature output signal. Any of the sensors 8010a to 8010d may be configured to be sensed via I 2 C and SPI provide digital values, where sensors 8010a to 8010d are slave devices on the bus. In some embodiments, any of the sensors 8010a to 8010d can be programmed to have any desired duty cycle range, such as, but not limited to, a range of 0.1% to 100%. In some embodiments, any of the sensors 8010a to 8010d can be configured to acquire and provide force and / or displacement information to a user only when the sensor 8010a to 8010d detects a specific force and / or displacement threshold.

[0381] In some embodiments, any of the sensors 8010a to 8010d can be located on a portion (e.g., a center portion) of the corresponding hub adapter 8004a to 8004d or connected to a portion of the corresponding hub adapter 8004a to 8004d. The corresponding magnet 8006a to 8006d (e.g., a strong magnet or a rare earth magnet) can be located on a portion (e.g., a center portion) of the corresponding hub 2909, 2910, 2912, or 2914 or connected to a portion of the corresponding hub 2909, 2910, 2912, or 2914. In some embodiments, the center or center portion of the magnet 8006a to 8006d can be aligned or approximately aligned with the center portion of the corresponding sensor 8010a to 8010d. Displacement can be determined based on the offset between the center portion of the magnet 8006a to 8006d and the center portion of the corresponding sensor 8010a to 8010d.

[0382] Figure 26B An exemplary embodiment of magnetically connecting the hub adapter 8004b and the hub 2910 is shown, which can be used with any embodiment of the robotic control system disclosed herein, including the robotic control system 8000 or Figure 26A Part of an embodiment of a robot control system is shown. Figure 26B The diagram schematically illustrates the range of different forces that can be applied to the hub and the corresponding hub adapter. Figure 26B In the example shown, a range of different forces that can be applied to hub 2910 and hub adapter 8004b is shown. However, those skilled in the art will appreciate that any of the same or similar types of forces can be applied to any of the other hubs described herein (e.g., hubs 2909, 2912, and 2914).

[0383] For example, in some arrangements and in some applications, it may be possible to act on the hub (e.g. Figure 26B The forces on the hub 2910 in the figure may include: 身体 ) acts on an interventional device connected to the hub (e.g., Figure 26B forces on the entry conduit 2902 in the vessel, forces from connected conduits (e.g., Figure 26B Access catheter 2902) or other interventional device (F 导管 ) can act on the hub, the force (F) from the distal hemostatic valve (e.g., hemostatic valve 8046b relative to hub 2910) can act on the interventional device connected to the hub THV ), the distal anti-buckling force (F 抗屈曲 ), the force acting on the hub in the z direction from the hub bearing or roller (F 轴承z) (e.g., friction, inertia, and other resistances), the force (F) acting on the hub from the proximal hemostasis valve (e.g., hemostasis valve 8046a relative to hub 2910), THV2 ) (e.g., from a proximal instrument passing through the proximal hemostasis valve (e.g., from a guidewire 2907 relative to the hub 2910)), a proximal anti-buckling force (F 抗屈曲 ), gravity based on the mass of the hub (F g ), the force from the magnetic field in the y direction (F 磁体y ), the force from the magnetic field in the z direction (F 磁体z ), the force from the bearing or roller acting on the hub in the y direction (F 轴承y ), and / or forces from electrical and / or fluid lines acting on the hub (F 线 ), which can act in the z-direction, y-direction and / or x-direction and any combination of these directions. 导管 It can represent the friction between the device attached to the hub and other devices in contact with it. For example, but not limited to, F 导管 This may include frictional forces from the interaction between the catheter and the hub through which it passes, or from the interaction between the surgical catheter and the guide catheter. 身体 It can represent the net friction between the wall of the vasculature and the device attached to the hub.

[0384] In some embodiments, an anti-buckling support member, such as a telescoping tube, may be provided. The use of these support members may result in traction forces acting on the catheter or guidewire, and / or insertion or retraction forces from the outer surface of the shaft rubbing against the inner surface of the anti-buckling support member. In some embodiments, a distinction may be made between any portion of the anti-buckling system applying an external load to the hub. When the device is loaded in a compressed and buckled state, contact may exist between the device and the inner wall of the anti-buckling member (e.g., a split tube or telescoping tube in some embodiments). 抗屈曲 It may represent forces transmitted through fasteners / interlocking features that attach the anti-buckling component to the device hub, and / or friction between the device and portions of the anti-buckling device (eg, the walls of the extension tube).

[0385] F 保持器 The downward holding force that prevents the magnet in the hub adapter from being pulled vertically into the sterile barrier can be represented by F. 保持器 Counteracting the vertical lift force F from the magnetic connection 磁体y The downward retention force may be provided by any suitable retaining mechanism, such as a screw or other fastener.

[0386] In some arrangements and in some applications, it is possible to act on the hub adapter (e.g. Figure 26BThe forces on the hub adapter 8004b in the embodiment may include, but are not limited to, forces from the magnetic field in the y direction (F 磁体y ), the force from the magnetic field in the z direction (F 磁体z ), the force exerted on the hub adapter from the drive system (F 驱动 ), and / or the force of gravity from the mass of the hub adapter (F g适配器 ).

[0387] Figure 27 10. A wiring schematic diagram that can be used with any embodiment of the robotic control system 8000 disclosed herein is shown. As described above, some embodiments of the robotic control system 8000 can 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 hub adapter having a sensor (e.g., sensor 8010a, 8010b, 8010c, and 8010d) and any other components or features disclosed herein. Each sensor 8010a to 8010d can be a magnetometer. Each sensor 8010a to 8010d can have corresponding power and ground lines 8030a to 8030d, and an integrated circuit (IC) connected to each sensor 8010a to 8010d and the microcontroller 8038. 2 C) Communication lines 8032a to 8032d. Signal booster 8040 may be used to increase the magnitude of the signal from sensors 8010a to 8010d via at least communication lines 8032a to 8032d. Additionally, in some embodiments, the booster may be used to increase the magnitude of the signal from sensors 8010a to 8010d. 2 C signal is split into differential I 2 C signal, thereby reducing noise along long wiring lengths. A USB or other communication line 8042 can be connected to the microcontroller 8038 to provide a communication link with a host controller, computer, input device, etc.

[0388] Note that the hub is also referred to herein as a small circular element. The use of the term hub herein is intended to be synonymous with the term "small circular element." Therefore, any use of the terms hub or disc is intended to be used interchangeably and to refer to the same component. Note that the hub adapter is also referred to herein as a pulley. The use of the term hub adapter is intended to be synonymous with the term pulley. Therefore, any use of the terms hub adapter or pulley is intended to be used interchangeably and to refer to the same component.

[0389] Although certain 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. In fact, the novel methods and systems described herein can be implemented in various other forms. In addition, various omissions, substitutions, and changes can be made to the robot drive systems and methods described herein without departing from the spirit of the present disclosure. The attached claims and their equivalents are intended to cover such forms or modifications that fall within the scope and spirit of the present disclosure. Therefore, the scope of the present invention is limited only by reference to the attached claims.

[0390] Unless incompatible with this specification, features, materials, characteristics or groups described in conjunction with a particular aspect, embodiment or example are to be understood to be applicable to any other aspect, embodiment or example described in that section or elsewhere in this specification. 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 embodiments. Protection extends to any novel one or any novel combination of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one or any novel combination of the steps of any method or process so disclosed.

[0391] In addition, certain features described in this disclosure in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented independently in multiple embodiments or in any suitable subcombination. Furthermore, although the above features may be described as functioning in certain combinations, in some cases, one or more features from the claimed combination may be removed from the combination, and the combination may be claimed as a subcombination or a variation of the subcombination.

[0392] In addition, although operations may be described in the drawings or described in the specification in a particular order, such operations do not need to be performed in the particular order shown or in sequential order, or all operations need not be performed to obtain the desired results. Other operations that are not depicted or described may be included in the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any described operations. In addition, in other embodiments, the operations may be rearranged or reordered. Those skilled in the art will appreciate that, in some embodiments, the actual steps taken in the illustrated and / or disclosed processes may be different from those shown in the figures. Depending on the embodiment, some of the above-mentioned steps may be removed and other steps may be added. In addition, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. In addition, the separation of various system components in the above-mentioned embodiments should not be understood as requiring such separation in all embodiments, and it should be understood that the described components and systems may generally be integrated into a single product or packaged into multiple products.

[0393] For the purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not all such advantages may be achieved according to any particular embodiment. Thus, for example, those skilled in the art will recognize that the present disclosure may be implemented or performed in a manner that achieves one advantage or group of advantages as taught herein without necessarily achieving other advantages as taught or suggested herein.

[0394] Conditional language, such as "can," "could," "might," or "may," unless otherwise specifically stated or understood in the context of use, is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way required for one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without user input or prompting, whether such features, elements, and / or steps are included or will be performed in any particular embodiment.

[0395] Unless specifically stated otherwise, linking language such as the phrase "at least one of X, Y, and Z" should be interpreted differently in conjunction with the context as generally used to convey that an item, term, etc. is any one of X, Y, or Z. Thus, such linking language is generally not meant to imply that certain embodiments require the presence of at least one X, at least one Y, or at least one Z.

[0396] As used herein, the degree language, such as the terms "approximately", "about", "probably" and "substantially" used herein represent values, amounts or features close to the value, amount or feature that still perform the desired function or achieve the desired result. For example, the terms "approximately", "about", "probably" and "substantially" can refer to the amount less than 10%, less than 5%, less than 1%, less than 0.1% and less than 0.01%. As another example, in certain embodiments, the terms "probably parallel" and "substantially parallel" refer to values, amounts or features less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree or 0.1 degrees from completely parallel deviations. Scope disclosed herein also includes any and all overlaps, subranges and combinations thereof, and any specific values ​​within those ranges. For example, the language of "up to", "at least", "greater than", "less than", "between..." etc. includes the numbers listed. As used herein, the numbers and values ​​before terms such as "about" or "approximately" include the numbers listed. For example, "approximately 7 mm" includes "7 mm," and numbers and ranges preceding a term such as "about" or "approximately" should be interpreted as disclosing the numbers and ranges with or without such terms preceding the number or value, such that this application supports protection of numbers, values, and ranges disclosed in the specification and / or claims with or without such terms (e.g., "about" or "approximately") preceding the number, value, or range, e.g., "about two times to about five times" also includes disclosure of a range of "two times to five 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 in this specification, and may be defined by claims presented in this section or elsewhere in this specification or by claims presented in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims and is not limited to the examples described in this specification or during the prosecution of the application, which examples are to be construed as non-exclusive.

Claims

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

2. The robot control system according to claim 1, further comprising a driving magnet and a driven magnet, the driving magnet being connected to the hub adapter and the driven magnet being connected to the hub, wherein The driving magnet is configured to magnetically couple with the driven magnet in an operable 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 driving magnet.

3. The robot control system according to claim 2, wherein: The driven magnet biases the hub to maintain general alignment with the hub adapter in the axial direction when 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 robot control system of claim 1, wherein the sensor is a magnetometer. The robot control system according to claim 1 , wherein the sensor is an inductive sensor. 7 . The robotic control system of claim 1 , wherein the robotic control system is configured to provide a warning when the magnitude of the displacement reaches or exceeds a threshold.

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

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

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

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

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

13. The robotic control system of claim 12 , wherein the corrective action comprises 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 conduits 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 instructing the user to perform actions that will reduce the net external force on the hub.

14. The robotic control system of claim 12, wherein the corrective action comprises 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 connected to the hub adapter across a sterile barrier.

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

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

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

19. The robotic control system of claim 1 , wherein the interventional device is an aspiration catheter, an embolization deployment catheter, a stent deployment catheter, a shunt deployment catheter, a diagnostic angiography catheter, a stent retrieval catheter, a clot retriever, a balloon catheter, a catheter to facilitate percutaneous valve repair or replacement, or an ablation catheter.

20. The robotic control system of claim 1, further comprising a microcontroller electrically connected to the sensor.

21. The robot control system according to claim 1, further comprising: a second hub configured to adjust an axial position of a second interventional device; a second driven magnet connected 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 and 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 The second sensor is connected to the second hub or the second hub adapter and is configured to measure a magnitude of a second magnetic field.

22. The robot control system according to claim 1, wherein: 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.

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

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

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

26. The robot control system according to claim 1, wherein: The system is configured to determine whether the hub has contacted and is pushing against another adjacent hub.

27. The robot control system according to 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 process of the robotic control system.

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

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

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

31. The robotic control system of claim 1 , comprising a controller configured to perform a control function to cause at least movement of 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. The robot control system according to claim 1, wherein: 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 an out-of-range position or that the range of motion of the anti-buckling component is being exceeded.

33. 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. A robot control system comprising: a hub configured to adjust an axial position of the interventional device; a driven magnet connected to the hub; a hub adapter configured to move distally or proximally in an axial direction based at least on input provided by a user of the robotic control system; a driving magnet coupled to the hub adapter and configured to couple with the driven magnet coupled to the hub such that the driven magnet moves in response to movement of the driving magnet; a sensor coupled to the hub adapter, the sensor configured to measure a magnitude of a magnetic field from a 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 a magnitude of the magnetic field measured on the sensor; Wherein, the robotic control system is 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 value comprising a predetermined percentage of the separation force.

35. The robot control system according to claim 34, wherein: The driving 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. The robot control system according to claim 34, wherein: The driven magnet biases the hub to maintain general alignment with the hub adapter in the axial direction when the hub adapter moves in the axial direction.

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

38. The robotic control system of claim 34, wherein the robotic control system is 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. The robotic control system of claim 38, wherein the robotic control system is configured to increase the intensity of the warning by increasing the size of a warning sign displayed by the robotic control system, by increasing the hue or opacity of the warning sign, by changing the color of the warning sign, and / or by increasing the volume level of an audible warning or changing the pitch of the audible warning.

40. The robot control system according to claim 34, wherein: The robotic control system is configured to automatically perform corrective action when a magnitude of a net external force acting on the hub in the axial direction reaches or exceeds the threshold value.

41. The robotic control system of claim 40, wherein the corrective action comprises 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 conduits 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 instructing the user to perform actions that will reduce the net external force on the hub.

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

43. The robot control system according to claim 34, wherein: The robotic control system is configured to resist 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.

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

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

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

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

48. The robotic control system of claim 34, further comprising: a second hub configured to adjust an axial position of a second interventional device; a second driven magnet connected 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 and 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 The second sensor is connected to the second hub or the second hub adapter and is configured to measure a magnitude of a second magnetic field.

49. The robotic control system according to claim 34, wherein: 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.

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

51. The robot control system of claim 34, wherein: The system is configured to determine whether the hub has contacted and is pushing against another adjacent hub.

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

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

54. The robotic control system of claim 34, wherein 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.

55. A method of controlling movement of an interventional device through a sterile barrier, comprising: magnetically coupling a hub on the sterile side of the sterile barrier to a hub adapter on the non-sterile side of the sterile barrier such that, in an operable state, the hub moves in response to movement of the hub adapter; moving the hub in the at least one direction by moving the hub adapter in the at least one direction when the hub is magnetically coupled to the hub adapter; measuring the magnitude of a magnetic field from a magnet connected to the hub using a magnetic field sensor connected to the hub adapter; determining a magnitude of a net external force acting on the hub based on a magnitude of a magnetic field from the magnet connected to the hub; and When the magnitude of the net external force acting on the hub in the at least one direction reaches a threshold value comprising a predetermined percentage of the separation force, a warning is output to a user of the robotic control system.

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

57. The method of claim 55, comprising 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 the threshold.

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

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

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

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

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